Agency Information Collection Activities; Proposed Collection; Comment Request; Pilot Survey To Develop Standardized Reporting Forms for Federally Funded Public Health Projects, 40853-40855 [2021-16192]
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Federal Register / Vol. 86, No. 143 / Thursday, July 29, 2021 / Notices
Antibody Cocktails for the Passive
Immunization Component of PostExposure Prophylaxis.’’ It does not
establish any rights for any person and
is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. Therefore, clearance by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501–
3521) is not required for this guidance.
The previously approved collections of
information are subject to review by
OMB under the PRA. The collections of
information associated with
submissions of content and format of
labeling for drugs and biologics in 21
CFR 201.56 and 201.57 have been
approved under OMB control number
0910–0572; the collections of
information associated with
submissions of investigational new drug
applications in 21 CFR part 312 have
been approved under OMB control
numbers 0910–0014; the collections of
information associated with
submissions of applications for approval
to market a new drug in 21 CFR part 314
have been approved under 0910–0001;
the collections of information associated
with the reporting and recordkeeping of
postmarketing adverse drug experiences
have been approved under OMB control
numbers 0910–0001, 0910–0230, 0910–
0291, and 0910–0645; and the
collections of information associated
with general licensing provisions for
biologics in 21 CFR part 601 have been
approved under OMB control number
0910–0338.
III. Electronic Access
jbell on DSKJLSW7X2PROD with NOTICES
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
Dated: July 26, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–16175 Filed 7–28–21; 8:45 am]
BILLING CODE 4164–01–P
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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.
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 https://www.regulations.gov
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.
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov 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
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Fmt 4703
Sfmt 4703
40853
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 https://www.regulations.gov.
• 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:
• 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.
• 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
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday, 240–402–7500.
• 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
https://www.regulations.gov. Submit
both copies to the Dockets Management
E:\FR\FM\29JYN1.SGM
29JYN1
40854
Federal Register / Vol. 86, No. 143 / Thursday, July 29, 2021 / Notices
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: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov 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, PRAStaff@
fda.hhs.gov.
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-onvalue (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
Number of
respondents
Awardee activity
Total annual
responses
Average
burden per
response
Total hours
Initial Report .........................................................................
Progress Reports .................................................................
Supplement or Followup Report (if applicable) ...................
400
400
100
1
2
1
400
800
100
10
40
10
4,000
32,000
1,000
Total ..............................................................................
........................
........................
........................
........................
37,000
1 There
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Number of
responses per
respondent
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
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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
PO 00000
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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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29JYN1
40855
Federal Register / Vol. 86, No. 143 / Thursday, July 29, 2021 / Notices
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
Awardee activity
Number of
records per
recordkeeper
Total annual
records
Average burden per recordkeeping
Total hours
Records related to Initial Report .......
Records related to Progress Reports
Records related to Supplement or
Followup Report (if applicable).
400
400
100
1
2
1
400
800
100
0.5 hour (30 minutes) .......................
0.5 hour (30 minutes) .......................
0.5 hour (30 minutes) .......................
200
400
50
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,
but no less than 3 years, as
recommended by FDA (table 2).
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
respondents
Awardee activity
Coordination with partnering entities related to Initial Report ...................................................................................
Coordination with partnering entities related to Progress
Reports .............................................................................
Coordination with partnering entities related to Supplement
or Followup Report (if applicable) ....................................
Total ..............................................................................
1 There
Total annual
disclosures
Average
burden per
disclosure
Total hours
300
2
600
8
4,800
300
4
1,200
8
9,600
100
2
200
8
1,600
........................
........................
........................
........................
16,000
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.
jbell on DSKJLSW7X2PROD with NOTICES
Number of
disclosures
per
respondent
[FR Doc. 2021–16192 Filed 7–28–21; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–D–1216]
Electronic Study Data Submission;
Data Standards; Technical Rejection
Criteria for Study Data Effective Date
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration’s (FDA or Agency)
Center for Biologics Evaluation and
Research (CBER) and Center for Drug
Evaluation and Research (CDER) are
announcing the effective date for
Electronic Common Technical
Document (eCTD) validations
referenced in FDA’s ‘‘Technical
Rejection Criteria for Study Data’’ (TRC).
SUMMARY:
The eCTD validations will
become applicable on September 15,
2021.
DATES:
BILLING CODE 4164–01–P
You may submit either
electronic or written comments at any
time as follows:
ADDRESSES:
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20:14 Jul 28, 2021
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Sfmt 4703
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov 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 https://www.regulations.gov.
• 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’’).
E:\FR\FM\29JYN1.SGM
29JYN1
]]>Agencies
[Federal Register Volume 86, Number 143 (Thursday, July 29, 2021)]
[Notices]
[Pages 40853-40855]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-16192]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://www.regulations.gov 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:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
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 https://www.regulations.gov.
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:
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.
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 https://www.regulations.gov or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
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 https://www.regulations.gov.
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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov 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,
[email protected].
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\
----------------------------------------------------------------------------------------------------------------
Number of
Awardee activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
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)................
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 37,000
----------------------------------------------------------------------------------------------------------------
\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.
[[Page 40855]]
Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Awardee activity Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
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).
---------------------------------------------------------------------------------
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, but no less than 3 years, as recommended by FDA (table 2).
Table 3--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Awardee activity Number of disclosures Total annual Average burden Total hours
respondents per respondent disclosures per 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 Progress
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 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
