[Federal Register Volume 80, Number 95 (Monday, May 18, 2015)]
[Notices]
[Pages 28277-28278]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-11819]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Patient Preference Information--Submission, Review in Premarket 
Approval Applications, Humanitarian Device Exemption Applications, and 
De Novo Requests, and Inclusion in Device Labeling; Draft Guidance for 
Industry, Food and Drug Administration Staff, and Other Stakeholders; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft guidance for industry entitled ``Patient 
Preference Information--Submission, Review in PMAs, HDE Applications, 
and De Novo Requests, and Inclusion in Device Labeling.'' This document 
provides guidance on collecting and submitting patient preference 
information that may be used by FDA staff in decisionmaking relating to 
premarket approval applications (PMAs), Humanitarian Device Exemption 
(HDE) applications, and de novo requests. This draft guidance also 
outlines considerations for including patient preference information in 
labeling for patients and health care professionals. This draft 
guidance is not final nor is it in effect at this time.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by August 17, 2015.

ADDRESSES: 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requests for a single hard copy of the draft guidance document entitled 
``Patient Preference Information--Submission, Review in PMAs, HDE 
Applications, and De Novo Requests, and Inclusion in Device Labeling'' 
to the Office of the Center Director, Guidance and Policy Development, 
Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver 
Spring, MD 20993-0002 or the Office of Communication, Outreach, and 
Development, Center for Biologics Evaluation and Research, 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 request.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number 
found in brackets in the heading of this document.

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, 
[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, 240-402-
7911.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Patient Preference Information--Submission, Review in PMAs, 
HDE Applications, and De Novo Requests, and Inclusion in Device 
Labeling.'' FDA believes that patients can and should bring their own 
experiences to bear in helping the Agency to evaluate the risk-benefit 
profile of certain devices. This document provides guidance on 
collecting and submitting patient preference information that may be 
used by FDA staff in decision-making relating to PMAs, HDE 
applications, and de novo requests. The objectives of this draft 
guidance are: (1) To encourage voluntary submission of patient 
preference information by sponsors or other stakeholders in certain 
circumstances; (2) to outline recommended qualities of patient 
preference studies, which may result in valid scientific evidence; (3) 
to provide recommendations for collecting and submitting patient 
preference information to FDA; and (4) to outline

[[Page 28278]]

considerations for including patient preference information in labeling 
for patients and health care professionals. This draft guidance 
includes examples that illustrate how patient preference information 
may inform FDA's regulatory decisionmaking. The guidance applies to 
both diagnostic and therapeutic devices that are subject to these 
review processes. Additionally, this guidance may apply to other 
stakeholders such as patient groups and academia who may wish to 
conduct patient preference studies.

II. Significance of 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 Patient 
Preference Information--Submission, Review in PMAs, HDE Applications, 
and De Novo Requests, and Inclusion in Device Labeling. 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.

III. 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 http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance 
documents are also available at http://www.regulations.gov or from CBER 
at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. Persons unable to 
download an electronic copy of ``Patient Preference Information--
Submission, Review in PMAs, HDE Applications, and De Novo Requests, and 
Inclusion in Device Labeling'' may send an email request to [email protected] to receive an electronic copy of the document. 
Please use the document number 1500006 to identify the guidance you are 
requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to currently approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR 812.25(c) have been approved under 
OMB control number 0910-0078; the collections of information in 21 CFR 
part 807 subpart E have been approved under OMB control number 0910-
0120; the collections of information in 21 CFR part 814 subparts B and 
E have been approved under OMB control number 0910-0231; the 
collections of information in 21 CFR part 814 subpart H have been 
approved under OMB control number 0910-0332; and the collections of 
information in 21 CFR part 801 have been approved under OMB control 
number 0910-0485.

V. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.
    Specifically the Agency would like comments on the following 
questions:
    1. Section IV of the draft guidance recommends qualities for 
patient preference studies. Do you believe these recommended qualities 
are clear and understandable? If not, what should be reworded or 
edited? Is there anything missing? If so, what needs to be added?
    2. Under what conditions should health care professional or patient 
labeling include information about patient preference studies?
    3. How should sponsors present patient preference information in 
the health care professional and patient labeling?
    4. How should labeling indicate that only a subset of patients in a 
patient preference study were willing to accept certain risks in order 
to achieve probable benefits?
    5. How should sponsors and the FDA ensure that patients receive and 
understand patient preference information?

    Dated: May 12, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-11819 Filed 5-15-15; 8:45 am]
BILLING CODE 4164-01-P