Department of Health and Human Services August 2010 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Civil Money Penalties and No-Tobacco-Sale Orders for Tobacco Retailers.'' This guidance document is intended to describe FDA's current policies with respect to civil money penalties and no-tobacco-sale orders for retailers who violate requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) relating to tobacco products, including the FD&C Act requirement that tobacco products may not be sold or distributed in violation of FDA's ``Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents.'' When this guidance document is final, several provisions in the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) that relate to civil money penalties and no-tobacco-sale orders will become effective.

This is a notice in accordance with 35 U.S.C. 209(e) and 37 CFR 404.7(a)(1)(i) that the Technology Transfer Office of the Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), is contemplating the grant of worldwide co-exclusive licenses to practice the inventions embodied in the patents referred to below to Allylix, Incorporated and Valent BioSciences Corporation, having places of business in San Diego, CA and Libertyville, IL, respectively. The patent rights in these inventions have been assigned to the government of the United States of America. The patent(s) to be licensed are:

The Food and Drug Administration (FDA) has determined the regulatory review period for PRISTIQ and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of Patents and Trademarks, Department of Commerce, for the extension of patents which claim that human drug product.

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:

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``AHRQ Grants Reporting System (GRS).'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3520, AHRQ invites the public to comment on this proposed information collection.

This notice announces a solicitation for up to 20 additional eligible hospitals to participate in the Rural Community Hospital Demonstration program for a 5-year period.

The Agency for Healthcare Research and Quality (AHRQ) invites nominations of individuals qualified to serve as members of the U.S. Preventive Services Task Force (USPSTF).

The Food and Drug Administration (FDA) is announcing the availability of supplemental grant funds for the support of Food Emergency Response Laboratory Network (FERN) Microbiological Laboratories. The goal of these FERN Microbiological Laboratories supplements is a minor program expansion to enhance the lab capabilities to handle human pathogenic bacteria in animal feed.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

This notice announces a listening session to receive comments regarding implementation of section 10332 of the Patient Protection and Affordable Care Act (the Affordable Care Act), which amended section 1874 of the Social Security Act: Availability of Medicare Data for Performance Measurement. The purpose of the listening session is to solicit input from potential stakeholders on key components of the design of the program. We are soliciting input on the types of organizations that may be interested in receiving data as qualified entities under this provision; the criteria such organizations will have to meet for participation; procedures for CMS to approve interested organizations for participation; provider communities and geographic areas that might be served by these entities; data elements required, and the sources and types of other data that these organizations might match to Medicare claims; challenges in calculating performance measures from the data, and issues related to the identification, selection, and reporting of the performance measures.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the John E. Fogarty International Center, the National Institutes of Health 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 May 27, 2010 (volume 75, number 102, page 29763) and allowed 60 days for public comment. One comment was received from a member of the public. The purpose of this notice is to allow an additional 30 days for public comment.

As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services (DHHS) is hereby giving notice that the President's Council on Fitness, Sports and Nutrition (PCFSN) will hold a meeting. The meeting will be open to the public.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Acute Bacterial Skin and Skin Structure Infections: Developing Drugs for Treatment.'' The purpose of this draft guidance is to assist clinical trial sponsors and investigators in the development of antimicrobial drugs for the treatment of acute bacterial skin and skin structure infections (ABSSSI), impetigo, and minor cutaneous abscesses. FDA's thinking in this area has evolved in recent years, and this draft guidance, when finalized, will inform sponsors of the changes in the definitions of ABSSSI and the recommendations for clinical drug development.