83_FR_47250 83 FR 47069 - Listing of Color Additives Subject to Certification; D&C Black No. 4; Confirmation of Effective Date

83 FR 47069 - Listing of Color Additives Subject to Certification; D&C Black No. 4; Confirmation of Effective Date

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 181 (September 18, 2018)

Page Range47069-47069
FR Document2018-20288

The Food and Drug Administration (FDA or we) is confirming the effective date of July 10, 2018, for the final rule that appeared in the Federal Register of June 7, 2018, and that amended the color additive regulations to provide for the safe use of D&C Black No. 4 for coloring ultra-high molecular weight polyethylene (UHMWPE) non- absorbable sutures for use in general surgery.

Federal Register, Volume 83 Issue 181 (Tuesday, September 18, 2018) 
[Federal Register Volume 83, Number 181 (Tuesday, September 18, 2018)]
[Rules and Regulations]
[Page 47069]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-20288]



[[Page 47069]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 74

[Docket No. FDA-2017-C-0935]


Listing of Color Additives Subject to Certification; D&C Black 
No. 4; Confirmation of Effective Date

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; confirmation of effective date.

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SUMMARY: The Food and Drug Administration (FDA or we) is confirming the 
effective date of July 10, 2018, for the final rule that appeared in 
the Federal Register of June 7, 2018, and that amended the color 
additive regulations to provide for the safe use of D&C Black No. 4 for 
coloring ultra-high molecular weight polyethylene (UHMWPE) non-
absorbable sutures for use in general surgery.

DATES: Effective date of final rule published in the Federal Register 
of June 7, 2018 (83 FR 26356) confirmed: July 10, 2018.

ADDRESSES: For access to the docket to read background documents or 
comments received, go to https://www.regulations.gov and insert the 
docket number found in brackets in the heading of this final rule into 
the ``Search'' box and follow the prompts, and/or go to the Dockets 
Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Joseph M. Thomas, Center for Food 
Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 
5001 Campus Dr., College Park, MD 20740-3835, 301-796-9465.

SUPPLEMENTARY INFORMATION: In the Federal Register of June 7, 2018 (83 
FR 26356), we amended the color additive regulations to add Sec.  
74.3054, ``D&C Black No. 4,'' (21 CFR 74.3054) to provide for the safe 
use of D&C Black No. 4 for coloring UHMWPE non-absorbable sutures for 
use in general surgery.
    We gave interested persons until July 9, 2018, to file objections 
or requests for a hearing. We received no objections or requests for a 
hearing on the final rule. Therefore, we find that the effective date 
of the final rule that published in the Federal Register of June 7, 
2018, should be confirmed.

List of Subjects in 21 CFR Part 74

    Color additives, Cosmetics, Drugs.

    Therefore, under the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 321, 341, 342, 343, 348, 351, 352, 355, 361, 362, 371, 379e) and 
under authority delegated to the Commissioner of Food and Drugs, we are 
giving notice that no objections or requests for a hearing were filed 
in response to the June 7, 2018, final rule. Accordingly, the 
amendments issued in the final rule became effective July 10, 2018.

    Dated: September 12, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-20288 Filed 9-17-18; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 83, No. 181 / Tuesday, September 18, 2018 / Rules and Regulations 47069 DEPARTMENT OF HEALTH AND Therefore, under the Federal Food, the Department is eliminating the need HUMAN SERVICES Drug, and Cosmetic Act (21 U.S.C. 321, for this separate FOIA rule and reducing 341, 342, 343, 348, 351, 352, 355, 361, costs to the public as explained in the Food and Drug Administration 362, 371, 379e) and under authority preamble of the DoD-level FOIA rule delegated to the Commissioner of Food published at 83 FR 5196–5197. 21 CFR Part 74 and Drugs, we are giving notice that no This rule is not significant under [Docket No. FDA–2017–C–0935] objections or requests for a hearing were Executive Order (E.O.) 12866, filed in response to the June 7, 2018, ‘‘Regulatory Planning and Review’’; Listing of Color Additives Subject to final rule. Accordingly, the amendments therefore, E.O. 13771, ‘‘Reducing Certification; D&C Black No. 4; issued in the final rule became effective Regulation and Controlling Regulatory Confirmation of Effective Date July 10, 2018. Costs’’ does not apply. Dated: September 12, 2018. List of Subjects in 32 CFR Part 300 AGENCY: Food and Drug Administration, HHS. Leslie Kux, Freedom of information. Associate Commissioner for Policy. ACTION: Final rule; confirmation of effective date. [FR Doc. 2018–20288 Filed 9–17–18; 8:45 am] PART 300—[REMOVED] BILLING CODE 4164–01–P SUMMARY: The Food and Drug ■ Accordingly, by the authority of 5 Administration (FDA or we) is U.S.C. 301, 32 CFR part 300 is removed. confirming the effective date of July 10, DEPARTMENT OF DEFENSE Dated: September 13, 2018. 2018, for the final rule that appeared in Aaron T. Siegel, the Federal Register of June 7, 2018, Office of the Secretary Alternate OSD Federal Register Liaison and that amended the color additive Officer, Department of Defense. regulations to provide for the safe use of 32 CFR Part 300 [FR Doc. 2018–20228 Filed 9–17–18; 8:45 am] D&C Black No. 4 for coloring ultra-high [Docket ID: DOD–2017–OS–0029] BILLING CODE 5001–06–P molecular weight polyethylene (UHMWPE) non-absorbable sutures for RIN 0790–AJ71 use in general surgery. Defense Logistics Agency Freedom of DEPARTMENT OF HOMELAND DATES: Effective date of final rule SECURITY Information Act Program published in the Federal Register of June 7, 2018 (83 FR 26356) confirmed: AGENCY: Defense Logistics Agency, DoD. Coast Guard July 10, 2018. ACTION: Final rule. ADDRESSES: For access to the docket to 33 CFR Part 100 read background documents or SUMMARY: This final rule removes DoD’s regulation concerning the Defense [Docket No. USCG–2018–0725] comments received, go to https:// www.regulations.gov and insert the Logistics Agency Freedom of Special Local Regulations, Marine docket number found in brackets in the Information Act (FOIA) program. On Events Within the Fifth Coast Guard heading of this final rule into the February 6, 2018, the DoD published a District; Correction ‘‘Search’’ box and follow the prompts, FOIA program final rule as a result of and/or go to the Dockets Management the FOIA Improvement Act of 2016. AGENCY: Coast Guard, DHS. Staff, 5630 Fishers Lane, Rm. 1061, When the DoD FOIA program rule was ACTION: Notice of enforcement of Rockville, MD 20852. revised, it included DoD component regulation; correction. FOR FURTHER INFORMATION CONTACT: information and removed the Joseph M. Thomas, Center for Food requirement for component SUMMARY: The Coast Guard published a Safety and Applied Nutrition (HFS– supplementary rules. The DoD now has document in the Federal Register of 265), Food and Drug Administration, one DoD-level rule for the FOIA August 13, 2018, concerning a notice of 5001 Campus Dr., College Park, MD program that contains all the codified enforcement of regulations of special 20740–3835, 301–796–9465. information required for the local regulations for the Baltimore Air Department. Therefore, this part can be Show from October 4, 2018, through SUPPLEMENTARY INFORMATION: In the October 7, 2018. The document removed from the CFR. Federal Register of June 7, 2018 (83 FR contained incorrect times for the DATES: This rule is effective on 26356), we amended the color additive enforcement periods. regulations to add § 74.3054, ‘‘D&C September 18, 2018. FOR FURTHER INFORMATION CONTACT: FOR FURTHER INFORMATION CONTACT: Mr. Black No. 4,’’ (21 CFR 74.3054) to provide for the safe use of D&C Black Lewis Oleinick at 571–767–6194. Ron Houck, 410–576–2674. No. 4 for coloring UHMWPE non- SUPPLEMENTARY INFORMATION: It has been SUPPLEMENTARY INFORMATION: absorbable sutures for use in general determined that publication of this CFR Corrections surgery. part removal for public comment is We gave interested persons until July impracticable, unnecessary, and In the Federal Register of August 13, 9, 2018, to file objections or requests for contrary to public interest since it is 2018, in FR Doc. 2018–17282: a hearing. We received no objections or based on removing DoD internal 1. On page 39879, in the first column, requests for a hearing on the final rule. policies and procedures. correct the DATES caption to read: DLA internal guidance concerning the DATES: The regulations in 33 CFR daltland on DSKBBV9HB2PROD with RULES Therefore, we find that the effective date of the final rule that published in the implementation of the FOIA within 100.501 will be enforced for the Federal Register of June 7, 2018, should DLA will be published in DLA Baltimore Air Show regulated area be confirmed. Instruction (DLAI) 5400.11. listed in item b.23 in the table to This rule is one of 14 separate DoD § 100.501 from 2:45 p.m. through 4:30 List of Subjects in 21 CFR Part 74 FOIA rules. With the finalization of the p.m. on October 4, 2018, from 10:30 Color additives, Cosmetics, Drugs. DoD-level FOIA rule at 32 CFR part 286, a.m. through 5 p.m. on October 5, 2018, VerDate Sep<11>2014 16:42 Sep 17, 2018 Jkt 244001 PO 00000 Frm 00043 Fmt 4700 Sfmt 4700 E:\FR\FM\18SER1.SGM 18SER1


Document Created: 2018-09-18 01:18:04
Document Modified: 2018-09-18 01:18:04
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule; confirmation of effective date.
DatesEffective date of final rule published in the Federal Register of June 7, 2018 (83 FR 26356) confirmed: July 10, 2018.
ContactJoseph M. Thomas, Center for Food Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740-3835, 301-796-9465.
FR Citation83 FR 47069 
CFR AssociatedColor Additives; Cosmetics and Drugs
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