Notice2021-16192
Agency Information Collection Activities; Proposed Collection; Comment Request; Pilot Survey To Develop Standardized Reporting Forms for Federally Funded Public Health Projects
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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
July 29, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with a pilot survey to develop standardized reporting forms for capturing performance data for federally funded public health projects.
Full Text
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<title>Federal Register, Volume 86 Issue 143 (Thursday, July 29, 2021)</title>
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[Federal Register Volume 86, Number 143 (Thursday, July 29, 2021)]
[Notices]
[Pages 40853-40855]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-16192]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0584]
Agency Information Collection Activities; Proposed Collection;
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 an opportunity for public comment on the proposed collection
of certain information by the Agency. Under the Paperwork Reduction Act
of 1995 (PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on information collection
associated with a pilot survey to develop standardized reporting forms
for capturing performance data for federally funded public health
projects.
DATES: Submit either electronic or written comments on the collection
of information by September 27, 2021.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before September 27, 2021. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of September 27, 2021. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2021-N-0584 for ``Pilot Survey to Develop Standardized Reporting
Forms for Federally Funded Public Health Projects administered by the
Office of Regulatory Affairs (ORA).'' Received comments, those filed in
a timely manner (see ADDRESSES), will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Submit both copies to the Dockets Management
[[Page 40854]]
Staff. If you do not wish your name and contact information to be made
publicly available, you can provide this information on the cover sheet
and not in the body of your comments and you must identify this
information as ``confidential.'' Any information marked as
``confidential'' will not be disclosed except in accordance with 21 CFR
10.20 and other applicable disclosure law. For more information about
FDA's posting of comments to public dockets, see 80 FR 56469, September
18, 2015, or access the information at: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
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#144446554760757272547270753a7c7c673a737b62"><span class="__cf_email__" data-cfemail="5f0f0d1e0c2b3e39391f393b3e7137372c71383029">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information before
submitting the collection to OMB for approval. To comply with this
requirement, FDA is publishing notice of the proposed collection of
information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
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 performance 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 (pdf). 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.
We estimate the burden of the information collection 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 Total hours
respondents respondent responses per response
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Initial Report.................. 400 1 400 10 4,000
Progress 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.
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Table 2--Estimated Annual Recordkeeping Burden \1\
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Number of Average burden
Awardee activity Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
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Records related to Initial 400 1 400 0.5 hour (30 200
Report. minutes).
Records related to Progress 400 2 800 0.5 hour (30 400
Reports. minutes).
Records related to Supplement 100 1 100 0.5 hour (30 50
or Followup Report (if minutes).
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, 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
Awardee activity Number of disclosures Total annual Average burden Total hours
respondents per respondent disclosures per 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 Progress
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 progress reports
and the final report to submit to FDA (table 3).
Dated: July 26, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-16192 Filed 7-28-21; 8:45 am]
BILLING CODE 4164-01-P
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