26208 Federal Register / Vol. 87, No. 85 / Tuesday, May 3, 2022 / Notices 

Certain patients with early-stage solid 

tumors can be cured with local therapy 

alone (e.g., surgery, radiation, or 

chemoradiation), other patients require 

(neo)adjuvant systemic therapy in order 

to be cured, and others may progress to 

metastatic disease despite surgery and/ 

or systemic therapy. ctDNA is tumorderived fragmented DNA shed into a 

patient’s bloodstream that is not 

associated with cells. ctDNA quantity 

can vary among individuals and 

depends on the type of tumor, location, 

stage, tumor burden, and response to 

therapy. ctDNA as a biomarker has a 

number of potential regulatory and 

clinical uses in the early-stage setting 

that may assist and expedite drug 

development. In the early-stage cancer 

setting, ctDNA may be used to detect a 

certain targetable alteration, to enrich a 

high- or low-risk population for study in 

a trial, to reflect a patient’s response to 

treatment, or, potentially, as an early 

marker of efficacy. 

This draft guidance is being issued 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The draft guidance, when finalized, will 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 ‘‘Use of Circulating Tumor DNA for 

Early-Stage Solid Tumor Drug 

Development.’’ 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. Therefore, clearance by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (PRA) (44 U.S.C. 3501– 

3521) is not required for this guidance. 

The previously approved collections of 

information are subject to review by 

OMB under the PRA. The collections of 

information in 21 CFR parts 50 and 56 

have been approved under OMB control 

number 0910–0130; the collections of 

information in 21 CFR part 314 have 

been approved under OMB control 

number 0910–0001; the collections of 

information in 21 CFR part 312 have 

been approved under OMB control 

number 0910–0014; the collections of 

information in 21 CFR part 601 have 

been approved under OMB control 

number 0910–0338; the collections of 

information in 21 CFR part 800 have 

been approved under OMB control 

number 0910–0625 and the collections 

of information pertaining to submission 

of a biologics license application under 

section 351(k) of the Public Health 

Service Act (42 U.S.C. 262(k)) have been 

approved under OMB control number 

0910–0719. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at either 

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/medical-devices/deviceadvice-comprehensive-regulatoryassistance/guidance-documentsmedical-devices-and-radiation-emittingproducts, https://www.fda.gov/ 

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

www.regulations.gov. 

Dated: April 26, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–09459 Filed 5–2–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–4465] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Administrative 

Detention and Banned Medical Devices 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by June 2, 

2022. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be submitted to https://

www.reginfo.gov/public/do/PRAMain. 

Find this particular information 

collection by selecting ‘‘Currently under 

Review—Open for Public Comments’’ or 

by using the search function. All 

comments should be identified with the 

OMB control number 0910–0114. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Domini Bean, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–45, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–5733, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Administrative Detention and Banned 

Medical Devices 

OMB Control Number 0910–0114— 

Extension 

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), on 

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), on 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. 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 87, No. 85 / Tuesday, May 3, 2022 / Notices 26209 

In the Federal Register of November 

22, 2021 (86 FR 66315), we published a 

60-day notice requesting public 

comment on the proposed collection of 

information. One comment was received 

communicating general support for the 

information collection. Although the 

comment suggested the Agency’s 

burden estimate may be too low, no 

figures were provided. 

We estimate 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) and (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 BURDEN 1

21 CFR section Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

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. 

Administrative Detention Reporting— 

§ 800.55(g)(1) and (2): A person who 

would be entitled to claim the devices, 

if seized, may appeal a detention order 

by submitting a written request to the 

FDA District Director in whose district 

the devices are located. This written 

appeal could include a request for an 

informal hearing as defined in section 

201(y) of the FD&C Act (21 U.S.C. 

321(y)). In some cases, the appellant 

must include documents showing that 

that person has the legal right to appeal 

this order. 

Movement of Detained Devices— 

§ 800.55(h)(2): If detained devices are 

not in final form for shipment, the 

manufacturer may move them within 

the establishment where they are 

detained to complete the work needed 

to put them in final form. As soon as the 

devices are moved for this purpose, the 

individual responsible for their 

movement shall orally notify the FDA 

representative who issued the detention 

order, or another responsible district 

office official, of the movement of the 

devices. As soon as the devices are put 

in final form, they shall be segregated 

from other devices, and the individual 

responsible for their movement shall 

orally notify the FDA representative 

who issued the detention order, or 

another responsible district office 

official, of their new location. The 

devices put in final form shall not be 

moved further without FDA approval. 

Administrative Detention 

Recordkeeping—§ 800.55(k): The firm 

shall have, or establish, and maintain 

records relating to how the detained 

devices may have become adulterated or 

misbranded, records on any distribution 

of the devices before and after the 

detention period, records on the 

correlation of any in-process detained 

devices that are put in final form, 

records of any changes in, or process of, 

the devices permitted under the 

detention order, and records of any 

movement of the detained devices. 

Procedures for Banned Devices 

Informal Hearing Request— 

§ 895.21(d)(8): Section 895.21(d) 

describes the procedures for banning a 

device when the Commissioner decides 

to initiate such a proceeding. Under 

§ 895.21(d), the Commissioner may 

decide to initiate a proceeding to make 

a device a banned device. In that event, 

any interested persons may submit 

written comments and request an 

informal hearing within 30 days after 

the date of the publication of the 

proposed regulation. 

Banned Devices Reporting— 

§ 895.22(a): 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. 

Based on a review of the information 

collection since our last request for 

OMB approval, we have made no 

adjustments to our burden estimate. 

Dated: April 27, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–09455 Filed 5–2–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–D–0125] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Establishing That a 

Tobacco Product Was Commercially 

Marketed in the United States as of 

February 15, 2007 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

announcing that a proposed collection 

of information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Submit written comments 

(including recommendations) on the 

collection of information by June 2, 

2022. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be submitted to https://

www.reginfo.gov/public/do/PRAMain. 

Find this particular information 

collection by selecting ‘‘Currently under 

Review—Open for Public Comments’’ or 


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