Federal Register / Vol. 86, No. 123 / Wednesday, June 30, 2021 / Notices 34753 

partners to make sure that the evidence 

is understood and used. Seven current 

members’ terms will expire in 

November 2021. 

DATES: Nominations should be received 

on or before 60 days after date of 

publication. 

ADDRESSES: Nominations should be sent 

to Jaime Zimmerman via email at 

NationalAdvisoryCouncil@ahrq.hhs.gov. 

FOR FURTHER INFORMATION CONTACT: 

Jaime Zimmerman, AHRQ, at (301) 427– 

1456. 

SUPPLEMENTARY INFORMATION: 42 U.S.C. 

299c provides that the Secretary shall 

appoint to the Council twenty one 

appropriately qualified individuals. At 

least seventeen members shall be 

representatives of the public and at least 

one member shall be a specialist in the 

rural aspects of one or more of the 

professions or fields listed below. In 

addition, the Secretary designates, as ex 

officio members, representatives from 

other Federal agencies, principally 

agencies that conduct or support health 

care research, as well as Federal officials 

the Secretary may consider appropriate. 

42 U.S.C. 299c(c)(3). 

Seven current members’ terms will 

expire in November 2021. To fill these 

positions, we are seeking individuals 

who: (1) Are distinguished in the 

conduct of research, demonstration 

projects, and evaluations with respect to 

health care; (2) are distinguished in the 

fields of health care quality research or 

health care improvement; (3) are 

distinguished in the practice of 

medicine; (4) are distinguished in other 

health professions; (5) represent the 

private health care sector (including 

health plans, providers, and purchasers) 

or are distinguished as administrators of 

health care delivery systems; (6) are 

distinguished in the fields of health care 

economics, information systems, law, 

ethics, business, or public policy; and 

(7) represent the interests of patients 

and consumers of health care. 42 U.S.C. 

299c(c)(2). Individuals are particularly 

sought with experience and success in 

these activities. AHRQ will accept 

nominations to serve on the Council in 

a representative capacity. 

The Council meets in the Washington, 

DC, metropolitan area, generally in 

Rockville, Maryland, approximately 

three times a year to provide broad 

guidance to the Secretary and AHRQ’s 

Director on the direction of and 

programs undertaken by AHRQ. 

Seven individuals will be selected by 

the Secretary to serve on the Council 

beginning with the meeting in the 

spring of 2022. Members generally serve 

3-year terms. Appointments are 

staggered to permit an orderly rotation 

of membership. 

Interested persons may nominate one 

or more qualified persons for 

membership on the Council. Selfnominations are accepted. Nominations 

shall include: (1) A copy of the 

nominee’s resume or curriculum vitae; 

and (2) a statement that the nominee is 

willing to serve as a member of the 

Council. Selected candidates will be 

asked to provide detailed information 

concerning their financial interests, 

consultant positions and research grants 

and contracts, to permit evaluation of 

possible sources of conflict of interest. 

Please note that once a candidate is 

nominated, AHRQ may consider that 

nomination for future positions on the 

Council. 

The Department seeks a broad 

geographic representation. In addition, 

AHRQ conducts and supports research 

concerning priority populations, which 

include: Inner city; rural; low income; 

minority; women; children; elderly; and 

those with special health care needs, 

including those who have disabilities, 

need chronic care, or need end-of-life 

health care. See 42 U.S.C. 299(c). AHRQ 

also includes in its definition of priority 

populations those groups identified in 

Section 2(a) of Executive Order 13985 as 

members of underserved communities: 

Black, Latino, and Indigenous and 

Native American persons, Asian 

Americans and Pacific Islanders and 

other persons of color; members of 

religious minorities; lesbian, gay, 

bisexual, transgender, and queer 

(LGBTQ+) persons; persons with 

disabilities; persons who live in rural 

areas; and persons otherwise adversely 

affected by persistent poverty or 

inequality. Nominations of persons with 

expertise in health care for these 

priority populations are encouraged. 

Dated: June 24, 2021. 

Marquita Cullom, 

Acting Director. 

[FR Doc. 2021–13966 Filed 6–29–21; 8:45 am] 

BILLING CODE 4160–90–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for OMB Review; Head 

Start Program Performance Standards 

(OMB #0970–0148) 

AGENCY: Office of Head Start, 

Administration for Children and 

Families, HHS. 

ACTION: Request for public comment. 

SUMMARY: The Office Head Start (OHS), 

Administration for Children and 

Families (ACF), U.S. Department of 

Health and Human Services (HHS), is 

requesting a 3-year extension of the 

information collection requirements 

under the Head Start Program 

Performance Standards (OMB #0970– 

0148). There are no changes to the 

information collection. 

DATES: Comments due within 30 days of 

publication. OMB must make a decision 

about the collection of information 

between 30 and 60 days after 

publication of this document in the 

Federal Register. Therefore, a comment 

is best assured of having its full effect 

if OMB receives it within 30 days of 

publication. 

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 30-day Review—Open 

for Public Comments’’ or by using the 

search function. 

SUPPLEMENTARY INFORMATION: 

Description: Section 641A of the Head 

Start Act, 42 U.S.C. 9836A, directs HHS 

to develop ‘‘scientifically based and 

developmentally appropriate education 

performance standards related to school 

readiness’’ and ‘‘ensure that any such 

revisions in the standards do not result 

in the elimination of or any reduction in 

quality, scope, or types of health, 

educational, parental involvement, 

nutritional, social, or other services.’’ 

The Office of Head Start (OHS) 

announced in the Federal Register in 

2016 the first comprehensive revision of 

the Head Start Program Performance 

Standards (HSPPS) since their original 

release in 1975. This information 

collection was approved alongside the 

final rule for the HSPPS. 

This information collection is entirely 

recordkeeping and does not contain any 

standardized instruments to provide 

flexibility for local programs. These 

records are intended to act as a tool for 

grantees and delegate agencies to be 

used in their day-to-day operations. For 

example, this includes the requirement 

that programs maintain a waiting list of 

eligible families. There are no changes 

to the record keeping requirements. 

Respondents: Head Start Grantees. 

Depending on the standard, the 

calculated burden hours is based on the 

individual enrollee (1,054,720), family 

(956,120), program (3,020), or staff 

(265,030). In a few cases, only a 

proportion of one of these may apply. 


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34754 Federal Register / Vol. 86, No. 123 / Wednesday, June 30, 2021 / Notices 

ANNUAL BURDEN ESTIMATES

Instrument 

Total 

number of 

respondents 

Total 

number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total 

burden 

hours 

Annual 

burden 

hours 

1301.6(a) ............................................................................ 3,020 1 0.70 2,114 2,114 

1302.12(k) .......................................................................... 1,054,720 1 .166 175,084 175,084 

1302.14(c) .......................................................................... 3,020 1 2.00 6,040 6,040 

1302.16(b) .......................................................................... 3,020 1 5.00 15,100 15,100 

1302.33(a)–(b) ................................................................... 1,054,720 1 1.00 1,054,720 1,054,720 

1302.33(c)(2) ...................................................................... 294,632 1 2.00 589,264 589,264 

1302.42(a)–(b) ................................................................... 1,054,720 1 0.66 696,115 696,115 

1302.42(e) .......................................................................... 3,020 1 0.50 1,510 1,510 

1302.47(b)(7)(iv) ................................................................ 3,020 1 0.50 1,510 1,510 

1302.53(b)–(d) ................................................................... 3,020 1 0.166 501 501 

1302.90(a) .......................................................................... 3,020 1 0.50 1,510 1,510 

1302.90(b)(1)(i)–(iv), (b)(4) ................................................ 79,509 1 0.33 26,238 26,238 

1302.93(a) .......................................................................... 26,503 1 0.25 6,626 6,626 

1302.94(a) .......................................................................... 3,020 1 0.166 501 501 

1302.101(a)(4), 1302.102(b)–(c) ........................................ 3,020 1 79.00 238,580 238,580 

1302.102(d)(3) ................................................................... 110 1 10.00 1,100 1,100 

1303.12 .............................................................................. 3,020 1 0.166 501 501 

1303.22–24 ........................................................................ 956,120 1 0.33 315,520 315,520 

1303.42–53 ........................................................................ 260 1 40.00 10,400 10,400 

1303.70(c) .......................................................................... 200 1 1.00 200 200 

1303.72(a)(3) ..................................................................... 3,020 1 2.00 6,040 6,040 

1304.13 .............................................................................. 75 1 60.00 4,500 4,500 

1304.15(a) .......................................................................... 400 1 0.25 100 100 

Estimated Total Annual Burden 

Hours: 3,153,774. 

Authority: 42 U.S.C. 9836A. 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2021–14123 Filed 6–29–21; 8:45 am] 

BILLING CODE 4184–40–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–1960] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; MedWatch: The 

Food and Drug Administration Medical 

Products Reporting Program 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) 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 FDA’s 

MedWatch adverse experience reporting 

(AER) program. 

DATES: Submit either electronic or 

written comments on the collection of 

information by August 30, 2021. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before August 30, 

2021. The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of August 30, 2021. 

Comments received by mail/hand 

delivery/courier (for written/paper 

submissions) will be considered timely 

if they are postmarked or the delivery 

service acceptance receipt is 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– 

2014–N–1960 for ‘‘MedWatch: The FDA 

Medical Products Reporting Program.’’ 

Received comments, those filed in a 

timely manner (see ADDRESSES), will be 

placed in the docket and, except for 

those submitted as ‘‘Confidential 


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