[Federal Register Volume 88, Number 151 (Tuesday, August 8, 2023)]
[Notices]
[Pages 53490-53492]
[FR Doc No: 2023-16771]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-D-1716]

Registration and Listing of Cosmetic Product Facilities and
Products; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the availability of a draft guidance for industry entitled
``Registration and Listing of Cosmetic Product Facilities and
Products.'' This draft guidance, when finalized, will assist persons
submitting cosmetic product facility registrations and product listing
submissions to FDA under the Modernization of Cosmetics Regulation Act
of 2022 (MoCRA). This draft guidance is not final nor is it in effect
at this time.

DATES: Submit either electronic or written comments on the draft
guidance by September 7, 2023 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.

     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2023-D-1716 for ``Registration and Listing of Cosmetic Product
Facilities and Products.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Office of Cosmetics and Colors, Center for Food Safety and Applied
Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park,
MD 20740. Send two self-addressed adhesive labels to assist that office
in processing your request. See the SUPPLEMENTARY INFORMATION section
for electronic access to the draft guidance.

FOR FURTHER INFORMATION CONTACT: Jennifer Ross, Office of the Chief
Scientist, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 1, Rm. 4332, Silver Spring, MD 20993-0002,<PHONE_NUMBER> (this is
not a toll-free number), email: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Registration and Listing of Cosmetic Product Facilities and
Products.'' We are issuing the draft guidance consistent with our good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on this topic. It
does not establish any rights for any person and is not binding on FDA
or the public. You can use an alternate approach if it satisfies the
requirements of the applicable statutes and regulations.
    On December 29, 2022, the President signed the Consolidated
Appropriations Act, 2023 (Pub. L. 117-328) into law, which included
MoCRA. Among other provisions, MoCRA added section 607 to the Federal
Food, Drug, and Cosmetic Act (FD&C Act), establishing requirements for
cosmetic product facility registration and cosmetic product listing.
Section 607(a) of the FD&C Act requires every person that owns or
operates a facility that engages in the manufacturing or processing of
a cosmetic product for distribution in the United States to register
each facility with FDA no later than one year after the date of
enactment. FDA previously had a voluntary cosmetics registration
program (see 21 CFR parts 710 and 720). Because the information in the
voluntary cosmetics registration program differs from the information
required to be submitted under MoCRA, FDA does not consider previous
submissions to the voluntary cosmetics registration program to satisfy
the registration and listing mandated by MoCRA. Accordingly, FDA ended
its voluntary registration program as of March 27, 2023, while we work
toward establishing a new system, and information in the voluntary
cosmetics registration program will not be transferred to this new
system. In addition to the registration requirements, section 607(c) of
the FD&C Act requires that for each cosmetic product, the responsible
person submit to FDA ``a cosmetic product listing.'' Certain small
businesses, as defined in section 612 of the FD&C Act, are exempt from
the registration and listing requirements.
    While electronic submission of registration and listing information
is not required, FDA is strongly encouraging electronic submission to
facilitate efficiency and timeliness of data submission and management
by FDA. To that end, FDA will make an electronic portal available to
streamline the data entry process for registration and product listing.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to collections of information subject to
review and approval by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521). As
required by the PRA, FDA published an analysis of burden associated
with reporting provisions found in section 607 of the FD&C Act in the
Federal Register of May 1, 2023 (88 FR 26564) and is currently inviting
comment on the proposed collection of information. As required by the
PRA, FDA will publish a subsequent notice announcing that the proposed
collection of information has been submitted to OMB for review and
approval, and provide an additional opportunity for public comment.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/CosmeticGuidances, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov. Use the FDA

websites listed in the previous sentence to find the most current
version of the guidance.

    Dated: August 2, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-16771 Filed 8-7-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 136 (Tuesday, July 16, 2019)]
[Notices]
[Pages 34045-34046]
[FR Doc No: 2019-15036]

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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

Hazardous Materials: Notice of Applications for Special Permits

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA),
DOT.

ACTION: List of applications for modification of special permits.

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SUMMARY: In accordance with the procedures governing the application
for, and the processing of, special permits from the Department of
Transportation's Hazardous Material Regulations, notice is hereby given
that the Office of Hazardous Materials Safety has received the
application described herein. Each mode of transportation for which a
particular special permit is requested is indicated by a number in the
``Nature of Application'' portion of the table below as follows: 1--
Motor vehicle, 2--Rail freight, 3--Cargo vessel, 4--Cargo aircraft
only, 5--Passenger-carrying aircraft.

DATES: Comments must be received on or before July 31, 2019.

ADDRESSES: Record Center, Pipeline and Hazardous Materials Safety
Administration, U.S. Department of Transportation Washington, DC 20590.
    Comments should refer to the application number and be submitted in
triplicate. If confirmation of receipt of comments is desired, include
a self-addressed stamped postcard showing the special permit number.

FOR FURTHER INFORMATION CONTACT: Ryan Paquet, Director, Office of
Hazardous Materials Approvals and Permits Division, Pipeline and
Hazardous Materials Safety Administration, U.S. Department of
Transportation, East Building, PHH-30, 1200 New Jersey Avenue
Southeast, Washington, DC 20590-0001,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Copies of the applications are available for
inspection in the Records Center, East Building, PHH-30, 1200 New
Jersey Avenue Southeast, Washington DC or at http://regulations.gov.
    This notice of receipt of applications for special permit is
published in accordance with part 107 of the Federal hazardous
materials transportation law (49 U.S.C. 5117(b); 49 CFR 1.53(b)).

    Issued in Washington, DC, on July 2, 2019.
Donald P. Burger,
Chief, General Approvals and Permits Branch.

                                              SPECIAL PERMITS DATA
----------------------------------------------------------------------------------------------------------------
                                                                  Regulation(s)         Nature of the special
        Application  number                 Applicant               affected               permits thereof
----------------------------------------------------------------------------------------------------------------
4661-M.............................  ALBEMARLE U.S. INC....  180.205(b),             To modify the special
                                                              180.205(c),             permit to authorize
                                                              180.205(f),             additional Class 3 hazmat.
                                                              180.205(g), 180.213.    (modes 1, 2, 3)
8451-M.............................  AUTOLIV ASP, INC......  172.320, 173.54(a),     To modify the special
                                                              173.54(j), 173.56(b),   permit to increase the
                                                              173.57, 173.58,         weight of the explosives.
                                                              173.60.                 (modes 1, 2, 4)
9998-M.............................  ACCUMULATORS, INC.....  173.302(a)............  To modify the permit to add
                                                                                a new line of piston-type
                                                                                hydro-pneumatic
                                                                                accumulators (to the
                                                                                currently permitted
                                                                                bladder-type
                                                                                accumulators). (modes 1,
                                                                                2, 3, 4)
10915-M............................  LUXFER INC............  172.203(a),             To modify the special
                                                              172.301(c),             permit to authorize a
                                                              173.302a(a)(1),         change to the marking
                                                              173.304a(a)(1),         requirements of CFFC-
                                                              180.205.                14(b)(ii). (modes 1, 2, 3,
                                                                                4, 5)
14298-M............................  VERSUM MATERIALS, LLC.  180.209(a),             To modify the special
                                                              180.209(b),             permit to authorize the
                                                              180.209(b)(1)(iv).      addition of tungsten
                                                                                hexafluoride as an
                                                                                authorized hazardous
                                                                                material. (modes 1, 2, 3)
15130-M............................  SUNDANCE HELICOPTERS,   72.101(j)(1),           To modify the special
                                      INC.                    175.30(a).              permit to authorize
                                                                                additional Class 2
                                                                                hazardous materials. (mode
                                                                                4)
16518-M............................  MIDWEST HELICOPTER      172.200, 172.301(c),    To modify the special
                                      AIRWAYS.                175.33.                 permit to add additional
                                                                                hazmat. (mode 4)
16624-M............................  FRAMATOME INC.........  173.301(a)(1),          To modify the special
                                                              173.302(a).             permit to authorize non-
                                                                                DOT specification
                                                                                packaging for the safe
                                                                                containment of the
                                                                                compressed helium in
                                                                                certain of its
                                                                                non[hyphen]Class 7 nuclear
                                                                                fuel component products.
                                                                                (mode 1)
20323-M............................  Cuberg, Inc...........  173.185(a)(1)(i)......  To modify the special
                                                                                permit to authorize an
                                                                                additional outer
                                                                                packaging. (mode 4)
20499-M............................  INMAR, INC............  Subchapter C..........  To modify the special
                                                                                permit to change it from
                                                                                an MMS to an offer type
                                                                                permit. (modes 1, 2)
20567-M............................  OMNI TANKER PTY. LTD..  107.503(b),             To modify the special
                                                              107.503(c),             permit to authorize
                                                              172.102(c)(3),          additional cargo tank
                                                              172.203(a), 173.241,    designs. (mode 1)
                                                              173.242, 173.243,
                                                              178.345-1, 178.347-1,
                                                              178.348-1, 180.405,
                                                              180.413(d).
20621-M............................  SIGMA-ALDRICH           173.56(b), 173.224(c),  To modify the special
                                      INTERNATIONAL GM.       173.225(b).             permit to authorize the
                                                                                use of a higher density
                                                                                expandable foam and to
                                                                                authorize a smaller
                                                                                package. (modes 1, 2, 3,
                                                                                4, 5)
20796-M............................  SODASTREAM USA INC....  172.400, 172.200,       To modify the special
                                                              172.300.                permit to include IMDG and
                                                                                ICAO references. (modes 1,
                                                                                2, 3)
20883-M............................  DEPARTMENT OF THE ARMY  173.302(a), 175.3.....  To modify the permit to
                                      (MILITARY SURFACE                               authorize party status.
                                      DEPLOYMENT &                                    (modes 1, 3, 4)
                                      DISTRIBUTION COMMAND).
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2019-15036 Filed 7-15-19; 8:45 am]
 BILLING CODE 4909-60-P


[Federal Register Volume 85, Number 221 (Monday, November 16, 2020)]
[Notices]
[Pages 73031-73032]
[FR Doc No: 2020-25204]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following exempt
wholesale generator filings:

    Docket Numbers: EG21-35-000.
    Applicants: Flat Ridge Interconnection LLC.
    Description: Notice of Self-Certification of Exempt Wholesale
Generator Status of Flat Ridge Interconnection LLC.
    Filed Date: 11/6/20.
    Accession Number: 20201106-5218.
    Comments Due: 5 p.m. ET 11/27/20.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER19-2373-002; ER10-1841-019; ER10-1845-019;

ER10-1852-044; ER10-1905-019; ER10-1907-018; ER10-1918-019; ER10-1925-
019; ER10-1927-019; ER10-1950-019; ER10-1951-026; ER10-1970-018; ER10-
1972-018; ER10-2005-019; ER10-2006-019; ER10-2078-019; ER11-26-019;
ER11-4462-047; ER12-1660-018; ER13-2458-013; ER13-2461-013; ER16-1872-
009; ER16-2506-010; ER17-2270-010; ER17-838-022; ER18-1771-008; ER18-
2224-008; ER18-2246-007; ER19-1003-006; ER19-1393-006; ER19-1394-006;
ER19-2382-002; ER19-2398-003; ER19-2437-002; ER19-2461-002; ER19-987-
006; ER20-122-002; ER20-975-001.
    Applicants: Ashtabula Wind I, LLC, Ashtabula Wind II, LLC,
Ashtabula Wind III, LLC, Butler Ridge Wind Energy Center, LLC, Crowned
Ridge Interconnection, LLC, Crowned Ridge Wind, LLC, Crowned Ridge Wind
II, LLC, Crystal Lake Wind Energy I, LLC, Crystal Lake Wind Energy II,
LLC, Crystal Lake Wind III, LLC, Emmons-Logan Wind, LLC, Endeavor Wind
I, LLC, Endeavor Wind II, LLC, Florida Power & Light Company, FPL
Energy Mower County, LLC, FPL Energy North Dakota Wind, LLC, FPL Energy
North Dakota Wind II, LLC, FPL Energy Oliver Wind I, LLC, FPL Energy
Oliver Wind II, LLC, Garden Wind, LLC, Hancock County Wind, LLC,
Hawkeye Power Partners, LLC, Heartland Divide Wind Project, LLC,
Langdon Renewables, LLC, Marshall Solar, LLC, NextEra Energy Duane
Arnold, LLC, NextEra Energy Point Beach, LLC, Oliver Wind III, LLC,
Pegasus Wind, LLC, Pheasant Run Wind, LLC, Story County Wind, LLC,
Stuttgart Solar, LLC, Tuscola Bay Wind, LLC, Tuscola Wind II, LLC,
White Oak Energy LLC, NEPM II, LLC, NextEra Energy Services
Massachusetts, LLC, NextEra Energy Marketing, LLC.
    Description: Notification of Change in Status of NextEra Resources
Entities.
    Filed Date: 11/5/20.
    Accession Number: 20201105-5187.
    Comments Due: 5 p.m. ET 11/27/20.

    Docket Numbers: ER21-321-000.
    Applicants: RRE Power LLC, Bridge Solar LLC.
    Description: Petition of for Limited Waiver of RRE Power LLC, et
al.
    Filed Date: 10/30/20.
    Accession Number: 20201030-5463.
    Comments Due: 5 p.m. ET 11/20/20.

    Docket Numbers: ER21-351-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Sec.  205(d) Rate Filing: 2020-11-06_Surplus
Interconnection Product Study Clarification Filing to be effective 1/6/
2021.
    Filed Date: 11/6/20.
    Accession Number: 20201106-5162.
    Comments Due: 5 p.m. ET 11/27/20.

    Docket Numbers: ER21-352-000.
    Applicants: Flat Ridge Interconnection LLC.
    Description: Baseline eTariff Filing: Filing of Common Facilities
Agreement to be effective 12/1/2020.
    Filed Date: 11/6/20.
    Accession Number: 20201106-5163.
    Comments Due: 5 p.m. ET 11/27/20.
    Docket Numbers: ER21-353-000.

    Applicants: Oakland Power Company LLC.
    Description: Sec.  205(d) Rate Filing: Notices of Succession and
Revisions to Tariffs and Agreements (I) to be effective 10/30/2020.
    Filed Date: 11/6/20.
    Accession Number: 20201106-5166.
    Comments Due: 5 p.m. ET 11/27/20.

    Docket Numbers: ER21-354-000.
    Applicants: Moss Landing Power Company LLC.
    Description: Sec.  205(d) Rate Filing: Notices of Succession and
Revisions to Tariffs and Agreements (II) to be effective 10/30/2020.
    Filed Date: 11/6/20.
    Accession Number: 20201106-5170.
    Comments Due: 5 p.m. ET 11/27/20.

    Docket Numbers: ER21-355-000.
    Applicants: Pacific Gas and Electric Company.
    Description: Sec.  205(d) Rate Filing: 1st Amendment to CDWR Hyatt-
Thermalito LGIA (SA 273) to be effective 1/6/2021.
    Filed Date: 11/6/20.
    Accession Number: 20201106-5172.
    Comments Due: 5 p.m. ET 11/27/20.

    Docket Numbers: ER21-356-000.
    Applicants: Flat Ridge 2 Wind Energy LLC.
    Description: Sec.  205(d) Rate Filing: Certificate of Concurrence
to Common Facilities Agreement to be effective 12/1/2020.
    Filed Date: 11/6/20.
    Accession Number: 20201106-5182.
    Comments Due: 5 p.m. ET 11/27/20.

    Docket Numbers: ER21-357-000.
    Applicants: Public Service Company of New Mexico.
    Description: Sec.  205(d) Rate Filing: Executed Engineering and
Procurement Agreement between PNM and 201LC 8me LLC to be effective 10/
20/2020.
    Filed Date: 11/6/20.
    Accession Number: 20201106-5183.
    Comments Due: 5 p.m. ET 11/27/20.

    Docket Numbers: ER21-358-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Original ISA, Service
Agreement No. 5823; Queue No. AC2-103 to be effective 10/12/2020.
    Filed Date: 11/9/20.
    Accession Number: 20201109-5068.
    Comments Due: 5 p.m. ET 11/30/20.

    Docket Numbers: ER21-359-000.
    Applicants: Flat Ridge 3 Wind Energy, LLC.
    Description: Sec.  205(d) Rate Filing: CFA, Common Facilities
Agreement to be effective 12/1/2020.
    Filed Date: 11/9/20.
    Accession Number: 20201109-5067.
    Comments Due: 5 p.m. ET 11/30/20.

    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by querying
the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: November 9, 2020.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2020-25204 Filed 11-13-20; 8:45 am]
BILLING CODE 6717-01-P


MEMORANDUM

DATE:		7/9/2014

TO:		Clean Power Plan for Existing Power Plants; Docket Id: OAR - 2013-0602

FROM:	Joe Bryson, EPA

SUBJECT:	7/9/2014, APPA Meeting Regarding Proposed Clean Power Plan for Existing Power Plants  --------------------------------------------------------------------------------

SUMMARY

      A meeting was held between EPA and the attendee listed below on 7/9/2014 to discuss the proposed Clean Power Plan for Existing Power Plants. The Clean Power Plan for Existing Power Plants was proposed on June 2, 2014.        ATTENDEES

Joe Bryson, CPPD OAP OAR EPA

Tanzina Islam, APPA