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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Federal Register / Vol. 86, No. 147 / Wednesday, August 4, 2021 / Notices 41975 

1The bi-weekly COVID–19 PCA Survey Tool 

(comprised of six questions) is currently approved 

under the HHS Secretary’s Public Health 

Emergency Authority to waive the requirements of 

the Paperwork Reduction Act during the Public 

Health Emergency for reporting on a voluntary 

basis. 

request clearance: (1) Health Center 

COVID–19 Data Collection Survey Tool, 

(2) Addendum to COVID–19 Data 

Collection Survey Tool, and (3) the 

Health Center COVID–19 Vaccine 

Program Readiness Assessment Tool. 

This revised information collection 

request also includes two newly added 

forms: (1) Primary Care Association 

(PCA) COVID–19 Data Collection 

Survey Tool 1 and (2) the Health Center 

COVID–19 Vaccine Program Conditions 

of Participation Agreement. 

A 60-day notice published in the 

Federal Register on April 23, 2021, vol. 

86, No. 77; pp. 21756–57. There were no 

public comments. 

Need and Proposed Use of the 

Information: HRSA uses the data 

collected to optimize COVID–19 testing 

and vaccination; track health center 

capacity and the impact of COVID–19 

on operations, patients, and staff; and 

better understand training and technical 

assistance, funding, and other health 

center resource needs. The data allow 

HRSA to assess health center capacity 

prior to program enrollment, supporting 

successful vaccine allocation strategies, 

while providing HRSA with information 

on the effectiveness of vaccine 

distribution through this program. In 

addition, the data inform HRSA in 

resource allocation and technical 

assistance to health centers. 

The readiness assessment supports 

HRSA’s analysis of health center ability 

to successfully participate in the Health 

Center COVID–19 Vaccine Program. 

These data are critical to determine 

health center capacity to implement the 

vaccination program as well as comply 

with program requirements. These data 

are used to assess program readiness 

including: 

• Ability to safely store the vaccine 

• Availability of trained and 

credentialed staff and other staff 

capacity 

• Reporting capacity 

• Sufficient PPE 

• Plan for vaccine transport 

The health center weekly survey and 

addendum support HRSA’s ability to 

monitor progress towards the 

development and delivery of COVID–19 

prevention, preparedness, and/or 

response activities; and ensure 

appropriate vaccine administration as 

well as better understand training and 

technical assistance, funding, and other 

health center resource needs. 

The Conditions of Participation 

Agreement governs all COVID–19 

vaccination activities at all health center 

sites that receive COVID–19 vaccine 

through the HRSA Health Center 

COVID–19 Vaccine Program. Health 

Centers that sign the agreement agree to 

adhere to each of the stated 

requirements. 

The PCA weekly survey increases 

information sharing between health 

centers, PCAs, and HRSA in order to 

better support COVID–19 emergency 

response efforts inclusive of testing and 

vaccination activities. Data collected 

from the survey tool is used to track and 

monitor issues/challenges to program 

implementation and assess the need for 

the delivery/dissemination of targeted 

training and technical assistance. 

Likely Respondents: HRSA-supported 

health centers, look-alikes, and PCAs. 

Burden Statement: Burden in this 

context means the time expended by 

persons to generate, maintain, retain, 

disclose or provide the information 

requested. This includes the time 

needed to review instructions; to 

develop, acquire, install, and utilize 

technology and systems for the purpose 

of collecting, validating, and verifying 

information, processing and 

maintaining information, and disclosing 

and providing information; to train 

personnel and to be able to respond to 

a collection of information; to search 

data sources; to complete and review 

the collection of information; and to 

transmit or otherwise disclose the 

information. The total annual burden 

hours estimated for this ICR are 

summarized in the table below. 

TOTAL ESTIMATED ANNUALIZED BURDEN HOURS

Form name Number of respondents 

Number of 

responses to 

form per 

respondent 

Total 

responses 

Average 

burden 

per response 

(in hours) 

Total 

burden 

hours 

Condition of Participation Agreement 

(one-time completion for vaccine 

program participants only).

1,467 (Total health centers, including look-alikes, in 2019).1 1,467 .25 366.75 

Readiness Assessment Tool (onetime completion for vaccine program participants only).1,467 (Total health centers, including look-alikes, in 2019).1 1,467 .50 733.50 

Health Center COVID–19 Data Collection Survey Tool (weekly completion of existing 20 questions).1,389 (Total health centers in 2019) 48 66,672 1.00 66,672.00 

Addendum to COVID–19 Data Collection Survey Tool (weekly completion for vaccine program participants only).1,389 (Total health centers in 2019) 48 66,672 .50 33,336.00 

PCA COVID–19 Data Collection Survey Tool (bi-weekly completion of 

existing six questions).

52 ..................................................... 6 312 .75 234.00 

Total ........................................... 5,764 ................................................ ........................ 136,590 ........................ 101,342.25 

HRSA specifically requests comments 

on (1) the necessity and utility of the 

proposed information collection for the 

proper performance of the agency’s 

functions, (2) the accuracy of the 

estimated burden, (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected, and (4) the 

use of automated collection techniques 

or other forms of information 


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41976 Federal Register / Vol. 86, No. 147 / Wednesday, August 4, 2021 / Notices 

technology to minimize the information 

collection burden. 

Maria G. Button, 

Director, Executive Secretariat. 

[FR Doc. 2021–16591 Filed 8–3–21; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Charter Amendment for the Advisory 

Committee on Heritable Disorders in 

Newborns and Children 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: In accordance with the 

Federal Advisory Committee Act 

(FACA) and section 1111 of the Public 

Health Service (PHS) Act, HHS is 

hereby giving notice that the charter for 

the Advisory Committee on Heritable 

Disorders in Newborns and Children 

(ACHDNC) has been amended to set the 

time period for appointment of members 

to a term of up to 4 years. The effective 

date of the amendment is July 30, 2021. 

FOR FURTHER INFORMATION CONTACT: Mia 

Morrison (DFO), Maternal and Child 

Health Bureau, HRSA, 5600 Fishers 

Lane, Rockville, Maryland 20857; 301– 

443–2521; or mmorrison@hrsa.gov. 

SUPPLEMENTARY INFORMATON: The 

ACHDNC provides advice and 

recommendations to the Secretary of 

HHS on policy, program development, 

and other matters of significance 

concerning certain activities described 

in section 1111 of the PHS Act (42 

U.S.C. 300b–10), as further described 

below. The ACHDNC is also governed 

by the provisions of the FACA, as 

amended (5 U.S.C. App.), which sets 

forth standards for the formation and 

use of advisory committees. The 

ACHDNC advises the Secretary of HHS 

about aspects of newborn and childhood 

screening and technical information for 

the development of policies and 

priorities that will enhance the ability of 

the state and local health agencies to 

provide for newborn and child 

screening, counseling and health care 

services for newborns and children 

having, or at risk for, heritable 

disorders. The ACHDNC will review 

and report regularly on newborn and 

childhood screening practices, 

recommend improvements in the 

national newborn and childhood 

screening programs, and fulfill 

responsibilities described in section 

1111 of the PHS Act. In addition, the 

ACHDNC’s recommendations regarding 

inclusion of additional conditions for 

screening, following adoption by the 

Secretary, are considered evidenceinformed preventive health services 

provided for in the comprehensive 

guidelines supported by HRSA through 

the Recommended Uniform Screening 

Panel (RUSP) pursuant to section 2713 

of the PHS Act (42 U.S.C. 300gg–13). 

Under this provision, non-grandfathered 

group health plans and health insurance 

issuers offering group or individual 

health insurance are required to provide 

insurance coverage without cost-sharing 

(a co-payment, co-insurance, or 

deductible) for preventive services for 

plan years (i.e., policy years) beginning 

on or after the date that is one year from 

the Secretary’s adoption of the 

condition for screening. 

The filing date of the ACHDNC 

charter remains November 10, 2020. A 

copy of the ACHDNC charter is 

available on the ACHDNC website at 

https://www.hrsa.gov/advisorycommittees/heritable-disorders/ 

index.html. A copy of the charter also 

can be obtained by accessing the FACA 

database that is maintained by the 

Committee Management Secretariat 

under the General Services 

Administration. The website address for 

the FACA database is http://

www.facadatabase.gov/. 

Maria G. Button, 

Director, Executive Secretariat. 

[FR Doc. 2021–16618 Filed 8–3–21; 8:45 am] 

BILLING CODE 4165–15–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: National 

Health Service Corps Scholar/Students 

To Service Travel Worksheet, OMB No. 

0915–0278—Extension 

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 October 4, 2021. 

ADDRESSES: Submit your comments to 

paperwork@hrsa.gov or mail the HRSA 

Information Collection Clearance 

Officer, Room 14N136B, 5600 Fishers 

Lane, Rockville, MD 20857. 

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: When 

submitting comments or requesting 

information, please include the 

information request collection title for 

reference. 

Information Collection Request Title: 

National Health Service Corps Scholar/ 

Students to Service Travel Worksheet, 

OMB No. 0915–0278—Extension. 

Abstract: Clinicians participating in 

the HRSA National Health Service 

Corps (NHSC) Scholarship Program (SP) 

and the Students to Service (S2S) Loan 

Repayment Program (LRP) use the 

online Travel Request Worksheet to 

request and receive travel funds from 

the federal government to visit eligible 

NHSC sites to which they may be 

assigned in accordance with the Public 

Health Service Act, section 331(c)(1). 

The travel approval process is 

initiated when an NHSC scholar or S2S 

participant notifies the NHSC of an 

impending interview at one or more 

NHSC-approved practice sites. The 

Travel Request Worksheet is also used 

to initiate the relocation process after a 

NHSC scholar or S2S participant has 

successfully been matched to an 

approved practice site in accordance 

with the Public Health Service Act, 

section 331(c)(3). Upon receipt of a 

completed Travel Request Worksheet, 

the NHSC will review and approve or 

disapprove the request and promptly 

notify the scholar or S2S participant and 

the NHSC logistics contractor regarding 

travel arrangements and authorization of 

the funding for the site visit or 

relocation. 

Need and Proposed Use of the 

Information: This information will 

facilitate NHSC scholar and S2S 

participants’ receipt of federal travel 

funds that are used to visit high-need 

NHSC-approved practice sites. The 

Travel Request Worksheet is also used 

to initiate the relocation process after a 

NHSC scholar or S2S participant has 


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