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; Availability, 57919-57921 [2016-20221]

Download as PDF Federal Register / Vol. 81, No. 164 / Wednesday, August 24, 2016 / Notices presentation or to support a presentation, are subject to inspection. We cannot assume responsibility for coordinating the receipt, transfer, transport, storage, set up, safety, or timely arrival of any personal belongings or items used for presentation or to support a presentation. Note: Individuals who are not registered in advance will not be permitted to enter the building and will be unable to attend the meeting. The public may not enter the building earlier than 45 minutes prior to the convening of the meeting. All visitors must be escorted in areas other than the lower and first floor levels in the Central Building. Authority: Sec. 222 of the Public Health Service Act (42 U.S.C. 217a) and sec. 10(a) of Pub. L. 92–463 (5 U.S.C. App. 2, sec. 10(a) and 41 CFR 102–3). Dated: August 16, 2016. Andrew M. Slavitt, Acting Administrator, Centers for Medicare & Medicaid Services. BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2015–D–1580] 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; Availability Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ‘‘Patient Preference Information—Voluntary Submission, Review in PMAs, HDE Applications, and De Novo Requests, and Inclusion in Decision Summaries and Device Labeling.’’ This document explains the principal concepts that sponsors and other stakeholders should consider when choosing to collect patient preference information (PPI), which may inform FDA’s benefit-risk determinations in the premarket review of premarket approval applications (PMAs), humanitarian device exemption mstockstill on DSK3G9T082PROD with NOTICES SUMMARY: VerDate Sep<11>2014 20:16 Aug 23, 2016 Jkt 238001 Submit either electronic or written comments on this guidance at any time. General comments on Agency guidance documents are welcome at any time. ADDRESSES: You may submit comments as follows: DATES: Electronic Submissions [FR Doc. 2016–20187 Filed 8–23–16; 8:45 am] AGENCY: (HDE) applications, and de novo classification requests. This guidance also discusses FDA’s inclusion of PPI in its decision summaries and provides recommendations for the inclusion of such information in device labeling for certain devices. FDA is also issuing a Level 2 updated version of the guidance document entitled ‘‘Factors To Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications,’’ originally issued on March 28, 2012, that has been edited to be consistent with this guidance document. Submit electronic comments in the following way: • Federal eRulemaking Portal: http:// www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http:// 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 http://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/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 57919 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– 2015–D–1580 for ‘‘Patient Preference Information—Voluntary Submission, Review in PMAs, HDE Applications, and De Novo Requests, and Inclusion in Decision Summaries and Device Labeling.’’ If you are making submissions that also address the edits to the Level 2 guidance, the submissions received must include the Docket No. FDA–2011–D–0577 for ‘‘Factors To Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications.’’ Received comments will be placed in the docket(s) noted and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at http://www.regulations.gov or at the Division of Dockets Management 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 http:// www.regulations.gov. Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/ regulatoryinformation/dockets/ default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http:// www.regulations.gov and insert the E:\FR\FM\24AUN1.SGM 24AUN1 57920 Federal Register / Vol. 81, No. 164 / Wednesday, August 24, 2016 / Notices mstockstill on DSK3G9T082PROD with NOTICES docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. 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 guidance document entitled ‘‘Patient Preference Information—Voluntary Submission, Review in PMAs, HDE Applications, and De Novo Requests, and Inclusion in Decision Summaries and 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. 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 guidance entitled ‘‘Patient Preference Information—Voluntary Submission, Review in PMAs, HDE Applications, and De Novo Requests, and Inclusion in Decision Summaries and Device Labeling.’’ FDA believes that patients can and should bring their own experiences to bear in helping the Agency to evaluate the benefit-risk profiles of certain devices. This kind of input can be important to consider during FDA’s decisionmaking for these devices. This document explains the principal concepts that sponsors and other stakeholders should consider when choosing to collect PPI, which may inform FDA’s benefit-risk VerDate Sep<11>2014 20:16 Aug 23, 2016 Jkt 238001 determinations in the premarket review of PMAs, HDE applications, and de novo requests. This guidance also discusses FDA’s inclusion of PPI in its decision summaries and provides recommendations for the inclusion of such information in device labeling for certain devices. The objectives of this guidance are: (1) To encourage submission of PPI, if available, by sponsors or other stakeholders to FDA and to aid in FDA decisionmaking; (2) to outline recommended qualities of patient preference studies, which may result in valid scientific evidence; (3) to provide recommendations for collecting and submitting PPI to FDA; and (4) to discuss FDA’s inclusion of PPI in its decision summaries and provide recommendations for the inclusion of such information in device labeling, where appropriate. The guidance also includes hypothetical examples that illustrate how PPI may inform FDA’s decisionmaking. The guidance applies to both diagnostic and therapeutic devices that are subject to these review processes. Additionally, this guidance may be information to other stakeholders such as patient groups and academia who may wish to conduct patient preference studies. In the Federal Register of May 18, 2015 (80 FR 28277), FDA announced the availability of the draft of this guidance and interested persons were invited to comment by August 17, 2015. FDA has considered all of the public comments received in finalizing this guidance. FDA is also issuing a Level 2 update to the guidance document entitled ‘‘Factors To Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications,’’ which was originally issued on March 28, 2012, to ensure consistency with the terminology and concepts presented in this guidance. II. Significance of Guidance This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on ‘‘Patient Preference Information—Voluntary Submission, Review in PMAs, HDE Applications, and De Novo Requests, and Inclusion in Decision Summaries and 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. PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 III. Electronic Access Persons interested in obtaining a copy of the 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.fda.gov/BiologicsBlood Vaccines/GuidanceCompliance Regulatoryinformation/Guidances/ default.htm or http:// www.regulations.gov. Persons unable to download an electronic copy of ‘‘Patient Preference Information—Voluntary Submission, Review in PMAs, HDE Applications, and De Novo Requests, and Inclusion in Decision Summaries and Device Labeling’’ or ‘‘Factors To Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications’’ 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 or 1772 respectively 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; the collections of information in 21 CFR part 822 have been approved under OMB control number 0910–0449; the collections of information in 21 CFR part 801 have been approved under OMB control number 0910–0485; and the collections of information in the guidance document ‘‘Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff’’ have been approved under OMB control number 0910–0756. E:\FR\FM\24AUN1.SGM 24AUN1 Federal Register / Vol. 81, No. 164 / Wednesday, August 24, 2016 / Notices • 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’’). Dated: August 2, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–20221 Filed 8–23–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2007–D–0369] Bioequivalence Recommendations for Fidaxomicin; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry on generic fidaxomicin tablets entitled ‘‘Draft Guidance on Fidaxomicin.’’ The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for fidaxomicin tablets. SUMMARY: 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 October 24, 2016. DATES: ADDRESSES: You may submit comments as follows: mstockstill on DSK3G9T082PROD with NOTICES Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: http:// www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http:// 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 http://www.regulations.gov. VerDate Sep<11>2014 20:16 Aug 23, 2016 Jkt 238001 Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Division of Dockets Management, 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– 2007–D–0369 for ‘‘Draft Guidance on Fidaxomicin.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ will be publicly viewable at http://www.regulations.gov or at the Division of Dockets Management 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 http:// www.regulations.gov. Submit both copies to the Division of Dockets Management. 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 PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 57921 the information at: http://www.fda.gov/ regulatoryinformation/dockets/ default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http:// 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 Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993– 0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Xiaoqiu Tang, Center for Drug Evaluation and Research (HFD–600), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 4730, Silver Spring, MD 20993–0002, 301–796–5850. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of June 11, 2010 (75 FR 33311), FDA announced the availability of a guidance for industry entitled ‘‘Bioequivalence Recommendations for Specific Products,’’ which explained the process that would be used to make productspecific BE recommendations available to the public on FDA’s Web site at http://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm. As described in that guidance, FDA adopted this process to develop and disseminate product-specific BE recommendations and to provide a meaningful opportunity for the public to consider and comment on those recommendations. This notice announces the availability of draft BE recommendations for generic fidaxomicin tablets. FDA initially approved new drug application (NDA) 201699 for DIFICID (fidaxomicin) in May 2011. Currently, there are no approved ANDAs for this product. We are now issuing a draft guidance for industry on BE recommendations for generic fidaxomicin tablets (‘‘Draft Guidance on Fidaxomicin’’). On May 6, 2015, Cubist Pharmaceuticals, Inc. submitted a E:\FR\FM\24AUN1.SGM 24AUN1

Agencies

[Federal Register Volume 81, Number 164 (Wednesday, August 24, 2016)]
[Notices]
[Pages 57919-57921]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-20221]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


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; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of the guidance entitled ``Patient Preference 
Information--Voluntary Submission, Review in PMAs, HDE Applications, 
and De Novo Requests, and Inclusion in Decision Summaries and Device 
Labeling.'' This document explains the principal concepts that sponsors 
and other stakeholders should consider when choosing to collect patient 
preference information (PPI), which may inform FDA's benefit-risk 
determinations in the premarket review of premarket approval 
applications (PMAs), humanitarian device exemption (HDE) applications, 
and de novo classification requests. This guidance also discusses FDA's 
inclusion of PPI in its decision summaries and provides recommendations 
for the inclusion of such information in device labeling for certain 
devices. FDA is also issuing a Level 2 updated version of the guidance 
document entitled ``Factors To Consider When Making Benefit-Risk 
Determinations in Medical Device Premarket Approval and De Novo 
Classifications,'' originally issued on March 28, 2012, that has been 
edited to be consistent with this guidance document.

DATES: Submit either electronic or written comments on this guidance at 
any time. General comments on Agency guidance documents are welcome at 
any time.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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-2015-D-1580 for ``Patient Preference Information--Voluntary 
Submission, Review in PMAs, HDE Applications, and De Novo Requests, and 
Inclusion in Decision Summaries and Device Labeling.'' If you are 
making submissions that also address the edits to the Level 2 guidance, 
the submissions received must include the Docket No. FDA-2011-D-0577 
for ``Factors To Consider When Making Benefit-Risk Determinations in 
Medical Device Premarket Approval and De Novo Classifications.'' 
Received comments will be placed in the docket(s) noted and, except for 
those submitted as ``Confidential Submissions,'' publicly viewable at 
http://www.regulations.gov or at the Division of Dockets Management 
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 http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the

[[Page 57920]]

docket number, found in brackets in the heading of this document, into 
the ``Search'' box and follow the prompts and/or go to the Division of 
Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    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 guidance document entitled 
``Patient Preference Information--Voluntary Submission, Review in PMAs, 
HDE Applications, and De Novo Requests, and Inclusion in Decision 
Summaries and 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.

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 guidance entitled ``Patient 
Preference Information--Voluntary Submission, Review in PMAs, HDE 
Applications, and De Novo Requests, and Inclusion in Decision Summaries 
and Device Labeling.'' FDA believes that patients can and should bring 
their own experiences to bear in helping the Agency to evaluate the 
benefit-risk profiles of certain devices. This kind of input can be 
important to consider during FDA's decisionmaking for these devices.
    This document explains the principal concepts that sponsors and 
other stakeholders should consider when choosing to collect PPI, which 
may inform FDA's benefit-risk determinations in the premarket review of 
PMAs, HDE applications, and de novo requests. This guidance also 
discusses FDA's inclusion of PPI in its decision summaries and provides 
recommendations for the inclusion of such information in device 
labeling for certain devices.
    The objectives of this guidance are: (1) To encourage submission of 
PPI, if available, by sponsors or other stakeholders to FDA and to aid 
in FDA decisionmaking; (2) to outline recommended qualities of patient 
preference studies, which may result in valid scientific evidence; (3) 
to provide recommendations for collecting and submitting PPI to FDA; 
and (4) to discuss FDA's inclusion of PPI in its decision summaries and 
provide recommendations for the inclusion of such information in device 
labeling, where appropriate. The guidance also includes hypothetical 
examples that illustrate how PPI may inform FDA's decisionmaking. The 
guidance applies to both diagnostic and therapeutic devices that are 
subject to these review processes. Additionally, this guidance may be 
information to other stakeholders such as patient groups and academia 
who may wish to conduct patient preference studies.
    In the Federal Register of May 18, 2015 (80 FR 28277), FDA 
announced the availability of the draft of this guidance and interested 
persons were invited to comment by August 17, 2015. FDA has considered 
all of the public comments received in finalizing this guidance.
    FDA is also issuing a Level 2 update to the guidance document 
entitled ``Factors To Consider When Making Benefit-Risk Determinations 
in Medical Device Premarket Approval and De Novo Classifications,'' 
which was originally issued on March 28, 2012, to ensure consistency 
with the terminology and concepts presented in this guidance.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on ``Patient Preference Information--Voluntary 
Submission, Review in PMAs, HDE Applications, and De Novo Requests, and 
Inclusion in Decision Summaries and 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 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.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryinformation/Guidances/default.htm or http://www.regulations.gov. Persons unable to 
download an electronic copy of ``Patient Preference Information--
Voluntary Submission, Review in PMAs, HDE Applications, and De Novo 
Requests, and Inclusion in Decision Summaries and Device Labeling'' or 
``Factors To Consider When Making Benefit-Risk Determinations in 
Medical Device Premarket Approval and De Novo Classifications'' 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 
or 1772 respectively 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; the collections of 
information in 21 CFR part 822 have been approved under OMB control 
number 0910-0449; the collections of information in 21 CFR part 801 
have been approved under OMB control number 0910-0485; and the 
collections of information in the guidance document ``Requests for 
Feedback on Medical Device Submissions: The Pre-Submission Program and 
Meetings with Food and Drug Administration Staff'' have been approved 
under OMB control number 0910-0756.


[[Page 57921]]


    Dated: August 2, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-20221 Filed 8-23-16; 8:45 am]
BILLING CODE 4164-01-P