Agency Information Collection Request; 30-Day Public Comment Request, 51902-51903 [2021-20183]
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51902
Federal Register / Vol. 86, No. 178 / Friday, September 17, 2021 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN
Number of
respondents
FDA form; survey
Number of
responses
per
respondent
Average
burden per
response
(hours)
Total annual
responses
Biosimilar User Fee Cover Sheet (Form FDA 3792) ..........
60
1
60
Annual Survey .....................................................................
Request for discontinuation from BPD program .................
Request to move products to discontinued section of the
Biosimilar List.
Biosimilar product applications (351(k)(2)(A)) .....................
Interchangeable product applications (351(k)(2)(B) ............
Patent infringement notifications .........................................
Formal Meetings GFI Recommendations ...........................
60
10
5
1
1
1
60
10
5
4
2
4
69
2.25
1
2.25
2.30
Total ..............................................................................
........................
........................
In anticipation of increased
participation in the BPD program, we
have increased our estimate to reflect an
increase in the number of respondents
since last OMB review. We have also
made adjustments to reflect information
collection consolidated from OMB
control number 0910–0719. We invite
comment on our estimates and
assumptions.
Dated: September 9, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–20060 Filed 9–16–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Comments on the ICR must be
received on or before October 18, 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 30-day Review—Open
for Public Comments’’ or by using the
search function.
FOR FURTHER INFORMATION CONTACT:
Sherrette Funn, Sherrette.Funn@hhs.gov
or (202) 795–7714. When submitting
comments or requesting information,
please include the document identifier
0990–0313–30D and project title for
reference.
DATES:
Interested
persons are invited to send comments
regarding this burden estimate or any
other aspect of this collection of
information, including any of the
following subjects: (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.
Title of the Collection: 2021 National
Blood Collection & Utilization Survey.
SUPPLEMENTARY INFORMATION:
[Document Identifier: OS–0990–0313]
Agency Information Collection
Request; 30-Day Public Comment
Request
Office of the Secretary, Health
and Human Services (HHS).
ACTION: Notice.
AGENCY:
In compliance with the
requirement of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, is publishing the
following summary of a proposed
collection for public comment.
SUMMARY:
Total hours
9
2
9
159
0.5 (30 minutes).
1 .....................
1 .....................
0.5 (30 minutes).
860 .................
860 .................
2 .....................
21.42 ..............
30
7,740
1,720
18
3,405
314
........................
12,985.5
60
10
2.5
Type of Collection: Revision.
OMB No. 0990–0313: Office of the
Assistant Secretary for Health.
Abstract: The 2021 National Blood
Collection and Utilization Survey is a
biennial survey of the blood collection
and utilization community to produce
reliable and accurate estimates of
national and regional collections,
utilization and safety of all blood
products. The survey includes a core of
standard questions on blood collection,
processing, and utilization practices.
The rapidly changing environment in
blood supply and demand makes it
important to have regular, periodic data
describing the state of U.S. blood
collections and transfusions for
understanding the dynamics of blood
safety and availability. Two sections
were added to the survey to capture
information on the impact of the
COVID–19 pandemic on the blood
supply during the course of 2020. The
COVID–19 supplemental sections will
only be included on the survey once.
Survey respondents will consist of
blood collection centers, cord blood
banks, and hospitals that perform blood
transfusions, except those reporting
fewer than 100 inpatient surgeries per
year. For the purposes of this ICR,
federal burden is only being placed on
facilities located within the fifty states
and the District of Columbia.
OMB approval is requested for three
years. The total estimated annual
burden is 4,532 hours.
ESTIMATED ANNUALIZED BURDEN TABLE
Number of
respondents
Type of respondent
Transfusing Hospitals ......................................................................................
Hospital Blood Banks ......................................................................................
Community-based blood center .......................................................................
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Number
responses
per
respondent
2,140
76
50
E:\FR\FM\17SEN1.SGM
Average
burden per
response
(in hours)
1
1
1
17SEN1
Total burden
hours
2
2
2
4,280
152
100
51903
Federal Register / Vol. 86, No. 178 / Friday, September 17, 2021 / Notices
ESTIMATED ANNUALIZED BURDEN TABLE—Continued
Number of
respondents
Type of respondent
Total ..........................................................................................................
2,266
[FR Doc. 2021–20183 Filed 9–16–21; 8:45 am]
Dated: September 13, 2021.
Tyeshia M. Roberson-Curtis,
Program Analyst, Office of Federal Advisory
Committee Policy.
BILLING CODE 4150–41–P
[FR Doc. 2021–20113 Filed 9–16–21; 8:45 am]
Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance
Officer, Office of the Secretary.
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institutes of Health
National Institute of Neurological
Disorders and Stroke; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting 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.
Name of Committee: National Institute of
Neurological Disorders and Stroke Initial
Review Group; Neurological Sciences and
Disorders C Study Section: Neurological
Sciences and Disorders Panel–C (NSD–C).
Date: October 6, 2021.
Time: 10:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate
cooperative agreement applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852 (Virtual
Meeting).
Contact Person: Diana M. Cummings,
Ph.D., Scientific Review Officer, Scientific
Review Branch, National Institute of
Neurological Disorders and Stroke, NIH,
NSC, 6001 Executive Blvd., Suite 3208,
Rockville, MD 20852, cummingsdi@
ninds.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.853, Clinical Research
Related to Neurological Disorders; 93.854,
Biological Basis Research in the
Neurosciences, National Institutes of Health,
HHS)
VerDate Sep<11>2014
16:19 Sep 16, 2021
Jkt 253001
National Cancer Institute; Notice of
Meeting
Pursuant to section 10(a) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the National Cancer Institute
Council of Research Advocates.
The meeting will be held as a virtual
meeting and is open to the public.
Individuals who plan to view the virtual
meeting and need special assistance or
other reasonable accommodations to
view the meeting, should notify the
Contact Person listed below in advance
of the meeting. The meeting will be
videocast and can be accessed from the
NIH Videocasting and Podcasting
website (https://videocast.nih.gov).
Name of Committee: National Cancer
Institute Council of Research Advocates.
Date: September 29, 2021.
Time: 12:00 p.m. to 4:00 p.m. EST.
Agenda: Welcome and Chairwoman’s
Remarks, NCI Updates, Legislative Update,
and Director’s Update.
Place: National Institutes of Health, 9000
Rockville Pike, Building 31, Bethesda, MD
20892–2580 (Virtual Meeting).
Contact Person: Amy Williams, NCI Office
of Advocacy Relations, National Cancer
Institute, NIH, 31 Center Drive, Building 31,
Room 10A28, Bethesda, MD 20892–2850,
(301) 496–9723, williaam@mail.nih.gov.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
Information is also available on the
Institute’s/Center’s home page: NCRA: https://
deainfo.nci.nih.gov/advisory/ncra/ncra.htm,
where an agenda and any additional
information for the meeting will be posted
when available.
This notice is being published less than 15
days prior to the meeting due to scheduling
difficulties.
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
Number
responses
per
respondent
Average
burden per
response
(in hours)
........................
........................
Total burden
hours
4,532
(Catalogue of Federal Domestic Assistance
Program Nos. 93.392, Cancer Construction;
93.393, Cancer Cause and Prevention
Research; 93.394, Cancer Detection and
Diagnosis Research; 93.395, Cancer
Treatment Research; 93.396, Cancer Biology
Research; 93.397, Cancer Centers Support;
93.398, Cancer Research Manpower; 93.399,
Cancer Control, National Institutes of Health,
HHS)
Dated: September 13, 2021.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2021–20075 Filed 9–16–21; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Aging; 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.
Name of Committee: National Institute on
Aging Special Emphasis Panel; Multi-site
Clinical Trial Implementation.
Date: November 2, 2021.
Time: 10:00 a.m. to 1:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute on Aging,
Gateway Building, 7201 Wisconsin Avenue,
Bethesda, MD 20892 (Video Meeting).
Contact Person: Isis S. Mikhail, MD, MPH,
DrPH, Scientific Review Officer, Scientific
Review Branch, National Institute on Aging,
National Institutes of Health, Gateway
Building 2C212, 7201 Wisconsin Avenue,
Bethesda, MD 20892, (301) 402–7704,
mikhaili@mail.nih.gov.
Name of Committee: National Institute on
Aging Special Emphasis Panel Triadic Care.
E:\FR\FM\17SEN1.SGM
17SEN1
]]>Agencies
[Federal Register Volume 86, Number 178 (Friday, September 17, 2021)]
[Notices]
[Pages 51902-51903]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-20183]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Document Identifier: OS-0990-0313]
Agency Information Collection Request; 30-Day Public Comment
Request
AGENCY: Office of the Secretary, Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement of the Paperwork Reduction
Act of 1995, the Office of the Secretary (OS), Department of Health and
Human Services, is publishing the following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be received on or before October 18,
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 30-day Review--
Open for Public Comments'' or by using the search function.
FOR FURTHER INFORMATION CONTACT: Sherrette Funn, [email protected]
or (202) 795-7714. When submitting comments or requesting information,
please include the document identifier 0990-0313-30D and project title
for reference.
SUPPLEMENTARY INFORMATION: Interested persons are invited to send
comments regarding this burden estimate or any other aspect of this
collection of information, including any of the following subjects: (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.
Title of the Collection: 2021 National Blood Collection &
Utilization Survey.
Type of Collection: Revision.
OMB No. 0990-0313: Office of the Assistant Secretary for Health.
Abstract: The 2021 National Blood Collection and Utilization Survey
is a biennial survey of the blood collection and utilization community
to produce reliable and accurate estimates of national and regional
collections, utilization and safety of all blood products. The survey
includes a core of standard questions on blood collection, processing,
and utilization practices. The rapidly changing environment in blood
supply and demand makes it important to have regular, periodic data
describing the state of U.S. blood collections and transfusions for
understanding the dynamics of blood safety and availability. Two
sections were added to the survey to capture information on the impact
of the COVID-19 pandemic on the blood supply during the course of 2020.
The COVID-19 supplemental sections will only be included on the survey
once.
Survey respondents will consist of blood collection centers, cord
blood banks, and hospitals that perform blood transfusions, except
those reporting fewer than 100 inpatient surgeries per year. For the
purposes of this ICR, federal burden is only being placed on facilities
located within the fifty states and the District of Columbia.
OMB approval is requested for three years. The total estimated
annual burden is 4,532 hours.
Estimated Annualized Burden Table
----------------------------------------------------------------------------------------------------------------
Average
Number of Number burden per Total burden
Type of respondent respondents responses per response (in hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
Transfusing Hospitals........................... 2,140 1 2 4,280
Hospital Blood Banks............................ 76 1 2 152
Community-based blood center.................... 50 1 2 100
---------------------------------------------------------------
[[Page 51903]]
Total....................................... 2,266 .............. .............. 4,532
----------------------------------------------------------------------------------------------------------------
Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance Officer, Office of the
Secretary.
[FR Doc. 2021-20183 Filed 9-16-21; 8:45 am]
BILLING CODE 4150-41-P
