[Federal Register Volume 83, Number 114 (Wednesday, June 13, 2018)]
[Notices]
[Pages 27618-27619]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12636]
[[Page 27618]]
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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Representative Input; Draft Guidance for Industry, Food and Drug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the availability of a draft guidance for industry, FDA staff, and other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 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.
DATES: Submit either electronic or written comments on the draft
guidance by September 11, 2018 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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-2018-D-1893 for ``Patient-Focused Drug Development: Collecting
Comprehensive and Representative Input; Draft Guidance for Industry,
Food and Drug Administration Staff, and Other Stakeholders;
Availability.'' 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.
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.gpo.gov/fdsys/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.
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: Meghana Chalasani, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1146, Silver Spring, MD 20993-0002, 240-
402-6525, Fax: 301-847-8443, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing availability of a draft 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 from patients and
caregivers 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
[[Page 27619]]
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.
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 ``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.
This guidance is not subject to Executive Order 12866.
II. 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)(1) (methodological approaches), which are relevant and
objective and ensure that such data are accurate and representative of
the intended population, that a person seeking to collect patient
experience data to inform regulatory decision making may use.
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
I.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 utilize
robust and meaningful patient and caregiver input that can more
consistently inform drug development, and, as appropriate, regulatory
decision making.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.
Dated: June 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-12636 Filed 6-12-18; 8:45 am]
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