Proposed Collection; 60-Day Comment Request; Evaluation of Office of Acquisitions System (OASYS) and FFRDC Contract Administration System (FCAS) Vendor Portals National Cancer Institute (NCI), 27093-27094 [2021-10476]
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khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 86, No. 95 / Wednesday, May 19, 2021 / Notices
and 120 mg, and CALAN (verapamil
hydrochloride) tablets, 40 mg, 80 mg,
120 mg, and 160 mg, were withdrawn
from sale for reasons of safety or
effectiveness.
After considering the citizen petitions
and reviewing Agency records and
based on the information we have at this
time, FDA has determined under
§ 314.161 that ISOPTIN (verapamil
hydrochloride) tablets, 40 mg, 80 mg,
and 120 mg, and CALAN (verapamil
hydrochloride) tablets, 40 mg, 80 mg,
120 mg, and 160 mg, were not
withdrawn for reasons of safety or
effectiveness. The petitioner has
identified no data or other information
suggesting that ISOPTIN (verapamil
hydrochloride) tablets, 40 mg, 80 mg,
and 120 mg, and CALAN (verapamil
hydrochloride) tablets, 40 mg, 80 mg,
120 mg, and 160 mg, were withdrawn
for reasons of safety or effectiveness. We
have carefully reviewed our files for
records concerning the withdrawal of
ISOPTIN (verapamil hydrochloride)
tablets, 40 mg, 80 mg, and 120 mg, and
CALAN (verapamil hydrochloride)
tablets, 40 mg, 80 mg, 120 mg, and 160
mg, from sale. We have also
independently evaluated relevant
literature and data for possible
postmarketing adverse events. We have
reviewed the available evidence and
determined that these drug products
were not withdrawn from sale for
reasons of safety or effectiveness.
Accordingly, the Agency will
continue to list ISOPTIN (verapamil
hydrochloride) tablets, 40 mg, 80 mg,
and 120 mg, and CALAN (verapamil
hydrochloride) tablets, 40 mg, 80 mg,
120 mg, and 160 mg, in the
‘‘Discontinued Drug Product List’’
section of the Orange Book. The
‘‘Discontinued Drug Product List’’
delineates, among other items, drug
products that have been discontinued
from marketing for reasons other than
safety or effectiveness. ANDAs that refer
to ISOPTIN (verapamil hydrochloride)
tablets, 40 mg, 80 mg, and 120 mg, and
CALAN (verapamil hydrochloride)
tablets, 40 mg, 80 mg, 120 mg, and 160
mg, may be approved by the Agency as
long as they meet all other legal and
regulatory requirements for the approval
of ANDAs. If FDA determines that
labeling for these drug products should
be revised to meet current standards, the
Agency will advise ANDA applicants to
submit such labeling.
Dated: May 7, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–10552 Filed 5–18–21; 8:45 am]
BILLING CODE 4164–01–P
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16:43 May 18, 2021
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment
Request; Evaluation of Office of
Acquisitions System (OASYS) and
FFRDC Contract Administration
System (FCAS) Vendor Portals
National Cancer Institute (NCI)
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
In compliance with the
requirement of the Paperwork
Reduction Act of 1995 to provide
opportunity for public comment on
proposed data collection projects, the
National Cancer Institute (NCI) will
publish periodic summaries of propose
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
DATES: Comments regarding this
information collection are best assured
of having their full effect if received
within 60 days of the date of this
publication.
FOR FURTHER INFORMATION CONTACT: To
obtain a copy of the data collection
plans and instruments, submit
comments in writing, or request more
information on the proposed project,
contact: Marla Jacobson, 9609 Medical
Center Drive, MSC 9742, Rockville, MD
20850 or call non-toll-free number 240–
276–5267 or Email your request,
including your address to:
marla.jacobson@nih.gov. Formal
requests for additional plans and
instruments must be requested in
writing.
SUPPLEMENTARY INFORMATION: Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 requires: Written
comments and/or suggestions from the
public and affected agencies are invited
to address one or more of the following
points: (1) Whether the proposed
collection of information is necessary
for the proper performance of the
function of the agency, including
whether the information will have
practical utility; (2) The accuracy of the
agency’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 minimizes
the burden of the collection of
information on those who are to
respond, including the use of
appropriate automated, electronic,
SUMMARY:
PO 00000
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27093
mechanical, or other technological
collection techniques or other forms of
information technology.
Proposed Collection Title: Evaluation
of Office of Acquisitions System
(OASYS) and FFRDC Contract
Administration System (FCAS) Vendor
Portals National Cancer Institute (NCI),
0925–NEW, Expiration Date XX/XX/
XXXX, National Cancer Institute (NCI),
National Institutes of Health (NIH).
Need and Use of Information
Collection: The National Cancer
Institute (NCI) Office of Acquisitions
(OA), located within the Office of the
Director (OD) in the Office of
Management (OM) at the National
Cancer Institute (NCI), awards and
administers contracts and simplified
acquisitions in support of the Institute’s
mission to prevent, diagnose and treat
cancer. During the acquisition process,
the OA ensures that customer service is
paramount, and communications are
open and continuous. Currently
requests and correspondence are sent to
and received from vendors through
email with the exception of the FFRDC
Contractor who submits through the
FCAS Vendor Portal which is in
production. To streamline processes,
increase transparency and gain
efficiencies, the OA developed OASYS
and FCAS vendor portals to replace
processes that are handled through
email (future OASYS Vendor Portal
Users) and were (current FCAS Vendor
Portal Users) to individual OA
recipients. The FCAS Vendor Portal and
in the future, the OASYS Vendor Portal
will serve as a one-stop shop for
transmission of requests, reports,
deliverables and other correspondence
due on numerous research and
development, in support of R&D
contracts as well as those contract
vehicles awarded using various Federal
Acquisition Procedures including but
not limited to FAR Part 8, Required
Sources of Supplies and Services, FAR
Part 13, Simplified Acquisition
Procedures, and FAR Part 12,
Acquisition of Commercial Items. These
reports and deliverables cover a wide
variety of topics in the areas of cancer
research including prevention,
detection, diagnosis, and control.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
12,120.
E:\FR\FM\19MYN1.SGM
19MYN1
27094
Federal Register / Vol. 86, No. 95 / Wednesday, May 19, 2021 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent
Average time
per response
(in hours)
Total annual
burden hours
Type of respondent
Registration—OASYS ...................
Registration—FCAS ......................
Survey—OASYS ...........................
Survey—FCAS ..............................
Data Field Information—OASYS ..
Data Field Information—FCAS .....
Corporations .................................
Corporations .................................
Individuals ....................................
Individuals ....................................
Individuals ....................................
Individuals ....................................
400
400
120
120
1,249
1,249
1
1
1
1
48
48
8/60
8/60
6/60
6/60
6/60
6/60
53
53
12
12
5,995
5,995
Totals .....................................
.......................................................
3,538
120,944
..........................
12,120
Dated: May 13, 2021.
Diane Kreinbrink,
Project Clearance Liaison, National Cancer
Institute, National Institutes of Health.
[FR Doc. 2021–10476 Filed 5–18–21; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
khammond on DSKJM1Z7X2PROD with NOTICES
Number of
respondents
Form name
Name of Committee: National Cancer
Institute Special Emphasis Panel; SEP–7: NCI
Clinical and Translational Cancer Research.
Date: June 17–18, 2021.
Time: 9:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Cancer Institute at Shady
Grove, 9609 Medical Center Drive, Room
7W104, Rockville, Maryland 20850
(Telephone Conference Call).
Contact Person: Robert F. Gahl, Ph.D.,
Scientific Review Officer, Special Review
Branch, Division of Extramural Activities,
National Cancer Institute, NIH, 9609 Medical
Center Drive, Room 7W104, Rockville,
Maryland 20850, 240–276–7286, robert.gahl@
nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel; SEP–1 NCI
Clinical and Translational Cancer Research.
Date: June 23, 2021.
Time: 12:00 p.m. to 6:00 p.m.
VerDate Sep<11>2014
16:43 May 18, 2021
Jkt 253001
Agenda: To review and evaluate grant
applications.
Place: National Cancer Institute at Shady
Grove, 9609 Medical Center Drive, Room
7W244, Rockville, Maryland 20850
(Telephone Conference Call).
Contact Person: John Paul Cairns, Ph.D.,
Scientific Review Officer, Research Programs
Review Branch, Division of Extramural
Activities, National Cancer Institute, NIH,
9609 Medical Center Drive, Room 7W244,
Rockville, Maryland 20850, 240–276–5415,
paul.cairns@nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel; NCI U01
Review: Integrating Biospecimen Science
Approaches into Clinical Assay.
Date: June 29, 2021.
Time: 11:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Cancer Institute at Shady
Grove, 9609 Medical Center Drive, Room
7W116, Rockville, Maryland 20850
(Telephone Conference Call).
Contact Person: Klaus B. Piontek, Ph.D.,
Scientific Review Officer, Research Programs
Review Branch, Division of Extramural
Activities, National Cancer Institute, NIH,
9609 Medical Center Drive, Room 7W116,
Rockville, Maryland 20850, 240–276–5413,
klaus.piontek@nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel; Aging,
Cancer Initiating Cells, and Cancer
Progression (U01).
Date: June 29, 2021.
Time: 12:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Cancer Institute at Shady
Grove, 9609 Medical Center Drive, Room
7W606, Rockville, Maryland 20850
(Telephone Conference Call).
Contact Person: Timothy C. Meeker, M.D.,
Scientific Review Officer, Special Review
Branch, Division of Extramural Activities,
National Cancer Institute, NIH, 9609 Medical
Center Drive, Room 7W606, Rockville,
Maryland 20850, 240–276–6464, meekert@
mail.nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel; SEP–10:
NCI Clinical and Translational Cancer
Research.
Date: July 8, 2021.
Time: 10:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
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Place: National Cancer Institute at Shady
Grove, 9609 Medical Center Drive, Room
7W634, Rockville, Maryland 20850
(Telephone Conference Call).
Contact Person: Michael E. Lindquist,
Ph.D., Scientific Review Officer, Research
Programs Review Branch, Division of
Extramural Activities, National Cancer
Institute, NIH, 9609 Medical Center Drive,
Room 7W634, Rockville, Maryland 20850,
240–276–5735, mike.lindquist@nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel; New
Cohorts to Assess Environmental Exposures
and Cancer Risk and Coordinating Center
(UG3/UH3 and U24).
Date: July 13, 2021.
Time: 11:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Cancer Institute at Shady
Grove, 9609 Medical Center Drive, Room
7W624, Rockville, Maryland 20850
(Telephone Conference Call).
Contact Person: Timothy C. Meeker, M.D.,
Scientific Review Officer, Special Review
Branch, Division of Extramural Activities,
National Cancer Institute, NIH, 9609 Medical
Center Drive, Room 7W624, Rockville,
Maryland 20850, 240–276–6464, meekert@
mail.nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel; SEP–3 NCI
Clinical and Translational Cancer Research.
Date: July 20, 2021.
Time: 10:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Cancer Institute at Shady
Grove, 9609 Medical Center Drive, Room
7W120, Rockville, Maryland 20850
(Telephone Conference Call).
Contact Person: Majed M. Hamawy, Ph.D.,
Scientific Review Officer, Research Programs
Review Branch, Division of Extramural
Activities, National Cancer Institute, NIH,
9609 Medical Center Drive, Room 7W120,
Rockville, Maryland 20850, 240–276–6457,
mh101v@nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel; R13
Conference Grant Review.
Date: July 27, 2021.
Time: 11:00 a.m. to 4:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Cancer Institute at Shady
Grove, 9609 Medical Center Drive, Room
E:\FR\FM\19MYN1.SGM
19MYN1
]]>Agencies
[Federal Register Volume 86, Number 95 (Wednesday, May 19, 2021)]
[Notices]
[Pages 27093-27094]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-10476]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment Request; Evaluation of Office
of Acquisitions System (OASYS) and FFRDC Contract Administration System
(FCAS) Vendor Portals National Cancer Institute (NCI)
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement of the Paperwork Reduction
Act of 1995 to provide opportunity for public comment on proposed data
collection projects, the National Cancer Institute (NCI) will publish
periodic summaries of propose projects to be submitted to the Office of
Management and Budget (OMB) for review and approval.
DATES: Comments regarding this information collection are best assured
of having their full effect if received within 60 days of the date of
this publication.
FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data
collection plans and instruments, submit comments in writing, or
request more information on the proposed project, contact: Marla
Jacobson, 9609 Medical Center Drive, MSC 9742, Rockville, MD 20850 or
call non-toll-free number 240-276-5267 or Email your request, including
your address to: [email protected]. Formal requests for additional
plans and instruments must be requested in writing.
SUPPLEMENTARY INFORMATION: Section 3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 requires: Written comments and/or suggestions
from the public and affected agencies are invited to address one or
more of the following points: (1) Whether the proposed collection of
information is necessary for the proper performance of the function of
the agency, including whether the information will have practical
utility; (2) The accuracy of the agency'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 minimizes the burden of the collection of information on those who
are to respond, including the use of appropriate automated, electronic,
mechanical, or other technological collection techniques or other forms
of information technology.
Proposed Collection Title: Evaluation of Office of Acquisitions
System (OASYS) and FFRDC Contract Administration System (FCAS) Vendor
Portals National Cancer Institute (NCI), 0925-NEW, Expiration Date XX/
XX/XXXX, National Cancer Institute (NCI), National Institutes of Health
(NIH).
Need and Use of Information Collection: The National Cancer
Institute (NCI) Office of Acquisitions (OA), located within the Office
of the Director (OD) in the Office of Management (OM) at the National
Cancer Institute (NCI), awards and administers contracts and simplified
acquisitions in support of the Institute's mission to prevent, diagnose
and treat cancer. During the acquisition process, the OA ensures that
customer service is paramount, and communications are open and
continuous. Currently requests and correspondence are sent to and
received from vendors through email with the exception of the FFRDC
Contractor who submits through the FCAS Vendor Portal which is in
production. To streamline processes, increase transparency and gain
efficiencies, the OA developed OASYS and FCAS vendor portals to replace
processes that are handled through email (future OASYS Vendor Portal
Users) and were (current FCAS Vendor Portal Users) to individual OA
recipients. The FCAS Vendor Portal and in the future, the OASYS Vendor
Portal will serve as a one-stop shop for transmission of requests,
reports, deliverables and other correspondence due on numerous research
and development, in support of R&D contracts as well as those contract
vehicles awarded using various Federal Acquisition Procedures including
but not limited to FAR Part 8, Required Sources of Supplies and
Services, FAR Part 13, Simplified Acquisition Procedures, and FAR Part
12, Acquisition of Commercial Items. These reports and deliverables
cover a wide variety of topics in the areas of cancer research
including prevention, detection, diagnosis, and control.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 12,120.
[[Page 27094]]
Estimated Annualized Burden Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average time
Form name Type of respondent Number of responses per per response Total annual
respondents respondent (in hours) burden hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Registration--OASYS............................. Corporations...................... 400 1 8/60 53
Registration--FCAS.............................. Corporations...................... 400 1 8/60 53
Survey--OASYS................................... Individuals....................... 120 1 6/60 12
Survey--FCAS.................................... Individuals....................... 120 1 6/60 12
Data Field Information--OASYS................... Individuals....................... 1,249 48 6/60 5,995
Data Field Information--FCAS.................... Individuals....................... 1,249 48 6/60 5,995
-------------------------------------------------------------------
Totals...................................... .................................. 3,538 120,944 ............... 12,120
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dated: May 13, 2021.
Diane Kreinbrink,
Project Clearance Liaison, National Cancer Institute, National
Institutes of Health.
[FR Doc. 2021-10476 Filed 5-18-21; 8:45 am]
BILLING CODE 4140-01-P
