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Amendments to Sterility Test Requirements for Biological Products; Correction

---
identifier: "/us/fr/2012-12594"
source: "fr"
legal_status: "authoritative_unofficial"
title: "Amendments to Sterility Test Requirements for Biological Products; Correction"
title_number: 0
title_name: "Federal Register"
section_number: "2012-12594"
section_name: "Amendments to Sterility Test Requirements for Biological Products; Correction"
positive_law: false
currency: "2012-05-24"
last_updated: "2012-05-24"
format_version: "1.1.0"
generator: "[email protected]"
agency: "Health and Human Services Department"
document_number: "2012-12594"
document_type: "rule"
publication_date: "2012-05-24"
agencies:
  - "Health and Human Services Department"
  - "Food and Drug Administration"
cfr_references:
  - "21 CFR Part 600"
  - "21 CFR Part 610"
  - "21 CFR Part 680"
rin: "0910-AG16"
fr_citation: "77 FR 30887"
fr_volume: 77
docket_ids:
  - "Docket No. FDA-2011-N-0080"
effective_date: "2012-06-04"
fr_action: "Final rule, correction."
---

#  [Corrected]

**AGENCY:**

Food and Drug Administration, HHS.

**ACTION:**

Final rule, correction.

**SUMMARY:**

The Food and Drug Administration (FDA) is correcting a  final rule that appeared in the *Federal Register* of May 3, 2012. (77 FR 26162). The final rule provides manufacturers of biological products greater flexibility, as appropriate, and encourages use of the most appropriate and state-of-the-art test methods for assuring the safety of biological products. The rule was published with an inaccurate citation in the codified section of the rule. This notice corrects that error.

**DATES:**

Effective June 4, 2012.

**FOR FURTHER INFORMATION CONTACT:**

Paul E. Levine, Jr., Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-1448, 301-827-6210.

**SUPPLEMENTARY INFORMATION:**

In FR Doc. 2012-10649, appearing on page 26162 in the *Federal Register* of Thursday, May 3, 2012, the following correction is made:

**21 CFR Part 680**

§ 680.3

1. On page 26175, in the second column, in Part 680 Additional Standards for Miscellaneous Products, in § 680.3 Tests, paragraph (c), in line 4, “§ 601.12” is corrected to read “§ 610.12”.

Dated: May 18, 2012.

Leslie Kux,

Assistant Commissioner for Policy.