NOTICES
INDEPENDENT REGULATORY REVIEW COMMISSION
Notice of Comments Issued
[43 Pa.B. 4191]
[Saturday, July 20, 2013]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final-form regulation must be submitted within 2 years of the close of the public comment period or it will be deemed withdrawn.
Close of the Public IRRC Comments Reg. No. Agency/Title Comment Period Issued 16A-5425 State Board of Pharmacy
Collaborative Management of Drug Therapy
43 Pa.B. 2439 (May 4, 2013)6/3/13 7/3/13 106-10 Environmental Hearing Board
Practice and Procedure
43 Pa.B. 2591 (May 11, 2013)6/10/13 7/10/13
State Board of Pharmacy
Regulation #16A-5425 (IRRC #3006)
Collaborative Management of Drug Therapy
July 3, 2013 We submit for your consideration the following comments on the proposed rulemaking published in the May 4, 2013 Pennsylvania Bulletin. Our comments are based on criteria in Section 5.2 of the Regulatory Review Act (RRA) (71 P. S. § 745.5b). Section 5.1(a) of the RRA (71 P. S. § 745.5a(a)) directs the State Board of Pharmacy (Board) to respond to all comments received from us or any other source.
1. Section 27.1. Definitions.—Clarity.
Section 27.302 (relating to collaborative agreement for management of drug therapy in a non-institutional setting) uses the undefined term ''non-institutional setting.'' While we recognize that the term institutions is defined in existing Section 27.1 and includes in (iii) what the term does not include, the proposed regulation is unclear as to what settings qualify as non-institutional. In the final-form regulation, we ask the Board to clarify for the regulated community what constitutes a non-institutional setting by explicitly defining this term. The Board may also consider revising the definition of ''institutions'' if necessary to provide additional clarity between the two terms.
2. Section 27.301. Written protocol for the management of drug therapy in an institutional setting.—Clarity; Implementation procedures.
Comments submitted by the House Professional Licensure Committee (Committee) point out that Section 9.1(e)(10) of the Pharmacy Act specifies that written agreements or protocols must be filed with the Board and the State Board of Medicine and/or the State Board of Osteopathic Medicine, and that Section 9.3(k)(2) requires a collaborative agreement to comply with the requirements of Section 9.1(e). The Committee recommends, and we agree, that the Board clarify in Section 27.301(d) that the written protocol must be filed with the appropriate boards.
Likewise, we agree with the Committee's recommendation that the Board add a similar requirement to Section 27.302 for written collaborative agreements.
3. Section 27.302. Collaborative agreement for management of drug therapy in a non-institutional setting.—Protection of the public health, safety and welfare; Clarity; Implementation Procedures.
The Pennsylvania Medical Society commented that the regulation does not provide for physicians to have access to pharmacist records for regular review. Paragraph (f)(6) does require the collaborative agreement to contain a method for documenting decisions made and a plan for communication or feedback. Would adding a provision that explicitly provides physician access to pharmacist records provide clarity regarding the intent of the regulation, as well as greater protection of the public health, safety and welfare of patients? We ask the Board to consider this suggestion and explain why such a provision is or is not needed in the final rulemaking.
Environmental Hearing Board
Regulation #106-10 (IRRC #3008)
Practice and Procedure
July 10, 2013 We submit for your consideration the following comments on the proposed rulemaking published in the May 11, 2013 Pennsylvania Bulletin. Our comments are based on criteria in Section 5.2 of the Regulatory Review Act (71 P. S. § 745.5b). Section 5.1(a) of the Regulatory Review Act (71 P. S. § 745.5a(a)) directs the Environmental Hearing Board (Board) to respond to all comments received from us or any other source.
1. Section 1021.32. Filing.—Implementation procedures; Reasonableness; Clarity.
This section addresses conventional, electronic and facsimile filing. We have three concerns. First, Subsection (c)(14) allows the Board to reject electronic filings. Under what grounds would the Board reject a document that was filed electronically? This should be explained in the final-form rulemaking.
Second, under Subsection (c)(15), if a party electronically files or serves a document and that filing or service is untimely because of a technical issue, the party can seek relief from the Board. However, such relief cannot be sought if there is a technical problem with a notice of appeal that was filed or served electronically. What is the reason for this difference?
Third, Subsection (d) pertains to facsimile filing. If a party experiences technical difficulty filing a document via facsimile, can that party seek appropriate relief from the Board? If so, we suggest that the Board add appropriate language to this subsection. If not, we ask the Board to explain the reason for excluding it from the rulemaking.
2. Section 1021.34. Service by a party.—Clarity.
Under Subsection (g), if an electronic filing was not successfully transmitted, the party sending the filing must ''immediately upon notification of the deficiency'' serve the document by other listed methods. The requirement of immediate notification lacks clarity. Has the Board considered including a specific time period, such as 24 hours, for correcting the deficiency and serving the document?
3. Section 1021.51. Commencement, form and content.—Clarity.
Subsection (f)(1)(iii) uses the terms ''notice of appeal'' and ''notice of filing.'' What is the difference between the terms? If there is no difference, we recommend that the term ''notice of appeal'' be used instead of ''notice of filing.''
4. Section 1021.94. Dispositive motions other than summary judgment motions.—Implementation procedures; Reasonableness; Clarity.
Subsection (c) explains the procedures that must be followed for one party to join the dispositive motion of another party. We ask the Board to respond to the following questions as it develops the final-form rulemaking. First, what form, if any must a notification that a party is joining a dispositive motion take? Second, how did the Board determine that 15 days is a reasonable amount of time in which to file a notification? Third, under what circumstances would the Board permit, by way of an order, a party to raise additional issues in support of the dispositive motion? Finally, how does a party wishing to raise additional issues request such permission in the notification and must a separate pleading or motion be filed?
We have similar questions on Section 1021.94a, pertaining to summary judgment motions.
SILVAN B. LUTKEWITTE, III,
Chairperson
[Pa.B. Doc. No. 13-1367. Filed for public inspection July 19, 2013, 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.
