Department of Health and Human Services June 21, 2005 – Federal Register Recent Federal Regulation Documents

Update on Leukocyte Reduction of Blood and Blood Components; Public Workshop
Document Number: 05-12185
Type: Notice
Date: 2005-06-21
Agency: Food and Drug Administration, Department of Health and Human Services
Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practices and Related Regulations for Blood and Blood Components; and Requirements for Donor Testing, Donor Notification, and “Lookback”
Document Number: 05-12180
Type: Notice
Date: 2005-06-21
Agency: Food and Drug Administration, Department of Health and Human Services
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''.
Office of Planning, Research and Evaluation; Secondary Analysis of Data From the National Survey of Child Abuse and Neglect
Document Number: 05-12157
Type: Notice
Date: 2005-06-21
Agency: Administration for Children and Families, Department of Health & Human Services, Children and Families Administration, Department of Health and Human Services
Funds are available to support grants for secondary analysis of data available from the National Survey on Child and Adolescent Well-Being (NSCAW). NSCAW provides longitudinal data from multiple informants on the functioning, well-being, and services provided to a national probability sample of children and families who come into contact with the child welfare system through an investigation of child maltreatment. Data are available through licensing agreements from the National Data Archive on Child Abuse and Neglect at Cornell University (http://www.ndacan.cornell.edu). Applicants' planned analyses should be designed to advance the state of knowledge in child maltreatment, child welfare services, child and family services, and/or child development for high risk children.
Government-Owned Inventions; Availability for Licensing
Document Number: 05-12130
Type: Notice
Date: 2005-06-21
Agency: Department of Health and Human Services, National Institutes of Health
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.
National Institute of Environmental Health Sciences 2006 Strategic Plan
Document Number: 05-12129
Type: Notice
Date: 2005-06-21
Agency: Department of Health and Human Services, National Institutes of Health
The NIEHS is updating its 2000 strategic plan entitled NIEHS Strategic Plan 2000A Five-Year Program: New Opportunities in Environmental Health Research. To anticipate, meet, and set priorities for environmental health research, training, resources, and technologies, NIEHS requests input from scientists, members of the public, and all interested parties. The goal of this strategic planning process is to identify barriers to progress for future research and to define future needs and directions for environmental health. In addition, the NIEHS seeks the nomination of individuals qualified to participate in a workshop to discuss the plan in more detail. The existing NIEHS strategic plan can be viewed at http:// www.niehs.nih.gov/external/plan2000/home.htm.
Submission for OMB Review; Comment Request; Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial
Document Number: 05-12128
Type: Notice
Date: 2005-06-21
Agency: Department of Health and Human Services, National Institutes of Health
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.
Agency Information Collection Activities; Proposed Collection; Comment Request; Export of Food and Drug Administration Regulated Products-Export Certificates
Document Number: 05-12109
Type: Notice
Date: 2005-06-21
Agency: Food and Drug Administration, Department of Health and Human Services
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 information collection requirements imposed on firms that intend to export to countries that require an export certificate as a condition of entry for FDA regulated products, pharmaceuticals, biologics, and devices as indicated in the Federal Food, Drug, and Cosmetic Act (the act), as amended.
Determination That PYRIDOSTIGMINE BROMIDE Tablets, 30 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 05-12108
Type: Notice
Date: 2005-06-21
Agency: Food and Drug Administration, Department of Health and Human Services
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.