80 FR 80650 - Hepatitis C Virus “Lookback” Requirements Based on Review of Historical Testing Records; Technical Amendment
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 248 (December 28, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 248 (December 28, 2015)
| Page Range | 80650-80651 | |
| FR Document | 2015-32477 |
[Federal Register Volume 80, Number 248 (Monday, December 28, 2015)] [Rules and Regulations] [Pages 80650-80651] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-32477] ======================================================================= ----------------------------------------------------------------------- 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
![80650 Federal Register / Vol. 80, No. 248 / Monday, December 28, 2015 / Rules and Regulations
License License Federal Register
Country Entity requirement review policy citation
d. 15 str. 2 ul. Novy Arbat, Moscow
119019, Russia.
* * * * * *
Transservice LLC, a.k.a., the following For all items subject to Presumption of denial 80 FR [INSERT FR PAGE
three aliases: the EAR. (See § 744.11 NUMBER]; 12/28/2015.
—Limited Liability Company of the EAR)
Transservis;.
—Obschestvo S Ogranichennoi
Otvetstvennostyu Transservis; and
—OOO Transservis.
35 Prospekt Gubkina, Omsk, Omskaya
Oblast 664035, Russia.
* * * * * *
* * * * * * *
SWITZERLAND * * * * * *
LTS Holding Limited (f.k.a. IPP-Inter- For all items subject to Presumption of denial ...... 80 FR [INSERT FR PAGE
national Petroleum Products Ltd.), the EAR. (See § 744.11 NUMBER]; 12/28/2015.
Rue du Conseil-General 20, Geneva of the EAR).
1204, Switzerland. (See alternate ad-
dress under United Kingdom).
* * * * * *
* * * * * * *
UNITED KING- * * * * * *
DOM.
Fentex Properties LTD., Tortola, British For all items subject to Presumption of denial ...... 80 FR [INSERT FR PAGE
Virgin Islands. the EAR. (See § 744.11 NUMBER]; 12/28/2015.
of the EAR).
LTS Holding Limited (f.k.a. IPP-Inter- For all items subject to Presumption of denial ...... 80 FR [INSERT FR PAGE
national Petroleum Products Ltd.), the EAR. (See § 744.11 NUMBER]; 12/28/2015.
Tortola, British Virgin Islands. (See of the EAR).
alternate address under Switzerland).
* * * * * *
Dated: December 22, 2015. DEPARTMENT OF HEALTH AND historical testing records. FDA is taking
Eric L. Hirschhorn, HUMAN SERVICES this action because the HCV ‘‘lookback’’
Under Secretary of Commerce for Industry regulations based on review of historical
and Security. Food and Drug Administration testing records expired on August 24,
[FR Doc. 2015–32607 Filed 12–24–15; 8:45 am] 2015, due to the sunset provision
21 CFR Parts 606 and 610 provided under the regulation.
BILLING CODE 3510–33–P
[Docket No. FDA–1999–N–0114 (formerly DATES: This rule is December 28, 2015.
1999N–2337)] FOR FURTHER INFORMATION CONTACT:
RIN 0910–AB76 Gretchen Opper, Center for Biologics
Evaluation and Research, Food and
Hepatitis C Virus ‘‘Lookback’’ Drug Administration, 10903 New
Requirements Based on Review of Hampshire Ave., Bldg. 71, Rm. 7301,
Historical Testing Records; Technical Silver Spring, MD 20993–0002, 240–
Amendment 402–7911.
AGENCY: Food and Drug Administration, SUPPLEMENTARY INFORMATION: In the
HHS. Federal Register of August 24, 2007 (72
Final rule; technical
ACTION: FR 48766), FDA published a final rule
mstockstill on DSK4VPTVN1PROD with RULES
amendment. entitled ‘‘Current Good Manufacturing
Practice for Blood and Blood
SUMMARY: The Food and Drug Components; Notification of Consignees
Administration (FDA) is amending the and Transfusion Recipients Receiving
biologics regulations by removing the Blood and Blood Components at
Hepatitis C Virus (HCV) ‘‘lookback’’ Increased Risk of Transmitting Hepatitis
requirements regarding review of C Virus Infection (‘Lookback’).’’ Under
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![Federal Register / Vol. 80, No. 248 / Monday, December 28, 2015 / Rules and Regulations 80651
§ 610.48 (21 CFR 610.48) of the final § 606.160 [Amended] FOR FURTHER INFORMATION CONTACT: If
rule, FDA established HCV ‘‘lookback’’ ■ 3. Amend § 606.160(b)(1)(viii) by you have questions on this rule, call or
requirements based on review of removing ‘‘§§ 610.46, 610.47, and, email LT Lindsay Cook, Marine Safety
historical testing records. The 610.48’’ and adding in its place Unit Chicago, U.S. Coast Guard;
requirements under § 610.48 were to ‘‘§§ 610.46 and 610.47’’. telephone (630) 986–2155, email
remain in effect for 8 years after the date Lindsay.N.Cook@uscg.mil.
of publication of the final rule in the PART 610—GENERAL BIOLOGICAL SUPPLEMENTARY INFORMATION:
Federal Register (§ 610.48(e)). Section PRODUCTS STANDARDS
610.48(e) specifically provides that the I. Table of Abbreviations
section expired on August 24, 2015; ■ 4. The authority citation for 21 CFR CFR Code of Federal Regulations
therefore, FDA is removing this part 610 continues to read as follows: DHS Department of Homeland Security
regulation from Title 21 of the Code of Authority: 21 U.S.C. 321, 331, 351, 352, E.O. Executive order
Federal Regulations. 353, 355, 360, 360c, 360d, 360h, 360i, 371, FR Federal Register
372, 374, 381; 42 U.S.C. 216, 262, 263, 263a, NPRM Notice of proposed rulemaking
FDA is also making conforming 264. Pub. L. Public Law
changes to other biologics regulations § Section
where § 610.48 is referenced. § 610.48 [Removed and Reserved] U.S.C. United States Code
FDA is revising the biologics ■ 5. Remove and reserve § 610.48. II. Background Information and
regulations as follows: Dated: December 21, 2015. Regulatory History
• Removing and reserving § 610.48. Leslie Kux,
The Coast Guard is issuing this
• Revising § 606.100(b)(19) (21 CFR Associate Commissioner for Policy. temporary rule without prior notice and
606.100(b)(19)) by removing the [FR Doc. 2015–32477 Filed 12–24–15; 8:45 am] opportunity to comment pursuant to
reference to § 610.48. BILLING CODE 4164–01–P authority under section 4(a) of the
• Revising § 606.160(b)(1)(viii) by Administrative Procedure Act (APA) (5
removing the reference to § 610.48. U.S.C. 553(b)). This provision
Publication of this document DEPARTMENT OF HOMELAND authorizes an agency to issue a rule
constitutes final action under the SECURITY without prior notice and opportunity to
Administrative Procedure Act (5 U.S.C. comment when the agency for good
553). FDA has determined that notice Coast Guard cause finds that those procedures are
and public comments are unnecessary ‘‘impracticable, unnecessary, or contrary
because the amendments to the 33 CFR Part 165 to public interest.’’ Under 5 U.S.C.
regulations provide only technical [Docket Number USCG–2015–1074] 553(b)(B), the Coast Guard finds that
changes to remove and update good cause exists for not publishing a
information and are nonsubstantive. RIN 1625–AA00
notice of proposed rulemaking (NPRM)
List of Subjects Safety Zone; New Year’s Eve Firework with respect to this rule because doing
Displays, Chicago River, Chicago, IL so would be impracticable. The final
21 CFR Part 606 details for this event were not known to
AGENCY: Coast Guard, DHS. the Coast Guard until there was
Blood, Labeling, Laboratories, ACTION: Temporary final rule. insufficient time remaining before the
Reporting and recordkeeping
event to publish a NPRM. Thus,
requirements. SUMMARY: The Coast Guard is delaying the effective date of this rule to
establishing a temporary safety zone
21 CFR Part 610 wait for a comment period to run would
that encompasses all waters of the Main
be impracticable because it would
Biologics, Labeling, Reporting and Branch of the Chicago River between the
inhibit the Coast Guard’s ability to
recordkeeping requirements. Michigan Avenue Highway Bridge and
protect the public and vessels from the
Therefore, under the Federal Food, the west entrance to the Chicago Harbor
hazards associated with multiple barge
Drug, and Cosmetic Act and the Public Lock. The safety zone is intended to
based firework displays on the Main
Health Service Act, and under authority restrict vessels from a portion of the
Branch of the Chicago River.
delegated to the Commissioner of Food Main Branch of the Chicago River from
We are issuing this rule, and under 5
and Drugs, 21 CFR parts 606 and 610 are 11:30 p.m. on December 31, 2015 to
U.S.C. 553(d)(3), the Coast Guard finds
amended as follows: 12:15 a.m. on January 1, 2016. This
that good cause exists for making this
temporary safety zone is necessary to
temporary rule effective less than 30
PART 606—CURRENT GOOD protect the surrounding public and
days after publication in the Federal
MANUFACTURING PRACTICE FOR vessels from the hazards associated with
Register. For the same reasons
BLOOD AND BLOOD COMPONENTS multiple barge based firework displays
discussed in the preceding paragraph,
for Chicago’s New Year’s Eve
waiting for a 30 day notice period to run
■ 1. The authority citation for 21 CFR Celebration.
would be impracticable.
part 606 continues to read as follows: DATES: This rule will be effective from
Authority: 21 U.S.C. 321, 331, 351, 352, 11:30 p.m. on December 31, 2015 to III. Legal Authority and Need for Rule
355, 360, 360j, 371, 374; 42 U.S.C. 216, 262, 12:15 a.m. on January 1, 2016. The legal basis for the rule is the
263a, 264. ADDRESSES: To view documents Coast Guard’s authority to establish
mstockstill on DSK4VPTVN1PROD with RULES
§ 606.100 [Amended]
mentioned in this preamble as being safety zones: 33 U.S.C. 1231; 33 CFR
available in the docket, go to http:// 1.05–1, 160.5; Department of Homeland
■ 2. Amend § 606.100(b)(19) www.regulations.gov, type USCG–2015– Security Delegation No. 0170.1.
introductory text by removing 1074 in the ‘‘SEARCH’’ box and click December 31, 2015 and January 1,
‘‘§§ 610.46, 610.47, and 610.48’’ and ‘‘SEARCH.’’ Click on Open Docket 2016 Chicago’s New Year’s Eve firework
adding in its place ‘‘§§ 610.46 and Folder on the line associated with this displays will take place from multiple
610.47’’. rule. barge based launch sites on the Main
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Document Created: 2018-03-02 09:24:02
Document Modified: 2018-03-02 09:24:02
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Final rule; technical amendment. | |
| Dates | This rule is December 28, 2015. | |
| 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. | |
| FR Citation | 80 FR 80650 | |
| RIN Number | 0910-AB76 | |
| CFR Citation | 21
CFR
606 21 CFR 610 | |
| CFR Associated | Blood; Labeling; Laboratories; Reporting and Recordkeeping Requirements and Biologics |
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