[Federal Register Volume 60, Number 198 (Friday, October 13, 1995)]
[Notices]
[Pages 53382-53383]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-25327]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Statement of Organization, Functions, and Delegations of 
Authority

    Part H, Chapter HF (Food and Drug Administration) of the Statement 
of Organization, Functions, and Delegations of Authority for the 
Department of Health and Human Services (35 FR 3685, February 25, 1970, 
and 56 FR 29484, June 27, 1991, as amended most recently in pertinent 
part at 59 FR 43128, August 22, 1994) is amended to reflect the 
transfer of the International Affairs Staff from the Office of Health 
Affairs to report directly to the Deputy Commissioner for External 
Affairs, Office of External Affairs (OEA), in the Food and Drug 
Administration (FDA). Chapter HF is further amended to establish the 
Industry and Small Business Liaison Staff.
    The International Affairs Staff will continue to serve as the 
Agency focal point for developing and maintaining international 
communications and programs. FDA believes that the increase in 
international activity with regard to FDA regulated products and 
activities necessitates the elevation of the International Affairs 
Staff to the office level within OEA and that this action enhances the 
management and coordination of Agency international activities.
    The Office of External Affairs has realigned its industry liaison 
functions within the immediate office of the Deputy Commissioner for 
External Affairs and established a new Industry and Small Business 
Liaison Staff. The new staff will serve as the Agency focal point for 
overall industry liaison and communication activities within FDA. FDA 
believes that stronger emphasis should be placed on promoting 
understanding of and compliance with FDA regulations among regulated 
industry, industry trade and scientific associations, and professional 
societies.
    Under section HF-B, Organization:
    1. Delete the subparagraph International Affairs Staff (HFA56), 
under the Office of Health Affairs (HFA5), in its entirety and insert a 
new subparagraph, International Affairs Staff (HFAQA), under the Office 
of External Affairs (HFAQ), reading as follows:
    International Affairs Staff (HFAQA). Serves as the Agency focal 
point for developing and maintaining international communications and 
programs.
     Establishes and provides an Agency liaison on international 
activities with the Department, Public Health Service (PHS), and other 
Federal agencies, foreign governments, including foreign 

[[Page 53383]]
embassies, and international organizations.
    Represents the Agency at meetings, conferences, and symposia 
relating to international obligations; briefs Agency participants in 
such international activities.
    Establishes, identifies, interprets, and clarifies, in cooperation 
with appropriate Agency components, the Agency's international 
obligations and needs, including those associated with bilateral 
programs which involve extra budgetary support.
    Establishes and maintains an international information exchange 
program concerning Agency policies and programs to provide interchange 
between FDA and counterpart agencies in foreign countries and 
international organizations.
     Assists in the development, negotiation, and monitoring of 
agreements with foreign governments and international organizations in 
cooperation with appropriate Agency components; and acts as the Agency 
focal point for intergovernmental conferences.
    Negotiates the preparation and implementation of technical 
assistance programs (including formal training programs and surveys) 
with foreign governments and international organizations in areas 
relating to the Agency mission. Coordinates ongoing technical 
assistance operations with appropriate components within the 
Department, PHS, and the Agency.
    Directs the Agency's International Visitors Program, providing 
participants with policy briefings, technical training, and/or 
assistance in response to specific needs.
    2. Insert a new subparagraph, Industry and Small Business Liaison 
Staff (HFAQB), under the Office of External Affairs (HFAQ), reading as 
follows:
    Industry and Small Business Liaison Staff (HFAQB). Advises and 
assists the Commissioner and other Agency officials on industry-related 
issues which have an impact on policy, direction, and goals.
    Serves as the Agency focal point for overall industry liaison and 
communication activities within FDA, including FDA centers, and between 
FDA and FDA-regulated industry, industry trade associations, and 
scientific associations.
    Serves as a liaison with other Agency components to provide advice 
and assistance to small manufacturers and scientific associations to 
promote their understanding of and compliance with FDA regulations.
    Develops and maintains effective channels of communication with 
regulated industry, professional societies, and trade and scientific 
associations.
    3. Prior Delegations of Authority. Pending further delegations, 
directives, or orders by the Commissioner of Food and Drugs, all 
delegations of authority to positions of the affected organizations in 
effect prior to this date shall continue in effect in them or their 
successors.

    Dated: September 11, 1995.
David A. Kessler,
Commissioner of Food and Drugs.
[FR Doc. 95-25327 Filed 10-12-95; 8:45 am]
BILLING CODE 4160-01-F