[Federal Register Volume 60, Number 177 (Wednesday, September 13, 1995)]
[Rules and Regulations]
[Pages 47477-47478]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-22636]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 19
Duty to Report Violations; Amendment
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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[[Page 47478]]
SUMMARY: The Food and Drug Administration (FDA) is amending the
regulation that gives the responsibility to perform the centralized
investigative activities in FDA to another office. The responsibility
was recently transferred from the Division of Ethics and Program
Integrity, Office of Management and Operations, FDA, to the Office of
Internal Affairs, FDA. This action will codify this transfer of
functions.
EFFECTIVE DATE: September 13, 1995.
FOR FURTHER INFORMATION CONTACT: Tommy L. Hampton, Office of Internal
Affairs (HF-9), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-0243.
SUPPLEMENTARY INFORMATION: In the Federal Register of -January 23, 1995
(60 FR 4417), the Department of Health and Human Services published a
notice to reflect an organizational change in 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, were transferred to the new
Office of Internal Affairs within the Office of the Commissioner.
-The new Office of Internal Affairs will serve as an FDA
investigative resource to conduct internal FDA investigations and
support the Office of Inspector General investigations. Therefore, the
agency is amending 21 CFR 19.21 to reflect the organizational change.
List of Subjects in 21 CFR Part 19
Conflict of interests.
-Therefore, under the Federal Food, Drug, and Cosmetic Act and
under authority delegated to the Commissioner of Food and Drugs, 21 CFR
part 19 is amended as follows:
PART 19--STANDARDS OF CONDUCT AND CONFLICTS OF INTEREST
-1. The authority citation for 21 CFR part 19 continues to read as
follows:
-Authority: Sec. 701 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 371).
-2. Section 19.21 is amended in paragraph (a) by removing
``Division of Ethics and Program Integrity, Office of Management and
Operations'' and adding in its place ``Office of Internal Affairs,
Office of the Commissioner'' ; in paragraph (b) by removing ``Division
of Ethics and Program Integrity'' the two times it appears and adding
in its place ``Office of Internal Affairs''; and in paragraph (c) by
removing ``Division of Ethics and Program Integrity'' and adding in its
place ``Office of Internal Affairs''.
Dated: September 5, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-22636 Filed 9-12-95; 8:45 am]
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