[Federal Register Volume 60, Number 14 (Monday, January 23, 1995)]
[Notices]
[Pages 4417-4418]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-1551]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
Food and Drug Administration 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 52 FR 34851, September 15, 1987) is amended to reflect an
organizational change in the Food and Drug Administration (FDA).
The positions assigned to perform the centralized investigative
activities located in the Division of Ethics and Program Integrity,
Office of Management, Office of Management and Systems, FDA, will be
transferred to the new Office of Internal Affairs within the Office of
the Commissioner. The functions and staff associated with the
activities will report directly to FDA's Deputy Commissioner/Senior
Advisor in the Immediate Office of the Commissioner. Since these
activities could involve investigations of alleged employee misconduct
anywhere in the Agency and because of the importance of providing the
FDA Commissioner with an early warning of any potential misconduct, the
Deputy Commissioner/Senior Advisor to the Commissioner is the
appropriate person to direct these activities. Functional statements
for the newly established Office of Internal Affairs are identified
below.
Under section HF-B, Organization:
1. Insert a new paragraph (a-5), Office of Internal Affairs (HFA-G)
under the Office of the Commissioner (HFA) reading as follows:
Provides a centralized Agencywide investigative resource for the
Commissioner, the Deputy Commissioners, and top Agency management.
Provides a centralized investigative liaison between FDA and the
Office of the Inspector General (OIG).
Serves as an FDA investigative resource to conduct internal FDA
investigations and to support OIG investigations. [[Page 4418]]
Conducts special assignments relative to the functions of this
Office as requested.
2. Delete subparagraph (h-7), Division of Ethics and Program
Integrity (HFA72) in its entirety and insert a new subparagraph under
the Office of Management and Systems (HFA6), Office of Management
(HFA7) reading as follows:
(h-7) Division of Ethics and Program Integrity (HFA72). Directs and
coordinates a multidiscipline team of administrative and/or program
specialists who conduct scheduled reviews of FDA Headquarters and field
components to determine adherence to existing managerial policy and
practices; assures that recommendations resulting from the review
findings are implemented.
Directs FDA's personnel security program and provides professional
leadership and authoritative guidance in these areas. Formulates policy
and procedures necessary to maintain the integrity of privileged
information submitted by industry.
Implements Internal Control Reviews in accordance with OMB
guidelines.
Directs the formulation of FDA policies and procedures concerning
conflicts of interest and employee associations with regulated
industries, reviews financial interests including outside activities of
FDA employees, decides conflict of interest issues, and counsels and
trains employees on the avoidance of conflicts of interest.
Acts on FDA liaison with the Office of the Inspector General (OIG)
regarding audits. Coordinates preparation of FDA responses to OIG audit
findings, monitors implementation of FDA responses.
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: January 5, 1995.
Donna E. Shalala,
Secretary.
[FR Doc. 95-1551 Filed 1-20-95; 8:45 am]
BILLING CODE 4160-01-M
