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Federal Register / Vol. 86, No. 125 / Friday, July 2, 2021 / Notices
project. The projects 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
Number of respondents total over request period
Instrument
Center re-engagement call and roster update for teaching staff survey Teaching staff survey

Estimated Total Annual Burden Hours: 600.
Authority: 658Oa5 as amended by the CCDBG Act of 2014 9.
Mary B. Jones, ACF/OPRE Certifying Officer.
FR Doc. 202114148 Filed 7121; 8:45 am BILLING CODE 418424P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration Docket No. FDA2020D0420

Providing Regulatory Submissions in Alternate Electronic Format; Guidance for Industry; Availability AGENCY:

Food and Drug Administration,
HHS.
ACTION:

Notice of availability.

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
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SUMMARY:

VerDate Sep<11>2014

17:12 Jul 01, 2021

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Number of responses per respondent total over request period
80
1,120

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 elses 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
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Avg. burden per response in hours
Total/annual burden in hours
.50
.50

40
560

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 HFA305, 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
2020D0420 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, 2404027500.
Confidential SubmissionsTo 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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