64438 Federal Register / Vol. 88, No. 180 / Tuesday, September 19, 2023 / Notices 

• Improve Data Visibility and 

Accessibility: Prioritize which data 

assets to make widely available first 

based on value to the mission and the 

most significant number of stakeholders. 

• Enable Advanced Data Analytics: 

Ensure experts can easily combine and 

analyze information from various 

internal and external sources to gain 

comprehensive insights. 

• Enhance Secure Data Exchange: 

Improve interoperable and secure data 

exchange and collaboration across FDA 

and its public health partners. 

Goal 5: Adopt AI and Mission-Driven 

Innovations: Drive exploration and 

address impacts of emerging 

technologies and trends, such as AI and 

virtual reality, on FDA’s IT portfolio and 

regulatory operations. Proactively 

identify opportunities and risks to 

FDA’s mission and inform responsible 

use of technology. Enhance partnerships 

with external experts to leverage these 

technologies and promptly respond to 

their impact. 

Objectives 

• Balance Policy and Technology 

Value: Develop ethical guidance for 

technology use while maximizing 

business value, such as Guidance on AI 

Strategy. Ensure responsible actions by 

conducting comprehensive research and 

analysis to fully understand 

technological advancements’ potential 

impacts and implications on society. 

• Ensure Responsible Use of 

Innovations: Deploy technological 

innovations, such as AI/Machine 

Learning, responsibly with an 

understanding of regulatory impacts and 

effective risk response strategies. 

Establish appropriate guardrails where 

necessary. 

• Provide Proactive Thought 

Leadership: Lead as a partner in creating 

novel use cases for emerging 

technologies through a deep 

understanding of business processes, 

industry, and technology. Stay at the 

forefront of technological advancements 

by harnessing industry expertise and 

fostering collaboration. 

• Foster Innovation: Create an 

environment where innovative 

approaches are encouraged, identified, 

shared, and evaluated for use in driving 

operational efficiency and developing 

new capabilities. Apply a structured 

process to manage the innovation 

lifecycle from ideation to investment to 

adoption (or project shutdown) to 

produce usable innovations. 

Goal 6: Cultivate Talent and 

Leadership: Mature Agency-wide IT 

competencies to deepen technology 

expertise and keep pace with the 

accelerated rate of change in FDA’s 

regulated industries and technology. 

Develop holistic leaders equipped to 

lead through change and drive FDA’s 

digital transformation journey forward. 

Deliver enterprise IT services with an 

Agency-first mindset. Given the 

continued competition for talent, 

proactively build a robust talent 

pipeline for targeted roles leveraging a 

combination of recruitment, retention, 

and talent development strategies. 

Objectives 

• Instill OneFDA Mindset: Cultivate 

an Agency-first approach to IT so that 

decisions promote and protect the 

health of the American people first and 

foremost. 

• Attract and Retain Talent: Build a 

diverse talent pipeline through a 

compelling employee value proposition 

and total compensation approach, talent 

acquisition, employee engagement, and 

talent development strategies. Drive 

improvements across the employee 

lifecycle from recruitment to retirement. 

• Hire and Develop Resilient Leaders: 

Strengthen leadership competencies 

required to drive holistic 

transformational IT initiatives in a 

dynamic environment successfully. 

• Develop Skills for the Future of 

Work: Develop IT skills and 

competencies required to deliver 

current and future IT services through 

upskilling, reskilling, and continuous 

learning. 

IV. Electronic Access 

Persons with access to the internet 

may obtain an electronic version of the 

IT Strategy at https://

www.regulations.gov. 

Dated: September 13, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–20136 Filed 9–18–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–3490] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Application for 

Participation in Food and Drug 

Administration Fellowship and 

Traineeship Programs 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on ‘‘Application for 

Participation in Food and Drug 

Administration Fellowship and 

Traineeship Programs.’’ 

DATES: Either electronic or written 

comments on the collection of 

information must be submitted by 

November 20, 2023. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. The https://

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

November 20, 2023. Comments received 

by mail/hand delivery/courier (for 

written/paper submissions) will be 

considered timely if they are received 

on or before that date. 

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: 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 88, No. 180 / Tuesday, September 19, 2023 / Notices 64439 

• 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– 

2023–N–3490 for ‘‘Application for 

Participation in Food and Drug 

Administration Fellowship and 

Traineeship Programs.’’ Received 

comments, those filed in a timely 

manner (see ADDRESSES), 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. 

FOR FURTHER INFORMATION CONTACT: 

Amber Sanford, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–8867, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3521), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Application for Participation in FDA 

Fellowship and Traineeship Programs 

OMB Control Number 0910–0780— 

Extension 

This information collection supports 

FDA fellowship and traineeship 

programs. Sections 1104, 1302, 3301, 

3304, 3320, 3361, 3393, and 3394 of 

Title 5 of the United States Code 

authorize Federal Agencies to rate 

applicants for Federal jobs. The 

information collection involves brief 

online applications completed by 

applicants applying to FDA’s 

Fellowship and Traineeship programs. 

These voluntary online applications 

will allow the Agency to easily and 

efficiently elicit and review information 

from students and healthcare 

professionals who are interested in 

becoming involved in FDA-wide 

activities. The process will reduce the 

time and cost of submitting written 

documentation to the Agency and lessen 

the likelihood of applications being 

misrouted within the Agency mail 

system. It will assist the Agency in 

promoting and protecting the public 

health by encouraging outside persons 

to share their expertise with FDA. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Medical Device Fellowship Program ................................... 250 1 250 1 250 

FDA Traineeship Program ................................................... 1,000 1 1,000 1 1,000 

Total .............................................................................. ........................ ........................ ........................ ........................ 1,250 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 


ddrumheller on DSK120RN23PROD with NOTICES1
64440 Federal Register / Vol. 88, No. 180 / Tuesday, September 19, 2023 / Notices 

Based on a review of the information 

collection since our last request for 

OMB approval, we have made no 

adjustments to our burden estimate. 

Dated: September 14, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–20229 Filed 9–18–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–2286] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Voluntary National 

Retail Food Regulatory Program 

Standards 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Submit written comments 

(including recommendations) on the 

collection of information by October 19, 

2023. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be submitted to https://

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. The OMB 

control number for this information 

collection is 0910–0621. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Domini Bean, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–5733, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Voluntary National Retail Food 

Regulatory Program Standards 

OMB Control Number 0910–0621— 

Revision 

This information collection helps 

support implementation of FDA’s 

Voluntary National Retail Food 

Regulatory Program Standards (the 

Retail Program Standards). Regulatory 

Program Standards play a critical role in 

an integrated food safety system and 

serve as the foundation for mutual 

reliance between FDA and other 

regulatory agencies that work to ensure 

food safety. The Retail Program 

Standards define what constitutes a 

highly effective and responsive program 

for the regulation of foodservice and 

retail food establishments. The Retail 

Program Standards are intended to 

provide a foundation upon which 

continuous improvements can be made 

with the ultimate goal to reduce the 

occurrence of factors that cause and 

contribute to foodborne illness. In 

support of this goal, FDA works 

cooperatively with our State, local, 

Territorial, and Tribal partners using a 

risk-based approach to leverage limited 

resources. We engage in education and 

outreach efforts to facilitate 

collaboration with our partners in food 

safety. The Retail Program Standards 

represent an important component of a 

comprehensive strategic approach to 

help ensure the safety and security of 

the food supply at the retail level. 

Respondents to the information 

collection are State, local, Territorial, 

and Tribal governments. 

The Retail Program Standards were 

revised most recently in August 2022 

and include the following elements: (1) 

regulatory foundation; (2) trained 

regulatory staff; (3) inspection program 

based on Hazard Analysis and Critical 

Control Point principles; (4) uniform 

inspection program, (5) foodborne 

illness and food defense preparedness 

and response; (6) compliance and 

enforcement; (7) industry and 

community relations; (8) program 

support and resources; and (9) program 

assessment. These elements are 

enumerated and discussed on our 

website at https://www.fda.gov/food/ 

voluntary-national-retail-foodregulatory-program-standards/ 

voluntary-national-retail-foodregulatory-program-standards-august2022 along with worksheets and 

assessments that allow FDA to 

determine conformance with the Retail 

Program Standards. State, local, 

territorial, tribal, and Federal regulatory 

agencies that participate in the 

voluntary program are required to report 

information demonstrating that a 

program self-assessment, a risk factor 

study of the regulated industry, and an 

independent outside audit (verification 

audit) have been completed. The 

information also includes Form FDA 

3958, ‘‘Voluntary National Retail Food 

Regulatory Program Standards FDA 

National Registry Report,’’ which may 

be completed electronically at https://

www.fda.gov/food/voluntary-nationalretail-food-regulatory-programstandards/voluntary-national-retailfood-regulatory-program-standardsaugust-2022. 

Finally, we are revising the 

information collection to include 

additional Agency resources. We have 

created a dedicated emailbox at 

retailfoodprotectionteam@fda.hhs.gov to 

receive requests for program 

documentation and have developed the 

following instruments to support the 

standardization of food safety 

inspection officer candidates: 

• Proposed Form FDA 5017, 

‘‘Standardized Retail Food Safety 

Inspection Officer Waiver of Annual 

Maintenance Requirement Form,’’ 

pertains to requests for waivers from 

maintenance requirements, referenced 

in section 3–403 of the ‘‘FDA 

Procedures for Standardization of Retail 

Food Safety Inspection Officers.’’ FDA 

uses the information submitted on Form 

FDA 5017 to determine a food safety 

inspection officer’s eligibility for 

restandardization. 

• Proposed Form FDA 5018, 

‘‘Standardized Retail Food Safety 

Inspection Officer Annual Maintenance 

Form,’’ provides verification that a food 

safety inspection officer has met 

program standardization requirements 

in accordance with section 3–403 of the 

‘‘FDA Procedures for Standardization of 

Retail Food Safety Inspection Officers.’’ 

• Proposed Form FDA 5019, 

‘‘Standardized Food Safety Inspection 

Officer Nomination Form,’’ allows FDA 

to collect qualification information from 

food safety inspection officer 

candidates. 

In the Federal Register of August 30, 

2023 (88 FR 42372) FDA published a 60- 

day notice requesting public comment 

on the proposed collection of 

information. No comments were 

received. 

We estimate the burden of this 

collection of information as follows: 


ddrumheller on DSK120RN23PROD with NOTICES1