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 


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13352 Federal Register / Vol. 89, No. 36 / Thursday, February 22, 2024 / Notices 

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 § 10.115(g)(5) 

(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 the 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: 

David Reasner, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, Rm. 6373, 

Silver Spring, MD 20993, 301–837– 

7667, or James Myers, Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

7301, Silver Spring, MD 20993–0002, 

240–402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA 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.’’ 

This guidance provides considerations 

for 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 (85 FR 61008). The 

September 2020 guidance was 

published to support public health 

efforts following a declaration, under 

section 319 of the Public Health Service 

Act (PHS Act) (42 U.S.C. 247d), by the 

Secretary of Health and Human Services 

of a public health emergency related to 

COVID–19. In the Federal Register of 

March 13, 2023 (88 FR 15417) FDA 

listed certain guidance documents that 

FDA was revising to continue in effect 

for 180 days after the expiration of the 

COVID–19 PHE declaration on May 11, 

2023, during which time FDA planned 

to further revise the guidances. The 

September 2020 guidance on assessing 

COVID–19-related symptoms in 

outpatient adult and adolescent subjects 

in clinical trials of drugs and biological 

products for treatment or prevention of 

COVID–19 is included in this list. 

FDA is issuing this guidance for 

immediate implementation in 

accordance with our good guidance 

practices regulation (§ 10.115(g)(3)) 

without initially seeking prior comment 

because the Agency has determined that 

prior public participation is not feasible 

or appropriate (see § 10.115(g)(2) and 

section 701(h)(1)(C)(i) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

371(h)(1)(C)(i))). Specifically, we are not 

seeking prior comment because 

although the COVID–19 public health 

emergency under section 319 of the PHS 

Act has expired, COVID–19 remains a 

serious health risk for some individuals, 

and there is a need to ensure that 

sponsors are aware of FDA’s 

recommendations to facilitate timely 

development of drugs and biological 

products for treatment and prevention 

of COVID–19. FDA is committed to 

supporting continued development of 

products to treat or prevent the COVID– 

19 virus by providing timely guidance. 

This guidance document is being 

implemented immediately, but it 

remains subject to comment in 

accordance with the Agency’s good 

guidance practices. 

FDA considered comments received 

on the 2020 guidance. Changes from the 

2020 guidance to this guidance include 

updating the reference list to refer 

sponsors to new resources that could 

support their drug development 

program (e.g., patient-focused drug 

development guidance series); 

providing considerations for 

determining which subset of symptoms, 

and aspects of those symptoms, to 

assess (e.g., mechanism of action of the 

drug); clarifying the item-level questions 

to make them more specific and 

adequate to support development of 

endpoint measures (e.g., recall period, 

response options); and adding 

recommendations for global scale 

measures to align with the concepts of 

interest. In addition, editorial changes 

were made to improve clarity. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (§ 10.115). The 

guidance represents the current thinking 

of FDA on ‘‘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.’’ 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 parts 312 

pertaining to investigational new drug 

applications have been approved under 

OMB control number 0910–0014. The 

collections of information in 21 CFR 

part 314 pertaining to new drug 

applications have been approved under 

OMB control number 0910–0001. The 

collections of information in 21 CFR 

part 601 pertaining to biologics license 

applications have been approved under 

OMB control number 0910–0338. The 

collections of information in 21 CFR 

parts 50 and 56 pertaining to protection 

of human subjects and institutional 

review boards have been approved 

under OMB control number 0910–0130. 

The collections of information in 21 

CFR part 11 pertaining to electronic 

records and signatures have been 

approved under OMB control number 

0910–0303. 

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/ 

vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents, or 

https://www.regulations.gov. 

Dated: February 16, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–03622 Filed 2–21–24; 8:45 am] 

BILLING CODE 4164–01–P 


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