Federal Register / Vol. 89, No. 230 / Friday, November 29, 2024 / Notices 94735 

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. 

Administrative Detention and Banned 

Medical Devices—21 CFR 800.55, 

895.21, and 895.22 

OMB Control Number 0910–0114— 

Extension 

This information collection supports 

FDA regulations. FDA has the statutory 

authority under section 304(g) of the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act) (21 U.S.C. 334(g)) to detain 

during established inspections devices 

that are believed to be adulterated or 

misbranded. Section 800.55 (21 CFR 

800.55), regarding administrative 

detention, includes among other things 

certain reporting requirements 

(§ 800.55(g)(1) and (2)) and 

recordkeeping requirements 

(§ 800.55(k)). Under § 800.55(g), an 

appellant of a detention order must 

show documentation of ownership if 

devices are detained at a place other 

than that of the appellant. Under 

§ 800.55(k), the owner or other 

responsible person must supply records 

about how the devices may have 

become adulterated or misbranded, in 

addition to records of distribution of the 

detained devices. These recordkeeping 

requirements for administrative 

detentions permit FDA to trace devices 

for which the detention period expired 

before a seizure is accomplished or 

injunctive relief is obtained. 

FDA also has the statutory authority 

under section 516 of the FD&C Act (21 

U.S.C. 360f) to ban devices that present 

substantial deception or an 

unreasonable and substantial risk of 

illness or injury. Section 895.21 (21 CFR 

895.21), regarding banned devices, 

contains certain reporting requirements. 

Section 895.21(d) describes the 

procedures for banning a device when 

the Commissioner of Food and Drugs 

(the Commissioner) decides to initiate 

such a proceeding. Under 21 CFR 

895.22, a manufacturer, distributor, or 

importer of a device may be required to 

submit to FDA all relevant and available 

data and information to enable the 

Commissioner to determine whether the 

device presents substantial deception, 

unreasonable and substantial risk of 

illness or injury, or unreasonable, direct, 

and substantial danger to the health of 

individuals. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Administrative detention reporting requirements— 

800.55(g) & (h) ................................................................. 1 1 1 25 25 

Banned devices reporting requirements—895.21(d)(8) and 

895.22(a) .......................................................................... 26 1 26 16 416 

Total .............................................................................. ........................ ........................ ........................ ........................ 441 

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

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN1 

21 CFR section Number of 

recordkeepers 

Number of 

records per 

recordkeepers 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

Records regarding device adulteration or misbranding and 

records of distribution of detained devices—800.55(k) ... 1 1 1 20 20 

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

During the past several years, there 

has been an average of less than one 

new administrative detention action per 

year. Each administrative detention will 

have varying amounts of data and 

information that must be maintained. 

FDA’s estimate of the burden under the 

administrative detention provision is 

based on FDA’s discussion with one of 

the firms whose devices had been 

detained. 

Based on our evaluation of the 

information collection we have made no 

adjustment to our current estimates. 

Dated: November 19, 2024. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2024–28044 Filed 11–27–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–4754] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Financial 

Disclosure by Clinical Investigators 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing an opportunity for public 

comment on the proposed collection of 


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94736 Federal Register / Vol. 89, No. 230 / Friday, November 29, 2024 / Notices 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on financial 

disclosure by clinical investigators. 

DATES: Either electronic or written 

comments on the collection of 

information must be submitted by 

January 28, 2025. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. The https://

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

January 28, 2025. Comments received by 

mail/hand delivery/courier (for written/ 

paper submissions) will be considered 

timely if they are received on or before 

that date. 

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–N–4754 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; Financial 

Disclosure by Clinical Investigators.’’ 

Received comments, those filed in a 

timely manner (see ADDRESSES), 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. 

FOR FURTHER INFORMATION CONTACT: 

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: 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, 

including each proposed extension of an 

existing 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. 

Financial Disclosure by Clinical 

Investigators 

OMB Control Number 0910–0396— 

Extension 

Respondents to this collection are 

sponsors of marketing applications that 

contain clinical data from studies 

covered by the regulations. These 

sponsors represent pharmaceutical, 

biologic, and medical device firms. 

Respondents are also clinical 

investigators who provide financial 

information to the sponsors of 

marketing applications. 


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Federal Register / Vol. 89, No. 230 / Friday, November 29, 2024 / Notices 94737 

Table 1 shows information that is the 

basis of the estimated number of 

respondents in tables 2 through 4. 

TABLE 1—ESTIMATED NUMBER OF APPLICATIONS, CLINICAL TRIALS, AND INVESTIGATORS SUBJECT TO THE REGULATION

BY TYPE OF APPLICATION 1

Application type 

Total number 

of 

applications 

Number of 

applications 

affected 

Number 

of trials 

Number of 

investigators 

Drugs: 

New drug application (NDA), new molecular entity (NME) ......................... 35 35 3 to 10 .......... 3 to 100. 

NDA non-NME ............................................................................................. 94 44 3 to 10 .......... 3 to 100. 

NDA efficacy supplement ............................................................................ 171 100 1 to 3 ............ 10 to 30. 

Abbreviated new drug application (ANDA) .................................................. 685 1 1.1 ................ 2. 

ANDA supplement ....................................................................................... 10,366 1 1 ................... 2. 

CBER Biologics: 

Biologics license application (BLA) ............................................................. 26 26 3 to 10 .......... 3 to 100. 

BLA efficacy supplement ............................................................................. 26 26 1 to 3 ............ 10 to 30. 

CDER Biologics: 

BLAs ............................................................................................................ 19 19 3 to 10 .......... 3 to 100. 

BLA efficacy supplements ........................................................................... 64 50 1 to 3 ............ 10 to 30. 

Medical Devices: 

Premarket approval (PMA) .......................................................................... 43 50 1 to 31 .......... 10 to 20. 

PMA supplement ......................................................................................... 28 30 to 3 ............... 3 to 10. 

Reclassification devices ............................................................................... 0 0 0 ................... 0. 

510(k) ........................................................................................................... 3401 254 1 ................... 3 to 10. 

De Novo requests ........................................................................................ 84 76 1 to 3 ............ 10 to 20. 

1Source: Agency estimates. 

FDA estimates the burden of this 

collection of information as follows: 

Reporting Burden 

Under § 54.4(a) (21 CFR 54.4(a)), 

applicants submitting an application 

that relies on clinical studies must 

submit a complete list of clinical 

investigators who participated in a 

covered clinical study, and must either 

certify to the absence of certain financial 

arrangements with clinical investigators 

(Form FDA 3454) or, under § 54.4(a)(3), 

disclose to FDA the nature of those 

arrangements and the steps taken by the 

applicant or sponsor to minimize the 

potential for bias (Form FDA 3455). 

FDA estimates that almost all 

applicants submit a certification 

statement under § 54.4(a)(1) and (2). 

Preparation of the statement using Form 

FDA 3454 should require no more than 

1 hour per study. The number of 

respondents is based on the estimated 

number of affected applications. 

When certification is not possible and 

disclosure is made using Form FDA 

3455, the applicant must describe, 

under § 54.4(a)(3), the financial 

arrangements or interests and the steps 

that were taken to minimize the 

potential for bias in the affected study. 

As the applicant would be fully aware 

of those arrangements and the steps 

taken to address them, describing them 

will be straightforward. The Agency 

estimates that it will take about 5 hours 

to prepare this narrative. Based on our 

experience with this collection, FDA 

estimates that approximately 10 percent 

of the respondents with affected 

applications will submit disclosure 

statements. 

TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden 

per response 

Total 

hours 

Certification—54.4(a)(1) and (2)—Form FDA 3454 ........ 712 1 712 1 712 

Disclosure—54.4(a)(3)—Form FDA 3455 ....................... 71 1 71 5 355 

Total .......................................................................... .......................... .......................... ........................ ........................ 1,067 

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

Recordkeeping Burden 

Under § 54.6 (21 CFR 54.6), the 

sponsors of covered studies must 

maintain complete records of 

compensation agreements with any 

compensation paid to nonemployee 

clinical investigators, including 

information showing any financial 

interests held by the clinical 

investigator, for 2 years after the date of 

approval of the applications. Sponsors 

of covered studies maintain many 

records regarding clinical investigators, 

including protocol agreements and 

investigator resumes or curriculum 

vitae. FDA estimates an average of 15 

minutes will be required for each 

recordkeeper to add this record to the 

clinical investigators’ file. 


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94738 Federal Register / Vol. 89, No. 230 / Friday, November 29, 2024 / Notices 

TABLE 3—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

21 CFR section Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total 

hours 2

Recordkeeping—54.6 ...................................................... 712 1 712 0.25 178 

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

2 Numbers have been rounded. 

Third-Party Disclosure Burden 

Under § 54.4(b), clinical investigators 

supply to the sponsor of a covered study 

financial information sufficient to allow 

the sponsor to submit complete and 

accurate certification or disclosure 

statements. Clinical investigators are 

accustomed to supplying such 

information when applying for research 

grants. Also, most people know the 

financial holdings of their immediate 

family and records of such interests are 

generally accessible because they are 

needed for preparing tax records. For 

these reasons, FDA estimates that the 

time required for this task may range 

from 5 to 15 minutes; we used the 

median, 10 minutes, for the average 

burden per disclosure (see table 4). To 

estimate the number of respondents for 

each FDA Center, we took the median 

number of investigators for each 

application type, multiplied each 

median number of investigators by the 

number of affected applications for that 

application type, then summed those 

products to get the total number of 

respondents for the Center. 

TABLE 4—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

21 CFR section Number of 

respondents 

Number of 

disclosures per 

respondent 

Total annual 

disclosures 

Average 

burden per 

disclosure 

Total 

hours 2

54.4(b)—Clinical Investigators ......................................... 13,646 1 13,646 0.17 2,320 

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

2 Numbers have been rounded. 

The burden for this information 

collection request has changed since the 

last OMB approval. We have adjusted 

our estimated burden for the 

information collection to reflect the 

number of submissions we received in 

the last few years. These adjustments 

result in an increase of 557 total annual 

responses and a corresponding increase 

of 87 total hours. 

Dated: November 19, 2024. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2024–28034 Filed 11–27–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–D–0084] 

Use of Circulating Tumor 

Deoxyribonucleic Acid for CurativeIntent Solid Tumor Drug Development; 

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 ‘‘Use of 

Circulating Tumor DNA for CurativeIntent Solid Tumor Drug Development.’’ 

This guidance is intended to help 

sponsors planning to use circulating 

cell-free plasma derived tumor DNA 

(ctDNA) as a biomarker in cancer 

clinical trials conducted under an 

investigational new drug application 

(IND) and/or to support marketing 

approval of drugs and biological 

products for treating solid tumor 

malignancies in the early-stage 

(curative-intent) setting. This guidance 

finalizes the draft guidance entitled 

‘‘Use of Circulating Tumor DNA for 

Early-Stage Solid Tumor Drug 

Development’’ issued on May 2, 2022. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on November 29, 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– 

2022–D–0084 for ‘‘Use of Circulating 


khammond on DSK9W7S144PROD with NOTICES