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2020, to comment on the draft guidance.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draft guidance and those comments 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draft guidance dated February 2020.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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80122 Federal Register / Vol. 85, No. 239 / Friday, December 11, 2020 / Notices 

each of the objectives proposed during 

the entire period of performance. The 

current standardized format and data 

submission by applicants increases 

efficiency in reviewing, awarding, and 

monitoring each project. 

This revision to the clearance package 

will incorporate an additional form for 

participants, the QPU. The QPU is 

completed via HRSA’s Electronic 

Handbook and prompts recipients to 

report on progress of activities that were 

submitted using the SWP in the original 

application. The QPU will automatically 

populate activities from the recipient’s 

SWP form on a quarterly basis. For each 

activity listed in the submitted SWP for 

any particular quarter within the project 

period, recipients will select and submit 

a single selection response for each 

activity status from a pull-down menu 

with five options: Activity is on 

Schedule, Activity is Complete, Timing 

is off track, Activity will be missed if 

action is not taken, and Activity cannot 

be achieved. Information provided will 

be utilized by the program staff to 

regularly assess overall progress of 

program requirements and analyze data 

in order to monitor award recipient 

compliance and track progress against 

proposed targets and goals. Information 

gathered will allow for an improved and 

more efficient method for identifying 

whether projects’ goals are being 

advanced or achieved, as set forth in 45 

CFR 75.342. Program staff will also use 

information provided over the period of 

performance to see emerging trends and 

to assess whether an award recipient 

requires technical assistance to address 

challenges that the award recipient may 

be experiencing with the 

implementation of the project. Seeking 

OMB approval comports with the 

regulatory requirement imposed by 45 

CFR 75.206(a), Paperwork clearances. 

Likely Respondents: Recipients of 

HRSA Bureau of Health Workforce’s 

research and training grants and 

cooperative agreements. 

Burden Statement: Burden in this 

context means the time expended by 

persons to generate, maintain, retain, 

disclose or provide the information 

requested. This includes the time 

needed to review instructions; to 

develop, acquire, install, and utilize 

technology and systems for the purpose 

of collecting, validating, and verifying 

information, processing and 

maintaining information, and disclosing 

and providing information; to train 

personnel and to be able to respond to 

a collection of information; to search 

data sources; to complete and review 

the collection of information; and to 

transmit or otherwise disclose the 

information. The total annual burden 

hours estimated for this ICR are 

summarized in the table below. 

TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS

Form name Number of respondents 

Number of responses per 

respondent 

Total responses 

Average burden per response (in 

hours) 

Total annual 

burden hours 

Standardized Work Plan (SWP) .......................................... 1,000 1 1,000 1.00 1,000 

Quarterly Progress Update (QPU) Form ............................. 1,000 4 4,000 .10 400 

Total .............................................................................. 1 1,000 ¥ 5,000 ¥ 1,400 

1The 1,000 Standardized Work Plan (SWP) respondents reflects the number of new grant applications submitted annually. The 1,000 Quarterly Progress Update (QPU) respondents reflects the current volume of funded, active grants. 

HRSA specifically requests comments 

on (1) the necessity and utility of the 

proposed information collection for the 

proper performance of the agency’s 

functions, (2) the accuracy of the 

estimated burden, (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected, and (4) the 

use of automated collection techniques 

or other forms of information 

technology to minimize the information 

collection burden. 

Maria G. Button, 

Director, Executive Secretariat. 

[FR Doc. 2020–27318 Filed 12–10–20; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

Findings of Research Misconduct 

AGENCY: Office of the Secretary, HHS. 

ACTION: Notice. 

SUMMARY: Findings of research 

misconduct have been made against 

Charles A. Downs (Respondent), former 

Adjunct Assistant Professor, Arizona 

Health Sciences Center, University of 

Arizona (UA). Respondent engaged in 

research misconduct in research 

supported by U.S. Public Health Service 

(PHS) funds, specifically National 

Center for Advancing Translation 

Sciences (NCATS), National Institutes of 

Health (NIH), grant UL1 TR000454. The 

administrative actions, including 

supervision for a period of four (4) 

years, were implemented beginning on 

November 18, 2020, and are detailed 

below. 

FOR FURTHER INFORMATION CONTACT: 

Elisabeth A. Handley, Director, Office of 

Research Integrity, 1101 Wootton 

Parkway, Suite 240, Rockville, MD 

20852, (240) 453–8200. 

SUPPLEMENTARY INFORMATION: Notice is 

hereby given that the Office of Research 

Integrity (ORI) has taken final action in 

the following case: 

Charles A. Downs, University of 

Arizona: Based on the report of an 

investigation conducted by UA and 

analysis conducted by ORI in its 

oversight review, ORI found that 

Respondent, former Adjunct Assistant 

Professor, Arizona Health Sciences 

Center, UA, engaged in research 

misconduct in research supported by 

PHS funds, specifically NCATS, NIH, 

grant UL1 TR000454. 

Respondent neither admits nor denies 

ORI’s findings of research misconduct. 

Respondent and ORI desire to close this 

matter without further expense of time 

and other resources and thus have 

entered into a Voluntary Settlement 

Agreement (Agreement). 

ORI found that Respondent engaged 

in research misconduct by intentionally, 

knowingly, or recklessly falsifying and/ 

or fabricating data included in the 

following six (6) grant applications 

submitted for PHS funds: 

• R01 NR016242–01, submitted to the 

National Institute of Nursing Research 

(NINR), NIH 

• R01 NR016242–01A1, submitted to 

NINR, NIH 

• R01 NR016957–01, submitted to 

NINR, NIH 

• R01 NR016957–01A1, submitted to 

NINR, NIH 


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