Incorporating Voluntary Patient Preference Information Over the Total Product Life Cycle; Guidance for Industry, Food and Drug Administration Staff and Other Interested Parties; Availability, 72856-72858 [2024-20069]

Download as PDF 72856 Federal Register / Vol. 89, No. 173 / Friday, September 6, 2024 / Notices actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA’s determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B). FDA has approved for marketing the human drug product, SEGLUROMET (ertugliflozin and metformin hydrochloride) indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are not adequately controlled on a regimen containing ertugliflozin or metformin or in patients who are already treated with both ertugliflozin and metformin. Subsequent to this approval, the USPTO received patent term restoration application for SEGLUROMET (U.S. Patent Nos. 9,308,204 and 9,439,902) from Pfizer Inc., and the USPTO requested FDA’s assistance in determining the patents’ eligibility for patent term restoration. In a letter dated June 12, 2019, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of SEGLUROMET represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product’s regulatory review period. lotter on DSK11XQN23PROD with NOTICES1 II. Determination of Regulatory Review Period FDA has determined that the applicable regulatory review period for SEGLUROMET is 2,976 days. Of this time, 2,610 days occurred during the testing phase of the regulatory review period, while 366 days occurred during the approval phase. These periods of time were derived from the following dates: 1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective: October 28, 2009. The applicant claims October 29, 2009, as the date the investigational new drug application (IND) became effective. However, FDA records indicate that the IND effective date was October 28, 2009, which was 30 days after FDA receipt of the IND. 2. The date the application was initially submitted with respect to the human drug product under section 505 of the FD&C Act: December 19, 2016. FDA has verified the applicant’s claim that the new drug application (NDA) for SEGLUROMET (NDA 209806) was initially submitted on December 19, 2016. 3. The date the application was approved: December 19, 2017. FDA has verified the VerDate Sep<11>2014 16:42 Sep 05, 2024 Jkt 262001 applicant’s claim that NDA 209806 was approved on December 19, 2017. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its applications for patent extension, this applicant seeks 415 days or 424 days of patent term extension. III. Petitions Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as specified in § 60.30 (21 CFR 60.30), any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must comply with all the requirements of § 60.30, including but not limited to: must be timely (see DATES), must be filed in accordance with § 10.20, must contain sufficient facts to merit an FDA investigation, and must certify that a true and complete copy of the petition has been served upon the patent applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41–42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Submit petitions electronically to https://www.regulations.gov at Docket No. FDA–2013–S–0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Dated: September 3, 2024. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2024–20148 Filed 9–5–24; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2015–D–1580] Incorporating Voluntary Patient Preference Information Over the Total Product Life Cycle; Guidance for Industry, Food and Drug Administration Staff and Other Interested Parties; Availability AGENCY: Food and Drug Administration, HHS. ACTION: PO 00000 Notice of availability. Frm 00037 Fmt 4703 Sfmt 4703 The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ‘‘Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle.’’ This draft guidance explains the principal concepts that sponsors and other interested parties should consider when choosing to collect and submit patient preference information (PPI). The knowledge gleaned from the use of PPI could be used across the total product life cycle, including for review in investigational device exemption (IDE) applications, premarket approval (PMA) applications, humanitarian device exemption (HDE) applications, De Novo classification requests, or premarket notifications (510(k)s). This draft 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. This draft guidance is not final nor is it for implementation at this time. DATES: Submit either electronic or written comments on the draft guidance by December 5, 2024 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance at any time as follows: SUMMARY: 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’’). E:\FR\FM\06SEN1.SGM 06SEN1 Federal Register / Vol. 89, No. 173 / Friday, September 6, 2024 / Notices lotter on DSK11XQN23PROD with NOTICES1 Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand Delivery/Courier (for written/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– 2015–D–1580 for ‘‘Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle.’’ 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, 240–402–7500. • 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.govinfo.gov/content/pkg/FR-201509-18/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:// VerDate Sep<11>2014 16:42 Sep 05, 2024 Jkt 262001 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, 240–402–7500. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). 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 ‘‘Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle’’ to the Office of Policy, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993–0002. Send one self-addressed adhesive label to assist that office in processing your request. FOR FURTHER INFORMATION CONTACT: David Gebben, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1316, Silver Spring, MD 20993–0002, 301–796–6461 or James Myers, 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 entitled ‘‘Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle.’’ 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 decision-making for these devices across the total product life cycle. This draft guidance proposes expanded recommendations to the 2016 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’’ (2016 PPI Guidance). Since the issuance of the 2016 PPI Guidance, there have been many developments in the use of PPI for devices, including an increase in PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 72857 industry-sponsored PPI studies provided to FDA for consideration as part of a benefit-risk assessment, and numerous collaborations between FDA scientists and a variety of interested parties to conduct PPI studies to inform clinical trial design and FDA decision making across a wide range of diseases, conditions, and device areas. In addition, FDA has cohosted or participated in numerous convenings and international collaborations to advance scientific methods and practical applications of PPI. Meanwhile, FDA has expanded its benefit-risk guidance framework to apply to the total product life cycle, including the submission and review of IDE applications, 510(k)s, PMAs, De Novo requests, and HDEs applications, and FDA decisions involving administrative, enforcement, and other actions. This expansion of the 2016 PPI Guidance is intended to reflect this broadened scope as well as developments in the field of health preference research. 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 ‘‘Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle.’’ 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. II. 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/medical-devices/ device-advice-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. This guidance document is also available at https://www.regulations.gov, https:// www.fda.gov/regulatory-information/ search-fda-guidance-documents or https://www.fda.gov/vaccines-bloodbiologics/guidance-complianceregulatory-information-biologics. Persons unable to download an electronic copy of ‘‘Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle’’ may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number GUI01500006 and complete title to E:\FR\FM\06SEN1.SGM 06SEN1 72858 Federal Register / Vol. 89, No. 173 / Friday, September 6, 2024 / Notices identify the guidance you are requesting. III. Paperwork Reduction Act of 1995 While this guidance contains no new collection of information, it does refer to previously approved FDA collections of information. The previously approved collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork 21 CFR part; guidance; or FDA form Topic 807, subpart E ......................................................................... 814, subparts A through E ...................................................... 814, subpart H ......................................................................... 812 ........................................................................................... 860, subpart D ......................................................................... ‘‘Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program’’. 800, 801, 809, and 830 ........................................................... Premarket notification .............................................................. Premarket approval ................................................................. Humanitarian Use Devices; Humanitarian Device Exemption Investigational Device Exemption ........................................... De Novo classification process ............................................... Q-submissions and Early Payor Feedback Request Programs for Medical Devices. Medical Device Labeling Regulations; Unique Device Identification. Protection of Human Subjects and Institutional Review Boards. 50, 56 ....................................................................................... [FR Doc. 2024–20069 Filed 9–5–24; 8:45 am] Dated: August 30, 2024. Miguelina Perez, Program Analyst, Office of Federal Advisory Committee Policy. BILLING CODE 4164–01–P [FR Doc. 2024–20094 Filed 9–5–24; 8:45 am] Dated: August 30, 2024. Lauren K. Roth, Associate Commissioner for Policy. BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institutes of Health National Institute on Aging; Notice of Closed Meeting Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. lotter on DSK11XQN23PROD with NOTICES1 Reduction Act of 1995 (PRA) (44 U.S.C. 3501–3521). The collections of information in the following table have been approved by OMB: Name of Committee: National Institute on Aging Special Emphasis Panel; NSC BBA. Date: October 10, 2024. Time: 9:30 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institute on Aging, 5601 Fishers Lane, Rockville, MD 20892 (Virtual Meeting). Contact Person: Bita Nakhai, Ph.D., Scientific Review Officer, National Institute of Aging, National Institute of Health, 5601 Fishers Lane, 2C212, Rockville, MD 20852, 301–402–7701, nakhaib@nia.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging Research, National Institutes of Health, HHS) VerDate Sep<11>2014 16:42 Sep 05, 2024 Jkt 262001 Center for Scientific Review; Notice of Closed Meetings Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, 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 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Molecular, Cellular and Developmental Neuroscience Integrated Review Group; Neurogenesis and Cell Fate Study Section. Date: October 2, 2024. Time: 9:00 a.m. to 7:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Adem Can, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4190, MSC 7850, Bethesda, MD 20892, (301) 435– 1042, cana2@csr.nih.gov. PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 OMB control No. 0910–0120 0910–0231 0910–0332 0910–0078 0910–0844 0910–0756 0910–0485 0910–0130 Name of Committee: Brain Disorders and Clinical Neuroscience Integrated Review Group; Pathophysiology of Eye Disease—1 Study Section Pathophysiology of Eye Disease—1 Study Section (PED1). Date: October 7–8, 2024. Time: 9:00 a.m. to 7:00 p.m. Agenda: To review and evaluate grant applications. Place: Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda, MD 20814 (InPerson Meeting). Contact Person: Afia Sultana, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4189, Bethesda, MD 20892, (301) 827–7083, sultanaa@mail.nih.gov. Name of Committee: Biobehavioral and Behavioral Processes Integrated Review Group; Child Psychopathology and Developmental Disabilities Study Section. Date: October 7–8, 2024. Time: 9:00 a.m. to 8:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Michael L. Bloom, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6187, MSC 7804, Bethesda, MD 20892, 301–451– 0132, bloomm2@mail.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; ECHO IDeA States Pediatric Clinical Trials Networks. Date: October 7–8, 2024. Time: 3:00 p.m. to 5:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Andrew M. Wolfe, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Dr., Room 6214, Bethesda, MD 20892, andrew.wolfe@nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, E:\FR\FM\06SEN1.SGM 06SEN1

Agencies

[Federal Register Volume 89, Number 173 (Friday, September 6, 2024)]
[Notices]
[Pages 72856-72858]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-20069]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Incorporating Voluntary Patient Preference Information Over the 
Total Product Life Cycle; Guidance for Industry, Food and Drug 
Administration Staff and Other Interested Parties; 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 draft guidance entitled ``Incorporating 
Voluntary Patient Preference Information over the Total Product Life 
Cycle.'' This draft guidance explains the principal concepts that 
sponsors and other interested parties should consider when choosing to 
collect and submit patient preference information (PPI). The knowledge 
gleaned from the use of PPI could be used across the total product life 
cycle, including for review in investigational device exemption (IDE) 
applications, premarket approval (PMA) applications, humanitarian 
device exemption (HDE) applications, De Novo classification requests, 
or premarket notifications (510(k)s). This draft 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. This draft guidance is not final nor is 
it for implementation at this time.

DATES: Submit either electronic or written comments on the draft 
guidance by December 5, 2024 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time 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'').

[[Page 72857]]

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/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-2015-D-1580 for ``Incorporating Voluntary Patient Preference 
Information over the Total Product Life Cycle.'' 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, 240-402-7500.
     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.govinfo.gov/content/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, 240-402-7500.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    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 
``Incorporating Voluntary Patient Preference Information over the Total 
Product Life Cycle'' to the Office of Policy, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your 
request.

FOR FURTHER INFORMATION CONTACT: David Gebben, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1316, Silver Spring, MD 20993-0002, 301-796-6461 or 
James Myers, 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 entitled 
``Incorporating Voluntary Patient Preference Information over the Total 
Product Life Cycle.'' 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 decision-making for these devices 
across the total product life cycle.
    This draft guidance proposes expanded recommendations to the 2016 
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'' (2016 PPI Guidance). Since the 
issuance of the 2016 PPI Guidance, there have been many developments in 
the use of PPI for devices, including an increase in industry-sponsored 
PPI studies provided to FDA for consideration as part of a benefit-risk 
assessment, and numerous collaborations between FDA scientists and a 
variety of interested parties to conduct PPI studies to inform clinical 
trial design and FDA decision making across a wide range of diseases, 
conditions, and device areas. In addition, FDA has cohosted or 
participated in numerous convenings and international collaborations to 
advance scientific methods and practical applications of PPI. 
Meanwhile, FDA has expanded its benefit-risk guidance framework to 
apply to the total product life cycle, including the submission and 
review of IDE applications, 510(k)s, PMAs, De Novo requests, and HDEs 
applications, and FDA decisions involving administrative, enforcement, 
and other actions. This expansion of the 2016 PPI Guidance is intended 
to reflect this broadened scope as well as developments in the field of 
health preference research.
    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 
``Incorporating Voluntary Patient Preference Information over the Total 
Product Life Cycle.'' 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.

II. 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/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also 
available at https://www.regulations.gov, https://www.fda.gov/regulatory-information/search-fda-guidance-documents or https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics. Persons unable to download an electronic copy of 
``Incorporating Voluntary Patient Preference Information over the Total 
Product Life Cycle'' may send an email request to [email protected] to receive an electronic copy of the document. 
Please use the document number GUI01500006 and complete title to

[[Page 72858]]

identify the guidance you are requesting.

III. Paperwork Reduction Act of 1995

    While this guidance contains no new collection of information, it 
does refer to previously approved FDA collections of information. The 
previously approved collections of information are subject to review by 
the Office of Management and Budget (OMB) under the Paperwork Reduction 
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information 
in the following table have been approved by OMB:

------------------------------------------------------------------------
 21 CFR part; guidance; or FDA
             form                       Topic           OMB control No.
------------------------------------------------------------------------
807, subpart E................  Premarket                      0910-0120
                                 notification.
814, subparts A through E.....  Premarket approval...          0910-0231
814, subpart H................  Humanitarian Use               0910-0332
                                 Devices;
                                 Humanitarian Device
                                 Exemption.
812...........................  Investigational                0910-0078
                                 Device Exemption.
860, subpart D................  De Novo                        0910-0844
                                 classification
                                 process.
``Requests for Feedback and     Q-submissions and              0910-0756
 Meetings for Medical Device     Early Payor Feedback
 Submissions: The Q-Submission   Request Programs for
 Program''.                      Medical Devices.
800, 801, 809, and 830........  Medical Device                 0910-0485
                                 Labeling
                                 Regulations; Unique
                                 Device
                                 Identification.
50, 56........................  Protection of Human            0910-0130
                                 Subjects and
                                 Institutional Review
                                 Boards.
------------------------------------------------------------------------


    Dated: August 30, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-20069 Filed 9-5-24; 8:45 am]
BILLING CODE 4164-01-P

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