80_FR_28372 80 FR 28277 - 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Applications, Humanitarian Device Exemption Applications, and De Novo Requests, and Inclusion in Device Labeling; Draft Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders; Availability

80 FR 28277 - 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Applications, Humanitarian Device Exemption Applications, and De Novo Requests, and Inclusion in Device Labeling; Draft Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 95 (May 18, 2015)

Page Range28277-28278
FR Document2015-11819

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Patient Preference Information--Submission, Review in PMAs, HDE Applications, and De Novo Requests, and Inclusion in Device Labeling.''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 This draft guidance also outlines considerations for including patient preference information in labeling for patients and health care professionals. This draft guidance is not final nor is it in effect at this time.

Federal Register, Volume 80 Issue 95 (Monday, May 18, 2015) 
[Federal Register Volume 80, Number 95 (Monday, May 18, 2015)]
[Notices]
[Pages 28277-28278]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-11819]


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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De Novo Requests, and Inclusion in Device Labeling; Draft Guidance for 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.

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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the availability of a draft guidance for industry entitled ``Patient 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

Federal Register / Vol. 80, No. 95 / Monday, May 18, 2015 / Notices 28277 studies for medical devices. It does not Dated: May 12, 2015. Labeling’’ to the Office of the Center establish any rights for any person and Leslie Kux, Director, Guidance and Policy is not binding on FDA or the public. Associate Commissioner for Policy. Development, Center for Devices and You can use an alternative approach if [FR Doc. 2015–11820 Filed 5–15–15; 8:45 am] Radiological Health, Food and Drug it satisfies the requirements of the BILLING CODE 4164–01–P Administration, 10903 New Hampshire applicable statute and regulations. Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993–0002 or the Office of III. Electronic Access DEPARTMENT OF HEALTH AND Communication, Outreach, and HUMAN SERVICES Development, Center for Biologics Persons interested in obtaining a copy Evaluation and Research, Food and of the draft guidance may do so by Food and Drug Administration Drug Administration, 10903 New downloading an electronic copy from [Docket No. FDA–2015–D–1580] Hampshire Ave., Bldg. 71, Rm. 3128, the Internet. A search capability for all Silver Spring, MD 20993–0002. Send Center for Devices and Radiological one self-addressed adhesive label to Health guidance documents is available Patient Preference Information— Submission, Review in Premarket assist that office in processing your at http://www.fda.gov/MedicalDevices/ request. Approval Applications, Humanitarian DeviceRegulationandGuidance/ Submit electronic comments on the Device Exemption Applications, and GuidanceDocuments/default.htm. draft guidance to http:// De Novo Requests, and Inclusion in Guidance documents are also available www.regulations.gov. Submit written Device Labeling; Draft Guidance for at http://www.regulations.gov. Persons Industry, Food and Drug comments to the Division of Dockets unable to download an electronic copy Administration Staff, and Other Management (HFA–305), Food and Drug of ‘‘Adaptive Designs for Medical Stakeholders; Availability Administration, 5630 Fishers Lane, Rm. Device Clinical Studies; Draft Guidance 1061, Rockville, MD 20852. Identify for Industry and Food and Drug AGENCY: Food and Drug Administration, comments with the docket number Administration Staff’’ may send an HHS. found in brackets in the heading of this email request to CDRH-Guidance@ ACTION: Notice. document. fda.hhs.gov to receive an electronic FOR FURTHER INFORMATION CONTACT: copy of the document. Please use the SUMMARY: The Food and Drug Anindita Saha, Center for Devices and document number GUD1500005 to Administration (FDA or Agency) is Radiological Health, Food and Drug identify the guidance you are announcing the availability of a draft Administration, 10903 New Hampshire requesting. guidance for industry entitled ‘‘Patient Ave., Bldg. 66, Rm. 5414, Silver Spring, Preference Information—Submission, IV. Paperwork Reduction Act of 1995 MD 20993–0002, 301–796–2537, Review in PMAs, HDE Applications, Anindita.Saha@fda.hhs.gov; or Stephen and De Novo Requests, and Inclusion in This draft guidance refers to Ripley, Center for Biologics Evaluation Device Labeling.’’ This document previously approved collections of and Research, Food and Drug provides guidance on collecting and information found in FDA regulations. Administration, 10903 New Hampshire submitting patient preference These collections of information are Ave., Bldg. 71, Rm. 7301, Silver Spring, information that may be used by FDA subject to review by the Office of MD 20993, 240–402–7911. staff in decisionmaking relating to Management and Budget (OMB) under premarket approval applications SUPPLEMENTARY INFORMATION: the Paperwork Reduction Act of 1995 (PMAs), Humanitarian Device I. Background (44 U.S.C. 3501–3520). The collections Exemption (HDE) applications, and de of information in 21 CFR part 807, novo requests. This draft guidance also FDA is announcing the availability of subpart E, which have been approved outlines considerations for including a draft guidance for industry entitled under 0910–0120; 21 CFR part 812, patient preference information in ‘‘Patient Preference Information— which have been approved under 0910– labeling for patients and health care Submission, Review in PMAs, HDE 0078; 21 CFR part 814, subparts A, B, professionals. This draft guidance is not Applications, and De Novo Requests, and C, which have been approved under final nor is it in effect at this time. and Inclusion in Device Labeling.’’ FDA OMB control number 0910–0231; and believes that patients can and should DATES: Although you can comment on 21 CFR part 814, subpart H, which have bring their own experiences to bear in any guidance at any time (see 21 CFR helping the Agency to evaluate the risk- been approved under OMB control 10.115(g)(5)), to ensure that the Agency number 0910–0332. benefit profile of certain devices. This considers your comment on this draft document provides guidance on V. Comments guidance before it begins work on the collecting and submitting patient final version of the guidance, submit preference information that may be used Interested persons may submit either either electronic or written comments by FDA staff in decision-making relating electronic comments regarding this on the draft guidance by August 17, to PMAs, HDE applications, and de document to http://www.regulations.gov 2015. novo requests. The objectives of this or written comments to the Division of ADDRESSES: An electronic copy of the draft guidance are: (1) To encourage Dockets Management (see ADDRESSES). It guidance document is available for voluntary submission of patient is only necessary to send one set of download from the Internet. See the preference information by sponsors or asabaliauskas on DSK5VPTVN1PROD with NOTICES comments. Identify comments with the SUPPLEMENTARY INFORMATION section for other stakeholders in certain docket number found in brackets in the information on electronic access to the circumstances; (2) to outline heading of this document. Received guidance. Submit written requests for a recommended qualities of patient comments may be seen in the Division single hard copy of the draft guidance preference studies, which may result in of Dockets Management between 9 a.m. document entitled ‘‘Patient Preference valid scientific evidence; (3) to provide and 4 p.m., Monday through Friday, and Information—Submission, Review in recommendations for collecting and will be posted to the docket at http:// PMAs, HDE Applications, and De Novo submitting patient preference www.regulations.gov. Requests, and Inclusion in Device information to FDA; and (4) to outline VerDate Sep<11>2014 18:52 May 15, 2015 Jkt 235001 PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 E:\FR\FM\18MYN1.SGM 18MYN1

28278 Federal Register / Vol. 80, No. 95 / Monday, May 18, 2015 / Notices considerations for including patient 21 CFR 812.25(c) have been approved DEPARTMENT OF HEALTH AND preference information in labeling for under OMB control number 0910–0078; HUMAN SERVICES patients and health care professionals. the collections of information in 21 CFR This draft guidance includes examples part 807 subpart E have been approved Food and Drug Administration that illustrate how patient preference under OMB control number 0910–0120; [Docket No. FDA–2013–N–0545] information may inform FDA’s the collections of information in 21 CFR regulatory decisionmaking. The part 814 subparts B and E have been Agency Information Collection guidance applies to both diagnostic and approved under OMB control number Activities; Announcement of Office of therapeutic devices that are subject to 0910–0231; the collections of Management and Budget Approval; these review processes. Additionally, information in 21 CFR part 814 subpart Infant Formula Requirements this guidance may apply to other H have been approved under OMB AGENCY: Food and Drug Administration, stakeholders such as patient groups and academia who may wish to conduct control number 0910–0332; and the HHS. patient preference studies. collections of information in 21 CFR ACTION: Notice. part 801 have been approved under II. Significance of Guidance OMB control number 0910–0485. SUMMARY: The Food and Drug This draft guidance is being issued Administration (FDA) is announcing V. Comments that a collection of information entitled, consistent with FDA’s good guidance practices regulation (21 CFR 10.115). ‘‘Infant Formula Requirements’’ has Interested persons may submit either The draft guidance, when finalized, will been approved by the Office of electronic comments regarding this Management and Budget (OMB) under represent the current thinking of FDA document to http://www.regulations.gov on Patient Preference Information— the Paperwork Reduction Act of 1995. or written comments to the Division of Submission, Review in PMAs, HDE FOR FURTHER INFORMATION CONTACT: FDA Dockets Management (see ADDRESSES). It PRA Staff, Office of Operations, Food Applications, and De Novo Requests, is only necessary to send one set of and Drug Administration, 8455 and Inclusion in Device Labeling. It comments. Identify comments with the Colesville Rd., COLE–14526, Silver does not establish any rights for any docket number found in brackets in the Spring, MD 20993–0002, PRAStaff@ person and is not binding on FDA or the public. You can use an alternative heading of this document. Received fda.hhs.gov. approach if it satisfies the requirements comments may be seen in the Division SUPPLEMENTARY INFORMATION: On March of the applicable statutes and of Dockets Management between 9 a.m. 4, 2015, the Agency submitted a regulations. and 4 p.m., Monday through Friday, and proposed collection of information will be posted to the docket at http:// entitled, ‘‘Infant Formula III. Electronic Access www.regulations.gov. Requirements’’ to OMB for review and Persons interested in obtaining a copy Specifically the Agency would like clearance under 44 U.S.C. 3507. An of the draft guidance may do so by comments on the following questions: Agency may not conduct or sponsor, downloading an electronic copy from and a person is not required to respond the Internet. A search capability for all 1. Section IV of the draft guidance recommends qualities for patient to, a collection of information unless it Center for Devices and Radiological displays a currently valid OMB control Health guidance documents is available preference studies. Do you believe these recommended qualities are clear and number. OMB has now approved the at http://www.fda.gov/MedicalDevices/ information collection and has assigned DeviceRegulationandGuidance/ understandable? If not, what should be OMB control number 0910–0256. The GuidanceDocuments/default.htm. reworded or edited? Is there anything approval expires on April 30, 2018. A Guidance documents are also available missing? If so, what needs to be added? copy of the supporting statement for this at http://www.regulations.gov or from 2. Under what conditions should information collection is available on CBER at http://www.fda.gov/ health care professional or patient the Internet at http://www.reginfo.gov/ BiologicsBloodVaccines/ labeling include information about public/do/PRAMain. GuidanceCompliance patient preference studies? RegulatoryInformation/default.htm. Dated: May 12, 2015. Persons unable to download an 3. How should sponsors present Leslie Kux, electronic copy of ‘‘Patient Preference patient preference information in the Associate Commissioner for Policy. Information—Submission, Review in health care professional and patient [FR Doc. 2015–11821 Filed 5–15–15; 8:45 am] PMAs, HDE Applications, and De Novo labeling? BILLING CODE 4164–01–P Requests, and Inclusion in Device 4. How should labeling indicate that Labeling’’ may send an email request to only a subset of patients in a patient CDRH-Guidance@fda.hhs.gov to receive preference study were willing to accept DEPARTMENT OF HEALTH AND an electronic copy of the document. certain risks in order to achieve HUMAN SERVICES Please use the document number probable benefits? 1500006 to identify the guidance you National Institutes of Health are requesting. 5. How should sponsors and the FDA ensure that patients receive and National Institute of Allergy and IV. Paperwork Reduction Act of 1995 understand patient preference Infectious Diseases; Notice of Closed asabaliauskas on DSK5VPTVN1PROD with NOTICES This guidance refers to currently information? Meetings. approved collections of information Dated: May 12, 2015. Pursuant to section 10(d) of the found in FDA regulations. These Federal Advisory Committee Act, as Leslie Kux, collections of information are subject to amended (5 U.S.C. App.), notice is review by the Office of Management and Associate Commissioner for Policy. hereby given of the following meetings. Budget (OMB) under the Paperwork [FR Doc. 2015–11819 Filed 5–15–15; 8:45 am] The meetings will be closed to the Reduction Act of 1995 (44 U.S.C. 3501– BILLING CODE 4164–01–P public in accordance with the 3520). The collections of information in provisions set forth in sections VerDate Sep<11>2014 18:52 May 15, 2015 Jkt 235001 PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 E:\FR\FM\18MYN1.SGM 18MYN1


Document Created: 2015-12-16 07:39:27
Document Modified: 2015-12-16 07:39:27
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesAlthough 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.
ContactAnindita 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.
FR Citation80 FR 28277 
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