80 FR 76859 - Listing of Color Additives Exempt From Certification; Mica-Based Pearlescent Pigments; Confirmation of Effective Date
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 238 (December 11, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 238 (December 11, 2015)
| Page Range | 76859-76860 | |
| FR Document | 2015-31232 |
[Federal Register Volume 80, Number 238 (Friday, December 11, 2015)] [Rules and Regulations] [Pages 76859-76860] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-31232] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 73 [Docket No. FDA-2015-C-1154] Listing of Color Additives Exempt From Certification; Mica-Based Pearlescent Pigments; 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 November 2, 2015, for the final rule that appeared in the Federal Register of September 30, 2015, and that amended the color additive regulations to provide for the safe use of mica-based pearlescent pigments prepared from titanium dioxide and mica as a color additive in certain distilled spirits. DATES: Effective date of final rule published in the Federal Register of September 30, 2015 (80 FR 58600), confirmed: November 2, 2015. FOR FURTHER INFORMATION CONTACT: Salome Bhagan, Center for Food Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835, 240-402-3041. SUPPLEMENTARY INFORMATION: In the Federal Register of September 30, 2015 (80 FR 58600), we amended the color additive regulations in Sec. 73.350 Mica-based pearlescent pigments (21 CFR [[Page 76860]] 73.350) to increase the maximum permitted alcohol content of distilled spirits to which mica-based pearlescent pigments may be added from 23 percent to 25 percent alcohol by volume, and to remove the current limitation for distilled spirits mixtures containing more than 5 percent wine on a proof gallon basis. We gave interested persons until October 30, 2015, 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 September 30, 2015, should be confirmed. List of Subjects in 21 CFR Part 73 Color additives, Cosmetics, Drugs, Foods, Medical devices. 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, and redelegated to the Director, Center for Food Safety and Applied Nutrition, we are giving notice that no objections or requests for a hearing were filed in response to the September 30, 2015, final rule. Accordingly, the amendments issued thereby became effective November 2, 2015. Dated: December 4, 2015. Susan Bernard, Director, Office of Regulations, Policy and Social Sciences, Center for Food Safety and Applied Nutrition. [FR Doc. 2015-31232 Filed 12-10-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 238 / Friday, December 11, 2015 / Rules and Regulations 76859
(4) Approval of coverage under a application will result in continuation (5) Changes that have the potential for
general permit shall be determined by of coverage of the applicable adverse impacts to water resources or
the Executive Director or by any other withdrawal, consumptive use or competing water users.
manner that the Commission shall diversion under the general permit, (e) Notice and approval. (1)
establish for any general permit. until the Commission takes final action Applications for modifications are
(5) The Commission may set a fee for on the pending individual approval subject to the notice requirements of
NOIs to any general permit. application. § 806.15.
(6) A project sponsor shall provide (f) Action of the Commission. Action (2) The Commission or Executive
notice for NOIs in accordance with by the Executive Director denying or Director may approve, approve with
§ 806.15(h) and any additional notice revoking coverage under a general conditions or deny an application for
requirements that the Commission may permit under paragraph (d) of this minor modification, or direct that an
adopt for any general permit. section, or requiring an individual application for major modification be
(7) The requirements of § 806.16 approval under paragraph (e) of this made.
apply to the review of NOIs to any section, is not a final action of the (3) The Commission may approve,
general permit. Commission until the project sponsor approve with conditions or deny an
(8) Upon reissuance or amendment of submits and the Commission takes final application for major modification.
a general permit, all project sponsors action on an individual approval
Dated: December 7, 2015.
permitted to divert, withdraw or application.
consumptively use water in accordance Stephanie L. Richardson,
■ 7. Add § 806.18 to read as follows:
with the previous general permit shall Secretary to the Commission.
be permitted to continue to operate with § 806.18 Approval modifications. [FR Doc. 2015–31174 Filed 12–10–15; 8:45 am]
the renewed or modified general permit (a) General. A project sponsor shall BILLING CODE 7040–01–P
unless otherwise notified by the submit an application for modification
Commission. of a current approval prior to making a
(9) Notice of receipt of NOIs shall be change in the design, operational plans, DEPARTMENT OF HEALTH AND
published on the Commission’s Web or use as presented in the application HUMAN SERVICES
site and in any other manner that the upon which the approval was originally
Commission shall establish for any issued, and that will affect the terms Food and Drug Administration
general permit. and conditions of the current approval.
(d) Denial of coverage. The Executive (b) Applications for modification. A 21 CFR Part 73
Director will deny or revoke coverage project sponsor may apply for a
under a general permit when one or modification of a current approval by [Docket No. FDA–2015–C–1154]
more of the following conditions exist: submitting an application for
(1) The project or project sponsor does modification to the Commission. Listing of Color Additives Exempt
not or can no longer meet the criteria for (c) Minor modifications. The From Certification; Mica-Based
coverage under a general permit. following are minor modifications: Pearlescent Pigments; Confirmation of
(2) The diversion, withdrawal or (1) Correction of typographical errors; Effective Date
consumptive use, individually or in (2) Changes to monitoring or metering
AGENCY: Food and Drug Administration,
combination with other similar conditions;
(3) Addition of sources of water for HHS.
Commission regulated activities, is ACTION: Final rule; confirmation of
causing or has the potential to cause consumptive use;
(4) Changes to the authorized water effective date.
adverse impacts to water resources or
uses;
competing water users. (5) Changes to conditions setting a SUMMARY: The Food and Drug
(3) The project does not comport with Administration (FDA or we) is
schedule for developing, implementing,
§ 806.21(a) or (b). confirming the effective date of
and/or reporting on monitoring, data
(4) The project includes other November 2, 2015, for the final rule that
collection and analyses;
diversions, withdrawals or consumptive (6) Changes to the design of intakes; appeared in the Federal Register of
uses that require an individual approval (7) Increases to total system limits that September 30, 2015, and that amended
and the issuance of both an individual were established based on the projected the color additive regulations to provide
approval and a general permit for the demand of the project; and for the safe use of mica-based
project would constitute an undue (8) Modifications of extraction well pearlescent pigments prepared from
administrative burden on the network used for groundwater titanium dioxide and mica as a color
Commission. remediation systems. additive in certain distilled spirits.
(5) The Executive Director determines (d) Major modifications. Major DATES: Effective date of final rule
that a project cannot be effectively modifications are changes not published in the Federal Register of
regulated under a general permit and is considered to be minor modifications. September 30, 2015 (80 FR 58600),
more effectively regulated under an Major modifications may include, but confirmed: November 2, 2015.
individual approval. are not limited to:
(e) Requiring an individual approval. FOR FURTHER INFORMATION CONTACT:
(1) Increases in the quantity of water
If coverage is denied or revoked under withdrawals, consumptive uses or Salome Bhagan, Center for Food Safety
paragraph (d) of this section, the project diversions; and Applied Nutrition (HFS–265), Food
sponsor shall be notified in writing. The (2) Increases to peak day consumptive and Drug Administration, 5100 Paint
notice will include a brief statement for water use; Branch Pkwy., College Park, MD 20740–
tkelley on DSK9F6TC42PROD with RULES
the reasons for the decision. If coverage (3) Increases to the instantaneous 3835, 240–402–3041.
under a general permit was previously withdrawal rate or changes from a single SUPPLEMENTARY INFORMATION: In the
granted, the notice will also include a withdrawal rate to a varied withdrawal Federal Register of September 30, 2015
deadline for submission of an rate; (80 FR 58600), we amended the color
application for an individual approval. (4) Changes affecting passby flow additive regulations in § 73.350 Mica-
Timely submission of a complete requirements; and based pearlescent pigments (21 CFR
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![76860 Federal Register / Vol. 80, No. 238 / Friday, December 11, 2015 / Rules and Regulations
73.350) to increase the maximum provide for the safety of the Dated: November 24, 2015.
permitted alcohol content of distilled participants, crew, spectators, sponsor J.S. Spaner,
spirits to which mica-based pearlescent safety vessels, and general users of the Captain, U.S. Coast Guard, Captain of the
pigments may be added from 23 percent waterway. During the enforcement Port San Diego.
to 25 percent alcohol by volume, and to period, persons and vessels are [FR Doc. 2015–31267 Filed 12–10–15; 8:45 am]
remove the current limitation for prohibited from entering into, transiting BILLING CODE 9110–04–P
distilled spirits mixtures containing through, or anchoring within this
more than 5 percent wine on a proof regulated area unless authorized by the
gallon basis. Captain of the Port, or his designated DEPARTMENT OF HOMELAND
We gave interested persons until representative. SECURITY
October 30, 2015, to file objections or
requests for a hearing. We received no DATES: The regulations for the marine Coast Guard
objections or requests for a hearing on event listed in 33 CFR 100.1101, Table
the final rule. Therefore, we find that 1, Item 5, will be enforced from 5:30 33 CFR Part 117
the effective date of the final rule that p.m. to 8:30 p.m. on Sunday, December [Docket No. USCG–2015–0974]
published in the Federal Register of 13, 2015 and Sunday, December 20,
September 30, 2015, should be 2015. Drawbridge Operation Regulation; Des
confirmed. Allemands Bayou, Des Allemands, LA
FOR FURTHER INFORMATION CONTACT: If
List of Subjects in 21 CFR Part 73 AGENCY: Coast Guard, DHS.
you have questions on this document,
Color additives, Cosmetics, Drugs, call or email Petty Officer Randolph ACTION:Notice of deviation from
Foods, Medical devices. Pahilanga, Waterways Management, drawbridge regulation.
Therefore, under the Federal Food, U.S. Coast Guard Sector San Diego, CA; SUMMARY: The Coast Guard has issued a
Drug, and Cosmetic Act (21 U.S.C. 321, telephone (619) 278–7656, email temporary deviation from the operating
341, 342, 343, 348, 351, 352, 355, 361, D11MarineEventsSD@uscg.mil. schedule that governs the Burlington
362, 371, 379e) and under authority Northern Santa Fe Railroad swing span
delegated to the Commissioner of Food SUPPLEMENTARY INFORMATION: The Coast
Guard will enforce the special local drawbridge across Des Allemands
and Drugs, and redelegated to the Bayou, mile 14.0, at Des Allemands, St.
Director, Center for Food Safety and regulations in 33 CFR 100.1101 in
support of the San Diego Parade of Charles and Lafourche Parishes,
Applied Nutrition, we are giving notice Louisiana. This deviation is necessary to
that no objections or requests for a Lights (Item 5 on Table 1 of 33 CFR
perform two extensive rest pier
hearing were filed in response to the 100.1101). The Coast Guard will enforce
rehabilitations to the bridge. This
September 30, 2015, final rule. the special local regulations in the San deviation allows the bridge to remain in
Accordingly, the amendments issued Diego Bay in San Diego, CA from 5:30 its closed-to-navigation position for
thereby became effective November 2, p.m. to 8:30 p.m. on Sunday, December three eight-hour periods during three
2015. 13, 2015 and Sunday, December 20, consecutive days on two separate
Dated: December 4, 2015. 2015. occasions.
Susan Bernard, Under the provisions of 33 CFR DATES: This deviation is effective from
Director, Office of Regulations, Policy and 100.1101, persons and vessels are 7 a.m. on January 13, 2016 through 3
Social Sciences, Center for Food Safety and prohibited from entering into, transiting p.m. on January 22, 2016.
Applied Nutrition. through, or anchoring within this ADDRESSES: The docket for this
[FR Doc. 2015–31232 Filed 12–10–15; 8:45 am] regulated area unless authorized by the deviation, [USCG–2015–0974] is
BILLING CODE 4164–01–P Captain of the Port, or his designated available at http://www.regulations.gov.
representative. The Coast Guard may be Type the docket number in the
assisted by other Federal, State, or local ‘‘SEARCH’’ box and click ‘‘SEARCH’’.
DEPARTMENT OF HOMELAND law enforcement agencies in patrol and Click on Open Docket Folder on the line
SECURITY notification of this regulation. associated with this deviation.
Coast Guard This document is issued under FOR FURTHER INFORMATION CONTACT: If
authority of 5 U.S.C. 552(a) and 33 CFR you have questions on this temporary
33 CFR Part 100 100.1101. In addition to this document deviation, call or email Donna Gagliano,
in the Federal Register, the Coast Guard Bridge Specialist, Coast Guard;
[Docket No. USCG–2015–1016] telephone 504–671–2128, email
will provide the maritime community
with advance notification of this Donna.Gagliano@uscg.mil.
Special Local Regulation; Southern
enforcement period via the Local Notice SUPPLEMENTARY INFORMATION: The
California Annual Marine Events for
the San Diego Captain of the Port Zone to Mariners and local advertising by the Burlington Northern Santa Fe Railroad
event sponsor. swing span drawbridge across Des
AGENCY: Coast Guard, DHS. Allemands Bayou, mile 14.0, at Des
If the Captain of the Port Sector San Allemands, St. Charles and Lafourche
ACTION: Notice of enforcement of Diego or his designated representative
regulation. Parishes, Louisiana, has a vertical
determines that the regulated area need clearance of three feet above mean high
SUMMARY: The Coast Guard will enforce not be enforced for the full duration water in the closed-to-navigation
tkelley on DSK9F6TC42PROD with RULES
the San Diego Parade of Lights special stated on this document, he or she may position and unlimited in the open-to-
local regulations on Sunday, December use a Broadcast Notice to Mariners or navigation position.
13, 2015 and Sunday, December 20, other communications coordinated with The draw currently operates under 33
2015. This event occurs in north San the event sponsor to grant general CFR 117.440(b). For purposes of this
Diego Bay in San Diego, CA. These permission to enter the regulated area. deviation, the bridge will not be
special local regulations are necessary to required to open from 7 a.m. to 3 p.m.
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Document Created: 2018-03-02 09:13:42
Document Modified: 2018-03-02 09:13:42
| 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; confirmation of effective date. | |
| Dates | Effective date of final rule published in the Federal Register of September 30, 2015 (80 FR 58600), confirmed: November 2, 2015. | |
| Contact | Salome Bhagan, Center for Food Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835, 240-402-3041. | |
| FR Citation | 80 FR 76859 | |
| CFR Associated | Color Additives; Cosmetics; Drugs; Foods and Medical Devices |
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