Department of Health and Human Services October 2009 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on guidance on reagents for detection of specific novel influenza A viruses.

As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the Advisory Committee on Blood Safety and Availability (ACBSA) will hold a meeting. The meeting will be open to the public.

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System 13.'' This document is intended to provide guidance to mammography facilities and their personnel. It represents FDA's current thinking on the final regulations implementing the Mammography Quality Standards Act of 1992 (MQSA). This guidance document updates previous guidance. This draft guidance is not final nor is it in effect at this time.

The Food and Drug Administration (FDA) is announcing the availability of the special controls guidance document entitled ``Class II Special Controls Guidance Document: Respiratory Viral Panel Multiplex Nucleic Acid Assay,'' and two companion special controls guidance documents entitled ``Class II Special Controls Guidance Document: Testing for Human Metapneumovirus (hMPV) Using Nucleic Acid Assays'' and ``Class II Special Controls Guidance Document: Testing for Detection and Differentiation of Influenza A Virus Subtypes Using Multiplex Nucleic Acid Assays.'' These guidance documents describe a means by which respiratory viral panel multiplex nucleic acid assays may comply with the requirement of special controls for class II devices. The guidance documents include recommendations for performance

Notice is hereby given that the Office of Research Integrity (ORI) and the Assistant Secretary for Health have taken final action in the following case:

Section 931 of the Public Health Service Act (PHS Act), 42 U.S.C. 299c, established a National Advisory Council for Healthcare Research and Quality (the Council). The Council is to advise the Secretary of HHS (Secretary) and the Director of the Agency for Healthcare Research and Quality (AHRQ) on matters related to activities of the Agency to improve the quality, safety, efficiency, and effectiveness of health care for all Americans.

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Implementation of Medical Device Establishment Registration and Device Listing Requirements Established by the Food and Drug Administration Amendments Act of 2007.'' The purpose of this guidance is to explain recent changes in the device registration and listing program to owner/operators and official correspondents of device establishments and to help them fulfill these new requirements. The guidance also describes the information that owner/operators of device establishments must submit to register their establishments and list their devices electronically, using FDA Form No. 3673. Those owner/operators seeking a waiver from the electronic submission requirement must submit their requests in writing to FDA with a complete explanation of why their registration and listing information cannot reasonably be submitted electronically. This guidance document is immediately in effect, but it remains subject to comment in accordance with the agency's good guidance practices (GGPs).

Vitamin D is a fat-soluble vitamin that is naturally present in very few foods, added to others, and available as a dietary supplement. It is also produced endogenously when ultraviolet rays from sunlight strike the skin and trigger vitamin D synthesis. Vitamin D obtained from sun exposure, food, and supplements is biologically inert and must undergo two hydroxylations in the body for activation. The first occurs in the liver and converts vitamin D to 25-hydroxyvitamin D [25(OH)D], also known as calcidiol. The second occurs primarily in the kidney and forms the physiologically active 1,25-dihydroxyvitamin D [1,25(OH)2D], also known as calcitriol.

The Food and Drug Administration (FDA) is correcting a notice; extension of comment period that appeared in the Federal Register of October 1, 2009 (74 FR 50810). The notice; extension of comment period announced that FDA is extending to December 28, 2009, the comment period for a notice that originally published in the Federal Register of July 1, 2009 (74 FR 31457). The notice; extension of comment period published with an inadvertent error in the DATES section. This document corrects that error.