[Federal Register Volume 84, Number 190 (Tuesday, October 1, 2019)]
[Notices]
[Pages 52114-52115]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-21226]
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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Important to Patients; Draft Guidance for Industry, Food and Drug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the availability of a draft guidance for industry, FDA staff, and other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: 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.
DATES: Submit either electronic or written comments on the draft
guidance by December 30, 2019 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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-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.
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
[[Page 52115]]
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 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 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]; 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 draft 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. 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 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: 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.
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)(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 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'' (available at
https://www.fda.gov/media/99140/download), 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.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, or https://www.regulations.gov.
Dated: September 25, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-21226 Filed 9-30-19; 8:45 am]
BILLING CODE 4164-01-P