Department of Health and Human Services June 2005 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or agency) is announcing the availability of a revised guidance document entitled ``Guidance for Industry and FDA: Establishing and Maintaining a List of U.S. Dairy Product Manufacturers/Processors With Interest in Exporting to Chile.'' The guidance explains that FDA has established a list that is provided to the government of Chile and posted on FDA's Internet site, which identifies U.S. dairy product manufacturers that have expressed interest to FDA in exporting dairy products to Chile, are subject to FDA jurisdiction, and are not the subject of a pending judicial enforcement action (e.g., injunction or seizure) or a pending warning letter. Application for inclusion on the list is voluntary. However, Chile has advised that dairy products from firms not on this list could be delayed or prevented by Chilean authorities from entering commerce in Chile. The revised guidance document describes the recommended process for U.S. manufacturers to follow to be included on the list and explains FDA's request, on Chile's behalf, that this information be updated every 2 years.

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 the information collection requirements contained in FDA's current good manufacturing practice (CGMP) and related regulations for blood and blood components; and requirements for donor testing, donor notification, and ``lookback''.

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.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Cancer Institute (NCI), 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 January 24, 2005, page 3376 and allowed 60-days for public comment. Three requests for more information were received. Additional information on the proposed collection was sent to each requestor. The purpose of this notice is to allow an additional 30 days for public comment. 5 CFR 1320.5 (General requirements) Reporting and Recordkeeping Requirements: Final Rule requires that the agency inform the potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number. This information is required to be stated in the 30-day Federal Register Notice. Proposed Collection: Title: Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial. Type of Information Collection Request: Revision, OMB control number 0925-0407, expiration date July 31, 2005. Need and Use of Information Collection: This trial is designed to determine if screening for prostate, lung, colorectal and ovarian cancer can reduce mortality from these cancers which currently cause an estimated 263,000 deaths annually in the U.S. The design is a two-armed randomized trial of men and women aged 55 to 74 at entry. The total sample size t is 154,938. The primary endpoint of the trial is cancer- specific mortality for each of the four cancer sites (prostate, lung, colorectum, and ovary). In addition, cancer incidence, stage shift, and case survival are to be monitored to help understand and explain results. Biologic prognostic characteristics of the cancers will be measured and correlated with mortality to determine the mortality predictive value of these intermediate endpoints. Basic demographic data, risk factor data for the four cancer sites and screening history data, as collected from all subjects at baseline, will be used to assure comparability between the screening and control groups and make appropriate adjustments in analysis. Further, demographic and risk factor information may be used to analyze the differential effectiveness of screening in high versus low risk individuals. Frequency of Response: On occasion. Affected Public: Individuals or households. Type of Respondents: Adult men and women. The annual reporting burden is as follows: Estimated Number of Respondents: 145,852; Estimated Number of Responses Per Respondent: 1.14; Average Burden Hours Per Response: 0.14; and Estimated Total Annual Burden Hours Requested: 23,278. The annualized cost to respondents is estimated at: $232,780. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.

The Food and Drug Administration (FDA) has determined that PYRIDOSTIGMINE BROMIDE tablets, 30 milligrams (mg), for the treatment of myasthenia gravis, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for PYRIDOSTIGMINE BROMIDE tablets, 30 mg, for the treatment of myasthenia gravis.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Nonclinical Evaluation of Late Radiation Toxicity of Therapeutic Radiopharmaceuticals.'' The purpose of this draft guidance is to provide recommendations to industry for designing nonclinical toxicity studies to determine potential late radiation toxicities (radiation- induced injuries occurring after a latency period of several months to years) of therapeutic radiopharmaceuticals administered systemically. The purpose of such studies is to help minimize the risk of late- occurring irreversible radiation toxicities in clinical studies of therapeutic radiopharmaceuticals.

Funds are provided for Area Poverty Research Center cooperative agreements for qualified institutions to provide a focused agenda expanding our understanding of the causes, consequences and effects of poverty in local geographic areas or specific substantive areas, especially in states or regional areas of high concentrations of poverty. These cooperative agreements are intended to create a research opportunity for scholars and institutions otherwise unlikely to participate extensively in HHS programs to support the Nation's poverty research effort. I. Funding Opportunity Description

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor's name from Rhodia Limited to Rhodia UK Limited.

This proposed rule would establish the Medicare Integrity Program (MIP) and implement program integrity activities that are funded from the Federal Hospital Insurance Trust Fund. This proposed rule would set forth the definition of eligible entities; services to be procured; competitive requirements based on Federal acquisition regulations and exceptions (guidelines for automatic renewal); procedures for identification, evaluation, and resolution of conflicts of interest; and limitations on contractor liability. This proposed rule would bring certain sections of the Medicare regulations concerning fiscal intermediaries and carriers into conformity with the Social Security Act (the Act). The rule would distinguish between those functions that the statute requires to be included in agreements with fiscal intermediaries and those that may be included in the agreements. It would also provide that some or all of the functions may be included in carrier contracts. Currently all these functions are mandatory for carrier contracts.

The Children's Bureau announces the availability of funds and requests applications to develop, implement, evaluate and disseminate a training curriculum for public child welfare agency supervisors. This curriculum will strengthen supervision of staff interventions with older youth who are in foster care and/or in independent living programs. These youth, mostly ages 16 to 21, need assistance in making a successful transition to adulthood, as well as achieving self-sufficiency to avoid long-term dependency on the social welfare system. These youth often face decisions with regard to personal housing, transportation, employment and education. They need workers who can guide them and who understand these challenges. The target youth also need workers who have a working knowledge of adolescent transition programs. ``In the continuing work of the Muskie School of Public Service, University of Southern Maine and National Resource Center for Youth Services, College of Continuing Education University of Oklahoma, four core principles have emerged as essential in order for adolescent transitional living programs to be successful.'' It is the thinking of current experts in the field that programs for youth are more likely to be successful when these four principles are incorporated into the program design regardless of the type of services provided. The principles are: (1) Positive youth development; (2) Collaboration; (3) Cultural competence; and (4) Permanent connections.