Notice2022-13642
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
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
June 27, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 122 (Monday, June 27, 2022)</title>
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[Federal Register Volume 87, Number 122 (Monday, June 27, 2022)]
[Notices]
[Pages 38165-38167]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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\
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Number of Average
Awardee activity Number of responses per Total annual burden per Total hours
respondents respondent responses response
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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)................
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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\
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Number of Records per Total annual
Awardee activity recordkeepers recordkeeper records Average burden per recordkeeping Total hours
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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).
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Total.................................. .............. .............. .............. ........................................... 650
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\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\
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Number of
Number of disclosures Total annual Average
Awardee activity respondents per disclosures burden per Total hours
respondent disclosure
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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)....................
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Total....................... .............. .............. .............. .............. 16,000
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\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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