Patient-Focused Drug Development: Methods To Identify What Is Important to Patients; Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders; Availability, 11077-11079 [2022-04152]
Download as PDF
11077
Federal Register / Vol. 87, No. 39 / Monday, February 28, 2022 / Notices
automatically be transferred to the grant
recipient’s Performance Data Form;
• Assisted households, regardless of
the type(s) of LIHEAP assistance or
funding source, excluding households
that only receive nominal payments of
$50 or less;
• Assisted households, by type of
LIHEAP assistance and funding source,
having at least one vulnerable member
who is at least 60 years or older,
disabled, or 5 years old or younger;
• Assisted households, by type of
LIHEAP assistance and funding source,
with at least one member age 2 years or
under;
• Assisted households, by type of
LIHEAP assistance and funding source,
with at least one member ages 3 years
through 5 years; and
• Assisted households, regardless of
the type(s) of LIHEAP assistance or
funding source, having at least one
member 60 years or older, disabled, or
5 years old or younger.
Indian tribal grant recipients are
required to submit data only on the
number of households, by funding
source, receiving heating, cooling,
energy crisis, and/or weatherization
benefits.
In FFY 2020, OCS updated the form
to allow for the reporting of households
served by separate LIHEAP funding
types and benefits provided by the
following: (1) Funds from regular
LIHEAP FFY appropriations acts,
including any Continuing Resolutions
and final appropriations acts, reallotted
prior year funds, and federal LIHEAP
funds carried-over to or expended in the
current year; (2) supplemental funds
from the Coronavirus Aid, Relief, and
Economic Security Act (the CARES Act)
(Pub. L. 116–136); and (3) funds from
any subsequent supplemental LIHEAP
appropriations acts. ACF proposes
similar changes to the report for FFY
2022, including the addition of lines
that allow for the reporting of
households served by LIHEAP funds
from the American Rescue Plan Act of
2021 (Pub. L. 117–2). OCS has also
updated the request to reflect the
current number of expected respondents
and appropriate reporting dates.
The information is being collected for
the Department’s annual LIHEAP Report
to Congress. The data also provides
information about the need for LIHEAP
funds. Finally, the data are used in the
calculation of LIHEAP performance
measures under the Government
Performance and Results Act of 1993.
The data elements will allow the
accuracy of measuring LIHEAP targeting
performance and LIHEAP cost
efficiency.
Respondents: State governments,
tribal governments, U.S. territories, and
the District of Columbia.
ANNUAL BURDEN ESTIMATES
Total number
of respondents
Instrument
Assisted Household Report—Long Form ........................................................
Assisted Household Report—Short Form .......................................................
Estimated Total Annual Burden
Hours: 2,710.
Authority: U.S.C. 8629 and 45 CFR.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2022–04085 Filed 2–25–22; 8:45 am]
BILLING CODE 4184–80–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–D–4247]
Patient-Focused Drug Development:
Methods To Identify What Is Important
to Patients; Guidance for Industry,
Food and Drug Administration Staff,
and Other Stakeholders; Availability
AGENCY:
Food and Drug Administration,
HHS.
khammond on DSKJM1Z7X2PROD with NOTICES
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance for industry, FDA staff, and
other stakeholders entitled ‘‘PatientFocused Drug Development: Methods
To Identify What Is Important to
Patients.’’ This guidance (Guidance 2) is
SUMMARY:
VerDate Sep<11>2014
17:23 Feb 25, 2022
Jkt 256001
56
151
the second in a series of four
methodological guidance documents
that FDA committed to develop to
describe how to collect and submit
information from patients and
caregivers to be used for medical
product development and regulatory
decision making. This guidance
finalizes the draft guidance of the same
title issued on October 1, 2019.
DATES: The announcement of the
guidance is published in the Federal
Register on February 28, 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,
PO 00000
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Total number
of responses
per
respondent
1
1
Average
burden hours
per response
43
2
Annual
burden hours
2,408
302
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.’’
E:\FR\FM\28FEN1.SGM
28FEN1
khammond on DSKJM1Z7X2PROD with NOTICES
11078
Federal Register / Vol. 87, No. 39 / Monday, February 28, 2022 / Notices
Instructions: All submissions received
must include the Docket No. FDA–
2019–D–4247 for ‘‘Patient-Focused Drug
Development: Methods To Identify
What Is Important to Patients.’’
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-201509-18/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, 240–402–7500.
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,
VerDate Sep<11>2014
17:23 Feb 25, 2022
Jkt 256001
4th Floor, Silver Spring, MD 20993–
0002, or to 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:
Shannon Cole, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6306,
Silver Spring, MD 20993–0002, 301–
796–9208, Shannon.Cole@fda.hhs.gov,
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, FDA staff, and
other stakeholders entitled ‘‘PatientFocused Drug Development: Methods
To Identify What Is Important to
Patients.’’ This guidance (Guidance 2) is
the second in a series of four
methodological patient-focused drug
development guidance documents that
FDA committed to develop to describe
how stakeholders (patients, researchers,
medical product developers, and others)
can collect and submit information from
patients and caregivers to be used for
medical product development and
regulatory decision making. This series
of guidance documents is intended to
facilitate the advancement and use of
systematic approaches to collect and use
robust and meaningful patient and
caregiver input that can more
consistently inform medical product
development and regulatory decision
making. The purpose of Guidance 2 is
to present a range of methods and
established best research practices to
identify what is important to patients
with respect to burden of disease,
burden of treatment, and the benefits
and risks in the management of the
patient’s disease. In particular, the
methods and best practices presented
can help elicit relevant information
from patients and other stakeholders,
such as how their disease affects their
daily lives; what they find most
troublesome; and the challenges,
problems, and burdens of the treatment
for the disease.
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
This guidance finalizes the draft
guidance entitled ‘‘Patient-Focused
Drug Development: Methods To Identify
What Is Important to Patients’’ issued on
October 1, 2019 (84 FR 52114). FDA
considered comments received on the
draft guidance as the guidance was
finalized. Changes from the draft to the
final guidance include incorporating the
definitions of relevant terms within the
body of the document instead of as part
of a glossary. In addition, editorial
changes and methodological
clarifications 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 ‘‘Patient-Focused
Drug Development: Methods To Identify
What Is Important to Patients.’’ It does
not establish any rights for any person
and is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
This guidance refers to collections of
information from individuals under
treatment or clinical examination in
connection with research, which are not
subject to review by the Office of
Management and Budget (OMB) under 5
CFR 1320.3(h)(5). Therefore, clearance
by the OMB under the Paperwork
Reduction Act of 1995 (PRA) (44 U.S.C.
3501–3521) is not required for this
guidance. This guidance also refers to
previously approved FDA collections of
information. The previously approved
collections of information are subject to
review by OMB under the PRA. The
information collections described in this
guidance are submitted to FDA to
support the medical product’s
effectiveness and to support claims in
approved medical product labeling (see
21 CFR 314.50, 314.126, and 601.2). The
information collections have been
approved under OMB control numbers
0910–0001 and 0910–0338. The
collections of information in 21 CFR
parts 50 and 56 have been approved
under OMB control number 0910–0130.
III. Additional Information
Section 3002 of Title III, Subtitle A, of
the 21st Century Cures Act (Pub. L. 114–
255) directs FDA to develop patientfocused drug development guidance to
address a number of areas including
under section 3002(c)(2):
Methodological approaches that may be
used to develop and identify what is
important to patients with respect to
burden of disease, burden of treatment,
and the benefits and risks in the
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Federal Register / Vol. 87, No. 39 / Monday, February 28, 2022 / Notices
management of the patient’s disease. In
addition, FDA committed to meet
certain performance goals under the
sixth authorization of the Prescription
Drug User Fee Act. These goal
commitments were developed in
consultation with patient and consumer
advocates, healthcare professionals, and
other public stakeholders, as part of
negotiations with regulated industry.
Section J.1 of the commitment letter,
‘‘Enhancing the Incorporation of the
Patient’s Voice in Drug Development
and Decision-Making’’ (https://
www.fda.gov/downloads/ForIndustry/
UserFees/PrescriptionDrugUserFee/
UCM511438.pdf), outlines work,
including the development of a series of
guidance documents and associated
public workshops to facilitate the
advancement and use of systematic
approaches to collect and use robust
and meaningful patient and caregiver
input that can more consistently inform
drug development, and, as appropriate,
regulatory decision making.
IV. Electronic Access
Persons with access to the internet
may obtain the guidance at https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents, or
https://www.regulations.gov.
Dated: February 22, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–04152 Filed 2–25–22; 8:45 am]
BILLING CODE 4164–01–P
11079
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Food and Drug Administration
[Docket No. FDA–2021–N–0002]
[Docket No. FDA–2022–N–0030]
New Animal Drugs; Withdrawal of
Approval of New Animal Drug
Application
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notification of withdrawal.
The Food and Drug
Administration (FDA) is withdrawing
approval of a new animal drug
application (NADA) at the sponsor’s
request because the product is no longer
manufactured or marketed.
DATES: The approval is withdrawn as of
February 28, 2022.
FOR FURTHER INFORMATION CONTACT:
Sujaya Dessai, Center for Veterinary
Medicine (HFV–212), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–402–5761,
sujaya.dessai@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Elanco US
Inc., 2500 Innovation Way, Greenfield,
IN 46140, has requested that FDA
withdraw approval of NADA 093–329
for use of a prolonged-release bolus
containing sulfamethazine in cattle
because the product is no longer
manufactured or marketed.
Therefore, under authority delegated
to the Commissioner of Food and Drugs
and in accordance with § 514.116 Notice
of withdrawal of approval of application
(21 CFR 514.116), notice is given that
approval of NADA 093–329, and all
supplements and amendments thereto,
is hereby withdrawn February 28, 2022.
Elsewhere in this issue of the Federal
Register, FDA is amending the animal
drug regulations to reflect the voluntary
withdrawal of approval of this
application.
SUMMARY:
Dated: February 14, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
Fresenius Kabi USA, LLC, et al.;
Withdrawal of Approval of Five
Abbreviated New Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of five
abbreviated new drug applications
(ANDAs) from multiple applicants. The
applicants notified the Agency in
writing that the drug products were no
longer marketed and requested that the
approval of the applications be
withdrawn.
SUMMARY:
Approval is withdrawn as of
March 30, 2022
DATES:
FOR FURTHER INFORMATION CONTACT:
Martha Nguyen, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1676,
Silver Spring, MD 20993–0002, 240–
402–6980, Martha.Nguyen@fda.hhs.gov.
The
applicants listed in the table have
informed FDA that these drug products
are no longer marketed and have
requested that FDA withdraw approval
of the applications under the process
described in § 314.150(c) (21 CFR
314.150(c)). The applicants have also,
by their requests, waived their
opportunity for a hearing. Withdrawal
of approval of an application or
abbreviated application under
§ 314.150(c) is without prejudice to
refiling.
SUPPLEMENTARY INFORMATION:
[FR Doc. 2022–03539 Filed 2–25–22; 8:45 am]
khammond on DSKJM1Z7X2PROD with NOTICES
BILLING CODE 4164–01–P
Application No.
Drug
Applicant
ANDA 065408 ....
Epirubicin Hydrochloride (HCl) Injection, 150 milligrams (mg)/
75 milliliters (mL) (2 mg/mL), 10 mg/5 mL (2 mg/mL), 50
mg/25 mL (2 mg/mL), and 200 mg/100 mL (2 mg/mL).
Epirubicin HCl Injection, 200 mg/100 mL (2 mg/mL) and 50
mg/25 mL (2 mg/mL).
Idarubicin HCl Injection, 1 mg/mL ............................................
Fludarabine Phosphate for Injection, 50 mg/vial .....................
Gabapentin Capsules, 100 mg, 300 mg, and 400 mg ............
Fresenius Kabi USA, LLC, Three Corporate Dr., Lake Zurich,
IL 60047.
ANDA 065411 ....
ANDA 065440 ....
ANDA 077790 ....
ANDA 091008 ....
VerDate Sep<11>2014
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Do.
Do.
Hospira, Inc., 275 North Field Dr., Lake Forest, IL 60045.
Jiangsu Hengrui Pharmaceuticals Co., Ltd., U.S. Agent,
Venus Pharmaceutical Laboratories Inc., 506 Carnegie
Center, Suite 100, Princeton, NJ 08540.
E:\FR\FM\28FEN1.SGM
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Agencies
[Federal Register Volume 87, Number 39 (Monday, February 28, 2022)]
[Notices]
[Pages 11077-11079]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-04152]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-D-4247]
Patient-Focused Drug Development: Methods To Identify What Is
Important to Patients; Guidance for Industry, Food and Drug
Administration Staff, and Other Stakeholders; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry, FDA staff, and other
stakeholders entitled ``Patient-Focused Drug Development: Methods To
Identify What Is Important to Patients.'' This guidance (Guidance 2) is
the second in a series of four methodological guidance documents that
FDA committed to develop to describe how to collect and submit
information from patients and caregivers to be used for medical product
development and regulatory decision making. This guidance finalizes the
draft guidance of the same title issued on October 1, 2019.
DATES: The announcement of the guidance is published in the Federal
Register on February 28, 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.''
[[Page 11078]]
Instructions: All submissions received must include the Docket No.
FDA-2019-D-4247 for ``Patient-Focused Drug Development: Methods To
Identify What Is Important to Patients.'' 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, 240-402-7500.
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, 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: Shannon Cole, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6306, Silver Spring, MD 20993-0002, 301-
796-9208, [email protected], 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, FDA
staff, and other stakeholders entitled ``Patient-Focused Drug
Development: Methods To Identify What Is Important to Patients.'' This
guidance (Guidance 2) is the second in a series of four methodological
patient-focused drug development guidance documents that FDA committed
to develop to describe how stakeholders (patients, researchers, medical
product developers, and others) can collect and submit information from
patients and caregivers to be used for medical product development and
regulatory decision making. This series of guidance documents is
intended to facilitate the advancement and use of systematic approaches
to collect and use robust and meaningful patient and caregiver input
that can more consistently inform medical product development and
regulatory decision making. The purpose of Guidance 2 is to present a
range of methods and established best research practices to identify
what is important to patients with respect to burden of disease, burden
of treatment, and the benefits and risks in the management of the
patient's disease. In particular, the methods and best practices
presented can help elicit relevant information from patients and other
stakeholders, such as how their disease affects their daily lives; what
they find most troublesome; and the challenges, problems, and burdens
of the treatment for the disease.
This guidance finalizes the draft guidance entitled ``Patient-
Focused Drug Development: Methods To Identify What Is Important to
Patients'' issued on October 1, 2019 (84 FR 52114). FDA considered
comments received on the draft guidance as the guidance was finalized.
Changes from the draft to the final guidance include incorporating the
definitions of relevant terms within the body of the document instead
of as part of a glossary. In addition, editorial changes and
methodological clarifications 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 ``Patient-Focused Drug Development: Methods
To Identify What Is Important to Patients.'' It does not establish any
rights for any person and is not binding on FDA or the public. You can
use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
This guidance refers to collections of information from individuals
under treatment or clinical examination in connection with research,
which are not subject to review by the Office of Management and Budget
(OMB) under 5 CFR 1320.3(h)(5). Therefore, clearance by the OMB under
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. This guidance also refers to previously
approved FDA collections of information. The previously approved
collections of information are subject to review by OMB under the PRA.
The information collections described in this guidance are submitted to
FDA to support the medical product's effectiveness and to support
claims in approved medical product labeling (see 21 CFR 314.50,
314.126, and 601.2). The information collections have been approved
under OMB control numbers 0910-0001 and 0910-0338. The collections of
information in 21 CFR parts 50 and 56 have been approved under OMB
control number 0910-0130.
III. Additional Information
Section 3002 of Title III, Subtitle A, of the 21st Century Cures
Act (Pub. L. 114-255) directs FDA to develop patient-focused drug
development guidance to address a number of areas including under
section 3002(c)(2): Methodological approaches that may be used to
develop and identify what is important to patients with respect to
burden of disease, burden of treatment, and the benefits and risks in
the
[[Page 11079]]
management of the patient's disease. In addition, FDA committed to meet
certain performance goals under the sixth authorization of the
Prescription Drug User Fee Act. These goal commitments were developed
in consultation with patient and consumer advocates, healthcare
professionals, and other public stakeholders, as part of negotiations
with regulated industry. Section J.1 of the commitment letter,
``Enhancing the Incorporation of the Patient's Voice in Drug
Development and Decision-Making'' (https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM511438.pdf), outlines
work, including the development of a series of guidance documents and
associated public workshops to facilitate the advancement and use of
systematic approaches to collect and use robust and meaningful patient
and caregiver input that can more consistently inform drug development,
and, as appropriate, regulatory decision making.
IV. 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,
https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.
Dated: February 22, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-04152 Filed 2-25-22; 8:45 am]
BILLING CODE 4164-01-P