The Federal Register

Addressing Asthma From a Public Health Perspective; Notice of Availability of Funds

Wed, May 28 2003 11:00:00 GMT

Application Deadline: July 14, 2003.
A. Authority and Catalog of Federal Domestic Assistance Number

This program is authorized under section 301 and 317 of the Public Health Service Act [42 U.S.C. section 241 and 247b], as amended. The Catalog of Federal Domestic Assistance number is 93.283.

B. Purpose

The Centers for Disease Control and Prevention (CDC) announces the availability of fiscal year (FY) 2003 funds for a cooperative agreement program for ``Addressing Asthma from a Public Health Perspective.'' This program addresses the ``Healthy People 2010'' focus areas Environmental Health, Occupational Safety and Health, and Respiratory Diseases.

The purpose of the program is to provide the impetus to begin development of program capacity to address asthma from a public health perspective in order to bring about: (1) A focus of asthmarelated activity within the agency; (2) an increased understanding of asthma related data and its application to program planning through development o

Requirements for Liquid Medicated Animal Feed and Free-Choice Medicated Animal Feed

Wed, May 28 2003 11:00:00 GMT

The Food and Drug Administration (FDA) is proposing to change the regulations for liquid medicated feed and freechoice medicated feed. By changing the regulations for liquid medicated feed, FDA wants to clarify: What data are required to demonstrate chemical and physical stability of a drug in liquid feed; how such data may be submitted for use in the new animal drug approval process; and which liquid medicated feeds may be manufactured in a feed manufacturing facility that has not obtained a medicated feed mill license from FDA. By changing the regulations for freechoice medicated feed, FDA wants to ensure that they are consistent with the requirements for liquid medicated feed, and that provisions for freechoice medicated feed and liquid medicated feed comply with the terms of the Animal Drug Availability Act (ADAA) of 1996.

Determination That Periactin Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

Wed, May 28 2003 11:00:00 GMT

The Food and Drug Administration (FDA) has determined that Periactin (cyproheptadine hydrochloride (HCl)) 4milligram (mg) tablets were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for cyproheptadine HCl 4mg tablets.

FDA/Industry Exchange Workshop on FDA Clinical Trials Statutory and Regulatory Requirements; Public Workshop

Wed, May 28 2003 11:00:00 GMT

The Food and Drug Administration (FDA) Philadelphia District, in cooperation with the Society of Clinical Research Associates, (SoCRA) is announcing a workshop on FDA clinical trial statutory and regulatory requirements. Topics for discussion include: Financial incentives and funding, preIND (investigational new drug application) meetings and FDA meeting process, medical device aspects of clinical research, informed consent requirements, adverse event reporting, how FDA conducts bioresearch inspections, ethics in clinical research, FDA and confidence in the conduct of clinical research, and how FDA addresses fraud in clinical research. This 2day 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:

Agency Information Collection Activities: Proposed Collection: Comment Request

Wed, May 28 2003 11:00:00 GMT

In compliance with the requirement for opportunity for public comment on proposed data collection projects (section 3506(c)(2)(A) of Title 44, United States Code, as amended by the Paperwork Reduction Act of 1995, Public Law 10413), the Health Resources and Services Administration (HRSA) publishes periodic summaries of proposed projects being developed for submission to OMB under the Paperwork Reduction Act of 1995. To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, call the HRSA Reports Clearance Officer on (301) 4431129.

Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected;

Availability of Funds

Wed, May 28 2003 11:00:00 GMT

This notice extends the deadline for fiscal year 2003 applications for Chiropractic Demonstration Project (CHIRO) Grants (Sec. 755(b)(3) of the Public Health Service Act) and expands the purpose of the Program. An August 9, 2002 Federal Register notice in the HRSA Preview (67 FR 52049) announced that the deadline for applications for the Chiropractic Demonstration Projects Program was March 31, 2003 and that the purpose of the Chiropractic Demonstration Projects Program is to carry out demonstration projects in which chiropractors and physicians collaborate to identify and provide effective treatment for spinal and lowerback conditions. The FY 2003 Appropriations Act, Public Law 1087, expanded the purpose of the program to add funding for training components. Therefore, the deadline for applications is extended to June 20, 2003. Please mail applications to HRSA Grants Application Center, 901 Russell Avenue, Suite 450, Gaithersburg, Maryland 20857, postmarked no later than June 20, 2003.

HRSA-03-101 Fiscal Year 2003 Competitive Application Cycle for the Comprehensive Geriatrics Education Program (CGEP)

Wed, May 28 2003 11:00:00 GMT

The Health Resources and Services Administration (HRSA) announces that applications will be accepted for the Comprehensive Geriatrics Education Program for Fiscal Year 2003.

Authorizing legislation: These applications are solicited under the authority of Title VIII, Section 855 of the Public Health Service (PHS) Act, as amended.

Purpose: Grants will be awarded to eligible entities for programs thatProvide training to individuals who will provide geriatric care for the elderly by enhancing the knowledge, skills, and leadership potential of registered nurses (RN) providing care to older adults in a variety of settings. Projects must demonstrate that the preparation of RNs benefits licensed practical nurses (LPN) and certified nurse assistants (CNA). Each project must describe the program for RNs and the specific activities designed to develop and strengthen the skills of LPNs and CNAs to promote quality care for the geriatric population.

Statutory matching or cost sharing requirement: N