Federal Register / Vol. 88, No. 205 / Wednesday, October 25, 2023 / Notices 73347 

Dated: October 19, 2023. 

Alison Barkoff, 

Senior official performing the duties of the 

Administrator and the Assistant Secretary for 

Aging. 

[FR Doc. 2023–23563 Filed 10–24–23; 8:45 am] 

BILLING CODE 4154–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0584] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Standardized 

Reporting Forms for Food and Drug 

Administration Federally Funded 

Public Health Projects and Agreements 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) 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 November 

24, 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 0910–0909. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Rachel Showalter, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 240–994–7399, 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. 

Standardized Reporting Forms for FDA 

Federally Funded Public Health 

Projects 

OMB Control Number 0910–0909— 

Revision 

This information collection supports 

federally funded public health projects 

administered by FDA. As part of FDA’s 

efforts to protect the public health, we 

work collaboratively with State partners 

to enhance oversight of FDA-regulated 

products. Consistent with applicable 

regulations, we collect information 

related to an awardee’s progress in 

completing agreed-upon performance 

metrics. 

To increase our efficiency in 

evaluating program effectiveness and 

return-on-investment (ROI)/return-onvalue (ROV) for the federally funded 

projects that we administer, we 

developed and established the use of 

digital forms under a pilot project 

information collection that contain 

tailored, standardized questions to 

capture data elements necessary to 

measure/track ROI/ROV, best practices, 

and program effectiveness. Forms are 

submitted by email and aggregated into 

dynamic reports by program for FDA 

evaluators allowing for quick 

comparison of program data between 

report periods and comparable metrics 

to evaluate program success or lack of 

performance in a timely manner. The 

pilot project confirmed that the use of 

standardized forms will reduce the time 

required by awardees in completing and 

submitting data collection reports. 

Additional findings include: a drastic 

increase in data quality, a significant 

reduction in the number of follow-ups 

needed to request additional 

information or clarify responses, and the 

ability to aggregate data quickly into a 

useable format for programmatic review 

and respond effectively to requests for 

program performance data. Coupled 

with positive feedback from FDA data 

users and external partners received 

during the pilot project, we considered 

the pilot phase a success and plans to 

continue use of tailored forms for 

program performance metrics including 

ROI/ROV data for its current and new 

funded public health projects moving 

forward. 

Respondents complete an initial 

report and progress/performance reports 

which include data fields to identify the 

award project and contact person and 

directs specific questions to respondents 

regarding project and progress updates. 

As the public, partnering awardees, and 

FDA data users provide feedback 

through various opportunities, we will 

revise the reports tailoring for project 

specificity and purpose, to include, but 

not limited to, improvements in metrics 

analysis, question clarity, and 

formatting and design, such as dropdown menu selections and potential 

common response indicators. This 

method will ensure a continuation of 

the reduced time for respondents and 

allow us to more quickly process 

information and determine impacts at 

the Agency level as observed during the 

pilot. As information will be requested 

of actively funded projects, it still may 

become necessary to request additional 

information for a particular project to 

complete the performance evaluation(s) 

in a timely manner. To ensure data is 

sufficient, on a case-by-case basis, FDA 

anticipates a need for follow-up 

questionnaire(s) to supplement the 

progress reports and as instruments of 

collection are developed and fine-tuned 

through this effort. We do not have any 

specific adjustments or revisions to the 

approved forms at this time, other than 

the inclusion of PRA statements. Due to 

the evolving nature of public health 

issues, non-substantive modifications 

may be made to the forms during the 3- 

year approval period of this information 

collection. Prior to implementation, 

such modifications will be submitted to 

OMB for approval, and they will be 

made available for public review and 

comment during the standard 

information collection extension/ 

revision approval process. 

In the Federal Register of July 29, 

2021 (86 FR 40853), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. Subsequent to the close of the 

60-day notice public comment period, 

additional comments were received 

from internal and external stakeholders 

through our solicitation of feedback 

external to the PRA public comment 

opportunity. Upon our review, these 

comments were generally supportive of 

the piloted forms, and many contained 

suggestions for additional technical 

improvements. At the same time, none 

of the comments suggested any change 

to our estimated burden and we have 

therefore retained those currently 

submitted. While we are not making 

changes to the forms with this 

submission, we plan to implement 

changes based on the feedback received 

as part of the continuous improvement 

process for the information collection 

over the next few years. 

Description of Respondents: 

Respondents to the information 

collection are State, local, Tribal and 

Territorial governments who are 

recipients of FDA-funded projects who 

submit required information to FDA. 


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73348 Federal Register / Vol. 88, No. 205 / Wednesday, October 25, 2023 / Notices 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Awardee activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses Average burden per response Total hours 

Initial Report; Update Reports; Supplement Reports (if applicable).330 3.303 1,090 28.17 hours ......................................

(28 hours and 10 minutes) ...............

30,700 

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

We estimate that 330 respondents will 

participate in FDA funded projects and 

agreements annually and will submit 2 

to 4 reports within a single yearlong 

budget period (Table 1). To ensure 

adequate reporting will be achieved 

over the course of these projects, the 

option for a supplement report is 

included in the estimated reporting 

burden; however, the need for these 

reports will be determined on a case-bycase basis with the FDA project 

manager. The estimated burden for each 

of the individual reporting activities 

was calculated based on the annual 

number of submissions and distributed 

among respondents. 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Awardee activity Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records Average burden per recordkeeping Total hours 

Initial Report, Updated Reports, or 

Supplement Reports (if applicable).

330 3.303 1,090 0.5 hours ..........................................

(30 minutes) .....................................

545 

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

Recordkeeping activities include 

storing and maintaining records related 

to submitting a request to participate in 

the project and compiling reports. 

Respondents should use current record 

retention capabilities for electronic or 

paper storage to achieve these activities. 

We assume it will take 0.5 hour/year to 

ensure the documents related to 

submitting a request to participate in the 

program are retained properly according 

to their existing recordkeeping policies, 

but no less than 3 years, as 

recommended by FDA (Table 2). The 

estimated burden for each of the 

individual reporting activities was 

calculated based on the annual number 

of submissions and distributed among 

respondents. 

TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

Awardee-entity activity Number of 

respondents 

Number of 

disclosures 

per respondent 

Total annual 

disclosures Average burden per disclosure Total hours 

Coordination with partnering entities 

related to Initial Report, Update 

Reports, and Supplement Report 

(if applicable).

200 7 1,400 8 ....................................................... 11,200 

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

For those funded projects that involve 

a participant composed of partnering 

entities in the program, FDA is taking 

into consideration the time that 

partnering entities will spend 

coordinating with each other. We 

estimate that 200 respondents will work 

with their respective partnering entities 

and the average number of partnering 

entities will be 2. We assume each 

respondent will spend 8 hours 

coordinating with each partnering entity 

on each response for an estimated 7 

responses or reports each (Table 3). The 

estimated burden for each of the 

individual reporting activities was 

calculated based on the annual number 

of submissions and distributed among 

respondents. 

We are requesting OMB approval for 

conclusion of the pilot project and 

continued use of the forms for 

programmatic data collection needs. 

There are no adjustments or revisions to 

the estimated burden. However, this 

request results in an adjustment 

decrease in the number of responses, to 

correct data-entry errors in the database 

related to the previous submission to 

OMB. 

Dated: October 20, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–23560 Filed 10–24–23; 8:45 am] 

BILLING CODE 4164–01–P 


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