Agency Information Collection Activities: Proposed Collection: Public Comment Request Information Collection Request Title: Standardized Work Plan Form for Use with Applications to the Bureau of Health Workforce Research and Training Grants and Cooperative Agreements OMB No. 0906-0049-Revision, 80121-80122 [2020-27318]
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Federal Register / Vol. 85, No. 239 / Friday, December 11, 2020 / Notices
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.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the guidance to the Policy and
Regulations Staff (HFV–6), Center for
Veterinary Medicine, Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855. Send one selfaddressed adhesive label to assist that
office in processing your requests. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance document.
FOR FURTHER INFORMATION CONTACT:
William Burkholder, Center for
Veterinary Medicine (HFV–229), Food
and Drug Administration, 7519 Standish
Pl., Rockville, MD 20855, 240–402–
5900, william.burkholder@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
jbell on DSKJLSW7X2PROD with NOTICES
I. Background
In the Federal Register of February
13, 2020 (85 FR 8297), FDA published
the notice of availability for a draft
guidance entitled ‘‘Pre-Submission
Consultation Process for Animal Food
Additive Petitions or Generally
Recognized as Safe (GRAS) Notices,’’
giving interested persons until April 13,
2020, to comment on the draft guidance.
FDA received two comments on the
draft guidance and those comments
were considered as the guidance was
finalized. Editorial changes were made
to improve clarity. The guidance
announced in this notice finalizes the
draft guidance dated February 2020.
This guidance provides uniform,
consistent process information to
industry to facilitate effective and
efficient review of pre-consultation
submissions for animal food additive
petitions or GRAS substances and
preparation of food use authorization
requests.
This level 1 guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on the pre-submission
consultation process for animal food
additive petitions or GRAS notices for
intended use in animal food. 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.
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23:25 Dec 10, 2020
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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 in 21 CFR 570.17 and 571.1
have been approved under OMB control
number 0910–0546; the collections of
information under 21 CFR part 570,
subpart E have been approved under
OMB control number 0910–0342; and
the collections of information under 21
CFR part 58 have been approved under
OMB control number 0910–0119.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/animal-veterinary/
guidance-regulations/guidanceindustry, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
Dated: December 7, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2020–27256 Filed 12–10–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request Information
Collection Request Title: Standardized
Work Plan Form for Use with
Applications to the Bureau of Health
Workforce Research and Training
Grants and Cooperative Agreements
OMB No. 0906–0049—Revision
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with the
Paperwork Reduction Act of 1995,
HRSA has submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR have been provided to OMB.
OMB will accept further comments from
SUMMARY:
PO 00000
Frm 00132
Fmt 4703
Sfmt 4703
80121
the public during the review and
approval period. OMB may act on
HRSA’s ICR only after the 30 day
comment period for this notice has
closed.
DATES: Comments on this ICR should be
received no later than January 11, 2021.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under Review—Open for
Public Comments’’ or by using the
search function.
A 60-day Federal Register Notice was
published in the Federal Register on
September 15, 2020, Vol. 85, No. 179,
pp.57221–57222. There were no public
comments.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email Lisa
Wright-Solomon, the HRSA Information
Collection Clearance Officer at
paperwork@hrsa.gov or call (301) 443–
1984.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Standardized Work Plan Form for Use
with Applications to the Bureau of
Health Workforce Research and
Training Grants and Cooperative
Agreements, OMB No. 0906–0049—
Revision
Abstract: HRSA’s Bureau of Health
Workforce requires applicants of
training and research grants and
cooperative agreements to submit work
plans via the Standardized Work Plan
(SWP) form.
The information in the SWP describes
the timeframes and progress required
during the grant period of performance
to address each of the needs detailed in
the Purpose and Need section of the
application, as required in the Notice of
Funding Opportunity announcement.
Applicants use the SWP form when
they submit their proposals, and award
recipients and Project Officers use the
SWP information to assist in monitoring
progress once HRSA makes the awards.
HRSA proposes a revision to the SWP
to include a Quarterly Progress Update
(QPU) for award recipients to provide
information to HRSA on a quarterly
basis on each activity listed in the SWP.
Need and Proposed Use of the
Information: The information collected
by the SWP form standardizes and
streamlines the data used by HRSA in
reviewing applications and monitoring
awardees. The form asks applicants to
provide a description of the activities or
steps the applicant will take to achieve
E:\FR\FM\11DEN1.SGM
11DEN1
80122
Federal Register / Vol. 85, No. 239 / Friday, December 11, 2020 / Notices
each of the objectives proposed during
the entire period of performance. The
current standardized format and data
submission by applicants increases
efficiency in reviewing, awarding, and
monitoring each project.
This revision to the clearance package
will incorporate an additional form for
participants, the QPU. The QPU is
completed via HRSA’s Electronic
Handbook and prompts recipients to
report on progress of activities that were
submitted using the SWP in the original
application. The QPU will automatically
populate activities from the recipient’s
SWP form on a quarterly basis. For each
activity listed in the submitted SWP for
any particular quarter within the project
period, recipients will select and submit
a single selection response for each
activity status from a pull-down menu
with five options: Activity is on
Schedule, Activity is Complete, Timing
is off track, Activity will be missed if
action is not taken, and Activity cannot
be achieved. Information provided will
be utilized by the program staff to
regularly assess overall progress of
program requirements and analyze data
in order to monitor award recipient
compliance and track progress against
proposed targets and goals. Information
gathered will allow for an improved and
more efficient method for identifying
whether projects’ goals are being
advanced or achieved, as set forth in 45
CFR 75.342. Program staff will also use
information provided over the period of
performance to see emerging trends and
to assess whether an award recipient
requires technical assistance to address
challenges that the award recipient may
be experiencing with the
implementation of the project. Seeking
OMB approval comports with the
regulatory requirement imposed by 45
CFR 75.206(a), Paperwork clearances.
Likely Respondents: Recipients of
HRSA Bureau of Health Workforce’s
research and training grants and
cooperative agreements.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install, and utilize
technology and systems for the purpose
of collecting, validating, and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this ICR are
summarized in the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Average burden per response (in
hours)
Number of respondents
Number of responses per
respondent
Standardized Work Plan (SWP) ..........................................
Quarterly Progress Update (QPU) Form .............................
1,000
1,000
1
4
1,000
4,000
1.00
.10
1,000
400
Total ..............................................................................
1 1,000
¥
5,000
¥
1,400
Form name
Total responses
Total annual
burden hours
1 The
1,000 Standardized Work Plan (SWP) respondents reflects the number of new grant applications submitted annually. The 1,000 Quarterly Progress Update (QPU) respondents reflects the current volume of funded, active grants.
HRSA specifically requests comments
on (1) the necessity and utility of the
proposed information collection for the
proper performance of the agency’s
functions, (2) the accuracy of the
estimated burden, (3) ways to enhance
the quality, utility, and clarity of the
information to be collected, and (4) the
use of automated collection techniques
or other forms of information
technology to minimize the information
collection burden.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2020–27318 Filed 12–10–20; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
jbell on DSKJLSW7X2PROD with NOTICES
Office of the Secretary
Findings of Research Misconduct
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
Findings of research
misconduct have been made against
SUMMARY:
VerDate Sep<11>2014
00:32 Dec 11, 2020
Jkt 253001
Charles A. Downs (Respondent), former
Adjunct Assistant Professor, Arizona
Health Sciences Center, University of
Arizona (UA). Respondent engaged in
research misconduct in research
supported by U.S. Public Health Service
(PHS) funds, specifically National
Center for Advancing Translation
Sciences (NCATS), National Institutes of
Health (NIH), grant UL1 TR000454. The
administrative actions, including
supervision for a period of four (4)
years, were implemented beginning on
November 18, 2020, and are detailed
below.
FOR FURTHER INFORMATION CONTACT:
Elisabeth A. Handley, Director, Office of
Research Integrity, 1101 Wootton
Parkway, Suite 240, Rockville, MD
20852, (240) 453–8200.
SUPPLEMENTARY INFORMATION: Notice is
hereby given that the Office of Research
Integrity (ORI) has taken final action in
the following case:
Charles A. Downs, University of
Arizona: Based on the report of an
investigation conducted by UA and
analysis conducted by ORI in its
oversight review, ORI found that
PO 00000
Frm 00133
Fmt 4703
Sfmt 4703
Respondent, former Adjunct Assistant
Professor, Arizona Health Sciences
Center, UA, engaged in research
misconduct in research supported by
PHS funds, specifically NCATS, NIH,
grant UL1 TR000454.
Respondent neither admits nor denies
ORI’s findings of research misconduct.
Respondent and ORI desire to close this
matter without further expense of time
and other resources and thus have
entered into a Voluntary Settlement
Agreement (Agreement).
ORI found that Respondent engaged
in research misconduct by intentionally,
knowingly, or recklessly falsifying and/
or fabricating data included in the
following six (6) grant applications
submitted for PHS funds:
• R01 NR016242–01, submitted to the
National Institute of Nursing Research
(NINR), NIH
• R01 NR016242–01A1, submitted to
NINR, NIH
• R01 NR016957–01, submitted to
NINR, NIH
• R01 NR016957–01A1, submitted to
NINR, NIH
E:\FR\FM\11DEN1.SGM
11DEN1
]]>Agencies
[Federal Register Volume 85, Number 239 (Friday, December 11, 2020)]
[Notices]
[Pages 80121-80122]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-27318]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Public Comment Request Information Collection Request Title:
Standardized Work Plan Form for Use with Applications to the Bureau of
Health Workforce Research and Training Grants and Cooperative
Agreements OMB No. 0906-0049--Revision
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the Paperwork Reduction Act of 1995, HRSA
has submitted an Information Collection Request (ICR) to the Office of
Management and Budget (OMB) for review and approval. Comments submitted
during the first public review of this ICR have been provided to OMB.
OMB will accept further comments from the public during the review and
approval period. OMB may act on HRSA's ICR only after the 30 day
comment period for this notice has closed.
DATES: Comments on this ICR should be received no later than January
11, 2021.
ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular
information collection by selecting ``Currently under Review--Open for
Public Comments'' or by using the search function.
A 60-day Federal Register Notice was published in the Federal
Register on September 15, 2020, Vol. 85, No. 179, pp.57221-57222. There
were no public comments.
FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance
requests submitted to OMB for review, email Lisa Wright-Solomon, the
HRSA Information Collection Clearance Officer at [email protected] or
call (301) 443-1984.
SUPPLEMENTARY INFORMATION: Information Collection Request Title:
Standardized Work Plan Form for Use with Applications to the Bureau of
Health Workforce Research and Training Grants and Cooperative
Agreements, OMB No. 0906-0049--Revision
Abstract: HRSA's Bureau of Health Workforce requires applicants of
training and research grants and cooperative agreements to submit work
plans via the Standardized Work Plan (SWP) form.
The information in the SWP describes the timeframes and progress
required during the grant period of performance to address each of the
needs detailed in the Purpose and Need section of the application, as
required in the Notice of Funding Opportunity announcement.
Applicants use the SWP form when they submit their proposals, and
award recipients and Project Officers use the SWP information to assist
in monitoring progress once HRSA makes the awards. HRSA proposes a
revision to the SWP to include a Quarterly Progress Update (QPU) for
award recipients to provide information to HRSA on a quarterly basis on
each activity listed in the SWP.
Need and Proposed Use of the Information: The information collected
by the SWP form standardizes and streamlines the data used by HRSA in
reviewing applications and monitoring awardees. The form asks
applicants to provide a description of the activities or steps the
applicant will take to achieve
[[Page 80122]]
each of the objectives proposed during the entire period of
performance. The current standardized format and data submission by
applicants increases efficiency in reviewing, awarding, and monitoring
each project.
This revision to the clearance package will incorporate an
additional form for participants, the QPU. The QPU is completed via
HRSA's Electronic Handbook and prompts recipients to report on progress
of activities that were submitted using the SWP in the original
application. The QPU will automatically populate activities from the
recipient's SWP form on a quarterly basis. For each activity listed in
the submitted SWP for any particular quarter within the project period,
recipients will select and submit a single selection response for each
activity status from a pull-down menu with five options: Activity is on
Schedule, Activity is Complete, Timing is off track, Activity will be
missed if action is not taken, and Activity cannot be achieved.
Information provided will be utilized by the program staff to regularly
assess overall progress of program requirements and analyze data in
order to monitor award recipient compliance and track progress against
proposed targets and goals. Information gathered will allow for an
improved and more efficient method for identifying whether projects'
goals are being advanced or achieved, as set forth in 45 CFR 75.342.
Program staff will also use information provided over the period of
performance to see emerging trends and to assess whether an award
recipient requires technical assistance to address challenges that the
award recipient may be experiencing with the implementation of the
project. Seeking OMB approval comports with the regulatory requirement
imposed by 45 CFR 75.206(a), Paperwork clearances.
Likely Respondents: Recipients of HRSA Bureau of Health Workforce's
research and training grants and cooperative agreements.
Burden Statement: Burden in this context means the time expended by
persons to generate, maintain, retain, disclose or provide the
information requested. This includes the time needed to review
instructions; to develop, acquire, install, and utilize technology and
systems for the purpose of collecting, validating, and verifying
information, processing and maintaining information, and disclosing and
providing information; to train personnel and to be able to respond to
a collection of information; to search data sources; to complete and
review the collection of information; and to transmit or otherwise
disclose the information. The total annual burden hours estimated for
this ICR are summarized in the table below.
Total Estimated Annualized Burden--Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Form name Number of responses per Total per response Total annual
respondents respondent responses (in hours) burden hours
----------------------------------------------------------------------------------------------------------------
Standardized Work Plan (SWP).... 1,000 1 1,000 1.00 1,000
Quarterly Progress Update (QPU) 1,000 4 4,000 .10 400
Form...........................
-------------------------------------------------------------------------------
Total....................... \1\ 1,000 - 5,000 - 1,400
----------------------------------------------------------------------------------------------------------------
\1\ The 1,000 Standardized Work Plan (SWP) respondents reflects the number of new grant applications submitted
annually. The 1,000 Quarterly Progress Update (QPU) respondents reflects the current volume of funded, active
grants.
HRSA specifically requests comments on (1) the necessity and
utility of the proposed information collection for the proper
performance of the agency's functions, (2) the accuracy of the
estimated burden, (3) ways to enhance the quality, utility, and clarity
of the information to be collected, and (4) the use of automated
collection techniques or other forms of information technology to
minimize the information collection burden.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2020-27318 Filed 12-10-20; 8:45 am]
BILLING CODE 4165-15-P
