Federal Register / Vol. 88, No. 180 / Tuesday, September 19, 2023 / Notices 64435 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for Office of Management 

and Budget (OMB) Review; Temporary 

Assistance for Needy Families (TANF) 

Data Reporting for Work Participation 

(OMB #0970–0338) 

AGENCY: Office of Family Assistance; 

Administration for Children and 

Families; United States Department of 

Health and Human Services. 

ACTION: Request for public comments. 

SUMMARY: The Administration for 

Children and Families (ACF) is 

requesting to extend approval of the 

Temporary Assistance for Needy 

Families (TANF) Data Reporting for 

Work Participation, with proposed 

revisions. Revisions are intended to 

improve the clarity of the instructions, 

streamline reporting, and ensure all 

instructions are up-to-date. 

DATES: Comments due within 30 days of 

publication. OMB must make a decision 

about the collection of information 

between 30 and 60 days after 

publication of this document in the 

Federal Register. Therefore, a comment 

is best assured of having its full effect 

if OMB receives it within 30 days of 

publication. 

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 30-day Review-Open 

for Public Comments’’ or by using the 

search function. You can also obtain 

copies of the proposed collection of 

information by emailing infocollection@

acf.hhs.gov. Identify all emailed 

requests by the title of the information 

collection. 

SUPPLEMENTARY INFORMATION: 

Description: This request includes the 

following information collections: work 

verification procedures, the Caseload 

Reduction Documentation Process, the 

TANF Data Report, the Separate State 

Program (SSP)-Maintenance of Effort 

(MOE) Data Report, and TANF sampling 

instructions. The data and information 

from these reports and processes are 

used–and will continue to be used–for 

program analysis and oversight, 

including the calculation and 

administration of the work participation 

rate and associated penalties. Congress 

provides federal funds to operate TANF 

programs in the states, the District of 

Columbia, Guam, Puerto Rico, the U.S. 

Virgin Islands, and for approved 

federally recognized tribes and Alaskan 

Native Villages. We are proposing to 

continue the same information 

collections with only changes to 

instructions to improve clarity and 

eliminate data elements and guidance 

that are no longer relevant. The Work 

Verification Plan Guidance has been 

updated to reflect current regulation. 

The TANF and SSP–MOE Data Report 

instructions were revised to streamline 

the data collection, reduce the burden 

on respondents by eliminating 

unnecessary data elements, and clarify 

confusing data elements. The TANF and 

SSP–MOE Data Report layouts were also 

updated to reflect the streamlined 

instructions. The TANF Sample Manual 

was revised to eliminate outdated and 

unused sections. 

Respondents: The 50 states of the 

U.S., the District of Columbia, Guam, 

Puerto Rico, and the U.S. Virgin Islands. 

ANNUAL BURDEN ESTIMATES

Instrument 

Total 

number of 

respondents 

Annual 

number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total annual 

burden hours 

Preparation and Submission of Data Verification Procedures sections 

261.60–261.63 ............................................................................................. 54 1 640 34,560 

Caseload Reduction Documentation Process, ACF–202 sections 261.41 

and 261.44 ................................................................................................... 54 1 120 6,480 

Reasonable Cause/Corrective Compliance Documentation Process sections 

262.4, 262.6, and 262.7; section 261.51 ..................................................... 54 2 240 25,920 

TANF Data Report Part 265 ............................................................................ 54 4 2,100 453,600 

SSP–MOE Data Report–Part 265 ................................................................... 29 4 714 82,824 

TANF Sampling and Statistical Methods Manual Part 265.5 .......................... 30 4 48 5,760 

Estimated Total Annual Burden 

Hours: 609,144. 

Authority: 42 U.S.C. 601, 607, 609, 

611, 613, and 1302. 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2023–20165 Filed 9–18–23; 8:45 am] 

BILLING CODE 4184–36–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–3636] 

Food and Drug Administration 

Information Technology Strategy; 

Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; request for comment. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of an 

information technology (IT) strategic 

plan entitled the ‘‘FDA Information 

Technology Strategy’’ and a request for 

comment on this IT Strategy. As part of 

our User Fee Program commitments and 

Omnibus Bill requirements, FDA will 

develop and publish an FDA Data and 

Technology Strategic Plan by September 

29, 2023. This plan will define and 

shape the future course of FDA’s data 

and technology capabilities, building on 

the existing FDA Modernization 

Framework. The plan will also integrate 

Agency and center strategies. 

DATES: Submit either electronic or 

written comments on the Strategy by 

October 30, 2023, to ensure that the 

Agency considers your comments on 

this Strategy for future iterations of the 

IT Strategy. 

ADDRESSES: You may submit comments 

as follows: 


ddrumheller on DSK120RN23PROD with NOTICES1
64436 Federal Register / Vol. 88, No. 180 / Tuesday, September 19, 2023 / Notices 

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– 

2023–N–3636 for ‘‘FDA IT Strategy.’’ 

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. 

Submit written requests for single 

copies of this IT strategy to the Office of 

Digital Transformation, Food and Drug 

Administration, FDA Library, 5630 

Fishers Lane, Rm. 1087, Rockville, MD 

20857. Send one self-addressed 

adhesive label to assist that office in 

processing your request or include a Fax 

number to which the strategy may be 

sent. See the SUPPLEMENTARY

INFORMATION section for information on 

electronic access to the draft strategy. 

FOR FURTHER INFORMATION CONTACT: Casi 

Alexander, Office of Digital 

Transformation, Food and Drug 

Administration, FDA Library, 5630 

Fishers Lane, Rm. 1087, Rockville, MD 

20857, 240–402–5171, email: 

Casi.Alexander@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a request for comment on its draft 

strategy, entitled ‘‘FDA Information 

Technology Strategy’’. 

The Office of Digital Transformation 

(ODT) was established in September 

2021 and reports directly to the Office 

of the Commissioner. ODT provides the 

vision and leadership in information 

technology, data, and cybersecurity 

needed to advance FDA’s mission and 

strategic priorities. ODT has published a 

series of strategy documents known as 

the FDA Modernization Framework. 

The framework includes the Technology 

Modernization Action Plan, Data 

Modernization Action Plan, Enterprise 

Modernization Action Plan, 

Cybersecurity Modernization Action 

Plan, and the Leadership Modernization 

Action Plan. The FDA Modernization 

Framework aims to develop an 

integrated technology, data, 

cybersecurity, business, and leadership 

approach to advancing FDA’s public 

health mission in collaboration with 

industry. 

As part of FDA’s fulfillment of 

requirements in section 3627 of the 

Consolidated Appropriations Act, 2023 

(Pub. L. 117–328), and commitments 

described in section IV.A.2. of the 

‘‘PDUFA Reauthorization Performance 

Goals and Program Enhancements Fiscal 

Years 2023–2027’’ (PDUFA VI 

commitment letter), FDA will work with 

industry while developing a 

comprehensive framework for guiding 

the Agency’s work and allocating 

annual technology budgets and 

resources. The FDA IT Strategy, 

covering Fiscal Years 2024–2026, 

defines and shapes the future course of 

FDA’s data and technology capabilities 

as FDA transitions to the next phase of 

its journey. The Agency took a 

collaborative approach to strategy 

development by gathering input from 

numerous internal and external 

stakeholders that resulted in the draft 

FDA IT Strategy. Stakeholder input is 

crucial for developing a comprehensive 

plan that best meets the needs and goals 

of industry and the Agency. Comments 

on the strategy will be considered for 

future iterations of the FDA IT Strategy. 

Once adopted, this strategy will serve as 

the basis for developing an internal 

operational plan with objectives, tactics, 

and performance measures. 

As part of this effort, FDA will hold 

an FDA Digital Transformation 

Symposium on December 4 to 7, 2023, 

to discuss this groundbreaking IT 

Strategy and encourage further 

collaboration, innovation, and 

transformation. On December 4 and 5, 

the Symposium will be shaped around 

the six new strategic goals, highlighting 

supporting objectives and initiatives. 

The FDA Digital Transformation 

Symposium will extend to December 6 

and 7 to engage IT vendors in a Reverse 

Industry Day and other vendor-focused 

events. Registration information will be 

found on www.FDA.gov for this event. 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 88, No. 180 / Tuesday, September 19, 2023 / Notices 64437 

II. Requested Feedback 

Interested persons are invited to 

provide detailed comments to ODT (see 

ADDRESSES) on the specific IT Strategy 

Goals and Objectives within FDA’s 

Agency-wide IT Strategy. To facilitate 

comment, FDA has developed a series of 

questions in this section. The questions 

are not meant to be exhaustive, and FDA 

is also interested in any other pertinent 

information stakeholders would like to 

share on this topic. FDA encourages 

stakeholders to provide the specific 

rationale and basis for their comments, 

including any available supporting data 

and information. 

1. Which goals and objectives are 

most important to you? Why? 

2. Describe up to five ways the FDA 

IT Strategy will impact your industry? 

3. What gaps do you see in the FDA 

IT Strategy’s goals or objectives? 

4. What challenges or risks do you 

foresee in executing the FDA IT 

Strategy? 

III. FDA IT Strategy Goals and 

Objectives 

Goal 1: Create a Shared OneFDA 

Ecosystem: Establish greater access to 

trusted data and shared resources across 

Centers, Offices, and external 

stakeholders. Encourage and facilitate 

cross-functional investment in 

technology to support enterprise 

business objectives for speed, scale, and 

value through robust Agency level 

governance processes, enhanced 

collaboration channels, and technology 

products and services. Shift FDA’s 

culture to make sharing across Centers 

and Offices and with external 

stakeholders (where appropriate) the 

norm—where prioritizing Agency-level 

public health outcomes improves results 

for everyone. 

Objectives 

• Enhance Communication and 

Collaboration: Foster information and 

resource sharing with internal and 

external stakeholders to achieve both 

Agency and specific stakeholder 

outcomes, using a variety of 

communication channels to reach 

broader audiences. Enable collaboration 

and develop strong partnerships across 

Centers and Offices through integrated 

technologies and platforms. 

• Promote Transparency: Actively 

involve impacted stakeholders in IT 

solution planning, development, and 

execution to drive expected outcomes. 

• Optimize Investments: Align the 

diverse needs across FDA to the 

overarching strategy through stronger 

financial fidelity, enhanced budget 

coordination, and improved financial 

planning. Ensure effective IT resource 

utilization, transparency in IT budget 

allocation, and measurement of results 

achieved. 

• Strengthen Governance: Ensure the 

effective and efficient use of IT in 

enabling FDA to achieve mission 

outcomes through established 

standards, responsible procurement, 

and more robust decision-making and 

accountability mechanisms. 

Goal 2: Strengthen IT Infrastructure: 

Continue to modernize and secure the 

foundational IT infrastructure for all IT 

services and solutions. Proactively 

provide the ability to adapt to changes 

in workload demand, detect issues 

before they impact stakeholders, and 

quickly resolve technology issues to 

avoid disruptions to day-to-day 

operations. 

Objectives 

• Provide Flexible Infrastructure 

Offerings: Provide a marketplace with 

usage-based models for users to identify 

and implement the infrastructure 

solutions based on their business 

requirements with an appropriate 

chargeback model. 

• Accelerate Cloud Adoption: 

Empower users with cloud offerings to 

meet their mission needs, e.g., 

scalability and agility. Provide best 

practice guidance on cloud models, e.g., 

hybrid and transition strategies based on 

the unique needs across Centers and 

Offices. 

• Ensure Service Availability: Provide 

stable access to IT services through 

proactive, continuous monitoring of IT 

infrastructure service performance (e.g., 

Service Level Agreements, Operating 

Level Agreements) and feedback from 

FDA users to identify potential 

problems and implement targeted 

improvements. 

• Implement Zero Trust Approach: 

Establish a comprehensive zero trust 

and risk-based approach to obtain 

optimal maturity level by upgrading, 

modernizing, and enhancing FDA’s 

security and cyber defenses. 

Goal 3: Modernize Enterprise Services 

and Capabilities: Optimize the IT 

services portfolio to support everyday 

needs with cross-cutting, missioncritical offerings and benefit from 

economies of scale. Ensure enterprise IT 

services are stable, resilient, and 

adaptive, with opportunities for 

stakeholders to tailor solutions, where 

appropriate, and feedback loops to drive 

continuous improvement. 

Objectives 

• Increase Business Alignment: Lead 

with a business-first approach to 

modernizing enterprise services and 

capabilities to ensure technology 

enables the capabilities defined in 

FDA’s Business Capability Model and 

supporting business processes. 

• Scale Operations: Develop and 

drive adoption of enterprise solutions 

for standard capabilities, e.g., Finance/ 

Budget, Human Resources, 

Acquisitions, Inspections, Freedom of 

Information Act requests, and 

Complaints Management with 

continuous user testing, while providing 

flexibility for customization where 

relevant. Manage the lifecycle of 

applications within the enterprise 

portfolio. 

• Increase Digital Maturity: Maximize 

the use of technology (e.g., data, 

automation) in core business areas and 

enable processes to improve their ability 

to adapt to changes and scale. 

• Improve Customer Experience: 

Create customer-centric solutions that 

enhance satisfaction by improving 

accessibility to IT solutions, including 

external-facing systems (e.g., Electronic 

Submission Gateway Next Generation), 

streamlining processes, and easing 

adoption. Increase stakeholder 

engagement with FDA IT services by 

prioritizing customer and employee 

feedback and establishing formal 

feedback loops. 

• Modernize FDA Cybersecurity 

Defenses: Upgrade, enhance, and 

modernize FDA’s critical cyber defenses 

and practices to address the evolving 

threat landscape where risks to FDA’s 

critical assets, industry, and sensitive 

data exist. 

• Reduce Technology Debt: 

Decommission legacy systems, 

applications, and End-of-Life devices 

and reinvest in enterprise solutions and 

business process improvements to 

minimize technical debt and enterprise 

risk. 

Goal 4: Share Data for Mission 

Outcomes: Identify common data assets 

critical to stakeholders across FDA and 

make them widely available and 

consumable to drive operational 

efficiencies and excellence. Leverage 

valuable data assets and insights to 

develop new capabilities and services 

and enable public health innovation. 

Objectives 

• Enhance Data Governance: 

Implement Artificial Intelligence (AI)- 

powered best practices for governance 

and data management that improve data 

quality, security, and the speed and 

accuracy of insights and decisions. 

• Foster OneFDA Data Literacy: 

Educate the workforce on best practices 

and the benefits of consuming, 

analyzing, and making data-based 

decisions. 


ddrumheller on DSK120RN23PROD with NOTICES1
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