[Federal Register Volume 76, Number 202 (Wednesday, October 19, 2011)]
[Proposed Rules]
[Pages 64880-64881]
[FR Doc No: 2011-26890]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R05-OAR-2011-0017; EPA-R05-OAR-2011-0106; FRL-9480-7]

Approval and Promulgation of Air Quality Implementation Plans;
Ohio and Indiana; Redesignation of the Cincinnati-Hamilton Area to
Attainment of the 1997 Annual Standard for Fine Particulate Matter

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to approve Ohio's and Indiana's requests to
redesignate their respective portions of the Cincinnati-Hamilton OH-IN-
KY nonattainment area (for Ohio: Butler, Clermont, Hamilton, and Warren
Counties, Ohio; for IN: a portion of

Dearborn County) to attainment for the 1997 annual National Ambient Air
Quality Standard (NAAQS or standard) for fine particulate matter
(PM2.5). The Ohio Environmental Protection Agency (Ohio EPA)
submitted its request on December 9, 2010, and the Indiana Department
of Environmental Management (IDEM) submitted its request on January 25,
2011. Kentucky's request to redesignate its portion of the Cincinnati-
Hamilton area, submitted to EPA to on January 27, 2011, will be
addressed in a separate rulemaking action. EPA's proposal here involves
several additional related actions. EPA has previously determined that
the entire Cincinnati-Hamilton (OH-IN-KY) area has attained the 1997
annual PM2.5 standard. EPA is proposing to approve, as
revisions to the Ohio and Indiana State Implementation Plans (SIPs),
the States' plans for maintaining the 1997 annual PM2.5
NAAQS through 2021 in the area. EPA is proposing to approve the 2005
emissions inventories for the Ohio and Indiana portions of the
Cincinnati-Hamilton area as meeting the comprehensive emissions
inventory requirement of the Clean Air Act (CAA). Finally, EPA finds
adequate and is proposing to approve Ohio and Indiana's Nitrogen Oxides
(NOX) and PM2.5 Motor Vehicle Emission Budgets
(MVEBs) for 2015 and 2021 for the Cincinnati-Hamilton area.

DATES: Comments must be received on or before November 18, 2011.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R05-
OAR-2011-0017 (Ohio); EPA-R05-OAR-2011-0106 (Indiana), by one of the
following methods:
    1. http://www.regulations.gov: Follow the on-line instructions for
submitting comments.
    2. E-mail<EMAIL_ADDRESS>    3. Fax:<PHONE_NUMBER>.
    4. Mail: Doug Aburano, Chief, Control Strategies Section, Air
Programs Branch (AR-18J), U.S. Environmental Protection Agency, 77 West
Jackson Boulevard, Chicago, Illinois 60604.
    5. Hand Delivery: Doug Aburano, Chief, Control Strategies Section,
Air Programs Branch (AR-18J), U.S. Environmental Protection Agency, 77
West Jackson Boulevard, Chicago, Illinois 60604. Such deliveries are
only accepted during the Regional Office normal hours of operation, and
special arrangements should be made for deliveries of boxed
information. The Regional Office official hours of business are Monday
through Friday, 8:30 a.m. to 4:30 p.m., excluding Federal holidays.

Please see the direct final rule which is located in the Rules section
of this Federal Register for detailed instructions on how to submit
comments.

FOR FURTHER INFORMATION CONTACT: Carolyn Persoon, Environmental
Engineer, Control Strategies Section, Air Programs Branch (AR-18J),
Environmental Protection Agency, Region 5, 77 West Jackson Boulevard,
Chicago, Illinois 60604,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In the Final Rules section of this Federal
Register, EPA is approving the determination of attainment,
redesignation, and SIP as a direct final rule without prior proposal
because the Agency views this as a noncontroversial action and
anticipates no adverse comments. A detailed rationale for the approval
is set forth in the direct final rule. If no adverse comments are
received in response to this rule, no further activity is contemplated.
If EPA receives adverse comments, the direct final rule will be
withdrawn and all public comments received will be addressed in a
subsequent final rule based on this proposed rule. EPA will not
institute a second comment period. Any parties interested in commenting
on this action should do so at this time. Please note that if EPA
receives adverse comment on an amendment, paragraph, or section of this
rule and if that provision may be severed from the remainder of the
rule, EPA may adopt as final those provisions of the rule that are not
the subject of an adverse comment. For additional information, see the
direct final rule which is located in the Rules section of this Federal
Register.

    Dated: October 7, 2011.
Susan Hedman,
Regional Administrator, Region 5.
[FR Doc. 2011-26890 Filed 10-18-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: August 23, 2010 (Volume 75, Number 162)]
[Rules and Regulations]
[Page 51666-51668]
[DOCID:fr23au10-11]

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DEPARTMENT OF TRANSPORTATION

14 CFR Part 97

[Docket No. 30739; Amdt. No. 3387]

Standard Instrument Approach Procedures, and Takeoff Minimums and
Obstacle Departure Procedures; Miscellaneous Amendments

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This rule establishes, amends, suspends, or revokes Standard
Instrument Approach Procedures (SIAPs) and associated Takeoff Minimums
and Obstacle Departure Procedures for operations at certain airports.
These regulatory actions are needed because of the adoption of new or
revised criteria, or because of changes occurring in the National
Airspace System, such as the commissioning of new navigational
facilities, adding new obstacles, or changing air traffic requirements.
These changes are designed to provide safe and efficient use of the
navigable airspace and to promote safe flight operations under
instrument flight rules at the affected airports.

DATES: This rule is effective August 23, 2010. The compliance date for
each SIAP, associated Takeoff Minimums, and ODP is specified in the
amendatory provisions.
    The incorporation by reference of certain publications listed in
the regulations is approved by the Director of the Federal Register as
of August 23, 2010.

ADDRESSES: Availability of matter incorporated by reference in the
amendment is as follows:
    For Examination--
    1. FAA Rules Docket, FAA Headquarters Building, 800 Independence
Avenue, SW., Washington, DC 20591;
    2. The FAA Regional Office of the region in which the affected
airport is located;
    3. The National Flight Procedures Office, 6500 South MacArthur
Blvd., Oklahoma City, OK 73169 or
    4. The National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, call 202-741-
6030, or go to: http://www.archives.gov/federal_register/code_of_
federal_regulations/ibr_locations.html.
    Availability_All SIAPs are available online free of charge. Visit
nfdc.faa.gov to register. Additionally, individual SIAP and Takeoff
Minimums and ODP copies may be obtained from:
    1. FAA Public Inquiry Center (APA-200), FAA Headquarters Building,
800 Independence Avenue, SW., Washington, DC 20591; or
    2. The FAA Regional Office of the region in which the affected
airport is located.

FOR FURTHER INFORMATION CONTACT: Harry J. Hodges, Flight Procedure
Standards Branch (AFS-420) Flight Technologies and Programs Division,
Flight Standards Service, Federal Aviation Administration, Mike
Monroney Aeronautical Center, 6500 South MacArthur Blvd., Oklahoma
City, OK 73169 (Mail Address: P.O. Box 25082 Oklahoma City, OK 73125)
telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: This rule amends Title 14, Code of Federal
Regulations, part 97 (14 CFR part 97) by amending the referenced SIAPs.
The complete regulatory description of each SIAP is listed on the
appropriate FAA Form 8260, as modified by the National Flight Data
Center (FDC)/Permanent Notice to Airmen (P-NOTAM), and is incorporated
by reference in the amendment under 5 U.S.C. 552(a), 1 CFR part 51, and
Sec.  97.20 of Title 14 of the Code of Federal Regulations.
    The large number of SIAPs, their complex nature, and the need for a
special format make their verbatim publication in the Federal Register
expensive and impractical. Further, airmen do not use the regulatory
text of the SIAPs, but refer to their graphic depiction on charts
printed by publishers of aeronautical materials. Thus, the advantages
of incorporation by reference are realized and publication of the
complete description of each SIAP contained in FAA form documents is
unnecessary. This amendment provides the affected CFR sections and
specifies the types of SIAP and the corresponding effective dates. This
amendment also identifies the airport and its location, the procedure
and the amendment number.

The Rule

    This amendment to 14 CFR part 97 is effective upon publication of
each separate SIAP as amended in the transmittal. For safety and
timeliness of change considerations, this amendment incorporates only
specific changes contained for each SIAP as modified by FDC/P-NOTAMs.
    The SIAPs, as modified by FDC P-NOTAM, and contained in this
amendment are based on the criteria contained in the U.S. Standard for
Terminal Instrument Procedures (TERPS). In developing these changes to
SIAPs, the TERPS criteria were applied only to specific conditions
existing at the affected airports. All SIAP amendments in this rule
have been previously issued by the FAA in a FDC NOTAM as an emergency
action of immediate flight safety relating directly to published
aeronautical charts. The circumstances which created the need for all
these SIAP amendments requires making them effective in less than 30
days.
    Because of the close and immediate relationship between these SIAPs
and safety in air commerce, I find that notice and public procedure
before adopting these SIAPs are impracticable and contrary to the
public interest and, where applicable, that good cause exists for
making these SIAPs effective in less than 30 days.

Conclusion

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore--(1) Is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. For the same reason, the FAA
certifies that this amendment will not have a significant economic
impact on a substantial number of small entities under the criteria of
the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 97

    Air traffic control, Airports, Incorporation by reference, and
Navigation (air).

    Issued in Washington, DC, on August 6, 2010.
John M. Allen,
Director, Flight Standards Service.

Adoption of the Amendment

0
Accordingly, pursuant to the authority delegated to me, Title 14, Code
of Federal regulations, part 97, 14 CFR part 97, is amended by amending
Standard Instrument Approach Procedures, effective at 0901 UTC on the
dates specified, as follows:

PART 97--STANDARD INSTRUMENT APPROACH PROCEDURES

0
1. The authority citation for part 97 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40103, 40106, 40113, 40114, 40120,
44502, 44514, 44701, 44719, 44721-44722.

0
2. Part 97 is amended to read as follows:

Sec. Sec.  97.23, 97.25, 97.27, 97.29, 97.31, 97.33, 97.35  [AMENDED]

    By amending: Sec.  97.23 VOR, VOR/DME, VOR or TACAN, and VOR/DME or
TACAN; Sec.  97.25 LOC, LOC/DME, LDA, LDA/DME, SDF, SDF/DME; Sec.
97.27 NDB, NDB/DME; Sec.  97.29 ILS, ILS/DME, MLS, MLS/DME, MLS/RNAV;
Sec.  97.31 RADAR SIAPs; Sec.  97.33 RNAV SIAPs; and Sec.  97.35 COPTER
SIAPs, Identified as follows:

Effective Upon Publication

----------------------------------------------------------------------------------------------------------------
     AIRAC Date         State            City              Airport        FDC No.    FDC Date       Subject
----------------------------------------------------------------------------------------------------------------
23-Sep-10..........  OK.........  Sand Springs......  William R Pogue       0/0508    7/15/10  NDB Rwy 35, Amdt
                                                       Muni.                                    2E.
23-Sep-10..........  OK.........  Sand Springs......  William R Pogue       0/1461    7/15/10  VOR/DME A, Amdt
                                                       Muni.                                    3.
23-Sep-10..........  AL.........  Clanton...........  Chilton County...     0/1946    5/27/10  Takeoff Minimums
                                                                                and (Obstacle)
                                                                                Departure
                                                                                Procedures Orig.
23-Sep-10..........  NH.........  Lebanon...........  Lebanon Muni.....     0/2536    7/19/10  VOR/DME Rwy 7,
                                                                                Amdt 1.
23-Sep-10..........  NH.........  Lebanon...........  Lebanon Muni.....     0/2537    7/19/10  ILS Or LOC Rwy
                                                                                18, Amdt 5A.
23-Sep-10..........  NH.........  Berlin............  Berlin RGNL......     0/2958    7/21/10  VOR B, Amdt 2A.
23-Sep-10..........  VT.........  Highgate..........  Franklin County       0/2999    7/21/10  VOR/DME Rwy 19,
                                                       State.                                   Amdt 4.
23-Sep-10..........  VT.........  Highgate..........  Franklin County       0/3000    7/21/10  RNAV (GPS) Rwy
                                                       State.                                   19, Orig.
23-Sep-10..........  VT.........  Highgate..........  Franklin County       0/3001    7/21/10  RNAV (GPS) Rwy 1,
                                                       State.                                   Amdt 2.
23-Sep-10..........  NC.........  Raleigh/Durham....  Raleigh-Durham        0/4050     8/4/10  ILS Or LOC Rwy
                                                       Intl.                                    23R, Amdt 11;
                                                                                ILS Rwy 23R (CAT
                                                                                II), Amdt 11;
                                                                                ILS Rwy 23R (CAT
                                                                                III), Amdt 11.
23-Sep-10..........  CA.........  Hanford...........  Hanford Muni.....     0/4457    7/29/10  RNAV (GPS) Rwy
                                                                                32, Amdt 1.
23-Sep-10..........  MA.........  Boston............  Gen Edward            0/5074    7/15/10  RNAV (GPS) Rwy
                                                       Lawrence Logan                           27, Orig-A.
                                                       Intl.
23-Sep-10..........  MA.........  Boston............  Gen Edward            0/5075    7/15/10  RNAV (GPS) Rwy
                                                       Lawrence Logan                           32, Orig-A.
                                                       Intl.
23-Sep-10..........  MA.........  Boston............  Gen Edward            0/5076    7/15/10  RNAV (GPS) Rwy
                                                       Lawrence Logan                           22L, Orig.
                                                       Intl.
23-Sep-10..........  MA.........  Boston............  Gen Edward            0/5081    7/15/10  RNAV (GPS) Rwy
                                                       Lawrence Logan                           33L, Orig-B.
                                                       Intl.
23-Sep-10..........  MA.........  Boston............  Gen Edward            0/5082    7/15/10  RNAV (GPS) Rwy
                                                       Lawrence Logan                           15R, Orig-B.
                                                       Intl.
23-Sep-10..........  ME.........  Pittsfield........  Pittsfield Muni..     0/5401     7/7/10  NDB Rwy 36, Amdt
                                                                                4.
23-Sep-10..........  AK.........  Galena............  Edward G. Pitka,      0/5799    7/15/10  VOR/DME Rwy 25,
                                                       Sr.                                      Amdt 10.
23-Sep-10..........  CQ.........  Saipan............  Saipan/Francisco      0/5800    6/10/10  GPS Rwy 25, Amdt
                                                       C. Ada/Saipan                            1B.
                                                       Intl.
23-Sep-10..........  AK.........  Galena............  Edward G. Pitka,      0/5801    7/15/10  VOR/DME Rwy 7,
                                                       Sr.                                      Amdt 7.
23-Sep-10..........  AK.........  Nome..............  Nome.............     0/6640    6/22/10  RNAV (GPS) Rwy 3,
                                                                                Orig.
23-Sep-10..........  AK.........  Nome..............  Nome.............     0/6641    6/22/10  RNAV (GPS) Rwy
                                                                                10, Orig.
23-Sep-10..........  AK.........  Nome..............  Nome.............     0/6642    6/22/10  NDB/DME Rwy 3,
                                                                                Amdt 2.
23-Sep-10..........  AK.........  Nome..............  Nome.............     0/6643    6/22/10  NDB A, Orig.
23-Sep-10..........  AK.........  Nome..............  Nome.............     0/6644    6/22/10  VOR Rwy 28, Amdt
                                                                                2.
23-Sep-10..........  AK.........  Nome..............  Nome.............     0/6645    6/22/10  VOR/DME Rwy 10,
                                                                                Amdt 2.
23-Sep-10..........  AK.........  Clarks Point......  Clarks Point.....     0/6649    7/15/10  RNAV (GPS) Rwy
                                                                                18, Orig.
23-Sep-10..........  AK.........  Clarks Point......  Clarks Point.....     0/6652    7/15/10  RNAV (GPS) Rwy
                                                                                36, Orig.
23-Sep-10..........  AK.........  Quinhagak.........  Quinhagak........     0/7691    7/15/10  RNAV (GPS) Rwy
                                                                                12, Orig.
23-Sep-10..........  AK.........  Quinhagak.........  Quinhagak........     0/7692    7/15/10  RNAV (GPS) Rwy
                                                                                30, Orig.
23-Sep-10..........  MA.........  Boston............  Gen Edward            0/8349    7/15/10  ILS Or LOC Rwy
                                                       Lawrence Logan                           4R, Amdt 9B.
                                                       Intl.

23-Sep-10..........  MA.........  Boston............  Gen Edward            0/8350    7/15/10  ILS Or LOC Rwy
                                                       Lawrence Logan                           33L, Amdt 3.
                                                       Intl.
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2010-20395 Filed 8-20-10; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 79, Number 219 (Thursday, November 13, 2014)]
[Notices]
[Page 67531]
[FR Doc No: 2014-26731]

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DEPARTMENT OF TRANSPORTATION

Office of the Secretary of Transportation

Notice of Availability of Guidance on Accelerated Decisionmaking
in Environmental Reviews

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

ACTION: Notice of availability.

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SUMMARY: DOT is announcing the availability of guidance implementing
Section 1319 of MAP-21, on Accelerated Decisionmaking in Environmental
Reviews. This section of MAP-21 provides for the use of errata sheets
on the Draft Environmental Impact Statement, in lieu of a Final EIS
(FEIS), when the EIS has limited or factual changes. It also states
that the lead agency under NEPA shall issue a combined FEIS and ROD
unless circumstances exist to make it impracticable. This eliminates
the 30-day wait period between the release of the FEIS and ROD. This
guidance builds on the interim guidance that was released by FHWA and
FTA in January 2013, but applies to the entire Department. The FHWA and
FTA interim guidance is retained as a supplemental appendix specific to
those agencies. The guidance is available at http://www.dot.gov/office-policy/transportation-policy/guidance-accelerated-decision-making-environmental-reviews.

FOR FURTHER INFORMATION CONTACT: Rebecca Higgins, Department of
Transportation, 1200 New Jersey Ave. SE. W84-318, Washington, DC 20590;
email<EMAIL_ADDRESS>telephone<PHONE_NUMBER>.

    Issue Date: November 3, 2014.
Shoshana Lew, Deputy Assistant Secretary for Policy.
[FR Doc. 2014-26731 Filed 11-12-14; 8:45 am]
BILLING CODE 4910-9X-P


[Federal Register Volume 87, Number 41 (Wednesday, March 2, 2022)]
[Notices]
[Pages 11722-11724]
[FR Doc No: 2022-04398]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-3292]

Master Protocols: Efficient Clinical Trial Design Strategies To
Expedite Development of Oncology Drugs and Biologics; 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 final guidance for industry entitled ``Master
Protocols: Efficient Clinical Trial Design Strategies to Expedite
Development of Oncology Drugs and Biologics.'' This guidance provides
advice to sponsors of drugs and biologics for cancer treatment
regarding the design and conduct of clinical trials, other than first-
in-human trials, intended to simultaneously evaluate more than one
investigational drug and/or more than one cancer type within the same
overall trial structure (master protocols) in adult and pediatric
cancers. In contrast to traditional trial designs, where a single drug
is tested in a single disease population in one clinical trial, master
protocols use a single infrastructure, trial design, and protocol to
simultaneously evaluate multiple drugs and/or disease populations in
multiple substudies, allowing for efficient and accelerated drug
development.

DATES: The announcement of the guidance is published in the Federal
Register on March 2, 2022.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2018-D-3292 for ``Master Protocols: Efficient Clinical Trial Design
Strategies to Expedite Development of Oncology Drugs and Biologics.''
Received comments will be placed in the docket

and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002, or 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 that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Lee Pai-Scherf, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 2314, Silver Spring, MD 20993, 301-796-
3400; or Stephen Ripley, Center for Biologics Evaluation and Research,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a final guidance for industry
entitled ``Master Protocols: Efficient Clinical Trial Design Strategies
to Expedite Development of Oncology Drugs and Biologics.''
    This guidance provides recommendations to sponsors of drugs or
biologics for the treatment of cancer regarding the design and conduct
of clinical trials intended to simultaneously evaluate more than one
investigational drug and/or more than one cancer type within the same
overall trial structure (master protocols) in adult and pediatric
cancers. In general, the recommended phase 2 dose should have been
established for an investigational drug or drugs evaluated in a master
protocol. It also describes aspects of master protocol designs and
trial conduct and related considerations, such as biomarker
codevelopment and statistical analysis considerations, and provides
advice on the information that sponsors should submit to FDA and on how
sponsors can interact with FDA to facilitate efficient review.
    This guidance does not address all issues relating to clinical
trial design, statistical analysis, or the biomarker development
process. Those topics are addressed in the International Council for
Harmonisation (ICH) guidances for industry ``E9 Statistical Principles
for Clinical Trials'' and ``E10 Choice of Control Group and Related
Issues in Clinical Trials'' and the guidance for industry and FDA staff
``In Vitro Companion Diagnostic Devices.''
    This guidance finalizes the draft guidance of the same name issued
on October 1, 2018 (83 FR 49398). FDA considered comments received on
the draft guidance as the guidance was finalized. Changes from the
draft to the final guidance include adding information about a dose-
finding or safety lead-in component in basket trials when evaluating an
investigational drug combination and comparison between experimental
arms in umbrella trials and acceptable statistical approaches.
Revisions were also made to various sections of the draft guidance to
clarify the information to be submitted to FDA to support amendments to
expand the protocol, the frequency of cumulative safety updates, the
role of ad hoc institutional review board meetings, the role of the
safety assessment committee, and informed consent requirements.
    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 ``Master Protocols: Efficient Clinical Trial
Design Strategies to Expedite Development of Oncology Drugs and
Biologics.'' It does not establish any rights for any person and is not
binding on FDA or the public. You can use an alternative approach if it
satisfies the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR 314.50(d)(5) (clinical data section) and
(d)(6) (statistical section) have been approved under OMB control
number 0910-0001; the collections of information in 21 CFR part 312,
subpart B, for the submission of investigational new drug applications
(INDs), including protocols, protocol amendments, and information
amendments, have been approved under OMB control number 0910-0014.
Sponsors may request comment and advice on an IND as well as request
meetings with FDA under 21 CFR part 312, subpart C (OMB control number
0910-0014).
    The collections of information in 21 CFR part 11 have been approved
under OMB control number 0910-0303; the collections of information in
parts 50 and 56 for the protection of human subjects and institutional
review boards have been approved under OMB control numbers 0910-0130;
Responsibilities of sponsors and investigators (21 CFR part 312,
subpart D) are also covered under OMB control number 0910-0014; the
collections of information in 21 CFR part 601 have been approved under

OMB control number 0910-0338; the collections of information in
Sec. Sec.  201.56 and 201.57 for the content and format requirements
for labeling of human prescription drug and biological products have
been approved under OMB control number 0910-0572.
    In addition, the following collections of information in FDA's
guidances have been approved by OMB (https://www.fda.gov/regulatory-information/search-fda-guidance-documents):
     Collections in FDA's draft guidance for industry entitled
``Formal Meetings Between the FDA and Sponsors and Applicants for PDUFA
Products'' have been approved under OMB control number 0910-0429.
     Collections in FDA's guidance for industry entitled
``Special Protocol Assessment'' have been approved under OMB control
number 0910-0470.
     Collections in FDA's guidance for industry entitled
``Establishment and Operation of Clinical Trial Data Monitoring
Committees'' have been approved under OMB control number 0910-0581.
     Collections in FDA's guidance for industry entitled
``Oversight of Clinical Investigations--A Risk-Based Approach to
Monitoring'' have been approved under OMB control number 0910-0733.
     Collections in FDA's guidance for industry entitled
``Expedited Programs for Serious Conditions--Drugs and Biologics'' have
been approved under OMB control number 0910-0765.
     Collections in FDA's guidance for industry entitled
``E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1)''
have been approved under OMB control number 0910-0843.

III. Electronic Access

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

    Dated: February 24, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-04398 Filed 3-1-22; 8:45 am]
BILLING CODE 4164-01-P