Clinical Considerations for Studies of Devices Intended To Treat Opioid Use Disorder; Draft Guidance for Industry and Food and Drug Administration Staff; Availability, 48888-48889 [2023-15968]

Download as PDF 48888 Federal Register / Vol. 88, No. 144 / Friday, July 28, 2023 / Notices B. Prescription Drug Program Fees FDA will issue invoices and payment instructions for FY 2024 program fees under the new fee schedule in August 2023. Under section 736(a)(2)(A)(i) of the FD&C Act, prescription drug program fees are due on October 2, 2023. FDA will issue invoices in December 2024 for products that qualify for FY 2024 program fee assessments after the October 2023 billing. C. Fee Waivers and Refunds To qualify for consideration for a waiver or reduction under section 736(d) of the FD&C Act, an exemption under section 736(k) of the FD&C Act, or the return of an application or program fee paid under section 736 of the FD&C Act, including if the fee is claimed to have been paid in error, a person must submit to FDA a written request justifying such waiver, reduction, exemption or return not later than 180 days after such fee is due (section 736(i) of the FD&C Act). A request submitted under this paragraph must include any legal authorities under which the request is made. Dated: July 24, 2023. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2023–15911 Filed 7–27–23; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2023–D–0466] Clinical Considerations for Studies of Devices Intended To Treat Opioid Use Disorder; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ‘‘Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder.’’ Design of clinical studies for devices intended to treat opioid use disorder (OUD) is challenging. This guidance provides recommendations for the design of pivotal clinical studies for devices intended to treat opioid use disorder (‘‘OUD device studies’’) and used to support marketing submissions. These recommendations are applicable lotter on DSK11XQN23PROD with NOTICES1 SUMMARY: VerDate Sep<11>2014 17:16 Jul 27, 2023 Jkt 259001 to the design and development of clinical studies to provide a reasonable assurance of safety and effectiveness for a device intended to treat OUD. 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 October 26, 2023 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’’). 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– 2023–D–0466 for ‘‘Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder.’’ Received comments will be placed in PO 00000 Frm 00103 Fmt 4703 Sfmt 4703 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:// 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 ‘‘Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder’’ to the Office of Policy, Guidance and Policy Development, Center for Devices E:\FR\FM\28JYN1.SGM 28JYN1 48889 Federal Register / Vol. 88, No. 144 / Friday, July 28, 2023 / Notices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993–0002. Send one selfaddressed adhesive label to assist that office in processing your request. FOR FURTHER INFORMATION CONTACT: Megha Reddy, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2568, Silver Spring, MD 20993–0002, 240–402–2980. SUPPLEMENTARY INFORMATION: I. Background The opioid overdose crisis is a serious and complex challenge facing the United States. The Agency has already taken significant steps to decrease unnecessary exposure to opioids, prevent new cases of opioid use disorder (OUD) and support the treatment of people with OUD. The Center for Devices and Radiological Health (CDRH) is committed to helping to end this national crisis. This guidance provides recommendations for the design of pivotal clinical studies for devices intended to treat OUD (hereafter ‘‘OUD device studies’’) and used to support marketing submissions. These recommendations are applicable to the design and development of clinical studies to provide a reasonable 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 CDRH guidance documents is available at https://www.fda.gov/medical-devices/ device-advice-comprehensive- regulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. This guidance document is also available at https://www.regulations.gov or https:// www.fda.gov/regulatory-information/ search-fda-guidance-documents. Persons unable to download an electronic copy of ‘‘Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder’’ may send an email request to CDRHGuidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number GUI00019017 and complete title to 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. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501– 3521) is not required for this guidance. The previously approved collections of information are subject to review by OMB under the PRA. The collections of information in the following FDA guidance have been approved by OMB as listed in the following table: Guidance Topic ‘‘Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff’’. Q-submissions .. Dated: July 24, 2023. Lauren K. Roth, Associate Commissioner for Policy. renewal fee rate for accreditation bodies applying to be recognized in the thirdparty certification program that is authorized by the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the FDA Food Safety Modernization Act (FSMA). We are also announcing the fee rate for certification bodies that are applying to be directly accredited by FDA. [FR Doc. 2023–15968 Filed 7–27–23; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Food Safety Modernization Act ThirdParty Certification Program User Fee Rate for Fiscal Year 2024 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or we) is announcing the fiscal year (FY) 2024 annual fee rate for recognized accreditation bodies and accredited certification bodies, and the initial and SUMMARY: VerDate Sep<11>2014 17:16 Jul 27, 2023 Jkt 259001 This fee is effective on October 1, 2023, and will remain in effect through September 30, 2024. DATES: [Docket No. FDA–2023–N–2897] lotter on DSK11XQN23PROD with NOTICES1 assurance of safety and effectiveness for a device intended to treat OUD. OUD device studies designed using the recommendations set out in this guidance may advance the treatment of OUD by providing scientific evidence that aids FDA in determining whether there is a reasonable assurance that a device intended to treat OUD is safe and effective. These recommendations may change as more information becomes available, and the research community gains experience with different designs in relation to OUD device studies. 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 this topic. 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. FOR FURTHER INFORMATION CONTACT: Olufunmilayo (Funmi) Ariyo, Food and Drug Administration, 404 Powder Mill Rd., Beltsville, MD 20705–4304, 240– 402–4989; or the FSMA Fee Staff, Office of Food Policy and Response, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, FSMAFeeStaff@fda.hhs.gov. SUPPLEMENTARY INFORMATION: PO 00000 Frm 00104 Fmt 4703 Sfmt 4703 OMB control No. 0910–0756 I. Background Section 307 of FSMA (Pub. L. 111– 353), Accreditation of Third-Party Auditors, amended the FD&C Act to create a new provision, section 808, under the same name. Section 808 of the FD&C Act (21 U.S.C. 384d) directs FDA to establish a program for accreditation of third-party certification bodies 1 conducting food safety audits and issuing food and facility certifications to eligible foreign entities (including registered foreign food facilities) that meet our applicable requirements. Under this provision, we established a system for FDA to recognize accreditation bodies to accredit certification bodies, except for limited circumstances in which we may directly 1 For the reasons explained in the third-party certification final rule (80 FR 74570 at 74578– 74579, November 27, 2015), and for consistency with the implementing regulations for the thirdparty certification program in 21 CFR parts 1, 11, and 16, this notice uses the term ‘‘third-party certification body’’ rather than the term ‘‘third-party auditor’’ used in section 808(a)(3) of the FD&C Act. E:\FR\FM\28JYN1.SGM 28JYN1

Agencies

[Federal Register Volume 88, Number 144 (Friday, July 28, 2023)]
[Notices]
[Pages 48888-48889]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-15968]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-D-0466]


Clinical Considerations for Studies of Devices Intended To Treat 
Opioid Use Disorder; Draft Guidance for Industry and Food and Drug 
Administration Staff; 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 ``Clinical 
Considerations for Studies of Devices Intended to Treat Opioid Use 
Disorder.'' Design of clinical studies for devices intended to treat 
opioid use disorder (OUD) is challenging. This guidance provides 
recommendations for the design of pivotal clinical studies for devices 
intended to treat opioid use disorder (``OUD device studies'') and used 
to support marketing submissions. These recommendations are applicable 
to the design and development of clinical studies to provide a 
reasonable assurance of safety and effectiveness for a device intended 
to treat OUD. 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 October 26, 2023 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'').

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-2023-D-0466 for ``Clinical Considerations for Studies of Devices 
Intended to Treat Opioid Use Disorder.'' 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 
``Clinical Considerations for Studies of Devices Intended to Treat 
Opioid Use Disorder'' to the Office of Policy, Guidance and Policy 
Development, Center for Devices

[[Page 48889]]

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: Megha Reddy, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 2568, Silver Spring, MD 20993-0002, 240-402-2980.

SUPPLEMENTARY INFORMATION: 

I. Background

    The opioid overdose crisis is a serious and complex challenge 
facing the United States. The Agency has already taken significant 
steps to decrease unnecessary exposure to opioids, prevent new cases of 
opioid use disorder (OUD) and support the treatment of people with OUD. 
The Center for Devices and Radiological Health (CDRH) is committed to 
helping to end this national crisis. This guidance provides 
recommendations for the design of pivotal clinical studies for devices 
intended to treat OUD (hereafter ``OUD device studies'') and used to 
support marketing submissions. These recommendations are applicable to 
the design and development of clinical studies to provide a reasonable 
assurance of safety and effectiveness for a device intended to treat 
OUD. OUD device studies designed using the recommendations set out in 
this guidance may advance the treatment of OUD by providing scientific 
evidence that aids FDA in determining whether there is a reasonable 
assurance that a device intended to treat OUD is safe and effective. 
These recommendations may change as more information becomes available, 
and the research community gains experience with different designs in 
relation to OUD device studies.
    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 this topic. 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 CDRH 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 or https://www.fda.gov/regulatory-information/search-fda-guidance-documents. Persons unable to download an electronic 
copy of ``Clinical Considerations for Studies of Devices Intended to 
Treat Opioid Use Disorder'' may send an email request to [email protected] to receive an electronic copy of the document. 
Please use the document number GUI00019017 and complete title to 
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. 
Therefore, clearance by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not 
required for this guidance. The previously approved collections of 
information are subject to review by OMB under the PRA. The collections 
of information in the following FDA guidance have been approved by OMB 
as listed in the following table:

------------------------------------------------------------------------
                                                           OMB  control
            Guidance                      Topic                 No.
------------------------------------------------------------------------
``Requests for Feedback on       Q-submissions..........       0910-0756
 Medical Device Submissions:
 The Pre-Submission Program and
 Meetings with Food and Drug
 Administration Staff''.
------------------------------------------------------------------------


    Dated: July 24, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-15968 Filed 7-27-23; 8:45 am]
BILLING CODE 4164-01-P

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