Department of Health and Human Services April 21, 2005 – Federal Register Recent Federal Regulation Documents

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.