Department of Health and Human Services August 2007 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``FDA Guidance for Industry: Exports Under the FDA Export Reform and Enhancement Act of 1996.'' The guidance document addresses issues pertaining to the exportation of human drugs, animal drugs, biologics, devices, food, food additives, color additives and dietary supplements under the FDA Export Reform and Enhancement Act.

The Food and Drug Administration (FDA) is confirming the effective date of July 20, 2007, for the final rule that appeared in the Federal Register of June 19, 2007 (72 FR 33664). The final rule amended the color additive regulations to provide for the safe use of D&C Black No. 3 (bone black, subject to FDA batch certification) as a color additive in the following cosmetics: Eyeliner, eye shadow, mascara, and face powder.

The President's Council on Bioethics (Edmund D. Pellegrino, MD, Chairman) will hold its thirtieth meeting, at which it will (1) Discuss a projected ``white paper'' on the neurological standard for the determination of death; (2) continue the exploratory phase of a potential inquiry into the ``crisis'' of the healing professions with expert presentations and Council discussions; and (3) continue the exploratory phase of a potential inquiry into ethical issues associated with nanotechnology with expert presentations and Council discussions. Subjects discussed at past Council meetings (although not on the agenda for the September 2007 meeting) include: therapeutic and reproductive cloning, assisted reproduction, reproductive genetics, the ethics of health care, neuroscience, aging retardation, organ transplantation, newborn screening, human dignity, personalized medicine, and lifespan- extension. Publications issued by the Council to date include: Human Cloning and Human Dignity: An Ethical Inquiry (July 2002); Beyond Therapy: Biotechnolody and the Pursuit of Happiness (October 2003); Being Human: Readings from the President's Council on Bioethics (December 2003); Monitoring Stem Cell Research (January 2004), Reproduction and Responsibility: The Regulation of New Biotechnologies (March 2004), Alternative Sources of Human Pluripotent Stem Cells: A White Paper (May 2005), and Taking Care: Ethical Caregiving in Our Aging Society (September 2005). Reports on the bioethical significance of the concept of human dignity and on organ procurement, transplantation, and allocation are forthcoming.

The Food and Drug Administration (FDA) is announcing a public meeting entitled ``Preparation for ICH meetings in Yokohama, Japan'' to provide information and receive comments on the International Conference on Harmonization (ICH) as well as the upcoming meetings in Yokohama, Japan. The topics to be discussed are the topics for discussion at the forthcoming ICH Steering Committee Meeting. The purpose of the meeting is to solicit public input prior to the next Steering Committee and Expert Working Groups meetings in Yokohama, Japan, October 27 through November 1, 2007, at which discussion of the topics underway and the future of ICH will continue. Date and Time: The meeting will be held on Wednesday, October 10, 2007, from 12:30p.m. to 3 p.m. Location: The meeting will be held at 5600 Fishers Lane, 3rd floor, Conference Room D and E, Rockville, MD 20857. For security reasons, all attendees are asked to arrive no later than 12:20 p.m., as you will be escorted from the front entrance of 5600 Fishers Lane to Conference Room D and E. Contact Person: All participants must register with Tammie Bell, Office of the Commissioner, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, by e-mail: Tammie.Bell2@fda.hhs.gov or fax: 301-827-0003. Registration and Requests for Oral Presentations: Send registration information (including name, title, firm name, address, telephone, and fax number), written material and requests to make oral presentations, to the contact person by October 8, 2007. If you need special accommodations due to a disability, please contact Tammie Bell at least 7 days in advance. Transcripts: Transcripts of the meeting may be requested in writing from the Freedom of Information Office (HFI-35), Food and Drug Administration, 5600 Fishers Lane, rm. 12A-16, Rockville, MD 20857, approximately 15 working days after the meeting at a cost of 10 cents per page.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by G. C. Hanford Manufacturing Co. The ANADA provides for the use of ampicillin sodium powder in aqueous solution by injection in horses for the treatment of various bacterial infections.

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 Food and Drug Administration (FDA) is announcing a public meeting entitled ``Preparation for International Cooperation on Cosmetics Regulations (ICCR) Meeting in Brussels, Belgium'' to provide information on the process and receive comments on issues that may be relevant to discussions being held at the ICCR meeting in Brussels, Belgium. The purpose of the meeting is to solicit public input prior to the first meeting of this group in Brussels on September 27, 2007. Date and Time: The meeting will be held on Tuesday, August 28, 2007, from 2 p.m. to 3:30 p.m. Location: The meeting will be held at 5600 Fishers Lane, 3rd fl., Chesapeake Conference Room, Rockville, MD 20857. For security reasons, all attendees must preregister and are asked to arrive no later than 1:50 p.m., as you will be escorted from the front entrance of 5600 Fishers Lane to the Chesapeake Conference Room. Contact Person: All participants must register with Michelle Limoli, Office of the Commissioner, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, by e-mail: michelle.limoli@fda.hhs.gov or FAX: 301-827-0003. Registration and Requests for Oral Presentations: Send registration information (including name, title, firm name, address, telephone, and fax number), and written material and requests to make oral presentations, to the contact person by August 21, 2007. If you need special accommodations due to a disability, please contact Michelle Limoli at least 7 days in advance. Transcripts: Transcripts of the meeting may be requested in writing from the Freedom of Information Office (HFI-35), Food and Drug Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857, approximately 15 working days after the meeting at a cost of 10 cents per page.

This notice announces the 18th meeting of the American Health Information Community Electronic Health Records Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.)

This notice announces the 13th meeting of the American Health Information Community Confidentiality, Privacy, and Security Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92- 463, 5 U.S.C., App.).

This notice announces the eighth meeting of the American Health Information Community Personalized Healthcare Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.).

This proposed rule would amend the definition of Medicaid rehabilitative services in order to provide for important beneficiary protections such as a person-centered written rehabilitation plan and maintenance of case records. The proposed rule would also ensure the fiscal integrity of claimed Medicaid expenditures by clarifying the service definition and providing that Medicaid rehabilitative services must be coordinated with but do not include services furnished by other programs that are focused on social or educational development goals and available as part of other services or programs. These services and programs include, but are not limited to, foster care, child welfare, education, child care, prevocational and vocational services, housing, parole and probation, juvenile justice, public guardianship, and any other non-Medicaid services from Federal, State, or local programs.

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of an exclusive license worldwide to practice the inventions embodied in: U.S. Patent Application Numbers 60/206,693 filed May 24, 2000, 10/ 296,423 filed November 22, 2002 and corresponding foreign applications entitled ``Method for Preventing Strokes by Inducing Tolerance to E- Selectin'' and U.S. Patent Application Numbers 60/828,732 filed October 9, 2006 and 60/905,741 filed March 8, 2007 entitled ``Treatment and Prevention of Inflammation'' to Novavax, Inc., having a place of business in Rockville, Maryland. The patent rights in these inventions have been assigned to the United States of America. The contemplated exclusive license may be limited to the use of E- selectin for the prevention or treatment of stroke.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Environmental Impact Considerations'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 which requires 60 days for public comment on proposed information collection projects, the Indian Health Service (IHS) is publishing for comment a summary of a proposed information collection to be submitted to the Office of Management and Budget (OMB) for review. Proposed Collection: Title: 0917-0006, ``Application for Participation in the IHS Scholarship Program.'' Type of Information Collection Request: Three-year extension, without change of currently approved information collection, 0917-0006, ``Application for Participation in the IHS Scholarship Program.'' Form Number(s): IHS- 856, 856-2 through 856-8, IHS-815, IHS-816, IHS-817, IHS-818, D-02, F- 02, F-04, G-02, G-04, H-07, H-08, J-04, J-05, K-03, K-04, and L-03. Reporting formats are contained in an IHS Scholarship Program application booklet. Need and Use of Information Collection: The IHS Scholarship Branch needs this information for program administration and uses the information to solicit, process, and award IHS Pre- graduate, Preparatory, and/or Health Professions Scholarship grants and monitor the academic performance of awardees and to place awardees at payback sites. The IHS Scholarship Program is streamlining the application to reduce the time needed by applicants to complete and provide the information. The IHS Scholarship Program plans on using information technology to make the application electronically available on the internet. Affected Public: Individuals, not-for-profit institutions and State, local or tribal government. Type of Respondents: Students pursuing health care professions. The table below provides: Types of data collection instruments, Estimated number of respondents, Number of responses per respondent, Annual number of responses, Average burden hour per response, and Total annual burden hour(s).

The Food and Drug Administration (FDA) is announcing its intent to accept and consider a single source application (RFA-FDA-07- 006) for the awarding of a Cooperative Agreement to the National Alliance for Hispanic Health (the Alliance). The purpose of the agreement is to empower consumers to improve their health by providing better consumer health information; ensure that health information available to consumers is clear, informative, and effective; leverage opportunities to eliminate health disparities in subpopulations; respond to the health promotion and disease prevention objectives of the Department of Health and Human Services (HHS) ``Healthy People 2010'' document; and improve health literacy for Hispanic Americans. FDA anticipates providing $ 35,000.00 (direct and indirect costs) in fiscal year (FY) 2007 in support of this project. Subject to the availability of funds and successful performance, two additional years of support up to $35,000.00 per year (direct and indirect) will be available.

The Food and Drug Administration (FDA) has determined that MIVACRON (mivacurium chloride) injection equivalent to (EQ) 2 milligrams (mg) base/milliliter (mL) was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for mivacurium chloride injection EQ 2 mg base/mL.

The Food and Drug Administration (FDA) is classifying an in vitro human immunodeficiency virus (HIV) drug resistance genotype assay into class II (special controls). The special control that will apply to this device is the guidance document entitled ``Class II Special Controls Guidance Document: In Vitro HIV Drug Resistance Genotype Assay.'' FDA is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of this device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control for this device.