Department of Health and Human Services April 4, 2005 – Federal Register Recent Federal Regulation Documents
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Draft Guidance for Industry on Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics.'' This is the first of a series of guidances that will provide recommendations to sponsors on endpoints for cancer clinical trials submitted to FDA to support effectiveness claims in new drug applications (NDAs), biologics license applications (BLAs), or supplemental applications. Sponsors are encouraged to use this draft guidance to design cancer clinical trials and to discuss protocols with the agency. This draft guidance provides background information and discusses general regulatory principles. Each subsequent guidance will focus on endpoints for specific cancer types (e.g., lung cancer, colon cancer) to support drug approval or labeling claims. These guidances are expected to speed the development and improve the quality of protocols submitted to the agency to support anticancer effectiveness claims.
Food Labeling: Serving Sizes of Products That Can Reasonably Be Consumed At One Eating Occasion; Updating of Reference Amounts Customarily Consumed; Approaches for Recommending Smaller Portion Sizes
The Food and Drug Administration (FDA) is issuing this advance notice of proposed rulemaking (ANPRM) to request comment on whether to amend certain provisions of the agency's nutrition labeling regulations concerning serving size. FDA is issuing this ANPRM in response to recommendations of the Obesity Working Group (OWG), which was created by the Commissioner of FDA (the Commissioner) to develop an action plan to address the Nation's obesity problem. Comments on whether, and if so, how to amend the agency's serving size regulations will inform any FDA rulemaking that may result from this ANPRM.
Food Labeling; Prominence of Calories
The Food and Drug Administration (FDA) is issuing this advance notice of proposed rulemaking (ANPRM) to request comment on whether to amend certain provisions of the agency's nutrition labeling regulations to give more prominence to calories on food labels. FDA is issuing this ANPRM in response to recommendations of the Obesity Working Group (OWG), which was created by the Commissioner of Food and Drugs (the Commissioner) to develop an action plan to address the Nation's obesity problem. Comments on whether and, if so, how to give greater emphasis to calories on the nutrition label will inform any FDA rulemaking that may result from this ANPRM.
Government-Owned Inventions; Availability for Licensing
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.
Secretary's Advisory Committee on Genetics, Health, and Society; Office of the Secretary, HHS; Request for Public Comment
The Secretary's Advisory Committee on Genetics, Health, and Society (SACGHS) is requesting public comment on a draft report on coverage and reimbursement of genetic tests and services.
National Toxicology Program (NTP); Liaison and Scientific Review Office (LSRO); Announcement of National Toxicology Program (NTP) Workshop on “Animal Models for the NTP Rodent Cancer Bioassay: Strains & Stocks-Should We Switch?”
Over the past year, the National Toxicology Program (NTP) has developed and refined a vision for toxicology in the 21st century (``NTP Vision'') and a roadmap for implementing this vision (``NTP Roadmap'') that will strategically position the program at the forefront for providing scientific data and the interpretation of those data for public health decision-making (see SUPPLEMENTARY INFORMATION for additional detail). As part of the NTP Roadmap, the program will convene a series of public workshops to review aspects of the existing testing program. The first workshop is scheduled for June 16-17, 2005, at the NIEHS in Research Triangle Park, NC and will focus on evaluating stocks and strains currently used in the NTP rodent cancer bioassay in order to improve the ability of the bioassay to identify substances that may pose a carcinogenic hazard for humans. In particular, the goal of this workshop is to seek scientific input as to whether the NTP should continue to use both the F344 rat and B6C3F1 mouse models, use other strains, and/or use multiple strains as previously suggested (Festing, 1995). Future workshops will address other study design issues such as diet, length of study, and age at exposure. The NTP invites public comments on the appropriateness of the F344N and B6C3F1 models currently used and the submission of historical control data for rodent models that the NTP might consider at the workshop. The program will include plenary sessions as well as three breakout group meetings for in-depth discussions of rat models, mouse models, and the multiple strain approach. Following the meeting, the NTP will prepare a workshop report and present its proposed testing strategy to the NTP Board of Scientific Counselors for their consideration and input. Attendance at the meeting is limited only by the space available. Members of the public may register to attend the workshop on a first- come, first-served basis per the procedures outlined below. A copy of the agenda and any additional information on the workshop, including participants and background materials, will be posted on the NTP Web site when available (https://ntp.niehs.nih.gov select ``Meetings and Workshops'')
Submission for OMB Review; Comment Request; Outcome Evaluation of the Small Grants Program for Behavioral Research in Cancer Control
Under the provisions of section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the (National Cancer Institute), 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 August 31, 2004, page 53079 and allowed 60 days for public comment. No public comment was received. 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. Proposed Collection: Title: Outcome Evaluation of the Small Grants Program for Behavioral Research in Cancer Control. Type of Information Collection Request: New. Need and Use of Information Collection: The Small Grants Program support projects that can be completed in a short period of time, such as pilot projects, development and testing of new methodologies, secondary data analyses, or innovative studies that provide a basis for more extended research. This evaluation is being conducted to identify progress of this program in establishing a cohort of scientists with a high level of research expertise in behavioral research cancer control. A primary objective of this study is to determine if the program's small grants R03 funding mechanism is effective in attracting investigators to the field of behavioral research and if so, what impact does the program have on the career of successful applicants. The findings will provide valuable information regarding (1) effectiveness of the program in attracting investigators to the field; (2) the impact of the program on investigators careers; and (3) the overall benefit provided by the program through the R03 funding mechanism and assist the agency in determining whether changes to the program are necessary in future. Frequency of Response: On occasion. Affected Public: Individuals; teaching institutions or other non-profit. Type of Respondents: Grantees funded under PAR 99-006 (n = 80). Type of Respondents: Principal Investigator awarded grants funded by PAR 00-006 (Dec. 1999-Nov. 2001); Estimated Number of Respondents: 80; Estimated Number of Response Per Respondent: 1; Average Burden Hours Per Response: 75; and Estimated Total Annual Burden Hours Requested: 60.
Proposed Data Collection; Comment Request; Survey of Colorectal Cancer Screening Policies, Programs, and Systems in U.S. Health Plans
In compliance with the provisions of section 3507(1)(D) of the Paperwork Reduction Act of 1995, for opportunity for public comments on proposed data collection projects, the National Institutes of Health (NIH), National Cancer Institute (NCI) 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 29, 2004 (Volume 69, No. 209, pages 63159-63160) and allowed 60 days for public comment. No public comments were received. 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 number. Proposed Collection: Title: Survey of Colorectal Cancer Screening Policies, Programs, and Systems in U.S. Health Plans. Type of Information Collection Request: New. Need and Use of Information Collection: This study will obtain information on policies, programs, and practices for colorectal cancer screening among health plans in the U.S. The purpose of the study is to assess (1) health plan policies, programs, and practices for colorectal cancer screening; (2) health plan activities in response to the National Committee on Quality Assurance's new Health Employer Data Information Set measure for colorectal cancer screening; and (3) characteristics of health plans and plan policies and activities that may be associated with higher rates of colorectal cancer screening. A questionnaire will be administered by mail or Internet using a national sample of health plans. Study participants will be health plan medical directors or administrators, and they will select their preferred response mode. Burden estimates are as follows:
Use of Ozone-Depleting Substances; Removal of Essential-Use Designations
The Food and Drug Administration (FDA) is amending its regulation on the use of ozone-depleting substances (ODSs) in self- pressurized containers to remove the essential-use designations for albuterol used in oral pressurized metered-dose inhalers (MDIs). Under the Clean Air Act, FDA, in consultation with the Environmental Protection Agency (EPA), is required to determine whether an FDA- regulated product that releases an ODS is an essential use of the ODS. Two albuterol MDIs that do not use an ODS have been marketed for more than 3 years. FDA has determined that the two non-ODS MDIs will be satisfactory alternatives to albuterol MDIs containing ODSs and is removing the essential-use designation for albuterol MDIs as of December 31, 2008. Albuterol MDIs containing an ODS cannot be marketed after this date.
New Animal Drugs; Limitations of Use
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the limitations to conditions of use for products approved under 22 new animal drug applications (NADAs) and 5 abbreviated new animal drug applications (ANADAs). In error, a label statement warning against the use of these products in calves to be processed for veal was not codified at the time supplemental NADAs or ANADAs were approved. FDA is also amending the animal drug regulations to reflect the approved preslaughter withdrawal periods and milk withholding period in cattle following use of penicillin G procaine aqueous suspension. This action is being taken to improve the accuracy of the animal drug regulations.
Food Labeling; Guidelines for Voluntary Nutrition Labeling of Raw Fruits, Vegetables, and Fish; Identification of the 20 Most Frequently Consumed Raw Fruits, Vegetables, and Fish; Reopening of the Comment Period
The Food and Drug Administration (FDA) is reopening until June 3, 2005, the comment period for a proposed rule published in the Federal Register of March 20, 2002. In that document, FDA proposed to amend its voluntary nutrition labeling regulations by updating the names and nutrition labeling values for the 20 most frequently consumed raw fruits, vegetables, and fish in the United States. Since publication of the proposed rule, the agency has received new data in comments that it intends to use to further update the nutrition labeling values. The agency also intends to use additional data from the U.S. Department of Agriculture (USDA) for certain nutrients in raw produce. Those data became available after the close of the comment period. FDA is reopening the comment period to allow all interested parties the opportunity to review its tentative nutrition labeling values based upon data FDA received within and after the comment period, and to comment on the additional nutrient data for some of the 20 most frequently consumed raw fruits, vegetables, and fish. FDA will evaluate any new data submissions during this reopened comment period and will consider use of those data in a final rule.
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