Hepatitis C Virus “Lookback” Requirements Based on Review of Historical Testing Records; Technical Amendment, 80650-80651 [2015-32477]

Download as PDF 80650 Federal Register / Vol. 80, No. 248 / Monday, December 28, 2015 / Rules and Regulations Country License requirement Entity d. 15 str. 2 ul. Novy Arbat, Moscow 119019, Russia. * * * Transservice LLC, a.k.a., the following three aliases: —Limited Liability Company Transservis;. —Obschestvo S Ogranichennoi Otvetstvennostyu Transservis; and —OOO Transservis. 35 Prospekt Gubkina, Omsk, Omskaya Oblast 664035, Russia. * * * License review policy * For all items subject to the EAR. (See § 744.11 of the EAR) Presumption of denial * 80 FR [INSERT FR PAGE NUMBER]; 12/28/2015. * * * * * * * * * * * * * * * LTS Holding Limited (f.k.a. IPP-International Petroleum Products Ltd.), Rue du Conseil-General 20, Geneva 1204, Switzerland. (See alternate address under United Kingdom). * * * For all items subject to the EAR. (See § 744.11 of the EAR). Presumption of denial ...... 80 FR [INSERT FR PAGE NUMBER]; 12/28/2015. * * * * * * * * * * * UNITED KINGDOM. * * * * * Fentex Properties LTD., Tortola, British Virgin Islands. For all items subject to the EAR. (See § 744.11 of the EAR). For all items subject to the EAR. (See § 744.11 of the EAR). LTS Holding Limited (f.k.a. IPP-International Petroleum Products Ltd.), Tortola, British Virgin Islands. (See alternate address under Switzerland). * * Dated: December 22, 2015. Eric L. Hirschhorn, Under Secretary of Commerce for Industry and Security. [FR Doc. 2015–32607 Filed 12–24–15; 8:45 am] Presumption of denial ...... 80 FR [INSERT FR PAGE NUMBER]; 12/28/2015. Presumption of denial ...... 80 FR [INSERT FR PAGE NUMBER]; 12/28/2015. * * DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 606 and 610 BILLING CODE 3510–33–P [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. mstockstill on DSK4VPTVN1PROD with RULES * * SWITZERLAND Final rule; technical amendment. ACTION: The Food and Drug Administration (FDA) is amending the biologics regulations by removing the Hepatitis C Virus (HCV) ‘‘lookback’’ requirements regarding review of SUMMARY: VerDate Sep<11>2014 Federal Register citation 13:41 Dec 24, 2015 Jkt 238001 PO 00000 Frm 00016 Fmt 4700 Sfmt 4700 * * 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 E:\FR\FM\28DER1.SGM 28DER1 Federal Register / Vol. 80, No. 248 / Monday, December 28, 2015 / Rules and Regulations § 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 § 610.48 were to remain in effect for 8 years after the date of publication of the final rule in the Federal Register (§ 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 § 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. § 606.160 List of Subjects Safety Zone; New Year’s Eve Firework Displays, Chicago River, Chicago, IL 21 CFR Part 606 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: mstockstill on DSK4VPTVN1PROD with RULES ■ Authority: 21 U.S.C. 321, 331, 351, 352, 355, 360, 360j, 371, 374; 42 U.S.C. 216, 262, 263a, 264. 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’’. VerDate Sep<11>2014 13:41 Dec 24, 2015 Jkt 238001 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. ■ [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] BILLING CODE 4164–01–P DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket Number USCG–2015–1074] RIN 1625–AA00 Coast Guard, DHS. Temporary final rule. The Coast Guard is establishing a temporary safety zone that encompasses all waters of the Main Branch of the Chicago River between the Michigan Avenue Highway Bridge and the west entrance to the Chicago Harbor Lock. The safety zone is intended to restrict vessels from a portion of the Main Branch of the Chicago River from 11:30 p.m. on December 31, 2015 to 12:15 a.m. on January 1, 2016. This temporary safety zone is necessary to protect the surrounding public and vessels from the hazards associated with multiple barge based firework displays for Chicago’s New Year’s Eve Celebration. DATES: This rule will be effective from 11:30 p.m. on December 31, 2015 to 12:15 a.m. on January 1, 2016. ADDRESSES: To view documents mentioned in this preamble as being available in the docket, go to https:// www.regulations.gov, type USCG–2015– 1074 in the ‘‘SEARCH’’ box and click ‘‘SEARCH.’’ Click on Open Docket Folder on the line associated with this rule. SUMMARY: 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: ■ 4. The authority citation for 21 CFR part 610 continues to read as follows: ■ ACTION: 21 CFR Part 610 [Amended] PART 610—GENERAL BIOLOGICAL PRODUCTS STANDARDS § 610.48 PO 00000 Frm 00017 Fmt 4700 If you have questions on this rule, call or email LT Lindsay Cook, Marine Safety Unit Chicago, U.S. Coast Guard; telephone (630) 986–2155, email Lindsay.N.Cook@uscg.mil. SUPPLEMENTARY INFORMATION: FOR FURTHER INFORMATION CONTACT: 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’’. ■ AGENCY: Blood, Labeling, Laboratories, Reporting and recordkeeping requirements. § 606.100 [Amended] 80651 Sfmt 4700 I. Table of Abbreviations CFR Code of Federal Regulations DHS Department of Homeland Security E.O. Executive order FR Federal Register NPRM Notice of proposed rulemaking Pub. L. Public Law § Section U.S.C. United States Code II. Background Information and Regulatory History The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are ‘‘impracticable, unnecessary, or contrary to public interest.’’ Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because doing so would be impracticable. The final details for this event were not known to the Coast Guard until there was insufficient time remaining before the event to publish a NPRM. Thus, delaying the effective date of this rule to wait for a comment period to run would be impracticable because it would inhibit the Coast Guard’s ability to protect the public and vessels from the hazards associated with multiple barge based firework displays on the Main Branch of the Chicago River. We are issuing this rule, and under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this temporary rule effective less than 30 days after publication in the Federal Register. For the same reasons discussed in the preceding paragraph, waiting for a 30 day notice period to run would be impracticable. III. Legal Authority and Need for Rule The legal basis for the rule is the Coast Guard’s authority to establish safety zones: 33 U.S.C. 1231; 33 CFR 1.05–1, 160.5; Department of Homeland Security Delegation No. 0170.1. December 31, 2015 and January 1, 2016 Chicago’s New Year’s Eve firework displays will take place from multiple barge based launch sites on the Main E:\FR\FM\28DER1.SGM 28DER1

Agencies

[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.

-----------------------------------------------------------------------

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
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