[Federal Register Volume 85, Number 48 (Wednesday, March 11, 2020)]
[Notices]
[Pages 14190-14191]
[FR Doc No: 2020-04953]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RD20-1-000]

Commission Information Collection Activities (FERC-725G); Comment
Request; Extension

AGENCY: Federal Energy Regulatory Commission.

ACTION: Notice of information collection and request for comments.

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SUMMARY: In compliance with the requirements of the Paperwork Reduction
Act of 1995, the Federal Energy Regulatory Commission (Commission or
FERC) is soliciting public comment on the currently approved
information collection FERC-725G (Mandatory Reliability Standards for
the Bulk-Power System: PRC Standards: Regional Reliability Standard
PRC-006-NPCC-2 Automatic Underfrequency Load-Shedding (UFLS)) and
submitting the information collection to the Office of Management and
Budget (OMB) for review. Any interested person may file comments
directly with OMB and should address a copy of those comments to the
Commission as explained below.

DATES: Comments on the collection of information are due May 11, 2020.

ADDRESSES: Comments filed with OMB, identified by OMB Control No. 1902-
0252, should be sent via email to the Office of Information and
Regulatory Affairs<EMAIL_ADDRESS>Attention: Federal Energy
Regulatory Commission Desk Officer.
    A copy of the comments should also be sent to the Commission, in
Docket No. RD20-1-000, by either of the following methods:
     eFiling at Commission's Website: http://www.ferc.gov/docs-filing/efiling.asp
     Mail/Hand Delivery/Courier: Federal Energy Regulatory
Commission, Secretary of the Commission, 888 First Street NE,
Washington, DC 20426.
    Instructions: All submissions must be formatted and filed in
accordance with submission guidelines at: http://www.ferc.gov/help/submission-guide.asp. For user assistance, contact FERC Online Support
by email at<EMAIL_ADDRESS>or by phone at:<PHONE_NUMBER>
(toll-free), or<PHONE_NUMBER> for TTY.
    Docket: Users interested in receiving automatic notification of
activity in this docket or in viewing/downloading comments and
issuances in this docket may do so at http://www.ferc.gov/docs-filing/docs-filing.asp.

FOR FURTHER INFORMATION CONTACT: Ellen Brown may be reached by email at
<EMAIL_ADDRESS>telephone at<PHONE_NUMBER>, and fax at (202)
273-0873.

SUPPLEMENTARY INFORMATION:
    Title: FERC-725G (Mandatory Reliability Standards for the Bulk-
Power System: Regional Reliability Standard PRC-006-NPCC-2, Automatic
Underfrequency Load-Shedding (UFLS).
    OMB Control No.: 1902-0252.
    Type of Request: Revisions to the information collection, as
discussed in Docket No. RD20-1-000.
    Abstract: The proposed regional Reliability Standard applies to
generator owners, planning coordinators, distribution providers, and
transmission owners in the Northeast Power Coordinating Council Region
and is designed to ensure the development of an effective automatic
underfrequency load shedding (UFLS) program to preserve the security
and integrity of the Bulk-Power System during declining system
frequency events in coordination with the NERC continent-wide UFLS
Reliability Standard PRC-006-1. The Commission also proposes to approve
the related violation risk factors, violation severity levels,
implementation plan, and effective date proposed by NERC.
    On August 8, 2005, Congress enacted into law the Electricity
Modernization Act of 2005, which is Title XII, Subtitle A, of the
Energy Policy Act of 2005 (EPAct 2005).\1\ EPAct 2005 added a new
section 215 to the FPA, which required a Commission-certified Electric
Reliability Organization (ERO) to develop mandatory and enforceable
Reliability Standards, which are subject to Commission review and
approval. Once approved, the Reliability Standards may be enforced by
the ERO subject to Commission oversight, or the Commission can
independently enforce Reliability Standards.\2\
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    \1\ Energy Policy Act of 2005, Public Law No. 109-58, Title XII,
Subtitle A, 119 Stat. 594, 941 (codified at 16 U.S.C. 824o).
    \2\ 16 U.S.C. 824o(e)(3).
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    On February 3, 2006, the Commission issued Order No. 672,
implementing section 215 of the FPA.\3\ Pursuant to Order No. 672, the
Commission certified one organization, North American Electric
Reliability Corporation (NERC), as the ERO.\4\ The Reliability
Standards developed by the ERO and approved by the Commission apply to
users, owners and operators of the Bulk-Power System as set forth in
each Reliability Standard.
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    \3\ Rules Concerning Certification of the Electric Reliability
Organization; and Procedures for the Establishment, Approval, and
Enforcement of Electric Reliability Standards, Order No. 672, FERC
Stats. & Regs. ] 31,204, order on reh'g, Order No. 672-A, FERC
Stats. & Regs. ] 31,212 (2006).
    \4\ North American Electric Reliability Corp., 116 FERC ]
61,062, order on reh'g and compliance, 117 FERC ] 61,126 (2006),
order on compliance, 118 FERC ] 61,190, order on reh'g, 119 FERC ]
61,046 (2007), aff'd sub nom. Alcoa Inc. v. FERC, 564 F.3d 1342
(D.C. Cir. 2009).
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    On December 23, 2019, the North American Electric Reliability
Corporation (NERC) and Northeast Power Coordinating Council, Inc.
(NPCC) filed a joint petition seeking approval of proposed regional
Reliability Standard PRC-006-NPCC-2 (NPCC Automatic Underfrequency Load
Shedding). NERC and NPCC state that regional Reliability Standard PRC-
006-NPCC-2 establishes consistent and coordinated requirements for the
design,

implementation, and analysis of automatic underfrequency load shedding
(UFLS) programs among all NPCC applicable entities. These requirements
are more stringent and specific than the NERC continent-wide UFLS
Reliability Standard, PRC-006-3, and were established such that the
declining frequency is arrested and recovered in accordance with NPCC
performance requirements. NPCC revised currently effective Regional
Reliability Standard PRC-006-NPCC-1 to remove redundancies with the
Reliability Standard PRC-006-3, clarify obligations for registered
entities, improve communication of island boundaries to affected
registered entities, and provide entities with the flexibility to
calculate net load shed for UFLS in certain situations.
    On February 19, 2020, the Commission issued a Delegated Letter
Order, Docket No. RD20-1-000, approving proposed Reliability Standard
PRC-006-NPCC-2, the associated VRFs and VSLs, the Effective Date, and
the retirement of the currently effective Regional Reliability Standard
PRC-006-NPCC-1. The effective date for Reliability Standard PRC-006-
NPCC-2 is as of the date of this order, January 18, 2020.
    Type of Respondents: Generator owners, planning coordinators,
distribution providers, and transmission owners in the Northeast Power
Coordinating Council (NPCC) Region.
    Estimate of Annual Burden: \5\ Our estimates are based on the NERC
Compliance Registry Summary of Entities as of January 31, 2019.
According to the NERC compliance registry, and Functions as of, which
indicates there are registered as GO, PC, DP and TO entities.
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    \5\ Burden is defined as the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or provide information to or for a federal agency. See 5
CFR 1320 for additional information on the definition of information
collection burden.
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    The individual burden estimates are based on the time needed to
gather data, run studies, and analyze study results to design or update
the underfrequency load shedding programs. Additionally, documentation
and the review of underfrequency load shedding program results by
supervisors and management is included in the administrative
estimations. These are consistent with estimates for similar tasks in
other Commission approved standards.
    Estimates for the additional burden and cost imposed by the order
in Docket No. RD20-1-000 follow:
    Commission estimates the annual burden and cost \6\ as follows.
Burden and cost for the information collection as follows:
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    \6\ The Commission staff estimates that industry is similarly
situated in terms of hourly cost (for wages plus benefits). Based on
the Commission's FY (Fiscal Year) 2019 average cost (for wages plus
benefits), $80.00/hour is used.

    RD20-1-000--Mandatory Reliability Standards for the Bulk-Power System: Regional Reliability Standard PRC-006-NPCC-2 Automatic Underfrequency Load
                                                                        Shedding
                                                                         [UFLS]
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                                                   Average annual
    Reliability standard &       Average annual      number of      Average annual    Average burden hrs. &     Total annual burden hours &    Cost per
          requirement             number \1\ of    responses per   total number of    cost ($) per response         cost ($) (rounded)        respondent
                                   respondents       respondent       responses                                                                  ($)
                                             (1)              (2)  (1) * (2) = (3)  (4)......................  (3) * (4) = (5).............    (5) / (1)
--------------------------------------------------------------------------------------------------------------------------------------------------------
GO............................               125                1              125  24 hrs.; $80.............  3,000 hrs.; $10,000.........          $80
PC............................                 2                1                2  24 hrs.; $80.............  48 hrs.; $160...............          $80
DP............................                51                1               51  24 hrs.; $80.............  1,224 hrs.; $4,080..........          $80
TO............................                39                1               39  24 hrs.; $80.............  936 hrs.; $3,120............  ...........
                               ----------------------------------------------------                           ------------------------------------------
    Total.....................  ................  ...............  ...............  .........................  5,208 hrs.; $17,360.........  ...........
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Comments: Comments are invited on: (1) Whether the collection of
information is necessary for the proper performance of the functions of
the Commission, including whether the information will have practical
utility; (2) the accuracy of the agency's estimate of the burden and
cost of the collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility and clarity of the information collection; and (4) ways to
minimize the burden of the collection of information on those who are
to respond, including the use of automated collection techniques or
other forms of information technology.

    Dated: March 5, 2020.
Kimberly D. Bose,
Secretary.
[FR Doc. 2020-04953 Filed 3-10-20; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 229 (Tuesday, November 29, 2016)]
[Notices]
[Pages 85974-85976]
[FR Doc No: 2016-28654]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-E-0622]

Determination of Regulatory Review Period for Purposes of Patent
Extension; NUWIQ

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for NUWIQ and is publishing this notice of
that determination as required by law. FDA has made the determination
because of the submission of an application to the Director of the U.S.
Patent and Trademark Office (USPTO), Department of Commerce, for the
extension of a patent which claims that human biological product.

DATES: Anyone with knowledge that any of the dates as published (see
the SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by January
30, 2017. Furthermore, any interested person may petition FDA for a
determination regarding whether the applicant for extension acted with
due diligence during the regulatory review period by May 30, 2017. See
``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

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-2016-E-0622 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; NUWIQ.'' 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.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human biological products, the
testing phase begins when the exemption to permit the clinical
investigations of the biological becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human biological product and
continues until FDA grants permission to market the biological product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, half the testing phase must be subtracted as well as any
time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
biological product will include all of the testing phase and approval
phase as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human biologic product NUWIQ
(Antihemophilic Factor (Recombinant)). NUWIQ is indicated for adults
and children with Hemophilia A for:
     On-demand treatment and control of bleeding episodes;
     perioperative management of bleeding;
     routine prophylaxis to reduce the frequency of bleeding
episodes.

Subsequent to this approval, the USPTO received a patent term
restoration application for NUWIQ (U.S. Patent No. 7,572,619) from
Octapharma AG, and the USPTO requested FDA's assistance in determining
this patent's eligibility for patent term restoration. In a letter
dated April 20, 2016, FDA advised the USPTO that this human biological
product had undergone a regulatory review period and that the approval
of NUWIQ represented the first permitted commercial marketing or use of
the product. Thereafter, the USPTO requested that FDA determine the
product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
NUWIQ is 2,622 days. Of this time, 2,165 days occurred during the
testing phase of the regulatory review period, while 457 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(i)) became effective: July 2,
2008. FDA has verified the applicant's claim that the date the
investigational new drug application became effective was on July 2,
2008.
    2. The date the application was initially submitted with respect to
the human biological product under section 351 of the Public Health
Service Act (42 U.S.C. 262): June 5, 2014. FDA has verified the
applicant's claim that the biologics license application (BLA) for
NUWIQ (BLA 125555/0) was initially submitted on June 5, 2014.
    3. The date the application was approved: September 4, 2015. FDA
has verified the applicant's claim that BLA 125555/0 was approved on
September 4, 2015.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 1,336 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and ask for
a redetermination (see DATES). Furthermore, any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must be timely (see DATES) and contain
sufficient facts to merit an FDA investigation. (See H. Rept. 857, part
1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the
format specified in 21 CFR 10.30.
    Submit petitions electronically to http://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written

petitions (two copies are required) to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

    Dated: November 22, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-28654 Filed 11-28-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 200 (Tuesday, October 18, 2022)]
[Notices]
[Pages 63080-63082]
[FR Doc No: 2022-22617]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-D-1744]

Characterizing, Collecting, and Reporting Immune-Mediated Adverse
Reactions in Cancer Immunotherapeutic Clinical Trials; Draft Guidance
for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled
``Characterizing, Collecting, and Reporting Immune-Mediated Adverse
Reactions in Cancer Immunotherapeutic Clinical Trials.'' This guidance
is intended for sponsors of cancer immunotherapeutic drugs that
modulate the endogenous immune system and may break immunologic
tolerance to normal organs and tissues; it provides recommendations
regarding the data that should be collected and evaluated

to assess whether adverse events are immune-mediated adverse reactions
(imARs) and the data on imARs that should be included in a new drug
application (NDA) or biologics license application (BLA) for a cancer
immunotherapeutic drug.

DATES: Submit either electronic or written comments on the draft
guidance by December 19, 2022 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2022-D-1744 for ``Characterizing, Collecting, and Reporting Immune-
Mediated Adverse Reactions in Cancer Immunotherapeutic Clinical
Trials.'' Received comments will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Marc Theoret, Center for Drug
Evaluation and Research (HFD-150), Food and Drug Administration, 10903
New Hampshire Ave, Silver Spring, MD 20993-0002,<PHONE_NUMBER>; or
Stephen Ripley, Center for Biologics Evaluation and Research, Office of
Communication, Outreach, and Development, 10903 New Hampshire Ave.,
Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Characterizing, Collecting, and Reporting Immune-Mediated
Adverse Reactions in Cancer Immunotherapeutic Clinical Trials.'' This
guidance is intended for sponsors of cancer immunotherapeutic drugs
that modulate the endogenous immune system and may break immunologic
tolerance to normal organs and tissues; it provides recommendations
regarding the data that should be collected and evaluated to assess
whether adverse events are imARs and the data on imARs that should be
included in an NDA or BLA for a cancer immunotherapeutic drug.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on
``Characterizing, Collecting, and Reporting Immune-Mediated Adverse
Reactions in Cancer Immunotherapeutic Clinical Trials.'' 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 part 312 have been approved under OMB control
number 0910-0014; the collections of information in 21 CFR part 314
including the submission of labeling, have been approved under OMB
control number 0910-0001; and the collections

of information in 21 CFR part 601 have been approved under OMB control
number 0910-0338.

III. Electronic Access

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

    Dated: October 11, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-22617 Filed 10-17-22; 8:45 am]
BILLING CODE 4164-01-P