[Federal Register Volume 85, Number 117 (Wednesday, June 17, 2020)]
[Notices]
[Pages 36600-36601]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-13046]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-D-1893]
Patient-Focused Drug Development: Collecting Comprehensive and
Representative Input; Guidance for Industry, Food and Drug
Administration Staff, and Other Stakeholders; 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, FDA staff, and other
stakeholders entitled ``Patient-Focused Drug Development: Collecting
Comprehensive and Representative Input.'' This guidance is the first of
a series of four methodological guidance documents that FDA committed
to develop to address in a stepwise manner how to collect and submit
information from patients and caregivers for medical product
development and regulatory decision making. This guidance finalizes the
draft guidance of the same title issued on June 13, 2018.
DATES: The announcement of the guidance is published in the Federal
Register on June 17, 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-2018-D-1893 for ``Patient-Focused Drug Development: Collecting
Comprehensive and Representative Input.'' 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.
[[Page 36601]]
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: Meghana Chalasani, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6304, Silver Spring, MD 20993-0002, 240-
402-6525, Fax: 301-847-8443, [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, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry, FDA
staff, and other stakeholders entitled ``Patient-Focused Drug
Development: Collecting Comprehensive and Representative Input.'' This
guidance (Guidance 1) is the first of a series of four guidance
documents that FDA committed to develop to address in a stepwise manner
how stakeholders (patients, researchers, medical product developers,
and others) can collect and submit information on the patient
experience 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 1 is to present methods for collecting information
on the patient experience that is representative of the intended
population to inform the development and evaluation of medical products
throughout the medical product lifecycle. In addition, this document
discusses methods on how to operationalize and standardize the
collection, analysis, and dissemination of patient experience data.
Guidance 1 also includes a glossary of terms that will be used in one
or more of the series of four guidance documents.
From the outset, FDA recognized that developing this guidance would
benefit from public input from the wider community of patients, patient
advocates, academic researchers, expert practitioners, drug developers,
and other stakeholders. On December 18, 2017, FDA conducted a public
workshop to discuss this topic. FDA considered stakeholder input from
the workshop and associated public docket when drafting this guidance
(FDA-2017-N-5896).
This guidance finalizes the draft guidance entitled ``Patient-
Focused Drug Development: Collecting Comprehensive and Representative
Input,'' issued on June 13, 2018 (83 FR 27618). FDA considered comments
received on the draft guidance as the guidance was finalized. Changes
from the draft to the final guidance include removing most of the
section and appendix on methods for collecting and analyzing patient
experience data since that information will be covered in later
guidances in the series. 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 ``Patient-Focused Drug Development:
Collecting Comprehensive and Representative Input.'' 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
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 under 5 CFR 1320.3(h)(5). This guidance also
refers to previously approved FDA collections of information. These
collections of information are subject to review by the Office of
Management and Budget under the Paperwork Reduction Act of 1995 (44
U.S.C. 3501-3521). The collections of information in 21 CFR parts 50
and 56 have been approved under OMB control number 0910-0130.
III. Electronic Access
Persons with access to the internet may obtain the guidance at
either 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: June 10, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-13046 Filed 6-16-20; 8:45 am]
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