94734 Federal Register / Vol. 89, No. 230 / Friday, November 29, 2024 / Notices 

Dated: November 25, 2024. 

Maura Calsyn, 

Principal Deputy Administrator for the 

Administration for Community Living, 

performing the delegable duties of the 

Administrator and the Assistant Secretary for 

Aging. 

[FR Doc. 2024–28052 Filed 11–27–24; 8:45 am] 

BILLING CODE 4154–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–4731] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Administrative 

Detention and Banned Medical Devices 

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 

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 information 

collection associated with 

administrative detention and banned 

medical devices. 

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–4731 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; 

Administrative Detention and Banned 

Medical Devices.’’ 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: 

Amber Sanford, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–8867, 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 


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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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