Department of Health and Human Services April 2005 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is responding to objections and is denying requests that it has received for a hearing on the final rule that amended the food additive regulations authorizing the use of neotame as a nonnutritive sweetener in food. After reviewing the objections to the final rule and the requests for a hearing, the agency has concluded that the objections do not raise issues of material fact that justify a hearing or otherwise provide a basis for revoking the amendment to the regulation.

The Department of Health and Human Service (DHHS), Office of Public Health and Science (OPHS), is seeking nominations of qualified candidates to be considered for appointment as a member of the Advisory Committee on Minority Health (ACMH or Committee). In accordance with Public Law 105-392, the Committee provides advice to the Deputy Assistant Secretary for Minority Health (DASMH), on the development of goals and specific program activities of the Office of Minority Health (OMH) designed to improve the health of racial and ethnic minority groups. Nominations of qualified candidates are being sought to fill vacant positions on the Committee.

Funds are provided for Graduate Student Research Grants to Support field-initiated research activities. This grant program is part of a larger set of Head Start research announcements. Three other grant funding mechanisms are being offered concurrently with the one described in this announcement. They include: (1) Head Start Graduate Student Research Partnership Development Grants, (2) Head Start-University Partnership Research Grants: Curriculum Development and Enhancement for Head Start and Early Head Start Programs, and (3) American Indian-Alaska Native Head Start- University Partnerships. For more information, please see these other Head Start Research announcements listed in the Federal Register or listed on https://www.Grants.Gov, or send an inquiry to the e-mail address listed above. Funding for this grant program is shared with the Head Start Graduate Student Research Partnership Development Grants. Relative funding for the two sets of Head Start Graduate Student Research Grants is contingent upon the results of the review process.

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of March 4, 2005 (70 FR 10651). The document announced the withdrawal of approval of 76 new drug applications (NDAs) and 60 abbreviated new drug applications (ANDAs). The document inadvertently withdrew approval of ANDA 76-214 for Sotalol Hydrochloride Tablets, 80 milligrams (mg), 120 mg, and 160 mg, held by TorPharm, c/o Apotex Corp., 616 Heathrow Dr., Lincolnshire, IL 60069. FDA confirms that approval of ANDA 76-214 is still in effect.

This notice requests nominations for individuals to serve on the Advisory Panel on Medicare Education (the Panel). The Panel advises and makes recommendations to the Secretary of the Department of Health and Human Services (HHS) (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) (the Administrator) on opportunities for CMS to optimize the effectiveness of the National Medicare Education Program and other CMS programs that help Medicare beneficiaries understand the Medicare program and the range of health plan options available. Nominees must be knowledgeable in the field of managing a drug benefit.

In compliance with the requirement of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of Loan Repayment, the National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on December 10, 2004, and allowed 60 days for public comment. No responses to the notice 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. The programs have existing data collections with an OMB control number (OMB No. 0925- 0361, expiration date 12/31/2004). An extension has been granted until March 2005 due to an administrative delay caused by a change in office responsible for the LRPs.

This notice is to inform interested parties of corrections to the Head Start Tribally Controlled Land Grant College and University Partnerships Program Announcement that was published on Wednesday, April 13, 2005. The following corrections should be noted: (1) Under Priority Areas I, Section VII. Agency Contacts, Program Office Contact, please delete the following name, address, phone number, and e-mail address: Katherine Gray, U.S. Department of Health and Human Services, Administration for Children and Families, ACYF Head Start Bureau, 330 C Street, SW., Switzer Room 2211, Washington, DC 20447. Phone: 312-353-2260. E-mail: kgray@acf.hhs.gov. Please replace the deleted name, address, phone number, and e-mail address with the following: Rosalind Dailey, U.S. Department of Health and Human Services, Administration for Children and Families, ACYF Head Start Bureau, 330 C Street, SW., Switzer Room 2211, Washington, DC 20447. Phone: 202-205-8653. E-mail: rdailey@acf.hhs.gov. All information in this notice of correction is accurate and replaces information specified in the April 13 notice. Applications are still due by the deadline date that was published in the April 13 notice (May 13 for Letters of Intent or Preapplications and June 13 for Applications).

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry and FDA staff entitled ``Application User Fees for Combination Products.'' This document provides guidance to industry and FDA staff on marketing application user fees for combination products. The guidance also describes how the ``barrier to innovation'' waiver provision under the prescription drug user fee provisions of the Federal Food, Drug, and Cosmetic Act (the act) may be applied to innovative combination products in the infrequent situation where FDA requires the submission of two marketing applications.