List of Patient Preference-Sensitive Priorities; Establishment of a Public Docket; Request for Comments
| Published date | 03 May 2019 |
| Citation | 84 FR 19084 |
| Record Number | 2019-09051 |
| Section | Notices |
| Court | Food And Drug Administration,Health And Human Services Department |
Federal Register, Volume 84 Issue 86 (Friday, May 3, 2019)
[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]
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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.
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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
