[Federal Register Volume 85, Number 245 (Monday, December 21, 2020)]
[Notices]
[Pages 83092-83095]
[FR Doc No: 2020-28068]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-2217]

Agency Information Collection Activities; Proposed Collection;
Comment Request; New Animal Drugs for Investigational Use

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing an opportunity for public comment on the proposed collection
of certain information by the Agency. Under the Paperwork Reduction Act
of 1995 (PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the reporting and
recordkeeping requirements of our regulations concerning new animal
drugs for investigational use.

DATES: Submit either electronic or written comments on the collection
of information by February 19, 2021.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before February 19, 2021. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of February 19, 2021. 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.

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-N-2217 for ``New Animal Drugs for Investigational Use.''
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,<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>.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

New Animal Drugs for Investigational Use--21 CFR Part 511

OMB Control Number 0910-0117--Extension

    FDA has the authority under the Federal Food, Drug, and Cosmetic
Act (FD&C Act) to approve new animal drugs. A new animal drug
application (NADA) cannot be approved until, among other things, the
new animal drug has been demonstrated to be safe and effective for its
intended use(s). In order to properly test a new animal drug for an
intended use, appropriate scientific investigations must be conducted.
Under specific circumstances, section 512(j) of the FD&C Act (21 U.S.C.
360b(j)) permits the use of an investigational new animal drug to
generate data to support a NADA approval. Section 512(j) of the FD&C
Act authorizes us to issue regulations relating to the investigational
use of new animal drugs.
    Our regulations in part 511 (21 CFR part 511) set forth the
conditions for investigational use of new animal drugs and require
reporting and recordkeeping. The information collected is necessary to
protect the

public health. We use the information to determine that investigational
animal drugs are distributed only to qualified investigators, adequate
drug accountability records are maintained, and edible food products
from treated food-producing animals are safe for human consumption. We
also use the information collected to monitor the validity of the
studies submitted to us to support new animal drug approval.
    Reporting: Our regulations require that certain information be
submitted to us in a ``Notice of Claimed Investigational Exemption for
a New Animal Drug'' (NCIE) to qualify for the exemption and to control
shipment of the new animal drug and prevent potential abuse. The NCIE
must contain, among other things, the following specific information:
(1) Identity of the new animal drug, (2) labeling, (3) statement of
compliance of any non-clinical laboratory studies with good laboratory
practices, (4) name and address of each clinical investigator, (5) the
approximate number of animals to be treated or amount of new animal
drug(s) to be shipped, and (6) information regarding the use of edible
tissues from investigational animals (Sec.  511.1(b)(4) (21 CFR
511.1(b)(4))). If the new animal drug is to be used in food-producing
animals (e.g., cattle, swine, chickens, fish, etc.), certain data must
be submitted to us to obtain authorization for the use of edible food
products from treated food-producing animals (Sec.  511.1(b)(5)). We
require sponsors upon request to submit information with respect to the
investigation to determine whether there are grounds for terminating
the exemption (Sec.  511.1(b)(6)). We require sponsors to report
findings that may suggest significant hazards pertinent to the safety
of the new animal drug (Sec.  511.1(b)(8)(ii)). We also require
reporting by importers of investigational new animal drugs for clinical
investigational use in animals (Sec.  511.1(b)(9)). The information
provided by the sponsor in the NCIE is needed to help ensure that the
proposed investigational use of the new animal drug is safe and that
any edible food will not be distributed without proper authorization
from FDA. Information contained in an NCIE submission is monitored
under our Bioresearch Monitoring Program. This program permits us to
monitor the validity of the studies and to help ensure the proper use
of the drugs is maintained by the investigators.
    Recordkeeping: If the new animal drug is only for tests in vitro or
in laboratory research animals, the person distributing the new animal
drug must maintain records showing the name and post office address of
the expert or expert organization to whom it is shipped and the date,
quantity, and batch or code mark of each shipment and delivery for a
period of 2 years after such shipment or delivery (Sec.  511.1(a)(3)
and (b)(3)). We require complete records of the investigation,
including records of the receipt and disposition of each shipment or
delivery of the investigational new animal drug (Sec.  511.1(b)(7)). We
also require records of all reports received by a sponsor from
investigators to be retained for 2 years after the termination of an
investigational exemption or approval of a new animal drug application
(Sec.  511.1(b)(8)(i)).
    Description of Respondents: Respondents to this collection of
information are persons who use new animal drugs for investigational
purposes. Investigational new animal drugs are used primarily by drug
industry firms, academic institutions, and the government.
Investigators may include individuals from these entities, as well as
research firms and members of the medical professions.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                         Number of
       21 CFR section/activity           Number of     responses per   Total annual   Average burden     Total
                                        respondents     respondent       responses     per  response     hours
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511.1(b)(4); submission of NCIE.....             279            5.94           1,657               1       1,657
511.1(b)(5); submission of data to               279            0.10              28               8         224
 obtain authorization for the use of
 edible food products...............
511.1(b)(6); submission of any                   279            .001            0.28               1        0.28
 additional information upon request
 of FDA.............................
511.1(b)(8)(ii); reporting of                    279            0.05              14               2          28
 findings that may suggest
 significant hazards pertinent to
 the safety of the new animal drug..
511.1(b)(9); reporting by importers              279            0.05              14               8         112
 of investigational new animal drugs
 for clinical investigational use in
 animals............................
                                     ---------------------------------------------------------------------------
    Total...........................  ..............  ..............           1,713  ..............       2,021
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                               Table 2--Estimated Annual Recordkeeping Burden \1\
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                                                      No. of records                      Average
       21 CFR section/activity            No. of            per        Total annual     burden per       Total
                                       recordkeepers   recordkeeper       records      recordkeeping     hours
----------------------------------------------------------------------------------------------------------------
511.1(a)(3); maintain records                    279            0.99             276               1         276
 showing the name and post office
 address of the expert or expert
 organization to whom the new animal
 drug is shipped and the date,
 quantity, and batch or code mark of
 each shipment and delivery for a
 period of 2 years after such
 shipment or delivery...............
511.1(b)(3); maintain records                    279            5.94           1,657               1       1,657
 showing the name and post office
 address of the expert or expert
 organization to whom the new animal
 drug or feed containing same is
 shipped and the date, quantity, and
 batch or code mark of each shipment
 and delivery for a period of 2
 years after such shipment or
 delivery...........................

511.1(b)(7); maintain records of the             279            5.94           1,657             3.5       5,800
 investigation, including records of
 the receipt and disposition of each
 shipment or delivery of the
 investigational new animal drug....
511.1(b)(8)(i); maintain records of              279            5.94           1,657             3.5       5,800
 all reports received by a sponsor
 from investigators.................
Total...............................  ..............  ..............           5,247  ..............      13,533
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The estimate of the time required for reporting requirements,
record preparation, and maintenance for this collection of information
is based on our informal communication with industry. Based on the
number of sponsors subject to animal drug user fees, we estimate that
there are 279 respondents. We use this estimate consistently throughout
the table and calculate the ``number of responses per respondent'' by
dividing the total annual responses by number of respondents. We note
an apparent difference in the estimated number of respondents from the
previous renewal issued in 2018. There was an error in calculating the
number of sponsors subject to animal drug user fees in the 2018
renewal. When calculating the number of recordkeepers, we inadvertently
used the number of sponsors that paid user fees (i.e., those that did
not qualify for user fee waivers) as opposed to the total number of
sponsors subject to animal drug user fees. Both fee-paying and non-fee-
paying sponsors are respondents with respect to this information
collection.
    Additional information needed to make a final calculation of the
total burden hours (i.e., the number of respondents, the number of
recordkeepers, the number of NCIEs received, etc.) is derived from our
records. There is a small increase in the total burden hours which we
attribute to an increase in the number of annual responses and records.

    Dated: December 14, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-28068 Filed 12-18-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 134 (Monday, July 14, 2014)]
[Notices]
[Pages 40789-40790]
[FR Doc No: 2014-16428]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2007-0039]

Intertek Testing Services NA, Inc.: Grant of Renewal of
Recognition

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: Notice.

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SUMMARY: This notice announces the Occupational Safety and Health
Administration's final decision granting renewal of recognition of
Intertek Testing Services NA, Inc., as a Nationally Recognized Testing
Laboratory (NRTL) under 29 CFR 1910.7.

DATES: The renewal of recognition becomes effective on July 14, 2014.

FOR FURTHER INFORMATION CONTACT: Information regarding this notice is
available from the following sources:
    Press inquiries: Contact Mr. Frank Meilinger, Director, OSHA Office
of Communications, U.S. Department of Labor, 200 Constitution Avenue
NW., Room N-3647, Washington, DC 20210; telephone:<PHONE_NUMBER>;
email<EMAIL_ADDRESS>    General and technical information: Contact Mr. David Johnson,
Director, Office of Technical Programs and Coordination Activities,
Directorate of Technical Support and Emergency Management, Occupational
Safety and Health Administration, U.S. Department of Labor, 200
Constitution Avenue NW., Room N-3655, Washington, DC 20210; telephone:
(202) 693-2110; email<EMAIL_ADDRESS>OSHA's Web page
includes information about the NRTL Program (see http://www.osha.gov/dts/otpca/nrtl/index.html).

SUPPLEMENTARY INFORMATION:

I. Background

    OSHA recognition of an NRTL signifies that the organization meets
the requirements specified by 29 CFR 1910.7. Recognition is an
acknowledgment that the organization can perform independent safety
testing and certification of the specific products covered within its
scope of recognition, and is not a delegation or grant of government
authority. As a result of recognition, employers may use products
properly approved by the NRTL to meet OSHA standards that require
testing and certification. OSHA maintains an informational Web site for
each NRTL at http://www.osha.gov/dts/otpca/nrtl/index.html that details
its scope of recognition.
    OSHA processes applications submitted by an NRTL for renewal of
recognition following requirements in Appendix A to 29 CFR 1910.7. OSHA
conducts renewals in accordance with the procedures in 29 CFR 1910.7,
App. A II.C. In accordance with these procedures, NRTLs submit a
renewal request to OSHA between nine months and one year before the
expiration date of its current recognition. A renewal request includes
a request for renewal and any additional information demonstrating its
continued compliance with the terms of its recognition and 29 CFR
1910.7. If OSHA has not conducted an on-site assessment of the NRTL
headquarters and any key sites within the past 18 to 24 months, it will
schedule the necessary on-site assessment prior to the expiration date
of the NRTL's recognition. Upon review of the submitted material and,
as necessary, the successful completion of the on-site assessment, OSHA
announces its preliminary decision to grant or deny renewal in the
Federal Register and solicits comments from the public. OSHA then
publishes a final Federal Register notice responding to any comments
and renewing the NRTL's recognition for a period of five years, or
denying the renewal of recognition.
    Intertek Testing Services NA, Inc. (ITSNA), initially received OSHA
recognition as an NRTL on September 13, 1989 (54 FR 37845). The most
recent renewal for ITSNA was on May 29, 2001, for a five-year period
expiring on May 29, 2006. ITSNA submitted a timely request for renewal,
dated August 25, 2005 (see Ex. OSHA-2007-0039-0015), and retained its
recognition pending OSHA's final decision in this renewal process. The
current addresses of ITSNA facilities recognized by OSHA and included
as part of the renewal request are:
    1. ITSNA Cortland, 3933 U.S. Route 11, Cortland, New York 13045;
    2. ITSNA Atlanta, 1950 Evergreen Boulevard, Duluth, Georgia 30096;
    3. ITSNA Boxborough, 70 Codman Hill Road, Boxborough, Massachusetts
01719;

    4. ITSNA Lexington, 731 Enterprise Drive, Lexington, Kentucky
40510;
    5. ITSNA San Francisco, 1365 Adams Court, Menlo Park, California
94025;
    6. ITSNA Los Angeles, 25791 Commercentre Drive, Lake Forest,
California 92630;
    7. ITSNA Minneapolis, 7250 Hudson Boulevard, Suite 100, Oakdale,
Minnesota 55128;
    8. ITSNA Madison, 8431 Murphy Drive, Middleton, Wisconsin 53562;
    9. ITSNA SEMKO, Box 1103, S-164 22, Kista, Stockholm,
Sweden;
    10. ITSNA Chicago, 545 East Algonquin Road, Suite F, Arlington
Heights, Illinois 60005;
    11. ITSNA Hong Kong, 2/F., Garment Centre, 576 Castle Peak Road,
Kowloon, Hong Kong;
    12. ITSNA Vancouver, 1500 Brigantine Drive, Coquitlam, British
Columbia, Canada V3K 7C1;
    13. ITSNA Fairfield, 41 Plymouth Street, Fairfield, New Jersey
07004; and
    14. ITSNA Dallas, 1809 10th Street, Suite 400, Plano, Texas 75074.
    OSHA evaluated ITSNA's application for renewal and made a
preliminary determination that ITSNA can continue to meet the
requirements prescribed by 29 CFR 1910.7 for recognition. OSHA
conducted audits of the: ITSNA Cortland site on August 25-27, 2009 and
June 18-19, 2008; ITSNA Atlanta site on March 12-13, 2008; ITSNA
Boxborough site on March 21-22, 2013; ITSNA San Francisco site on April
23-24, 2012; ITSNA Hong Kong site on August 19-21, 2013; ITSNA
Vancouver site on October 16-17, 2008; and ITSNA Dallas site on March
1-2, 2013. OSHA found non-conformances with the requirements of 29 CFR
1910.7. ITSNA addressed these issues sufficiently to meet the
applicable NRTL requirements. Accordingly, OSHA determined that it did
not need to conduct an on-site review of ITSNA's facilities for this
request for renewal based on its evaluation of ITSNA's application and
all other available information.
    OSHA published the preliminary notice announcing ITSNA's renewal
request in the Federal Register on February 24, 2014 (79 FR 10196). The
Agency requested comments by March 11, 2014, but received no comments
in response to this notice. OSHA now is proceeding with this final
notice to grant ITSNA's request for renewal of recognition.
    To obtain or review copies of all public documents pertaining to
the ITSNA's application, go to www.regulations.gov or contact the
Docket Office, Occupational Safety and Health Administration, U.S.
Department of Labor, 200 Constitution Avenue NW., Room N-2625,
Washington, DC 20210. Docket No. OSHA-2007-0039 contains all materials
in the record concerning ITSNA's recognition.

II. Final Decision and Order

    Pursuant to the authority granted under 29 CFR 1910.7, OSHA hereby
gives notice of the renewal of recognition of ITSNA as an NRTL. OSHA
NRTL Program staff reviewed the renewal request for ITSNA and other
pertinent information. Based on this review of the renewal request for
ITSNA and other pertinent information, OSHA finds that ITSNA meets the
requirements of 29 CFR 1910.7 for renewal of its recognition, subject
to the specified limitation and conditions. OSHA limits the renewal of
ITSNA's recognition to include the terms and conditions of ITSNA's
scope of recognition. The scope of recognition for ITSNA is available
in the Federal Register notice dated September 13, 1989 (54 FR 37845),
or on OSHA's Web site at http://www.osha.gov/dts/otpca/nrtl/its.html.

Conditions

    In addition to those conditions already required by 29 CFR 1910.7,
ITSNA also must abide by the following conditions of recognition:
    1. ITSNA must inform OSHA as soon as possible, in writing, of any
change of ownership, facilities, or key personnel, and of any major
change in its operations as an NRTL, and provide details of the
change(s);
    2. ITSNA must meet all the terms of its recognition and comply with
all OSHA policies pertaining to this recognition; and
    3. ITSNA must continue to meet the requirements for recognition,
including all previously published conditions on ITSNA's scope of
recognition, in all areas for which it has recognition.

III. Authority and Signature

    David Michaels, Ph.D., MPH, Assistant Secretary of Labor for
Occupational Safety and Health, 200 Constitution Avenue NW.,
Washington, DC 20210, authorized the preparation of this notice.
Accordingly, the Agency is issuing this notice pursuant to 29 U.S.C.
657(g)(2), Secretary of Labor's Order No. 1-2012 (77 FR 3912, Jan. 25,
2012), and 29 CFR 1910.7.

    Signed at Washington, DC, on July 9, 2014.
David Michaels,
Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2014-16428 Filed 7-11-14; 8:45 am]
BILLING CODE 4510-26-P


[Federal Register Volume 77, Number 71 (Thursday, April 12, 2012)]
[Notices]
[Page 22005]
[FR Doc No: 2012-8795]

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SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of Investor Education and Advocacy, Washington, DC
20549-0213.

Extension:
    Regulation FD, OMB Control No. 3235-0536, SEC File No. 270-475.

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') is soliciting comments on the collection of
information summarized below. The Commission plans to submit this
existing collection of information to the Office of Management and
Budget for extension and approval.
    Regulation FD (17 CFR 243.100 et seq.)--Other Disclosure Materials
requires public disclosure of material information from issuers of
publicly traded securities so that investors have current information
upon which to base investment decisions. The purpose of the regulation
is to require: (1) An issuer that intentionally discloses material
information, to do so through public disclosure, not selective
disclosure; and (2) to make prompt public disclosure of material
information that was unintentionally selectively disclosed. We estimate
that approximately 13,000 issuers make Regulation FD disclosures
approximately five times a year for a total of 58,000 submissions
annually, not including an estimated 7,000 issuers who file Form 8-K to
comply with Regulation FD. We estimate that it takes 5 hours per
response (58,000 responses x 5 hours) for a total burden of 290,000
hours annually. In addition, we estimate that 25% of the 5 hours per
response (1.25 hours) is prepared by the filer for an annual reporting
burden of 72,500 hours (1.25 hours per response x 58,000 responses).
    Written comments are invited on: (a) Whether the proposed
collection of information is necessary for the proper performance of
the functions of the agency, including whether the information has
practical utility; (b) the accuracy of the agency's estimate of the
burden imposed by the collection of information; (c) ways to enhance
the quality, utility, and clarity of the information collected; and (d)
ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques or other forms of information technology. Consideration will
be given to comments and suggestions submitted in writing within 60
days of this publication.
    Please direct your written comments to Thomas Bayer, Director/Chief
Information Officer, Securities and Exchange Commission, c/o Remi
Pavlik-Simon, 6432 General Green Way, Alexandria, Virginia 22312; or
send an email to<EMAIL_ADDRESS>
    Dated: April 6, 2012.
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-8795 Filed 4-11-12; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 81, Number 9 (Thursday, January 14, 2016)]
[Notices]
[Pages 1957-1958]
[FR Doc No: 2016-00536]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0307]

Revised Preventive Measures To Reduce the Possible Risk of
Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob
Disease by Blood and Blood Products; 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 document entitled ``Revised Preventive Measures
to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob
Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood
Products; Guidance for Industry.'' The guidance document provides blood
collecting establishments and manufacturers of plasma derivatives with
comprehensive recommendations intended to minimize the possible risk of
transmission of Creutzfeldt-Jakob Disease (CJD) and Variant
Creutzfeldt-Jakob Disease (vCJD) from blood and blood products. The
guidance amends the guidance document entitled ``Guidance for Industry:
Revised Preventive Measures to Reduce the Possible Risk of Transmission
of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob
Disease (vCJD) by Blood and Blood Products'' dated May 2010 (2010
guidance) by finalizing and incorporating the recommendations from the
draft document entitled ``Draft Guidance for Industry: Amendment to
'Guidance for Industry: Revised Preventive Measures to Reduce the
Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant
Creutzfeldt-Jakob Disease by Blood and Blood Products''' dated June
2012 (2012 draft guidance).

DATES: Submit either electronic or written comments on Agency guidances
at any time.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, 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-2012-D-0307 for Revised Preventive Measures to Reduce the Possible
Risk of Transmission of Creutzfeldt-Jakob Disease and Variant
Creutzfeldt-Jakob Disease by Blood and Blood Products; Guidance for
Industry. Received comments will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at http://www.regulations.gov or at the Division of Dockets Management
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 http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the guidance to 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 the 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 guidance document.

FOR FURTHER INFORMATION CONTACT: Tami Belouin, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a document entitled ``Revised
Preventive Measures to Reduce the Possible Risk of Transmission of
Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by
Blood and Blood Products; Guidance for Industry.'' The guidance
document provides blood collecting establishments and manufacturers of
plasma derivatives with comprehensive recommendations intended to
minimize the possible risk of transmission of CJD and vCJD from blood
and blood products. The guidance is the latest in a series of guidances
addressing the risk of CJD and vCJD transmission by blood and blood
products.
    The guidance amends the 2010 guidance (May 27, 2010; 75 FR 29768)
and finalizes the 2012 draft guidance (June 11, 2012; 77 FR 34390) by
providing revised labeling recommendations for plasma-derived products,
including albumin and products containing plasma-derived albumin. The
guidance also provides manufacturers of plasma-derived products with
recommendations on how to report the labeling changes to FDA under 21
CFR 601.12. Additional changes to the guidance include adding
information in the background section relevant to the new labeling
recommendations; providing updated information on the global vCJD and
Bovine Spongiform Encephalopathy epidemics; clarifying the reentry
criteria for a donor with a family history of CJD; clarifying the
requirements related to biological product deviation reporting; and,
updating, adding, and removing certain footnotes and references. FDA
received four comments on the 2012 draft guidance, and those comments
were considered in the finalization of the draft guidance.
    This guidance does not address potential changes to the geographic
exposure based deferrals for risk of vCJD. FDA discussed such potential
changes with its Transmissible Spongiform Encephalopathies Advisory
Committee in June 2015 and intends to address revised recommendations
for geographic donor deferrals in future guidance documents.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on Revised Preventive Measures to Reduce the
Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant
Creutzfeldt-Jakob Disease by Blood and Blood Products; Guidance for
Industry. 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

    This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR 601.12 have been approved under
OMB control number 0910-0338; the collections of information in 21 CFR
606.100 have been approved under OMB control number 0910-0116; and the
collections of information in 21 CFR 600.14 and 606.171 have been
approved under OMB control number 0910-0458.

III. Electronic Access

    Persons with access to the Internet may obtain the guidance at
either http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: January 7, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-00536 Filed 1-13-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 158 (Wednesday, August 17, 2022)]
[Notices]
[Pages 50693-50694]
[FR Doc No: 2022-17689]

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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

[Docket No. PHMSA-2022-0084]

Pipeline Safety: Request for Special Permit; Columbia Gulf
Transmission, LLC

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

ACTION: Notice.

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

SUMMARY: PHMSA is publishing this notice to solicit public comments on
a request for special permit received from Columbia Gulf Transmission,
LLC (CGT). The special permit request is seeking relief from compliance
with certain requirements of the Federal pipeline safety regulations.
At the conclusion of the 30-day comment period, PHMSA will review the
comments received from this notice as part of its evaluation to grant
or deny the special permit request.

DATES: Submit any comments regarding this special permit request by
September 16, 2022.

ADDRESSES: Comments should reference the docket number for this special
permit request and may be submitted in the following ways:
     E-Gov Website: http://www.Regulations.gov. This site
allows the public to enter comments on any Federal Register notice
issued by any agency.
     Fax: 1-202-493-2251.
     Mail: Docket Management System: U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Docket Management System: U.S. Department
of Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590, between
9:00 a.m. and 5:00 p.m., Monday through Friday, except Federal
holidays.
    Instructions: You should identify the docket number for the special
permit request you are commenting on at the beginning of your comments.
If you submit your comments by mail, please submit two (2) copies. To
receive confirmation that PHMSA has received your comments, please
include a self-addressed stamped postcard. Internet users may submit
comments at http://www.Regulations.gov.

    Note: There is a privacy statement published on http://www.Regulations.gov. Comments, including any personal information
provided, are posted without

changes or edits to http://www.Regulations.gov.

    Confidential Business Information: Confidential Business
Information (CBI) is commercial or financial information that is both
customarily and actually treated as private by its owner. Under the
Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from
public disclosure. If your comments responsive to this notice contain
commercial or financial information that is customarily treated as
private, that you actually treat as private, and that is relevant or
responsive to this notice, it is important that you clearly designate
the submitted comments as CBI. Pursuant to 49 Code of Federal
Regulations (CFR) 190.343, you may ask PHMSA to give confidential
treatment to information you give to the agency by taking the following
steps: (1) mark each page of the original document submission
containing CBI as ``Confidential''; (2) send PHMSA, along with the
original document, a second copy of the original document with the CBI
deleted; and (3) explain why the information you are submitting is CBI.
Unless you are notified otherwise, PHMSA will treat such marked
submissions as confidential under the FOIA, and they will not be placed
in the public docket of this notice. Submissions containing CBI should
be sent to Kay McIver, DOT, PHMSA-PHP-80, 1200 New Jersey Avenue SE,
Washington, DC 20590-0001. Any commentary PHMSA receives that is not
specifically designated as CBI will be placed in the public docket for
this matter.

FOR FURTHER INFORMATION CONTACT:
    General: Ms. Kay McIver by telephone at<PHONE_NUMBER>, or by email
at [email protected].
    Technical: Mr. Steve Nanney by telephone at<PHONE_NUMBER>, or by
email at [email protected].

SUPPLEMENTARY INFORMATION: PHMSA received a special permit request on
June 22, 2022, from CGT, a subsidiary of TC Energy, Inc., seeking a
waiver from the requirements of 49 CFR 192.611(a) and (d): Change in
class location: Confirmation or revision of maximum allowable operating
pressure, and 49 CFR 192.619(a): Maximum allowable operating pressure:
Steel or plastic pipelines.
    This special permit is being requested in lieu of pipe replacement,
pressure reduction, or new pressure tests for a Class 1 to 3 location
change on seven (7) gas transmission pipeline segments totaling
41,265.00 feet (approximately 7.815 miles). These pipeline segments,
which have changed from a Class 1 to a Class 3 location, are as
follows:

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Maximum  allowable
                                                          Outside                                                                     operating pressure
 Special permit segment No.        County, state          diameter              Line name            Length  (feet)   Year installed      (pounds per
                                                          (inches)                                                                       square  inch
                                                                                gauge)
--------------------------------------------------------------------------------------------------------------------------------------------------------
1...........................  Madison, KY...........               30  ML 100.....................         6,600.00             1954                 935
2...........................  Madison, KY...........               30  ML 200.....................         6,500.00        1963/1964               1,007
3...........................  Madison, KY...........               36  ML 300.....................         7,450.00             1970               1,007
4...........................  Madison, KY...........               36  ML 300.....................           165.00             1970               1,007
5...........................  Madison, KY...........               30  ML 100.....................         6,800.00             1954                 935
6...........................  Madison, KY...........               30  ML 200.....................         6,850.00        1963/1964               1,007
7...........................  Madison, KY...........               36  ML 300.....................         6,900.00             1970               1,007
--------------------------------------------------------------------------------------------------------------------------------------------------------

    The special permit request, proposed special permit with
conditions, and draft environmental assessment (DEA) for the above
listed CGT pipeline segments are available for review and public
comments in Docket No. PHMSA-2022-0084. PHMSA invites interested
persons to review and submit comments on the special permit request and
DEA in the docket. Please include any comments on potential safety and
environmental impacts that may result if the special permit is granted.
Comments may include relevant data.
    Before issuing a decision on the special permit request, PHMSA will
evaluate all comments received on or before the comments closing date.
Comments received after the closing date will be evaluated, if it is
possible to do so without incurring additional expense or delay. PHMSA
will consider each relevant comment it receives in making its decision
to grant or deny this special permit request.

    Issued in Washington, DC, on August 11, 2022, under authority
delegated in 49 CFR 1.97.
Alan K. Mayberry,
Associate Administrator for Pipeline Safety.
[FR Doc. 2022-17689 Filed 8-16-22; 8:45 am]
BILLING CODE 4910-60-P


[Federal Register Volume 81, Number 22 (Wednesday, February 3, 2016)]
[Notices]
[Page 5739]
[FR Doc No: 2016-01915]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP15-513-000]

Texas Gas Transmission, LLC; Notice of Availability of the
Environmental Assessment for the Proposed Northern Supply Access
Project

    The staff of the Federal Energy Regulatory Commission (FERC or
Commission) has prepared this environmental assessment (EA) for the
Northern Supply Access Project (Project) proposed by Texas Gas
Transmission, LLC (Texas Gas) in the above-referenced docket. Texas Gas
requests authorization to construct and operate natural gas facilities
in Ohio, Indiana, Kentucky, Tennessee, Mississippi, and Louisiana to
provide an additional 384,000 million standard cubic feet per day of
natural gas of north to south transportation capacity on Texas Gas's
existing system.
    The EA assesses the potential environmental effects of the
construction and operation of the Project in accordance with the
requirements of the National Environmental Policy Act. The FERC staff
concludes that approval of the proposed Project, with appropriate
mitigating measures, would not constitute a major federal action
significantly affecting the quality of the human environment.
    The Project involves modifications at eight existing compressor
stations in Morehouse Parish, Louisiana; Coahoma County, Mississippi;
Tipton County, Tennessee; Webster, Breckinridge, and Jefferson
Counties, Kentucky; and Lawrence and Dearborn Counties, Indiana. Texas
Gas would also construct one new 23,877 horsepower compressor station
in Hamilton County, Ohio.
    The FERC staff mailed copies of the EA to federal, state, and local
government representatives and agencies; elected officials;
environmental and public interest groups; Native American tribes;
potentially affected landowners within 0.5 mile of the above ground
facilities; interested individuals and groups; newspapers and libraries
in the project area; and parties to this proceeding. Everyone on our
environmental mailing list will receive a CD version of the EA. In
addition, the EA is available for public viewing on the FERC's Web site
(www.ferc.gov) using the eLibrary link. A limited number of copies of
the EA are available for distribution and public inspection at: Federal
Energy Regulatory Commission, Public Reference Room, 888 First Street
NE., Room 2A, Washington, DC 20426,<PHONE_NUMBER>.
    Any person wishing to comment on the EA may do so. Your comments
should focus on the potential environmental effects, reasonable
alternatives, and measures to avoid or lessen environmental impacts.
The more specific your comments, the more useful they will be. To
ensure that the Commission has the opportunity to consider your
comments prior to making its decision on this Project, it is important
that we receive your comments in Washington, DC on or before February
25, 2016.
    For your convenience, there are three methods you can use to file
your comments with the Commission. In all instances please reference
the Project docket number (CP15-513-000) with your submission. The
Commission encourages electronic filing of comments and has expert
staff available to assist you at<PHONE_NUMBER> or<EMAIL_ADDRESS>    (1) You can file your comments electronically using the eComment
feature located on the Commission's Web site (www.ferc.gov) under the
link to Documents and Filings. This is an easy method for submitting
brief, text-only comments on a project;
    (2) You can also file your comments electronically using the
eFiling feature on the Commission's Web site (www.ferc.gov) under the
link to Documents and Filings. With eFiling, you can provide comments
in a variety of formats by attaching them as a file with your
submission. New eFiling users must first create an account by clicking
on ``eRegister.'' You must select the type of filing you are making. If
you are filing a comment on a particular project, please select
``Comment on a Filing''; or
    (3) You can file a paper copy of your comments by mailing them to
the following address: Kimberly D. Bose, Secretary, Federal Energy
Regulatory Commission, 888 First Street NE., Room 1A, Washington, DC
20426.
    Any person seeking to become a party to the proceeding must file a
motion to intervene pursuant to Rule 214 of the Commission's Rules of
Practice and Procedures (18 CFR 385.214).\1\ Only intervenors have the
right to seek rehearing of the Commission's decision. The Commission
grants affected landowners and others with environmental concerns
intervenor status upon showing good cause by stating that they have a
clear and direct interest in this proceeding which no other party can
adequately represent. Simply filing environmental comments will not
give you intervenor status, but you do not need intervenor status to
have your comments considered.
---------------------------------------------------------------------------

    \1\ See the previous discussion on the methods for filing
comments.
---------------------------------------------------------------------------

    Additional information about the Project is available from the
Commission's Office of External Affairs, at (866) 208-FERC, or on the
FERC Web site (www.ferc.gov) using the eLibrary link. Click on the
eLibrary link, click on ``General Search,'' and enter the docket
numbers excluding the last three digits in the Docket Number field
(i.e., CP15-513). Be sure you have selected an appropriate date range.
For assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or for TTY,
contact<PHONE_NUMBER>. The eLibrary link also provides access to the
texts of formal documents issued by the Commission, such as orders,
notices, and rulemakings.
    In addition, the Commission offers a free service called
eSubscription which allows you to keep track of all formal issuances
and submittals in specific dockets. This can reduce the amount of time
you spend researching proceedings by automatically providing you with
notification of these filings, document summaries, and direct links to
the documents. Go to www.ferc.gov/docs-filing/esubscription.asp.

    Dated: January 27, 2016.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2016-01915 Filed 2-2-16; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 161 (Tuesday, August 22, 2017)]
[Notices]
[Page 39890]
[FR Doc No: 2017-17745]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4322-DR; Docket ID FEMA-2017-0001]

New York; Major Disaster and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This is a notice of the Presidential declaration of a major
disaster for the State of New York (FEMA-4322-DR), dated July 12, 2017,
and related determinations.

DATES: The declaration was issued July 12, 2017.

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, 2017, 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 a severe winter storm and snowstorm
during the period of March 14-15, 2017, 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. You are
further authorized to provide snow assistance under the Public
Assistance program for a limited period of time during or proximate
to the incident period. 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, Seamus K. Leary, 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:

    Albany, Broome, Chenango, Clinton, Columbia, Cortland, Delaware,
Dutchess, Essex, Franklin, Fulton, Greene, Hamilton, Herkimer,
Madison, Montgomery, Oneida, Orleans, Otsego, Rensselaer, Saratoga,
Schenectady, Schoharie, Suffolk, Sullivan, Tioga, Tompkins, and
Ulster Counties for Public Assistance.
    Albany, Broome, Chenango, Clinton, Columbia, Cortland, Delaware,
Dutchess, Essex, Franklin, Fulton, Greene, Hamilton, Herkimer,
Madison, Montgomery, Oneida, Orleans, Otsego, Rensselaer, Saratoga,
Schenectady, Schoharie, Sullivan, Tioga, Tompkins, and Ulster
Counties for snow assistance under the Public Assistance program for
any continuous 48-hour period during or proximate to the incident
period.
    All areas within the State of New York are eligible 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.

Brock Long,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2017-17745 Filed 8-21-17; 8:45 am]
 BILLING CODE 9111-23-P


[Federal Register Volume 83, Number 19 (Monday, January 29, 2018)]
[Notices]
[Pages 4064-4065]
[FR Doc No: 2018-01606]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2018-0004]

Area Maritime Security Advisory Committee (AMSC), Eastern Great
Lakes and Regional Sub-Committee Vacancies

AGENCY: Coast Guard, DHS.

ACTION: Solicitation for membership.

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

SUMMARY: This notice requests individuals interested in serving on the
Area Maritime Security Committee (AMSC), Eastern Great Lakes, and the
four regional sub-committees: Northeast Ohio Region, Northwestern
Pennsylvania Region, Western New York Region, and Eastern New York
Region submit their applications for

membership to the Federal Maritime Security Coordinator (FMSC),
Buffalo. The Committee assists the FMSC, Buffalo, in developing,
reviewing, and updating the Area Maritime Security Plan for their area
of responsibility.

DATES: Requests for membership should reach the FMSC, Buffalo, on
February 28, 2018.

ADDRESSES: Applications for membership should be submitted to the
following address: Federal Maritime Security Coordinator, Buffalo,
Attention: CDR Karen Jones, 1 Fuhrmann Boulevard, Buffalo, NY 14203-
3189.

FOR FURTHER INFORMATION CONTACT: For questions about submitting an
application, or about the AMSC in general, contact:
    For the Northeast Ohio Region Sub-Committee Executive Coordinator:
Mr. Peter Killmer at<PHONE_NUMBER>.
    For the Northwestern Pennsylvania Region Sub-Committee Executive
Coordinator: Mr. Joseph Fetscher at<PHONE_NUMBER>.
    For the Western New York Region Sub-Committee Executive
Coordinator: Mr. Shawn Larrabee at<PHONE_NUMBER>.
    For the Eastern New York Region Sub-Committee Executive
Coordinator: Mr. Ralph Kring at<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority

    Section 102 of the Maritime Transportation Security Act (MTSA) of
2002 (Pub. L. 107-295) added section 70112 to Title 46 of the U.S.
Code, and authorized the Secretary of the Department in which the Coast
Guard is operating to establish Area Maritime Security Advisory
Committees for any port area of the United States. (See 33 U.S.C. 1226;
46 U.S.C.; 33 CFR 1.05-1, 6.01; Department of Homeland Security
Delegation No. 0170.1). The MTSA includes a provision exempting these
AMSCs from the Federal Advisory Committee Act (FACA), Public Law 92-
436, 86 Stat. 470 (5 U.S.C. App.2). The AMSCs shall assist the FMSC in
the development, review, update, and exercising of the Area Maritime
Security Plan for their area of responsibility. Such matters may
include, but are not limited to: Identifying critical port
infrastructure and operations; identifying risks (threats,
vulnerabilities, and consequences); determining mitigation strategies
and implementation methods; developing and describing the process to
continually evaluate overall port security by considering consequences
and vulnerabilities, how they may change over time, and what additional
mitigation strategies can be applied; and providing advice to, and
assisting the FMSC in developing and maintaining the Area Maritime
Security Plan.

AMSC Membership

    Members of the AMSC should have at least five years of expertise
related to maritime or port security operations. We are seeking to fill
the following vacancies with this submission:
    (A) Northeast Ohio Region Sub-Committee (no new members): No
applications are being taken for this Sub-Committee at this time.
    (B) Northwestern Pennsylvania Region Sub-Committee (no new
members): No applications are being taken for this Sub-Committee at
this time.
    (C) Western New York Region Sub-Committee (no new members): No
applications are being taken for this Sub-Committee at this time.
    (D) Eastern New York Region Sub-Committee (2 members): Executive
Board member to serve as (one) Chairperson of the Sub-Committee and
concurrently as member of the Eastern Great Lakes AMSC when so convened
by the FMSC, and (one) Vice Chairperson.
    Applicants may be required to pass an appropriate security
background check prior to appointment to the Committee. Applicants must
register with and remain active as Coast Guard HOMEPORT users if
appointed. Members' terms of office will be for five years; however, a
member is eligible to serve additional terms of office. Members will
not receive any salary or other compensation for their service on an
AMSC. In accordance with 33 CFR 103, members may be selected from the
Federal, Territorial, or Tribal governments; the State government and
political subdivisions of the State; local public safety, crisis
management, and emergency response agencies; law enforcement and
security organizations; maritime industry, including labor; other port
stakeholders having a special competence in maritime security; and port
stakeholders affected by security practices and policies.
    The Department of Homeland Security does not discriminate in
selection of Committee members on the basis of race, color, religion,
sex, national origin, political affiliation, sexual orientation, gender
identity, marital status, disability and genetic information, age,
membership in an employee organization, or any other non-merit factor.
The Department of Homeland Security strives to achieve a widely diverse
candidate pool for all of its recruitment actions.
    Request for Applications: Those seeking membership are not required
to submit formal applications to the local FMSC, however, because we do
have an obligation to ensure that a specific number of members have the
prerequisite maritime security experience, we encourage the submission
of resumes highlighting experience in the maritime and security
industries.

    Dated: January 9, 2018.
J.S. Dufresne,
Captain, U.S. Coast Guard, Federal Maritime Security Coordinator,
Buffalo.
[FR Doc. 2018-01606 Filed 1-26-18; 8:45 am]
 BILLING CODE 9110-04-P


                    UNITED STATES OF AMERICA

            DEPARTMENT OF TRANSPORTATION

                    OFFICE OF THE SECRETARY

                             WASHINGTON, DC

Issued by the Department of Transportation on March 2, 2004

NOTICE OF ACTION TAKEN -- DOCKETS OST-2004-16997

________________________________________________________________________
_____________

This serves as notice to the public of the action described below, taken
by the Department official indicated (no additional confirming order
will be issued in this matter).

Application of   Continental Airlines, Inc.  filed  1/28/04   for:

XX  Exemption for two years under 49 U.S.C. §40109 to provide the
following service:

Scheduled foreign air transportation of persons, property and mail
between New York/Newark (Liberty International Airport) and Punta Cana,
Dominican Republic, and to integrate this authority with its existing
certificate and exemption authority.

Applicant rep:  R. Bruce Keiner<PHONE_NUMBER>  DOT Analyst: Sylvia
Moore<PHONE_NUMBER>

D I S P O S I T I O N

XX  Granted (subject to conditions, see below)

The above action was effective when taken:  March 2, 2004, through
March 2, 2006

Action taken by:   Paul L. Gretch, Director

		    Office of International Aviation

XX   The authority granted is consistent with the overall state of
aviation relations between the United States and the Dominican Republic.

Except to the extent exempted or waived, this authority is subject to
the terms, conditions, and limitations indicated:  	XX  Holder’s
certificates of public convenience and necessity

		XX  Standard exemption conditions (attached)

_____________________________________

Conditions:  The route integration authority granted is subject to the
condition that any service provided under this authority shall be
consistent with the applicable bilateral aviation agreements between the
United States and the foreign countries involved.  Furthermore, (a)
nothing in the award of this authority requested should be construed as
conferring upon Continental additional rights (including code-share,
fifth-freedom

intermediate and/or beyond rights) to serve markets where U.S. carrier
entry is limited unless Continental first notifies the Department of its
intent to serve such a market and unless and until the Department has
completed any necessary carrier selection procedures to determine which
carrier(s) should be authorized to exercise such rights; and (b) should
there be a request by any carrier to use the limited-entry route rights
that are included in Continental’s authority by virtue of the route
integration and blanket code-share

(See Reverse Side)

2

authority granted here, but that are not then being used by Continental,
the holding of such authority will not be considered as providing any
preference for Continental in a competitive carrier selection proceeding
to determine which carrier(s) should be entitled to use the authority at
issue.

___________________________________

On the basis of data officially noticeable under Rule 24(g) of the
Department’s regulations, we found Continental qualified to provide
the services authorized.

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that (1) our action was consistent with Department
policy; (2) grant of the authority was consistent with the public
interest; and (3) grant of the authority would not constitute a major
regulatory action under the Energy Policy and Conservation Act of 1975.
To the extent not granted, we denied all requests in the referenced
Docket.  We may amend, modify, or revoke the authority granted in this
Notice at any time without hearing at our discretion.

Persons entitled to petition the Department for review of the action set
forth in this Notice under the Department’s regulations, 14 CFR §
385.30, may file their petitions within seven (7) days after the date of
issuance of this Notice.  This action was effective when taken, and the
filing of a petition for review will not alter such effectiveness.

An electronic version of this order is available on the World Wide Web
at

  HYPERLINK "http://dms.dot.gov//reports/reports_ aviation.asp"
http://dms.dot.gov//reports/reports_ aviation.asp

U.S. Carrier Exemption Conditions

In the conduct of the operations authorized, the U.S. carrier
applicant(s) shall:

(1)  Hold at all times effective operating authority from the government
of each country served;

(2)  Comply with applicable requirements concerning oversales contained
in 14 CFR 250 (for scheduled operations, if authorized);

(3)  Comply with the requirements for reporting data contained in 14 CFR
241;

(4)  Comply with requirements for minimum insurance coverage, and for
certifying that coverage to the Department, contained in 14 CFR 205;

(5)  Except as specifically exempted or otherwise provided for in a
Department Order, comply with the requirements of 14 CFR 203, concerning
waiver of Warsaw Convention liability limits and defenses;

(6)  Comply with all applicable requirements of the Federal Aviation
Administration and with all applicable U.S. Government requirements
concerning security.  To assure compliance with all applicable U.S.
Government requirements concerning security, the holder shall, before
commencing any new service (including charter flights) to or from a
foreign airport, contact its Principal Security Inspector (PSI) to
advise the PSI of its plans and to find out whether the Transportation
Security Administration has determined that security is adequate to
allow such airport(s) to be served; and

(7)  Comply with such other reasonable terms, conditions, and
limitations required by the public interest as may be prescribed by the
Department of Transportation, with all applicable orders and regulations
of other U.S. agencies and courts, and with all applicable laws of the
United States.

The authority granted shall be effective only during the period when the
holder is in compliance with the conditions imposed above.

										08/2003


[Federal Register Volume 84, Number 23 (Monday, February 4, 2019)]
[Notices]
[Pages 1480-1481]
[FR Doc No: 2019-00860]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2019-0035]

Towing Safety Advisory Committee

AGENCY: U.S. Coast Guard, Department of Homeland Security.

ACTION: Notice of Federal Advisory Committee meeting.

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SUMMARY: The Towing Safety Advisory Committee and its subcommittees
will meet in Miami, Florida, to review and discuss recommendations from
its subcommittees and to receive briefs on items listed in the agenda.
All meetings will be open to the public.

DATES: Meetings. The subcommittees of the Towing Safety Advisory
Committee will meet on Wednesday, February 20, 2019, from 8 a.m. to 5
p.m. to conduct work-group sessions. The full Committee will meet on
Thursday, February 21, 2019, from 8 a.m. to 5 p.m. These meetings may
end early if the subcommittees or the Committee has completed its
business, or the meetings may be extended based on the number of public
comments.
    Comments and supporting documentation. To ensure your comments are
reviewed by Committee members before the meetings, submit your written
comments no later than February 14, 2019.

ADDRESSES: All meetings will be held at the Hyatt Place Miami Airport
West/Doral, 3655 NW 82nd Ave., Miami, Florida 33166; hotel website:
www.hyattplacemiamiairportwest.com.
    For information on facilities or services for individuals with
disabilities, or to request special assistance at the meetings, contact
the individuals listed in the FOR FURTHER INFORMATION CONTACT section
as soon as possible.
    Written comments must be submitted using the Federal eRulemaking
Portal at http://www.regulations.gov. If you encounter technical
difficulties when trying to submit comments, contact the individual
listed in the FOR FURTHER INFORMATION CONTACT of this document.
    Instructions: You are free to submit comments at any time,
including orally at the meetings, but if you want Committee members to
review your comment before the meetings, please submit your comments no
later than February 14, 2019. We are particularly interested in
comments on the issues in the ``Agenda'' section below. You must
include ``Department of Homeland Security'' and the docket number USCG-
2019-0035. For more information about the privacy and the docket,
review the Privacy and Security Notice for the Federal Docket
Management System at https://www.regulations.gov/privacyNotice.
    Docket Search: For access to the docket or to read documents or
comments related to this notice, go to http://www.regulations.gov,
insert USCG-2019-0035 in the Search box, press Enter, and then click on
the item you wish to view.

FOR FURTHER INFORMATION CONTACT: Mr. Douglas Scheffler, Alternate
Designated Federal Officer of the Towing Safety Advisory Committee,
Commandant (CG-OES-2), U.S. Coast Guard, 2703 Martin Luther King Jr.
Avenue SE, Stop 7509, Washington, DC 20593-7509; telephone 202-372-
1087, fax<PHONE_NUMBER> or email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Notice of this meeting is in compliance with
the Federal Advisory Committee Act, Title 5 United States Code
Appendix.
    The Towing Safety Advisory Committee provides advice and
recommendations to the Department of Homeland Security on matters
relating to shallow-draft inland and coastal waterway navigation and
towing safety. On December 4, 2018, the source of this stated purpose
of the Committee, 33 U.S.C. 1231a, was repealed by the Frank Lobiondo
Coast Guard Authorization Act of 2018 (PL 115-282, 132 Stat 4192) but
section 601(d) of this Authorization Act allows the Towing Safety
Advisory Committee to remain in force or in effect for a period of up
to 2 years. Section 601(a) of the Authorization Act has established the
National Towing Safety Advisory Committee, which has the same stated
purpose and that will eventually replace the Towing Safety Advisory
Committee.

Agenda of Meetings

    On February 20 and 21, 2019, from 8 a.m. to 5 p.m., the Towing
Safety Advisory Committee and its subcommittees will meet to review,
discuss, deliberate, and formulate recommendations, as appropriate, on
the following tasks:
     46 Code of Federal Regulations Subchapter M Implementation
(Task 16-01).
     Towing Liquefied Natural Gas Barges (Task 16-03).
     Load Line Exemption Review for River Barges on Lakes Erie
and Ontario (Task 17-02).
    All current Towing Safety Advisory Committee tasks can be found at
https://homeport.uscg.mil/Lists/Content/DispForm.aspx?&ID=574&Source=https://homeport.uscg.mil/missions/ports-and-waterways/safety-advisory-committees/tsac/recommendations-reports.
    A copy of all meeting documentation, including any draft final
reports, will be available at https://homeport.uscg.mil/missions/ports-and-waterways/safety-advisory-committees/tsac/announcements no later
than February 13, 2019. Alternatively, you may contact the individual
listed in the FOR FURTHER INFORMATION CONTACT section above.
    Public comments or questions will be taken throughout the meeting
as the Committee discusses the issues and prior to deliberations and
voting. There will also be a public comment period at the end of the
meeting. Speakers are requested to limit their comments to 3 minutes.
Please note that the public comment period may end before the period
allotted, following the last call for comments. Please contact the
individual listed in the FOR FURTHER INFORMATION CONTACT section above
to register as a speaker.

Notices of Future 2019 Towing Safety Advisory Committee Meetings

    To receive automatic email notices of future Towing Safety Advisory
Committee meetings in 2019, go to the online docket, USCG-2019-0035
(http://www.regulations.gov/#!docketDetail;D=USCG-2019-0035), and
select the Sign-up-for-Email-Alerts option. We plan to use the same
docket number for all Towing Safety Advisory Committee meeting notices
in 2019, so when the next meeting notice is published you will receive
an email alert from http://www.regulations.gov when the notice appears
in this docket, in addition to notices of other items being added to
the docket.

    Dated: January 29, 2019.
Jeffrey G. Lantz,
Director of Commercial Regulations and Standards.
[FR Doc. 2019-00860 Filed 2-1-19; 8:45 am]
 BILLING CODE 9110-04-P