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

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original new animal drug application (NADA) filed by Boehringer Ingelheim Vetmedica, Inc. The NADA provides for veterinary prescription use of an injectable suspension of protamine zinc recombinant human insulin for the reduction of hyperglycemia and hyperglycemia-associated clinical signs in cats with diabetes mellitus.

The Food and Drug Administration (FDA) is extending to January 29, 2009, the comment period for the proposed rule that appeared in the Federal Register of October 1, 2009. In the proposed rule, FDA requested comments on postmarketing safety reporting requirements for combination products. The agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Allergy and Infectious Diseases (NIAID), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on October 16, 2009, pages 53259-53260 and allowed 60 days for public comment. Three public comments were received and responses were sent to each person. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.

The Food and Drug Administration's (FDA's) Center for Veterinary Medicine (CVM) is seeking sponsors interested in participating in a pilot project to test the electronic submission of margin of safety and nonclinical toxicology study data using the Standard for Exchange of Nonclinical Data (SEND), a new electronic data standard format which is used to support review activity. FDA anticipates that a successful pilot will enable CVM to accept margin of safety and nonclinical toxicology study data related to investigational new animal drug (INAD) files and new animal drug applications (NADA's) electronically in SEND format.

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``PET DrugsCurrent Good Manufacturing Practice (CGMP).'' Elsewhere in this issue of the Federal Register, we are issuing final regulations on CGMPs for positron emission tomography (PET) drugs. We are issuing the guidance to help PET drug producers better understand FDA's thinking concerning compliance with the PET CGMP regulations.

This document corrects several technical and typographical errors in the final rule with comment period that appeared in the November 25, 2009, Federal Register entitled ``Medicare Program; Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2010''.

The Food and Drug Administration (FDA) is establishing a public docket to obtain information on suggested elements for approved tobacco retailer training programs. FDA is establishing this docket in order to provide an opportunity for interested parties to provide information and share views on elements that should be included in an effective retailer training program as provided for in the Family Smoking Prevention and Tobacco Control Act (the Tobacco Control Act).

Under the procedures in this final rule, Medicare beneficiaries and, under certain circumstances, providers and suppliers of health care services can appeal adverse determinations regarding claims for benefits under Medicare Part A and Part B pursuant to sections 1869 and 1879 of the Social Security Act (the Act). Section 521 of the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 (BIPA) amended section 1869 of the Act to provide for significant changes to the Medicare claims appeal procedures. After publication of a proposed rule implementing the section 521 changes, additional new statutory requirements for the appeals process were enacted in Title IX of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA). In March 2005, we published an interim final rule with comment period to implement these statutory changes. This final rule responds to comments on the interim final rule regarding changes to these appeal procedures, makes revisions where warranted, establishes the final implementing regulations, and explains how the new procedures will be put into practice.

The CERHR announces the availability of a teleconference line to allow presentation of oral comments at the expert panel meeting on December 16-18, 2009, at the Hilton Alexandria Old Town, 1767 King Street, Alexandria, VA. Information regarding the soy formula expert panel meeting was announced in the Federal Register (74 FR 53508) published on October 19, 2009, and is available on the CERHR Web site (https://cerhr.niehs.nih.gov). The guidelines and deadlines published in this Federal Register notice still apply, except that the deadline for registering to attend or to present oral comments by telephone is now December 11, 2009.