[Federal Register Volume 89, Number 173 (Friday, September 6, 2024)]
[Notices]
[Pages 72856-72858]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-20069]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-1580]


Incorporating Voluntary Patient Preference Information Over the 
Total Product Life Cycle; Guidance for Industry, Food and Drug 
Administration Staff and Other Interested Parties; 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the availability of the draft guidance entitled ``Incorporating 
Voluntary Patient Preference Information over the Total Product Life 
Cycle.'' This draft guidance explains the principal concepts that 
sponsors and other interested parties should consider when choosing to 
collect and submit patient preference information (PPI). The knowledge 
gleaned from the use of PPI could be used across the total product life 
cycle, including for review in investigational device exemption (IDE) 
applications, premarket approval (PMA) applications, humanitarian 
device exemption (HDE) applications, De Novo classification requests, 
or premarket notifications (510(k)s). This draft guidance also 
discusses FDA's inclusion of PPI in its decision summaries and provides 
recommendations for the inclusion of such information in device 
labeling for certain devices. This draft guidance is not final nor is 
it for implementation at this time.

DATES: Submit either electronic or written comments on the draft 
guidance by December 5, 2024 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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'').

[[Page 72857]]

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-2015-D-1580 for ``Incorporating Voluntary Patient Preference 
Information over the Total Product Life Cycle.'' 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.
     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)).
    An electronic copy of the guidance document is available for 
download from the internet. See the SUPPLEMENTARY INFORMATION section 
for information on electronic access to the guidance. Submit written 
requests for a single hard copy of the draft guidance document entitled 
``Incorporating Voluntary Patient Preference Information over the Total 
Product Life Cycle'' to the Office of Policy, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your 
request.

FOR FURTHER INFORMATION CONTACT: David Gebben, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1316, Silver Spring, MD 20993-0002, 301-796-6461 or 
James Myers, Center for Biologics Evaluation and Research, Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, 
Silver Spring, MD 20993, 240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance entitled 
``Incorporating Voluntary Patient Preference Information over the Total 
Product Life Cycle.'' FDA believes that patients can and should bring 
their own experiences to bear in helping the Agency to evaluate the 
benefit-risk profiles of certain devices. This kind of input can be 
important to consider during FDA's decision-making for these devices 
across the total product life cycle.
    This draft guidance proposes expanded recommendations to the 2016 
guidance entitled ``Patient Preference Information--Voluntary 
Submission, Review in Premarket Approval Applications, Humanitarian 
Device Exemption Applications, and De Novo Requests, and Inclusion in 
Decision Summaries and Device Labeling'' (2016 PPI Guidance). Since the 
issuance of the 2016 PPI Guidance, there have been many developments in 
the use of PPI for devices, including an increase in industry-sponsored 
PPI studies provided to FDA for consideration as part of a benefit-risk 
assessment, and numerous collaborations between FDA scientists and a 
variety of interested parties to conduct PPI studies to inform clinical 
trial design and FDA decision making across a wide range of diseases, 
conditions, and device areas. In addition, FDA has cohosted or 
participated in numerous convenings and international collaborations to 
advance scientific methods and practical applications of PPI. 
Meanwhile, FDA has expanded its benefit-risk guidance framework to 
apply to the total product life cycle, including the submission and 
review of IDE applications, 510(k)s, PMAs, De Novo requests, and HDEs 
applications, and FDA decisions involving administrative, enforcement, 
and other actions. This expansion of the 2016 PPI Guidance is intended 
to reflect this broadened scope as well as developments in the field of 
health preference research.
    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 
``Incorporating Voluntary Patient Preference Information over the Total 
Product Life Cycle.'' 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. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do 
so by downloading an electronic copy from the internet. A search 
capability for all Center for Devices and Radiological Health guidance 
documents is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also 
available at https://www.regulations.gov, https://www.fda.gov/regulatory-information/search-fda-guidance-documents or https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics. Persons unable to download an electronic copy of 
``Incorporating Voluntary Patient Preference Information over the Total 
Product Life Cycle'' may send an email request to [email protected] to receive an electronic copy of the document. 
Please use the document number GUI01500006 and complete title to

[[Page 72858]]

identify the guidance you are requesting.

III. Paperwork Reduction Act of 1995

    While this guidance contains no new collection of information, it 
does refer to previously approved FDA collections of information. The 
previously approved collections of information are subject to review by 
the Office of Management and Budget (OMB) under the Paperwork Reduction 
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information 
in the following table have been approved by OMB:

------------------------------------------------------------------------
 21 CFR part; guidance; or FDA
             form                       Topic           OMB control No.
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807, subpart E................  Premarket                      0910-0120
                                 notification.
814, subparts A through E.....  Premarket approval...          0910-0231
814, subpart H................  Humanitarian Use               0910-0332
                                 Devices;
                                 Humanitarian Device
                                 Exemption.
812...........................  Investigational                0910-0078
                                 Device Exemption.
860, subpart D................  De Novo                        0910-0844
                                 classification
                                 process.
``Requests for Feedback and     Q-submissions and              0910-0756
 Meetings for Medical Device     Early Payor Feedback
 Submissions: The Q-Submission   Request Programs for
 Program''.                      Medical Devices.
800, 801, 809, and 830........  Medical Device                 0910-0485
                                 Labeling
                                 Regulations; Unique
                                 Device
                                 Identification.
50, 56........................  Protection of Human            0910-0130
                                 Subjects and
                                 Institutional Review
                                 Boards.
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    Dated: August 30, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-20069 Filed 9-5-24; 8:45 am]
BILLING CODE 4164-01-P