Department of Health and Human Services March 28, 2007 – Federal Register Recent Federal Regulation Documents

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 National Institutes of Health (NIH) is providing notice of the ``Priority List of Drugs for Which Pediatric Studies Are Needed.'' The NIH develops the list in consultation with the Food and Drug Administration (FDA) and pediatric experts, as mandated by the Best Pharmaceuticals for Children Act. This list prioritizes certain drugs that are most in need of study for use by children to ensure their safety and efficacy. The NIH will update the list at least annually until the Act expires on October 1, 2007.

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 Center for Complementary and Alternative Medicine (NCCAM), at 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.

The Food and Drug Administration (FDA) has determined the regulatory review period for INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of two applications to the Director of Patents and Trademarks, Department of Commerce, for the extension of patents which claim that medical device.

The Food and Drug Administration (FDA) Chicago District, in cooperation with the Society of Clinical Research Associates (SoCRA), is announcing a workshop on FDA clinical trial statutory and regulatory requirements. This 2-day workshop for the clinical research community targets sponsors, monitors, clinical investigators, institutional review boards, and those who interact with them for the purpose of conducting FDA-regulated clinical research. The workshop will include both industry and FDA perspectives on proper conduct of clinical trials regulated by FDA. Date and Time: The public workshop is scheduled for May 16, 2007, from 8:30 a.m. to 5 p.m. and May 17, 2007, from 8:30 a.m. to 4:30 p.m. Location: The public workshop will be held at the Oak Brook Hills Marriott Resort, 3500 Midwest Rd., Oak Brook, IL 60523, 630-850-5555, FAX: 630-850-5569. Contact: Marie Falcone, Food and Drug Administration, U.S. Customhouse, 200 Chestnut St., rm. 900, Philadelphia, PA 19106, 215- 717-3703, FAX: 215-597-5798, e-mail: marie.falcone@fda.hhs.gov. Registration: Send registration information (including name, title, firm name, address, telephone, and fax number) and the registration fee of $575 (member), $650 (nonmember), or $525 (Federal Government employee nonmember). (Registration fee for nonmembers includes a 1-year membership.) The registration fee for FDA employees is waived. Make the registration fee payable to SoCRA, 530 West Butler Ave., suite 109, Chalfont, PA, 18914. To register via the Internet go to www.socra.org (FDA has verified the Web site address, but is not responsible for subsequent changes to the Web site after this document publishes in the Federal Register). The registrar will also accept payment by major credit cards. For more information on the meeting, or for questions on registration, contact 800-SoCRA92 (800-762-7292), or 215-822-8644, or via e-mail: socramail@aol.com. Attendees are responsible for their own accommodations. To make reservations at the Oak Brook Hills Marriott Resort, at the reduced conference rate, contact the Oak Brook Hills Marriott Resort (see Location) before April 24, 2007, citing meeting code SCRSCRA. The registration fee will be used to offset the expenses of hosting the conference, including meals, refreshments, meeting rooms, and materials. Space is limited, therefore interested parties are encouraged to register early. Limited onsite registration may be available. Please arrive early to ensure prompt registration. If you need special accommodations due to a disability, please contact Marie Falcone (see Contact) at least 7 days in advance of the workshop.

Pursuant to section 814 of the Native American Programs Act of 1974 (the Act) 42 U.S.C. 2992b-1, ANA herein describes its proposed interpretive rules, statements of general policy and rules of agency procedure or practice in relation to the Social and Economic Development Strategies (hereinafter referred to as SEDS), Native Language Preservation and Maintenance (hereinafter referred to as Native Language), Environmental Regulatory Enhancement (hereinafter referred to as Environmental), Environmental Mitigation (hereinafter referred to as Mitigation), Improving the Well-Being of Children Native American Healthy Marriage Initiative (hereinafter referred to as Healthy Marriage) programs and any Special Initiatives. Under the statute, ANA is required to provide members of the public an opportunity to comment on proposed changes in interpretive rules, statements of general policy and rules of agency procedure or practice and to give notice of the final adoption of such changes at least thirty (30) days before the changes become effective. This Notice also provides additional information about ANA's plan for administering the programs. On July 18, 2005, ANA published a Notice of Public Comment (NOPC) in the Federal Register (Vol. 70, No. 136) announcing an administrative policy change on the number of awards an eligible applicant could receive under the SEDS program, Catalog of Federal Domestic Assistance number 93.612. This change only affected the Healthy Marriage program. On November 21, 2006, ANA published the annual NOPC in the Federal Register (Vol. 71, No. 224), which did not include a necessary correction to the revised administrative policy published on July 18, 2005. On December 22, 2006, ANA published a third Federal Register notice (Vol. 71, No. 246) to clarify the revised administrative policy published on July 18, 2005, on the number of awards an eligible applicant could receive under the SEDS program, Catalog of Federal Domestic Assistance number 93.612. ANA received three responses to the December 22, 2006, NOPC clarification. After review and consideration of the comments received, ANA determined that the administrative policy originally published on July 18, 2005, required clarification and revision. This Notice clarifies the agency's intent and provides a definitive statement on the number of awards an eligible applicant can receive under the Catalog of Federal Domestic Assistance number 93.612.