[Federal Register Volume 85, Number 218 (Tuesday, November 10, 2020)]
[Notices]
[Pages 71654-71656]
[FR Doc No: 2020-24881]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-1264]

Enhancing the Diversity of Clinical Trial Populations--
Eligibility Criteria, Enrollment Practices, and Trial Designs; 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 ``Enhancing
the Diversity of Clinical Trial Populations--Eligibility Criteria,
Enrollment Practices, and Trial Designs.'' This guidance recommends
approaches that sponsors of clinical trials intended to support a new
drug application or a biologics license application can take to
increase enrollment of underrepresented populations in their clinical
trials. This guidance is being issued, in part, to satisfy the mandates
of the FDA Reauthorization Act of 2017 (FDARA). This guidance finalizes
the draft guidance of the same title issued on June 7, 2019.

DATES: The announcement of the guidance is published in the Federal
Register on November 10, 2020.

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-2019-D-1264 for ``Enhancing the Diversity of Clinical Trial
Populations--Eligibility Criteria, Enrollment Practices, and Trial
Designs.'' 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 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 the Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research, 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: Dat Doan, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 3334, Silver Spring, MD 20993,<PHONE_NUMBER>,
<EMAIL_ADDRESS>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, 240-
402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Enhancing the Diversity of Clinical Trial Populations--
Eligibility Criteria, Enrollment Practices, and Trial Designs.'' In
issuing this guidance, FDA is satisfying the mandates under section
610(a)(3) of FDARA (Pub. L. 115-52).
    One objective of eligibility criteria is to help protect
participants by excluding people for whom the risk of an adverse event
from participation is not likely to be reasonable in relation to any
potential benefit and the importance of the knowledge that may be
expected to result. FDA recognizes that certain exclusions are
appropriate when necessary to help protect these individuals. For
example, patients with varying degrees of kidney or liver impairment
are often excluded early in drug development programs because adequate
information is not available on how to adjust doses for such patients
or whether these patients could be more vulnerable to certain risks.
Medically complex patients with certain concomitant illnesses or those
taking particular drugs may also be excluded from drug development
programs. As data on excretory and metabolic pathways and drug-drug
interactions become available during the drug development program,
allowing appropriate dose adjustments, exclusions related to
concomitant medications or comorbidities should be narrowed. Similarly,
as the safety experience with a product increases, eligibility criteria
should be broadened to include more medically complex participants; any
remaining exclusions should be justified. This guidance provides
recommendations on broadening eligibility criteria in clinical trials
through inclusive trial practices, trial designs, and methodological
approaches.
    Beyond the limitations in participation imposed by narrow
eligibility criteria, potential participants may face additional
challenges to enrolling in clinical trials. A trial requiring
participants to make frequent visits to specific sites may result in an
added burden for participants, especially the elderly, children,
disabled, and cognitively impaired individuals who require
transportation or caregiver assistance, or participants who live far
from research facilities, such as those in rural or remote locations.
Financial costs (e.g., travel, missing work, dependent care) may also
impede participation, and study visits may interfere with jobs and/or
family and community obligations. Moreover,

for individuals under current clinical care on a regularly scheduled
basis (e.g., individuals with multiple chronic conditions), additional
clinical trial study visits may be psychologically, physically, and
financially burdensome and a disincentive for enrollment. This guidance
provides recommendations on how sponsors can improve the diversity of
enrolled participants by accounting for logistical and other
participant-related factors that could limit participation in clinical
trials.
    Clinical trials of investigational drugs intended to treat rare
diseases or conditions present a unique set of challenges. Because of
the limited numbers of patients, maximum participation in clinical
trials is essential for successful trial completion and interpretation.
Rare diseases often affect small, geographically dispersed patient
populations with disease-related travel limitations, so special efforts
may be necessary to enroll and retain these participants to ensure that
a broad spectrum of the patient population is represented. This
guidance provides recommendations on broadening clinical trial
eligibility criteria for clinical trials of investigational drugs
intended to treat rare diseases and recommendations on improving the
enrollment and retention of participants with rare diseases.
    This guidance finalizes the draft guidance of the same title issued
on June 7, 2019 (84 FR 26687). FDA considered comments received on the
draft guidance as the guidance was finalized. Changes to the guidance
include additional recommendations on broadening eligibility criteria,
such as the use of real-world data to find trial participants and the
use of mobile medical professionals to visit participants at their
locations instead of requiring participants to visit distant clinical
trial sites. FDA added information on the inclusion of racial and
ethnic minorities, with recommendations included from FDA's draft
guidance entitled ``Collection of Race and Ethnicity Data in Clinical
Trials.'' FDA also added recommendations on fostering community
engagement and making recruitment events more accessible as well as
information on how to reach participants with little or no internet
access. In addition, editorial changes were made to improve clarity.
    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 ``Enhancing the Diversity of Clinical Trial
Populations--Eligibility Criteria, Enrollment Practices, and Trial
Designs.'' 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.

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/biologics-guidances, or
https://www.regulations.gov.

    Dated: November 4, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-24881 Filed 11-9-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 20 (Tuesday, January 30, 2018)]
[Notices]
[Pages 4397-4398]
[FR Doc No: 2018-01761]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket Number FRA-2018-0002]

Petition for Waiver of Compliance

    Under part 211 of Title 49 of the Code of Federal Regulations
(CFR), this provides the public notice that on December 10, 2017, the
Railroading Heritage of Midwest America Inc. (RHMA) petitioned the
Federal Railroad Administration (FRA) for a waiver of compliance from
certain provisions of the Federal railroad safety regulations contained
at 49 CFR part 230, Steam Locomotive Inspection and Maintenance
Standards. FRA assigned the petition Docket Number FRA-2018-0002.
    RHMA maintains and operates the former Chicago, Milwaukee, St. Paul
& Pacific Railroad (Milwaukee Road) 4-8-4 steam locomotive No. 261.
Built in 1944 by the American Locomotive Company for the Milwaukee
Road, No. 261 is used for educational tours operating in the midwest.
RHMA is seeking relief from section 230.41(a), General, with respect to
the 5-year inspection interval for flexible staybolts with caps.
Specifically, RHMA is requesting permission to perform the 5-year
flexible staybolt inspection at the 7-year, 6-month interval. RHMA
feels that extending the 5-year inspection for removing the caps would
not increase the safety risk to the boiler and the additional cost is
not justified based on the low amount of annual service days.
    A copy of the petition, as well as any written communications
concerning the petition, is available for review online at
www.regulations.gov and in person at the U.S. Department of
Transportation's (DOT) Docket Operations Facility, 1200 New Jersey
Avenue SE, W12-140, Washington, DC 20590. The Docket Operations
Facility is open from 9 a.m. to 5 p.m., Monday through Friday, except
Federal Holidays.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or

comments. FRA does not anticipate scheduling a public hearing in
connection with these proceedings since the facts do not appear to
warrant a hearing. If any interested parties desire an opportunity for
oral comment and a public hearing, they should notify FRA, in writing,
before the end of the comment period and specify the basis for their
request.
    All communications concerning these proceedings should identify the
appropriate docket number and may be submitted by any of the following
methods:
     Website: http://www.regulations.gov. Follow the online
instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Operations Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue SE, W12-140, Washington, DC
20590.
     Hand Delivery: 1200 New Jersey Avenue SE, Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal Holidays.
    Communications received by March 16, 2018 will be considered by FRA
before final action is taken. Comments received after that date will be
considered if practicable.
    Anyone can search the electronic form of any written communications
and comments received into any of our dockets by the name of the
individual submitting the comment (or signing the document, if
submitted on behalf of an association, business, labor union, etc.).
Under 5 U.S.C. 553(c), DOT solicits comments from the public to better
inform its processes. DOT posts these comments, without edit, including
any personal information the commenter provides, to
www.regulations.gov, as described in the system of records notice (DOT/
ALL-14 FDMS), which can be reviewed at https://www.transportation.gov/privacy. See also https://www.regulations.gov/privacyNotice for the
privacy notice of regulations.gov.

Robert C. Lauby,
Associate Administrator for Railroad Safety, Chief Safety Officer.
[FR Doc. 2018-01761 Filed 1-29-18; 8:45 am]
 BILLING CODE 4910-06-P


[Federal Register Volume 88, Number 187 (Thursday, September 28, 2023)]
[Notices]
[Pages 66856-66858]
[FR Doc No: 2023-21252]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-3847]

Agency Information Collection Activities: Proposed Collection;
Comment Request; Adverse Experience Reporting for Licensed Biological
Products; and General Records

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) 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 proposed extension of the collection of
information applicable to required adverse experience reporting for
licensed biological products, and general records associated with the
manufacture and distribution of biological products.

DATES: Submit either electronic or written comments on the collection
of information by November 27, 2023.

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 November 27, 2023. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of November 27, 2023 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-2023-N-3847 for ``Adverse Experience Reporting for Licensed
Biological Products; and General Records.'' 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, 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>.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

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.

Adverse Experience Reporting For Licensed Biological Products; and
General Records--21 CFR Part 600

OMB Control Number 0910-0308--Extension

    This information collection helps support implementation of
statutory and regulatory authorities that govern adverse experience
reporting. Under the Public Health Service Act (PHS Act) (42 U.S.C.
262), FDA may only approve a biologics license application for a
biological product that is safe, pure, and potent. When a biological
product is approved and enters the market, the product is introduced to
a larger patient population in settings different from clinical trials.
New information generated during the postmarketing period offers
further insight into the benefits and risks of the product, and
evaluation of this information is important to ensure its safe use.
Regulations implementing adverse experience reporting (AER)
requirements applicable to biological products are codified in part 600
(21 CFR part 600). Regulations applicable to combination products
subject to regulations in part 600 are found in part 4 (21 CFR part
4)--Regulation of Combination Products. The collections of information
are intended to enable FDA to take actions necessary for the protection
of the public health in response to reports of adverse experiences
related to biologics licensed under any provision of section 351 of the
PHS Act.
    To assist respondents with the reporting provisions of the
information collection, FDA has created both paper-based and electronic
forms. Information may be submitted electronically through MEDWATCH or
the Vaccine Adverse Experience Reporting System (VAERS). AER reports
are filed using the MEDWATCH Form FDA-3500A (approved under OMB control
numbers 0910-0291 and 0910-0645) or the VAERS-1. Both versions of the
forms and instructions are available from the internet at https://vaers.hhs.gov/. The forms may also be downloaded, completed, and
submitted to the Agency by mail or facsimile.
    For operational efficiency, on March 20, 2023, we requested, and
OMB has approved, the addition of burden attributable to provisions set
forth in part 4, subpart B, previously included in OMB control number
0910-0834. When information regarding an event that involves a death or
serious injury, or an adverse event, associated with the use of the
combination product is received by the product sponsor, the information
must be provided to the other constituent part applicant(s) no later
than 5 calendar days after receipt under Sec.  4.103. Relatedly, Sec.
4.104 explains how and where to submit reports.
    We estimate the burden of this collection of information as
follows:

                       Table 1--Estimated Annual Reporting Burden--Biological Products \1\
----------------------------------------------------------------------------------------------------------------
                                                    Number of                     Average burden
   21 CFR section; activity        Number of      responses per    Total annual    per response     Total hours
                                  respondents       respondent       responses      (in hours)
----------------------------------------------------------------------------------------------------------------
600.80(c)(1), 600.80(d), and                109         3,806.95         414,958               1         414,958
 600.80(e); postmarketing 15-
 day Alert Reports............
600.82; notification of                      23            1.435              33               2              66
 discontinuance or
 interruption in manufacturing
600.80(c)(2); Periodic Adverse              109            3,697         402,973              28      11,283,244
 Experience Reports...........
600.81; distribution reports..              172            5.727             985               1             985
600.80(h)(2), 600.81(b)(2),                  35            1.886              66               1              66
 and 600.90; waiver requests..
                               ---------------------------------------------------------------------------------
    Total.....................  ...............  ...............  ..............  ..............      11,699,319
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                       Table 2--Estimated Annual Reporting Burden--Biological Products \1\
----------------------------------------------------------------------------------------------------------------
                                                                                Average burden
                                   Number of        Number of      Total annual         per
   21 CFR section; activity      recordkeepers     records per        records      recordkeeper     Total hours
                                                   recordkeeper                     (in hours)
----------------------------------------------------------------------------------------------------------------
600.12; \2\ Maintenance of                  131           40.145           5,259              32         168,288
 Records......................
600.12(b)(2); Recall Records..              216           3.4028             735              24          17,640
600.80(c)(1) and 600.80(k);                 109         7,503.95         817,931               1         817,931
 AER Records..................
                               ---------------------------------------------------------------------------------
    Total.....................  ...............  ...............  ..............  ..............       1,003,859
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ The recordkeeping requirements in Sec.   610.18(b) are included in the estimate for Sec.   600.12.

                      Table 3--Estimated Annual Reporting Burden--Combination Products \1\
----------------------------------------------------------------------------------------------------------------
                                                  Number of
  21 CFR section; activity       Number of     disclosures per   Total annual     Average burden per     Total
                                respondents      respondents      disclosures   disclosure (in hours)    hours
----------------------------------------------------------------------------------------------------------------
4.102, 4.103, 4.104, 4.105;                11               18             198  0.35 (21 minutes)....         69
 Postmarketing Safety
 Reporting for Combination
 Products, including
 associated reports and
 sharing information with
 other constituent part
 applicants.
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The burden for this information collection has changed since the
last OMB approval. The reporting and recordkeeping burden has increased
mostly due to an increase in the number of AER reports submitted to FDA
and the associated recordkeeping with these reports. We have also added
burden we believe attributable to post marketing safety reporting and
attendant recordkeeping and disclosures, as required under part 4,
subpart B.

    Dated: September 23, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-21252 Filed 9-27-23; 8:45 am]
BILLING CODE 4164-01-P