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 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 86, No. 125 / Friday, July 2, 2021 / Notices 35303 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of the guidance to the Division of 

Drug Information, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002, or to the Office of 

Communication, Outreach and 

Development, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 3128, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance document. 

FOR FURTHER INFORMATION CONTACT: Dat 

Doan, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 3334, Silver Spring, 

MD 20993–0002, 240–402–8926; or 

Stephen Ripley, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993–0002, 240– 

402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled 

‘‘Providing Regulatory Submissions in 

Alternate Electronic Format.’’ This 

guidance provides recommendations on 

an alternate electronic format for 

submissions that are covered under an 

exemption from or granted a waiver of 

the requirements of section 745A(a) of 

the FD&C Act (21 U.S.C. 379k–1). These 

recommendations pertain to the 

electronic format of content in NDAs, 

ANDAs, certain DMFs, certain BLAs, 

and certain INDs submitted to the 

Center for Drug Evaluation and Research 

or to the Center for Biologics Evaluation 

and Research. 

This guidance includes information 

on: (1) How to submit in alternate 

electronic format (without XML 

backbone), (2) submission of FDA forms, 

(3) pre-submission considerations, (4) 

submission structure, (5) file formats 

and versions, (6) datasets and study 

information, (7) transmitting electronic 

submissions, and (8) receipt dates. 

This guidance finalizes the draft 

guidance of the same title issued on 

March 11, 2020 (85 FR 14202). FDA 

considered comments received on the 

draft guidance as the guidance was 

finalized. Changes from the draft to final 

guidance include: (1) Minor edits to 

clarify recommendations for the 

location of the Table of Contents for the 

alternate electronic format, (2) an 

example of the folder structure, and (3) 

the process for submission if an 

electronic signature is not possible. In 

addition, editorial changes were made 

to improve clarity. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

This final guidance represents FDA’s 

current thinking on ‘‘Providing 

Regulatory Submissions in Alternate 

Electronic Format.’’ 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 part 312 have 

been approved under OMB control 

number 0910–0014; the collections of 

information in 21 CFR part 314 have 

been approved under OMB control 

number 0910–0001; and the collections 

of information in 21 CFR part 601 have 

been approved under OMB control 

number 0910–0338. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at https://

www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs, https://www.fda.gov/ 

vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, or https:// 

www.regulations.gov. 

Dated: June 28, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–14201 Filed 7–1–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0008] 

Circulatory System Devices Panel of 

the Medical Devices Advisory 

Committee; Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) announces a 

forthcoming public advisory committee 

meeting of the Circulatory System 

Devices Panel of the Medical Devices 

Advisory Committee. The general 

function of the committee is to provide 

advice and recommendations to the 

Agency on FDA’s regulatory issues. The 

meeting will be open to the public. 

DATES: The meeting will take place 

virtually on August 3, 2021, from 9 a.m. 

Eastern Time to 6 p.m. Eastern Time. 

ADDRESSES: Please note that due to the 

impact of the COVID–19 pandemic, all 

meeting participants will be joining this 

advisory committee meeting via an 

online teleconferencing platform. 

Answers to commonly asked questions, 

including information regarding special 

accommodations due to a disability, 

may be accessed at: https://

www.fda.gov/AdvisoryCommittees/ 

AboutAdvisoryCommittees/ 

ucm408555.htm. 

FOR FURTHER INFORMATION CONTACT: 

Aden Asefa, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Avenue, Bldg. 66, Rm. 5214, Silver 

Spring, MD 20993–0002, 


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