Agency Information Collection Activities; Proposed Collection; Comment Request; The National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR) Grantee Annual Performance Reporting (APR) and Final Report Forms, 46125-46126 [2020-16584]
Download as PDF
<![CDATA[
Federal Register / Vol. 85, No. 148 / Friday, July 31, 2020 / Notices
Dated: July 27, 2020.
Mary Lazare,
Principal Deputy Administrator.
[FR Doc. 2020–16583 Filed 7–30–20; 8:45 am]
BILLING CODE 4154–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Community Living
[OMB #0985–0050]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; The National
Institute on Disability, Independent
Living, and Rehabilitation Research
(NIDILRR) Grantee Annual
Performance Reporting (APR) and
Final Report Forms
Administration for Community
Living, HHS.
ACTION: Notice.
AGENCY:
The Administration for
Community Living (ACL) is announcing
an opportunity for the public to
comment on the proposed collection of
information listed above. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal agencies are required to
publish a 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 the
Proposed Extension without Change and
solicits comments on the information
collection requirements related to the
NIDILRR Grantee Annual Performance
Reporting (APR) and Final Report
Forms.
SUMMARY:
Comments on the collection of
information must be submitted
electronically by 11:59 p.m. (EST) or
postmarked by September 29, 2020.
ADDRESSES: Submit electronic
comments on the collection of
information to: Mary Darnell
Mary.Darnell@acl.hhs.gov. Submit
written comments on the collection of
information to Administration for
Community Living, Washington, DC
20201, Attention: Mary Darnell.
FOR FURTHER INFORMATION CONTACT:
Mary Darnell, Administration for
Community Living, 202–795–7337.
DATES:
VerDate Sep<11>2014
18:33 Jul 30, 2020
Jkt 250001
Under the
PRA (44 U.S.C. 3501–3520), 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 the PRA and includes agency
requests or requirements that members
of the public submit reports, keep
records, or provide information to a
third party. 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,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, ACL is publishing a notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, ACL invites
comments on our burden estimates or
any other aspect of this collection of
information, including:
(1) Whether the proposed collection
of information is necessary for the
proper performance of ACL’s functions,
including whether the information will
have practical utility;
(2) the accuracy of ACL’s estimate of
the burden of the proposed collection of
information, including the validity of
the methodology and assumptions used
to determine burden estimates;
(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.
The National Institute on Disability,
Independent Living, and Rehabilitation
Research (NIDILRR) Grantee Annual
Performance Reporting (APR) and Final
Report Forms collect data from all
NIDILRR Grantees via a web-based
reporting system and addresses specific
HHS regulations that shall be met by
applicants and grantees. HHS
regulations that apply to NIDILRR Grant
programs include Part 75 of the Uniform
Administrative Requirements, Cost
Principles and Audit requirements for
HHS Awards. Specifically, § 75.342
which requires grantees to submit an
annual performance report or, for the
last year of a project, a final report that
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
46125
evaluates: (a) The grantee’s progress in
achieving the objectives in its approved
application, (b) the effectiveness of the
project in meeting the purposes of the
program, and (c) the results of research
and related activities.
Additionally, GPRA requires all
federal agencies to implement
performance measurement systems that
include: (1) A five-year strategic plan,
(2) an annual performance plan, and (3)
an annual performance report.
Currently, NIDILRR has met these
requirements and has established
performance indicators to meet the
reporting requirements. The NIDILRR
APR System currently includes
reporting forms for all 10 of NIDILRR’s
grant programs.
Reporting forms for all 10 programs
are web-based. Data collected through
these forms (a) Facilitate program
planning and management; (b) respond
to ACL/HHS Grants Policy
Administration Manual (GPAM)
requirements and (c) respond to the
reporting requirements of the
Government Performance and Results
Act (GPRA) of 1993.
NIDILRR uses the information
gathered annually from these data
collection efforts to provide Congress
with the information mandated in
GPRA, provide OMB information
required for assessment of performance
on GPRA indicators, and support its
evaluation activities. Data collected
from the 10 grant programs will provide
a national description of the research
activities of approximately 255 NIDILRR
grantees. NIDILRR’s GPRA plan must
collect information to meet the
following mandates: (a) Implementation
of a comprehensive plan that includes
goals and objectives; (b) measurement of
the program’s progress in meeting its
objectives; and (c) submission of an
annual report on program performance,
including plans for program
improvement, as appropriate. The data
collection system addresses nearly all of
the agency’s GPRA indicators, either
directly or by providing information for
the agency’s other review processes.
The proposed data collection tools
may be found on the ACL website for
review at https://www.acl.gov/aboutacl/public-input.
Estimated Program Burden
ACL estimates the burden associated
with this collection of information as
follows:
E:\FR\FM\31JYN1.SGM
31JYN1
46126
Federal Register / Vol. 85, No. 148 / Friday, July 31, 2020 / Notices
Number of
responses
per
respondent
Number of
respondents
Average
burden hours
per
response
Total burden
hours
New Grantees ..................................................................................................
Continuations of Major Programs ....................................................................
Other Continuations .........................................................................................
75
124
76
1
1
1
52
22
10
3.900
2,728
760
Total ..........................................................................................................
275
........................
........................
7,388
Dated: July 27, 2020.
Mary Lazare,
Principal Deputy Administrator.
[FR Doc. 2020–16584 Filed 7–30–20; 8:45 am]
BILLING CODE 4154–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–3240]
List of Bulk Drug Substances for
Which There is a Clinical Need Under
Section 503B of the Federal Food,
Drug, and Cosmetic Act
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
developing a list of bulk drug
substances (active pharmaceutical
ingredients) for which there is a clinical
need (the 503B Bulks List). Drug
products that outsourcing facilities
compound using bulk drug substances
on the 503B Bulks List can qualify for
certain exemptions from the Federal
Food, Drug, and Cosmetic Act (FD&C
Act) provided certain conditions are
met. This notice identifies four bulk
drug substances that FDA has
considered and proposes to include on
the 503B Bulks List:
Diphenylcyclopropenone (DPCP),
glycolic acid, squaric acid dibutyl ester
(SADBE), and trichloroacetic acid
(TCA). This notice also identifies 19
bulk drug substances that FDA has
considered and proposes not to include
on the list: Diazepam, dobutamine
hydrochloride (HCl), dopamine HCl,
edetate calcium disodium, folic acid,
glycopyrrolate, hydroxyzine HCl,
ketorolac tromethamine, labetalol HCl,
mannitol, metoclopramide HCl,
moxifloxacin HCl, nalbuphine HCl,
polidocanol, potassium acetate,
procainamide HCl, sodium
nitroprusside, sodium thiosulfate, and
verapamil HCl. Additional bulk drug
substances nominated by the public for
inclusion on this list are currently under
SUMMARY:
VerDate Sep<11>2014
18:33 Jul 30, 2020
Jkt 250001
consideration and may be the subject of
future notices.
DATES: Submit either electronic or
written comments on the notice by
September 29, 2020.
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 29,
2020. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of September 29, 2020.
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:
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
• 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–
2018–N–3240 for ‘‘List of Bulk Drug
Substances for Which There is a Clinical
Need Under Section 503B of the Federal
Food, Drug, and Cosmetic Act.’’
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
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
E:\FR\FM\31JYN1.SGM
31JYN1
]]>Agencies
[Federal Register Volume 85, Number 148 (Friday, July 31, 2020)]
[Notices]
[Pages 46125-46126]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-16584]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Community Living
[OMB #0985-0050]
Agency Information Collection Activities; Proposed Collection;
Comment Request; The National Institute on Disability, Independent
Living, and Rehabilitation Research (NIDILRR) Grantee Annual
Performance Reporting (APR) and Final Report Forms
AGENCY: Administration for Community Living, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Administration for Community Living (ACL) is announcing an
opportunity for the public to comment on the proposed collection of
information listed above. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish a 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 the Proposed Extension without
Change and solicits comments on the information collection requirements
related to the NIDILRR Grantee Annual Performance Reporting (APR) and
Final Report Forms.
DATES: Comments on the collection of information must be submitted
electronically by 11:59 p.m. (EST) or postmarked by September 29, 2020.
ADDRESSES: Submit electronic comments on the collection of information
to: Mary Darnell [email protected]. Submit written comments on
the collection of information to Administration for Community Living,
Washington, DC 20201, Attention: Mary Darnell.
FOR FURTHER INFORMATION CONTACT: Mary Darnell, Administration for
Community Living, 202-795-7337.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), 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 the PRA and includes agency
requests or requirements that members of the public submit reports,
keep records, or provide information to a third party. 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, including each proposed extension of an existing
collection of information, before submitting the collection to OMB for
approval. To comply with this requirement, ACL is publishing a notice
of the proposed collection of information set forth in this document.
With respect to the following collection of information, ACL
invites comments on our burden estimates or any other aspect of this
collection of information, including:
(1) Whether the proposed collection of information is necessary for
the proper performance of ACL's functions, including whether the
information will have practical utility;
(2) the accuracy of ACL's estimate of the burden of the proposed
collection of information, including the validity of the methodology
and assumptions used to determine burden estimates;
(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.
The National Institute on Disability, Independent Living, and
Rehabilitation Research (NIDILRR) Grantee Annual Performance Reporting
(APR) and Final Report Forms collect data from all NIDILRR Grantees via
a web-based reporting system and addresses specific HHS regulations
that shall be met by applicants and grantees. HHS regulations that
apply to NIDILRR Grant programs include Part 75 of the Uniform
Administrative Requirements, Cost Principles and Audit requirements for
HHS Awards. Specifically, Sec. 75.342 which requires grantees to
submit an annual performance report or, for the last year of a project,
a final report that evaluates: (a) The grantee's progress in achieving
the objectives in its approved application, (b) the effectiveness of
the project in meeting the purposes of the program, and (c) the results
of research and related activities.
Additionally, GPRA requires all federal agencies to implement
performance measurement systems that include: (1) A five-year strategic
plan, (2) an annual performance plan, and (3) an annual performance
report. Currently, NIDILRR has met these requirements and has
established performance indicators to meet the reporting requirements.
The NIDILRR APR System currently includes reporting forms for all 10 of
NIDILRR's grant programs.
Reporting forms for all 10 programs are web-based. Data collected
through these forms (a) Facilitate program planning and management; (b)
respond to ACL/HHS Grants Policy Administration Manual (GPAM)
requirements and (c) respond to the reporting requirements of the
Government Performance and Results Act (GPRA) of 1993.
NIDILRR uses the information gathered annually from these data
collection efforts to provide Congress with the information mandated in
GPRA, provide OMB information required for assessment of performance on
GPRA indicators, and support its evaluation activities. Data collected
from the 10 grant programs will provide a national description of the
research activities of approximately 255 NIDILRR grantees. NIDILRR's
GPRA plan must collect information to meet the following mandates: (a)
Implementation of a comprehensive plan that includes goals and
objectives; (b) measurement of the program's progress in meeting its
objectives; and (c) submission of an annual report on program
performance, including plans for program improvement, as appropriate.
The data collection system addresses nearly all of the agency's GPRA
indicators, either directly or by providing information for the
agency's other review processes.
The proposed data collection tools may be found on the ACL website
for review at https://www.acl.gov/about-acl/public-input.
Estimated Program Burden
ACL estimates the burden associated with this collection of
information as follows:
[[Page 46126]]
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Number of responses per hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
New Grantees.................................... 75 1 52 3.900
Continuations of Major Programs................. 124 1 22 2,728
Other Continuations............................. 76 1 10 760
---------------------------------------------------------------
Total....................................... 275 .............. .............. 7,388
----------------------------------------------------------------------------------------------------------------
Dated: July 27, 2020.
Mary Lazare,
Principal Deputy Administrator.
[FR Doc. 2020-16584 Filed 7-30-20; 8:45 am]
BILLING CODE 4154-01-P
