
[Federal Register Volume 80, Number 248 (Monday, December 28, 2015)]
[Rules and Regulations]
[Pages 80650-80651]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-32477]


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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.

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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: 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

[[Page 80651]]

Sec.  610.48 (21 CFR 610.48) of the final rule, FDA established HCV 
``lookback'' requirements based on review of historical testing 
records. The requirements under Sec.  610.48 were to remain in effect 
for 8 years after the date of publication of the final rule in the 
Federal Register (Sec.  610.48(e)). Section 610.48(e) specifically 
provides that the section expired on August 24, 2015; therefore, FDA is 
removing this regulation from Title 21 of the Code of Federal 
Regulations.
    FDA is also making conforming changes to other biologics 
regulations where Sec.  610.48 is referenced.
    FDA is revising the biologics regulations as follows:
     Removing and reserving Sec.  610.48.
     Revising Sec.  606.100(b)(19) (21 CFR 606.100(b)(19)) by 
removing the reference to Sec.  610.48.
     Revising Sec.  606.160(b)(1)(viii) by removing the 
reference to Sec.  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

0
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.


Sec.  606.100  [Amended]

0
2. Amend Sec.  606.100(b)(19) introductory text by removing 
``Sec. Sec.  610.46, 610.47, and 610.48'' and adding in its place 
``Sec. Sec.  610.46 and 610.47''.


Sec.  606.160  [Amended]

0
3. Amend Sec.  606.160(b)(1)(viii) by removing ``Sec. Sec.  610.46, 
610.47, and, 610.48'' and adding in its place ``Sec. Sec.  610.46 and 
610.47''.

PART 610--GENERAL BIOLOGICAL PRODUCTS STANDARDS

0
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.


Sec.  610.48  [Removed and Reserved]

0
5. Remove and reserve Sec.  610.48.

    Dated: December 21, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-32477 Filed 12-24-15; 8:45 am]
 BILLING CODE 4164-01-P


