Document ID: FDA-2011-N-0080-0020
Agency: fda
Document Type: Rule
Title: Amendments to Sterility Test Requirements for Biological Products: Correction
Posted Date: 2012-05-24T04:00Z

[Federal Register Volume 77, Number 101 (Thursday, May 24, 2012)]
[Rules and Regulations]
[Pages 30887-30888]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-12594]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 600, 610, and 680

[Docket No. FDA-2011-N-0080]
RIN 0910-AG16

Amendments to Sterility Test Requirements for Biological 
Products; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule, correction.

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SUMMARY: The Food and Drug Administration (FDA) is correcting a

[[Page 30888]]

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:

Sec.  680.3  [Corrected]

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

    Dated: May 18, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-12594 Filed 5-23-12; 8:45 a.m.]
BILLING CODE 4160-01-P