Federal Register / Vol. 86, No. 147 / Wednesday, August 4, 2021 / Notices 41973 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–0405] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Medical Device 

Recall Authority 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, 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 September 

3, 2021. 

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. The OMB 

control number for this information 

collection is 0910–0432. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

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: In 

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

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Medical Device Recall Authority—21 

CFR Part 810 

OMB Control Number 0910–0432— 

Extension 

This collection of information 

implements section 518(e) of the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act) (21 U.S.C. 360h(e)) and part 

810 (21 CFR part 810), mandatory 

medical device recall authority 

provisions. Section 518(e) of the FD&C 

Act provides FDA with the authority to 

issue an order requiring an appropriate 

person, including manufacturers, 

importers, distributors, and retailers of a 

device, if FDA finds that there is 

reasonable probability that the device 

intended for human use would cause 

serious, adverse health consequences or 

death, to: (1) Immediately cease 

distribution of such device and (2) 

immediately notify health professionals 

and device-user facilities of the order 

and to instruct such professionals and 

facilities to cease use of such device. 

FDA will then provide the person 

named in the cease distribution and 

notification order with the opportunity 

for an informal hearing on whether the 

order should be amended to require a 

mandatory recall of the device. If, after 

providing the opportunity for an 

informal hearing, FDA determines that 

such an order is necessary, the Agency 

may amend the order to require a 

mandatory recall. 

FDA issued part 810 to implement the 

provisions of section 518 of the FD&C 

Act. The information collected under 

the mandatory recall authority 

provisions will be used by FDA to 

implement mandatory recalls. 

In the Federal Register of April 5, 

2021 (86 FR 17610), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity; 21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Collections Specified in the Order—810.10(d) ..................................................... 2 1 2 8 16 

Request for Regulatory Hearing—810.11(a) ........................................................ 1 1 1 8 8 

Written Request for Review—810.12(a) and (b) .................................................. 1 1 1 8 8 

Mandatory Recall Strategy—810.14 ..................................................................... 2 1 2 16 32 

Periodic Status Reports—810.16(a) and (b) ........................................................ 2 12 24 40 960 

Termination Request—810.17(a) .......................................................................... 2 1 2 8 16 

Total Hours .................................................................................................... ........................ ........................ ........................ ........................ 1,040 

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

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Activity; 21 CFR section Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total 

annual 

records 

Average 

burden per 

recordkeeping 

Total 

hours 

Documentation of Notifications to Recipients—810.15(b) .................................... 2 1 2 8 16 

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

TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

Activity; 21 CFR section Number of 

respondents 

Number of 

disclosures 

per 

respondent 

Total 

annual 

disclosures 

Average 

burden per 

disclosure 

Total 

hours 

Notification to Recipients—810.15(a) through (c) ................................................. 2 1 2 12 24 

Notification to Recipients; Follow-up—810.15(d) .................................................. 2 1 2 4 8 

Notification of Consignees by Recipients—810.15(e) .......................................... 10 1 10 1 10 

Total ............................................................................................................... ........................ ........................ ........................ ........................ 42 

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


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41974 Federal Register / Vol. 86, No. 147 / Wednesday, August 4, 2021 / Notices 

The burden estimates are based on 

FDA’s experience with voluntary recalls 

under 21 CFR part 7. FDA expects no 

more than two mandatory recalls per 

year, as most recalls are done 

voluntarily. 

Section 810.10(d)—Collections 

Specified in the Order—(Reporting)— 

FDA may require the person named in 

the cease distribution and notification 

order to submit certain information to 

the Agency, e.g., distribution 

information, progress reports. 

Section 810.11(a)—Request for 

Regulatory Hearing—(Reporting)—A 

request for regulatory hearing regarding 

the cease distribution and notification 

order must be submitted in writing to 

FDA. 

Section 810.12(a) and (b)—Written 

Request for Review—(Reporting)—In 

lieu of requesting a regulatory hearing 

under § 810.11, the person named in the 

cease distribution and notification order 

may submit a written request to FDA 

asking that the order be modified or 

vacated. A written request for review of 

a cease distribution and notification 

order shall identify each ground upon 

which the requestor relies in asking that 

the order be modified or vacated, 

address an appropriate cease 

distribution and notification strategy, 

and address whether the order should 

be amended to require a recall of the 

device that was the subject of the order 

and the actions required by such a recall 

order. 

Section 810.14—Mandatory Recall 

Strategy—(Reporting)—The person 

named in the cease distribution and 

notification order or a mandatory recall 

order must develop and submit a 

strategy to FDA for complying with the 

order that is appropriate for the 

individual circumstances. 

Section 810.15(a) through (c)— 

Notifications to Recipients—(ThirdParty Disclosure)—The person named in 

a cease distribution and notification 

order or a mandatory recall order must 

promptly notify each health 

professional, user facility, consignee, or 

individual of the order. 

Section 810.15(b)—Documentation of 

Notifications to Recipients— 

(Recordkeeping)—Telephone calls or 

other personal contacts may be made in 

addition to, but not as a substitute for, 

the verified written communication, and 

shall be documented in an appropriate 

manner. 

Section 810.15(d)—Notification to 

Recipients; Followup—(Third-Party 

Disclosure)—The person named in the 

cease distribution and notification order 

or mandatory recall order shall ensure 

that followup communications are sent 

to all who fail to respond to the initial 

communication. 

Section 810.15(e)—Notification of 

Consignees by Recipients—(Third-Party 

Disclosure)—Health professionals, 

device user facilities, and consignees 

should immediately notify their 

consignees of the order. 

Section 810.16(a) and (b)—Periodic 

Status Reports—(Reporting)—The 

person named in a cease distribution 

and notification order or a mandatory 

recall order must submit periodic status 

reports to FDA to enable the Agency to 

assess the person’s progress in 

complying with the order. The 

frequency of such reports and the 

Agency official to whom such reports 

must be submitted will be specified in 

the order. 

Section 810.17(a)—Termination 

Request—(Reporting)—The person 

named in a cease distribution and 

notification order or a mandatory recall 

order may request termination of the 

order by submitting a written request to 

FDA. The person submitting a request 

must certify that he or she has complied 

in full with all the requirements of the 

order and shall include a copy of the 

most current status report submitted to 

the Agency. 

Based on a review of the information 

collection since our last request for 

OMB approval, we have made no 

changes to the burden estimate. 

Dated: July 26, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–16635 Filed 8–3–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: Public 

Comment Request Information 

Collection Request Title: Health Center 

Program: COVID–19 Data Collection 

Tools, OMB No. 0906–0062—Revision 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement for opportunity for public 

comment on proposed data collection 

projects of the Paperwork Reduction Act 

of 1995, HRSA announces plans to 

submit an Information Collection 

Request (ICR), described below, to the 

Office of Management and Budget 

(OMB). Prior to submitting the ICR to 

OMB, HRSA seeks comments from the 

public regarding the burden estimate, 

below, or any other aspect of the ICR. 

DATES: Comments on this ICR should be 

received no later than September 3, 

2021. 

ADDRESSES: Written comments and 

recommendations for the proposed 

information collection should be sent 

within 30 days of publication of this 

notice to 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. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and draft 

instruments, email paperwork@hrsa.gov 

or call Lisa Wright-Solomon, the HRSA 

Information Collection Clearance Officer 

at (301) 443–1984. 

SUPPLEMENTARY INFORMATION: 

Information Collection Request Title: 

Health Center Program: COVID–19 Data 

Collection Tools, OMB No. 0906–0062— 

Revision. 

Abstract: This information collection 

request was previously approved by 

OMB on June 11, 2020, as an emergency 

clearance (OMB No.: 0906–0062). HRSA 

is currently undertaking the standard 

Paperwork Reduction Act process for 

normal OMB approval. 

During the COVID–19 public health 

emergency, HRSA-supported health 

centers and Federally Qualified Health 

Center Look-Alikes (look-alikes) have 

played a key role in providing testing 

and care for those affected by the virus. 

HRSA has awarded billions of dollars in 

new funding to support health center 

awardees and look-alikes in the 

detection, prevention, diagnosis, and 

treatment of COVID–19. This funding 

has enabled health centers to maintain 

or increase their staffing levels, conduct 

training, provide COVID–19 treatment, 

and administer millions of tests for both 

existing and new patients. In addition, 

HRSA, in collaboration with the Centers 

for Disease Control and Prevention, 

launched the Health Center COVID–19 

Vaccine program as part of an 

Administration initiative focused on 

health equity. This occurred in February 

2021 to directly allocate COVID–19 

vaccines to HRSA-supported health 

centers. 

This ICR to support the 

implementation of COVID–19 relief 

funding and response activities includes 

forms previously submitted in the 

emergency information collection 


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