May 2, 2006 – Federal Register Recent Federal Regulation Documents

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.

This notice announces a meeting of the Uniform Formulary Beneficiary Advisory Panel. The panel will review and comment on recommendations made to the Director, TRICARE Management Activity, by the Pharmacy and Therapeutics Committee regarding the Uniform Formulary. The meeting will be open to the public. Seating is limited and will be provided only to the first 220 people signing in. All persons must sign in legibly. Notice of this meeting is required under the Federal Advisory Committee Act.

Pursuant to the authorities in the Federal Advisory Committee Act (Pub. L. 92-463) and under the Secure Rural Schools and Community Self-Determination Act of 2000 (Pub. L. 106-393) the Kootenai National Forest's Lincoln County Resource Advisory Committee will meet on Wednesday May 10, 2006 at 6 p.m. at the Forest Supervisor's Office in Libby, Montana for a business meeting. The meeting is open to the public.

The Corporation published a final rule under part 1412 on February 13, 2006 (71 FR 7402) limiting golden parachute and indemnification payments to institution-related parties (IRPs) by Farm Credit System institutions, including their subsidiaries, service corporations and affiliates. The purpose of the rule is to prevent abuses in golden parachute and indemnity payments and to protect the assets of the institution and the Farm Credit System Insurance Fund. In accordance with 12 U.S.C. 2252, the effective date of the final rule is 30 days from the date of publication in the Federal Register during which either or both Houses of Congress are in session. Based on the records of Congress, the effective date of the regulation is April 26, 2006.

The notice sets forth the schedule and proposed agenda of a forthcoming meeting of the National Assessment Governing Board. This notice also describes the functions of the Board. Notice of this meeting is required under section 10(a)(2) of the Federal Advisory Committee Act. This document is intended to notify members of the general public of their opportunity to attend. Individuals who will need special accommodations in order to attend the meeting (i.e., interpreting services, assistive listening devices, materials in alternative format) should notify Munira Mwalimu at 202-357-6938 or at Munira.Mwalimu@ed.gov no later than May 1, 2006. We will attempt to meet requests after this date, but cannot guarantee availability of the requested accommodation. The meeting site is accessible to individuals with disabilities.

The Rural Housing Service is amending its regulations to change the threshold for surety requirements guaranteeing payment and performance from a $100,000 contract amount to the maximum Rural Development Single Family Housing area lending limit. This limit will vary by locality. This will liberalize the requirement for surety and take into account the increased construction cost of single family homes in Rural Development's Single Family Housing Program. This will ease the burden on small contractors for whom obtaining surety is difficult and expensive, thereby reducing costs to our single family housing borrowers. On August 26, 2005 (70 FR 50222), the Rural Housing Service proposed to change the surety requirements for Single Family Housing loans under Section 502 of the Housing Act of 1949 (42 U.S.C. 1472). The rule, open for comment for a period of 60 days, received two comments regarding its implementation in Rural Housing procedure. The first comment is in favor of this final rule, thus reinforcing the idea that reducing costs for the contractor by raising the threshold at which surety is required, ultimately benefits the borrower through greater cost savings. The second comment does not favor the proposed rule. The essence of this argument is based upon protecting federal funds, by providing surety (performance and payment bonds). The cost of surety places a greater financial burden on the borrower, as well as making it more difficult for small contractors in rural areas to service RHS borrowers. RHS oversees the construction process until the project is complete, insuring that Federal funds are properly disbursed for the adequate amount of completed construction demonstrated by the contractor. In addition, surety requirements are not entirely eliminated in Single Family Housing. If the borrower requests surety or the loan official feels that additional security is needed for a specific project, then surety will be provided.

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.

The Alcohol and Tobacco Tax and Trade Bureau is adopting as a final rule, with some changes, a proposed amendment to the regulations pertaining to wine vintage date labeling.

Pursuant to the authorities in the Federal Advisory Committee Act (Pub. L. 92-463) and under the Secure Rural Schools and Community Self-Determination Act of 2000 (Pub. L. 106-393), the Boise and Payette National Forests' Southwest Idaho Resource Advisory Committee will conduct a business meeting, which is open to the public.

This final rule adopts, with specified changes, the interim rule establishing the Department of Homeland Security Acquisition Regulation (HSAR). This regulation supplements the Federal Acquisition Regulation (FAR) and provides a uniform department-wide acquisition regulation for the Department of Homeland Security (DHS). The HSAR provides specificity about the Department's organization, policies, procedures, and delegations of authority. The FAR and HSAR apply to all DHS entities, except the Transportation Security Administration (TSA).