[Federal Register Volume 86, Number 12 (Thursday, January 21, 2021)]
[Notices]
[Pages 6321-6322]
[FR Doc No: 2021-01206]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2015-0765; FRL-10018-08-ORD]

Board of Scientific Counselors (BOSC) Executive Committee
Meeting--January 2021

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of public meeting.

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SUMMARY: The Environmental Protection Agency (EPA), Office of Research
and Development (ORD), gives notice of a virtual meeting of the Board
of Scientific Counselors (BOSC) Executive Committee (EC) to review the
draft reports of the Homeland Security (HS) and Safe and Sustainable
Water Resources (SSWR) subcommittees. Due to unforeseen circumstances,
EPA is announcing this meeting with less than 15 calendar days' notice.

DATES: The initial meeting will be held over one day via
videoconference on Wednesday, January 27, 2021, from 2 p.m. to 5 p.m.
(EDT). Attendees must register by January 26, 2021.
    If an additional meeting is necessary to complete the draft reports
a follow-up will be held on Thursday, February 11, 2021, from 3 p.m. to
5 p.m. (EDT). Attendees must register by February 10, 2021.
    Meeting times are subject to change. These series of meetings are
open to the public. Comments must be received by January 26, 2021, to
be considered by the Executive Committee. Requests for the draft agenda
or making a presentation at the meeting will be accepted until January
26, 2021.

ADDRESSES: Instructions on how to connect to the videoconference will
be provided upon registration at https://www.eventbrite.com/e/us-epa-bosc-executive-committee-meeting-tickets-130024345317.
    Submit your comments to Docket ID No. EPA-HQ-ORD-2015-0765 by one
of the following methods:
     www.regulations.gov: Follow the online instructions for
submitting comments.

    Note: Comments submitted to the www.regulations.gov website are
anonymous unless identifying information is included in the body of
the comment.

     Email: Send comments by electronic mail (email) to:
<EMAIL_ADDRESS>Attention Docket ID No. EPA-HQ-ORD-2015-0765.

    Note: Comments submitted via email are not anonymous. The
sender's email will be included in the body of the comment and
placed in the public docket which is made available on the internet.

    Instructions: All comments received, including any personal
information provided, will be included in the public docket without
change and may be made available online at www.regulations.gov.
Information claimed to be Confidential Business Information (CBI) or
other information whose disclosure is restricted by statute will not be
included in the public docket, and should not be submitted through
www.regulations.gov or email. For additional information about the
EPA's public docket visit the EPA Docket Center homepage at http://www.epa.gov/dockets/.
    Public Docket: Publicly available docket materials may be accessed
Online at www.regulations.gov.
    Copyrighted materials in the docket are only available via hard
copy. The telephone number for the ORD Docket Center is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: The Designated Federal Officer (DFO),
Tom Tracy, via phone/voicemail at:<PHONE_NUMBER>; or via email at:
<EMAIL_ADDRESS>    Any member of the public interested in receiving a draft agenda,
attending the meeting, or making a presentation at the meeting should
contact Tom Tracy no later than January 26, 2021.

SUPPLEMENTARY INFORMATION: The Board of Scientific Counselors (BOSC) is
a federal advisory committee that provides advice and recommendations
to EPA's Office of Research and Development on technical and management
issues of its research programs. The meeting agenda and materials will
be posted to https://www.epa.gov/bosc.
    Proposed agenda items for the meeting include, but are not limited
to, the following: review the HS and SSWR draft reports.
    Information on Services Available: For information on translation
services, access, or services for individuals with disabilities, please
contact Tom Tracy at<PHONE_NUMBER> or<EMAIL_ADDRESS>

To request accommodation of a disability, please contact Tom Tracy at
least ten days prior to the meeting to give the EPA adequate time to
process your request.

(Authority: Pub. L. 92-463, 1, Oct. 6, 1972, 86 Stat. 770)

Mary Ross,
Director, Office of Science Advisor, Policy and Engagement.
[FR Doc. 2021-01206 Filed 1-19-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 82, Number 217 (Monday, November 13, 2017)]
[Notices]
[Pages 52306-52308]
[FR Doc No: 2017-24483]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-5138]

S5(R3) Detection of Toxicity to Reproduction for Human
Pharmaceuticals; International Council for Harmonisation; 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 or Agency) is announcing
the availability of a draft guidance entitled ``S5(R3) Detection of
Toxicity to Reproduction for Human Pharmaceuticals.'' The draft
guidance was prepared under the auspices of the International Council
for Harmonisation (ICH), formerly the International Conference on
Harmonisation. The draft guidance replaces the existing guidance
entitled ``S5(R2) Detection of Toxicity to Reproduction for Human
Pharmaceuticals.'' The draft guidance is intended to align with other
ICH guidances, elaborate on concepts to consider when designing
studies, and identify potential circumstances in which a risk
assessment can be made based on preliminary studies. It also clarifies
the qualification and potential use of alternative assays.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115 (g)(5)), to ensure that the Agency considers your comment on
this draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by February 12, 2018.

ADDRESSES: 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 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 Office, 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-D-5138 for ``S5(R3) Detection of Toxicity to Reproduction for
Human Pharmaceuticals.'' 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 Office 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.'' 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 Office. 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.
    Submit written requests for single copies of this draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research (CDER), Food and Drug Administration, 10001 New Hampshire
Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002, or
the Office of Communication, Outreach and Development, Center for
Biologics Evaluation and Research (CBER), Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-
0002. Send one self-addressed adhesive label to assist that office in
processing your requests. The guidance may also be obtained by mail by
calling CBER at 1-800-835-4709 or<PHONE_NUMBER>. See the SUPPLEMENTARY
INFORMATION section for electronic access to the draft guidance
document.

FOR FURTHER INFORMATION CONTACT: Regarding the guidance: Abigail
Jacobs, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6474, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>; or Martin (Dave) Green, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 3270, Silver Spring, MD 20993-0002,
301-796-2640. Regarding the ICH: Amanda Roache, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1176, Silver Spring, MD 20993-0002, 301-
796-4548.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``S5(R3) Detection of Toxicity to Reproduction for Human
Pharmaceuticals.'' In recent years, regulatory authorities and industry
associations have participated in many important initiatives to promote
international harmonization of regulatory requirements. FDA has
participated in several meetings designed to enhance harmonization and
is committed to seeking scientifically based, harmonized technical
procedures for pharmaceutical development. One of the goals of
harmonization is to identify and reduce differences in technical
requirements for drug development among regulatory agencies.
    ICH was organized to provide an opportunity for harmonization
initiatives to be developed with input from both regulatory and
industry representatives. FDA also seeks input from consumer
representatives and others. ICH is concerned with harmonization of
technical requirements for the registration of pharmaceutical products
for human use among regulators around the world. The six founding
members of the ICH are the European Commission; the European Federation
of Pharmaceutical Industries Associations; the Japanese Ministry of
Health, Labour, and Welfare; the Japanese Pharmaceutical Manufacturers
Association; CDER and CBER, FDA; and the Pharmaceutical Research and
Manufacturers of America. The Standing Members of the ICH Association
include Health Canada and

Swissmedic. Any party eligible to become a member in accordance with
the ICH Articles of Association can apply for membership in writing to
the ICH Secretariat. The ICH Secretariat, which coordinates the
preparation of documentation, operates as an international nonprofit
organization and is funded by the members of the ICH Association.
    The ICH Assembly is the overarching body of the Association and
includes representatives from each of the ICH members and observers.
    In August 2017, the ICH Assembly endorsed the draft guidance titled
``S5(R3) Detection of Toxicity to Reproduction for Human
Pharmaceuticals'' and agreed that the guidance should be made available
for public comment. The draft guidance is the product of the S5(R3)
Safety Expert Working Group of the ICH. Comments about this draft will
be considered by FDA and the S5(R3) Safety Expert Working Group.
    The draft guidance replaces the existing guidance entitled ``S5(R2)
Detection of Toxicity to Reproduction for Human Pharmaceuticals.'' The
guidance has undergone major revisions to align with other ICH
guidances, elaborate on concepts to consider when designing studies,
and identify potential circumstances in which a risk assessment can be
made based on preliminary studies. It also clarifies the qualification
and potential use of alternative assays.
    To support using alternative assays, compounds that are either
positive or negative in their ability to induce embryolethality or
malformations are used in the process of qualifying the assays.
Although a number of compounds have been identified in the draft
guidance's Annex, section 11.3.4, Tables 9-6 and 9-7, with the type of
information for the compounds, the list is not complete; therefore, FDA
is requesting data in the form of public comments to the docket for
additional positive and negative reference compounds for potential
inclusion into the list. These compounds can be either pharmaceuticals
or non-pharmaceuticals and should be commercially available. For
additional guidance, please refer to Endnote 3 in the S5(R3) guidance.
This is not a request for data for the compounds already listed in
Table 9-6, nor is this a request for examples of assays that could be
used.
    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 ``S5(R3)
Detection of Toxicity to Reproduction for Human Pharmaceuticals.'' 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. This guidance
is not subject to Executive Order 12866.

II. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at https://www.regulations.gov, https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.

    Dated: November 2, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-24483 Filed 11-9-17; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 78, Number 145 (Monday, July 29, 2013)]
[Notices]
[Pages 45549-45550]
[FR Doc No: 2013-18126]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4129-DR; Docket ID FEMA-2013-0001]

New York; Major Disaster and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This is a notice of the Presidential declaration of a major
disaster for the State of New York (FEMA-4129-DR), dated July 12, 2013,
and related determinations.

DATES: Effective Date: July 12, 2013.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated July 12, 2013, the President issued a major disaster declaration
under the authority of the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the ``Stafford
Act''), as follows:

    I have determined that the damage in certain areas of the State
of New York resulting from severe storms and flooding during the
period of June 28 to July 4, 2013, is of sufficient severity and
magnitude to warrant a major disaster declaration under the Robert
T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C.
5121 et seq. (the ``Stafford Act''). Therefore, I declare that such
a major disaster exists in the State of New York.
    In order to provide Federal assistance, you are hereby
authorized to allocate from funds available for these purposes such
amounts as you find necessary for Federal disaster assistance and
administrative expenses.
    You are authorized to provide Public Assistance in the
designated areas and Hazard Mitigation throughout the State.
Consistent with the requirement that Federal assistance be
supplemental, any Federal funds provided under the Stafford Act for
Hazard Mitigation will be limited to 75 percent of the total
eligible costs. Federal funds provided under the Stafford Act for
Public Assistance also will be limited to 75 percent of the total
eligible costs, with the exception of projects that meet the
eligibility criteria for a higher Federal cost-sharing percentage
under the Public Assistance Alternative Procedures Pilot Program for
Debris Removal implemented pursuant to Section 428 of the Stafford
Act.
    Further, you are authorized to make changes to this declaration
for the approved assistance to the extent allowable under the
Stafford Act.

    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, under
Executive Order 12148, as amended, Regis Leo Phelan, of FEMA is
appointed to act as the Federal Coordinating Officer for this major
disaster.
    The following areas of the State of New York have been designated
as adversely affected by this major disaster:

    Allegany, Chenango, Cortland, Delaware, Franklin, Herkimer,
Madison, Montgomery, Niagara, Oneida, Otsego, and Warren Counties
for Public Assistance.
    All counties within the State of New York are eligible to apply
for assistance under the Hazard Mitigation Grant Program.

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households in Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2013-18126 Filed 7-26-13; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 81, Number 158 (Tuesday, August 16, 2016)]
[Notices]
[Pages 54660-54661]
[FR Doc No: 2016-19415]

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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

[Docket No. PHMSA-2016-0042; Notice No. 2016-06]

Hazardous Materials: Termination of Designated Approval Agencies
Approvals

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

ACTION: Notice.

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SUMMARY: This notice is to advise interested persons that PHMSA has
terminated the Designated Approval Agencies approvals listed herein.
PHMSA, via certified mail, attempted to contact all of the below listed
approval holders during May 2015. PHMSA issued a Show Cause letter via
certified mail requesting a response within 30 days with their intent
with respect to the approval. None of the companies complied with the
requirements of the letter. Thus, PHMSA issued a Termination letter via
certified mail in December 2015. To date, PHMSA has not received any
correspondence concerning the below listed approval numbers.

FOR FURTHER INFORMATION CONTACT: Mr. Ryan Paquet, Director, Approvals
and Permits Division, Office of Hazardous

Materials Safety,<PHONE_NUMBER>, PHMSA, 1200 New Jersey Avenue SE.,
Washington, DC 20590 or at<EMAIL_ADDRESS>    Correspondence with respect to the below listed approval numbers
should be sent to<EMAIL_ADDRESS>with a subject line ``Termination
Letter'' and should be in writing; state in detail any alleged errors
of fact and law; enclose any additional information needed to support
the request; and state in detail the modification of the final decision
sought.

SUPPLEMENTARY INFORMATION:

I. Introduction

    In this notice, PHMSA's Approvals and Permits Division is
terminating the approvals listed below based on a change in
circumstances rendering the approval no longer necessary (49 CFR
107.713(b)(1)); and/or violations of your approval and the HMR that
demonstrate a lack of fitness (49 CFR 107.713(b)(4)).

II. Background

    On March 17, 2014, PHMSA held a mandatory Designated Approvals
Agency (DAA) meeting. In May 2015, PHMSA mailed a Show Cause letter to
each DAA that did not attend this meeting, requesting the DAA provide
current operating status. The companies below did not respond to the
Show Cause letter. In December 2015, PHMSA issued a Termination letter
to each DAA listed below. As of January 1, 2016, PHMSA has not received
any correspondence from these DAAs, and PHMSA terminated the approvals
of the approval holders listed below. This Federal Register notice
serves as an official announcement of termination of those approvals.

III. Action

    PHMSA has terminated the below listed approvals, and this Federal
Register notice serves as an official announcement to the public.

IV. Approvals Terminated

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             ID No.                      Approval holder/company
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107-94-01.......................  Pacific Marine Repair, Inc..........
IM-9703.........................  TDI, Inc............................
IA-0301.........................  ATech Engineering...................
IM-9603.........................  Unicon International................
IA-8105.........................  British Engine......................
IM-9602.........................  Commercial Union Insurance Company..
IA-0401.........................  Trimac Transportation Services, Inc.
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    Issued in Washington, DC, on August 10, 2016, under authority
delegated in 49 CFR part 107.
William S. Schoonover,
Deputy Associate Administrator, Pipeline and Hazardous Materials Safety
Administration.
[FR Doc. 2016-19415 Filed 8-15-16; 8:45 am]
 BILLING CODE 4910-60-P