[Federal Register Volume 88, Number 205 (Wednesday, October 25, 2023)]
[Notices]
[Pages 73347-73348]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-23560]


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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.

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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, 
<a href="/cdn-cgi/l/email-protection#a7f7f5e6f4d3c6c1c1e7c1c3c689cfcfd489c0c8d1"><span class="__cf_email__" data-cfemail="94c4c6d5c7e0f5f2f2d4f2f0f5bafcfce7baf3fbe2">[email protected]</span></a>.

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-on-value (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 drop-down 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.

[[Page 73348]]

    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                      Number of
                Awardee activity                     Number of      responses per     Total annual       Average burden per response       Total hours
                                                    respondents       respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Initial Report; Update Reports; Supplement                   330            3.303            1,090   28.17 hours.......................          30,700
 Reports (if applicable).                                                                            (28 hours and 10 minutes).........
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There 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-by-
case 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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                      Number of
                Awardee activity                     Number of       records per      Total annual    Average burden per recordkeeping     Total hours
                                                   recordkeepers     recordkeeper       records
--------------------------------------------------------------------------------------------------------------------------------------------------------
Initial Report, Updated Reports, or Supplement               330            3.303            1,090   0.5 hours.........................             545
 Reports (if applicable).                                                                            (30 minutes)......................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There 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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                      Number of
             Awardee-entity activity                 Number of     disclosures per    Total annual      Average burden per disclosure      Total hours
                                                    respondents       respondent      disclosures
--------------------------------------------------------------------------------------------------------------------------------------------------------
Coordination with partnering entities related to             200                7            1,400   8.................................          11,200
 Initial Report, Update Reports, and Supplement
 Report (if applicable).
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There 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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