[Federal Register Volume 84, Number 86 (Friday, May 3, 2019)]
[Notices]
[Pages 19084-19085]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-09051]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-1619]


List of Patient Preference-Sensitive Priorities; Establishment of 
a Public Docket; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of a public docket; request for comments.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
announcing the availability of the list of patient preference-sensitive 
priorities on FDA's website entitled, ``Patient Preference-Sensitive 
Areas: Using Patient Preference Information (PPI) in Medical Device 
Evaluation.'' As part of FDA's commitments for the reauthorization of 
the Medical Device User Fee Amendments of 2017 (MDUFA IV), the Center 
for Devices and Radiological Health (CDRH) committed to publish a list 
of priority areas where preference-sensitive data can inform regulatory 
decision making. FDA is also establishing a docket to solicit public 
input on this list of preference-sensitive areas that may impact the 
design and conduct of premarket medical device clinical studies, 
benefit-risk assessments, and postmarket evaluation.

DATES: Submit either electronic or written comments on the notice by 
July 2, 2019 to ensure that the Agency considers your comment on the 
list of patient preference-sensitive priorities.

ADDRESSES: You may submit comments on this notice 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 Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for 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-N-1619 for ``List of Patient Preference-Sensitive Priorities; 
Establishment of a Public Docket; Requests for Comments'' 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.

FOR FURTHER INFORMATION CONTACT: Anindita Saha, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5414, Silver Spring, MD 20993-0002, 301-796-2537.

SUPPLEMENTARY INFORMATION:

I. Background

    In 2016, the FDA issued 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--
Guidance for Industry, Food and Drug Administration Staff, and Other 
Stakeholders'' (Ref. 1), outlining how stakeholders, including industry 
and patient advocacy organizations, can voluntarily collect and submit 
PPI that may be used by FDA staff in regulatory decision making.
    As part of FDA's commitment for the reauthorization of MDUFA IV), 
FDA committed to advancing patient input and involvement and to 
identify patient preference-sensitive priority areas that may inform 
regulatory decision making (Ref. 2). FDA seeks to successfully build on 
our strong commitment to patients by engaging them to understand and 
considering their experience and perspectives, as it relates to medical 
device clinical studies, benefit-risk assessments, and postmarket 
surveillance.
    As such, on December 7-8, 2017, FDA cohosted a collaborative 
workshop with the Centers of Excellence in Regulatory Science and 
Innovation entitled, ``Advancing Use of Patient Preference Information 
as Scientific Evidence in Medical Product Evaluation'' (Ref. 3). This 
workshop discussed the current progress on incorporating PPI into

[[Page 19085]]

benefit-risk assessments and used case examples, explored PPI methods, 
and future research topics to improve the use of PPI in regulatory 
decisions.
    Based on feedback attained during the workshop, FDA identified the 
following parameters to assist in the identification of the priority 
list of patient preference-sensitive areas for medical device review, 
where:
     FDA staff are looking to better understand the full impact 
of the disease or condition and treatment options on patients and/or 
caregivers;
     Patients may value the benefits and risks of a technology 
or treatment differently from healthcare professionals and/or 
caregivers;
     Population-level differences in patient perspectives are 
not well understood, due to differences in:
    [cir] Demographic characteristics;
    [cir] Stages of disease; or
    [cir] Disease phenotype; and
     There is significant public health impact (such as high 
mortality or morbidity rates and high prevalence rates of the disease, 
or few treatment options available such as in rare diseases).

II. Patient Preference-Sensitive Priority Areas

    Based on the above parameters, FDA generated a list of priority 
preference-sensitive areas, and organized the areas into the following 
categories:
     Patient values in diagnosis and treatment;
     Relevant clinical endpoints for specific patient 
populations;
     Patient benefit-risk trade-offs for treatment options or 
diagnostic approaches; and
     Impact of uncertainty in the benefit-risk tradeoffs.
    The current collated list of identified patient preference-
sensitive areas can be found on the FDA website at https://www.fda.gov/about-fda/cdrh-patient-engagement/priority-list-patient-preference-sensitive-areas. The priorities listed on the web page may be broadly 
applicable to many diagnostic/therapeutic areas, while others are 
specific to a disease/condition or technology. This is not an 
exhaustive list of all patient preference-sensitive areas, and the 
prioritization of these areas may shift over time as health 
technologies and patient preference methodologies advance.

III. Other Issues for Consideration

    FDA is soliciting public input from interested persons on the 
identified priority list of patient preference-sensitive topics 
captured on the FDA website at https://www.fda.gov/about-fda/cdrh-patient-engagement/priority-list-patient-preference-sensitive-areas. In 
addition, FDA is interested in responses to the following questions:
    1. Do any existing topics on the Priority List of Patient 
Preference-Sensitive Areas need to be refined to better represent 
patient preference-sensitive areas important to regulatory efforts? 
And, if so, how? Please provide an explanation to support any 
recommended refinements.
    2. Are there other areas not listed on the FDA website at https://www.fda.gov/about-fda/cdrh-patient-engagement/priority-list-patient-preference-sensitive-areas that FDA should consider as priority patient 
preference-sensitive areas? If there are additional areas for 
consideration, please identify and provide an explanation for each 
additional area using the parameters outlined in Section I: Background.
    3. Are there ongoing studies or published studies that adequately 
address any of these patient preference-sensitive areas in a regulatory 
context? If so, please provide information or references regarding the 
studies.

IV. References

    The following references are on display at the Dockets Management 
Staff (see ADDRESSES) and are available for viewing by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also 
available electronically at https://www.regulations.gov. FDA has 
verified the website addresses, as of the date this document publishes 
in the Federal Register, but websites are subject to change over time.

1. 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--Guidance for Industry, Food and Drug 
Administration Staff, and Other Stakeholders, available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/patient-preference-information-voluntary-submission-review-premarket-approval-applications.
2. MDUFA Performance Goals and Procedures, Fiscal Years 2019 through 
2022, available at https://www.fda.gov/media/102699/download.
Advancing Use of Patient Preference Information as Scientific 
Evidence in Medical Product Evaluation Workshop at https://www.fda.gov/science-research/advancing-regulatory-science/advancing-use-patient-preference-information-scientific-evidence-medical-product-evaluation.

    Dated: April 29, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-09051 Filed 5-2-19; 8:45 am]
BILLING CODE 4164-01-P