[Federal Register Volume 87, Number 122 (Monday, June 27, 2022)]
[Notices]
[Pages 38165-38167]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-13642]


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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; Pilot Survey To 
Develop Standardized Reporting Forms for Federally Funded Public Health 
Projects

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 July 27, 2022.

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

[[Page 38166]]

collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The title of this 
information collection is Pilot Survey to Develop Standardized 
Reporting Forms for Federally Funded Public Health Projects. 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, 
<a href="/cdn-cgi/l/email-protection#9bcbc9dac8effafdfddbfdfffab5f3f3e8b5fcf4ed"><span class="__cf_email__" data-cfemail="08585a495b7c696e6e486e6c692660607b266f677e">[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.

Pilot Survey To Develop Standardized Reporting Forms for Federally 
Funded Public Health Projects

OMB Control Number 0910-NEW

    This information collection supports federally funded public health 
projects administered by the Agency's Office of Regulatory Affairs 
(ORA). 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 pertaining 
to federally funded programs, we currently collect information related 
to an awardee's progress in completing agreed-upon performance metrics 
3 to 4 times a year during the reporting period. Respondents to the 
information collection are recipients of FDA-funded projects who submit 
required information to FDA in free text and narrative form via 
portable document format. 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 intend 
to develop and establish the use of digital forms that contain 
standardized questions to capture data elements necessary to measure/
track ROI/ROV. We believe the use of standardized forms will reduce the 
time required by awardees in completing and submitting progress 
reports.
    As part of the pilot, respondents will 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. Based on public 
feedback, we hope to revise the reports, tailoring for project 
specificity and purpose, to include, but not limited to, improvements, 
such as drop-down menu selections and potential common response 
indicators that will reduce time for respondents and allow us to more 
quickly process information and determine impacts at the Agency level. 
As information will be requested of actively funded projects, it 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 followup questionnaire(s) to supplement the progress reports 
as instruments of collection are developed and fine-tuned through this 
effort.
    In the Federal Register of July 29, 2021 (86 FR 40853), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    We estimate the burden of the information collection as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
        Awardee activity             Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
Initial Report..................             400               1             400              10           4,000
Updated Reports.................             400               2             800              40          32,000
Supplement or Followup Report                100               1             100              10           1,000
 (if applicable)................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          37,000
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    We estimate that 400 respondents will participate under this pilot 
project and will submit an average of 3 to 4 reports within a single 
budget year (table 1). To ensure adequate reporting will be achieved 
over the course of this pilot, the option for a supplement or followup 
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.

                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                Number of      Records per    Total annual
              Awardee activity                recordkeepers   recordkeeper       records          Average  burden per  recordkeeping        Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Records related to Initial Report..........             400               1             400  0.5 hour (30 minutes)......................             200
Records related to Updated Reports.........             400               2             800  0.5 hour (30 minutes)......................             400
Records related to Supplement or Followup               100               1             100  0.5 hour (30 minutes)......................              50
 Report (if applicable).
                                            ------------------------------------------------------------------------------------------------------------
    Total..................................  ..............  ..............  ..............  ...........................................             650
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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,

[[Page 38167]]

but no less than 3 years, as recommended by FDA (table 2).

                           Table 3--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
                                     Number of      disclosures    Total annual       Average
        Awardee activity            respondents         per         disclosures     burden per      Total hours
                                                    respondent                      disclosure
----------------------------------------------------------------------------------------------------------------
Coordination with partnering                 300               2             600               8           4,800
 entities related to Initial
 Report.........................
Coordination with partnering                 300               4           1,200               8           9,600
 entities related to Updated
 Reports........................
Coordination with partnering                 100               2             200               8           1,600
 entities related to Supplement
 or Followup Report (if
 applicable)....................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          16,000
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    For those pilot 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 in a pilot project. We estimate that 300 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 
this pilot. We estimate that seven respondents will need to coordinate 
with an average of two partnering entities to create updated reports 
and the final report to submit to FDA (table 3).

    Dated: June 21, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-13642 Filed 6-24-22; 8:45 am]
BILLING CODE 4164-01-P


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