Federal Register / Vol. 88, No. 192 / Thursday, October 5, 2023 / Notices 69205 

Dated: October 2, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–22188 Filed 10–4–23; 8:45 am] 

BILLING CODE 4164–01–C 

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Drugs for Treatment; Draft Guidance 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this draft guidance is to assist sponsors 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 


ddrumheller on DSK120RN23PROD with NOTICES1EN05OC23.077</GPH>

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 S ARS-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-Co V-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 
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. 

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 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 88, No. 192 / Thursday, October 5, 2023 / Notices 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/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. 

SUMMARY: 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. 

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 

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 

AGENCY: Office of the Secretary, HHS. 

ACTION: Notice. 

SUMMARY: 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. 


ddrumheller on DSK120RN23PROD with NOTICES1