Department of Health and Human Services March 6, 2012 – Federal Register Recent Federal Regulation Documents
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Tribal Consultation Meetings
Pursuant to the Improving Head Start for School Readiness Act of 2007, Public Law 110-134, notice is hereby given of one-day Tribal Consultation Sessions to be held between the Department of Health and Human Services, Administration for Children and Families, Office of Head Start leadership and the leadership of Tribal Governments operating Head Start (including Early Head Start) programs. The purpose of these Consultation Sessions is to discuss ways to better meet the needs of American Indian and Alaska Native children and their families, taking into consideration funding allocations, distribution formulas, and other issues affecting the delivery of Head Start services in their geographic locations [42 U.S.C. 9835, Section 640(l)(4)].
Agency Information Collection Activities; Proposed Collection; Comment Request; Annual Reporting Requirements for the Older American Act Title VI Grant Program
The Administration on Aging (AoA) is announcing that the proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
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.
Abbott Laboratories; Filing of Food Additive Petition
The Food and Drug Administration (FDA) is announcing that Abbott Laboratories has filed a petition proposing that the food additive regulations be amended to provide for the expanded safe use of vitamin D3 as a nutrient supplement in food.
Pandemic Influenza Vaccines-Amendment
Amendment to declaration issued on March 1, 2010 (75 FR 10268) pursuant to section 319F-3 of the Public Health Service Act (42 U.S.C. 247d-6d) to extend the effective time period, reformat the declaration, modify or clarify terms of the declaration and republish the declaration in its entirety, as amended.
Pilot Program for Early Feasibility Study Investigational Device Exemption Applications; Termination of Acceptance of Nominations and Extending the Duration of the Program
The Food and Drug Administration (FDA) is announcing the termination of the acceptance of nominations for the Early Feasibility Study Investigational Device Exemption (IDE) Applications pilot program. This program allowed the submission of nominations from sponsors of innovative device technologies to participate in a pilot program for early feasibility study IDE applications. FDA is also announcing that the duration of the pilot program is extended to May 8, 2013, for sponsors that have already been accepted for the program.
Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments; Availability
Under the Food and Drug Administration Modernization Act of 1997 (Modernization Act), the Food and Drug Administration (FDA) is required to report annually in the Federal Register on the status of postmarketing requirements and commitments required of, or agreed upon by, holders of approved drug and biological products. This notice is the Agency's report on the status of the studies and clinical trials that applicants have agreed to, or are required to, conduct.
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