[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Developing and Submitting Proposed Draft Guidance Relating to 
Patient Experience Data; Draft Guidance for Industry and Other 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the availability of a draft guidance for industry entitled ``Developing 
and Submitting Proposed Draft Guidance Relating to Patient Experience 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 This draft guidance is being developed under the 21st Century 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person seeking to develop and submit a proposed draft guidance relating 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proposed draft guidance to the Agency.

DATES: Submit either electronic or written comments on the draft 
guidance by March 21, 2019 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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:
    <bullet> 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.
    <bullet> 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:
    <bullet> 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.
    <bullet> 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.
    <bullet> 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, <a href="/cdn-cgi/l/email-protection#f28287989b8693dc84939b968b93b2949693dc9a9a81dc959d84"><span class="__cf_email__" data-cfemail="a3d3d6c9cad7c28dd5c2cac7dac2e3c5c7c28dcbcbd08dc4ccd5">[email protected]</span></a>; 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]
 BILLING CODE 4164-01-P


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