Federal Register / Vol. 89, No. 36 / Thursday, February 22, 2024 / Notices 13349 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–D–1873] 

Select Updates for the Medical Device 

User Fee Small Business Qualification 

and Certification Guidance; Draft 

Guidance for Industry; Availability; 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘Select Updates for the 

Medical Device User Fee Small Business 

Qualification and Certification 

Guidance.’’ The guidance includes 

select updates to the guidance ‘‘Medical 

Device User Fee Small Business 

Qualification and Certification’’ which 

describe how FDA plans to determine if 

a small business is experiencing 

‘‘financial hardship’’ which makes them 

eligible for a waiver of their registration 

fee. The guidance will detail what 

information FDA will review and 

consider in making this determination. 

This draft guidance is not final nor is it 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written comments on the draft guidance 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 April 22, 2024 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

Submit electronic or written comments 

on the proposed collection of 

information in the draft guidance by 

April 22, 2024. 

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– 

2018–D–1873 for ‘‘Select Updates for 

the Medical Device User Fee Small 

Business Qualification and Certification 

Guidance.’’ 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 draft guidance document 

entitled ‘‘Select Updates for the Medical 

Device User Fee Small Business 

Qualification and Certification 

Guidance’’ to 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 or include a Fax number to 

which the draft guidance may be sent. 

See the SUPPLEMENTARY INFORMATION

section for information on electronic 

access to the draft guidance. 

FOR FURTHER INFORMATION CONTACT: 

With regard to the draft guidance: 

Jason Brookbank, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5234, Silver Spring, 

MD 20993–0002, 301–796–5498, 

Jason.Brookbank@fda.hhs.gov 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. 

With regard to the proposed collection 

of information: JonnaLynn Capezzuto, 

Office of Operations, Food and Drug 

Administration, Three White Flint 

North, 10A–12M, 11601 Landsdown St., 

North Bethesda, MD 20852, 301–796– 

3794, PRAStaff@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Select Updates for the Medical Device 

User Fee Small Business Qualification 

and Certification Guidance.’’ On 

December 29, 2022, the Food and Drug 


lotter on DSK11XQN23PROD with NOTICES1
13350 Federal Register / Vol. 89, No. 36 / Thursday, February 22, 2024 / Notices 

Omnibus Reform Act of 2022 was 

signed into law as part of the 

Consolidated Appropriations Act, 2023, 

Public Law 117–328. section 3309 of the 

Omnibus—‘‘Small Business Fee 

Waiver’’—amended section 738(a)(3)(B) 

of the Federal Food, Drug, and Cosmetic 

Act (FD&C Act) by adding clause (ii) 

‘‘Small business fee waiver.’’ The 

amended language gave FDA the 

discretion, beginning in fiscal year 2025, 

to waive the annual registration fee for 

device establishments that are small 

businesses if FDA determines that 

paying such fee represents a financial 

hardship. Additionally, the amended 

statute acknowledges that device 

establishments may be located in 

countries without a national taxing 

authority (NTA). As a result of this 

amended statutory language, FDA is 

issuing this draft guidance to propose 

select updates to the guidance ‘‘Medical 

Device User Fee Small Business 

Qualification and Certification’’ which 

will describe how FDA plans to 

determine if a small business is 

experiencing ‘‘financial hardship’’ 

which makes them eligible for a waiver 

of their registration fee. The guidance 

details what information FDA will 

review and consider in making this 

determination. 

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 Select Updates for the Medical 

Device User Fee Small Business 

Qualification and Certification 

guidance. 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. 

Persons unable to download an 

electronic copy of ‘‘Select Updates for 

the Medical Device User Fee Small 

Business Qualification and Certification 

Guidance’’ may send an email request to 

CDRH-Guidance@fda.hhs.gov to receive 

an electronic copy of the document. 

Please use the document number 

GUI00018007 and complete title to 

identify the guidance you are 

requesting. 

III. Paperwork Reduction Act of 1995 

Under the PRA (44 U.S.C. 3501– 

3521), Federal Agencies must obtain 

approval from the Office of Management 

and Budget (OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

MDUFMA Small Business Qualification 

Certification 

OMB Control Number 0910–0508— 

Revision 

This information collection helps 

support implementation of the Medical 

Device User Fee and Modernization Act 

of 2002 (MDUFMA) (Pub. L. 107–250), 

most recently reauthorized in 2022 from 

October 1, 2022, until September 30, 

2027. To qualify as a ‘‘small business,’’ 

and therefore be eligible for reduced or 

waived fees, respondents submit 

information to FDA so we can 

determine whether the applicant is a 

small business. Sections 738(d)(2)(A) 

and (e)(2)(A) of the FD&C Act (21 U.S.C. 

379j(d)(2)(A) and (e)(2)(A)) define a 

‘‘small business’’ as an entity that 

reported $100 million or less of gross 

receipts or sales in its most recent 

Federal income tax return, including 

such returns of its affiliates, partners, 

and parent firms. If a firm’s gross 

receipts or sales are no more than $30 

million (including all affiliates, 

partners, and parent firms), they will 

also qualify for a waiver of the fee for 

their first (ever) premarket application 

(PMA), product development protocol 

(PDP), biological licensing application 

(BLA), or premarket report. 

The proposed updates to the Small 

Business Guidance describe how small 

businesses can show ‘‘financial 

hardship’’ to qualify for a small business 

waiver of the registration fee. 

Manufacturers seeking the small 

business fee waiver may provide 

evidence of a reported $1 million or less 

of gross receipts or sales in its most 

recent Federal income tax return, as 

well as evidence that they have filed a 

petition for bankruptcy and that the 

bankruptcy is currently active. 

The proposed updates also reflect 

how firms based in jurisdictions 

without an NTA need not submit a 

certification from their NTA to be 

eligible for fee waivers or reductions. 

Additionally, FDA intends to 

consolidate the forms previously known 

as FDA 3602 and FDA 3602A into a 

single form to be completed by foreign 

as well as U.S. businesses/applicants. 

We propose the following revisions to 

the information collection: 

• Consolidation of forms FDA 3602 

and FDA 3602A into a single form, FDA 

3602, to be completed by foreign as well 

as domestic businesses; and 

• Addition of a ‘‘Registration & 

Listing Fee Waiver’’ section in the 

revised form, which asks if the 

business/applicant will apply for a 

registration and listing fee waiver and 

whether they have registered in the past. 

FDA recommends that applicants 

seeking this waiver include 

documentation supporting eligibility, 

including evidence that applicants have 

filed a petition for bankruptcy in United 

States Bankruptcy Court and that the 

bankruptcy is currently active (debts 

have yet to be discharged or a 

reorganization plan has not been 

confirmed) as well as evidence of prior 

registration as applicable. 

FDA estimates the burden of this 

collection of information as follows: 


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Federal Register / Vol. 89, No. 36 / Thursday, February 22, 2024 / Notices 13351 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

FDA Form No. Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total 

hours 

FDA 3602 MDUFA Small Business Certification Request .................. 4,500 1 4,500 1 4,500 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Because we assume that current 

bankruptcy documentation is readily 

available to applicants, we assume no 

change to the Average Burden per 

Response for this information 

collection. Based on a review of the 

information collection since our last 

request for OMB approval, we have 

made no adjustments to our total burden 

estimate. 

Dated: February 16, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–03619 Filed 2–21–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–D–0584] 

Assessing COVID–19-Related 

Symptoms in Outpatient Adult and 

Adolescent Subjects in Clinical Trials 

of Drugs and Biological Products for 

COVID–19 Prevention or Treatment; 

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 

‘‘Assessing COVID–19-Related 

Symptoms in Outpatient Adult and 

Adolescent Subjects in Clinical Trials of 

Drugs and Biological Products for 

COVID–19 Prevention or Treatment.’’ 

Although the public health emergency 

declared by the Department of Health 

and Human Services under section 319 

of the Public Health Services Act has 

ended, COVID–19 remains an ongoing 

public health problem with continued 

prevention and treatment efforts. FDA is 

issuing this guidance to provide 

sponsors and investigators with 

considerations for approaches on how 

common COVID–19-related symptoms 

can be measured and analyzed in 

clinical trials evaluating drugs or 

biological products for the prevention or 

treatment of COVID–19 in outpatient 

adult and adolescent subjects. This 

guidance supersedes the guidance of the 

same name issued on September 29, 

2020. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on February 22, 2024. 

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– 

2024–D–0584 for ‘‘Assessing COVID–19- 

Related Symptoms in Outpatient Adult 

and Adolescent Subjects in Clinical 

Trials of Drugs and Biological Products 

for COVID–19 Prevention or 

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 


lotter on DSK11XQN23PROD with NOTICES1