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]]

=======================================================================
-----------------------------------------------------------------------

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.

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

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

2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR