[47 Pa.B. 1300]
[Saturday, March 4, 2017]

[Continued from previous Web Page]

Opposed to a 5-day provisional period

 Multiple commentators disapproved of a provisional period as short as 5 days, but did not offer any other recommendation.

 Several commentators stated that a 5-day window period in which to allow parents to submit full immunizations, the next dose or a medical certificate was totally unrealistic, given the fact that that 5-day period was the busiest time within the school year.

 Several commentators stated that the 5-day provisional period was not enough time to give a child all the vaccines needed, let alone multiple doses of the same vaccine. No one should be forced to give their child that many vaccines at once. One commentator stated that it was not healthy to cram the vaccination schedule into 5 days. One commentator stated that there are dangers to receiving too many vaccines too close together, and she would rather keep her child home from school than expose her to that danger. One commentator stated that a child could be ill with a viral illness, and requiring any vaccine, much less multiple vaccines, would add stress to the immune system and misery to the suffering child. The commentator also noted that children with generally fragile health would be extra stressed by having so many vaccines administered within 5 days. Because the point of vaccines is to assure immunity to disease, it makes sense to maximize the success of each dose.

 One commentator stated that the 5-day immunization catch-up window was insufficient. The commentator stated that she vaccinated her children on a delayed schedule and did everything in her power to make sure they had all the legally required immunizations on time, but she was concerned that there was not consideration for parents who chose to space out vaccinations. Instead, a large number of vaccinations might have to be given on the same day. She felt that harsher requirements like these will further isolate people like her who are concerned about the safety of vaccines but still see their importance. She felt this was needlessly burdensome.

 Another commentator stated that the 5-day period was too short because doctors give the shots over a period of months, not in a few days.

 One commentator opposed deleting the provisional period because requiring children to play catch-up when their bodies are not designed to handle an assault of toxins all at once is not in the best interests of children or society. The commentator asked whether the Department would want to get all of these vaccines at once. The commentator stated that this is what would happen as parents and doctors race to meet mandatory deadlines that have nothing to do with safety or health. It could and likely would be disastrous for many families with sick and injured children as a result.

 Another commentator stated that, in her opinion, the vaccine industry had already managed to convince the CDC to schedule an unsafe amount of vaccines in just a few years in a child's life (49 vaccines by 6 years of age). The commentator stated that the shortening of any catch up time is just another way of putting children at risk. The commentator asked that the Department not punish the children. The commentator stated that catching up on all vaccines in 5 days is actually criminal because someone can seriously be hurt doing that. The commentator stated that all vaccines contain some of the following: carcinogens, neurotoxins, retroviruses and foreign, human, animal and insect proteins from a variety of different sources. The commentator stated that this overloaded the child's immune system with too much too fast and will most definitely cause some kind of disease process to begin. The commentator stated that a body needs time to manage and release all those toxins. The commentator asked that the Department not decrease the provisional period. The commentator stated that a child should not be put at risk when it was not necessary to do so.

 The Department has not revised this final-form rulemaking based on the rationale it set out at the beginning of this section. The Department's intention is not to require a child to obtain all vaccinations at the same time on the same date. The Department believes that the number of children lacking all vaccines at school entry are minimal, and those children who have no or very few vaccinations have some type of medical or religious/philosophical exemption. To the extent there are no grounds for an exemption, either medical or religious/philosophical, presumably parents and guardians are acting responsibly, taking the medical advice of their primary care practitioners and are giving their children vaccinations on schedule. If a child does lack immunizations upon school entry or for continued attendance, the child may enter school and attend school so long as the child has at least one dose of a multidose vaccine on the child's first day of attendance for that school year. If additional doses are required and are medically appropriate within the first 5 days of school, the child shall have either the final dose during that 5-day period, or shall have the next scheduled dose and also provide a medical certificate setting out the schedule for the remaining doses. If the child has at least one dose, but needs additional doses, and those doses are not medically appropriate during the first 5 days of school, the child may provide a medical certificate on or before the 5th school day scheduling those doses. The medical certificate shall be signed by a physician, CRNP or PA. If the child is to receive the immunizations from the Department or a public health department, a public health official may sign the medical certificate. This allows for the child to receive vaccinations in a safe and medically appropriate way according to the child's health care practitioner. A child shall have the single dose of a single dose vaccine to enter school. However, there is only one single dose vaccine on the required list—Tdap.

 Further, if a health care practitioner feels that the number or type of vaccines required for a particular child to meet the regulatory requirement is medically contraindicated, the child may also obtain a medical exemption. That exemption may be for a particular time period, or may exempt the child entirely from receiving a particular vaccine or vaccines. See § 23.84.

 In addition, if a child is seriously ill at the time the child should be entering school, it seems unlikely that the child will be entering school, and the question of immunizations is moot or at least delayed until the child is well enough to start school. There is a medical exemption available for children in frail health whose medical providers determine should not have the vaccination, and the medical schedule allows the physician, CRNP or PA to set out an appropriate schedule for immunizations to be completed.

 In addition, the Department notes that there are no scientific studies showing that combination vaccines, or multiple vaccines at one time, are harmful to children. In fact, neither ACIP nor AAP would recommend the simultaneous administration of any vaccines until these studies showed the combinations to be both safe and effective. Studies have shown that the recommended vaccines are as effective in combination as they are individually, and that these combinations carry no greater risk for adverse side effects. Consequently, ACIP and AAP recommend simultaneous administration of all routine childhood vaccines when appropriate. The Department discussed these issues more fully elsewhere in this preamble.

 One commentator stated that the worst of the Department's proposed amendments would be to change the 8- month provisional period to a 5-day provisional period. She asked that the Department respect parental rights.

 The Department understands that many commentators believe that the decision whether to vaccinate their children should be made by them alone, and that immunizations should not be mandated. The Department is charged with protecting the health and safety of the citizens of this Commonwealth, and with choosing the most efficient and effective way of doing so. See section 2102(a) of The Administrative Code of 1929. After reviewing all the comments and the proposed rulemaking, the Department stands firm on its belief that the benefit of reducing and changing the provisional period outweighs risks and burdens. The Department notes that parents and guardians still have recourse to the statutorily provided medical and religious/philosophical exemptions, which are reflected in § 23.84.

 One commentator asked what schools would do with children who receive live versions of vaccines. These children are contagious. The commentator asks whether schools will keep them separate from those who cannot receive vaccines, the medically unable who are mentioned in the proposed rulemaking. The commentator stated that this is hypocritical. Families should be allowed to retain their medical freedom and their choices, particularly those attending charter schools, those who are homeschooled and those in private institutions. The commentator asked: who is medically unable; who makes that determination; and will all children be tested to make sure they are not going to have reactions before being injected. The commentator's child was not tested before getting a round of vaccinations and ended up in the hospital for 8 days. She stated that she has three different doctors telling her to skip vaccines but this may not be enough for proper ''paperwork'' or exemptions.

 The Department disagrees with the commentator and has not revised this final-form rulemaking. There are several vaccines required for school entry that contain live virus, including varicella and MMR. A child who has received a live vaccine is rarely, if ever, contagious. Vaccines: What You Should Know, p. 88; Pink Book, p. 25. Transmission of measles and mumps vaccine viruses to household or other contacts has never been documented. Transmission of varicella virus has been reported very rarely. Pink Book, p. 25. With respect to the commentator's question regarding the Department's reference to children who are medically unable to receive the vaccination, a child with a medical exemption is medically unable to receive a vaccination. One commentator stated that she has three doctors who have told her not to have her child vaccinated; the Department is certain that in that case one of them would sign a medical exemption. The Department has not revised the medical exemption language of the regulation, and cannot eliminate it as it is required by law.

 One commentator stated that a 5-day provisional period would be very difficult, and asked whether the Department notified physicians of this proposed amendment.

 Several commentators stated that they are not paid by their school districts to come in before the beginning of the school year to go through records to determine a child's vaccination status and whether they should be excluded and to contact the family, and that they do not work over the summer. Contact numbers are not valid, and many families are away on holiday trips right before the start of school, making families difficult to reach. Many families move at this time and change school districts. The commentators stated that the amount of work involved in the first few days of school made it impossible to comply with a 5-day provisional period, particularly with respect to the 7th grade requirement for MCV and Tdap, and the 12th grade requirement for MCV.

 One commentator stated that although the 8-month provisional period is too long, a 5-day provisional period would be too short. She stated that as of the date of her letter, she had 126 6th grade students who did not have the required immunizations needed for 7th grade. She stated that she has sent home notice explaining what was needed. She stated that she did the same thing last year, but started with 80 provisionally enrolled students.

 Several commentators stated that high student-to-school-nurse ratios made it impossible to implement a 5-day provisional period. One commentator noted that school administrators are supportive of the work, but that they do not track students or learn the nuances of the immunization regulations. The commentator questioned whether they were willing to do so.

 One commentator stated that 5 days was an unrealistic amount of time to police immunizations at the beginning of a school year.

 One commentator stated that while school nurses are in agreement that the vaccine compliance rate in this Commonwealth needs to be increased to increase herd immunity, they do not see how they would be able to complete the new requirements on such short notice. According to the commentator, school nurses are so busy at the start of the school year gathering medications, organizing care plans, notifying teachers of health needs and developing emergency care plans that they cannot see clear at this time to organize a 5-day compliance/exclusion plan. One commentator noted that school administrations would need time to receive notification, understand the new requirements and get notifications in place. More time would be needed to get the plan in place.

 Because the Department is aware of concerns of schools and school nurses in implementing this final-form rulemaking within the time frame originally proposed, the Department decided to extend the time for implementation. This final-form rulemaking is published in time for kindergarten registration in March 2017 for the 2017-2018 school year to enable schools to provide information to parents and guardians regarding the amendments. This will provide schools and school nurses with the remaining months of the 2016-2017 school year to begin to prepare for implementing the amendments. Schools and school nurses will be able to begin to review implementation status of students, provide information to parents and guardians, and determine which students may have issues in fall 2017-2018. Although not all issues regarding the time necessary to implement the amendments will be resolved by this extended period prior to August 1, 2017, the Department is hopeful that the 5-month to 6-month period prior to implementation will allow parents and guardians ample time to take steps to comply with the requirements, thus lessening time needed by schools to enforce the requirements at the start of the 2017-2018 school year. The Department also acknowledges the need for education and outreach on this final-form rulemaking, and particularly the 5-day requirement, and intends to do both with health care practitioners, schools and parents. The Department believes that sufficient outreach will significantly reduce the numbers of students in a provisional status at the beginning of the 2017-2018 school year. The Department is also hopeful, as other commentators in support of the 5-day provisional period have expressed, that parents and guardians who lag behind with immunizing their children will be encouraged to take more prompt action by the Department's stricter stance in this regard. This may ultimately decrease work for school nurses and school administrators as more children come into compliance.

 In addition, as a number of commentators pointed out, too lengthy a provisional period requires school nurses to send multiple written notices and make multiple phone calls to parents to attempt to gather all necessary immunization information.

 Several commentators asked the Department to add language to the regulations addressing paying certified school nurses for the time they would have to spend over the summer to check on the status of children's immunizations to have an accurate list of children to be excluded to the school administrator on the first day of school. If this were not in the regulations, one commentator stated that school nurses would be expected to come in on their own time, unlike school counselors who got paid to do so. Another commentator asked that the Department recommend school administrators adopt a plan for compensating school nurses for work done over the summer. One commentator asked that the Department encourage administrators to provide school nurses paid days to come in before the start of school to review immunizations. The commentators stated that this was imperative if the school nurses were to be ready for exclusions and to provide assistance to families who genuinely wish to be immunized.

 The Department has not revised this final-form rulemaking. The Department has no authority to require payment for school nurses, or to recommend that school administrators allow for paid school days or adopt a plan for financial compensation. The Department would hope that school nurses receive the appropriate support necessary from their administrations to allow them to carry out their important job of taking care of the health of students.

 One commentator stated that the 8-month period may be too long, but ''5 days is just a shame.''

 The Department has not revised this final-form rulemaking based on the rationale it set out at the beginning of this section, and based on its discussion regarding herd and community immunity.

 One commentator stated that a child could not obtain a medical certificate within 5 days. The commentator stated that most of the students dealt with were from another state or country with no provider and no insurance. The local health bureau cannot accommodate a 2-week to 4-week turnaround time now, and new patients will never get a private provider within 5 days.

 One commentator stated that 5 days was definitely not enough time to interact with one's health care provider or to create an immunization plan. The commentator noted that many primary care physicians are not even open all days of the week. The commentator stated that it was difficult to schedule to see one's physician on a nonacute matter, and the health of some children warranted more than routine consideration when making an immunization decision.

 The Department has not revised this final-form rulemaking. This final-form rulemaking is published in time for kindergarten registration, 5 to 6 months prior to the start of the 2017-2018 school year. The Department believes this is sufficient time to make schools and school staff aware of the amendments, notify parents and guardians, and allow them to seek out a health care practitioner if they do not already have one to provide medical care to their families. This will allow parents 5 to 6 months to bring their children's immunizations up-to-date or, in the alternative, to request a medical or religious/philosophical exemption. Again, as the Department has stated, it should be rare for a child to be in the position of attempting to obtain all ten required immunizations within a 5-day provisional period at the start of kindergarten. The Department does not believe that a health care practitioner would agree to do this, and the Department would never require it. If the medical practitioner providing the vaccinations believes certain vaccinations are medically contraindicated, then the child should be able to obtain a medical exemption.

 In addition, a child from another state or another country transferring into a school in this Commonwealth and unable to provide vaccine information immediately has 30 days to obtain the information or to show proof of immunity. A child without insurance or who is underinsured may qualify for the VFC Program, although, again, revaccination if a child has been vaccinated is not the preferred solution. Further, although there may be pockets of unvaccinated children, as the Department previously noted, not every school in this Commonwealth will be faced with hundreds of unvaccinated children on the first day of school.

10-day provisional period

 One commentator supported a 10-day provisional period, rather than a 5-day provisional period. The commentator stated that a 10-day period would allow time for parents and guardians to make appointments, arrange time off work, transportation and records to be returned back to school and processed by the school nurse but still convey the sense of urgency created by the final-form rulemaking without creating undue hardship for school personnel. According to the commentator, parents do not always return records to the school.

 The Department has not revised this final-form rulemaking in response to this comment. For the reasons provided at the beginning of this section, the Department believes a 5-day provisional period is commensurate with ensuring the public's health.

15-day provisional period

 PSBA recommended a 15-day time frame. PSBA supported replacing the former 8-month provisional period with a shorter time frame, but stated that a 5-day time period for compliance would be challenging to implement. PSBA noted that parents may, through no fault of their own, have difficulties scheduling an appointment with a provider during that time frame, may have to be absent from work or have other commitments and circumstances that would prevented them from being able to comply within 5 days. PSBA stated that schools would have to develop education and communications procedures and notices for families to ensure that they are aware of and fully understand the rules and consequences of noncompliance. PSBA pointed out that the surrounding states have provisional periods that run from 14 to 20 days. PSBA stated that a longer provisional period will be more successful in reaching the Department's goals.

 This final-form rulemaking is effective for the 2017-2018 school year and published in March 2017. Since kindergarten registration occurs in March, this should give schools and school nurses ample time to notify parents and develop communications regarding the regulations. In fact, the Department typically provides school nurses with a draft communication to be given to parents outlining the terms of the regulation.

 While the Department understands that some parents and guardians do delay in getting their child vaccinated, the regulation should not be based on those parents and guardians. Many parents ensure their children have appropriate vaccinations prior to the beginning of the school year. Parents and guardians will have 5 to 6 months to make appointments and ensure that their child is appropriately vaccinated in accordance with this final-form rulemaking. The new regulation adds MCV in 12th grade, and adds pertussis to the list of diseases against which a child shall be vaccinated to enter and attend school. Parents should be aware of all these requirements since the Department has not added a vaccination since 2011.

30-day provisional period

 PASA and several commentators supported a 30-day provisional period rather than a 5-day provisional period. PASA stated that the 5-day provisional enrollment period was unrealistic, given limitations on the ability of parents to schedule appointments, particularly in rural areas with limited access. PASA stated that it believed the 5-day period would result in considerable disruption of student learning and parental work and other obligations. PASA recommended a 30-day period as a first step towards a stricter time frame, and pointed out that it comported with the McKinney-Vento Homeless Education Assistance Improvements Act of 2001 (42 U.S.C.A. §§ 11431—11435), thereby creating a uniform standard that applies to all students—current residents, new residents or students defined as homeless.

 Many commentators stated that the start of the school year was the busiest time of the year, and adding reviewing immunization records and required exclusions to that period would be a strain on school nurses. One commentator stated that a 5-day provisional period was too drastic, and would be a strain not only on school nurses, students and parents, but also on doctors' offices and clinics. She asked the Department to explain why a 5-day period was selected.

 One commentator agreed that an 8-month provisional time period was too long, the provisional period had provided a buffer to gather data and begin contacting parents of children without the required documentation. The commentator recommended a 3-week to 4-week provisional period.

 Two commentators stated that, although the provisional time period needed to be modified, a 5-day provisional period was unrealistic and advocated for a 30-day provisional period. One commentator made this recommendation because parents could not obtain an appointment with the Department for 6 to 8 weeks. This commentator stated that there needed to be a transitional period of at least 1 school year before enforcing the 5-day provisional period.

 In responding, the Department clarifies the commentator's assumption that the Department will be able to provide immunizations for all children. Because of changes to the Federal grant program, the Department's VFC Program is limited to providing vaccines for uninsured and underinsured children, and to those of certain heritages. Having said that, the Department does not see the 5-day provisional period as creating problems for parents to obtain appointments with providers. This final-form rulemaking is effective for the 2017-2018 school year. Since kindergarten registration occurs in March, this should give schools and school nurses ample time to notify parents and develop communications regarding the regulations. In fact, the Department typically provides school nurses with a draft communication to be given to parents outlining the terms of the regulation.

 While the Department understands that some parents and guardians do delay in getting their child vaccinated, the regulation should not be based on those parents and guardians. Many parents ensure their children have appropriate vaccinations prior to the beginning of the school year. Parents will have 5 to 6 months to make appointments and ensure that their children are appropriately vaccinated in accordance with the existing regulation. The Department believes that this 5-month to 6-month period is a sufficient transition time to inform parents and guardians, and encourage them to comply with the amendments. In addition, final-form rulemaking only adds one new vaccine, MCV in 12th grade, since children being immunized against diphtheria and tetanus in this Commonwealth prior to this final-form rulemaking were receiving DTaP, in accordance with ACIP recommendations (unless the child had a contraindication for the pertussis vaccine or a religious/philosophical exemption) and so are already receiving a pertussis component in their vaccination. Parents should be aware of all these requirements since the Department has added no new vaccination since 2011.

60-day provisional period

 One commentator also pointed out that school nurses may or may not get paid over the summer, and that a 5-day provisional period would burden not only school nurses, but clinics and doctors' offices attempting to get children caught up in time, and school administrators who will be faced with large numbers of children to be excluded. This commentator recommended a 60-day provisional period.

 Several commentators stated that a 5-day provisional period is not nearly enough time to allow school nurses to assess immunization status of every child and notify parents. The commentators recommended a 60-day time period. One of these commentators stated that it did not give nurses sufficient time to notify parents, or give parents the necessary time to obtain the vaccinations for their children. The commentator stated that this time period did not allow for the proper spacing of immunizations of children who receive their immunizations later than recommended.

 One commentator stated that the 5-day provisional period was too short to complete the necessary work upon returning to school following summer vacation. The commentator stated that her 7th grade class was small compared to other school districts, but sorting through incoming medical forms is time consuming. The commentator stated that while her school district provides for her to work during the summer to update immunization records, most parents do not provide medical information during the summer months. The commentator stated that parents send updated medical information into school on the first days of the new school year. Updated medical information includes physical forms, dental forms, immunization records, medication orders, allergy action plans, physical education restrictions, medical plans of care for food allergies, documentation of new diagnoses and similar information. The commentator stated that the school nurse prioritizes what forms are reviewed first during the initial days of school, and the priority is to review forms that relate to daily medical treatments, medication administration, physical education restriction and new diagnoses. The commentator stated that immunization documentation can only be reviewed once medical treatment processes are in place, teachers and school staff are informed of medical needs and the daily first aid needs of students are met. The commentator stated that these things take time, and it will take more than 5 days to put these things in place and to ensure the safety of the children. The commentator stated that more than 5 days are necessary to review new immunization information to ensure that errors are not made in allowing a student to enter or continue in attendance or to ensure that a student is not excluded unnecessarily.

 The commentator went on to say that she was also concerned about excluding students who are missing a single dose vaccine on the first day of school. She recommended a 2-month provisional period in the case of both single dose and multiple dose vaccines. The commentator stated that a 2-month provisional period would provide time for physicians' offices to schedule visits for those parents who wait until the last minute, and also allows doctors to keep up with the supply of vaccine. The commentator stated that this would be beneficial to the student who has no control over whether or not the student gets the vaccine, and prevents the student from missing the first valuable days of class. The commentator stated that in the first days of school, a teacher will review expectations, provide supplies and build a relationship with the class. The commentator stated that a 2-month provisional period would also be beneficial to other students who would be impacted if a portion of the student body is missing at the beginning of the school year. The commentator stated that the parents in her school district do get immunizations done, although some do require the push of an impending exclusion. The commentator stated that all her 7th grade students are up to date, except those with religious and philosophical exemptions. The commentator stated that a 2-month provisional period would accomplish this without significant disruption that a first day exclusion would cause.

 The Department has heard from many commentators who are also school nurses that they are not paid for any work they perform during the summer. The Department does not have the authority to govern the manner in which school nurses receive reimbursement, or how they conduct their work. Further, as the Department has stated, few children, not already provided with exemptions, will have no vaccinations at the start of the 2017-2018 school year. Parents and guardians will have ample time to make decisions regarding vaccinating of children, and have no need to delay to a point where there is a concern that insufficient time is available to obtain the properly spaced vaccines, or that doctors' offices and clinics are burdened by an influx of children seeking vaccinations. Not every parent or guardian waits that long, or delays that number of vaccinations. Further, since a medical exemption is available, a parent or guardian may obtain a medical exemption for a child, and develop a schedule that will allow for appropriately spaced vaccinations. If a parent or guardian fails to adhere to this schedule, a child may be excluded from school.

 The Department acknowledges that nurses will need to review immunization records, as they do currently, but within a shorter time period. The regulations in place prior to this final-form rulemaking also required schools and school nurses to review a child's vaccination status prior to allowing that child to attend school, but gave the child a much longer time to obtain the required vaccinations before risking exclusion. See former § 23.85(e). The Department believes that its decision to extend the time for implementation from the 2016-2017 school year to the 2017-2018 school year will relieve some of the concerns expressed by schools and school nurses regarding implementation. This extended time frame for implementation, in time for kindergarten registration, will enable schools to provide information to parents and guardians regarding the changes to the regulation in plenty of time for the August 1, 2017, effective date. The extension gives schools and school nurses a large part of the remaining school year to prepare themselves and their students for the upcoming changes. It gives parents and guardians nearly 6 months to obtain required immunizations (only two of which are new) and make plans to see a physician, PA or CRNP. Further, children entering kindergarten and their parents and guardians will be made aware of the new requirements, which, for kindergarteners, are limited to the addition of pertussis to the list of diseases against which a child shall be immunized before entering and attending school. As the Department has noted, this simply acknowledges the fact that certain vaccines, like single antigen diphtheria, single antigen tetanus and single antigen pertussis vaccines, are not available in the United States. The only new vaccine requirement for other students will be the second MCV dose for those children entering 12th grade in 2017.

 Changing the time frame will also increase the amount of time the Department will have for education and outreach on this final-form rulemaking, particularly for the 5-day provisional period, which it intends to conduct with health care practitioners, schools, school nurses and parents. The Department believes that sufficient outreach will significantly reduce the numbers of students excluded or in a provisional status at the beginning of the 2017-2018 school year. Further, as the Department and other commentators have stated, parents and guardians who lag behind with immunizing their children, and who do not have a reason to obtain an exemption, should be encouraged to take more prompt action by the Department's stricter stance in this regard. This may ultimately decrease work for school nurses and school administrators as more children come into compliance.

 Multiple commentators, including HSLDA, stated that 5 days was far too short a time period for parents who choose to delay immunizations due to age, illness or merely the individual's liberty to choose. Multiple commentators pointed out that no nearby state has as short a provisional period, and that the average was 58 days. The commentators stated that parents would not have enough flexibility to obtain the required vaccines, and there may be danger in requiring too many vaccine doses in a short period of time. Many of these commentators stated that a longer period, such as 60 days, would be more reasonable and safer. One commentator stated that a longer time period, perhaps 60 days, would be safer for anyone who might have developed an allergy to eggs or other components used in the vaccines. Several commentators, including one who pointed out that parents who are citizens of the free nation of the United States, recommended a 60-day provisional period to allow parents a sufficient time to develop a plan to obtain vaccines for their children.

 Although the Department has stated that there is no evidence to indicate that multiple vaccines at one time create a health concern, the Department has taken into account the need for vaccines to be spaced out properly in developing its immunization requirements. Parents and guardians have ample time to make decisions regarding vaccinating of children, and have no need to delay to a point where there is a concern that insufficient time is available to obtain the properly spaced vaccines. Not every parent or guardian waits that long, or delays that number of vaccinations. Further, since a medical exemption is available, in the event that a child should not be vaccinated with the number of vaccinations needed for entry or attendance for medical reasons, a parent or guardian may obtain a medical exemption for a child. The parent or guardian also has ample time to work with the child's health care practitioner to develop an immunization schedule that will allow for appropriately spaced vaccinations. If a parent or guardian fails to adhere to this schedule at a later date, a child may be excluded from school.

 In response to the commentator's concern about eggs in vaccines, any child with a known allergy would be eligible for a medical exemption.

 Multiple commentators, including PACIC, stated that reducing the 240-day provisional period to 5 days is too extreme. PACIC stated that trying to get those children who are totally unvaccinated ten vaccines within 5 days could easily overwhelm the child's system. PACIC stated that this a reason that 60 days is the minimal provisional period appropriate. Several commentators stated that if children are ill, they need time to recover before they are vaccinated. Several of these commentators, including PACIC, stated that no nearby states have such a short time frame; the average period is 58 days. Multiple commentators stated that 5 days is not enough time to schedule appointments or for students who may be sick to recover before being vaccinated.

 PACIC takes the position that children who have no vaccinations will be overwhelmed if they have to get all ten vaccinations within 5 days. This is incorrect for several reasons. First, based on its immunization data, the Department has no reason to believe that a large number of children lack every dose of every required immunization, and PACIC does not provide a number. Secondly, children without an appropriate immunization have longer than 5 days to obtain the vaccination if the vaccine is a multidose vaccine. In fact, the child may continue to attend school without all required vaccinations so long as the child has the next required dose in the series during the 5-day period, and presents a medical certificate with an immunization schedule during that same time frame. The child shall adhere to that schedule. If it takes a child 7 days to obtain the schedule, the child may return to school on the 7th day.

 In addition, if children are ill when vaccines are required, and the child's physician believes that the child should not have a vaccination, the physician or the physician's designee may give a temporary medical exception, or a child can provide a medical certificate signed by those practitioners with the time frame for obtaining the immunization set out in the medical certificate, and may then be admitted to school.

 Finally, there is no scientific evidence that multiple vaccines overwhelm the child's system. Vaccines: What You Should Know, p. 99 and 100; Pink Book, p. 11. In fact, the Pink Book recommends that children receive all indicated vaccinations at the same time because it increases the chances that a child will be fully immunized by the appropriate age. Pink Book, p. 11 and 27.

 PACIC further stated that there is a paragraph in which the Department implies that the only other state with an 8-month provisional has a high MMR rate of vaccination because the state does not have a religious or medical exemption. PACIC stated that section 10 of the RAF for the proposed rulemaking states that schools in this Commonwealth have a relatively low number of exemptions. PACIC stated that this proves that the low vaccination rates are a reporting error and have nothing to do with exemptions, so this statement should be removed from the preamble to the proposed rulemaking, because it is misleading. PACIC stated that this could lead the reader to think that exemptions are a factor in these MMR percentage statistics, when they are not.

 The Department cannot make a change to the preamble to the proposed rulemaking. Further, it is and has always been the Department's opinion that the long provisional period, rather than the number of exemptions given, is what allows children to remain unvaccinated for the majority of the school year. Students eventually become vaccinated, but while they remain unvaccinated, there is still a concern for their health and the health of others, as the Department has explained in discussing herd or community immunity.

 Several commentators supported shortening the provisional period to 60 days to improve recordkeeping and give parents adequate time to complete the necessary vaccinations and paperwork. Several commentators stated that the shortened period would cause parents stress and unnecessary expense by requiring them to file extensions and take their sick child to the doctor for a waiver. These commentators stated that it would substantially increase paperwork as numerous waivers are filed requiring individual follow ups. These commentators stated that a 60-day provisional period would meet the need of ensuring timely filing without causing undue stress on parents or endangering sick children by leading parents to seek out vaccines under duress. Several commentators pointed out that there were no surrounding states with such short provisional periods. One commentator stated that her doctor's office would not give same day appointments for shots, even if the child was behind. Given the later reporting date, a 60-day provisional period would not interfere with data collection and analysis.

 The Department disagrees with the commentators, and has not revised this final-form rulemaking. Commentators who are also school nurses have indicated that a longer provisional period requires more follow-up, since multiple letters are sent to children and parents. Any regulation regarding exclusion for failure to obtain required immunizations will require follow-up by the school administrator or a designee.

 Further, if a child were seriously ill at the time the child was about to enter school, and too ill to be taken to a physician's office, the child is unlikely to be attending school. The question of what vaccinations are to be given is moot at that point. Of course, once the child is ready to return to school, if an exemption is warranted in the opinion of the physician or the physician's designee, the physician or the physician's designee may provide a medical exemption. Otherwise, upon the child's return to school, the child would be required to comply with the immunization requirements. A child may provide a medical certificate with the time frame for obtaining the required immunization or immunizations, so long as the missing vaccination is not a single dose vaccine, and the other requirements of the regulations regarding provisional admittance to school in § 23.85(e) have been met. The child would then be admitted to school.

 In addition, the Department has not reduced the provisional time frame for the purpose of obtaining more accurate reporting, although this may be a secondary benefit. The Department's concern is to ensure that children receive all necessary vaccinations upon entering school, ensuring their health and the health of those who cannot be vaccinated, in school and in the general public.

 Finally, the commentator is correct that no surrounding state has a provisional period as short as 5 days. The Department notes that West Virginia, which has a 240-day (8-month) provisional period, has very high vaccination rates. In the Department's opinion, this is because West Virginia has neither a religious/philosophical nor a medical exemption.

 Several commentators recommended shortening the provisional period to 60 days to give parents more time to comply with the immunization requirements and to make appointments for missed vaccines. One commentator stated that this time period would also allow a child to recover from any illness so that the child can receive the proper vaccinations. The commentator raised a concern that there could be a delay in the child's education because the parent might not be able to take time off from work immediately to file an exception. One commentator stated that this would be helpful in a variety of personal and medical circumstances.

 As previously stated, the Department has taken into account the need for vaccines to be spaced out properly in developing its immunization requirements. The Department and school nurses try to give parents ample time to learn new requirements, and some of the existing requirements have been in place for over 20 years. Parents and guardians have ample time to make decisions regarding vaccinating of children, and have no need to delay to a point where there is a concern that insufficient time is available to obtain the properly spaced vaccines. Not every parent or guardian waits that long, or delays that number of vaccinations.

90-day provisional period

 One commentator stated that the beginning of the school year involved a great deal of work, including dealing with medically fragile students and their parents, developing individualized health plans for them, instructing teachers on first aid care and emergency plans, and notifying teachers of students with allergies requiring EpiPen use. This commentator also pointed out that foreign students entering school could take some time to get insurance. This commentator recommended a 90-day provisional period.

 The Department has not revised this final-form rulemaking. The Department acknowledges that the beginning of the school year involves a good deal of work for school nurses in a variety of areas, including review of immunizations. The Department has previously explained in this preamble that it believes the extended implementation time period will help with that issue. With respect to foreign students entering school, the Department has built in a 30-day period allowing students coming into school in this Commonwealth to provide immunization records. Further, if a child does not have insurance, or is underinsured, the child is immediately eligible for the VFC Program.

 One commentator stated that with delayed reporting, it seemed unreasonable to limit the provisional period to 5 days. The commentator recommended a 90-day provisional period, the same as Virginia. According to the commentator, this would give plenty of time for students to catch up on vaccines and for schools to complete their reports. The commentator stated that a 5-day provisional period would be problematic for parents, doctors' offices and school administrators, and a 90-day period would eliminate any problem they would have with completing paperwork.

 One commentator stated that the 5-day provisional period did not give a parent enough time to make a doctor's appointment, because most doctors' offices make a person wait 1 to 2 weeks before the person can be fit into the office's busy schedule. The commentator recommended a 90-day provisional period.

 One commentator stated that giving parents only 5 days to give their children what may end up being several vaccines at once has the potential to result in a catastrophic reaction for children who may have undiagnosed sensitivities or predisposition to adverse reactions to vaccines. The commentator noted that giving several vaccines at once has never been studied for safety, even though industry representatives insist it is safe. There is no science. The commentator stated that studies that compare vaccinated children with other vaccinated children, concluding that they have similar rates of health issues are not evidence of safety, and are not good science.

 The commentator also stated that many of the current pediatric vaccines contain high levels of aluminum adjuvants, and some children are not able to quickly and effectively eliminate heavy metals. The commentator stated that recommending a rushed decision to receive several vaccines at once is not ethical when there is no health disease causing a public health emergency, and coercing the decision by withholding education from children violates the principle of informed consent. The commentator stated that this Commonwealth has one of the highest vaccination rates in the country. The commentator stated if the Department were concerned about reporting accuracy being skewed by the provisional period, shortening the provisional period to 90 days and changing the reporting date to December 31 is a more accurate reflection of vaccination rates.

 The Department has not revised this final-form rulemaking. The Department is not requiring parents to make a rushed decision to vaccinate their child. The requirements regarding vaccination have been in place for many years. The last time an immunization was added to the list was in 2011, and that included requiring Tdap and MCV for entry into the 7th grade. This final-form rulemaking adds pertussis to the list of diseases against which a child shall be immunized before entering and attending school; this acknowledges the fact that certain vaccines, like single antigen diphtheria, single antigen tetanus and single antigen pertussis vaccine, are not available in the United States. Children being immunized against diphtheria and tetanus in this Commonwealth prior to this final-form rulemaking were receiving DTaP, in accordance with ACIP recommendations (unless the child had a contraindication for the pertussis vaccine or a religious/philosophical exemption) and so are already receiving a pertussis component in their vaccination.

 The Department is also requiring a dose of MCV for entry into the 12th grade. Some children have had years to become appropriately immunized. The Department is not requiring a list of ten new immunizations for children in 2016 and requiring all of those immunizations for the upcoming school year. In fact, the Department has heard the comments of school nurses and the public and moved the effective date of this final-form rulemaking to the 2017-2018 school year. Parents should be notified in March 2017 of the publication of this final-form rulemaking, and a child attending school in this Commonwealth will be required to be up to date with immunizations for the 2017-2018 school year.

 Further, the Department is not coercing the decision by withholding education from a student. The parent or guardian may choose to obtain a religious/philosophical or medical exemption from the requirements and the child may continue to attend school.

 In addition, as the Department has previously explained, ''informed consent'' has a particular meaning in Commonwealth law. However, as the Department has noted the parent or guardian still provides consent for an immunization of a child, and may choose to withhold his consent for an immunization. The child may still attend school by choosing to obtain a religious/philosophical or medical exemption from the immunization requirements.

 Further, the Department discussed the issue regarding aluminum and other vaccine additives previously in this preamble.

 With respect to the comment regarding vaccination rates, the Department believes that changing the provisional period will give it a more accurate reflection of vaccination rates, but that it is not the only reason it has chosen to add a requirement for MCV in the 12th grade to the list of required immunizations. According to the CDC, meningococcal disease can be devastating, and often, and unexpectedly, strikes otherwise healthy people. Although meningococcal disease is uncommon, teens and young adults 16 through 23 years of age are at increased risk. Meningococcal bacteria can cause severe disease, including infections of the lining of the brain and spinal cord (meningitis) and blood stream infections (bacteremia or septicemia), and can result in permanent disabilities and even death. The Department has followed ACIP recommendations to add a second dose in the 12th grade.

30-day to 60-day provisional period

 Several commentators pointed out that school nurses do not work during the summer, and that it would be too difficult to collect all the necessary information, particularly since they would not get paid. One of these commentators recommended a 30-day to 60-day provisional period.

 One commentator stated that it would be difficult to enforce the proposed amendments within the first 5 days of school, which is a very busy time for school nurses. The commentator recommended a 30-day to 60-day time period.

 The Department has not revised this final-form rulemaking. For the reasons previously stated, the Department believes the appropriate time frame for a provisional period is 5 days.

 One commentator stated that although the 240-day provisional period is too long, a 30-day to 60-day period would be more appropriate. The commentator stated that the 2013-2014 school year kindergarten MMR rate was 86%. By 7th grade, which is the next grade for which there is available data, the rate was 95.8%. This Commonwealth's exemption rate is just under 3%, so exemptions are not the reason for the low kindergarten rate. The commentator stated that the Department's provisional rate is 17.9%, and that should have been shared in section 10 of the RAF, because it explains the low kindergarten rate. Since the median provisional period time frame around the United States is 30 days, the commentator recommended a 30-day to 60-day period. The commentator stated that this would raise the overall kindergarten vaccination rate and allow parents to plan accordingly.

 As the Department has previously stated, its review of the school level data, rather than the school district level data, causes concern about the pockets of nonimmunized children throughout this Commonwealth. The Department provided the medical and religious/philosophical exemption rates previously in this preamble. Because these schools show no medical or religious exemption, the number of nonimmunized children is clearly related to the number of provisionally enrolled students, which the data also show to be high in these same schools. The fact that numbers improve from one time period to another does not resolve the issue, as the Department has discussed, of children at a point in time in a school being underimmunized. This is particularly true for measles, and thereby creates a risk of a serious health event, which would take time and resources away from schools, school districts, the Department and the health care community. It would also create costs to parents, guardians, teachers and school employees, and children.

60-day to 70-day provisional period

 One commentator agreed that the current provisional period was long, but stated that 5 days was difficult given the real day-to-day lives of families. The commentator stated that this would put ill or immunocompromised children at risk for injury having so many vaccines to catch up in a 5-day period. The commentator stated that many of the most severe vaccine reactions and permanent injuries occur when multiple vaccines are given in a short period of time. The commentator recommended a more reasonable 60-day to 70-day period.

 The Department has not revised this final-form rulemaking. The Department previously stated its reasons and points out that ill or immunocompromised children may obtain a medical exemption. Further, the Department is not aware of any valid scientific study which states that the most severe vaccine reactions and permanent injuries occur when multiple vaccines are given in a short period of time. In fact, studies show that no ill effects occur in these circumstances. The Department addressed multiple vaccines previously in this preamble.

60-day to 90-day provisional period

 One commentator stated that it would be very difficult to comply with the 5-day provisional period because nurses were so busy collecting emergency cards, writing health plans, and making sure students who need medications have the paperwork and medications available. This commentator recommended a 60-day to 90-day provisional period.

 One commentator stated that a 5-day provisional period would not give school nurses adequate time to ensure the proper immunization status for all students involved. The commentator stated that school nurses are too busy and overwhelmed within the first few days of school dealing with chronic health issues, medications and assisting student transitions to a new school year. The commentator recommended a 60-day to 90-day transition period to give school nurses adequate time to inform and educate parents, and for physicians to come on board with the new requirements. The commentator stated that if the provisional period were only 5 days, there would be a rise in moral or ethical exemptions, and those children would never be immunized.

 One commentator, a homeschool parent whose children are vaccinated, as required by the regulations, stated that the 5-day period was too short. The commentator stated that parents who choose to delay immunizations will not have enough flexibility in obtaining the required vaccines. The commentator stated that there may be danger in requiring too many vaccine doses in a short period of time. Parents should have 60 to 90 days to develop a plan for their child to receive the required vaccinations.

 In developing its immunization requirements, the Department has taken into account the need for vaccines to be spaced out properly. Parents and guardians have ample time to make decisions regarding vaccinating their children, and have no need to delay to a point where there is a concern that insufficient time exists to obtain the properly spaced vaccines. Not every parent or guardian waits that long, or delays that number of vaccinations. Further, since a medical exemption is available, in a truly problematic situation, a parent or guardian may obtain a medical exemption for a child and develop an immunization schedule that will allow for appropriately spaced vaccinations. If a parent or guardian fails to adhere to this schedule, a child may be excluded from school. It is within the purview of a parent or guardian to obtain a religious/philosophical or medical exemption because of a shortened time frame.

 Several commentators stated that a 5-day provisional period was too short, the shortest of any state, and that this would put sick children, especially immunocompromised children, at risk for injury having so many vaccines to catch up in a 5-day provisional period. The commentators pointed out that children are not supposed to have vaccines if they are sick, but when they are healthy. The commentators stated that a 60-day to 90-day time period would be more reasonable and allow families time to plan and seek a schedule that is safer and more reasonable.

 The regulations do not require a child to have all the vaccines that the child is missing within a 5-day provisional period. The requirement is for the child to have the single dose of a single dose vaccine by the first day of school or face exclusion (this is limited to Tdap). In the case of a multidose vaccine, the amendments require that the child have at least one dose of the vaccine upon school entry. If additional doses are required and are medically appropriate within the first 5 days of school, the child must have either the final dose during those first 5 days of school or the next scheduled dose during that time period. During that same time period, the child shall also provide a medical certificate setting out the schedule for the remaining needed doses. If the child needs additional doses, but those doses are not medically appropriate during the first 5 days of school, the child may provide a medical certificate on or before the 5th school day scheduling those doses. The child may then be admitted to school. If the child is ill when the time comes for obtaining a vaccination, or a health care practitioner believes that the child is lacking so many vaccines that it would be medically inappropriate for the child to receive the required doses during the 5-day provisional period, the child may obtain a medical exemption from a physician or a designee. Further, if any dose of any vaccine is medically contraindicated, or if a child has a religious or philosophical objection to a vaccine, the child may obtain an exemption and still be admitted to school. As the Department has noted, there are no competent studies showing that having multiple vaccines at one time create a risk of injury.

 One commentator stated that if a provisional period was necessary, 30 to 60 days or 60 to 90 days would be easier to monitor and enforce. The commentator noted that no matter what the provisional period, there would parents who would not comply.

 The Department has not revised this final-form rulemaking. The Department is aware that there are parents and guardians who do not have their children vaccinated, choose not to have their children have certain vaccinations or simply fail to have their children vaccinated. The Department is issuing the regulation that it believes is necessary to protect children and the general public, regardless of the potential that some individuals will not comply.

 The Department also acknowledges that monitoring will take some effort on the part of schools and school employees. The Department believes that the safety benefit to children and the school staff is outweighed by the increase in effort to monitor immunization requirements. The Department notes that some commentators believe that a shorter provisional period will be easier to monitor than a longer one, since the shorter period will reduce the number of letters and reminders that schools will need to send to parents and guardians.

3-month to 6-month provisional period

 One commentator, identifying herself as a board-certified family physician, recommended a 3-month to 6-month provisional period, because missing a vaccine during this 3-month to 6-month period was not likely to have any significant effect on outcomes, but eliminating a provisional period would unduly stress parents, children, school personnel, providers and staff. The commentator stated that there were too many other time sensitive issues like responding to laboratory and diagnostic results, calling patients, school nurses caring for sick children, parents getting their children fed and helping their children with homework to make this school vaccination issue excessively and inappropriately time sensitive. The commentator stated that if a child has an illness, or is in an accident, vaccination is not the first priority. The commentator stated that if children consistently get their vaccines within 3 to 6 months of the required date, the number vaccine preventable illnesses will go down.

 The Department disagrees with the commentator. The Department agrees that, in certain circumstances, being concerned about whether or not a child has a vaccination would not be the first priority. In any event, if a child were seriously ill or in an accident, the child is unlikely to be attending school, and having his vaccinations checked. Of course, once the child returns to school, if the child has not again begun to obtain required vaccinations, the Department points out that a physician or a designee may, in the case of a serious illness or accident, provide a medical exemption if need be. The Department is following ACIP recommendations in only counting as valid immunizations provided within a specific time frame.

8-month provisional period

 One commentator stated that the 8-month provisional period should stay as it is, because it was well thought out when the law was created, and the increased risk to the student is not worth the perceived benefit.

 The Department disagrees with the commentator and has not revised this final-form rulemaking. In fact, the provisional period does not exist in statute. Rather, the provisional period is a regulation promulgated by the Department to implement the law, as is the present amendment to reduce that provisional period. The Department reviews its regulations periodically to ensure that they serve the needs of the people of this Commonwealth. In reviewing this particular regulation in the light of school immunization data, and the recent outbreaks of vaccine preventable diseases in California and this Commonwealth, the Department decided that an 8-month provisional period was too long, and must be shortened.

 One commentator expressed shock and outrage over the attempt to reduce the provisional period and recommended that it remain at 8 months because of the need for sufficient time for children to catch up with their vaccinations. The commentator stated that family friends had a son who had a severe reaction to so many vaccinations given at once to catch up. The commentator stated that there are many risks possible with the short time schedule proposed by the Department.

 The Department has not revised this final-form rulemaking. It is the Department's belief that the number of children who need multiple immunizations to attend school is small. Parents and guardians are aware of existing requirements and should be planning to obtain the appropriate vaccinations. In the event of illness, or other unforeseen circumstance, the child has the option of obtaining a medical exemption. Further, the intention of the 5-day period is not to require a child to get all vaccinations within that period, but in the case of multiple dose vaccines, to have at least one dose of each, and a schedule for the remaining doses. Although the Department has sympathy for the commentator's family friend, the Department is not aware of any valid scientific study stating that receiving more than one vaccine at the same time causes injury. In addition, the Department notes that medical and religious/philosophical exemptions are available to parents and guardians.

9-month provisional period

 One commentator stated that although the commentator recognized the need to immunize children, requiring the needed vaccines in a short time span might have negative effects on the child. The commentator recommended that 9 months be allowed for vaccinations.

 The Department has not revised this final-form rulemaking. The Department believes that to extend the provisional period further than it was originally, that is from 8 months to 9 months, will add to the number of children provisionally enrolled, create cross-over from one school year to the next and increase the number of schools with low vaccination rates. As previously stated, the Department is not aware of any valid scientific study stating that receiving more than one vaccine at the same time causes injury. In addition, the Department notes that medical and religious/philosophical exemptions are available to parents and guardians.

Provisional period in kindergarten and 6th grade

 One commentator also pointed out that school nurses may or may not get paid over the summer. One commentator stated that along with the many other things she has to do regarding health and safety, she is dealing with free and reduced lunch applications that come in by the hundreds during the first week of school. She recommended that the provisional enrollment period be changed to 8 months in the 6th grade. This would allow the school nurse and families to get vaccines and documentation, and would provide protection sooner. She also recommended the regulation be changed to a 3-month provisional period in kindergarten. In that way the school nurse could make kindergarten booster shots a priority.

 The Department has not revised this final-form rulemaking. As previously stated, the Department believes that the 5-day provisional period provides sufficient time to review records and take action as necessary, particularly given the Department's decision to extend the implementation period for the amendments, and make them effective for the 2017-2018 school year. Having different provisional periods in different grades will not work to increase vaccination rates overall. The Department is not attempting to raise rates simply from a reporting perspective, but to ensure that all children are safe from vaccine preventable diseases in schools.

Elimination of provisional period

All immunizations required on the first day of school

 Several commentators disapproved of a 5-day provisional period because of work issues for school nurses and difficulties for children and families and recommended eliminating the provisional period altogether.

 One commentator stated that she was concerned about making a kindergartener's first days of school be fraught with worries of whether or not the kindergartener would be allowed to attend school. She stated that this was not the way to get the kindergartener's school career off to a good start, because, after a whole summer of being told they were going to ''big kid school'' and being excited about going on the bus, they would be pulled into the office and told they would have to go home. She stated that this would not be a ''happy-faced child'' and would not create a good impression. She raised concerns that families from lower socioeconomic groups were the ones that were not complying with the immunization requirements.

 Several commentators suggested eliminating the 5-day period, and not giving a child a start date until the child's parents have either provided proof that the child has all the required vaccinations, or a medical certificate. Four of these commentators recommended that for kindergarten the Department eliminate the provisional enrollment period altogether, and require a child to be fully immunized before the child starts school. One commentator suggested that the only exceptions be those children with religious, moral, medical or homeless exemptions. One commentator stated that because the age of compulsory education is 8 years of age, if a parent attempting to register a child at 5 years of age did not submit proof of full immunization by the week prior to the start of school, the child would not be eligible for enrollment until the next school year at 6 years of age. One commentator suggested that starting and stopping school for a child entering kindergarten would not be in the best interests of the child. These commentators suggested that no child should be permitted to start school until a certified school nurse has given approval that the child has the necessary immunizations to start school. One commentator stated that provisional status does not seem to prompt parents to have the child's immunizations completed. Another commentator stated that eliminating the provisional period altogether would improve immunization rates.

 The Department agrees that excluding all children without the required immunizations on the first day of school would be the best way to ensure that children attending school are as safe as possible from vaccine-preventable diseases. The Department thinks that this would truly create too much work for school administrators and their designees (presumably, school nurses). This is particularly the case in light of the fact that so many commentators stated that they would not be paid for working over the summer. For the reasons previously stated, the Department believes that a 5-day provisional period achieves the same immunizations goal.

 One commentator recommended eliminating the provisional period altogether so that the time periods for single dose and multidose vaccinations would be the same. The commentator stated that a 5-day provisional period with a medical certificate was too complicated, and school nurses are too busy the first 5 days of school. The 5-day provisional period would put a tremendous pressure on the school nurse.

 The Department has not revised this final-form rulemaking. The Department does not believe that eliminating the 5-day provisional period altogether would eliminate work for the school nurse, as previously stated.

No set time for immunizations

 One commentator stated that this Commonwealth is one of the most difficult states in which to homeschool students, and asked that it not be made more difficult. The commentator stated that parents who choose to delay immunizations will not have enough flexibility in obtaining the required vaccines, and that any day of the school year should be acceptable.

 The Department has not revised this final-form rulemaking. Reducing the provisional period does not make obtaining an education any more difficult for a child who is homeschooled than one who attends a brick and mortar school. The immunization requirements are the same for both.

§ 23.85(e)(1)(i) and (ii)—Multiple dose vaccine series—medical certificate

 One commentator asked whether the Department had discussed or proposed the concept of a medical certificate with the American Academy of Pediatrics, meaning those pediatricians in this Commonwealth who would have to provide these certificates.

 PSBA commented that the Department would need time to develop a new medical certificate and make it available. PSBA and PSEA stated that doctors and parents would have to be educated on the new requirements and how to use the certificate. PSBA recommended that the Department develop and provide training and education materials to school entities and families to assist in this implementation.

 As the Department noted in the proposed rulemaking, the medical certificate is a new requirement. The Department set out the contents of the medical certificate in the proposed rulemaking, and has not revised that content in this final-form rulemaking except to specify the health care providers who may sign the form. The medical certificate is intended to contain student's immunization plan, setting out the schedule on which the student will receive the missing immunizations. The form is to be filled out and signed either by a physician, CRNP or PA, or, when the immunizations are being provided by the Department or a local health department, by a public health official. See the definition of ''medical certificate'' in § 23.82 (relating to definitions). The Department will provide the medical certificate form to schools. The Department attached a draft of the medical certificate form to the RAF for this final-form rulemaking as Attachment 3, and will also share that form with physician's groups, including AAP and other stakeholders, to obtain their input. The Department expects to post the medical certificate form on its web site by March 2017. The Department intends to provide training and educational materials to schools to use with families on this issue.

 Several commentators asked whether the medical certificate was something new, and if the Department would provide an official medical certificate to school nurses so that school nurses could have physicians complete the form for students. Several commentators asked about the form of the medical certificate and what it would look like. One commentator asked whether a printout from the child's physician, stating when the next appointment to get the immunizations completed was scheduled, was sufficient. Several commentators asked whether the medical certificate would be coming from the physician, and whether any writing from a practitioner would be sufficient. The commentators asked whether they should be providing a medical certificate.

 The medical certificate is a new requirement. The Department will make a medical certificate form available to schools by March 2017. No other form of written communication, including an appointment printout, is sufficient.

 One commentator was trying to be proactive by sending out letters regarding the proposed rulemaking and that people were confused about the term ''medical certificate.'' She stated that people were not going to know what that was and asked whether she could use the phrase ''you may submit documentation from your physician.''

 The Department cannot dictate to school nurses what letters they send to parents and children in their school districts. Until this final-form rulemaking is finally promulgated, the amended regulations are not effective. Therefore, the Department would recommend making no notification to parents until that time. With respect to the statement ''you may submit documentation from your physician,'' this is not accurate or compliant with the regulation. A parent shall submit a medical certificate signed by a PA, CRNP or physician that lists what immunizations remain to be obtained, and when they will be given. This is the only documentation acceptable to comply with the regulations. The regulations define ''medical certificate'' in those words. The Department attached the draft medical certificate form to the RAF for this final-form rulemaking and will publish the medical certificate form on its web site, seek input from stakeholder groups and provide the medical certificate form for school nurses to send out to parents in time for school registration in March 2017.

 One commentator asked whether a child could be excluded from school if the parent fails to adhere to the schedule on the certificate, and the practitioner keeps extending the date. Another commentator asked whether the school nurse was required to call the physician to see if the parents of a child with a medical certificate follows through with the appointment and completes the required immunizations. The commentator also asked what allowances were to be given for missed appointments. The commentator asked whether the child should be immediately excluded from school.

 The regulations place the responsibility on the school administrator and the school administrator's designee, who can be the school nurse, to check the medical certificate every 30 days to determine whether or not a child has received the required immunizations. It is certainly within the discretion of the school administrator or a designee to determine that the best way to carry out this responsibility is to telephone the physician's office, although HIPAA issues will arise unless the parent or guardian has given that office consent to speak with the school. With respect to the issue regarding missed appointments, the responsibility to obtain the required immunizations still remains on the parent and guardian of the child in question. If they do not provide the required information to the school, there is no requirement that the school go hunting for it, and the child is then at risk for exclusion for failure to comply with the immunization schedule included in the medical certificate.

 If the child's practitioner continues to update the schedule, the school administrator will need to determine what if any action to take, although the Department notes it is within the practitioner's scope of practice to make that determination, and the Department assumes a school would accept that update. The Department does not provide advice on what actions to take under these circumstances, since the Public School Code of 1949 places the responsibility on the school administrator or a designee.

 PSBA and PASA opposed the proposed amendment from 60 to 30 days for reviewing the medical certificate. While supporting a shortened time frame as a method to seek greater parental accountability, PSBA expressed concern that the increased requirement to monitor and contact parents on a monthly basis would create an administrative burden for school district staff who have to schedule additional time to review files and communicate with parents. PASA stated that this time frame was too burdensome given the realities of current resources and administrative capacity in school districts and school entities across this Commonwealth. PASA stated that due to budgetary reasons, since 2011, school districts have lost more than 600 administrators and administrative positions. In these associations' view, reducing the review period, while noble in its objective, ignores the realities of already overstressed and limited administrative capacities of school districts. PSBA and PASA recommended an interim step of 45 days to review the medical certificate to provide for improved monitoring of compliance with the immunization schedule.

 IRRC noted that commentators stated that the 30-day time frame creates an administrative burden, and that the commentators had requested a middle ground time frame. IRRC asked that the Department explain the reasonableness of the time frame and how it adequately protects the public's health.

 The Department is aware of budgetary issues that create difficulties in administering school districts. The Department notes that it received comments from school nurses stating that it is the school nurse, rather than the actual school administrator or other school staff, who oversees compliance with immunization requirements. The Department cannot speak to how each school district handles immunization compliance. The Department believes that 45 days is too long a time period to determine whether or not a student remains in compliance with that student's vaccine schedule. The Department points out that it has consistently sought throughout these amendments to shorten time frames in certain circumstances to 30 days. For example, the time frame for immunization records to be produced for children who transfer into a school in this Commonwealth or who are in foster care is 30 days. Likewise, the time frame for review of the medical certificate is 30 days. While some risk remains for every day a child goes without an immunization, the Department has attempted to balance that risk with the school's need for time to carry out this requirement. The Department believes that 30 days is the appropriate period of time.

 School nurses commenting on the proposed amendments have not suggested that once the initial review of the immunization status of their students is completed, it is too onerous to review every 30 days the status of those students missing some immunization. Further, not all children will be without vaccinations. The number provisionally admitted in the 2015-2016 school year was 21,175, or roughly 7.6% of students enrolled in reporting schools. See ''School Immunization Summary 2015-2016.'' School administrators will only be required to follow up with those students with missing or incomplete immunization records; if the commentators are correct, the pressure of a serious deadline may bring about compliance. As other commentators have noted, the shortened time period for compliance will shorten the time period for follow-up calls and letters from those required to call for that compliance. Further, the Department is providing ample notice of the shortened time frame for these compliance requirements. As has been discussed throughout this preamble, the Department intends to conduct outreach to all the parties concerned in the hopes of reducing the numbers of noncompliant children without exemptions by fall 2017.

 In addition, the Department is now requiring that, in the absence of an exemption or a waiver, a child may only remain in school without the required immunizations if he is complying with the immunization schedule in the medical certificate that has been signed by a physician, CRNP or PA. The Department's intention is to transform what was a seemingly endless time period (that is, 8 months) in which children could go without complying with the regulations and with little required compliance into a medically sanctioned time frame in which the child, his parents or guardians, and the physician, CRNP or PA giving the immunizations, agree that this immunization will be completed. This amendment signals the seriousness of the Department's purpose to ensure that children obtain vaccinations for their own protection, and to protect others from vaccine-preventable diseases as quickly as possible, rather than allowing these children to be at risk for a seemingly endless provisional period. If the school administrator or a designee takes up to 45 days to determine whether or not a child is complying with an immunization schedule set out by the physician, CRNP or PA, and only then seeks to obtain compliance, the Department's attempt to shorten the period in which nonimmunized children and adults remain at risk will not seem serious, and the Department's goal of stressing the importance of these compliance requirements will be undermined.

 One commentator stated that she supported the proposed amendment from 60 to 30 days for reviewing the medical certificate, but asked that the wording be changed to reflect that the school nurse would be excluding a child, since this is what actually occurs. One commentator asked that the regulation include the term ''designee,'' that is, the school nurse, since the school nurse actually looks at the certificates.

 The Department has not revised this final-form rulemaking, which already included the language allowing the school administrator's designee to review the medical certificate. Although the Department does not doubt that in many cases the onus of actually implementing the exclusion falls upon the school nurse, the language in question comes specifically from the Public School Code of 1949. Further, for these purposes, as recognized by one commentator, the school nurse may act as the designee of the school administrator, and is in fact doing so.

§ 23.85(e)(1)(ii) and (iii)—Multiple dose vaccine series—medical certificate

 IRRC commented that proposed § 23.85(e)(1)(ii) and (iii) ended with similar language that states that a child's parent or guardian shall provide a medical certificate scheduling the required doses on or before the 5th school day. IRRC stated that it is unclear whether the parent or guardian is to schedule the dose on or before the 5th day, or provide the certificate on or before the 5th day, and asked the Department to clarify this matter.

 The Department revised this final-form rulemaking. It was the Department's intention that the child either have the immunization on or before the 5th day, or that the parent or guardian present a medical certificate to the school on or before the 5th day. In this final-form rulemaking, § 23.85(e)(1)(ii) and (iii) states that the parent or guardian shall provide a medical certificate on or before the 5th school day scheduling the additional required doses. A minor change was made to § 23.85(e)(1)(iii) to add ''the'' and ''required'' to parallel § 23.85(e)(1)(ii).

 A commentator also raised issues regarding the cost of obtaining a medical certificate, stating that this was not sufficiently addressed by the Department in the proposed rulemaking.

 The Department acknowledged in the preamble and the RAF for the proposed rulemaking additional time and costs created by the need to obtain a medical certificate signed by a physician, CRNP or PA¹² in the event the child needs additional doses of a multiple dose vaccine. This should not add significantly to the time requirements for parents and guardians that have resulted from the regulations. For more than 30 years, children have been required to have certain immunizations to attend school, and must go to a health care provider to get either those immunizations or a medical exclusion. The health care provider giving an immunization may fill out the certificate of immunization and sign it.¹³ See the definition of ''certificate of immunization'' in § 23.82. Although the number of immunizations may have changed over those years, the requirement for a certificate of immunization has not. The regulations have always allowed children (those without medical or religious/philosophical exemptions) who are not appropriately vaccinated to attend school provisionally even if their vaccinations are not up to date. Under former § 23.85(e)(1) and (2), the provisional period as they existed prior to this final-form rulemaking, the Department required that parents and guardians have a ''plan for [the] completion of the required immunizations [that] is made part of the child's [school] health record,'' and, under former § 23.85(e)(3), that the plan be reviewed every 60 days by school administrators or their designees. Under former § 23.85(e)(3), immunizations were to be added to the child's certificate of immunization, also defined by the regulations, or entered into the school's electronic database.

 The Department's immunization data, drawn from its SILR reports, see § 23.86, shows that although many of the children admitted provisionally eventually do become vaccinated, they do not do so particularly quickly. Compare data on provisional admittance from the ''School Immunization Summary 2014-2015'' with the ''School Immunization Summary 2015-2016.'' This concerns the Department because the longer the periods of time in which clusters of nonimmunized children are allowed to remain in schools, the longer the remainder of children and adults who are not immunized or are unimmunized are at risk for potential outbreaks of disease. The Department has shortened the provisional period for this reason.

 The Department has also attempted to address this concern by formalizing the requirement of the plan of immunization by requiring a medical certificate. The medical certificate is actually a reviewed and accepted plan of obtaining immunizations by a date certain. Rather than a vague immunization plan, which is not required to be formally reviewed and accepted by the provider who will be providing the immunizations, the Department is requiring the immunization plan, in the form of a medical certificate, to be formally signed by a physician, CRNP or PA, or a public health official when the vaccines are given by the Department or a local health department. This at least provides some assurances that the immunization plan offered, and which permits the child to continue to attend school past the original 5-day period of the provisional admittance, has been discussed and approved between parents or guardians and health care providers. The Department believes this should encourage vaccinations to occur more quickly than is currently happening, at least among those children who will be immunized at some point during the school year. The Department acknowledges that those who do not believe in immunizations will continue to remain unvaccinated; they are permitted to do so under the law. This, to the Department, is one more reason to ensure the remainder of those children who have simply been slow to obtain up-to-date immunizations are immunized as quickly as possible.

 Despite these facts, the Department has figured in a time cost, as well as a cost for the paperwork itself in addressing the cost to the regulated community in the RAF for this final-form rulemaking. The cost of obtaining a medical certificate should be the cost currently involved in obtaining sign off on certificates of immunization. If there is additional cost, this could be a copayment, which the Department has determined, based on studies, to be at the highest amount $29.07, if privately obtained, or an administration fee, at the highest, approximately $24.13, if obtained from a public source, and a cost for completing paperwork. Although one study used a public fee amount of approximately $8.15, the Department's experience shows an administrative fee of approximately $24.13. See ''Supplement to Benefit,'' p. 4. The cost for completing paperwork can cost $5 to $55, although it appears that practices charging more than $21 are in the minority. See http://www.mgma.com/blog/should-your-medical-group-practice-charge-for-patient-forms and http://www.amednews.com/article/20071015/business/310159994/4/. The Department assumed a cost of approximately $20 per form, which appears to be roughly the most common amount charged. The Department and local health departments do not charge a paperwork fee.

 In the Department's view, the savings in prevention of vaccine preventable illnesses for both the child in question, and other children and adults with whom that child comes into contact, would outweigh the cost of the vaccine and the cost of the visit to obtain the medical certificate. The Department developed a medical certificate format for schools to use.

§ 23.85(g)(2)—Applicability—30-day waiver if transferring into school in this Commonwealth

 One commentator questioned the Department's allowing time for a student transferring into a school to provide proof of immunization. The commentator stated that a child transferring among schools in this Commonwealth should be able to obtain the child's immunization status when the child is withdrawn from school. The commentator noted that parents are routinely leaving schools and not withdrawing children, so that they never pick up immunization records. The commentator also noted that these children are not being enrolled immediately into school. In addition, the commentator questioned why the Department was allowing children whose immunological status could not be verified to risk the health of children who need to be protected by herd immunity. The commentator noted that if a child is coming from out-of-State and there is not a question of the child being homeless there was a risk.

 PACIC and two other commentators stated that a child should be given 60 days rather than 30 days to complete paperwork. According to one commentator, 30 days might not be enough and a child might be pressured to be revaccinated to attend school. IRRC also asked that the Department explain the reasonableness of the time frame and show how the time frame protects the public's health. IRRC asked that the Department provide evidence for why it chose a 30-day time period rather than any other.

 One commentator stated that a 90-day period would eliminate any problems with completing paperwork. The commentator was concerned that paperwork mix-ups in the 30-day window could result in revaccination.

 The Department has not revised this final-form rulemaking. If a child's school records exist, 30 days should be ample time to obtain them and to submit them to the new school. The Department agrees with some commentators that even 30 days may potentially put children and adults who cannot be vaccinated at risk from potential illness. The Department is attempting to balance the need for protection against disease with the need to allow a child and his parents or guardians the time to settle into a new school, a new area and to obtain necessary immunizations that may differ from those in other states. The Department is requiring children known to be unvaccinated, and who are being admitted provisionally on a formalized immunization plan approved by a medical provider, to have that medical certificate checked every 30 days to make certain the child is in compliance. See § 23.85(e)(3). This 30-day period seems to the Department to be an appropriate time frame to ensure compliance with the immunization plan and protect the remainder of the school population. It seems appropriate to the Department that a child who states that he is vaccinated, but needs time to provide records, receive that same 30-day period to provide evidence of immunization. It is the Department's hope that with the increasing prevalence of electronic records, 30 days will be unnecessary.

§ 23.85(g)(3)—Applicability—waiver if the child is in foster care

 One commentator raised a question regarding the implications of the proposed rulemaking for children in foster care, and asked that the final-form rulemaking address that issue.

 The Department adds § 23.85(g)(3) to allow for a 30-day waiver for children in foster care. A child will have 30 days to provide immunization records to the school showing proof of immunization, to provide a medical certificate or to satisfy the requirements for an exemption. A child who is unable to provide the necessary records may be excluded at the end of the 30-day period and in subsequent school years until the requirements of Chapter 23, Subchapter C are met.

§ 23.85(h)—Temporary waiver

 PASA supported the proposed subsection permitting the Secretary to issue a temporary waiver of the immunization requirements if a disaster emergency prevents the child from obtaining immunization records, or if a National shortage of vaccines occurs.

 The Department agrees with the commentator.

 IRRC asked whether there could be a regional shortage of vaccine and whether that should also trigger a temporary waiver.

 A regional shortage of vaccine is possible, although not likely. In the event of this occurrence, the Department would apply to the CDC for help and the CDC could choose to redirect available vaccine to the particular area in question. There would be no need to require a waiver.

§ 23.84. Exemption from immunization

 Several commentators raised objections to the philosophical exemption, even though it was not a part of the proposed rulemaking, stating that it was too generalized and encouraged parents who have secondary reasons to refuse immunizations to utilize that section as a loop hole to avoid complying with the requirements. One commentator said getting an exemption should be harder than just having to sign a card. One commentator recommended that the Department require church leaders in a child's denomination to legitimize a religious exemption in the same way that a physician signs off on a medical exemption. The commentator stated that this provision is a ''catch-all.'' One commentator recommended that temporary exemptions be reviewed annually, unless a longer period is indicated by the treating physician, and should not exceed a 24-month period. One commentator said that if the exemption were eliminated, parents could still refuse to immunize, but they would have to find alternative education arrangements rather the public school systems where fragile children were put at risk.

 The Department has not revised the regulation. The medical and religious exemptions to vaccine requirements are set in statute and may only be changed by the General Assembly. The so-called ''philosophical'' exemption is merely an explication of existing constitutional law regarding what constitutes a religious exemption. In fact, the Department has noted that in many schools with lower MMR rates there are no religious or medical exemptions. See School Level Data 2014 and 2015, Attachments 1 and 2 to the RAF for this final-form rulemaking. Further, with the change in reporting times from October to December in 2014, and then into March 2016 for the 2015-2016 school year, the immunization rates increased, and the number of children in provisional status decreased. See School Level Data 2014 and 2015, Attachments 1 and 2 to the RAF for this final-form rulemaking. This leads the Department to believe that students are simply waiting to be vaccinated. The Department does not believe that vaccination rates in this Commonwealth were impacted by large numbers of religious and medical exemptions; the 8-month provisional period was responsible for lower rates. Shortening the time period for providing a formalized immunization plan, now referred to as a medical certificate, and requiring adherence to that plan should increase vaccination rates more quickly.

 One commentator, identifying herself as a board-certified family practitioner, stated that there should be compelling philosophical reasons for parents to be permitted not to vaccinate their children. The commentator pointed out that the choice not to vaccinate a child impacts more than that child. There are children and adults who cannot be vaccinated (for example, those with HIV or undergoing chemotherapy). According to the commentator, several vaccine preventable diseases, like chickenpox, are contagious 1 or 2 days before any outward signs occur, so that unvaccinated children are subject to harm before anyone is aware of the danger.

 The Department agrees with the commentator, but has not amended the regulation. The medical and religious exemptions to vaccine requirements are set in statute and may only be changed by the General Assembly. The so-called ''philosophical'' exemption is merely an explication of existing constitutional law regarding what constitutes a religious exemption.

 Multiple commentators, including PACIC, stated that each school district creates its own language in communicating with parents regarding vaccine requirements, provisional periods and reporting. The commentators recommended that the regulations be amended to require school districts to use uniform language provided by the Department which would include § 23.24. Several commentators stated that without this information on these important rights, persons will not know whether there are substances in the vaccines that could cause dangerous side effects, and persons with particular religious beliefs, particularly regarding abortion, will be unable to exercise that right since some vaccines have aborted fetal tissue. Another commentator stated that school districts who do not share this information are misrepresenting the truth when they inform parents that immunizations are required for school admission. Several commentators stated that the Department and the Department of Education should create and administer a standard form.

 The Department has not revised the regulation. The Department believes that the language in statute and in the regulations stating that religious and medical exemptions are available is sufficient to inform parents and guardians of their availability. The requirements regarding medical and religious exemptions are not enforced by the Department. The statutorily permitted exemptions are within the purview of the school administrator and the designee to consider, and the Department does not have the statutory authority to regulate those exemptions. While the Department's enabling statutes give it, with the approval of the Board, the authority to create a list of diseases against which children shall be immunized to attend school, those statutes do not give the Department the authority to provide guidance on what constitutes a religious or medical exemption, or how those exemptions should be explained by a school to its students and their parents and guardians. The issue of whether a child has a medical contraindication to a vaccine and should be granted a medical exemption is a medical issue to be decided by the physician who signs the exemption or a designee. The issue of whether a school will accept a religious/philosophical exemption is up to the school and its solicitor. The Department cannot provide legal advice on either of these matters, either to the school or the public. Further, the Department cannot dictate language to school administrators. The Department is happy to, and does when requested, provide advice on communications.

 One commentator asked that no change to vaccine policy be made, and that the Department not take away the right to the current exemptions. The commentator stated that the number of unvaccinated children is not due to a lack of concern or unawareness of the risks involved in not vaccinating children; rather, it is a firm decision not to vaccinate based on religious beliefs and on evidence that vaccines, with their harmful ingredients, do more harm than good. Another commentator asked the Department to continue to allow parents the right to refuse vaccinations for their children.

 The Department has not eliminated the medical and religious exemptions that exist in statute and does not have the authority to eliminate those exemptions. Only the General Assembly can remove those exemptions. The Department disagrees with the commentator that valid, peer-reviewed, scientific studies exist that show vaccines do more harm than good. The Department points to the ''Benefits from Immunization'' study and supplement discussed more fully in this preamble.

 One commentator took issue with statements made by another commentator that a religious leader from a church legitimatize a religious exemption. The commentator stated that this was just another way of trying to strip parents of their right to be in charge of their children's health care. The commentator stated that parents do not need a religious leader to sign a paper saying that injecting children with aborted fetal tissue or animal DNA is against the parents' religion, the parent can state that themselves. The commentator stated that a parent's beliefs are a parent's beliefs. The commentator warned the Department that ''[y]ou are not the parent.''

 The Department cannot be responsible for the viewpoints of the commentators that write to express their opinions regarding these or any regulations. The Department received a wide range of differing views, most passionately held, on the issue of vaccination, exemptions and human and parental rights. As previously stated, the Department cannot make any an amendment to the exemption requirements in the Public School Code of 1949. Parents and guardians will still have access to the same exemptions that have always been available.

§ 23.86. School reporting

 Multiple commentators, including PASA and PSBA, supported the proposed amendment of the reporting date from October 15 of each school year to December 31 of each school year. Many of these commentators stated that the later reporting date would give the Department additional time to prepare more accurate reports. PSBA stated that this is consistent with the Department's current practice of granting extensions from the October deadline upon individual district request. PASA asked that the Department ensure that the data collected is absolutely necessary, and that the electronic system being used is easy to use and designed to minimize the reporting burden on local educational agencies. PASA also stated that training on the system should include webinars and on demand videos to minimize staff time and travel.

 The Department appreciates the commentators' support. In response to PASA's comments regarding the electronic system, the Department notes that the electronic system is currently in place, has been in place since approximately 2007 and is being utilized by school nurses now. Because not all school districts report electronically, the Department determined that requiring electronic reporting will speed up the process at every level, and hopefully result in more accurate reporting. The Department revised the language in proposed subsection (b) from those schools who ''cannot'' report electronically to those schools who are ''unable to'' report electronically to emphasize that all schools that have the means to complete reports electronically should do so. The Department intends to do training.

 PACIC commended the Department's decision to take action to correct statistical errors caused by years of insufficient data collection through the Department's flawed reporting system, which required data to be reported 7 months before the students final deadline to turn their paperwork into schools. The commentator stated that the Department should not use this as an excuse to require additional immunization requirements, but should analyze the data and decide whether to make changes. PACIC stated that since the level of exemptions is low, it must be realized that the low rate for MMR for kindergarteners is inaccurate. PACIC stated that the responsible thing to do in the light of statistical errors to correct the reporting, and then based on accurate data determine whether further action is necessary to reach the herd immunity goal, which PACIC notes is unspecified.

 The Department appreciates the support of the commentator, but does not believe its SILR reporting system to be flawed because reports were due 7 months prior to a deadline for students. In fact, students are required to have their immunizations on school entry and to attend school. Simply because the regulations allow for a provisional period to enable those students who may have had some problem in obtaining the required vaccination does not mean that all students are permitted by the regulation to wait that length of time. The Department's amendment to the requirement is to allow schools additional time to get all information, not to correct some mistake on the Department's part. Further, the Department's decision to add MCV in the 12th grade and to clarify the pertussis requirement had nothing to do with reporting of vaccine data. The Department's review of the rates of immunization in schools and school districts in this Commonwealth, which, admittedly, does rise with moving the report to a later date, did lead to the Department's concern with the length of the provisional period.

 Three commentators raised the question of privacy. One commentator asked how the Department and the Department of Education will protect medical privacy and ensure that children will not suffer the loss of privacy with the requirement of electronic reporting. The commentator stated that one school district places her child's immunization status on her lunch account, which means that everyone with access to her child's personal account can see her vaccination status on her lunch account. The commentator stated that this was a ridiculous system, and did not afford her daughter the privacy she deserves with respect to medical decisions.

 The Department's electronic reporting requirement does not require reporting of student identifying information to the Department. No student names or records are provided to the Department when reports are made under § 23.86. Under this section, schools report aggregate data to the Department, for example, numbers of immunizations by type and in certain years.

 With respect to the commentator's concern about a student's immunization information records, the Department's requirements for electronic reporting of aggregate immunization data have no impact on how a school chooses to keep its students' education records. In fact, that question involves section 444 of FERPA, which protects a student's privacy. FERPA does not apply to a child's immunization information, which is not considered to be a student education record within the purview of FERPA. See http://www.astho.org/programs/preparedness/public-health-emergency-law/public-health-and-schools-toolkit/comparison-of-ferpa-and-hipaa-privacy-rule/. If a school chooses to maintain immunization information as part of an education record, rather than as part of the records of the nurse's office, and a school did place immunization information kept in that manner on a lunch account that may be viewed by any person, a FERPA violation may have occurred. Enforcement of FERPA is not within the authority of the Department or of the Department of Education.

 IRRC asked whether the Department should also be seeking reporting of students in the 12th grade who were denied admission because they could not provide documentation of the required dose.

 The Department has not revised this final-form rulemaking. The Department's requirement for school reporting is based upon CDC requirements that the Department report certain information for the purposes of its Federal vaccine grant. The CDC only looks at data for kindergarten and 7th grade. Without an additional Federal reporting requirements, the Department is disinclined to place an additional administrative requirement on schools.

 Several commentators raised concerns that the Department is requiring electronic reporting of homeschool programs, but is not permitting those who homeschool their children, and are unable to report electronically, to report on paper forms.

 Significantly, these concerns were not raised during the public comment period on proposed rulemaking, but only during the period prior to the hearing before IRRC on October 20, 2016. The Department responded to those concerns at the hearing and revised this preamble to include its response. In fact, the commentators misapprehended the pertinent sections of this final-form rulemaking. Section 23.86(a) defines by example ''public, private, parochial or nonpublic school,'' and includes in that definition ''home education programs.'' This language has always existed in this section and is not new to this final-form rulemaking. In this final-form rulemaking, the Department adds subsection (b) that states that if ''a public, private, parochial or nonpublic school is unable to complete its report electronically, it shall report to the Department. . .using a form provided by the Department.'' The Department does not repeat the definitional phrase ''including vocational school, intermediate units, special education and home education programs'' in subsection (b). The Department does not need to carry the definitional phrase from subsection (a) to subsection (b). Once defined, the term remains defined throughout § 23.86. Accordingly, ''public, private, parochial or nonpublic school'' includes a home education program in subsections (a) and (b), regardless of whether the definitional phrase is included in both subsections. Therefore, even if a homeschool parent were required to report directly to the Department under subsection (a), which the parent is not, that parent could report on a paper form if he were to unable to report electronically under subsection (b).

 In addition, the Department has never required, and does not require in this final-form rulemaking, a homeschool parent to report directly to the Department. The Department does not collect information on individual students. Under this final-form rulemaking, homeschool parents will continue to provide information on their children's immunization status to the school in the school district in which they reside; it is the school that then reports to the Department. This final-form rulemaking does not change that process. A homeschool parent is not required to report to the Department directly, either electronically or on paper, but will continue providing information to the school their child would have attended.

C. Cost and Paperwork Estimate

1. Cost

a. Commonwealth

 The Commonwealth will incur some costs for the purchase of MCV through the expenditure of Federal immunization grant funds for the purposes of the VFC Program. The Commonwealth already expends Federal grant funds for the purchase of DTaP. The Department does not expect an increase in costs for DTaP from this final-form rulemaking, since pertussis is already included in the DTaP vaccine, which is the vaccine that most children were being given to meet the diphtheria and tetanus requirements. The Department makes vaccines available at no cost to private providers enrolled in the VFC Program for children through 18 years of age who have no insurance, who are Medicaid eligible, or who are Alaskan Native or American Indian. In addition, VFC Program vaccine is also made available to other public clinic sites (FQHCs and Rural Health Clinics) for the same population, and also for underinsured children through 18 years of age. Vaccines are made available to schools at no cost through the Department's School Immunization Catch-Up Program for those students who have no medical home or are unable to seek the immunization through a public clinic site. The Commonwealth will realize savings based on the amount of funds that will not be needed to control the outbreak of vaccine preventable diseases. The Department discussed potential costs related to vaccine preventable diseases elsewhere in this preamble.

 The Commonwealth may incur additional cost from printing and providing form medical certificates to schools in this Commonwealth.

b. Local government

 There will be no fiscal impact on local governments. Local governments may see a cost savings since local governments with county or municipal health departments do bear some of the cost of disease outbreak investigations and control measures. The Department addresses the potential impact of this final-form rulemaking on school districts, which may be considered to be local government, as follows.

c. Regulated community

 Families whose children's vaccinations are covered by their insurance plans (public or private) under the ACA will not see any out-of-pocket cost for MCV or DTaP vaccines, although they may have additional copayments. According to the Insurance Department, over 92% of the residents of this Commonwealth are covered by insurance. Families whose insurance plans do not cover these vaccinations, or who do not have insurance, may obtain vaccines at a small administrative fee from the VFC Program through VFC providers, the Department's State health centers and FQHCs. A child may not be denied a vaccine because of his family's inability to pay the administrative fee. The Department is available to provide a list of providers if necessary. The Department also provides vaccines to schools through its School Immunization Catch-Up Program, although it is up to the school to request participation. In addition, obtaining a medical certificate signed by a physician, CRNP or PA, or a medical exemption, may require an additional visit to the practitioner, and either an additional copayment or a paperwork fee. Trips to the practitioner's office could result in loss of work time; however, similar and greater losses in work time could result from failure to immunize the child. The Department discussed the costs related to an illness in reference to an outbreak situation elsewhere in this preamble. In addition, the Department made the effective date of this final-form rulemaking coincide with the beginning of the 2017-2018 school year but is publishing this final-form rulemaking in March 2017 so that parents and guardians have nearly 6 months to plan for their 12th grade students to receive an MCV vaccine, as well as to ensure that their children who are not up-to-date with existing requirements receive the appropriate immunizations. This should be sufficient time to plan for necessary appointments and avoid work time lost.

 The Department firmly believes that savings in prevention of childhood illness and death would outweigh the minimal cost of the MCV and DTaP vaccine, despite potential adverse events as described by commentators. The Department addressed the cost-benefit analysis of requiring MCV and pertussis vaccination and of childhood immunization in general elsewhere in this preamble.

 The Department deleted the proposed requirement which potentially added the greatest cost for parents and guardians, the requirement that a school was to accept a history of immunity from varicella only from a physician, CRNP or PA, rather than from a parent or guardian.

 School districts and schools may see added cost from time spent by school administrators and their designees (most likely school nurses) reviewing the immunization status of children for school entry and attendance. Although schools are already performing this responsibility, the time frame for the review has been reduced. The Department also extended the time to prepare for the implementation of the regulations in the 2017-2018 school year by publishing this final-form rulemaking in March 2017 in time for kindergarten registration and nearly 6 months prior to the start of the 2017-2018 school year. The Department believes that this additional time will enable schools to provide information to parents and guardians regarding the amendments to the regulations nearly 6 months prior to the effective date, and allow parents and guardians ample time to make plans to either obtain immunizations for their children or to obtain an exemption. The extended time for implementation will provide schools and school nurses with the remaining months of the 2016-2017 school year to begin to prepare for the amendments to the required immunizations (which are minimal) and for the shortened provisional period. Schools and school nurses will be able to begin to review immunization status of students, to provide information to parents and guardians and to determine which students may have issues in the beginning of the 2017-2018 school year. The Department believes that the 5-day provisional period is necessary, despite the potential increase in cost for time spent because the savings in the prevention of an outbreak of a childhood illness in a school district outweighs the cost in staff time. The Department more fully discussed the potential costs involved in a school outbreak of a childhood disease elsewhere in this preamble.

 To the extent that physicians or their designees are requested to provide a medical exemption for a student, these practitioners could also be affected tangentially. Physicians, CRNPs and PAs will also be affected by the fact that children missing doses of multiple dose vaccines will need the practitioner to sign a medical certificate setting out the time frame for obtaining those vaccinations for the child to be allowed to enter and attend school.

d. General public

 The general public will not see an increase in cost. Neither insurance costs nor the cost of the VFC Program should increase because the Commonwealth has chosen to add MCV to the list of required immunizations, or has formalized the addition of a vaccination against pertussis for school attendance. Because these immunizations are already recommended by ACIP, their cost has already been figured into both premium costs and the cost of the VFC Program.

 The general public will see a decrease in costs resulting from a reduction in medical treatment needed to treat the disease and a reduction in the loss of work to stay home with a sick child. The general public may see a benefit in the reduction of vaccine preventable diseases, such as pertussis, chickenpox, mumps and meningitis. Since the school environment is conducive to the contracting and transmission of diseases among children with no immunity, failure to immunize properly not only puts children at risk for contracting these debilitating diseases, it also places the public at risk since these diseases are then easily spread by staff and children outside the school setting and into the general public. The Department provided a more detailed explanation of studies supporting these conclusions elsewhere in this preamble. The cost of this final-form rulemaking on parents, guardians and students is addressed under ''regulated community.''

2. Paperwork estimates

a. Commonwealth and the regulated community

 Schools will be required to report in accordance with the new reporting requirements, which push reporting back to December of each year. School administrators and their designees, mainly school nurses, will continue to report the number of doses of individual antigens that have been administered to students. Although pertussis and MCV have been added to the list of required immunizations, neither of these requirements will impact school reporting, since pertussis is already included in the DTaP vaccine, which is the vaccine that most children were being given to meet the diphtheria and tetanus requirements, unless the child had a contraindication, and is already collected for reporting to the Department in kindergarten and 7th grade. MCV, required in the 12th grade, will not need to be counted for reporting to the Department. The paperwork caused by this requirement should be minimal, since school districts already complete an annual report regarding the number of immunizations. The Department is now requiring that schools provide their reports electronically, and will provide schools with training on the Department's electronic reporting system. Prior to this final-form rulemaking, schools were encouraged to report electronically, but were not required to do so. The Department will continue to allow schools that are unable to complete reports electronically to provide paper reports on forms provided by the Department.

 School administrators and their designees, mainly school nurses, will be required to review the immunization status of incoming children, as they are currently required to do, but within a shorter time frame. Since pertussis is already included in the DTaP vaccine, which is already counted, this will not require additional review by the school, the only new immunization schools shall ensure that students have is MCV, and only among the students entering 12th grade.

 School administrators and their designees will also be required to accept medical certificates, which must contain a formalized plan of immunization for those students who are not in compliance with the immunization requirements, and they will be required to review those medical certificates every 30 days, rather than every 60 days. Follow-up regarding those medical certificates, and exclusion of students when necessary, will be the responsibility of the school, as it has always been. School administrators and their designees already review immunization plans and make decisions regarding provisional enrollment. Because of the reasons cited in this preamble, this will now occur in a shorter time frame. The Department will provide a medical certificate form to schools and attached a draft copy to the RAF for this final-form rulemaking as Attachment 3.

 The Department will need to review and include reported numbers of doses in its report to the CDC for students in kindergarten and in the 7th grade, as it currently does. There will be no new vaccine listed on those reports.

 The additional paperwork requirements for the Commonwealth, including both the Department and the Department of Education, and the regulated community would be minimal since school districts already complete an annual report regarding the number of immunizations and follow up on provisional enrollment. Time frames will be shortened for those reasons previously cited in this preamble.

 Parents and guardians of children attending school in this Commonwealth, and those children who are not up-to-date with immunizations required for school entry and attendance at the beginning of the 2017-2018 school year, will be required to obtain either a medical certificate from a physician, CRNP or PA setting out the schedule upon which immunizations will be given, and signed by that provider. That medical certificate shall be submitted to the school within 5 days of the start of school to allow the student to remain in school while the immunization schedule is being followed. Parents and guardians will have to provide an updated certificate of immunization to the school as the child obtains his immunizations, or risk exclusion. A parent or guardian may provide the school with a medical or religious/philosophical exemption instead of the medical certificate to enable the child to remain in school without the required immunizations.

b. Local government

 There is no additional paperwork requirement for local government. The Department included school districts, which may be considered to be local government, under the ''regulated community'' heading.

c. General public

 There is no additional paperwork requirement for the general public. The Department addresses the cost of this final-form rulemaking on parents, guardians and students under the ''regulated community'' heading.

D. Statutory Authority

 The Department obtains its authority to promulgate regulations regarding immunizations in schools from several sources. Generally, the Disease Prevention and Control Law of 1955 provides the Board with the authority to issue rules and regulations on a variety of matters regarding communicable and noncommunicable diseases, including what control measures are to be taken with respect to which diseases, provisions for the enforcement of control measures, requirements concerning immunization and vaccination of persons and animals, and requirements for the prevention and control of disease in public and private schools. See section 16(a)(6) of the Disease Prevention and Control Law of 1955. Section 16(b) of the Disease Prevention and Control Law of 1955 gives the Secretary the authority to review existing regulations and make recommendations to the Board for changes the Secretary considers to be desirable.

 The Department also finds general authority for the promulgation of its regulations in The Administrative Code of 1929. Section 2102(g) of The Administrative Code of 1929 gives the Department this general authority. Section 2111(b) of The Administrative Code of 1929 provides the Board with additional authority to promulgate regulations deemed by the Board to be necessary for the prevention of disease, and for the protection of the lives and the health of the people of this Commonwealth. Section 2111 of The Administrative Code of 1929 further provides that the regulations of the Board shall become the regulations of the Department.

 The Department's specific authority for promulgating regulations regarding school immunizations is in The Administrative Code of 1929 and the Public School Code of 1949. Section 2111(c.1) of The Administrative Code of 1929 provides the Board with the authority to make and revise a list of communicable diseases against which children are required to be immunized as a condition of attendance at any public, private or parochial school, including kindergarten. The section requires the Secretary to promulgate the list, along with any rules and regulations necessary to insure the immunizations are timely, effective, and properly verified.

 Section 1303 of the Public School Code of 1949 provides that the Board will make and review a list of diseases against which children shall be immunized, as the Secretary may direct, before being admitted to school for the first time. The section provides that the school directors, superintendents, principals or other persons in charge of any public, private, parochial or other school, including kindergarten, shall ascertain whether the immunization has occurred, and certificates of immunization will be issued in accordance with rules and regulations promulgated by the Secretary with the sanction and advice of the Board.

E. Effective and Sunset Dates

 This final-form rulemaking will be effective August 1, 2017. This will allow parents, guardians and schools time to become familiar with the requirements, prepare for their implementation and obtain the required vaccinations prior to the start of the 2017-2018 school year. A sunset date has not been established. The Department will continually review and monitor the effectiveness of these regulations.

F. Regulatory Review

 Under section 5(a) of the Regulatory Review Act (71 P.S. § 745.5(a)), on March 29, 2016, the Department submitted a copy of the notice of proposed rulemaking, published at 46 Pa.B. 1798, to IRRC and the Chairpersons of the House Health and Human Services Committee and the Senate Public Health and Welfare Committee for review and comment.

 Under section 5(c) of the Regulatory Review Act, the Department shall submit to IRRC and the House and Senate Committees copies of comments received during the public comment period, as well as other documents when requested. In preparing the final-form rulemaking, the Department considered all comments from IRRC and the public.

 Under section 5.1(j.2) of the Regulatory Review Act (71 P.S. § 745.5a(j.2)), on October 19, 2016, the final-form rulemaking was deemed approved by the House and Senate Committees. Under section 5.1(e) of the Regulatory Review Act, IRRC met on October 20, 2016, and approved the final-form rulemaking.

G. Contact Person

 Questions regarding this final-form rulemaking may be submitted to Cynthia Findley, Director, Division of Immunization, Department of Health, 625 Forster Street, Harrisburg, PA 17108, (717) 787-5681. Speech and/or hearing impaired persons may use V/TT (717) 783-6514 or the Pennsylvania AT&T Relay Service at (800) 654-5984 (TT). Persons who require an alternative format of this final-form rulemaking may contact Cynthia Findley so that necessary arrangements may be made.

H. Findings

 The Department finds that:

 (1) Public notice of intention to adopt the regulations adopted by this order has been given under sections 201 and 202 of the act of July 31, 1968 (P.L. 769, No. 240) (45 P.S. §§ 1201 and 1202) and the regulations thereunder, 1 Pa. Code §§ 7.1 and 7.2.

 (2) A public comment period was provided as required by law and all comments were considered.

 (3) The adoption of regulations in the manner provided by this order is necessary and appropriate for the administration of the authorizing statutes.

I. Order

 The Department, acting under the authorizing statutes, orders that:

 (1) The regulations of the Department, 28 Pa. Code Chapter 23, are amended by amending §§ 23.82, 23.83, 23.85 and 23.86 to read as set forth in Annex A.

 (2) The Secretary shall submit this order and Annex A to the Office of General Counsel and the Office of Attorney General for approval as required by law.

 (3) The Secretary shall submit this order and Annex A to IRRC and the House and Senate Committees for their review and action as required by law.

 (4) The Secretary shall certify this order and Annex A and deposit them with the Legislative Reference Bureau as required by law.

 (5) This order shall take effect August 1, 2017.

KAREN M. MURPHY, PhD, RN, 
Secretary

 (Editor's Note: See 46 Pa.B. 7051 (November 5, 2016) for IRRC's approval order.)

 Fiscal Note: Fiscal Note 10-197 remains valid for the final adoption of the subject regulations.

Annex A

TITLE 28. HEALTH AND SAFETY

PART III. PREVENTION OF DISEASES

CHAPTER 23. SCHOOL HEALTH

Subchapter C. IMMUNIZATION

§ 23.82. Definitions.

 The following words and terms, when used in this subchapter, have the following meanings, unless the context clearly indicates otherwise:

 Ascertain—To determine whether or not a child is immunized as defined in this subchapter.

 Attendance at school—

 (i) The attendance at a grade, or special classes, kindergarten through 12th grade, including public, private, parochial, vocational, intermediate unit and home education students, and students of cyber and charter schools.

 (ii) The term does not cover the attendance of children at a childcare group setting, defined in § 27.1 (relating to definitions), located in a public, private or vocational school, or in an intermediate unit.

 Certificate of immunization—The official form furnished by the Department. The certificate is filled out by the parent or health care provider and signed by the health care provider, public health official or school nurse or a designee. The certificate is given to the school as proof of full immunization. The school maintains the certificate as the official school immunization record or stores the details of the record in a computer database.

 Department—The Department of Health of the Commonwealth.

 Full immunization—The completion of the requisite number of dosages of the specific antigens at recommended time and age intervals as set forth in § 23.83 (relating to immunization requirements).

 Immunization—The requisite number of dosages of the specific antigens at the recommended time intervals under this subchapter.

 Medical certificate—The official form furnished by the Department setting out the immunization plan for a student who is not fully immunized, filled out and signed by a physician, certified registered nurse practitioner or physician assistant, or by a public health official when the immunization is provided by the Department or a local health department, and given to a school as proof that the student is scheduled to complete the required immunizations.

 Record of immunization—A written document showing the date of immunization—that is, baby book, Health Passport, family Bible, other states' official immunization documents, International Health Certificate, immigration records, physician record, school health records and other similar documents or history.

 Secretary—The Secretary of the Department.

§ 23.83. Immunization requirements.

 (a) Duties of a school director, superintendent, principal or other person in charge of a public, private, parochial or nonpublic school. Each school director, superintendent, principal, or other person in charge of a public, private, parochial or nonpublic school in this Commonwealth, including vocational schools, intermediate units, and special education and home education programs, cyber and charter schools, shall ascertain that a child has been immunized in accordance with the requirements in subsections (b), (c) and (e) prior to admission to school for the first time, under section 1303 of the Public School Code of 1949 (24 P.S. § 13-1303a), regarding immunization required; penalty.

 (b) Required for attendance. All of the following immunizations are required as a condition of attendance at school in this Commonwealth:

 (1) Diphtheria, tetanus and pertussis. Four or more properly-spaced doses administered in a combination form (diphtheria and tetanus toxoids and acellular pertussis (DTaP) or diphtheria and tetanus toxoids and pertussis (DTP)). If a child has a contraindication to pertussis vaccine, the child shall receive diphtheria—tetanus toxoid vaccine (DT) to complete the vaccination series. The fourth dose shall be administered on or after the 4th birthday.

 (2) Poliomyelitis. Four properly-spaced doses of either oral polio vaccine or inactivated polio vaccine, which may be administered as a single antigen vaccine, or in a combination form. The fourth dose shall be administered on or after the 4th birthday and at least 6 months after the previous dose.

 (3) Measles (rubeola), mumps and rubella (German measles). One of the following:

 (i) Multiple antigens. Two properly-spaced doses of live attenuated measles, mumps, rubella combination vaccine, the first dose administered at 12 months of age or older.

 (ii) Single antigens. In the event the antigens were given separately, and not in a combination vaccine, the dosage is as follows:

 (A) Two properly-spaced doses of live attenuated measles vaccine, the first dose administered at 12 months of age or older.

 (B) One dose of live attenuated rubella vaccine, administered at 12 months of age or older.

 (C) Two properly-spaced doses of live attenuated mumps vaccine, administered at 12 months of age or older.

 (iii) Evidence of immunity. Evidence of immunity may be shown by a history of measles and rubella immunity proved by laboratory testing by a laboratory with the appropriate certification and a written statement of a history of mumps disease from a physician, certified registered nurse practitioner or physician assistant.

 (4) Hepatitis B. Three properly-spaced doses of hepatitis B vaccine, unless a child receives a vaccine as approved by the United States Food and Drug Administration for a two-dose regimen, or a history of hepatitis B immunity proved by laboratory testing. Hepatitis B vaccine may be administered as single antigen vaccine or in a combination form.

 (5) Varicella (chickenpox). One of the following:

 (i) Varicella vaccine. Two properly-spaced doses of varicella vaccine, the first dose administered at 12 months of age or older. Varicella vaccine may be administered as a single antigen vaccine or in a combination form.

 (ii) Evidence of immunity. Evidence of immunity may be shown by one of the following:

 (A) Laboratory evidence of immunity or laboratory confirmation of disease.

 (B) A written statement of a history of chickenpox disease from a parent, guardian, physician, certified registered nurse practitioner or physician assistant.

 (c) Special requirements for tetanus and diphtheria toxoids and acellular pertussis vaccine and meningococcal conjugate vaccine (MCV).

 (1) Required for entry into 7th grade. In addition to the immunizations listed in subsection (b), the following immunizations are required at any public, private, parochial or nonpublic school in this Commonwealth, including vocational schools, intermediate units, special education and home education programs, and cyber and charter schools, as a condition of entry for students entering the 7th grade, or, in an ungraded class, for students in the school year that the student is 12 years of age:

 (i) Tetanus and diphtheria toxoids and acellular pertussis vaccine (Tdap). One dose of Tdap in a combination form.

 (ii) Meningococcal conjugate vaccine (MCV). One dose of MCV.

 (iii) Exclusion. A child who does not have an exemption as permitted by § 23.84 (relating to exemption from immunization) and who does not receive the immunizations as required in subparagraphs (i) and (ii) may be excluded in that school year and each succeeding school year that the child fails to obtain the required immunization.

 (2) Required for entry into 12th grade. In addition to the immunizations listed in subsection (b) and this subsection, one dose of MCV is required for entry into 12th grade at any public, private, parochial or nonpublic school in this Commonwealth, including vocational schools, intermediate units, special education and home education programs, and cyber and charter schools, or, in an ungraded class, for students in the school year that the student is 18 years of age, if the child has not received a previous dose on or after the child's 16th birthday. A dose of MCV received at 16 years of age or older shall count as the 12th grade dose.

 (d) Child care group setting. Attendance at a child care group setting located in a public, private or vocational school, or in an intermediate unit, is conditional upon the child's satisfaction of the immunization requirements in § 27.77 (relating to immunization requirements for children in child care group settings).

 (e) Prekindergarten programs, early intervention programs' early childhood special education classrooms and private academic preschools. Attendance at a prekindergarten program operated by a school district, an early intervention program operated by a contractor or subcontractor including intermediate units, school districts and private vendors, or at private academic preschools is conditional upon the child's satisfaction of the immunization requirements in § 27.77.

 (f) Grace period. A vaccine dose administered within the 4-day period prior to the minimum age for the vaccination or prior to the end of the minimum interval between doses shall be considered a valid dose of the vaccine for purposes of this chapter. A dose administered greater than 4 days prior to minimum age or interval for a dose is invalid for purposes of this regulation and shall be repeated.

§ 23.85. Responsibilities of schools and school administrators.

 (a) Inform of requirements and ascertain immunization status. The administrator in charge of a school shall appoint a knowledgeable person to perform all of the following:

 (1) Inform the parent, guardian or emancipated child at registration or prior to registration, if possible, of the requirements of this subchapter.

 (2) Ascertain the immunization status of a child prior to admission to school or continued attendance at school.

 (i) The parent, guardian or emancipated child shall be asked for a completed certificate of immunization.

 (ii) In the absence of a certificate of immunization, the parent, guardian or emancipated child shall be asked for a record or history of immunization which indicates the month, day and year that immunizations were given. This information shall be recorded on the certificate of immunization and signed by the school official or the school official's designee, or the details of the record shall be stored in a computer database.

 (b) Admission to school or continued attendance. If the knowledgeable person designated by the school administrator is unable to ascertain whether a child has received the immunizations required under § 23.83 (relating to immunization requirements) or under subsection (e) or is exempt under § 23.84 (relating to exemption from immunization), the school administrator may admit the child to school or allow the child's continued attendance at school only according to the requirements of subsections (d) and (e).

 (c) Inform of specific immunization requirements. The parent or guardian of a child or the emancipated child who has not received the immunizations required under § 23.83 shall be informed of the specific immunizations required and advised to go to the child's usual source of care or nearest public clinic to obtain the required immunizations.

 (d) Requirements under which admission or continued attendance is permitted. A child not previously admitted to or not allowed to continue attendance at school because the child has not had the required immunizations shall be admitted to or permitted to continue attendance at school only upon presentation to the school administrator or school administrator's designee of a completed certificate of immunization or immunization record, upon submission of information sufficient for an exemption under § 23.84, or upon compliance with subsection (e).

 (e) Provisional admittance to school.

 (1) Multiple dose vaccine series. If a child has not received all of the antigens for a multiple dose vaccine series described in § 23.83 on the child's first day of attendance for that school year, the school administrator or the school administrator's designee may not provisionally admit the child to school unless the child has at least one dose of each multiple dose vaccine series required under § 23.83, and one of the following occurs:

 (i) The child receives the final dose of each multiple dose vaccine series required under § 23.83 within 5 school days of the child's first day of attendance, and the child's parent or guardian provides a certificate of immunization on or before the 5th school day.

 (ii) If the child needs additional doses of a multiple dose vaccine series to meet the requirements of § 23.83, the child receives the next scheduled dose during the 5 school days referenced in subparagraph (i), and the child's parent or guardian provides a medical certificate on or before the 5th school day scheduling the additional required doses.

 (iii) If the child needs additional doses of a multiple dose vaccine series to meet the requirements of § 23.83, but the next dose is not medically appropriate during the 5 school days referenced in subparagraph (i), the child's parent or guardian provides a medical certificate on or before the 5th school day scheduling the additional required doses.

 (2) Single dose vaccines. If a child has not received a vaccine for which only a single dose is required on the child's first day of attendance for that school year, the child may not be admitted to school.

 (3) Completion of required immunizations. The medical certificate shall be reviewed at least every 30 days by the school administrator or the school administrator's designee. Subsequent immunizations shall be entered on the certificate of immunization or entered in the school's computer database. Immunization requirements described in § 23.83 shall be completed in accordance with the requirements of the medical certificate. If, upon review, the requirements of the medical certificate are not met, the school administrator or the school administrator's designee may exclude the child from school.

 (4) Medical certificate. A school shall maintain the medical certificate until the official school immunization record is completed.

 (f) Certificate of immunization. A school shall maintain on file a certificate of immunization for a child enrolled. An alternative to maintaining a certificate on file is to transfer the immunization information from the certificate to a computer database. The certificate of immunization or a facsimile thereof generated by computer shall be returned to the parent, guardian or emancipated child or the school shall transfer the certificate of immunization (or facsimile) with the child's record to the new school when a child withdraws, transfers is promoted, graduates or otherwise leaves the school.

 (g) Applicability. This section does not apply to a child if one of the following occurs:

 (1) The child has not been immunized or is unable to provide immunization records due to being homeless. A school shall comply with Federal laws pertaining to the educational rights of homeless children, including the McKinney-Vento Homeless Education Assistance Improvements Act of 2001 (42 U.S.C.A. §§ 11431—11435).

 (2) The child, when moving or transferring into a school in this Commonwealth, is unable to provide immunization records immediately upon enrollment into the school. The child's parent or guardian shall have 30 days to provide immunization records to the school to show proof of immunization as set forth in § 23.83, a medical certificate as set forth in subsection (e) or to satisfy the requirements for an exemption as set forth in § 23.84. A child who is unable to provide the necessary records, medical certificate or exemption may be excluded at the end of the 30-day period and in subsequent school years until the requirements of this subchapter are met.

 (3) The child has not been immunized or is unable to provide immunization records on the first day of attendance for the school year due to being in foster care. A school shall comply with Federal laws pertaining to the educational rights of children in foster care, including the Fostering Connections to Success and Increasing Adoptions Act of 2008 (42 U.S.C.A. §§ 670—679c). The child's foster parent shall have 30 days to provide immunization records to the school to show proof of immunization as set forth in § 23.83, a medical certificate as set forth in subsection (e) or to satisfy the requirements for an exemption as set forth in § 23.84. A child who is unable to provide the necessary records, medical certificate or exemption may be excluded at the end of the 30-day period and in subsequent school years until the requirements of this subchapter are met.

 (4) The child obtains an exemption under § 23.84.

 (h) Temporary waiver. The Secretary may issue a temporary waiver of the immunization requirements in § 23.83. The details of the temporary waiver will be set out in a notice published in the Pennsylvania Bulletin. A temporary waiver may be issued under either of the following circumstances:

 (1) The Centers for Disease Control and Prevention, United States Department of Health and Human Services, recognizes a Nationwide shortage of supply for a particular vaccine.

 (2) In the event of a disaster impacting the ability of children transferring into a school to provide immunization records.

§23.86. School reporting.

 (a) A public, private, parochial or nonpublic school in this Commonwealth, including vocational schools, intermediate units, special education and home education programs, and cyber and charter schools, shall report immunization data to the Department electronically by December 31 of each year using a format and system provided by the Department.

 (b) In the event a public, private, parochial or nonpublic school is unable to complete its report electronically, it shall report to the Department by December 15 of each year using a form provided by the Department.

 (c) The school administrator or the school administrator's designee shall forward the reports to the Department as indicated on the reporting form provided by the Department.

 (d) Duplicate reports shall be submitted to the county health department if the school is located in a county with a full-time health department.

 (e) The school administrator or the school administrator's designee shall ensure that the school's identification information, including the name of the school, school district, county and school address, is correct, and shall make any necessary corrections prior to submitting the report.

 (f) Content of the reports must include all of the following information:

 (1) The month, day and year of the report.

 (2) The number of students attending school in each grade-level, or in an ungraded school, in each age group, as indicated on the reporting form.

 (3) The number of doses of each individual antigen given in each grade-level, or in an ungraded school, in each age group, as indicated on the reporting form.

 (4) The number of students attending school who were classed as medical exemptions in each grade-level, or in an ungraded school, in each age group, as indicated on the reporting form.

 (5) The number of students attending school who were classed as religious exemptions in each grade level, or in an ungraded school, in each age group, as indicated on the reporting form.

 (6) The number of students provisionally admitted in each grade level or, in an ungraded school, in any age group, as indicated on the reporting form.

 (7) The number of students in kindergarten, 7th grade or in an ungraded school, 12 years of age only, who were denied admission because of the student's inability to provide documentation of the required vaccine doses.

 (8) Other information as required by the Department.

[Pa.B. Doc. No. 17-377. Filed for public inspection March 3, 2017, 9:00 a.m.]

---

No part of the information on this site may be reproduced for profit or sold for profit.

This material has been drawn directly from the official Pennsylvania Bulletin full text database. Due to the limitations of HTML or differences in display capabilities of different browsers, this version may differ slightly from the official printed version.

---