80 FR 248 pgs. 80650-80651 - Hepatitis C Virus “Lookback” Requirements Based on Review of Historical Testing Records; Technical Amendment
Type: RULEVolume: 80Number: 248Pages: 80650 - 80651
Pages: 80650, 80651Docket number: [Docket No. FDA-1999-N-0114 (formerly 1999N-2337)]
FR document: [FR Doc. 2015-32477 Filed 12-24-15; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 606 and 610
[Docket No. FDA-1999-N-0114 (formerly 1999N-2337)]
RIN 0910-AB76
Hepatitis C Virus "Lookback" Requirements Based on Review of Historical Testing Records; Technical Amendment
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Final rule; technical amendment.
SUMMARY:
The Food and Drug Administration (FDA) is amending the biologics regulations by removing the Hepatitis C Virus (HCV) "lookback" requirements regarding review of historical testing records. FDA is taking this action because the HCV "lookback" regulations based on review of historical testing records expired on August 24, 2015, due to the sunset provision provided under the regulation.
DATES:
This rule is December 28, 2015.
FOR FURTHER INFORMATION CONTACT:
Gretchen Opper, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.
SUPPLEMENTARY INFORMATION:
[top] In the Federal Register of August 24, 2007 (72 FR 48766), FDA published a final rule entitled "Current Good Manufacturing Practice for Blood and Blood Components; Notification of Consignees and Transfusion Recipients Receiving Blood and Blood Components at Increased Risk of Transmitting Hepatitis C Virus Infection ('Lookback')." Under
FDA is also making conforming changes to other biologics regulations where §?610.48 is referenced.
FDA is revising the biologics regulations as follows:
• Removing and reserving §?610.48.
• Revising §?606.100(b)(19) (21 CFR 606.100(b)(19)) by removing the reference to §?610.48.
• Revising §?606.160(b)(1)(viii) by removing the reference to §?610.48.
Publication of this document constitutes final action under the Administrative Procedure Act (5 U.S.C. 553). FDA has determined that notice and public comments are unnecessary because the amendments to the regulations provide only technical changes to remove and update information and are nonsubstantive.
List of Subjects
21 CFR Part 606
Blood, Labeling, Laboratories, Reporting and recordkeeping requirements.
21 CFR Part 610
Biologics, Labeling, Reporting and recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act, and under authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 606 and 610 are amended as follows:
PART 606-CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS
1. The authority citation for 21 CFR part 606 continues to read as follows:
Authority:
21 U.S.C. 321, 331, 351, 352, 355, 360, 360j, 371, 374; 42 U.S.C. 216, 262, 263a, 264.
§?606.100 [Amended]
2. Amend §?606.100(b)(19) introductory text by removing "§§?610.46, 610.47, and 610.48" and adding in its place "§§?610.46 and 610.47".
§?606.160 [Amended]
3. Amend §?606.160(b)(1)(viii) by removing "§§?610.46, 610.47, and, 610.48" and adding in its place "§§?610.46 and 610.47".
PART 610-GENERAL BIOLOGICAL PRODUCTS STANDARDS
4. The authority citation for 21 CFR part 610 continues to read as follows:
Authority:
21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 360c, 360d, 360h, 360i, 371, 372, 374, 381; 42 U.S.C. 216, 262, 263, 263a, 264.
§?610.48 [Removed and Reserved]
5. Remove and reserve §?610.48.
Dated: December 21, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-32477 Filed 12-24-15; 8:45 am]
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