Federal Register / Vol. 86, No. 125 / Friday, July 2, 2021 / Notices 35301 

information from the public. 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 or reinstatement of an existing 

collection of information, and to allow 

a second opportunity for public 

comment on the notice. Interested 

persons are invited to send comments 

regarding the burden estimate or any 

other aspect of this collection of 

information, including the necessity and 

utility of the proposed information 

collection for the proper performance of 

the agency’s functions, the accuracy of 

the estimated burden, ways to enhance 

the quality, utility, and clarity of the 

information to be collected, and the use 

of automated collection techniques or 

other forms of information technology to 

minimize the information collection 

burden. 

DATES: Comments on the collection(s) of 

information must be received by the 

OMB desk officer by August 2, 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 30-day Review—Open 

for Public Comments’’ or by using the 

search function. 

To obtain copies of a supporting 

statement and any related forms for the 

proposed collection(s) summarized in 

this notice, you may make your request 

using one of following: 

1. Access CMS’ website address at 

website address at: https://

www.cms.gov/Regulations-andGuidance/Legislation/ 

PaperworkReductionActof1995/PRAListing.html. 

FOR FURTHER INFORMATION CONTACT: 

William Parham at (410) 786–4669. 

SUPPLEMENTARY INFORMATION: Under the 

Paperwork Reduction Act of 1995 (PRA) 

(44 U.S.C. 3501–3520), federal agencies 

must obtain approval from the Office of 

Management and Budget (OMB) for each 

collection of information they conduct 

or sponsor. The term ‘‘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 publish a 30-day notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension or 

reinstatement of an existing collection 

of information, before submitting the 

collection to OMB for approval. To 

comply with this requirement, CMS is 

publishing this notice that summarizes 

the following proposed collection(s) of 

information for public comment: 

1. Type of Information Collection 

Request: New collection (Request for a 

new OMB control number); Title of 

Information Collection: Evaluation of 

the Centers for Medicare & Medicaid 

Services (CMS) Network of Quality 

Improvement and Innovation 

Contractors (NQIIC); Use: The purpose 

of this Information Collection Request 

(ICR) is to collect data using telephone 

surveys to inform the program 

evaluation of the CMS NQIIC initiative. 

The purpose of NQIIC is to support 

quality improvement efforts across 

settings and programs for maximum 

impact to health care and value to 

taxpayers in a manner that aligns with 

CMS’ and Department of Health and 

Human Services (HHS) priorities. The 

NQIIC quality improvement efforts 

involve the QIN–QIO Program, which is 

one of the largest federal programs 

dedicated to improving health quality 

for Medicare beneficiaries. 

CMS evaluates the quality and 

effectiveness of the QIN–QIO Program 

as authorized in Part B of Title XI of the 

Social Security Act. This ICR is to 

conduct data collection using surveys 

with administrators or managers of 

nursing homes and hospitals. 

Subsequent to publishing the 60-day 

Federal Register notice on March 9, 

2021 (86 FR 13566), CMS conducted 

pre-testing with nursing home and 

hospital administrators using cognitive 

interviews, which provided substantive 

input from the targeted respondents to 

make sure that questions are clearly 

stated and understood as intended. We 

have made the required changes to 

questions to optimize response validity 

before fielding the survey. There was a 

slight decrease in burden hours. Form 

Number: CMS–10769 (OMB control 

number: 0938–NEW); Frequency: 

Yearly; Affected Public: State and 

Private Sector (Business or other forprofits); Number of Respondents: 1,000; 

Total Annual Responses: 1,000; Total 

Annual Hours: 290. (For policy 

questions regarding this collection, 

contact Jeff Mokry at 214–767–4021.) 

Dated: June 29, 2021. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2021–14227 Filed 7–1–21; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for OMB Review; 

Assessing the Implementation and 

Cost of High-Quality Early Care and 

Education: Field Test, OMB 0970–0499 

AGENCY: Office of Planning, Research, 

and Evaluation, Administration for 

Children and Families, HHS. 

ACTION: Request for public comment. 

SUMMARY: The Administration for 

Children and Families (ACF) at the U.S. 

Department of Health and Human 

Services (HHS) seeks approval to collect 

new information to use in testing 

measures of the implementation and 

costs of high-quality early care and 

education as part of the project, 

Assessing the Implementation and Cost 

of High-Quality Early Care and 

Education (ECE–ICHQ). The study 

received approval for a field test to 

validate and improve the psychometric 

properties of these measures in 

November 2019. This request is to add 

a measure to the approved field test to 

help further assess the associations 

between measures of implementation, 

cost, and quality. 

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 using the 

search function. 

SUPPLEMENTARY INFORMATION: 

Description: ACF seeks approval to 

collect new information to use in testing 

measures of the implementation and 

costs of high-quality early care and 

education as part of the ECE–ICHQ 


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35302 Federal Register / Vol. 86, No. 125 / Friday, July 2, 2021 / Notices 

project. The project’s goal is to create a 

technically sound and feasible 

instrument that will provide consistent, 

systematic measures of the 

implementation and costs of education 

and care in center-based settings that 

serve children from birth to age 5. The 

resulting measures will inform research, 

policy, and practice by improving 

understanding of variations in what 

centers do to support quality, their 

associated costs, and how resources for 

ECE may be better aligned with 

expectations for quality. The study 

received approval for a field test to 

validate and improve the psychometric 

properties of these measures in 

November 2019. For all previously 

approved materials for this study, see 

https://www.reginfo.gov/public/do/ 

PRAOMBHistory?ombControlNumber=

0970-0499. This request is to add a 

measure to the approved field test to 

help further assess the associations 

between measures of implementation, 

cost, and quality. The field test and this 

additional measure will include only 

remote data collection. 

Respondents: Teachers and aids. 

ANNUAL BURDEN ESTIMATES

Instrument 

Number of 

respondents 

(total over 

request period) 

Number of 

responses per 

respondent 

(total over 

request period) 

Avg. burden 

per response 

(in hours) 

Total/annual 

burden 

(in hours) 

Center re-engagement call and roster update for teaching staff survey 80 1 .50 40 

Teaching staff survey .............................................................................. 1,120 1 .50 560 

Estimated Total Annual Burden 

Hours: 600. 

Authority: § 658O(a)(5) as amended by the 

CCDBG Act of 2014 § 9. 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2021–14148 Filed 7–1–21; 8:45 am] 

BILLING CODE 4184–24–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–D–0420] 

Providing Regulatory Submissions in 

Alternate Electronic Format; Guidance 

for Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a final 

guidance for industry entitled 

‘‘Providing Regulatory Submissions in 

Alternate Electronic Format.’’ Under the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act), Congress granted FDA the 

authority to implement the statutory 

electronic submission requirements in 

guidance. In response, FDA 

implemented binding guidance 

requiring that new drug applications 

(NDAs), abbreviated new drug 

applications (ANDAs), certain drug 

master files (DMFs), certain biologics 

license applications (BLAs), and certain 

investigational new drug applications 

(INDs) be submitted to the Agency in 

electronic common technical document 

format. Recognizing that some 

submissions are exempt from this 

requirement and that waivers of the 

requirement may be granted on a caseby-case basis, the Agency is issuing this 

guidance to provide recommendations 

on an alternate electronic format for 

submissions covered under such 

exemptions and waivers. This guidance 

replaces the draft guidance of the same 

title issued on March 11, 2020. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on July 2, 2021. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances at any time as 

follows: 

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– 

2020–D–0420 for ‘‘Providing Regulatory 

Submissions in Alternate Electronic 

Format.’’ Received comments 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 


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