[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draft guidance of the same title issued on June 13, 2018.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, Meghana.Chalasani@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, Stephen.Ripley@fda.hhs.gov.

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]
BILLING CODE 4164-01-P


