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

This notice announces the availability of the draft toxicological profile for perfluoroalkyls, prepared by ATSDR, for review and comment.

This notice announces the development of Set 23 Toxicological Profiles. Set 23 Toxicological Profiles consists of three new drafts and two updated drafts. These profiles will be available to the public on or about October 17, 2009. Electronic access to these documents will be available at the ATSDR Web site: https://www.atsdr.cdc.gov/ toxpro2.html.

The Food and Drug Administration (FDA) is withdrawing approval of two new animal drug applications (NADAs) and an abbreviated new animal drug application (ANADA) listed in table 1 of this document. In a final rule published elsewhere in this issue of the Federal Register, FDA is amending the animal drug regulations to remove portions reflecting approval of these NADAs and ANADA.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Food Contact Substances Notification System'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

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: ``Health Literacy Item Set Supplemental to CAHPS Hospital SurveyPretest of Proposed Questions and Methodology.'' In accordance with the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)), AHRQ invites the public to comment on this proposed information collection.

The National Health and Nutrition Examination Survey (NHANES) is a program of periodic surveys conducted by the National Center for Health Statistics (NCHS) of the Centers for Disease Control and Prevention (CDC). Examination surveys conducted since 1960 by NCHS, have provided national estimates of health and nutritional status of the United States civilian non-institutionalized population. To add to the large amount of information collected for the purpose of describing the health of the population in the most recent survey, serum, urine and limited plasma samples were collected and stored for future research projects. Specimens are currently available from NHANES III (conducted from 1988-1994) and from NHANES 1999-2008. In 1999, NHANES became a continuous survey with data release every two years. Specimens are available from two year survey cycles after the demographic file has been released to the public. Participants in the survey that began in 1999 signed a separate consent document agreeing to specimen storage allowing their biologic specimens to be used for approved research projects.

The Food and Drug Administration (FDA) is announcing that Ajinomoto Co., Inc., has filed a petition proposing that the food additive regulations be amended to provide for the safe use of N-[N-[3- (3-hydroxy-4-methoxyphenyl) propyl-[alpha]-aspartyl]-L-phenylalanine 1- methyl ester, monohydrate (CAS Reg. No. 714229-20-6) for use as a non- nutritive sweetener in tabletop applications and powdered beverage mixes. Ajinomoto Co., Inc., also proposes that this additive be identified as advantame.

The Food and Drug Administration (FDA) is announcing the termination and the recharter of the Risk Communication Advisory Committee (the committee). These actions are needed to implement the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Food and Drug Administration Amendments Act of 2007, to change the committee from a discretionary to a statutory committee. This document also amends the agency's regulations which list advisory committees to reflect that the Risk Communication Advisory Committee has been rechartered and to revise the function statement.

Under the provisions of section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Fogarty International Center (FIC) and National Institute of Environmental Health Sciences (NIEHS), the National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on May 12, 2009, page 22172, and allowed 60-days for public comment. No comments were received from this notification regarding the cost and hour burden estimates. The purpose of this announcement is to allow an additional 30 days for public comment.