[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
