[Federal Register: June 23, 2010 (Volume 75, Number 120)]
[Rules and Regulations]
[Page 35650-35651]
[DOCID:fr23jn10-18]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG 2010-0368]

Safety Zone; Fourth of July Fireworks, City of Sausalito,
Sausalito, CA

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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SUMMARY: The Coast Guard will enforce the Fourth of July Fireworks,
City of Sausalito, safety zone from 11 a.m. through 9:30 p.m. on July
4, 2010, in position 37[deg]51'31'' N, 122[deg]28'28'' W. This action
is necessary to control vessel traffic and to ensure the safety of
event participants and spectators. During the enforcement period,
unauthorized persons or vessels are prohibited from entering into,
transiting through, or anchoring in the safety zone, unless authorized
by the Patrol Commander (PATCOM).

DATES: The regulations in 33 CFR 165.1191 will be enforced from 11 a.m.
through 9:30 p.m. on July 4, 2010.

FOR FURTHER INFORMATION CONTACT: If you have questions on this notice,
call or e-mail Lieutenant Simone Mausz, Sector San Francisco Waterways
Safety Division, U.S. Coast Guard; telephone<PHONE_NUMBER>, e-mail D11-
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    The Coast Guard will enforce the safety zone for the annual Fourth
of July Fireworks, City of Sausalito, safety zone in 33 CFR 165.1191 on
July 4, 2010, from 11 a.m. through 9:30 p.m. During the fireworks
display, the fireworks barge will be located approximately 1,000 feet
off-shore from Sausalito waterfront, North of Spinnaker Restaurant in
the Richardson Bay in position 37[deg]51'31'' N, 122[deg]28'28'' W.
    Under the provisions of 33 CFR 165.1191, unauthorized persons or
vessels are prohibited from entering into, transiting through, or
anchoring in the safety zone during all applicable effective dates and
times, unless authorized to do so by the PATCOM. Additionally, each
person who receives notice of a lawful order or direction issued by an
official patrol vessel shall obey the order of direction. The PATCOM is
empowered to forbid and control the regulated area. The PATCOM shall be
designated by the Commander, Coast Guard Sector San Francisco. The
PATCOM may, upon request, allow the transit of commercial vessels
through regulated areas when it is safe to do so.
    This notice is issued under authority of 33 CFR 165.1191 and 5
U.S.C. 552 (a). In addition to this notice in the Federal Register, the
Coast Guard will provide the maritime community with extensive advance
notification of this enforcement period via the Local Notice to
Mariners.
    If the Captain of the Port determines that the regulated area need
not be enforced for the full duration stated in this notice, he or she
may use a Broadcast Notice to Mariners to grant general permission to
enter the regulated area.

    Dated: June 11, 2010.
P.M. Gugg,
Captain, U.S. Coast Guard, Captain of the Port, Sector San Francisco.
[FR Doc. 2010-15150 Filed 6-22-10; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 83, Number 64 (Tuesday, April 3, 2018)]
[Notices]
[Pages 14270-14271]
[FR Doc No: 2018-06698]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: RP18-584-000.
    Applicants: Enable Gas Transmission, LLC.
    Description: Annual Revenue Crediting Filing of Enable Gas
Transmission, LLC.
    Filed Date: 3/23/18.
    Accession Number: 20180323-5202.
    Comments Due: 5 p.m. ET 4/4/18.

    Docket Numbers: RP18-234-001.
    Applicants: Northern Border Pipeline Company.
    Description: Compliance filing Settlement Compliance Period 2
Apr18-Dec19 to be effective 4/1/2018.
    Filed Date: 3/27/18.
    Accession Number: 20180327-5052.
    Comments Due: 5 p.m. ET 4/9/18.

    Docket Numbers: RP18-585-000.
    Applicants: Iroquois Gas Transmission System, L.P.
    Description: Sec.  4(d) Rate Filing: 032718 Negotiated Rates--
Uniper Global Commodities R-7650-02 to be effective 4/1/2018.
    Filed Date: 3/27/18.
    Accession Number: 20180327-5037.
    Comments Due: 5 p.m. ET 4/9/18.

    Docket Numbers: RP18-586-000.
    Applicants: Tennessee Gas Pipeline Company, L.L.C.
    Description: Sec.  4(d) Rate Filing: Volume No. 2--Neg. Rate Agmt--
MEX Gas Supply, S.L. SP301591--Amendment No. 2 to be effective 4/1/
2018.

    Filed Date: 3/27/18.
    Accession Number: 20180327-5100.
    Comments Due: 5 p.m. ET 4/9/18.

    Docket Numbers: RP18-587-000.
    Applicants: Iroquois Gas Transmission System, L.P.
    Description: Sec.  4(d) Rate Filing: 032718 Negotiated Rates--Vitol
Inc. R-7495-06 to be effective 4/1/2018.
    Filed Date: 3/27/18.
    Accession Number: 20180327-5104.
    Comments Due: 5 p.m. ET 4/9/18.

    Docket Numbers: RP18-588-000.
    Applicants: Iroquois Gas Transmission System, L.P.
    Description: Sec.  4(d) Rate Filing: 032718 Negotiated Rates--
Macquarie Energy LLC R-4090-16 to be effective 4/1/2018.
    Filed Date: 3/27/18.
    Accession Number: 20180327-5106.
    Comments Due: 5 p.m. ET 4/9/18.

    Docket Numbers: RP18-589-000.
    Applicants: Natural Gas Pipeline Company of America.
    Description: Sec.  4(d) Rate Filing: Amended Negotiated Rate
Agreement--DTE Energy to be effective 4/1/2018.
    Filed Date: 3/28/18.
    Accession Number: 20180328-5000.
    Comments Due: 5 p.m. ET 4/9/18.

    Docket Numbers: RP18-590-000.
    Applicants: Natural Gas Pipeline Company of America.
    Description: Sec.  4(d) Rate Filing: Amended Negotiated Rate
Filing--Tenaska Marketing Ventures to be effective 4/1/2018.
    Filed Date: 3/28/18.
    Accession Number: 20180328-5001.
    Comments Due: 5 p.m. ET 4/9/18.

    Docket Numbers: RP18-591-000.
    Applicants: Tennessee Gas Pipeline Company, L.L.C.
    Description: Sec.  4(d) Rate Filing: Volume No. 2--Neg Rate Agmt--
Sequent Energy Mgmt SP100239--Correct Exhibit A to be effective 4/1/
2018.
    Filed Date: 3/28/18.
    Accession Number: 20180328-5003.
    Comments Due: 5 p.m. ET 4/9/18.

    Docket Numbers: RP18-592-000.
    Applicants: Rover Pipeline LLC.
    Description: Sec.  4(d) Rate Filing: Non-Conforming Agreement--3 in
compliance with CP15-93 Order to be effective 5/1/2018.
    Filed Date: 3/28/18.
    Accession Number: 20180328-5028.
    Comments Due: 5 p.m. ET 4/9/18.

    Docket Numbers: RP18-593-000.
    Applicants: Rover Pipeline LLC.
    Description: Sec.  4(d) Rate Filing: Non-Conforming Agreement List
Update--3 to be effective 5/1/2018.
    Filed Date: 3/28/18.
    Accession Number: 20180328-5029.
    Comments Due: 5 p.m. ET 4/9/18.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or 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: March 28, 2018.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2018-06698 Filed 4-2-18; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 179 (Tuesday, September 16, 2014)]
[Notices]
[Pages 55445-55446]
[FR Doc No: 2014-21975]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

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

    Docket Numbers: EC14-133-000.
    Applicants: Avalon Solar Partners, LLC.
    Description: Application under Section 203 with Confidential
Exhibit I of Avalon Solar Partners, LLC.
    Filed Date: 9/4/14.
    Accession Number: 20140904-5222.
    Comments Due: 5 p.m. ET 9/25/14.

    Docket Numbers: EC14-135-000.
    Applicants: Calpine Fore River Energy Center, LLC, Constellation
Mystic Power, LLC.
    Description: Joint Application for Approval Under Section 203 of
the Federal Power Act of Calpine Fore River Energy Center, LLC, et. al.
    Filed Date: 9/5/14.
    Accession Number: 20140905-5187.
    Comments Due: 5 p.m. ET 9/26/14.

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

    Docket Numbers: EG14-93-000.
    Applicants: Beech Ridge Energy LLC.
    Description: Notice of Self-Certification of Exempt Wholesale
Generator Status of Beech Ridge Energy LLC.
    Filed Date: 9/8/14.
    Accession Number: 20140908-5054.
    Comments Due: 5 p.m. ET 9/29/14.

    Docket Numbers: EG14-94-000.
    Applicants: Beech Ridge Energy II LLC.
    Description: Notice of Self-Certification of Exempt Wholesale
Generator Status of Beech Ridge Energy II LLC.
    Filed Date: 9/8/14.
    Accession Number: 20140908-5055.
    Comments Due: 5 p.m. ET 9/29/14.

    Docket Numbers: EG14-95-000.
    Applicants: Beech Ridge Energy Storage LLC.
    Description: Notice of Self-Certification of Exempt Wholesale
Generator Status of Beech Ridge Energy Storage LLC.
    Filed Date: 9/8/14.
    Accession Number: 20140908-5056.
    Comments Due: 5 p.m. ET 9/29/14.

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

    Docket Numbers: ER10-1325-002; ER12-1946-002; ER14-2323-000; ER11-
2080-002; ER10-1333-002; ER14-2319-000; ER12-1958-002; ER14-2321-000;
ER10-1335-002.
    Applicants: CinCap V, LLC, Duke Energy Beckjord, LLC, Duke Energy
Carolinas, LLC, Duke Energy Commercial Asset Management, LLC, Duke
Energy Commercial Enterprises, Inc., Duke Energy Florida, Inc., Duke
Energy Piketon, LLC, Duke Energy Progress, Inc., Duke Energy Retail
Sales, LLC.
    Description: Supplement to June 30, 2014 Triennial Market Power
Analysis Update for the Southeast Region of Duke Energy Corporation MBR
Sellers.
    Filed Date: 9/5/14.
    Accession Number: 20140905-5176.
    Comments Due: 5 p.m. ET 9/26/14.

    Docket Numbers: ER11-2029-004; ER12-1400-003.
    Applicants: Cedar Creek II, LLC, Flat Ridge 2 Wind Energy LLC.
    Description: Notification of Change in Status of Cedar Creek II,
LLC, et. al.
    Filed Date: 9/5/14.
    Accession Number: 20140905-5189.
    Comments Due: 5 p.m. ET 9/26/14.

    Docket Numbers: ER12-2273-000.
    Applicants: Public Service Company of Colorado.
    Description: eTariff filing per 35.19a(b): 2014-9-5 Cadott, Tremplo
Refund Report Filing to be effective N/A.
    Filed Date: 9/5/14.
    Accession Number: 20140905-5145.
    Comments Due: 5 p.m. ET 9/26/14.

    Docket Numbers: ER14-2107-002.
    Applicants: Southwest Power Pool, Inc.
    Description: Compliance filing per 35: 1148 Substitute R18 American
Electric Power NITSA and NOA (Compliance Filing to be effective 5/1/
2014.
    Filed Date: 9/5/14.
    Accession Number: 20140905-5161.
    Comments Due: 5 p.m. ET 9/26/14.

    Docket Numbers: ER14-2793-000.
    Applicants: Imperial Valley Solar, LLC.
    Description: Tariff Withdrawal per 35.15: Notice of Cancellation to
be effective 9/5/2014.
    Filed Date: 9/5/14.
    Accession Number: 20140905-5140.
    Comments Due: 5 p.m. ET 9/26/14.

    Docket Numbers: ER14-2794-000.
    Applicants: Green Mountain Power Corporation, ISO New England Inc.

    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii): Rev.
Depreciation Rates for OATT Formula Transmission Rate and RNS Cost Calc
to be effective 10/1/2014.
    Filed Date: 9/8/14.
    Accession Number: 20140908-5025.
    Comments Due: 5 p.m. ET 9/29/14.

    Docket Numbers: ER14-2795-000.
    Applicants: Beech Ridge Energy LLC.
    Description: Baseline eTariff Filing per 35.1: Filing of
Assignment, Co-Tenancy, and Shared Facilities Agreement to be effective
9/9/2014.
    Filed Date: 9/8/14.
    Accession Number: 20140908-5049.
    Comments Due: 5 p.m. ET 9/29/14.

    Docket Numbers: ER14-2796-000.
    Applicants: Beech Ridge Energy II LLC.
    Description: Baseline eTariff Filing per 35.1: Filing of
Assignment, Co-Tenancy, and Shared Facilities Agreement to be effective
9/9/2014.
    Filed Date: 9/8/14.
    Accession Number: 20140908-5050.
    Comments Due: 5 p.m. ET 9/29/14.

    Docket Numbers: ER14-2797-000.
    Applicants: Beech Ridge Energy Storage LLC.
    Description: Baseline eTariff Filing per 35.1: Filing of
Assignment, Co-Tenancy, and Shared Facilities Agreement to be effective
9/9/2014.
    Filed Date: 9/8/14.
    Accession Number: 20140908-5051.
    Comments Due: 5 p.m. ET 9/29/14.

    Docket Numbers: ER14-2798-000.
    Applicants: Beech Ridge Energy II LLC.
    Description: Initial rate filing per 35.12 Application for Market-
Based Rate Authorization to be effective 11/8/2014.
    Filed Date: 9/8/14.
    Accession Number: 20140908-5052.
    Comments Due: 5 p.m. ET 9/29/14.

    Docket Numbers: ER14-2799-000.
    Applicants: Beech Ridge Energy Storage LLC.
    Description: Initial rate filing per 35.12 Application for Market-
Based Rate Authorization to be effective 11/8/2014.
    Filed Date: 9/8/14.
    Accession Number: 20140908-5053.
    Comments Due: 5 p.m. ET 9/29/14.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or 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: September 8, 2014.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2014-21975 Filed 9-15-14; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 43 (Monday, March 5, 2018)]
[Notices]
[Pages 9324-9325]
[FR Doc No: 2018-04400]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-7022]

Post-Marketing Pediatric-Focused Product Safety Reviews;
Establishment of a Public Docket; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice, establishment of a public docket; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA) is establishing a
public docket to collect comments related to the post-marketing
pediatric-focused safety reviews of products posted between October 23,
2017, and March 16, 2018, on FDA's website but not presented at the
March 23, 2018, Pediatric Advisory Committee (PAC) meeting. These
reviews are intended to be available for review and comment by members
of the PAC, interested parties (such as academic researchers, regulated
industries, consortia, and patient groups), and the general public.

DATES: Submit either electronic or written comments by March 30, 2018.

ADDRESSES: FDA is establishing a docket for public comment on this
document. The docket number is FDA-2017-N-7022. The docket will close
on March 30, 2018. Submit either electronic or written comments by that
date. Please note that late, untimely comments will not be considered.
Electronic comments must be submitted on or before March 30, 2018. The
https://www.regulations.gov electronic filing system will accept
comments until midnight Eastern Time at the end of March 30, 2018.
Comments received by mail/hand delivery/courier (for written/paper
submissions) will be considered timely if they are postmarked or the
delivery service acceptance receipt is on or before that date.
    You may submit comments 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 make 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-2017-N-7022 for ``Post-Marketing Pediatric-Focused Product Safety
Reviews; Establishment of a Public Docket; Request for Comments.''
Received comments, those filed in a timely manner (see ADDRESSES), 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.
     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.'' FDA 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.gpo.gov/fdsys/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.

FOR FURTHER INFORMATION CONTACT: Kenneth Quinto, Office of the
Commissioner, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 32, Rm. 5145, Silver Spring, MD 20993,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: FDA is responsible for protecting the public
health by assuring the safety, efficacy, and security of human and
veterinary drugs, biological products, medical devices, our Nation's
food supply, cosmetics, and products that emit radiation.
    FDA is establishing a public docket, Docket No. FDA-2017-N-7022, to
receive input on post-marketing pediatric-focused safety reviews of
products posted between October 23, 2017, and March 16, 2018, available
on FDA's website at https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/PediatricAdvisoryCommittee/ucm510701.htm but
not presented at the March 23, 2018, PAC meeting. FDA welcomes comments
by members of the PAC, as mandated by the Best Pharmaceuticals for
Children Act (Pub. L. 107-109) and the Pediatric Research Equity Act of
2003 (Pub. L. 108-155), interested parties (such as academic
researchers, regulated industries, consortia, and patient groups), and
the general public. The docket number is FDA-2017-N-7022. The docket
will open on March 19, 2018, and remain open until March 30, 2018. The
post-marketing pediatric-focused safety reviews are for the following
products from the following centers at FDA:

Center for Biologics Evaluation and Research

    1. EPICEL (cultured epidermal autographs) (humanitarian device
exemption (HDE))
    2. GARDASIL 9 (Human Papillomavirus 9-valent Vaccine, Recombinant)
    3. TRUMENBA (Meningococcal Group B Vaccine)

Center for Drug Evaluation and Research

    1. ATROPINE SULFATE OPHTHALMIC SOLUTION, USP 1%
    2. DYMISTA (azelastine hydrochloride/fluticasone propionate)
    3. EDURANT (rilpivirine); COMPLERA (emtricitabine, rilpivirine,
tenofovir disoproxil fumarate); ODEFSEY (emtricitabine, rilpivirine,
tenofovir alafenamide)
    4. EMEND (aprepitant) capsule and oral suspension
    5. EPIDUO FORTE (adapalene/benzoyl peroxide, 0.3%/2.5%) gel
    6. GADAVIST (gadobutrol); EOVIST (Primovist; gadoxetate disodium)
    7. GENVOYA (elvitegravir, cobicistat, emtricitabine, and tenofovir
alafenamide) oral tablets
    8. KAPVAY (clonidine extended-release) tablets
    9. MERREM IV (meropenem for injection)
    10. NAFTIN (naftifine hydrochloride)
    11. NUCALA (mepolizumab)
    12. OTIPRIO (6% ciprofloxacin otic suspension)
    13. PAZEO (olopatadine hydrochloride ophthalmic solution) 0.7%
    14. QNASL (beclomethasone dipropionate) nasal aerosol
    15. SAPHRIS (asenapine)
    16. TIVICAY (dolutegravir)
    17. TREXIMET (naproxen sodium; sumatriptan succinate)
    18. VALCYTE (valganciclovir)

Center for Devices and Radiological Health

    1. FLOURISH PEDIATRIC ESOPHAGEAL ATRESIA DEVICE (HDE)

    Dated: February 28, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-04400 Filed 3-2-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 86, Number 121 (Monday, June 28, 2021)]
[Notices]
[Pages 34020-34022]
[FR Doc No: 2021-13684]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-2099]

Sponsor Responsibilities--Safety Reporting Requirements and
Safety Assessment for Investigational New Drug Application and
Bioavailability/Bioequivalence Studies; Draft Guidance for Industry;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Sponsor
Responsibilities--Safety Reporting Requirements and Safety Assessment
for Investigational New Drug Application and Bioavailability/
Bioequivalence Studies.'' The draft guidance provides recommendations
for sponsors and sponsor-investigators to comply with the requirements
of investigational new drug application (IND) safety reporting and
safety reporting for bioavailability (BA) and bioequivalence (BE)
studies. In doing so, the guidance provides recommendations related to
the two IND safety reporting provisions that require assessment of
aggregate data to facilitate appropriate IND safety reporting
practices. An earlier draft guidance for industry entitled ``Safety
Assessment for IND Safety Reporting'' (December 2015) (the 2015 draft
guidance) has been incorporated into this draft guidance. However, this
content was revised to address feedback from stakeholders and comments
received on the 2015 draft guidance. Concurrent with the publication of
this draft guidance, we are withdrawing the 2015 draft guidance.
Additionally, this draft guidance incorporates content from the final
guidance for industry and investigators entitled ``Safety Reporting
Requirements for INDs and BA/BE Studies'' (December 2012) (the 2012
final guidance). This incorporated content remains largely unchanged in
this draft guidance.

DATES: Submit either electronic or written comments on the draft
guidance by September 27, 2021 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-2020-D-2099 for ``Sponsor Responsibilities--Safety Reporting
Requirements and Safety Assessment for Investigational New Drug
Application and Bioavailability/Bioequivalence Studies.'' 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,<PHONE_NUMBER>.
     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 Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Paul Gouge, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6328, Silver Spring, MD 20993-0002<EMAIL_ADDRESS>
or Stephen Ripley, Center for Biologics Evaluation and Research, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Sponsor Responsibilities--Safety Reporting Requirements and
Safety Assessment for Investigational New Drug Application and
Bioavailability/Bioequivalence Studies.'' The draft guidance provides
recommendations for sponsors and sponsor-investigators to facilitate
compliance with the requirements of IND safety reporting and safety
reporting for BA and BE studies under Sec. Sec.  312.32 and
320.31(d)(3) (21 CFR 312.32 and 320.31(d)(3)). In doing so, the draft
guidance provides recommendations for sponsors related to the two IND
safety reporting provisions (Sec.  312.32(c)(1)(i)(C) and (iv)) that
require assessment of aggregate data to facilitate appropriate IND
safety reporting practices. More generally, it provides sponsors and
sponsor-investigators recommendations regarding expedited safety
reporting requirements for human drug and biological products that are
being investigated under an IND and for drugs that are the subject of
BA and BE studies that are exempt from the IND requirements.
    In the Federal Register of December 17, 2015 (80 FR 78743), FDA
announced the availability of the 2015 draft guidance entitled ``Safety
Assessment for IND Safety Reporting.'' FDA received numerous comments
on the 2015 draft guidance, and these comments were carefully
considered and addressed by FDA in this draft guidance. Noteworthy
changes include revised recommendations on the following: (1) Planned
unblinding of safety data and implications for trial integrity, (2)
increased flexibility regarding the party reviewing safety information
across a development program for IND safety reporting purposes, (3)
clarification regarding the scope and methodology for aggregate
analyses, and (4) clarification regarding the plan for safety
surveillance, including what elements should be included in the plan.
Accordingly, concurrent with the publication of this draft guidance, we
are withdrawing the 2015 draft guidance.
    Further, this draft guidance incorporates content from the 2012
final guidance entitled ``Safety Reporting Requirements for INDs and
BA/BE Studies''. The content from the 2012 final guidance remains
largely unchanged in this draft guidance; however, this draft guidance
does not incorporate the investigator provisions of the 2012 final
guidance. FDA intends to publish a separate draft guidance on
investigator's responsibilities for safety reporting for human drug and
biological products that are being investigated under an IND.
    When this draft guidance and the draft guidance on investigator's
responsibilities for IND safety reporting are finalized, FDA plans to
withdraw the 2012 final guidance. However, until FDA finalizes these
two draft guidances, the 2012 final guidance remains in effect and
represents FDA's current thinking.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Sponsor
Responsibilities--Safety Reporting Requirements and Safety Assessment
for Investigational New Drug Application and Bioavailability/
Bioequivalence Studies.'' It does not establish any rights for any
person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by

OMB under the PRA. The collections of information in 21 CFR parts 312
and 320 have been approved under OMB control number 0910-0014.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: June 22, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-13684 Filed 6-25-21; 8:45 am]
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[Federal Register Volume 79, Number 247 (Wednesday, December 24, 2014)]
[Notices]
[Page 77473]
[FR Doc No: 2014-30050]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER15-631-000]

Crawfordsville Energy, LLC; Supplemental Notice That Initial
Market-Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding,
of Crawfordsville Energy, LLC's application for market-based rate
authority, with an accompanying rate schedule, noting that such
application includes a request for blanket authorization, under 18 CFR
part 34, of future issuances of securities and assumptions of
liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability is January 6, 2015.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426.
    The filings in the above-referenced proceeding(s) are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive email notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please email<EMAIL_ADDRESS>or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

    Dated: December 17, 2014.
Kimberly D. Bose,
Secretary.
[FR Doc. 2014-30050 Filed 12-23-14; 8:45 am]
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