Agency Information Collection Activities: Submission for OMB Review; Comment Request, 48692 [2010-19752]
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48692
Federal Register / Vol. 75, No. 154 / Wednesday, August 11, 2010 / Notices
their commitment to the success of this
program. The WHO represents a key
stakeholder in the implementation of
the program; providing unique
functions, technical and scientific
expertise, and capabilities that no other
organization in the world has.
Additional Information: The agency
program contact is Dr. Michael Perdue,
whom can be contacted at (202) 260–
0966 or Michael.Perdue@hhs.gov.
Paperwork Reduction Act of 1995 (44
U.S.C. Chapter 35). To request a copy of
the clearance requests submitted to
OMB for review, e-mail
paperwork@hrsa.gov or call the HRSA
Reports Clearance Office on (301) 443–
1129.
The following request has been
submitted to the Office of Management
and Budget for review under the
Paperwork Reduction Act of 1995:
Dated: August 3, 2010.
Nicole Lurie,
Assistant Secretary for Preparedness and
Response, U.S. Department of Health and
Human Services.
Proposed Project: The Stem Cell
Therapeutic Outcomes Database (OMB
No. 0915–0310)—Extension
[FR Doc. 2010–19861 Filed 8–10–10; 8:45 am]
BILLING CODE 4150–37–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Periodically, the Health Resources
and Services Administration (HRSA)
publishes abstracts of information
collection requests under review by the
Office of Management and Budget
(OMB), in compliance with the
The Stem Cell Therapeutic and
Research Act of 2005 provides for the
collection and maintenance of human
cord blood stem cells for the treatment
of patients and research. The Health
Resources and Services
Administration’s (HRSA) Healthcare
Systems Bureau (HSB) has established
the Stem Cell Therapeutic Outcomes
Database. Operation of this database
necessitates certain recordkeeping and
reporting requirements in order to
perform the functions related to
hematopoietic stem cell transplantation
under contract to the Department of
Health and Human Services (HHS). The
Act requires the Secretary of HHS to
contract for the establishment and
maintenance of information related to
patients who have received stem cell
Number of
respondents
Form
Responses per
respondent
Baseline Pre-TED (Transplant Essential Data) ...............
Product Forms (includes Infusion, HLA, and Infectious
Disease Marker inserts) ...............................................
100-Day Post-TED ...........................................................
6-Month Post-TED ...........................................................
12-Month Post-TED .........................................................
Annual Post-TED .............................................................
200
30
200
200
200
200
200
Total ..........................................................................
200
sroberts on DSKD5P82C1PROD with NOTICES
Written comments and
recommendations concerning the
proposed information collection should
be sent within 30 days of this notice to
the desk officer for HRSA, either by email to OIRA_submission@omb.eop.gov
or by fax to 202–395–6974. Please direct
all correspondence to the ‘‘attention of
the desk officer for HRSA.’’
Dated: August 5, 2010.
Wendy Ponton,
Director, Office of Management.
[FR Doc. 2010–19752 Filed 8–10–10; 8:45 am]
20
30
25
23.5
64
4,000
6,000
5,000
4,700
12,800
1.5
0.85
1.00
1.00
1.00
6,000
5,100
5,000
4,700
12,800
..........................
38,500
..........................
38,700
[Docket No. FDA–2010–N–0411]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Guide to Minimize
Microbial Food Safety Hazards of
Fresh-Cut Fruits and Vegetables
Food and Drug Administration,
HHS.
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
SUMMARY:
16:52 Aug 10, 2010
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Frm 00051
Fmt 4703
Total burden
hours
5,100
BILLING CODE 4165–15–P
VerDate Mar<15>2010
Hours per
Response
0.85
Food and Drug Administration
ACTION:
Total
responses
6,000
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
therapeutic products and to do so using
a standardized, electronic format. Data
are collected from transplant centers in
a manner similar to the data collection
activities conducted by the Center for
International Blood and Marrow
Transplant Research (CIBMTR) and are
used for ongoing analysis of transplant
outcomes. HRSA uses the information
in order to carry out its statutory
responsibilities. Information is needed
to monitor the clinical status of
transplantation, and to provide the
Secretary with an annual report of
transplant center-specific survival data.
The burden table for the year 2011
shows there will be approximately
12,800 annual follow-up assessments
due for the Blood Stem Cell
Transplantation Program’s Stem Cell
Therapeutic Outcomes Database. The
2007 30-Day Federal Register notice
included total burden hours of 32,040
and 225 respondents. The burden table
below includes 38,700 total burden
hours and 200 respondents. The
increase in burden is due to an increase
in the annual number of transplants.
The number of respondents has
decreased due to some centers no longer
performing unrelated stem cell
transplants and some centers are no
longer in business.
The estimate of burden is as follows:
Sfmt 4703
information by the agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal agencies are required to
publish 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 information collection provisions in
the guidance document entitled
‘‘Guidance for Industry: Guide to
Minimize Microbial Food Safety
Hazards of Fresh-Cut Fruits and
Vegetables.’’
DATES: Submit either electronic or
written comments on the collection of
information by October 12, 2010.
E:\FR\FM\11AUN1.SGM
11AUN1
]]>Agencies
[Federal Register Volume 75, Number 154 (Wednesday, August 11, 2010)]
[Notices]
[Page 48692]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-19752]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Submission for OMB
Review; Comment Request
Periodically, the Health Resources and Services Administration
(HRSA) publishes abstracts of information collection requests under
review by the Office of Management and Budget (OMB), in compliance with
the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). To request
a copy of the clearance requests submitted to OMB for review, e-mail
paperwork@hrsa.gov or call the HRSA Reports Clearance Office on (301)
443-1129.
The following request has been submitted to the Office of
Management and Budget for review under the Paperwork Reduction Act of
1995:
Proposed Project: The Stem Cell Therapeutic Outcomes Database (OMB No.
0915-0310)--Extension
The Stem Cell Therapeutic and Research Act of 2005 provides for the
collection and maintenance of human cord blood stem cells for the
treatment of patients and research. The Health Resources and Services
Administration's (HRSA) Healthcare Systems Bureau (HSB) has established
the Stem Cell Therapeutic Outcomes Database. Operation of this database
necessitates certain recordkeeping and reporting requirements in order
to perform the functions related to hematopoietic stem cell
transplantation under contract to the Department of Health and Human
Services (HHS). The Act requires the Secretary of HHS 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 are collected from transplant
centers in a manner similar to the data collection activities conducted
by the Center for International Blood and Marrow Transplant Research
(CIBMTR) and are used for ongoing analysis of transplant outcomes. HRSA
uses the information in order to carry out its statutory
responsibilities. Information is needed to monitor the clinical status
of transplantation, and to provide the Secretary with an annual report
of transplant center-specific survival data. The burden table for the
year 2011 shows there will be approximately 12,800 annual follow-up
assessments due for the Blood Stem Cell Transplantation Program's Stem
Cell Therapeutic Outcomes Database. The 2007 30-Day Federal Register
notice included total burden hours of 32,040 and 225 respondents. The
burden table below includes 38,700 total burden hours and 200
respondents. The increase in burden is due to an increase in the annual
number of transplants. The number of respondents has decreased due to
some centers no longer performing unrelated stem cell transplants and
some centers are no longer in business.
The estimate of burden is as follows:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Responses per Total Hours per Total burden
Form respondents respondent responses Response hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Baseline Pre-TED (Transplant Essential Data)........................... 200 30 6,000 0.85 5,100
Product Forms (includes Infusion, HLA, and Infectious Disease Marker 200 20 4,000 1.5 6,000
inserts)..............................................................
100-Day Post-TED....................................................... 200 30 6,000 0.85 5,100
6-Month Post-TED....................................................... 200 25 5,000 1.00 5,000
12-Month Post-TED...................................................... 200 23.5 4,700 1.00 4,700
Annual Post-TED........................................................ 200 64 12,800 1.00 12,800
--------------------------------------------------------------------------------
Total.............................................................. 200 ............... 38,500 .............. 38,700
--------------------------------------------------------------------------------------------------------------------------------------------------------
Written comments and recommendations concerning the proposed
information collection should be sent within 30 days of this notice to
the desk officer for HRSA, either by e-mail to OIRA_submission@omb.eop.gov or by fax to 202-395-6974. Please direct all
correspondence to the ``attention of the desk officer for HRSA.''
Dated: August 5, 2010.
Wendy Ponton,
Director, Office of Management.
[FR Doc. 2010-19752 Filed 8-10-10; 8:45 am]
BILLING CODE 4165-15-P
