NOTICES
INDEPENDENT REGULATORY REVIEW COMMISSION
Notice of Comments Issued
[34 Pa.B. 4797] Section 5(g) of the Regulatory Review Act (71 P. S. § 745.5(g)) provides that the Independent Regulatory Review Commission (Commission) may issue comments within 30 days of the close of the public comment period. The Commission comments are based upon the criteria contained in section 5.2 of the Regulatory Review Act (71 P. S. § 745.5b).
The Commission has issued comments on the following proposed regulations. The agency must consider these comments in preparing the final-form regulation. The final-form regulation must be submitted within 2 years of the close of the public comment period or it will be deemed withdrawn.
IRRC Close of the Public Comments Reg. No. Agency/Title Comment Period Issued 57-234 Pennsylvania Public Utility Commission
Public Utility Security Planning and Readiness
(34 Pa.B. 3138 (June 19, 2004))7/19/04 8/18/04 16A-6802 State Board of Examiners in Speech-Language and Hearing
Continuing Education
(34 Pa.B. 3143 (June 19, 2004))7/19/04 8/18/04 16A-5410 State Board of Pharmacy
Technology and Automation
(34 Pa.B. 3146 (June 19, 2004))7/19/04 8/18/04
____
Pennsylvania Public Utility Commission Regulation # 57-234 (IRRC # 2404)
Public Utility Security Planning and Readiness
August 18, 2004 We submit for consideration the following comments that include references to the criteria in the Regulatory Review Act (71 P. S. § 745.5b) which have not been met. The Pennsylvania Public Utility Commission (PUC) must respond to these comments when it submits the final-form regulation. The public comment period for this regulation closed on July 19, 2004. If the final-form regulation is not delivered within 2 years of the close of the public comment period, the regulation will be deemed withdrawn.
1. Section 101.1. Purpose.--Timetable for compliance; Clarity.
This section establishes the purpose of Chapter 101. It uses the terms ''jurisdictional utility'' and ''infrastructure.'' These terms are not defined. The PUC should either define these terms in § 101.2 or include a cross-reference to where these definitions can be found.
2. Section 101.2. Definitions.--Clarity.
Business continuity plan, contingency planning, business resumption and emergency response plan
This section uses three phrases to describe potential service interruptions. These include ''change or unforeseen circumstances'' in the definitions of ''business continuity plan'' and ''contingency planning''; ''natural causes or sabotage'' in the definition of ''emergency response plan''; and ''disaster'' in the definition of ''business resumption.'' Based on the executive summary included with the regulatory package, the aforementioned terms are subsumed under the defined term of ''abnormal operating conditions.'' Therefore, we recommend that these phrases be replaced with that defined term.
Business continuity plan, cyber security plan, emergency response plan and physical security plan
These definitions all contain a brief description of the term and duties for jurisdictional utilities to perform. As substantive provisions, the duties should not be included in these definitions. Rather, they should be moved to § 101.3.
Business recovery
The phrase ''less time-sensitive business operations'' is included in this definition. The PUC should include examples of ''less time-sensitive business operations'' in the preamble or the final-form regulation.
Critical functions
This definition includes the phrase ''several business days.'' This time frame is vague. The PUC should replace this phrase with a specific time frame.
Cyber security plan
The phrase ''appropriate backup'' is in the definition of ''cyber security plan.'' The PUC should provide examples of ''appropriate backup'' or define this phrase in the final-form regulation.
Paragraph (iv) begins with the phrase ''a recognition of.'' This phrase is superfluous and should be deleted.
Emergency response plan
This definition includes the phrase ''emergency management system.'' What is the ''emergency management system''? The PUC should either define this term in the final-form regulation or include an appropriate cross-reference.
3. Section 101.3. Plan requirements.--Economic impact; Clarity.
Subsection (a)
This subsection requires jurisdictional utilities to develop and maintain written physical security, cyber security, emergency response and business continuity plans. Do these four plans have to be independent or can they be one single plan? The PUC should explain what would be an acceptable format for maintaining these plans.
Subsection (c)
This subsection requires utilities to ''maintain a testing schedule of these plans.'' Subsection (d) requires that utilities submit The Physical and Cyber Security Planning Self Certification Form (form), which asks if the various plans have been tested. However, as currently written, this regulation does not require utilities to actually test their plans.
The PUC has indicated that the intent of this regulation is to require annual testing of each plan. Why is annual testing needed? If the PUC justifies the need for annual testing of each plan, the final-form regulation should be amended to reflect this requirement. Also, we recommend that a definition of the term ''test'' be added to § 101.2.
4. Subsection 101.5. Confidentiality of self certification form.--Clarity.
This section refers to the form filed with the PUC as a ''Physical and Cyber Security Self Certification Form.'' In Appendix A, the form is titled ''Physical and Cyber Security Planning Self Certification.'' (Emphasis added.) Section 101.1 also refers to the form as the ''Physical and Cyber Security Planning Self Certification.'' (Emphasis added.) For consistency, the PUC should add the word ''Planning'' to the form referenced in this section.
5. Section 101.6. Compliance.--Clarity.
Subsections (b) and (c)
These subsections state that the PUC may review the plans of a utility and inspect a utility's facility. We have two concerns. First, the PUC should explain the manner in which it will make a request when it elects to review the plans or facilities of a utility. For instance, will the PUC make a written request to the utility to review its plans or facilities?
Second, the PUC should explain the procedures involved with inspecting the facilities of a utility. Will the PUC conduct their inspection during normal business hours, and will the utility have notice that an inspection will occur?
Subsection (d)
This subsection allows a jurisdictional utility to submit a business continuity plan, cyber security plan, emergency response plan and physical security plan prepared for another entity if the other authority requires a ''substantially similar plan.'' We have two concerns.
First, if the other entity requires information not prescribed by the PUC, will that information be considered public or proprietary information? The PUC should explain.
Second, the phrase ''substantially similar plan'' is vague. The PUC should include specific guidelines in the final-form regulation for a jurisdictional utility to determine whether the plan it must file for another entity could be used to fulfill the requirements set forth in this regulation, or replace the existing phrase with ''meets the requirements of.''
6. Appendix A. Physical and cyber security planning self certification.--Reasonableness: Clarity.
Appendix A contains the form utilities are required to submit to the PUC. We have three concerns.
First, Items 2, 5, 9 and 12 ask if specific plans have been ''reviewed and updated in the past year.'' (Emphasis added.) If no update is necessary, would a utility's review suffice? The PUC should consider changing the above-mentioned lines to include the phrase ''reviewed and updated as needed.''
Second, Item 7 asks the following question: ''Has your company performed a vulnerability or risk assessment analysis as it relates to physical and/or cyber security?'' For the regulated community to understand what is expected during a ''vulnerability or risk assessment analysis,'' that phrase should be defined in § 101.2. In addition, the inclusion of the phrase ''and/or'' would make it difficult for the regulated community to know what is expected of them. Does the PUC expect each company to perform an analysis of their physical and cyber security each year? The final-form regulation should clarify this provision.
Finally, can this form be electronically filed with the PUC, or will utilities have to submit the form by mail, hand delivery or fax? The PUC should consider allowing electronic submission of this form.
7. Miscellaneous clarity.
Section 101.3 contains two subsections labeled (d). The final-form regulation should correct this typographical error.
____
State Board of Examiners in Speech-Language and Hearing Regulation # 16A-6802 (IRRC # 2406)
Continuing Education
August 18, 2004 We submit for consideration the following comments that include references to the criteria in the Regulatory Review Act (71 P. S. § 745.5b) which have not been met. The State Board of Examiners in Speech-Language and Hearing (Board) must respond to these comments when it submits the final-form regulation. The public comment period for this regulation closed on July 19, 2004. If the final-form regulation is not delivered within 2 years of the close of the public comment period, the regulation will be deemed withdrawn.
1. Section 45.13. Renewal; Inactive status; Required continuing education.--Fiscal impact; Reasonableness; Implementation procedures; Clarity.
Section 45.501. Credit hour requirements.--Fiscal impact; Reasonableness; Implementation procedures; Clarity.
In §§ 45.13(g) and 45.501(a), the proposed regulation, as published in the Pennsylvania Bulletin, indicates that the continuing education requirement will become effective in the biennial period following the effective date of the regulation. However, this does not match the language in these same sections in the draft regulation submitted by the Board to the House Professional Licensure Committee, Senate Consumer Protection and Professional Licensure Committee and the Commission. In addition, Board staff indicated that the hour requirement may be prorated if the regulation becomes effective in the midst of a biennial period.
The Board should clarify how and when the requirement will be implemented in the final-form regulation. It should also describe how it will provide adequate and timely notice to all licensees of the effective date and what will be required of licensees.
2. Section 45.2. Definitions.--Reasonableness; Clarity.
Continuing education record
There is unnecessary duplication and a minor inconsistency between the definition of this term and the list of required contents for the ''continuing education record'' in § 45.506(b). The contents described in the definition are almost identical to the list in § 45.506(b)(1)--(5). The only item not included in the definition is subsection (b)(6) which requires the record to include ''[t]he course approval number or an indication of the provider's status as a preapproved provider.'' In the final-form regulation, the definition of this term should reference § 45.506(b) to provide the reader with a complete description of ''continuing education record.''
3. Section 45.501. Credit hour requirements.--Reasonableness; Clarity.
Subsection (b)--Individual programs
Two commentators expressed concerns related to continuing education requirements for certification by the Department of Education. Act 48 of 1999 requires that certified educators complete 180 hours of continuing education programs every 5 years. This requirement includes hours in collegiate studies or courses or programs ''related to an area of the professional educator's assignment or certification'' (24 P. S. §§ 12-1205.2(c)(1)--(3)). The Pennsylvania State Education Association (PSEA) claimed that this proposed regulation duplicates the requirements under Act 48 of 1999. Both the PSEA and Pennsylvania Training and Technical Assistance Network request that the Board accept all continuing education provider programs approved under Act 48 of 1999 as approved continuing education providers for licensure renewal.
The Board states on page three of the Regulatory Analysis Form that it has ''. . . determined that it would accept all credits that conform to its proposed regulation even if a licensee used that same educational experience to fulfill his or her requirements from the Department of Education.'' To improve clarity and alleviate any misunderstanding, the Board should include this statement in the preamble of the final-form regulation.
Subsection (c)--Continuing education requirement
Subsection (c) states that the Board will not renew or reactivate a license ''until the continuing education required prior to the current biennial renewal period has been completed.'' This phrase and its application to new licensees are unclear. Does ''the continuing education required prior to the current biennial renewal period'' refer to courses taken 3 years earlier during a previous biennium? If so, how can new licensees comply with this provision if they are finishing their first biennial period as new licensees? The intent of this subsection needs to be clarified in the final-form regulation.
4. Section 45.504. Reporting completion of continuing education.--Clarity.
Subsection (a) requires licensees to provide ''. . . on forms provided by the Board, a signed statement certifying that the continuing education requirement has been met.'' The Board should consider describing the required content of these forms in the final-form regulation. A good example of the content for these forms can be found in the existing regulations of the State Board of Optometry in 49 Pa. Code § 23.87.
5. Section 45.505. Approval of continuing education programs.--Clarity.
In subsection (d)(3), denial of a program can be based on faculty being ''deemed not qualified to present the program.'' The Board should explain in the preamble of the final-form regulation how faculty qualifications will be determined.
6. Section 45.507. Disciplinary action authorized.--Clarity.
Subsection (b) states that a licensee ''. . . who fails to complete the required continuing education requirement within any biennial renewal period may be subject to discipline.'' The Board should explain in the preamble to the final-form regulation what disciplinary actions the Board will take if the continuing education requirements are not met.
____
State Board of Pharmacy Regulation # 16A-5410 (IRRC # 2405)
Technology and Automation
August 18, 2004 We submit for consideration the following comments that include references to the criteria in the Regulatory Review Act (71 P. S. § 745.5b) which have not been met. The State Board of Pharmacy (Board) must respond to these comments when it submits the final-form regulation. The public comment period for this regulation closed on July 19, 2004. If the final-form regulation is not delivered within 2 years of the close of the public comment period, the regulation will be deemed withdrawn.
1. General.--Possible conflict with existing regulations; Implementation procedures.
The Department of Health (Department) commented that its regulations may conflict with changes being proposed by the Board. For example, Department regulations require handwritten notations, use of indelible ink, separation of records and use of red ink to mark prescription orders in 28 Pa. Code §§ 25.53 (b) and (d) and 25.56 (a) and (b)). The Department requests ''that the Board either amend the proposed regulations or address any differences between the two regulations in the preamble.''
The House Professional Licensure Committee (House Committee) requests that the Board consult with the Department regarding its concerns before final regulations are submitted. We concur with the House Committee and suggest that these discussions should take into consideration provisions of the Electronic Transactions Act (ETA) (73 P. S. § 2260.303) that state electronic records can be substituted for written records.
2. Broad requirements to meet state and federal laws and regulations.--Clarity.
Several provisions require compliance with ''state and federal laws and regulations'' or contain similar language. These broad references are found in §§ 27.14(c)(11), 27.201(b)(2) and (5), 27.202(a), 27.203(a)(2)(i) and (3) and 27.204(c)(5).
In the preamble, the Board states its belief that these broad references are more accurate than specific citations. We disagree. Broad references do not give the regulated community guidance as to what requirements must be met. The broad references noted above should be replaced with specific citations to the applicable regulations or laws.
3. Section 27.1. Definitions.--Need; Reasonableness; Clarity.
Automated medication system
There are two concerns.
First, this definition excludes compounding. A commentator questions whether this definition would exclude inpatient pharmacies that use automated compounding systems. Is it the Board's intent to exclude these compounding processes?
Second, the definition of ''automated medication system'' states the term does not mean an ''automatic counting device.'' Since the term ''automatic counting device'' is not defined in regulation, it is unclear what is not included. A definition of the term ''automatic counting device'' should be added to the regulation.
Central processing center
It is not clear why a central processing center must engage ''solely in centralized prescription processing.'' Could a central processing center perform the functions of an originating pharmacy or a delivering pharmacy? The Board should explain the need for this limitation.
Originating pharmacy
The House Committee commented that this definition should be re-written so that licensees can clearly determine when a central fill pharmacy or a central processing center is an originating pharmacy. We agree. Additionally, the second sentence uses the undefined term ''centralized pharmacy.'' The Board should re-write this definition to make it clearer.
Prescription
The existing regulatory definition, consistent with the Pharmacy Act (63 P. S. § 390-2), limits prescriptions to a ''written or oral order.'' This regulatory definition should be amended to include an ''electronic order,'' consistent with this proposal.
4. Section 27.14. Supplies.--Clarity.
The House Committee commented that this section should reference the exemption in § 27.203(b). This section would be clearer with a reference to that exemption.
5. Section 27.201. Electronically transmitted prescriptions.--Feasibility; Reasonableness; Protection of the public; Clarity.
Subsection (a)
We have three concerns with subsection (a).
First, this subsection limits electronic transmittals to a ''data base exchange or e-mail.'' Given the rapid advance of communications technology described by commentators, a limitation to ''data base exchange or e-mail'' is already outdated and would be burdensome. The ETA contains a broad definition of ''electronic'' as ''relating to technology having electrical, digital, magnetic, wireless, optical, electromagnetic or similar capabilities'' (73 P. S. § 2260.103). Subsection (a) should allow any method of electronic communication that can reliably provide the information required in subsection (b). Alternatively, if there is a need to limit the methods of transmission, the regulation should provide the flexibility to petition the Board for approval of new technologies.
Second, this subsection requires the electronic prescription to not be ''altered, accessed, viewed, screened or manipulated by an intervening entity or person unless authorized by law.'' A commentator described a system that verifies the prescriber and confirms that a prescription contains the required data before the prescription is routed to the pharmacy. Is it the Board's intent to prohibit this system?
Finally, the meaning of this subsection is difficult to comprehend. Subsection (a) is a single sentence that contains 80 words and multiple concepts. Rewriting the subsection would improve its clarity. For example, the requirement to use a pharmacy of the patient's choice could be placed in a separate subsection.
Subsection (b)
There are three concerns.
First, subsection (b)(1) appropriately permits the use of electronic signatures under the ETA. However, there are other prescription requirements that the regulation does not address. For example, the regulation does not address the prescription requirements under 35 P. S. § 960.3(a). Specifically, subsection (a) of the ETA states
. . . unless the prescriber handwrites ''brand necessary'' or ''brand medically necessary,'' shall designate approval of substitution of a drug by a pharmacist pursuant to this act. Imprinted conspicuously on the prescription blanks shall be the words: ''In order for a brand name product to be dispensed, the prescriber must handwrite 'brand necessary' or 'brand medically necessary' in the space below.'' . . .The regulation should address the requirements of 35 P. S. § 960.3(a), as well as other concerns raised by commentators concerning the use of electronic prescriptions. Given the importance of the ETA to this regulation, it would be appropriate to address electronic prescription requirements in a separate subsection.
Second, a subparagraph should be added to paragraph (2) to specify how the requirement previously discussed will be addressed.
Finally, because paragraph (5) applies to all of § 27.201, it should be a separate subsection.
6. Section 27.202. Computerized recordkeeping systems.--Protection of the public; Need; Clarity.
Subsections (d) and (e) address computer down time and safeguards, but neither requires back up of information entered into a computerized recordkeeping system. In the event of a system failure, records could be lost or could no longer be reliably audited. Why isn't the Board requiring back up of computerized recordkeeping systems?
Also, we question if the last sentence in subsection (d) is needed because prescriptions can only be refilled if ''the number of refills authorized by the prescriber has not been exceeded'' at any time, not just when the system is down.
7. Section 27.204. Automated medication systems.--Protection of the public; Reasonableness; Clarity.
Policies, procedures and written plans
Subsections (c), (d) and (f)--(j) all require the use of a policy, procedure or written plan in one form or another. The House Committee commented that the regulation should assign an affirmative duty to the pharmacy to create these policies, procedures or written plans. We agree. For example, subsection (c)(1) places the responsibility on the pharmacist manager to review and approve certain policies and procedures. However, who has the responsibility to write the policies and procedures?
Subsection (b)
Paragraph (4) contains the phrase ''. . . with the time, date and initials or other identifier . . . .'' What ''other identifier'' does the Board consider to be an adequate method of electronically recording the activity of each pharmacist, technician or other authorized personnel?
Also, paragraph (4) concludes with the sentence ''It is the intent of this section to hold responsible each pharmacist for the transaction performed by that pharmacist, precluding the need for a final check of a prescription by one individual pharmacist prior to delivery.'' The House Committee commented that this sentence is not clear, and we agree. How does this sentence relate to the first sentence of the paragraph?
Subsection (d)
Paragraph (6) limits access for stocking and removal of medications to licensed pharmacists or ''qualified support personnel.'' Who are considered ''qualified support personnel''? Is it the Board's intent to limit access to individuals supervised by the licensed pharmacist? Would healthcare professionals such as physicians, nurses or others legally authorized to administer drugs be allowed to access an automated medication system? The regulation should specifically state who may access the automated medication system.
JOHN R. MCGINLEY, Jr.,
Chairperson
[Pa.B. Doc. No. 04-1618. Filed for public inspection August 27, 2004, 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.
