Notice2023-23560
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
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
October 25, 2023
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 88 Issue 205 (Wednesday, October 25, 2023)</title>
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[Federal Register Volume 88, Number 205 (Wednesday, October 25, 2023)]
[Notices]
[Pages 73347-73348]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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\
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Number of
Awardee activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
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Initial Report; Update Reports; Supplement 330 3.303 1,090 28.17 hours....................... 30,700
Reports (if applicable). (28 hours and 10 minutes).........
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\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\
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Number of
Awardee activity Number of records per Total annual Average burden per recordkeeping Total hours
recordkeepers recordkeeper records
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Initial Report, Updated Reports, or Supplement 330 3.303 1,090 0.5 hours......................... 545
Reports (if applicable). (30 minutes)......................
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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, 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\
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Number of
Awardee-entity activity Number of disclosures per Total annual Average burden per disclosure Total hours
respondents respondent disclosures
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Coordination with partnering entities related to 200 7 1,400 8................................. 11,200
Initial Report, Update Reports, and Supplement
Report (if applicable).
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\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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