Department of Health and Human Services May 2, 2006 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability for comments of a draft guidance document for industry (182) entitled ``Pharmacovigilance of Veterinary Medicinal Products; Data Elements for Submission of Adverse Event Reports'' (VICH GL42). This draft guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). The objective of this draft guidance document is to standardize the data for submission of adverse events relating to veterinary medicinal products.

The Food and Drug Administration (FDA) is announcing the availability of a guidance document entitled ``Guidance on the Labeling of Certain Uses of Lecithin Derived From Soy Under the Federal Food, Drug, and Cosmetic Act'' (the act). The guidance explains FDA's current thinking on the labeling of certain uses of lecithin derived from soy under the act. This guidance is part of FDA's implementation of the Food Allergen Labeling and Consumer Protection Act (FALCPA).

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.

The invention listed below is owned by an agency of the U.S. Government and is 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 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 February 23, 2006 on pages 9358-9359 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 control number. 5 CFR 1320.5: Reporting and Recordkeeping Requirements: Final Rule: Respondents to this collection of information are not required to respond unless the data collection instruments display a currently valid OMB control number. 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 of OMB No. 0925- 0522 and expiration date July 31, 2006. Need and Use of Information Collection: The purpose of the Sister Study is to study genetic and environmental risk factors for the development of breast cancer in a cohort of sisters of women who have had breast cancer. In the United States, there were approximately 210,000 new cases in 2003, accounting for 30% of all new cancer cases among women. 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 about 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 will 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. We are enrolling a cohort of 50,000 women who have not had breast cancer. Initial recruitment of the first 2000 women took place from August 2003- September 2004 before beginning nationwide recruitment in October 2004. The data collected in the initial phase allowed us to evaluate subject recruitment and data collection procedures, and helped us better target our recruitment efforts. We estimate that a cohort of 50,000 sisters aged 35-74 years would provide about 1500 breast cancer cases over five years (approximately 300 new cases per year once the cohort is fully enrolled). Frequency of Response: Burden calculations include eligibility screening for 22,750 more women, and completion of enrollment activities for 25,000 more women (difference due to expected 2,250 women, and completion of enrollment activities for 25,000 more women (difference due to expected 2,250 women whose time lag between initial screening and fully completing enrollment baseline activities is expected to cross OMB expiration/revision date) to reach 50,000. These women will complete one initial 15-minute screening (either on the telephone OR on the Internet), two 1-hour telephone interviews, 4 mailed self-administered questionnaires (90 minutes total), and will collect biological and household specimens. Also in the next 3 years, all 50,000 sisters will complete one annual update (10 minutes) and one biennial follow-up questionnaire (60 minutes); in addition 25,000 will complete a second annual update. Women diagnosed with breast cancer or other health outcomes of interest (~1800 allowing for 300 bc/year over our first 6 years, plus 1800 other outcomes) will be asked to provide additional information about their diagnosis (20 minutes per response) and their doctors will be contacted to provide documentation regarding diagnosis and treatments (15 minutes per response). In addition to direct Sister Study participants, up to 300 women will be recruited to provide an anonymous blood sample for Sister Study laboratory quality control activities. A total of up to 200 women (70 during the first year) will be recruited to provide a one-time blood and urine sample and complete a past 24-hour questionnaire. These samples will be used to test long-term storage effects and to provide quality control pools for future assays. Up to 100 women will be sampled on four occasions over the course of a year (20 in the first year), providing blood, urine, and dust samples. On each occasion an abbreviated version of the previously approved past 24-hour questionnaire will be completed. Thus up to 300 women will complete a 5-minute telephone screener to determine eligibility. The 200 women (maximum) who provide a one-time sample will complete a short form describing activities and medication use in the 24 hours prior to blood draw (10 minutes). The 100 women (maximum) will complete the 24-hour form with each of 4 blood draws. Estimated Number of Respondents: The estimated total number of respondents is 67,800, which includes ~12,500 enrolled per year over ~4 years, plus ~14,000 persons ultimately determined ineligible or refusals at initial screening, 3,500 persons who partially complete enrollment before terminating, and up to 300 women for anonymous quality sample collection. Affected Public: Individuals or households; doctors' offices. Type of Respondents: Unaffected sisters of women diagnosed with breast cancer, aged 35-74, from all socioeconomic backgrounds and ethnicities. The annual reporting burden is as follows: Estimated Number of Responses per Respondent: The table below shows the estimated number of responses per respondent per activity over the next 3 years. Average Burden Hours per Response: 6.0; Estimated Total Burden Hours Requested: 194,131 (over 3 years). The average annual burden hours requested is 64,710. The annualized cost to respondents is estimated at $135 (assuming $20 hourly wage x 6 hours + $15 babysitting estimate). There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.