77 FR 101 pgs. 30887-30888 - Amendments to Sterility Test Requirements for Biological Products; Correction
Type: RULEVolume: 77Number: 101Pages: 30887 - 30888
Docket number: [Docket No. FDA-2011-N-0080]
FR document: [FR Doc. 2012-12594 Filed 5-23-12; 8:45 a.m.]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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.
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:
§ 680.3 [Corrected]
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.
[FR Doc. 2012-12594 Filed 5-23-12; 8:45 a.m.]
BILLING CODE 4160-01-P