[Federal Register Volume 83, Number 245 (Friday, December 21, 2018)]
[Notices]
[Pages 65690-65691]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-27657]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-D-4455]
Developing and Submitting Proposed Draft Guidance Relating to
Patient Experience Data; Draft Guidance for Industry and Other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the availability of a draft guidance for industry entitled ``Developing
and Submitting Proposed Draft Guidance Relating to Patient Experience
Data.'' This draft guidance is being developed under the 21st Century
Cures Act (Cures Act), which directs FDA to issue guidance on how a
person seeking to develop and submit a proposed draft guidance relating
to patient experience data for consideration by FDA may submit such
proposed draft guidance to the Agency.
DATES: Submit either electronic or written comments on the draft
guidance by March 21, 2019 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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-2018-D-4455 for ``Developing and Submitting Proposed Draft Guidance
[[Page 65691]]
Relating to Patient Experience Data.'' 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; or the Office of Communication, Outreach and Development,
Center for Biologics Evaluation and Research (CBER), 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. The draft guidance may also be
obtained by mail by calling CBER at 1-800-835-4709 or 240-402-8010. See
the SUPPLEMENTARY INFORMATION section for electronic access to the
guidance document.
FOR FURTHER INFORMATION CONTACT: Pujita Vaidya, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1144, Silver Spring, MD 20993-0002, 301-
796-0684, 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
and other stakeholders entitled ``Developing and Submitting Proposed
Draft Guidance Relating to Patient Experience Data.'' This draft
guidance in being developed under section 3002(c)(5) of the Cures Act,
which directs FDA to issue guidance on how a person seeking to develop
and submit a proposed draft guidance relating to patient experience
data for consideration by FDA may submit such proposed draft guidance
to the Agency (see the Cures Act, https://www.congress.gov/114/plaws/publ255/PLAW-114publ255.pdf
Patient experience data should be collected and analyzed in a
methodologically sound and fit-for-purpose manner. There are several
options for contributing patient experience data to the medical product
development and regulatory decision-making process. One option is for
stakeholders to submit proposed recommendations and considerations
informed by patient experience data in the form of a proposed draft
guidance. Proposed draft guidance relating to patient experience data
that is developed and submitted by external stakeholders can be helpful
in bringing the patient's perspective into medical product development
and regulatory decision-making.
As stated previously, submitting proposed draft guidance for FDA's
consideration is not the only option for contributing patient
experience data. Patients, caregivers, patient and disease advocacy
groups, and other stakeholders with knowledge of or access to the
patient community, may be well-positioned to also make broader
contributions to advance medical product development. Recognizing that
stakeholders may be interested in pursuing other pathways to contribute
patient experience data, this draft guidance addresses questions
relating to both guidance development and other potential pathways for
contributing patient experience data.
In FDA's ``Plan for Issuance of Patient-Focused Drug Development
Guidance'' (Plan), available at https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM563618.pdf, the Agency
proposed issuing a draft guidance addressing this topic described in
section 3002 of the Cures Act during the second quarter of 2018. FDA
recognized that, like the other patient-focused drug development
guidances described in the Plan, developing this draft guidance would
also benefit from public input from the wider community of patients,
patient advocates, academic researchers, expert practitioners, drug
developers, and other stakeholders before FDA's drafting of the
guidance. On March 19, 2018, FDA conducted a public workshop to discuss
this topic. After the public workshop, FDA considered stakeholder input
from the workshop and the public docket and is now publishing this
draft guidance.
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 ``Developing
and Submitting Proposed Draft Guidance Relating to Patient Experience
Data.'' 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. 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/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
https://www.regulations.gov.
Dated: December 18, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-27657 Filed 12-20-18; 8:45 am]
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