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Applications, Humanitarian Device Exemption Applications, and De Novo Requests, and Inclusion in Device Labeling; Draft Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders; Availability, 28277-28278 [2015-11819]

Download as PDF Federal Register / Vol. 80, No. 95 / Monday, May 18, 2015 / Notices studies for medical devices. 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 statute and regulations. Dated: May 12, 2015. Leslie Kux, Associate Commissioner for Policy. III. Electronic Access DEPARTMENT OF HEALTH AND HUMAN SERVICES Persons interested in obtaining a copy of the draft guidance may do so by downloading an electronic copy from the Internet.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/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/default.htm. Guidance documents are also available at https://www.regulations.gov. Persons unable to download an electronic copy of ‘‘Adaptive Designs for Medical Device Clinical Studies; Draft Guidance for Industry and Food and Drug Administration Staff’’ may send an email request to CDRH-Guidance@ fda.hhs.gov to receive an electronic copy of the document. Please use the document number GUD1500005 to identify the guidance you are requesting. IV. Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information found in FDA regulations.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 part 807, subpart E, which have been approved under 0910–0120; 21 CFR part 812, which have been approved under 0910– 0078; 21 CFR part 814, subparts A, B, and C, which have been approved under OMB control number 0910–0231; and 21 CFR part 814, subpart H, which have been approved under OMB control number 0910–0332. asabaliauskas on DSK5VPTVN1PROD with NOTICES V. Comments Interested persons may submit either electronic comments regarding this document to https://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 https:// www.regulations.gov. VerDate Sep<11>2014 18:52 May 15, 2015 Jkt 235001 [FR Doc. 2015–11820 Filed 5–15–15; 8:45 am] BILLING CODE 4164–01–P 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. 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. SUMMARY: 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 ADDRESSES: PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 28277 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 https:// 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, Anindita.Saha@fda.hhs.gov; 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 riskbenefit 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 E:\FR\FM\18MYN1.SGM 18MYN1 28278 Federal Register / Vol. 80, No. 95 / Monday, May 18, 2015 / Notices 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. asabaliauskas on DSK5VPTVN1PROD with NOTICES 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 https://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/default.htm. Guidance documents are also available at https://www.regulations.gov or from CBER at https://www.fda.gov/ BiologicsBloodVaccines/ GuidanceCompliance RegulatoryInformation/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 CDRH-Guidance@fda.hhs.gov 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 VerDate Sep<11>2014 18:52 May 15, 2015 Jkt 235001 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 https://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 https:// 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 PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0545] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Infant Formula Requirements AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a collection of information entitled, ‘‘Infant Formula Requirements’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE–14526, Silver Spring, MD 20993–0002, PRAStaff@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: On March 4, 2015, the Agency submitted a proposed collection of information entitled, ‘‘Infant Formula Requirements’’ to OMB for review and clearance under 44 U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910–0256. The approval expires on April 30, 2018. A copy of the supporting statement for this information collection is available on the Internet at https://www.reginfo.gov/ public/do/PRAMain. SUMMARY: Dated: May 12, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–11821 Filed 5–15–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings. Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections E:\FR\FM\18MYN1.SGM 18MYN1

Agencies

[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 https://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,
Anindita.Saha@fda.hhs.gov; 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 https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at https://www.regulations.gov or from CBER
at https://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 CDRH-Guidance@fda.hhs.gov 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 https://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 https://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

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