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

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of January 5, 2005 (70 FR 824). The document provided the agency's annual comprehensive list of guidance documents. The list provided information on current guidance documents and those that have been withdrawn. The document was published with some inadvertent errors. This document corrects those errors.

The National Institutes of Health (NIH) announces its policy on enhancing public access to archived publications resulting From NIH- funded research. Beginning May 2, 2005, NIH-funded investigators are requested to submit to the NIH National Library of Medicine's (NLM) PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported, in whole or in part, with direct costs\1\ from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

The authority for the Demonstration Project has been extended with respect to chiropractors (see legislative authority below). The Health Resources and Services Administration (HRSA) announces that applications from qualified chiropractors who agree to serve underserved populations in Primary Care Health Professional Shortage Areas (HPSAs) throughout the Nation will be accepted by the National Health Service Corps (NHSC) for loan repayment awards. A two-year service commitment is required. There is no guarantee that participants in this demonstration project will have an opportunity to continue their service and loan repayments beyond the initial two-year service period. Chiropractors, with qualifying educational loans, must serve at organized primary health care sites in Primary Care HPSAs that have another NHSC clinician on staff who will be concurrently fulfilling an NHSC service commitment through the scholarship or loan repayment program and who is licensed to prescribe medications. This demonstration project will include an evaluation component to determine whether adding chiropractors as permanent NHSC members would enhance the effectiveness of the NHSC. A maximum of 40 individuals will be awarded loan repayment contracts under this demonstration project. Purpose: Eligible chiropractors will participate in the Loan Repayment Demonstration Project to determine whether their services will enhance the effectiveness of the NHSC. Legislative Authority: These applications are solicited under section 338L of the Public Health Service (PHS) Act, as amended by Public Law. 107-251 and Public Law 108-447. See also H.R. Conf. Rep. No. 108-792, at 1113, 1155 (2004); S. Rep. No. 108-345, at 41-42 (2004). Eligible Applicants: Eligible applicants must (1) be citizens or nationals of the United States, (2) possess a current unrestricted license to practice as a chiropractor in the State in which they intend to practice, (3) be negotiating or have secured employment at an eligible community site, and (4) meet the additional eligibility requirements outlined in the application materials. Chiropractors must also have a doctor of chiropractic degree from a four-year chiropractic college that is currently fully accredited by the Commission on Accreditation of the Council on Chiropractic Education, and successfully passed the entire examination by the National Board of Chiropractic Examiners. Funding Priorities or Preferences: Priority will be given to (A) applicants who have characteristics that increase the probability of their continuing to practice in HPSAs after they have completed service, and (B) subject to paragraph (A), applicants from disadvantaged backgrounds. A funding preference will also be given to applicants serving Primary Care HPSAs of greatest shortage (based on the HPSA scores). Statutory Matching or Cost Sharing Requirement: None. Review Criteria: Loan repayment applications will be evaluated to determine (1) the eligibility of the applicant, and (2) the applicant's priority for funding. Estimated Amount of this Competition: $2,000,000. Estimated Number of Awards: 40. Estimated or Average Size of Each Award: $50,000. Estimated Project Period: 2 years. Application Requests, Availability, Dates and Addresses: Application materials are available for downloading via the Web at https://nhsc.bhpr.hrsa.gov. Applicants may also request a hard copy of the application materials by contacting the National Health Service Corps at 1-800-638-0824. All application materials must be submitted in hard copy format. In order to be considered for an award, applications from chiropractors must be postmarked or delivered to the HRSA National Health Service Corps by no later than June 17, 2005 at 5 p.m. ET. Completed applications must be mailed or delivered to: Division of National Health Service Corps, NHSC Loan Repayment Program, c/o I.Q. Solutions, 11300 Rockville Pike, Suite 901, Rockville, MD, 20852. Applicants should request a legibly dated U.S. Postal Service postmark or obtain a legibly dated receipt from a commercial carrier or the U.S. Postal Service. Private metered postmarks shall not be acceptable as proof of timely mailing. Applications postmarked or submitted after the deadline date, or sent to any address other than that above, will be returned to the applicant and not processed. The NHSC will acknowledge receipt of the application if the applicant chooses to complete the notification postcard that is included in the application materials. Application Availability Date: February 2005. Application Deadline: June 17, 2005 at 5 p.m. et. Projected Award Date: September 30, 2005.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of two supplemental new animal drug applications (NADAs) filed by Schering-Plough Animal Health Corp. The supplemental NADAs provide for the addition of statements to labeling of subcutaneous implants containing zeranol warning against the use of these products in calves to be processed for veal.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Q8 Pharmaceutical Development.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). This draft guidance describes the suggested contents for the pharmaceutical development section in the quality module of a regulatory submission in the ICH M4 Common Technical Document (CTD) format. The draft guidance is intended to assist in the development of pharmaceutical studies that provide scientific understanding to support the establishment of specifications and manufacturing controls and serve as the basis for evaluating risk management over the life cycle of the product.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``S8 Immunotoxicity Studies for Human Pharmaceuticals.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance describes a weight-of-evidence approach to determining whether additional immunotoxicity testing for nonbiological pharmaceuticals is appropriate when the findings from standard toxicity studies indicate signs of immunotoxicity. The draft guidance is intended to provide recommendations on nonclinical testing to identify compounds that have the potential to be immunosuppressive and guidance on a weight-of-evidence decision making approach for immunotoxicity testing.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Clinical Lactation StudiesStudy Design, Data Analysis, and Recommendations for Labeling.'' This guidance discusses agency recommendations on how and when to conduct clinical lactation studies and how to assess the influence of drugs or biologic products on lactation. The goals of this guidance are to provide the basic framework for designing, conducting, and analyzing clinical lactation studies and to stimulate further study and research to assist in rational therapeutics for lactating patients.