Stimulant Use Disorders: Developing Drugs for Treatment; Draft Guidance for Industry; Availability, 69205-69207 [2023-22189]

Download as PDF Federal Register / Vol. 88, No. 192 / Thursday, October 5, 2023 / Notices 69205 U.S. FOOD & DRUG llt'IMINISTRAT!ON August 23, 2023 Beth Kraemer, RPh Director of Quality, Regulato1y & Technical Compliance dba SpectronR,x 9550 Zionsville Rd Suite 1 Indianapolis, IN 46268 Re: Revocation ofEUA200415 Dear Beth Kraemer: This letter is in response to the request from dha SpectronRx, received via email on March 24, 2023, that the U.S. Food and Drng Administration (FDA) revoke the EUA for the Hymon SARSCo V-2 Test Kit issued on May 22, 2020, and amended on August 11, 2020. dba SpectronRx indicated that they are discontinuing the distribution of the Hymon SARS-Co V-2 Test Kit and requested that the EUA be revoked. FDA understands that as of the date of this letter there will no longer be any viable Hymon SARS-CoV-2 Test Kit reagents remaining in distribution in the United States. The authorization of a device for emergency use under section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 360bbb-3) may, pursuant to section 564(g)(2) of the Act, be revoked when circumstances make such revocation appropriate to protect the public health or safety (section 564(gX2XC) of the Act). Because dba SpcctronRx has requested that FDA tenninate the EUA for the Hymon SARS-CoV-2 Test Kit, FDA has determined that it is appropriate to protect the public health or safety to revoke this authorization. Accordingly, FDA hereby revokes EUA200415 for the Hymon SARS-CoV-2 Test Kit, pursuant to section 564(gX2)(C) of the Act. As of the date of this Jetter, the Hymon SARS-CoV-2 Test Kit is no longer authorized for emergency use by FDA. Notice of this revocation will be published in the Federal Register, pursuant to section 564(h)(l) ofthe Act. Sincerely, llslf Jeffrey E. Shuren, M.D., J.D. Director Center for Devices and Radiological Health Food and Drug Administration [FR Doc. 2023–22188 Filed 10–4–23; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration BILLING CODE 4164–01–C ddrumheller on DSK120RN23PROD with NOTICES1 [Docket No. FDA–2023–D–1848] Stimulant Use Disorders: Developing Drugs for Treatment; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: VerDate Sep<11>2014 18:37 Oct 04, 2023 Jkt 262001 PO 00000 Notice of availability. Frm 00091 Fmt 4703 Sfmt 4703 The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ‘‘Stimulant Use Disorders: Developing Drugs for Treatment.’’ The purpose of this draft guidance is to assist sponsors in the clinical development of drugs for the treatment of stimulant use disorders. Specifically, this guidance addresses FDA’s current recommendations regarding the overall development program and clinical trial designs for the development of drugs to support indications of treatment of moderate to SUMMARY: E:\FR\FM\05OCN1.SGM 05OCN1 EN05OC23.077</GPH> Dated: October 2, 2023. Lauren K. Roth, Associate Commissioner for Policy. 69206 Federal Register / Vol. 88, No. 192 / Thursday, October 5, 2023 / Notices severe cocaine use disorder, treatment of moderate to severe methamphetamine use disorder, or treatment of moderate to severe prescription stimulant use disorder. Submit either electronic or written comments on the draft guidance by December 4, 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: DATES: 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’’). ddrumheller on DSK120RN23PROD 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– 2023–D–1848 for ‘‘Stimulant Use Disorders: Developing Drugs for Treatment.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential VerDate Sep<11>2014 18:37 Oct 04, 2023 Jkt 262001 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)). 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: Matthew Sullivan, Center for Drug PO 00000 Frm 00092 Fmt 4703 Sfmt 4703 Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 3126, Silver Spring, MD 20993–0002, 301– 796–1245. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ‘‘Stimulant Use Disorders: Developing Drugs for Treatment.’’ The purpose of this draft guidance is to assist sponsors in the clinical development of drugs for the treatment of stimulant use disorders. This draft guidance is intended to serve as a focus for continued discussions among the Division of Anesthesiology, Addiction Medicine, and Pain Medicine, pharmaceutical sponsors, the academic community, and the public. This draft guidance does not address treatment of intoxication or poisoning with various stimulants or treatment of withdrawal from stimulants. Because FDA has yet to approve any medication treatments for stimulant use disorders, this guidance reflects current recommendations based on a number of uncertainties about the best approach for treating stimulant use disorders and the best approach for evaluating response to treatment. FDA is engaged in an ongoing process to learn more about stimulant use disorders and their treatments to provide the best possible advice to sponsors. 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 ‘‘Stimulant Use Disorders: Developing Drugs for Treatment.’’ 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. Paperwork Reduction Act of 1995 While this guidance contains no 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 21 CFR part 312 relating to the submission of investigational new drug applications have been approved under OMB control number 0910–0014. The collections of information in 21 CFR part 314 relating to the submission of new drug applications have been approved under OMB control number E:\FR\FM\05OCN1.SGM 05OCN1 Federal Register / Vol. 88, No. 192 / Thursday, October 5, 2023 / Notices 0910–0001. The collections of information in 21 CFR 201.56 and 201.57 relating to certain prescription product labeling requirements have been approved under OMB control number 0910–0572. The collections of information pertaining to expedited programs for serious conditions for drugs and biologics and breakthrough therapy-designation for drugs and biologics have been approved under OMB control number 0910–0765. III. Electronic Access Persons with access to the internet may obtain the draft guidance at https:// www.fda.gov/drugs/guidancecompliance-regulatory-information/ guidances-drugs, https://www.fda.gov/ regulatory-information/search-fdaguidance-documents, or https:// www.regulations.gov. Dated: October 2, 2023. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2023–22189 Filed 10–4–23; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2023–N–0008] Radiological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Radiological Devices Panel of the Medical Devices Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA’s regulatory issues. The meeting will be open to the public. DATES: The meeting will take place virtually on November 7, 2023, from 9 a.m. to 12:15 p.m. eastern time. ADDRESSES: All meeting participants will be heard, viewed, captioned, and recorded for this advisory committee meeting via an online teleconferencing and/or video conferencing platform. Answers to commonly asked questions including information regarding special accommodations due to a disability may be accessed at: https://www.fda.gov/ AdvisoryCommittees/ AboutAdvisoryCommittees/ ucm408555.htm. ddrumheller on DSK120RN23PROD with NOTICES1 SUMMARY: VerDate Sep<11>2014 18:37 Oct 04, 2023 Jkt 262001 FOR FURTHER INFORMATION CONTACT: Jarrod Collier, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5214, Silver Spring, MD 20993–0002, Jarrod.Collier@ fda.hhs.gov, 240–672–5763, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572) in the Washington, DC area). A notice in the Federal Register about last-minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency’s website at https:// www.fda.gov/AdvisoryCommittees/ default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before the meeting. SUPPLEMENTARY INFORMATION: Agenda: The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. On November 7, 2023, the committee will discuss and make recommendations on the classification of blood irradiator devices for the prevention of metastasis, which are currently unclassified preamendments devices, to class III (general controls and premarket approval). FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available on FDA’s website at the time of the advisory committee meeting, and the background material will be posted on FDA’s website after the meeting. Background material and the link to the online teleconference meeting room will be available at https://www.fda.gov/ AdvisoryCommittees/Calendar/ default.htm. Scroll down and select the appropriate advisory committee meeting link. The meeting will include slide presentations with audio components to allow the presentation of materials in a manner that most closely resembles an in-person advisory committee meeting. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before October 25, 2023. Oral presentations from the public will be scheduled on November 7, 2023, between approximately 9:20 a.m. and 10:20 a.m. eastern time. Those PO 00000 Frm 00093 Fmt 4703 Sfmt 4703 69207 individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before October 17, 2023. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by October 18, 2023. For press inquiries, please contact the Office of Media Affairs at fdaoma@ fda.hhs.gov or 301–796–4540. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Ann Marie Williams at Annmarie.williams@ fda.hhs.gov or 240–507–6496 at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our website at https://www.fda.gov/ AdvisoryCommittees/ AboutAdvisoryCommittees/ucm111462. htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: September 29, 2023. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2023–22106 Filed 10–4–23; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES [Document Identifier: OS–0937–0025 Agency Information Collection Request. 60-Day Public Comment Request Office of the Secretary, HHS. Notice. AGENCY: ACTION: In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment. SUMMARY: E:\FR\FM\05OCN1.SGM 05OCN1

Agencies

[Federal Register Volume 88, Number 192 (Thursday, October 5, 2023)]
[Notices]
[Pages 69205-69207]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-22189]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-D-1848]


Stimulant Use Disorders: Developing Drugs for Treatment; Draft 
Guidance for Industry; 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 a draft guidance for industry entitled ``Stimulant 
Use Disorders: Developing Drugs for Treatment.'' The purpose of this 
draft guidance is to assist sponsors in the clinical development of 
drugs for the treatment of stimulant use disorders. Specifically, this 
guidance addresses FDA's current recommendations regarding the overall 
development program and clinical trial designs for the development of 
drugs to support indications of treatment of moderate to

[[Page 69206]]

severe cocaine use disorder, treatment of moderate to severe 
methamphetamine use disorder, or treatment of moderate to severe 
prescription stimulant use disorder.

DATES: Submit either electronic or written comments on the draft 
guidance by December 4, 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-1848 for ``Stimulant Use Disorders: Developing Drugs for 
Treatment.'' 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)).
    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: Matthew Sullivan, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 3126, Silver Spring, MD 20993-0002, 301-
796-1245.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Stimulant Use Disorders: Developing Drugs for Treatment.'' 
The purpose of this draft guidance is to assist sponsors in the 
clinical development of drugs for the treatment of stimulant use 
disorders. This draft guidance is intended to serve as a focus for 
continued discussions among the Division of Anesthesiology, Addiction 
Medicine, and Pain Medicine, pharmaceutical sponsors, the academic 
community, and the public. This draft guidance does not address 
treatment of intoxication or poisoning with various stimulants or 
treatment of withdrawal from stimulants.
    Because FDA has yet to approve any medication treatments for 
stimulant use disorders, this guidance reflects current recommendations 
based on a number of uncertainties about the best approach for treating 
stimulant use disorders and the best approach for evaluating response 
to treatment. FDA is engaged in an ongoing process to learn more about 
stimulant use disorders and their treatments to provide the best 
possible advice to sponsors.
    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 ``Stimulant 
Use Disorders: Developing Drugs for Treatment.'' 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. Paperwork Reduction Act of 1995

    While this guidance contains no 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 21 CFR part 312 relating to the submission of investigational new 
drug applications have been approved under OMB control number 0910-
0014. The collections of information in 21 CFR part 314 relating to the 
submission of new drug applications have been approved under OMB 
control number

[[Page 69207]]

0910-0001. The collections of information in 21 CFR 201.56 and 201.57 
relating to certain prescription product labeling requirements have 
been approved under OMB control number 0910-0572. The collections of 
information pertaining to expedited programs for serious conditions for 
drugs and biologics and breakthrough therapy-designation for drugs and 
biologics have been approved under OMB control number 0910-0765.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: October 2, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-22189 Filed 10-4-23; 8:45 am]
BILLING CODE 4164-01-P
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.