83_FR_26464 83 FR 26354 - Regulatory Program Fees and Water Charges Rates

83 FR 26354 - Regulatory Program Fees and Water Charges Rates

DELAWARE RIVER BASIN COMMISSION

Federal Register Volume 83, Issue 110 (June 7, 2018)

Page Range26354-26356
FR Document2018-12258

Notice is provided of the Commission's regulatory program fees and schedule of water charges for the fiscal year beginning July 1, 2018.

Federal Register, Volume 83 Issue 110 (Thursday, June 7, 2018)
[Federal Register Volume 83, Number 110 (Thursday, June 7, 2018)]
[Rules and Regulations]
[Pages 26354-26356]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-12258]


=======================================================================
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DELAWARE RIVER BASIN COMMISSION

18 CFR Parts 401 and 420


Regulatory Program Fees and Water Charges Rates

AGENCY: Delaware River Basin Commission.

ACTION: Final rule.

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

SUMMARY: Notice is provided of the Commission's regulatory program fees 
and schedule of water charges for the fiscal year beginning July 1, 
2018.

DATES: This final rule is effective July 1, 2018.

FOR FURTHER INFORMATION CONTACT: Elba L. Deck, CPA, Director of 
Administration and Finance, 609-883-9500, ext. 201.

SUPPLEMENTARY INFORMATION: The Delaware River Basin Commission 
(``DRBC'' or ``Commission'') is a Federal-interstate compact agency 
charged with managing the water resources of the Delaware River Basin 
on a regional basis without regard to political boundaries. Its members 
are the governors of the four basin states--Delaware, New Jersey, New 
York and Pennsylvania--and on behalf of the federal government, the 
North Atlantic Division Commander of the U.S. Army Corps of Engineers.
    In accordance with 18 CFR 401.43(c), on July 1 of every year 
beginning July 1, 2017, the Commission's regulatory program fees as set 
forth in Tables 1, 2 and 3 of that section are subject to an annual 
adjustment, commensurate with any increase in the annual April 12-month 
Consumer Price Index (CPI) for Philadelphia published by the U.S. 
Bureau of Labor Statistics during that

[[Page 26355]]

year. Pursuant to 18 CFR 420.43(c), the same indexed adjustment applies 
to the Commission's schedule of water charges for consumptive and non-
consumptive withdrawals of surface water within the basin. The 
referenced April 12-month CPI for 2018 showed an increase of 1.38%. 
Commensurate adjustments are thus required.
    This notification is made in accordance with 18 CFR 401.42(c) and 
18 CFR 420.42(c), which provide that a revised fee schedule will be 
published in the Federal Register by July 1. The revised fees also may 
be obtained by contacting the Commission during business hours or by 
checking the Commission's website.

List of Subjects

18 CFR Part 401

    Administrative practice and procedure, Project review, Water 
pollution control, Water resources.

18 CFR Part 420

    Water supply.

    For the reasons set forth in the preamble, the Delaware River Basin 
Commission amends parts 401 and 420 of title 18 of the Code of Federal 
Regulations as set forth below:

PART 401--RULES OF PRACTICE AND PROCEDURE

0
1. The authority citation for part 401 continues to read as follows:

    Authority: Delaware River Basin Compact (75 Stat. 688), unless 
otherwise noted.

Subpart C--Project Review Under Section 3.8 of the Compact

0
2. In Sec.  401.43, revise Tables 1, 2 and 3 to read as follows:


Sec.  401.43  Regulatory program fees.

* * * * *

         Table 1 To Sec.   401.43--Docket Application Filing Fee
------------------------------------------------------------------------
                               Docket application
        Project type                   fee               Fee maximum
------------------------------------------------------------------------
Water Allocation............  $411 per million      Greater of: $15,401
                               gallons/month of      \1\ or Alternative
                               allocation \1\, not   Review Fee.
                               to exceed $15,401
                               \1\.
                              Fee is doubled for
                               any portion to be
                               exported from the
                               basin..
Wastewater Discharge........  Private projects:     Alternative Review
                               $1,027 \1\.           Fee.
                              Public projects:
                               $513 \1\.
Other.......................  0.4% of project cost  Greater of: $77,003
                               up to $10,000,000     \1\ or Alternative
                               plus 0.12% of         Review Fee.
                               project cost above
                               $10,000,000 (if
                               applicable), not to
                               exceed $77,003 \1\.
------------------------------------------------------------------------
\1\ Subject to annual adjustment in accordance with paragraph (c) of
  this section.


                        Table 2 to Sec.   401.43--Annual Monitoring and Coordination Fee
----------------------------------------------------------------------------------------------------------------
                                                                      Annual fee             Allocation
----------------------------------------------------------------------------------------------------------------
Water Allocation..................................................        \1\ $308                    <4.99 mgm.
                                                                          \1\ $462            5.00 to 49.99 mgm.
                                                                          \1\ $667          50.00 to 499.99 mgm.
                                                                          \1\ $847       500.00 to 9,999.99 mgm.
                                                                        \1\ $1,027         > or = to 10,000 mgm.
----------------------------------------------------------------------------------------------------------------
                                                                        Annual fee     Discharge design capacity
----------------------------------------------------------------------------------------------------------------
Wastewater Discharge..............................................        \1\ $308                    <0.05 mgd.
                                                                          \1\ $626                0.05 to 1 mgd.
                                                                          \1\ $842                  1 to 10 mgd.
                                                                        \1\ $1,027                      >10 mgd.
----------------------------------------------------------------------------------------------------------------
\1\ Subject to annual adjustment in accordance with paragraph (c) of this section.


                Table 3 to Sec.   401.43--Additional Fees
------------------------------------------------------------------------
         Proposed action                  Fee             Fee maximum
------------------------------------------------------------------------
Emergency Approval Under 18 CFR   $5,000............  Alternative Review
 401.40.                                               Fee.
Late Filed Renewal Surcharge....  $2,000.
Modification of a DRBC Approval.  At Executive        Alternative Review
                                   Director's          Fee.
                                   discretion,
                                   Docket
                                   Application Fee
                                   for the
                                   appropriate
                                   project type.
Name change.....................  $1,027 \1\.
Change of Ownership.............  $1,540 \1\........
------------------------------------------------------------------------
\1\ Subject to annual adjustment in accordance with paragraph (c) of
  this section.

PART 420--BASIN REGULATIONS--WATER SUPPLY CHARGES

0
3. The authority citation for part 420 continues to read as follows:

    Authority: Delaware River Basin Compact, 75 Stat. 688.


0
4. In Sec.  420.41, revise paragraphs (a) and (b) to read as follows:


Sec.  420.41  Schedule of water charges.

* * * * *
    (a) $82.14 per million gallons for consumptive use, subject to 
paragraph (c) of this section; and
    (b) $0.82 per million gallons for non-consumptive use, subject to 
paragraph (c) of this section.
* * * * *


[[Page 26356]]


    Dated: June 1, 2018.
Pamela M. Bush,
Commission Secretary.
[FR Doc. 2018-12258 Filed 6-6-18; 8:45 am]
BILLING CODE 6360-01-P



                                              26354               Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Rules and Regulations

                                              (d) Subject                                                (1) Alternative Methods of Compliance               ac.yul@aero.bombardier.com; internet http://
                                               Air Transport Association (ATA) of                     (AMOCs): The Manager, New York ACO                     www.bombardier.com.
                                              America Code 32, Landing gear.                          Branch, FAA, has the authority to approve                 (4) You may view this service information
                                                                                                      AMOCs for this AD, if requested using the              at the FAA, Transport Standards Branch,
                                              (e) Reason                                              procedures found in 14 CFR 39.19. In                   2200 South 216th St., Des Moines, WA. For
                                                 This AD was prompted by a report                     accordance with 14 CFR 39.19, send your                information on the availability of this
                                              indicating that Belleville washers installed            request to your principal inspector or local           material at the FAA, call 206–231–3195.
                                              on the shimmy damper of the main landing                Flight Standards District Office, as                      (5) You may view this service information
                                              gear (MLG) may fail due to fatigue. We are              appropriate. If sending information directly           that is incorporated by reference at the
                                              issuing this AD to prevent a failed washer              to the manager of the certification office,            National Archives and Records
                                              segment migrating into the piston cavity and            send it to ATTN: Program Manager,                      Administration (NARA). For information on
                                              interfering with piston travel. As a result, the        Continuing Operational Safety, FAA, New                the availability of this material at NARA, call
                                              shimmy damper performance could be                      York ACO Branch, 1600 Stewart Avenue,                  202–741–6030, or go to: http://
                                              compromised, and an MLG shimmy could                    Suite 410, Westbury, NY 11590; telephone               www.archives.gov/federal-register/cfr/ibr-
                                              occur, potentially leading to an MLG failure            516–228–7300; fax 516–794–5531. Before                 locations.html.
                                              and affecting the airplane’s safe flight and            using any approved AMOC, notify your                     Issued in Des Moines, Washington, on May
                                              landing.                                                appropriate principal inspector, or lacking a          21, 2018.
                                                                                                      principal inspector, the manager of the local
                                              (f) Compliance                                          flight standards district office/certificate           James Cashdollar,
                                                 Comply with this AD within the                       holding district office.                               Acting Director, System Oversight Division,
                                              compliance times specified, unless already                 (2) Contacting the Manufacturer: For any            Aircraft Certification Service.
                                              done.                                                   requirement in this AD to obtain corrective            [FR Doc. 2018–11827 Filed 6–6–18; 8:45 am]
                                                                                                      actions from a manufacturer, the action must           BILLING CODE 4910–13–P
                                              (g) Maintenance or Inspection Program                   be accomplished using a method approved
                                              Revision                                                by the Manager, New York ACO Branch,
                                                 Within 30 days after the effective date of           FAA; or Transport Canada Civil Aviation
                                              this AD, revise the airplane maintenance or             (TCCA); or Bombardier Inc.’s TCCA Design               DELAWARE RIVER BASIN
                                              inspection program, as applicable, by                   Approval Organization (DAO). If approved by            COMMISSION
                                              incorporating maintenance review board                  the DAO, the approval must include the
                                              (MRB) report task number 320100–229,                    DAO-authorized signature.                              18 CFR Parts 401 and 420
                                              Restoration (Belleville Washer Replacement)
                                                                                                      (k) Related Information                                Regulatory Program Fees and Water
                                              of the MLG Shimmy Damper, of the MRB
                                              Report of the Bombardier CRJ700/900/1000                   (1) Refer to Mandatory Continuing                   Charges Rates
                                              Maintenance Requirements Manual (MRM)—                  Airworthiness Information (MCAI) Canadian
                                              Part 1, Volume 1, CSP B–053, Revision 17,               Airworthiness Directive CF–2017–14, dated              AGENCY:  Delaware River Basin
                                              dated June 25, 2017. The initial compliance             April 21, 2017, for related information. This          Commission.
                                              time for MRB report task number 320100–229              MCAI may be found in the AD docket on the              ACTION: Final rule.
                                              is specified in paragraphs (g)(1) and (g)(2) of         internet at http://www.regulations.gov by
                                              this AD, as applicable.                                 searching for and locating Docket No. FAA–             SUMMARY:   Notice is provided of the
                                                 (1) For any shimmy damper with 20,000                2017–1175.                                             Commission’s regulatory program fees
                                              total accumulated flight cycles or fewer as of             (2) For more information about this AD,             and schedule of water charges for the
                                              the effective date of this AD, the initial              contact Cesar Gomez, Aerospace Engineer,               fiscal year beginning July 1, 2018.
                                              compliance time is before the accumulation              Airframe and Mechanical Systems Section,
                                                                                                                                                             DATES: This final rule is effective July 1,
                                              of 26,000 total flight cycles.                          FAA, New York ACO Branch, 1600 Stewart
                                                                                                      Avenue, Suite 410, Westbury, NY 11590;                 2018.
                                                 (2) For any shimmy damper with 20,000
                                              total accumulated flight cycles or more as of           telephone 516–228–7318; fax 516–794–5531.              FOR FURTHER INFORMATION CONTACT: Elba
                                              the effective date of this AD, the initial                 (3) Service information identified in this          L. Deck, CPA, Director of
                                              compliance time is specified in paragraph               AD that is not incorporated by reference is            Administration and Finance, 609–883–
                                              (g)(2)(i) or (g)(2)(ii), whichever occurs later.        available at the addresses specified in                9500, ext. 201.
                                                 (i) Within 6,000 flight cycles after the             paragraphs (l)(3) and (l)(4) of this AD.               SUPPLEMENTARY INFORMATION: The
                                              effective date of this AD, but prior to the             (l) Material Incorporated by Reference                 Delaware River Basin Commission
                                              accumulation of 30,000 total flight cycles.                                                                    (‘‘DRBC’’ or ‘‘Commission’’) is a
                                                 (ii) Within 30 days after effective date of             (1) The Director of the Federal Register
                                              this AD.                                                approved the incorporation by reference                Federal-interstate compact agency
                                                                                                      (IBR) of the service information listed in this        charged with managing the water
                                              (h) Credit for Previous Actions                         paragraph under 5 U.S.C. 552(a) and 1 CFR              resources of the Delaware River Basin
                                                This paragraph provides credit for actions            part 51.                                               on a regional basis without regard to
                                              required by paragraph (g) of this AD, if those             (2) You must use this service information           political boundaries. Its members are
                                              actions were performed before the effective             as applicable to do the actions required by            the governors of the four basin states—
                                              date of this AD using Bombardier Temporary              this AD, unless this AD specifies otherwise.
                                                                                                         (i) Maintenance review board (MRB) report
                                                                                                                                                             Delaware, New Jersey, New York and
                                              Revision MRB–0070, dated October 20, 2015.                                                                     Pennsylvania—and on behalf of the
                                                                                                      task number 320100–229, Restoration
                                              (i) No Alternative Actions and/or Intervals             (Belleville Washer Replacement) of the MLG             federal government, the North Atlantic
                                                 After the airplane maintenance or                    Shimmy Damper, of the MRB Report of the                Division Commander of the U.S. Army
                                              inspection program has been revised, as                 Bombardier CRJ700/900/1000 Maintenance                 Corps of Engineers.
                                              required by paragraph (g) of this AD, no                Requirements Manual (MRM)—Part 1,                         In accordance with 18 CFR 401.43(c),
                                              alternative actions (e.g., inspections) and/or          Volume 1, CSP B–053, Revision 17, dated                on July 1 of every year beginning July
                                              intervals may be used unless the actions and/           June 25, 2017.                                         1, 2017, the Commission’s regulatory
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                                              or intervals are approved as an alternative                (ii) Reserved.                                      program fees as set forth in Tables 1, 2
                                              method of compliance (AMOC) in                             (3) For service information identified in
                                                                                                                                                             and 3 of that section are subject to an
                                              accordance with the procedures specified in             this AD, contact Bombardier, Inc., 400 Côte-
                                                                                                      Vertu Road West, Dorval, Québec H4S 1Y9,              annual adjustment, commensurate with
                                              paragraph (j)(1) of this AD.
                                                                                                      Canada; Widebody Customer Response                     any increase in the annual April 12-
                                              (j) Other FAA AD Provisions                             Center North America toll-free telephone 1–            month Consumer Price Index (CPI) for
                                                 The following provisions also apply to this          866–538–1247 or direct-dial telephone 1–               Philadelphia published by the U.S.
                                              AD:                                                     514–855–2999; fax 514–855–7401; email                  Bureau of Labor Statistics during that


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                                                                        Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Rules and Regulations                                                                           26355

                                              year. Pursuant to 18 CFR 420.43(c), the                                  business hours or by checking the                                       PART 401—RULES OF PRACTICE AND
                                              same indexed adjustment applies to the                                   Commission’s website.                                                   PROCEDURE
                                              Commission’s schedule of water charges
                                                                                                                       List of Subjects
                                              for consumptive and non-consumptive                                                                                                              ■ 1. The authority citation for part 401
                                              withdrawals of surface water within the                                  18 CFR Part 401                                                         continues to read as follows:
                                              basin. The referenced April 12-month                                       Administrative practice and                                             Authority: Delaware River Basin Compact
                                              CPI for 2018 showed an increase of                                       procedure, Project review, Water                                        (75 Stat. 688), unless otherwise noted.
                                              1.38%. Commensurate adjustments are                                      pollution control, Water resources.
                                              thus required.                                                                                                                                   Subpart C—Project Review Under
                                                                                                                       18 CFR Part 420
                                                This notification is made in                                                                                                                   Section 3.8 of the Compact
                                              accordance with 18 CFR 401.42(c) and                                       Water supply.
                                              18 CFR 420.42(c), which provide that a                                     For the reasons set forth in the                                      ■ 2. In § 401.43, revise Tables 1, 2 and
                                              revised fee schedule will be published                                   preamble, the Delaware River Basin                                      3 to read as follows:
                                              in the Federal Register by July 1. The                                   Commission amends parts 401 and 420
                                              revised fees also may be obtained by                                     of title 18 of the Code of Federal                                      § 401.43   Regulatory program fees.
                                              contacting the Commission during                                         Regulations as set forth below:                                         *     *      *     *      *

                                                                                                       TABLE 1 TO § 401.43—DOCKET APPLICATION FILING FEE
                                                          Project type                                                Docket application fee                                                                Fee maximum

                                              Water Allocation ...................           $411 per million gallons/month of allocation 1, not to ex-                             Greater of: $15,401 1 or Alternative Review Fee.
                                                                                               ceed $15,401 1.
                                                                                             Fee is doubled for any portion to be exported from the
                                                                                               basin.
                                              Wastewater Discharge .........                 Private projects: $1,027 1 ................................................            Alternative Review Fee.
                                                                                             Public projects: $513 1 ....................................................
                                              Other ....................................     0.4% of project cost up to $10,000,000 plus 0.12% of                                   Greater of: $77,003 1 or Alternative Review Fee.
                                                                                               project cost above $10,000,000 (if applicable), not to
                                                                                               exceed $77,003 1.
                                                  1 Subject    to annual adjustment in accordance with paragraph (c) of this section.

                                                                                            TABLE 2 TO § 401.43—ANNUAL MONITORING AND COORDINATION FEE
                                                                                                                                                                                               Annual fee                 Allocation

                                              Water Allocation .............................................................................................................................         1 $308                        <4.99    mgm.
                                                                                                                                                                                                     1 $462                5.00 to 49.99    mgm.
                                                                                                                                                                                                     1 $667              50.00 to 499.99    mgm.
                                                                                                                                                                                                     1 $847           500.00 to 9,999.99    mgm.
                                                                                                                                                                                                   1 $1,027             > or = to 10,000    mgm.

                                                                                                                                                                                               Annual fee        Discharge design capacity

                                              Wastewater Discharge ...................................................................................................................               1 $308                        <0.05    mgd.
                                                                                                                                                                                                     1 $626                     0.05 to 1   mgd.
                                                                                                                                                                                                     1 $842                       1 to 10   mgd.
                                                                                                                                                                                                   1 $1,027                           >10   mgd.
                                                  1 Subject    to annual adjustment in accordance with paragraph (c) of this section.

                                                                                                                      TABLE 3 TO § 401.43—ADDITIONAL FEES
                                                                     Proposed action                                                                    Fee                                                     Fee maximum

                                              Emergency Approval Under 18 CFR 401.40 ....                               $5,000 ............................................................... Alternative Review Fee.
                                              Late Filed Renewal Surcharge ..........................                   $2,000.
                                              Modification of a DRBC Approval .....................                     At Executive Director’s discretion, Docket Ap- Alternative Review Fee.
                                                                                                                          plication Fee for the appropriate project type.
                                              Name change ....................................................          $1,027 1.
                                              Change of Ownership ........................................              $1,540 1.
                                                  1 Subject    to annual adjustment in accordance with paragraph (c) of this section.


                                              PART 420—BASIN REGULATIONS—                                              ■ 4. In § 420.41, revise paragraphs (a)                                    (a) $82.14 per million gallons for
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                                              WATER SUPPLY CHARGES                                                     and (b) to read as follows:                                             consumptive use, subject to paragraph
                                                                                                                                                                                               (c) of this section; and
                                                                                                                       § 420.41        Schedule of water charges.
                                              ■ 3. The authority citation for part 420                                                                                                            (b) $0.82 per million gallons for non-
                                              continues to read as follows:                                            *         *        *         *         *                                consumptive use, subject to paragraph
                                                Authority: Delaware River Basin Compact,                                                                                                       (c) of this section.
                                              75 Stat. 688.                                                                                                                                    *      *     *     *    *


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                                              26356               Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Rules and Regulations

                                                Dated: June 1, 2018.                                  third party may not wish to be posted,                 information on the cover sheet and not
                                              Pamela M. Bush,                                         such as medical information, your or                   in the body of your comments and you
                                              Commission Secretary.                                   anyone else’s Social Security number, or               must identify this information as
                                              [FR Doc. 2018–12258 Filed 6–6–18; 8:45 am]              confidential business information, such                ‘‘confidential.’’ Any information marked
                                              BILLING CODE 6360–01–P
                                                                                                      as a manufacturing process. Please note                as ‘‘confidential’’ will not be disclosed
                                                                                                      that if you include your name, contact                 except in accordance with 21 CFR 10.20
                                                                                                      information, or other information that                 and other applicable disclosure law. For
                                                                                                      identifies you in the body of your                     more information about FDA’s posting
                                              DEPARTMENT OF HEALTH AND
                                                                                                      objection, that information will be                    of comments to public dockets, see 80
                                              HUMAN SERVICES
                                                                                                      posted on https://www.regulations.gov.                 FR 56469, September 18, 2015, or access
                                              Food and Drug Administration                              • If you want to submit an objection                 the information at: https://www.gpo.gov/
                                                                                                      with confidential information that you                 fdsys/pkg/FR-2015-09-18/pdf/2015-
                                              21 CFR Part 74                                          do not wish to be made available to the                23389.pdf.
                                                                                                      public, submit the objection as a                         Docket: For access to the docket to
                                              [Docket No. FDA–2017–C–0935]                            written/paper submission and in the                    read background documents or the
                                                                                                      manner detailed (see ‘‘Written/Paper                   electronic and written/paper comments
                                              Listing of Color Additives Subject to                   Submissions’’ and ‘‘Instructions’’).                   received, go to https://
                                              Certification; D&C Black No. 4                                                                                 www.regulations.gov and insert the
                                                                                                      Written/Paper Submissions
                                              AGENCY:    Food and Drug Administration,                                                                       docket number, found in brackets in the
                                                                                                         Submit written/paper submissions as                 heading of this document, into the
                                              HHS.
                                                                                                      follows:                                               ‘‘Search’’ box and follow the prompts
                                              ACTION:   Final rule.                                      • Mail/Hand delivery/Courier (for                   and/or go to the Dockets Management
                                                                                                      written/paper submissions): Dockets                    Staff, 5630 Fishers Lane, Rm. 1061,
                                              SUMMARY:    The Food and Drug
                                                                                                      Management Staff (HFA–305), Food and                   Rockville, MD 20852.
                                              Administration (FDA or we) is
                                                                                                      Drug Administration, 5630 Fishers
                                              amending the color additive regulations                                                                        FOR FURTHER INFORMATION CONTACT:
                                                                                                      Lane, Rm. 1061, Rockville, MD 20852.
                                              to provide for the safe use of D&C Black                   • For written/paper objections                      Joseph M. Thomas, Center for Food
                                              No. 4 for coloring ultra-high molecular                 submitted to the Dockets Management                    Safety and Applied Nutrition (HFS–
                                              weight polyethylene (UHMWPE) non-                       Staff, FDA will post your objection, as                265), Food and Drug Administration,
                                              absorbable sutures for use in general                   well as any attachments, except for                    5001 Campus Dr., College Park, MD
                                              surgery. This action is in response to a                information submitted, marked and                      20740–3835, 301–796–9465.
                                              color additive petition (CAP) submitted                 identified, as confidential, if submitted              SUPPLEMENTARY INFORMATION:
                                              by DSM Biomedical.                                      as detailed in ‘‘Instructions.’’                       I. Introduction
                                              DATES: This rule is effective July 10,                     Instructions: All submissions received
                                              2018. See section VIII for further                      must include the Docket No. FDA–                          In the Federal Register on March 6,
                                              information on the filing of objections.                2017–C–0935 for ‘‘Listing of Color                     2017 (82 FR 12531), we announced that
                                              Submit either electronic or written                     Additives Subject to Certification; D&C                we filed a color additive petition (CAP
                                              objections and requests for a hearing on                Black No. 4.’’ Received objections, those              7C0310) submitted by DSM Biomedical
                                              the final rule by July 9, 2018.                         filed in a timely manner (see                          (petitioner), 735 Pennsylvania Dr.,
                                                                                                      ADDRESSES), will be placed in the docket
                                                                                                                                                             Exton, PA 19341. The petition proposed
                                              ADDRESSES: You may submit objections
                                                                                                      and, except for those submitted as                     to amend the color additive regulations
                                              and requests for a hearing as follows.
                                                                                                      ‘‘Confidential Submissions,’’ publicly                 in part 73 (21 CFR part 73), Listing of
                                              Please note that late, untimely filed
                                                                                                      viewable at https://www.regulations.gov                Color Additives Exempt from
                                              objections will not be considered.
                                                                                                      or at the Dockets Management Staff                     Certification, to provide for the safe use
                                              Electronic objections must be submitted
                                                                                                      between 9 a.m. and 4 p.m., Monday                      of high-purity carbon black for coloring
                                              on or before July 9, 2018. The https://
                                                                                                      through Friday.                                        UHMWPE non-absorbable sutures for
                                              www.regulations.gov electronic filing
                                                                                                         • Confidential Submissions—To                       use in general surgery.1 After the
                                              system will accept comments until
                                                                                                      submit an objection with confidential                  petition was filed and during our
                                              midnight Eastern Time at the end of July
                                                                                                      information that you do not wish to be                 review, we determined that the color
                                              9, 2018. Objections received by mail/
                                                                                                      made publicly available, submit your                   additive will require batch certification
                                              hand delivery/courier (for written/paper
                                                                                                      objections only as a written/paper                     by FDA. We intend to give each certified
                                              submissions) will be considered timely
                                                                                                      submission. You should submit two                      batch of the subject color additive the
                                              if they are postmarked or the delivery
                                                                                                      copies total. One copy will include the                name D&C Black No. 4. Therefore, this
                                              service acceptance receipt is on or
                                                                                                      information you claim to be confidential               color additive will be identified as D&C
                                              before that date.
                                                                                                      with a heading or cover note that states               Black No. 4 and will be listed in part 74
                                              Electronic Submissions                                  ‘‘THIS DOCUMENT CONTAINS                               (21 CFR part 74), Listing of Color
                                                Submit electronic objections in the                   CONFIDENTIAL INFORMATION.’’ We                         Additives Subject to Certification.
                                              following way:                                          will review this copy, including the                   II. Identity and Specifications
                                                • Federal eRulemaking Portal:                         claimed confidential information, in our
                                                                                                                                                                D&C Black No. 4 is a high-purity
                                              https://www.regulations.gov. Follow the                 consideration of comments. The second
                                                                                                                                                             carbon black prepared by the oil furnace
                                              instructions for submitting comments.                   copy, which will have the claimed
                                                                                                                                                             process. It is manufactured by injecting
                                              Objections submitted electronically,                    confidential information redacted/
sradovich on DSK3GMQ082PROD with RULES




                                              including attachments, to https://                      blacked out, will be available for public                 1 The original petition did not specify that the
                                              www.regulations.gov will be posted to                   viewing and posted on https://                         color additive is to be used in sutures that are non-
                                              the docket unchanged. Because your                      www.regulations.gov. Submit both                       absorbable. Therefore, our March 6, 2017, notice of
                                              objection will be made public, you are                  copies to the Dockets Management Staff.                filing did not specify that the color additive is
                                                                                                                                                             intended for use in non-absorbable sutures.
                                              solely responsible for ensuring that your               If you do not wish your name and                       However, petitioner’s subsequent submissions to
                                              objection does not include any                          contact information to be made publicly                FDA indicated that the intended use of the additive
                                              confidential information that you or a                  available, you can provide this                        is for sutures that are non-absorbable.



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Document Created: 2018-06-07 00:49:47
Document Modified: 2018-06-07 00:49:47
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.
DatesThis final rule is effective July 1, 2018.
ContactElba L. Deck, CPA, Director of Administration and Finance, 609-883-9500, ext. 201.
FR Citation83 FR 26354 
CFR Citation18 CFR 401
18 CFR 420
CFR AssociatedAdministrative Practice and Procedure; Project Review; Water Pollution Control; Water Resources and Water Supply

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