Federal Register - January 5, 2021
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Source: Federal Register
312
Federal Register / Vol. 86, No. 2 / Tuesday, January 5, 2021 / Notices
coordination and collaboration with two new required narratives and associated drop-down menu data.
Comment Summary: Two AT grantees commented in support.
ACL Response: No changes made.
Leveraged Fundingeliminated Section B and folded data into Section A to simplify.
Comment Summary: Two AT grantees commented in support.
ACL Response: No changes made.
Instruction Manualdeleted redundant text and updated AT
Taxonomy.
Comment Summary: Two AT grantees commented in support.
ACL Response: No changes made.
Estimated Program Burden ACL estimates the burden associated with this collection of information as follows:
require no change in data burden estimates.
B The fifty-six grantees ask consumers to complete surveys that provide information on their performance related to the states measurable goals. Historical data from states indicates that the average state will ask for this information from 3,242
consumers at 1 minute per consumer to complete the question survey, for a total of 54 hours annually.
C The fifty-six grantees also ask consumers to complete customer satisfaction surveys. Historical data from states indicated that the average state asks for this information from 3,242 consumers at 1 minute per consumer, for a total of 54 hours annually.
A A web-based system that collects data from states.
B A performance measurement survey that states collect from individuals C A customer satisfaction survey that states collect from individuals.
A Fifty-six grantees report to ACL
using the web-based data collection system. A workgroup of grantees estimated that the average amount of time required to complete all responses to the data collection instrument is 80
hours annually. The estimated response burden includes time to review the instructions, gather existing data, and complete and review the data entries.
These estimates are based on the experience of staff who implement these programs at the state level. In addition, we project that clean-up and clarification of data elements will Number of responses
Annual burden per grantee
Total annual burden hours
Work-Based System
Performance Measurement
Customer Satisfaction
56
3,242
3,242
1.428
0.01666
0.01666
80
54
54
4,480
3.024
3,024
Subtotal
Program Support
Record Keeping Burden
56
56
4
0.14286
188
208
8
10,528
11,648
448
Subtotal
216
12,096
Total
404
22,624
Dated: December 29, 2020.
Lance Robertson, Administrator and Assistant Secretary for Aging.
on conducting the mouse embryo assay to support premarket submissions and lot release of assisted reproduction technology devices.
DATES: The announcement of the guidance is published in the Federal Register on January 5, 2021.
ADDRESSES: You may submit either electronic or written comments on Agency guidances at any time as follows:
FR Doc. 202029150 Filed 1421; 8:45 am BILLING CODE 415401P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration Docket No. FDA2019D2105
Mouse Embryo Assay for Assisted Reproduction Technology Devices;
Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY:
Food and Drug Administration,
HHS.
ACTION:
jbell on DSKJLSW7X2PROD with NOTICES
Hours per response
Notice of availability.
The Food and Drug Administration FDA or Agency is announcing the availability of a final guidance entitled Mouse Embryo Assay for Assisted Reproduction Technology Devices. This guidance document provides recommendations
SUMMARY:
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17:09 Jan 04, 2021
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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
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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 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.
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