80120 Federal Register / Vol. 85, No. 239 / Friday, December 11, 2020 / Notices 

for Drug Development Tools; Guidance 

for Industry; Availability’’ that appeared 

in the Federal Register of November 25, 

2020. The document announced the 

availability of a final guidance for 

industry and FDA staff that met the 21st 

Century Cures Act’s requirement to 

issue guidance on this qualification 

process and elaborated on the new 

qualification process and transparency 

requirements and discusses the 

taxonomy for biomarkers and other drug 

development tools. The document was 

published with incorrect information in 

the Paperwork Reduction Act of 1995 

section. This document corrects that 

error. 

FOR FURTHER INFORMATION CONTACT: 

Chris Leptak, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 22, Rm. 6461, Silver Spring, 

MD 20993–0002, 301–796–0017; or 

Stephen Ripley, Center for Biologics 

Evaluation and Research, 10903 New 

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

Silver Spring, MD 20993–0002; 240– 

402–7911. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of November 25, 2020 

(85 FR 75334), in FR Doc. 2020–26051, 

the following correction is made: 

On page 75336, in the first column, 

under the heading, ‘‘II. Paperwork 

Reduction Act of 1995’’, the paragraph 

is corrected to read: 

‘‘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 pertaining to submissions 

of investigational new drug applications 

have been approved under OMB control 

number 0910–0014; the collections of 

information pertaining to submissions 

of new drug applications and 

abbreviated new drug applications have 

been approved under OMB control 

number 0910–0001; and the collections 

of information pertaining to 

submissions of biologics license 

applications in 21 CFR part 601 have 

been approved under OMB control 

number 0910–0338.’’ 

Dated: December 8, 2020. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2020–27288 Filed 12–10–20; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–D–0064] 

Pre-Submission Consultation Process 

for Animal Food Additive Petitions or 

Generally Recognized as Safe Notices; 

Guidance for Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA, we, or Agency) is 

announcing the availability of a final 

guidance for industry #262 entitled 

‘‘Pre-Submission Consultation Process 

for Animal Food Additive Petitions or 

Generally Recognized as Safe (GRAS) 

Notices.’’ The guidance provides 

uniform, consistent process information 

to industry to facilitate effective and 

efficient review of pre-consultation 

submissions for animal food additives 

or GRAS notices for intended use in 

animal food. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on December 11, 2020. 

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–0064 for ‘‘Pre-Submission 

Consultation Process for Animal Food 

Additive Petitions or Generally 

Recognized as Safe (GRAS) Notices.’’ 

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 


jbell on DSKJLSW7X2PROD with NOTICES
Federal Register / Vol. 85, No. 239 / Friday, December 11, 2020 / Notices 80121 

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 Policy and 

Regulations Staff (HFV–6), Center for 

Veterinary Medicine, Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855. Send one selfaddressed adhesive label to assist that 

office in processing your requests. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the draft 

guidance document. 

FOR FURTHER INFORMATION CONTACT: 

William Burkholder, Center for 

Veterinary Medicine (HFV–229), Food 

and Drug Administration, 7519 Standish 

Pl., Rockville, MD 20855, 240–402– 

5900, william.burkholder@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background

In the Federal Register of February

13, 2020 (85 FR 8297), FDA published 

the notice of availability for a draft 

guidance entitled ‘‘Pre-Submission 

Consultation Process for Animal Food 

Additive Petitions or Generally 

Recognized as Safe (GRAS) Notices,’’ 

giving interested persons until April 13, 

2020, to comment on the draft guidance. 

FDA received two comments on the 

draft guidance and those comments 

were considered as the guidance was 

finalized. Editorial changes were made 

to improve clarity. The guidance 

announced in this notice finalizes the 

draft guidance dated February 2020. 

This guidance provides uniform, 

consistent process information to 

industry to facilitate effective and 

efficient review of pre-consultation 

submissions for animal food additive 

petitions or GRAS substances and 

preparation of food use authorization 

requests. 

This level 1 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 the pre-submission 

consultation process for animal food 

additive petitions or GRAS notices for 

intended use in animal food. 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 570.17 and 571.1 

have been approved under OMB control 

number 0910–0546; the collections of 

information under 21 CFR part 570, 

subpart E have been approved under 

OMB control number 0910–0342; and 

the collections of information under 21 

CFR part 58 have been approved under 

OMB control number 0910–0119. 

III. Electronic Access

Persons with access to the internet

may obtain the draft guidance at either 

https://www.fda.gov/animal-veterinary/ 

guidance-regulations/guidanceindustry, https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents, or https://

www.regulations.gov. 

Dated: December 7, 2020. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2020–27256 Filed 12–10–20; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: Public 

Comment Request Information 

Collection Request Title: Standardized 

Work Plan Form for Use with 

Applications to the Bureau of Health 

Workforce Research and Training 

Grants and Cooperative Agreements 

OMB No. 0906–0049—Revision 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: In compliance with the 

Paperwork Reduction Act of 1995, 

HRSA has submitted an Information 

Collection Request (ICR) to the Office of 

Management and Budget (OMB) for 

review and approval. Comments 

submitted during the first public review 

of this ICR have been provided to OMB. 

OMB will accept further comments from 

the public during the review and 

approval period. OMB may act on 

HRSA’s ICR only after the 30 day 

comment period for this notice has 

closed. 

DATES: Comments on this ICR should be 

received no later than January 11, 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 Review—Open for 

Public Comments’’ or by using the 

search function. 

A 60-day Federal Register Notice was 

published in the Federal Register on 

September 15, 2020, Vol. 85, No. 179, 

pp.57221–57222. There were no public 

comments. 

FOR FURTHER INFORMATION CONTACT: To 

request a copy of the clearance requests 

submitted to OMB for review, email Lisa 

Wright-Solomon, the HRSA Information 

Collection Clearance Officer at 

paperwork@hrsa.gov or call (301) 443– 

1984. 

SUPPLEMENTARY INFORMATION: 

Information Collection Request Title: 

Standardized Work Plan Form for Use 

with Applications to the Bureau of 

Health Workforce Research and 

Training Grants and Cooperative 

Agreements, OMB No. 0906–0049— 

Revision 

Abstract: HRSA’s Bureau of Health 

Workforce requires applicants of 

training and research grants and 

cooperative agreements to submit work 

plans via the Standardized Work Plan 

(SWP) form. 

The information in the SWP describes 

the timeframes and progress required 

during the grant period of performance 

to address each of the needs detailed in 

the Purpose and Need section of the 

application, as required in the Notice of 

Funding Opportunity announcement. 

Applicants use the SWP form when 

they submit their proposals, and award 

recipients and Project Officers use the 

SWP information to assist in monitoring 

progress once HRSA makes the awards. 

HRSA proposes a revision to the SWP 

to include a Quarterly Progress Update 

(QPU) for award recipients to provide 

information to HRSA on a quarterly 

basis on each activity listed in the SWP. 

Need and Proposed Use of the 

Information: The information collected 

by the SWP form standardizes and 

streamlines the data used by HRSA in 

reviewing applications and monitoring 

awardees. The form asks applicants to 

provide a description of the activities or 

steps the applicant will take to achieve 


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