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 Funding—eliminated 

Section B and folded data into Section 

A to simplify. 

Comment Summary: Two AT grantees 

commented in support. 

ACL Response: No changes made. 

Instruction Manual—deleted 

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: 

(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 

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 state’s 

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. 

Number of 

responses 

Hours per 

response 

Annual 

burden per 

grantee 

Total annual 

burden hours 

Work-Based System ........................................................................................ 56 1.428 80 4,480 

Performance Measurement ............................................................................. 3,242 0.01666 54 3.024 

Customer Satisfaction ...................................................................................... 3,242 0.01666 54 3,024 

Subtotal ..................................................................................................... ........................ ........................ 188 10,528 

Program Support ............................................................................................. 56 4 208 11,648 

Record Keeping Burden .................................................................................. 56 0.14286 8 448 

Subtotal ..................................................................................................... ........................ ........................ 216 12,096 

Total ................................................................................................... ........................ ........................ 404 22,624 

Dated: December 29, 2020. 

Lance Robertson, 

Administrator and Assistant Secretary for 

Aging. 

[FR Doc. 2020–29150 Filed 1–4–21; 8:45 am] 

BILLING CODE 4154–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2019–D–2105] 

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: Notice of availability. 

SUMMARY: 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 

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: 

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.’’ 


jbell on DSKJLSW7X2PROD with NOTICES
Federal Register / Vol. 86, No. 2 / Tuesday, January 5, 2021 / Notices 313 

Instructions: All submissions received 

must include the Docket No. FDA– 

2019–D–2105 for ‘‘Mouse Embryo Assay 

for Assisted Reproduction Technology 

Devices.’’ 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 

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)). 

An electronic copy of the guidance 

document is available for download 

from the internet. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance. Submit written requests for a 

single hard copy of the guidance 

document entitled ‘‘Mouse Embryo 

Assay for Assisted Reproduction 

Technology Devices’’ to the Office of 

Policy, Guidance and Policy 

Development, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5431, Silver Spring, 

MD 20993–0002. Send one selfaddressed adhesive label to assist that 

office in processing your request. 

FOR FURTHER INFORMATION CONTACT: PeiHsuan (Chris) Hung, Center for Devices 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 2647, Silver Spring, 

MD 20993–0002, 240–402–5928. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The majority of assisted reproduction 

technology (ART) devices directly or 

indirectly contact gametes and/or 

embryos during use. The mouse embryo 

assay (MEA) is used to assess the 

potential for embryotoxicity of devices 

that contact gametes and/or embryos. 

Several classification regulations under 

part 884 (21 CFR part 884) include 

special controls that require MEA 

testing or information. MEA may also be 

used by sponsors to support premarket 

submissions for other devices that are 

intended to contact gametes and/or 

embryos during their use. However, 

there are no voluntary consensus 

standards that describe how to conduct 

the MEA. This guidance provides 

recommendations for conducting the 

MEA to support premarket submissions 

and lot release for ART devices that are 

intended to contact gametes and/or 

embryos and to comply with the special 

controls for those devices classified 

under part 884 that require MEA testing 

or information. 

A notice of availability of the draft 

guidance appeared in the Federal 

Register of June 13, 2019 (84 FR 27637). 

FDA considered comments received and 

revised the guidance as appropriate in 

response to the comments, including 

minor technical edits and clarifications. 

Specifically, the final guidance includes 

revisions to recommend that liquidbased test articles should be prepared 

per the instructions for use; clarify 

FDA’s recommended exposure time for 

test articles depending on their clinical 

use duration; include additional 

specificity on the number of embryos 

that should be used; discuss how 

accelerated aging can also be used to 

develop test articles at the end of the 

proposed shelf-life; and when 

procedural modifications or options 

should be justified in the test report. In 

addition, FDA made editorial changes to 

the guidance for clarity. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on ‘‘Mouse Embryo 

Assay for Assisted Reproduction 

Technology Devices.’’ 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. Electronic Access 

Persons interested in obtaining a copy 

of the guidance may do so by 

downloading an electronic copy from 

the internet. A search capability for all 

Center for Devices and Radiological 

Health guidance documents is available 

at https://www.fda.gov/medical-devices/ 

device-advice-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. This 

guidance document is also available at 

https://www.regulations.gov and at 

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments. Persons unable to download 

an electronic copy of ‘‘Mouse Embryo 

Assay for Assisted Reproduction 

Technology Devices’’ may send an email 

request to CDRH-Guidance@fda.hhs.gov 

to receive an electronic copy of the 

document. Please use the document 

number 16015 and complete title to 

identify the guidance you are 

requesting. 

III. 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 the following FDA 

regulations have been approved by OMB 

as listed in the following table: 


jbell on DSKJLSW7X2PROD with NOTICES
314 Federal Register / Vol. 86, No. 2 / Tuesday, January 5, 2021 / Notices 

21 CFR part Topic OMB control 

No. 

807, subpart E ............................................................................ Premarket Notification ................................................................ 0910–0120 

800, 801, and 809 ...................................................................... Medical Device Labeling Regulations ........................................ 0910–0485 

Dated: December 28, 2020. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2020–29081 Filed 1–4–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–D–2199] 

Investigational New Drug Submissions 

for Individualized Antisense 

Oligonucleotide Drug Products: 

Administrative and Procedural 

Recommendations; Draft Guidance for 

Sponsor-Investigators; 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 draft 

guidance for industry entitled ‘‘IND 

Submissions for Individualized 

Antisense Oligonucleotide Drug 

Products: Administrative and 

Procedural Recommendations.’’ FDA is 

publishing this draft guidance to help 

sponsor-investigators (hereafter referred 

to as sponsors) developing 

individualized antisense 

oligonucleotide (ASO) drug products for 

a severely debilitating or life-threatening 

genetic disease. Most often, individuals 

with such diseases will not have 

adequate alternative therapy available 

for treating their disease. This draft 

guidance is intended to help sponsors of 

such development programs, who may 

be relatively unfamiliar with FDA 

regulations, processes, and practices, 

with the administrative and procedural 

aspects of interacting with FDA, 

including seeking feedback from FDA 

on their development programs and 

making regulatory submissions related 

to these development programs. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by March 8, 2021 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance at any time as follows: 

Electronic Submission 

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–2199 for ‘‘IND Submissions for 

Individualized Antisense 

Oligonucleotide Drug Products: 

Administrative and Procedural 

Recommendations.’’ 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 

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 draft 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. Send one self-addressed adhesive 

label to assist that office in processing 

your requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance document. 


jbell on DSKJLSW7X2PROD with NOTICES