Department of Health and Human Services August 15, 2012 – Federal Register Recent Federal Regulation Documents
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Submission for OMB Review; Comment Request; Population Assessment of Tobacco and Health (PATH) Study
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute on Drug Abuse (NIDA), 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 May 18, 2012, pages 29667-29668 and allowed 60-days for public comment. Two 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 control number. Proposed Collection: Title: Population Assessment of Tobacco and Health (PATH) Study. Type of Information Collection Request: NEW. Need and Use of Information Collection: This is a large national longitudinal cohort study on tobacco use behavior and health in the United States conducted under the direction of the National Institutes of Health (NIH) National Institute on Drug Abuse (NIDA) and in partnership with the Food and Drug Administration (FDA). The field test is scheduled to begin in the fall of 2012 and the baseline collection is scheduled to begin in the fall of 2013. Using annual interviews and the collection of biospecimens from adults, the PATH study is designed to establish a population-based framework for monitoring and evaluating the behavioral and health impacts of regulatory provisions by FDA as it meets its mandate under the Family Smoking Prevention and Tobacco Control Act (FSPTCA) to regulate tobacco-product advertising, labeling, marketing, constituents, ingredients, and additives. These regulatory changes are expected to influence tobacco-product risk perceptions, exposures, and use patterns in the short term, and to reduce tobacco-related morbidity and mortality in the long term. By measuring and accurately reporting tobacco product use behaviors and health effects associated with these regulatory changes, this study will provide an empirical evidence base to inform the development, implementation, and evaluation of tobacco-product regulations in the U.S. Frequency of Response: Annually. Affected Public: Individuals or households. Type of Respondents: Youth (ages 12-17) and Adults (ages 18+). The annual reporting burden for the field test is presented in Table 1, and the annual reporting burden for the baseline data collection is presented in Table 2. The annualized cost to respondents for the field test is estimated at: $22,993; and the annualized cost to respondents for the baseline data collection is: $1,792,156. There are no capital, operating, or maintenance costs.
Proposed Collection; Comment Request; The Sister Study: A Prospective Study of the Genetic and Environmental Risk Factors for Breast Cancer
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institute of Environmental Health Sciences (NIEHS), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title: The Sister Study: A Prospective Study of the Genetic and Environmental Risk Factors for Breast Cancer. Type of Information Collection Request: Revision. Need and Use of Information Collection: This is to continue the Phase II follow-up of the Sister Studya study of genetic and environmental risk factors for the development of breast cancer in a high-risk cohort of sisters of women who have had breast cancer. The etiology of breast cancer is complex, with both genetic and environmental factors likely playing a role. Environmental risk factors, however, have been difficult to identify. By focusing on genetically susceptible subgroups, more precise estimates of the contribution of environmental and other non- genetic factors to disease risk may be possible. Sisters of women with breast cancer are one group at increased risk for breast cancer; we would expect at least 2 times as many breast cancers to accrue in a cohort of sisters as would accrue in a cohort identified through random sampling or other means. In addition, a cohort of sisters should be enriched with regard to the prevalence of relevant genes and/or exposures, further enhancing the ability to detect gene- environment interactions. Sisters of women with breast cancer will also be at increased risk for ovarian cancer and possibly for other hormonally-mediated diseases. From August 2003 through July 2009, we enrolled a cohort of 50,884 women who had not had breast cancer. We estimated that after the cohort was fully enrolled, approximately 300 new cases of breast cancer will be diagnosed during each year of follow-up. Thus far 1,634 participants have reported being diagnosed with breast cancer. Frequency of Response: For the remainder of the study, women will be contacted once each year (when not scheduled for ``triennial'') to update contact information and health status (10 minutes per response); and asked to complete short (75 minutes per response) follow-up interviews or questionnaires (``triennial'') every three years. Follow-up and validation of reported incident breast cancer and other health outcomes is conducted under Clinical Exemption CE 2009-09-004. Affected Public: Study participants, next-of-kin/ proxies. Type of Respondents: Participants enrolled in high-risk cohort study of risk factors for breast cancer; next-of-kin/proxies. The annual reporting burden is as follows: Estimated Number of Respondents: 50,884 study participants or next-of-kin/proxies. Estimated Number of Responses per Respondent: See annualized table below:
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.
Draft Guidance for Industry: Necessity of the Use of Food Categories in Food Facility Registrations and Updates to Food Categories; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Necessity of the Use of Food Categories in Food Facility Registrations and Updates to Food Categories.'' The draft guidance identifies additional food categories to be included in food facility registrations as determined appropriate by FDA.
Draft Guidance for Industry on Suicidal Ideation and Behavior: Prospective Assessment of Occurrence in Clinical Trials; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Suicidal Ideation and Behavior: Prospective Assessment of Occurrence in Clinical Trials.'' The purpose of this guidance is to assist sponsors in prospectively assessing the occurrence of treatment-emergent suicidal ideation and behavior in clinical trials of drug and biological products, including drugs for psychiatric and nonpsychiatric indications. This guidance revises and replaces a previous draft guidance entitled ``Suicidality: Prospective Assessment of Occurrence in Clinical Trials'' issued in September 2010.
Tobacco Product Manufacturing Facility Visits
The Food and Drug Administration (FDA), Center for Tobacco Products (CTP) is announcing an invitation for participation in its Tobacco Product Manufacturing Facility Visits. This program is intended to give FDA staff an opportunity to visit facilities involved in the manufacturing of tobacco products, including any related laboratory testing, and observe the manufacturing operations of the tobacco industry. The purpose of this notice is to invite parties interested in participating in Tobacco Product Manufacturing Facility Visits to submit requests to CTP.
Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Studies on Consumer Responses to Nutrient Content Claims on Fortified Foods
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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on a study entitled ``Experimental Studies on Consumer Responses to Nutrient Content Claims on Fortified Foods.''
Privacy Act of 1974; System of Records Notice
In accordance with the requirements of the Privacy Act of 1974, HHS gives notice of a proposed alteration to two existing systems of records covering payroll records: 09-40-0006 entitled ``Public Health Service (PHS) Commissioned Corps Payroll Records, HHS/PSC/HRS,'' and 09-40-0010 entitled ``Pay, Leave and Attendance Records, HHS/PSC/ HRS.'' The systems are being amended to revise an existing routine use covering disclosures to contractors and to add a new routine use pertaining to system security. The routine use changes are described in more detail in the Supplementary Information section below.
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