8208 Federal Register / Vol. 89, No. 25 / Tuesday, February 6, 2024 / Notices 

Date: February 1, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–02356 Filed 2–5–24; 8:45 am] 

BILLING CODE 4161–01–C 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–D–1031] 

Reporting Amount of Listed Drugs and 

Biological Products Under Section 

510(j)(3) of the Federal Food, Drug, and 

Cosmetic Act; 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 final 

guidance for industry entitled 

‘‘Reporting Amount of Listed Drugs and 

Biological Products Under Section 

510(j)(3) of the Federal Food, Drug, and 

Cosmetic Act; Guidance for Industry; 

Availability.’’ This guidance addresses 

the process through which registrants of 

drug establishments should submit 

reports to FDA on the amount of each 

listed drug manufactured, prepared, 


ddrumheller on DSK120RN23PROD with NOTICES1EN06FE24.023</GPH>

-·■ U.S. FOOD & DRUG . ADMIN1$TllATIOI\I 

Donald C. Hall, Jr. Ph.D. 

Director of Operations 

Drexel Medicine -Diagnostics 

College of Medicine, Drexel tJnhrersity 

245 N. 15th Street, Room 510& 

Philadelphia; PA 19102 

Re: Revocation ofEUA220099 

Dear Dr. Hall: 

October 5, 2023 

This letter is in response to the request frori1 Drexel University College of Medicine, in 1:111 email 

receive_d September 29, 2023, that the U.S. Food and Drug Administration (FDA) withdraw the 

EUA for the- SARS~Co V-2 DUCoM-PDL Modified T etracore Assay,. issued on April 19, 2021. 

Drexel University College of Medicine indicated that they have discontinued use of the SARSCoV-2 DUCoM•PDL Modified Tetracore Assay at Drexel University, DrexelMedicine 

Diagnostics.located at 245 N. 15th Street, Room 5401, Philadelphia, PA 19102. 

The authorization ofa device for emergency use under section 564ofthe Federal Food, Drug, 

and Cos111etic Act (the Act) (21 U.S.C. 360bbb~3) may, pursua11t 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(g)(2)(C) ofthe Act), Because Drexel University College ofMedicine has. 

requested that FDA withdraw the EUA for the SARS•CoV-2 DUCoM-PDL Modified Tetracore 

Assay; FDA has determined that it is appropriate to protect the public health or safety to revoke 

this authorization. Accordingly, FDA hereby revokes EUA220099 for the SARS-Co\M 

DUCoM-PDL M<xiified TetraCQte Assay, pursuant to section 564(g)(2)(G) of the Act; As of the 

date of this letter, the SARS•Co V-2DlJCoM•PDL Modified Tetracore Assay is no longer 

authorized for emergency use by FDA. 

N◊tice of this. revocation will be published in the Federal Register, pursuant to section 564(h)(l) 

of the Act. • • 

Sincerely, 

I!$/! 

Jeffrey E. Shuren, M.D., J.D. 

Director 

Center for Devices and Radiological Health 

FoQd and Drug Administration 
Federal Register / Vol. 89, No. 25 / Tuesday, February 6, 2024 / Notices 8209 

propagated, compounded, or processed 

for commercial distribution, as required 

by the Federal Food, Drug, and 

Cosmetic Act (FD&C Act). This guidance 

finalizes the draft guidance of the same 

title published on November 1, 2021. To 

allow for the transition of technical 

updates to the NextGen Portal, FDA will 

delay implementation of the final 

guidance until February 26, 2024. The 

draft guidance will remain available 

until that date. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on February 6, 2024. 

Implementation of this guidance will be 

delayed until February 26, 2024, to 

allow for the transition of technical 

updates to the NextGen Portal. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances 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– 

2021–D–1031 for ‘‘Reporting Amount of 

Listed Drugs and Biological Products 

Under Section 510(j)(3) of the Federal 

Food, Drug, and Cosmetic Act.’’ 

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 this 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; or to Office of Communication, 

Outreach and Development, Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

3128, Silver Spring, MD 20993–0002. 

Send one self-addressed adhesive label 

to assist that office in processing your 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance document. 

FOR FURTHER INFORMATION CONTACT: Neil 

Stiber, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 4128, Silver Spring, 

MD 20993–0002, 301–796–8944; James 

Myers, Center for Biologics Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 71, Rm. 7226, Silver Spring, 

MD 20993–0002, 240–402–5923; or 

Linda Walter-Grimm, Center for 

Veterinary Medicine, Food and Drug 

Administration, 7519 Standish Pl. 

(HFV–240), Rockville, MD 20855, 240– 

753–3173. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled 

‘‘Reporting Amount of Listed Drugs and 

Biological Products Under Section 

510(j)(3) of the FD&C Act.’’ On March 

27, 2020, the Coronavirus Aid, Relief, 

and Economic Security Act (CARES 

Act) (Pub. L. 116–136) was enacted to 

aid response efforts and ease the 

economic impact of the Coronavirus 

Disease 2019 (COVID–19). In addition, 

the CARES Act included authorities to 

enhance FDA’s ability to assess, 

prevent, and mitigate possible drug 

shortages by, among other things, 

improving FDA’s visibility into drug 

supply chains. Section 3112(e) of the 

CARES Act added section 510(j)(3) of 

the FD&C Act (21 U.S.C. 360(j)(3)), 

which requires that each person 

(including repackers and relabelers) 

who registers with FDA under section 

510 of the FD&C Act with regard to a 

drug must report annually to FDA the 

amount of each listed drug that was 

manufactured, prepared, propagated, 

compounded, or processed by such 

person for commercial distribution. 

This guidance describes the process 

that should be used for such reporting 

by each person who registers with FDA 

under section 510 of the FD&C Act with 

regard to a listed drug (including a drug 


ddrumheller on DSK120RN23PROD with NOTICES1
8210 Federal Register / Vol. 89, No. 25 / Tuesday, February 6, 2024 / Notices 

1Health professionals may include but are not 

limited to pediatricians, family physicians, 

product that is in finished package form, 

a drug product that is not in finished 

package form, an active pharmaceutical 

ingredient, and other types of listed 

drugs, except for biological products or 

categories thereof exempted by an order 

under section 510(j)(3)(B) of the FD&C 

Act). Listed drugs subject to reporting 

include human drug products 

(including non-exempt biological 

products) marketed under an approved 

application, animal drug products 

marketed under an approved 

application, medical gases, homeopathic 

products, products marketed in 

accordance with requirements under 

section 505G of the FD&C Act (21 U.S.C. 

355h), often referred to as over-thecounter monograph drugs, and animal 

drug products that are not approved, 

conditionally approved, or indexed 

under sections 512, 571, and 572 of the 

FD&C Act (21 U.S.C. 360b, 360ccc, and 

360ccc–1). 

This guidance finalizes the draft 

guidance entitled ‘‘Reporting Amount of 

Listed Drugs and Biological Products 

Under Section 510(j)(3) of the FD&C 

Act’’ published on November 1, 2021 

(86 FR 60249). FDA considered 

comments received on the draft 

guidance as the guidance was finalized. 

Changes from the draft to the final 

guidance include changes to the 

recommended timeframe for report 

submission, as well as changes to the 

recommended units for the reporting of 

drugs that are not drug products in 

finished package form. These changes 

were made in response to public 

comments received and in the interest 

of facilitating drug amount data 

submission and improving data 

accuracy. Revisions also were made to 

clarify the reporting requirements 

applicable to registrants of listed drugs 

across the drug supply chain, including 

contract manufacturers. Further 

revisions were made to clarify and 

further detail how FDA plans to use 

data derived from the drug amount 

reporting program, including data 

submitted by each registrant in the drug 

supply chain. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on ‘‘Reporting Amount 

of Listed Drugs and Biological Products 

Under Section 510(j)(3) of the FD&C 

Act.’’ 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 207 

pertaining to registration of producers of 

drugs and listing of drugs in commercial 

distribution have been approved under 

OMB control number 0910–0045. The 

collections of information in 21 CFR 

parts 314 and 601 have been approved 

under OMB control numbers 0910–0001 

and 0910–0338, respectively. The 

collections of information pertaining to 

notifications of discontinuance or 

interruption in manufacturing under 21 

CFR 310.306 and 314.81(b)(3)(iii) have 

been approved under OMB control 

number 0910–0001. The collections of 

information relating to 21 CFR 600.81 

and 600.82 have been approved under 

OMB control number 0910–0308. The 

collections of information in 21 CFR 

parts 210 and 211 relating to current 

good manufacturing practice have been 

approved under OMB control number 

0910–0139. The collections of 

information in 21 CFR 514.80 have been 

approved under OMB control number 

0910–0284. The collections of 

information in 21 CFR 514.87 have been 

approved under OMB control number 

0910–0659. 

III. Electronic Access

Persons with access to the internet

may obtain the guidance at https://

www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs, https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents, https://

www.fda.gov/vaccines-blood-biologics/ 

guidance-compliance-regulatoryinformation-biologics/biologicsguidances, https://www.fda.gov/animalveterinary/guidance-regulations/ 

guidance-industry, or https://

www.regulations.gov. 

Dated: February 1, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–02369 Filed 2–5–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: Public 

Comment Request; Information 

Collection Request Title: Pediatric 

Mental Health Care Access Program 

National Impact Study 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement for opportunity for public 

comment on proposed data collection 

projects of the Paperwork Reduction Act 

of 1995, HRSA announces plans to 

submit an Information Collection 

Request (ICR), described below, to the 

Office of Management and Budget 

(OMB). Prior to submitting the ICR to 

OMB, HRSA seeks comments from the 

public regarding the burden estimate, 

below, or any other aspect of the ICR. 

DATES: Comments on this ICR should be 

received no later than April 8, 2024. 

ADDRESSES: Submit your comments to 

paperwork@hrsa.gov or mail the HRSA 

Information Collection Clearance 

Officer, Room 14N39, 5600 Fishers 

Lane, Rockville, Maryland, 20857. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and draft 

instruments, email paperwork@hrsa.gov 

or call Joella Roland, the HRSA 

Information Collection Clearance 

Officer, at (301) 443–3983. 

SUPPLEMENTARY INFORMATION: When 

submitting comments or requesting 

information, please include the ICR title 

for reference. 

Information Collection Request Title: 

Pediatric Mental Health Care Access 

Program National Impact Study, OMB 

No. 0915–xxxx—[New]. 

Abstract: This notice describes an 

information collection request for one of 

HRSA’s Maternal and Child Health 

Bureau programs, the Pediatric Mental 

Health Care Access (PMHCA) Program. 

The PMHCA Program aims to promote 

behavioral health integration into 

pediatric primary care by supporting the 

development of state, regional, and 

tribal pediatric mental health care 

teleconsultation access programs. The 

PMHCA Program supports pediatric 

health professionals (HPs) 1 in their 


ddrumheller on DSK120RN23PROD with NOTICES1