Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; the Stem Cell Therapeutic Outcomes Database, OMB No. 0915-0310-Revision, 43814-43815 [2019-18088]
Download as PDF
<![CDATA[
43814
Federal Register / Vol. 84, No. 163 / Thursday, August 22, 2019 / Notices
government-issued identification prior
to entry.
Maria G. Button,
Director, Division of the Executive Secretariat.
[FR Doc. 2019–18117 Filed 8–21–19; 8:45 am]
BILLING CODE 4165–15–P
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.
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request; the Stem Cell Therapeutic
Outcomes Database, OMB No. 0915–
0310–Revision
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
SUMMARY: In compliance with of 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 will be provided to OMB.
OMB will accept further comments from
the public during the review and
approval period.
DATES: Comments on this ICR should be
received no later than September 23,
2019.
ADDRESSES: Submit your comments,
including the ICR Title, to the desk
officer for HRSA, either by email to
OIRA_submission@omb.eop.gov or by
fax to (202) 395–5806.
Information Collection Request Title:
The Stem Cell Therapeutic Outcomes
Database OMB No. 0915–0310—
Revision.
Abstract: The Stem Cell Therapeutic
and Research Act of 2005, Public Law
(Pub. L.) 109–129, as amended by the
Stem Cell Therapeutic and Research
Reauthorization Act of 2015, Public Law
114–104 (the Act), provides for the
collection and maintenance of human
blood stem cells for the treatment of
patients and research. HRSA’s
Healthcare Systems Bureau has
established the Stem Cell Therapeutic
Outcomes Database. Operation of this
database necessitates certain
recordkeeping and reporting
requirements to perform the functions
related to hematopoietic stem cell
transplantation under contract to HHS.
The Act requires the Secretary to
contract for the establishment and
maintenance of information related to
patients who have received stem cell
therapeutic products and to do so using
a standardized, electronic format. Data
is collected from transplant centers,
under contract, by the Medical College
of Wisconsin’s Center for International
Blood and Marrow Transplant Research
and is used for ongoing analysis of
transplant outcomes. Over time, there is
an expected increase in the number of
recipients for whom data are reported as
an increasing number of transplants are
performed annually and survivorship
after transplantation improves.
A 60-day notice was published in the
Federal Register on March 7, 2019, vol.
84, No. 45; pp. 8334–8335. There were
no public comments.
Need and Proposed Use of the
Information: HRSA uses the information
to carry out its statutory responsibilities.
Information is needed to monitor the
clinical status of transplantation and
provide the Secretary of HHS with an
annual report of transplant center
specific survival data. Modifications of
these forms fall into several categories:
Consolidating questions and removing
duplicate questions across the forms,
implementing ‘check all that apply’
formatting to reduce data entry time,
and removing items no longer clinically
significant (e.g., drugs). These
modifications reduced the overall hours
of burden inventory.
Likely Respondents: Transplant
Centers.
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
respondents 1
Form name
Number of
responses per
respondent
Total
responses
Average
burden
per response
(in hours)
Total burden
hours
Baseline Pre-Transplant Essential Data (TED) ...................
Disease Classification ..........................................................
Product Form (includes Infusion, HLA, and Infectious Disease Marker inserts) ........................................................
100-day Post-TED ...............................................................
6 month Post-TED ...............................................................
1 year Post-TED ..................................................................
2 year Post-TED ..................................................................
3+ years Post-TED ..............................................................
200
200
48
48
9,600
9,600
2 0.68
3 0.43
6,560
4,160
200
200
200
200
200
200
45
48
43
40
34
172
9,000
9,600
8,600
8,000
6,800
34,400
1.00
0.85
0.85
0.65
0.65
4 0.52
9,000
8,160
7,310
5,200
4,420
17,773
Total ..............................................................................
200
........................
95,600
........................
62,583
1 The
total of 200 is the number of centers completing the form; the same group will complete all of the forms.
decimal is rounded down, and the actual number is .683333333.
3 The decimal is rounded down, and the actual number is .433333333.
4 The decimal is rounded up, and the actual number is .516667.
2 The
VerDate Sep<11>2014
16:37 Aug 21, 2019
Jkt 247001
PO 00000
Frm 00028
Fmt 4703
Sfmt 4703
E:\FR\FM\22AUN1.SGM
22AUN1
Federal Register / Vol. 84, No. 163 / Thursday, August 22, 2019 / Notices
Maria G. Button,
Director, Division of the Executive Secretariat.
[FR Doc. 2019–18088 Filed 8–21–19; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute On Aging; 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 on
Aging Special Emphasis Panel; AD Centers
Review.
Date: September 19–20, 2019.
Time: 1:30 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Bethesda North Marriott Hotel &
Conference Center, 5701 Marinelli Road,
Rockville, MD 20852.
Contact Person: Maurizio Grimaldi, MD,
Ph.D., Scientific Review Officer, Scientific
Review Branch, National Institute on Aging,
National Institutes of Health, 7201 Wisconsin
Avenue, Gateway Building, Suite 2W200,
Bethesda, MD 20892, 301–496–9374,
grimaldim2@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.866, Aging Research,
National Institutes of Health, HHS)
Dated: August 16, 2019.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–18079 Filed 8–21–19; 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 Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
VerDate Sep<11>2014
16:37 Aug 21, 2019
Jkt 247001
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 on
Aging Special Emphasis Panel; Aging and
Mobility.
Date: September 13, 2019.
Time: 4:30 p.m. to 6:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute on Aging,
Gateway Building, 7201 Wisconsin Avenue,
Suite 2W200, Bethesda, MD 20892.
Contact Person: Anita H. Undale, MD,
Ph.D., Scientific Review Officer, Scientific
Review Branch, National Institute on Aging,
National Institutes of Health, Gateway
Building, Suite 2W200, 7201 Wisconsin
Avenue, Bethesda, MD 20892, 301–827–
7428, anita.undale@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.866, Aging Research,
National Institutes of Health, HHS)
Dated: August 16, 2019.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–18078 Filed 8–21–19; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of General Medical
Sciences; 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: NIGMS Initial Review
Group Training and Workforce Development
Subcommittee—D Review of MARC and RISE
applications
PO 00000
Frm 00029
Fmt 4703
Sfmt 4703
43815
Date: October 24–25, 2019.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hilton Garden Inn Bethesda, 7301
Waverly Street, Bethesda, MD 20814.
Contact Person: Tracy Koretsky, Ph.D.,
Scientific Review Officer, Office of Scientific
Review, National Institute of General Medical
Sciences, National Institutes of Health, 45
Center Drive, MSC 6200, Room 3AN.12F,
Bethesda, MD 20892, 301 594 2886,
tracy.koretsky@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.375, Minority Biomedical
Research Support; 93.821, Cell Biology and
Biophysics Research; 93.859, Pharmacology,
Physiology, and Biological Chemistry
Research; 93.862, Genetics and
Developmental Biology Research; 93.88,
Minority Access to Research Careers; 93.96,
Special Minority Initiatives; 93.859,
Biomedical Research and Research Training,
National Institutes of Health, HHS)
Dated: August 16, 2019.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–18082 Filed 8–21–19; 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 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 on
Aging Special Emphasis Panel; Neuroimaging
of AD and Related Dementias.
Date: September 24, 2019.
Time: 1:00 p.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute on Aging,
Gateway Building, 7201 Wisconsin Avenue,
Suite 2C212, Bethesda, MD 20892.
Contact Person: Alexander Parsadanian,
Ph.D., Scientific Review Officer, Scientific
Review Branch, National Institute on Aging,
Gateway Building 2C/212, 7201 Wisconsin
Avenue, Bethesda, MD 20892, 301–496–
9666, parsadaniana@nia.nih.gov.
E:\FR\FM\22AUN1.SGM
22AUN1
]]>Agencies
[Federal Register Volume 84, Number 163 (Thursday, August 22, 2019)]
[Notices]
[Pages 43814-43815]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-18088]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Submission to OMB for
Review and Approval; Public Comment Request; the Stem Cell Therapeutic
Outcomes Database, OMB No. 0915-0310-Revision
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with of 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 will be provided
to OMB. OMB will accept further comments from the public during the
review and approval period.
DATES: Comments on this ICR should be received no later than September
23, 2019.
ADDRESSES: Submit your comments, including the ICR Title, to the desk
officer for HRSA, either by email to [email protected] or by
fax to (202) 395-5806.
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: The Stem Cell Therapeutic
Outcomes Database OMB No. 0915-0310--Revision.
Abstract: The Stem Cell Therapeutic and Research Act of 2005,
Public Law (Pub. L.) 109-129, as amended by the Stem Cell Therapeutic
and Research Reauthorization Act of 2015, Public Law 114-104 (the Act),
provides for the collection and maintenance of human blood stem cells
for the treatment of patients and research. HRSA's Healthcare Systems
Bureau has established the Stem Cell Therapeutic Outcomes Database.
Operation of this database necessitates certain recordkeeping and
reporting requirements to perform the functions related to
hematopoietic stem cell transplantation under contract to HHS. The Act
requires the Secretary to contract for the establishment and
maintenance of information related to patients who have received stem
cell therapeutic products and to do so using a standardized, electronic
format. Data is collected from transplant centers, under contract, by
the Medical College of Wisconsin's Center for International Blood and
Marrow Transplant Research and is used for ongoing analysis of
transplant outcomes. Over time, there is an expected increase in the
number of recipients for whom data are reported as an increasing number
of transplants are performed annually and survivorship after
transplantation improves.
A 60-day notice was published in the Federal Register on March 7,
2019, vol. 84, No. 45; pp. 8334-8335. There were no public comments.
Need and Proposed Use of the Information: HRSA uses the information
to carry out its statutory responsibilities. Information is needed to
monitor the clinical status of transplantation and provide the
Secretary of HHS with an annual report of transplant center specific
survival data. Modifications of these forms fall into several
categories: Consolidating questions and removing duplicate questions
across the forms, implementing `check all that apply' formatting to
reduce data entry time, and removing items no longer clinically
significant (e.g., drugs). These modifications reduced the overall
hours of burden inventory.
Likely Respondents: Transplant Centers.
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 Number of Average burden
Form name respondents responses per Total per response Total burden
\1\ respondent responses (in hours) hours
----------------------------------------------------------------------------------------------------------------
Baseline Pre-Transplant 200 48 9,600 \2\ 0.68 6,560
Essential Data (TED)...........
Disease Classification.......... 200 48 9,600 \3\ 0.43 4,160
Product Form (includes Infusion, 200 45 9,000 1.00 9,000
HLA, and Infectious Disease
Marker inserts)................
100-day Post-TED................ 200 48 9,600 0.85 8,160
6 month Post-TED................ 200 43 8,600 0.85 7,310
1 year Post-TED................. 200 40 8,000 0.65 5,200
2 year Post-TED................. 200 34 6,800 0.65 4,420
3+ years Post-TED............... 200 172 34,400 \4\ 0.52 17,773
-------------------------------------------------------------------------------
Total....................... 200 .............. 95,600 .............. 62,583
----------------------------------------------------------------------------------------------------------------
\1\ The total of 200 is the number of centers completing the form; the same group will complete all of the
forms.
\2\ The decimal is rounded down, and the actual number is .683333333.
\3\ The decimal is rounded down, and the actual number is .433333333.
\4\ The decimal is rounded up, and the actual number is .516667.
[[Page 43815]]
Maria G. Button,
Director, Division of the Executive Secretariat.
[FR Doc. 2019-18088 Filed 8-21-19; 8:45 am]
BILLING CODE 4165-15-P
