[Federal Register Volume 87, Number 169 (Thursday, September 1, 2022)]
[Proposed Rules]
[Pages 53708-53709]
[FR Doc No: 2022-18850]

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DEPARTMENT OF TRANSPORTATION

49 CFR Parts 23 and 26

[Docket No. DOT-OST-2022-0051]
RIN 2105-AE98

Disadvantaged Business Enterprise and Airport Concession
Disadvantaged Business Enterprise Program Implementation Modifications

AGENCY: Office of the Secretary (OST), U.S. Department of
Transportation (DOT).

ACTION: Notice of proposed rulemaking; extension of comment period.

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SUMMARY: The U.S. Department of Transportation is extending the comment
period for its Disadvantaged Business Enterprise (DBE) and Airport
Concession DBE (ACDBE) notice of proposed rulemaking. The original
comment period was scheduled to close on September 19, 2022. The
extension is granted in response to requests received from
stakeholders, who have stated the September 19 closing date does not
provide sufficient time for them to prepare and submit of comments to
the docket. The Department agrees to extend the comment period by 60
days. Therefore, the closing date for submission of comments is
extended to October 31, 2022, which will provide those entities
interested in commenting on the proposed rulemaking additional time to
submit comments to the docket.

DATES: The comment period for the proposed rule published July 21,
2022, at 87 FR 43620 is extended. Comments must be received on or
before October 31, 2022.

ADDRESSES: To ensure that you do not duplicate your docket submissions,
please submit them by only one of the following means:
     Federal eRulemaking Portal: Go to https://www.regulations.gov/docket/DOT-OST-2022-0051/document and follow the
online instructions for submitting comments.
     Mail: Docket Management Facility, U.S. Department of
Transportation, 1200 New Jersey Ave. SE, West Building Ground Floor
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery: West Building Ground Floor, Room W-12-140,
1200 New Jersey Ave. SE, between 9 a.m. and

5 p.m., Monday through Friday, except Federal holidays. The telephone
number is<PHONE_NUMBER>.
    Instructions: To ensure proper docketing of your comment, please
include the agency name and docket number DOT-OST-2022-0051 or the
Regulatory Identification Number (RIN), 2105-AE98 for the rulemaking at
the beginning of your comments. All comments received will be posted
without change to https://www.regulations.gov, including any personal
information provided.

FOR FURTHER INFORMATION CONTACT: Marc D. Pentino, Departmental Office
of Civil Rights, Office of the Secretary, 1200 New Jersey Avenue SE,
Washington, DC 20590; telephone number<PHONE_NUMBER>;
[email protected].

SUPPLEMENTARY INFORMATION:

Background

    On July 21, 2022, at 87 FR 43620, DOT published in the Federal
Register a notice of proposed rulemaking proposing to amend its
Disadvantaged Business Enterprise and Airport Concession Disadvantaged
Business Enterprise regulations at 49 CFR part 26 and part 23. The
proposal includes other provisions to update and strengthen the
Department's regulation, and to modernize the program's eligibility and
procedural requirements. In addition, the rulemaking proposed technical
corrections that have led to substantive misinterpretations of the
rules by recipients, program applicants and participants.
    The original comment period for the proposal would have closed
September 19, 2022. However, DOT stakeholders have expressed concern
that this closing date does not provide sufficient time to coordinate
with their respective members and working groups to develop comments to
the NPRM and/or to submit comments to the docket, particularly on
provisions they view are of a complex nature and impact operations.
    The Department has carefully considered the requests to extend the
comment period on the NPRM and agrees that given the length and breadth
of topics covered, a period beyond the 60-day comment period is
warranted. The Department finds that there is a strong interest in
timely issuance of this priority rulemaking but is interested in
providing the public with additional time to comment.
    To allow time for interested parties to submit comments, the
closing date is changed from September 19, 2022, to October 31, 2022.
All members of the public, including DOT recipients and sponsors, prime
contractors, small businesses, trade organizations, and consultants are
invited to submit comments.

    Signed in Washington, DC, on or around August 26, 2022 under
authority delegated in 49 CFR 1.27(a):
John Putnam,
General Counsel.
[FR Doc. 2022-18850 Filed 8-31-22; 8:45 am]
BILLING CODE 4910-9X-P


[Federal Register Volume 81, Number 48 (Friday, March 11, 2016)]
[Notices]
[Pages 13024-13025]
[FR Doc No: 2016-05529]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Policy Statement No. ANM-03-117-09]

Policy Statement on Guidance for Determination of System,
Hardware, and Software Development Assurance Levels on Transport
Category Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of cancellation of policy statement.

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SUMMARY: The Federal Aviation Administration (FAA) announces the
cancellation of Policy Statement Number ANM-03-117-09. The policy
statement is cancelled because it was superseded by an advisory
circular (AC) and is no longer necessary.

DATES: This policy statement is cancelled on March 11, 2016.

FOR FURTHER INFORMATION CONTACT: Linh Le, Federal Aviation
Administration, Transport Airplane Directorate, Transport Standards
Staff, Safety Management Branch, 1601 Lind Avenue SW., Renton, WA
98057-3356;

telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Background

    On January 15, 2004, the Transport Airplane Directorate, Aircraft
Certification Service, issued Policy Statement Number ANM-03-117-09,
Policy Statement on Guidance for Determination of System, Hardware, and
Software Development Assurance Levels on Transport Category Airplanes.
This policy statement standardized the methodology for assigning
development assurance levels (DAL) to systems, software, and complex
electronic hardware.
    In December 2010, the Society of Automotive Engineers (SAE) issued
the document, Aerospace Recommended Practice (ARP) 4754A, Guidelines
for Development of Civil Aircraft and Systems, as an acceptable method
for establishing a development assurance process. This document
contains an updated methodology for DAL assignment. In developing ARP
4754A, SAE considered the subject policy statement, with inputs and
guidance from the FAA. In September 2011, the FAA issued AC 20-174,
Development of Civil Aircraft and Systems, to formally recognize ARP
4754A and the DAL assignment methodology contained therein. The
Transport Airplane Directorate determined that AC 20-174 and ARP 4754A
provide an acceptable DAL assignment methodology for part 25 airplanes.
To ensure correct understanding of the Transport Airplane Directorate's
current policy for DAL assignments, the FAA is cancelling the subject
policy, in favor of AC 20-174.

Cancellation of Policy Statement

    As a result of the issuance of AC 20-174, Policy Statement Number
ANM-03-117-09 is no longer in effect and is herewith cancelled.

    Issued in Renton, Washington, on March 1, 2016.
Michael Kaszycki,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service, ANM-100.
[FR Doc. 2016-05529 Filed 3-10-16; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 75, Number 240 (Wednesday, December 15, 2010)]
[Notices]
[Page 78259]
[FR Doc No: 2010-31426]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0616]

Draft Guidance for Industry on Codevelopment of Two or More
Unmarketed Investigational Drugs for Use in Combination; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Codevelopment
of Two or More Unmarketed Investigational Drugs for Use in
Combination.'' This guidance is intended to assist sponsors in the
codevelopment of two or more novel (not previously marketed) drugs to
be used in combination to treat a disease or condition. This guidance
provides recommendations and advice on how to address certain
scientific and regulatory issues that will arise during codevelopment.
The guidance is not intended to apply to development of fixed-dose
combinations of already marketed drugs or to development of a single
new investigational drug to be used in combination with an approved
drug or drugs. The guidance is also not intended to apply to vaccines,
gene or cellular therapies, blood products, or medical devices.

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 14, 2011.

ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Colleen Locicero, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm 4216, Silver Spring, MD 20993-0002, 301-
796-1114.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Codevelopment of Two or More Unmarketed Investigational
Drugs for Use in Combination.'' The guidance is intended to assist
sponsors interested in developing two or more novel (not previously
marketed) drugs to be used in combination. Recent scientific advances
have increased our understanding of the pathophysiological processes
that underlie many complex diseases, such as cancer, cardiovascular
disease, and infectious diseases. This increased understanding has
provided further impetus for new therapeutic approaches that rely
primarily or exclusively on combinations of drugs directed at multiple
therapeutic targets to improve treatment response and minimize
development of resistance. In settings in which combination therapy
provides significant therapeutic advantages, there is growing interest
in the development of combinations of investigational drugs not
previously developed for any purpose.
    Because the existing developmental and regulatory paradigm focuses
primarily on assessment of the effectiveness and safety of a single new
investigational drug acting alone, or in combination with an approved
drug, FDA believes guidance is needed to assist sponsors in the
codevelopment of two or more unmarketed drugs. This guidance is
intended to describe a high-level, generally applicable approach to
codevelopment of two or more unmarketed drugs. It describes the
criteria for determining when codevelopment is an appropriate option,
makes recommendations about nonclinical and clinical development
strategies, and addresses certain regulatory process issues. The
guidance does not apply to vaccines, gene or cellular therapies, or
blood products.
    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 Agency's current thinking on companion
diagnostic devices. It does not create or confer any rights for or on
any person and does not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
requirements of the applicable statutes and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

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

    Dated: December 9, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-31426 Filed 12-14-10; 8:45 am]
BILLING CODE 4160-01-P