
[Federal Register Volume 78, Number 10 (Tuesday, January 15, 2013)]
[Rules and Regulations]
[Page 2892]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-00723]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 21

[Docket No. FDA-2011-N-0252]

Office of the Secretary

45 CFR Part 5b


Privacy Act, Exempt Record System; Withdrawal

AGENCY: Office of the Secretary, Food and Drug Administration, HHS.

ACTION: Direct final rule; withdrawal.

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SUMMARY: The Department of Health and Human Services (HHS) and the Food 
and Drug Administration (FDA) are withdrawing the direct final rule 
that August 28, 2012. HHS/FDA published the direct final rule to exempt 
scientific research misconduct proceedings records from certain 
requirements of the Privacy Act of 1974 in order to protect records 
compiled in the course of misconduct inquiries and investigations, and 
to safeguard the identity of confidential sources. The comment period 
closed on November 13, 2012. HHS/FDA is withdrawing the direct final 
rule because the Agency received significant adverse comment.

DATES: Effective Date: The direct final rule published at 77 FR 51910, 
August 28, 2012, is withdrawn effective January 10, 2013.

FOR FURTHER INFORMATION CONTACT: Frederick Sadler, Division of Freedom 
of Information, Food and Drug Administration, 12420 Parklawn Dr., 
Rockville, MD 20857, 301-796-8975, Frederick.Sadler@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: HHS and FDA are withdrawing the direct final 
rule that published in the Federal Register of Tuesday, August 28, 2012 
(77 FR 51910). HHS/FDA published the direct final rule to exempt 
scientific research misconduct proceedings records from certain 
requirements of the Privacy Act of 1974 in order to protect records 
compiled in the course of misconduct inquiries and investigations, and 
to safeguard the identity of confidential sources. The comment period 
closed on November 13, 2012. HHS/FDA is withdrawing the direct final 
rule because the Agency received significant adverse comment.

    Authority: Therefore, under 5 U.S.C. 552a, the direct final rule 
published on Tuesday, August 28, 2012, 77 FR 51910, is withdrawn.

    Dated: January 10, 2013.

    Approved:
Kathleen Sebelius
Secretary, Department of Health and Human Services.
[FR Doc. 2013-00723 Filed 1-10-13; 4:15 pm]
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