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Privacy Act, Exempt Record System; Withdrawal

---
identifier: "/us/fr/2013-00723"
source: "fr"
legal_status: "authoritative_unofficial"
title: "Privacy Act, Exempt Record System; Withdrawal"
title_number: 0
title_name: "Federal Register"
section_number: "2013-00723"
section_name: "Privacy Act, Exempt Record System; Withdrawal"
positive_law: false
currency: "2013-01-15"
last_updated: "2013-01-15"
format_version: "1.1.0"
generator: "[email protected]"
agency: "Health and Human Services Department"
document_number: "2013-00723"
document_type: "rule"
publication_date: "2013-01-15"
agencies:
  - "Health and Human Services Department"
  - "Food and Drug Administration"
  - null
cfr_references:
  - "21 CFR Part 21"
  - "45 CFR Part 5"
fr_citation: "78 FR 2892"
fr_volume: 78
docket_ids:
  - "Docket No. FDA-2011-N-0252"
effective_date: "2012-08-28"
fr_action: "Direct final rule; withdrawal."
---

#  Privacy Act, Exempt Record System; Withdrawal

**AGENCY:**

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

**ACTION:**

Direct final rule; withdrawal.

**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*Effective Date:* The direct final rule published at 77 FR 51910, August 28, 2012, is withdrawn effective January 10, 2013.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, *[email protected].*

**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.

Approved:

Dated: January 10, 2013.

Kathleen Sebelius

Secretary, Department of Health and Human Services.