NOTICES

INDEPENDENT REGULATORY REVIEW COMMISSION

Notice of Comments Issued

[31 Pa.B. 3827]

   Section 5(d) and (g) of the Regulatory Review Act (71 P. S. § 745.5(d) and (g)) provides that the designated standing committees may issue comments within 20 days of the close of the public comment period, and the Independent Regulatory Review Commission (Commission) may issue comments within 10 days of the close of the committees' comment period. The Commission's Comments are based upon the criteria contained in section 5.1(h) and (i) of the Regulatory Review Act (71 P. S. § 745.5a(h) and (i)).

   The Commission issued comments on the following proposed regulation. The agency must consider these comments in preparing the final-form regulation. The final-form regulation must be submitted by the date indicated.

			Final-form
			Submission
Reg. No.	Agency/Title	Issued	Deadline
10-137	Department of Health	6/28/01	5/29/03
	Newborn Disease       Screening and       Follow-Up
	31 Pa.B. 2271 (April 28, 2001)

Department of Health
Regulation No. 10-137
Newborn Disease Screening and Follow-Up
June 28, 2001

   We submit for consideration the following objections and recommendations regarding this regulation. Each objection or recommendation includes a reference to the criteria in the Regulatory Review Act (71 P. S. § 745.5a(h) and (i)) which have not been met. The Department of Health (Department) must respond to these Comments when it submits the final-form regulation. If the final-form regulation is not delivered by May 29, 2003, the regulation will be deemed withdrawn.

1.  Section 28.1. Definitions.--Clarity.

Hemoglobin diseases

   This definition includes a list of sickle cell diseases, including ''SS, SC, SV, S beta Thalassemia, S O Arab.'' A commentator stated that there is no hemoglobin named ''SV.'' We suggest the Department review the definition and consider replacing ''V'' with ''+ other variant.''

2.  Section 28.21. Responsibility for collecting and testing initial and repeat specimens.--Economic impact; Clarity

Subsection (c)

   Subsection (c) requires a healthcare provider to designate a ''newborn screening coordinator'' to perform several duties. We have two concerns.

   First, the regulation does not specify what qualifications the ''newborn screening coordinator'' must have. Included in the duties in paragraph (1), the newborn screening coordinator must ''ensure that a specimen collection form contains correct and complete information.'' (Emphasis added.) What level of medical training does the newborn screening coordinator need to ensure information is ''correct''?

   Second, paragraph (7) is vague. What is the intent of requiring the newborn screening coordinator to ''assist the Department in followup of an abnormal or presumptive abnormal test result''?

JOHN R. MCGINLEY, Jr.,   
Chairperson

[Pa.B. Doc. No. 01-1286. Filed for public inspection July 13, 2001, 9:00 a.m.]

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