Submission for OMB Review; Comment Request; Transfusion-Transmitted Retrovirus and Hepatitis Virus Rates and Risk Factors: Improving the Safety of the U.S. Blood Supply Through Hemovigilance, 79006-79008 [2010-31734]
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Federal Register / Vol. 75, No. 242 / Friday, December 17, 2010 / Notices
pending drug product application under
sections 505, 512, or 802 of the FD&C
Act (21 U.S.C. 355, 360b, or 382), or
under section 351 of the Public Health
Service Act (42 U.S.C. 262), effective
(see DATES), (see section 306(c)(1)(B),
(c)(2)(A)(iii), and 201(dd) of the FD&C
Act (21 U.S.C. 335a(c)(1)(B),
(c)(2)(A)(iii), and 321(dd))). Any person
with an approved or pending drug
product application who knowingly
employs or retains as a consultant or
contractor, or otherwise uses the
services of Dr. Akhigbe, in any capacity
during Dr. Akhigbe’s debarment, will be
subject to civil money penalties (section
307(a)(6) of the FD&C Act (21 U.S.C.
335b(a)(6))). If Dr. Akhigbe provides
services in any capacity to a person with
an approved or pending drug product
application during his period of
debarment he will be subject to civil
money penalties (section 307(a)(7) of the
FD&C Act). In addition, FDA will not
accept or review any abbreviated new
drug applications submitted by or with
the assistance of Dr. Akhigbe during his
period of debarment (section
306(c)(1)(B) of the FD&C Act (21 U.S.C.
335a(c)(1)(B)).
Any application by Dr. Akhigbe for
termination of debarment under section
306(d)(4) of the FD&C Act should be
identified with Docket No. FDA–2010–
N–0235 and sent to the Division of
Dockets Management (see ADDRESSES).
All such submissions are to be filed in
four copies. The public availability of
information in these submissions is
governed by 21 CFR 10.20(j).
Publicly available submissions may
be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
Dated: November 19, 2010.
Howard R. Sklamberg,
Director, Office of Enforcement, Office of
Regulatory Affairs.
Dates and Times: January 19, 2011,
8:30 a.m.–4 p.m., January 20, 2011, 8:30
a.m.–12:15 p.m.
Place: Hilton Washington DC/
Rockville Executive Meeting Center,
1750 Rockville Pike, Rockville, MD
20852. Telephone: (301) 468–1100.
Status: The meeting will be open to
the public.
Agenda: On the morning of January
19, following welcoming remarks from
the COGME Chair, HRSA senior
management, and the Executive
Secretary of COGME, there will be an
introduction of COGME members.
The rest of the first day will consist
of presentations covering various
aspects of graduate medical education,
Bureau of Health Professions activities
concerning health workforce issues, a
study of primary care physician
projections by state, and work of the
Medicare Payment and Advisory
Commission on GME issues.
On January 20, there will be
presentations on the findings and
recommendations of COGME’s 20th
report, Advancing Primary Care (cover
date December 2010). It is expected that
the rest of the morning will be taken up
in discussions in exploring the topic for
COGME’s next report.
Agenda items are subject to change as
priorities dictate.
FOR FURTHER INFORMATION CONTACT:
Anyone interested in obtaining a roster
of members or other relevant
information should write or contact
Jerald M. Katzoff, Executive Secretary,
COGME, Division of Medicine and
Dentistry, Bureau of Health Professions,
Parklawn Building, Room 9A–27, 5600
Fishers Lane, Rockville, Maryland
20857, Telephone (301) 443–4443. The
Web address for information on the
Council and the January 19–20, 2011
meeting agenda is https://cogme.gov.
Dated: December 9, 2010.
Robert Hendricks,
Director, Division of Policy and Information
Coordination.
[FR Doc. 2010–31776 Filed 12–16–10; 8:45 am]
BILLING CODE 4160–01–P
[FR Doc. 2010–31712 Filed 12–16–10; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
emcdonald on DSK2BSOYB1PROD with NOTICES
Health Resources and Services
Administration
National Institutes of Health
Council on Graduate Medical
Education; Notice of Meeting
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), notice is hereby given
of the following meeting:
Name: Council on Graduate Medical
Education (COGME).
VerDate Mar<15>2010
16:45 Dec 16, 2010
Jkt 223001
Submission for OMB Review;
Comment Request; TransfusionTransmitted Retrovirus and Hepatitis
Virus Rates and Risk Factors:
Improving the Safety of the U.S. Blood
Supply Through Hemovigilance
Summary: Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
Reduction Act of 1995, the National
Heart, Lung, and Blood Institute
(NHLBI), the National Institutes of
Health (NIH) has submitted to the Office
of Management and Budget (OMB) a
request to review and approve the
information collection listed below.
This proposed information collection
was previously published in the Federal
Register on September 28, 2010,
Volume 75, No. 187, pages 59724–59725
and allowed 60 days for public
comment. The purpose of this notice is
to allow an additional 30 days for public
comment. The National Institutes of
Health may not conduct or sponsor, and
the respondent is not required to
respond to, an information collection
that has been extended, revised, or
implemented on or after October 1,
1995, unless it displays a current valid
OMB control number.
Proposed Collection: Title:
Transfusion-transmitted retrovirus and
hepatitis virus rates and risk factors:
Improving the safety of the U.S. blood
supply through hemovigilance. Type of
Information Collection Request: NEW.
Need and Use of Information Collection:
Information on current risk factors in
blood donors as assessed using
analytical study designs is largely
unavailable in the U.S. Studies of risk
factor profiles among HIV-infected
donors were funded by the CDC for
approximately 10 years after
implementation of serologic screening
in the mid-1980s, whereas studies of
HTLV- and HCV-seropositive (and
indeterminate) donors, funded by NIH,
were conducted in the early 1990s, but
unfortunately, none of these studies is
ongoing. Infection trend analyses have
been conducted by the American Red
Cross (ARC). The findings show
continued HIV risk with the prevalence
of HIV in first time donors hovering
around 10 per 100,000 donations in
each of the last 10 years and the
incidence in repeat donors increasing
from 1.49 per 100,000 person-years in
1999–2000 to 2.16 per 100,000 personsyears in 2007–2008. While the
prevalence of HCV in first time donors
decreased over this time interval from
345 to 163 per 100,000 donations, the
incidence in repeat donors did not
decrease and evidence of incident
infection in first time donors increased.
Moreover specific age, gender and race/
ethnicity groups were over-represented.
Significantly increased incidence of
both HIV and HCV were observed in
2007/2008 compared to 2005/2006.
Similar analyses for HBV have shown
an incidence in all donors of 3.4 per
100,000 person-years which is lower
E:\FR\FM\17DEN1.SGM
17DEN1
79007
Federal Register / Vol. 75, No. 242 / Friday, December 17, 2010 / Notices
donors, including parenteral and sexual
risks, across the participating blood
collection organizations using a casecontrol study design.
(3) Determine nationallyrepresentative infectious disease marker
prevalence and incidence for HIV, HCV,
HBV, and HTLV overall and by
demographic characteristics of donors.
This will be accomplished by forming
research databases from operational data
at BSI and NYBC into formats that can
be combined with the ARC research
database.
(4) Analyze integrated risk factor and
infectious marker testing data together
because when taken together these may
show that blood centers are not
achieving the same degree of success in
educational efforts to prevent donation
by donors with risk behaviors across all
demographic groups.
Frequency of Response: Once.
Affected Public: Individuals. Type of
Respondents: Adult blood donors. The
annual reporting burden is as follows:
Estimated Number of Respondents:4150;
Estimated Number of Responses per
Respondent: 1; Average Burden of
Hours per Response: 0.58 and Estimated
Total Annual Burden Hours Requested:
2407. The annualized cost to
respondents is estimated at: $43,326
(based on $18 per hour). There are no
Capital Costs to report. There are no
Operating or Maintenance Costs to
report.
potential transmission risk because they
could be missed during routine testing.
As part of the project a comprehensive
research-quality biovigilance database
will be created that integrates existing
operational information on blood
donors, disease marker testing and
blood components collected by
participating organizations into a
research database. The combined
database will capture infectious disease
and risk factor information on nearly
60% of all blood donors and donations
in the country. Following successful
completion of the risk factor interviews
and research database development, the
biovigilance network pilot can be
expanded to include additional blood
centers and/or re-focused on other
safety threats as warranted, such as
XMRV. This pilot biovigilance network
will thereby establish a standardized
process for integration of information
across blood collection organizations.
The Specific Aims are to:
(1) Define consensus infectious
disease testing classification algorithms
for HIV, HCV, HBV, and HTLV that can
be used to consistently classify donation
testing results across blood collection
organizations in the U.S. This will allow
for better estimates of infection disease
marker prevalence and incidence in the
U.S.
(2) Determine current behavioral risk
factors associated with prevalent and
incident (when possible) HIV, HCV,
HBV and HTLV infections in blood
than earlier estimates, but remains
higher than for HIV and HCV.
This project represents a collaborative
pilot research study that will include a
comprehensive interview study of viral
infection positive blood donors at the
American Red Cross (ARC), Blood
Systems Inc. (BSI) and New York Blood
Center (NYBC) in order to identify the
current predominant risk factors for
virus positive donations and will also
establish a donor biovigilance capacity
that currently does not exist in the U.S.
At this time it is not easy to integrate
risk factor data and disease marker
surveillance information within or
across different blood collection
organizations because common
interview procedures and laboratory
confirmation procedures are not being
used and so we cannot easily tabulate
and analyze behavioral risks or viral
infections in U.S. blood donors. This
creates the potential for gaps in our
understanding of absolute incidence
and prevalence as well as risks that
could lead to transfusion-transmitted
disease. Combined data are critical for
appropriate national surveillance
efforts. For example, this information
could be used to target educational
interventions to reduce donations from
persons with high risk behaviors. This
is particularly important in the case of
behaviors associated with incident
(recently acquired) infections because
these donations have the greatest
TABLE 1–1—ESTIMATES OF HOUR BURDEN
Number of
respondents
Type of respondents
Frequency of
response
Average time
per response
Annual hour
burden
Cases ...............................................................................................................
Controls ............................................................................................................
1650
2500
1
1
0.58
0.58
957
1450
Total ..........................................................................................................
4150
........................
........................
2407
TABLE 1–2—ANNUALIZED COST TO RESPONDENTS
Number of
respondents
Type of respondents
Frequency of
response
Average time
per respondents
Hourly wage
rate
Respondent
cost
1650
2500
1
1
0.58
0.58
$18
18
17,226
26,100
Total ..............................................................................
emcdonald on DSK2BSOYB1PROD with NOTICES
Cases ...................................................................................
Controls ................................................................................
4150
........................
........................
........................
43,326
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies should
address one or more of the following
points: (1) Evaluate whether the
proposed collection of information is
necessary for the proper performance of
the function of the agency, including
whether the information will have
VerDate Mar<15>2010
16:45 Dec 16, 2010
Jkt 223001
practical utility; (2) Evaluate 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) Enhance the quality, utility, and
clarity of the information to be
collected; and (4) Minimize the burden
of the collection of information on those
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
who are to respond, including the use
of appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
Direct Comments to OMB: Written
comments and/or suggestions regarding
the item(s) contained in this notice,
especially regarding the estimated
E:\FR\FM\17DEN1.SGM
17DEN1
79008
Federal Register / Vol. 75, No. 242 / Friday, December 17, 2010 / Notices
public burden and associated response
time, should be directed to the: Office
of Management and Budget, Office of
Regulatory Affairs,
OIRA_submission@omb.eop.gov or by
fax to 202–395–6974, Attention: Desk
Officer for NIH. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and instruments, contact: Dr.
Simone Glynn, Project Officer, NHLBI,
Two Rockledge Center, Room 9142,
6701 Rockledge Drive, Bethesda, MD
20892–7950, or call 301–435–0065, or Email your request to
glynnsa@nhlbi.nih.gov.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30 days of the date of
this publication.
Dated: December 16, 2010.
Simone Glynn,
Branch Chief, Transfusion Medicine and
Cellular Therapeutics Branch, Division of
Blood Diseases and Resources, National
Heart, Lung, and Blood Institute, NIH.
[FR Doc. 2010–31734 Filed 12–16–10; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment
Request; Study of Substance Abuse
doc.com Module Project
In compliance with Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 concerning
opportunity for public comment on
proposed collections of information, the
National Institute on Drug Abuse
SUMMARY:
(NIDA), the National Institutes of Health
(NIH) will publish periodic summaries
of proposed projects to be submitted to
the Office of Management and Budget
(OMB) for review and approval.
Proposed Collection: Title: Study of
Substance Abuse doc.com Module
Project. Type of Information Collection
Request: NEW. Need and Use of
Information Collection: This is a request
for a two-year generic clearance to a
conduct research study to assess the
efficacy of a specific interactive webbased teaching module in the field of
professional education of healthcare
providers. This online module was
developed as a work product by the
same team of investigators from Drexel
University College of Medicine
(DUCOM) and University of
Pennsylvania School of Medicine (Penn
Med) under a contract as part of NIDA’s
Center of Excellence (CoE) for Physician
Information. This project will assess
efficacy of the NIDA CoE online
teaching module with educational
interventions in enhancing: (1) The
knowledge of healthcare professionals
about substance use disorders; (2)
attitudes of healthcare professionals
toward patients with these disorders
and (3) communication skills in
providing assessment and referral to
treatment for patients who abuse
substances. The overall goal of this
project is to assess the efficacy of an
educational intervention, which should
result in an increase in the involvement
of primary care providers in the
screening, managing and, when
appropriate, referring patients with
substance use disorders. This effort is
made according to Executive Order
12862, which directs Federal agencies
that provide significant services directly
Estimated number
of subjects
Respondents
to the public to survey customers to
determine the kind and quality of
services they want and their level of
satisfaction with existing services.
The project will utilize a randomized
cluster controlled trial design that
compares the group that receives
educational exposure to the set of new
educational interventions (NIDA online
teaching module plus educational
adjuncts) to a control group that
receives exposure to the standard
medical school or residency educational
curriculum related to substance use
disorders. The project will use a
repeated measures approach to assess
the educational intervention’s efficacy
(i.e., individuals will take surveys
before and after exposure to the
intervention or to the control
curriculum). The outcomes of the study
will be based on changes in knowledge,
attitudes and indirect measures of
communication skills before and after
the intervention, compared to the
changes in these parameters in the
control group.
Frequency of Response: This project
will be conducted annually or
biennially. Affected Public: Individuals
and businesses. Type of Respondents:
medical students and resident
physicians. The annual reporting
burden is calculated as follows:
Estimated Total Annual Number of
Respondents: 708; Estimated Number of
Responses per Respondent: 4 for
medical students; 2 for resident
physicians; Average Burden Hours per
Response: 0.17. Estimated Total Annual
Burden Hours Requested: 377; There are
no Capital Costs to report. There are no
Operating or Maintenance Costs to
report. The estimated annualized
burden is summarized below.
Estimated number
of surveys per
subject
Average burden
hours per survey
Estimated total
burden hours
400
308
4
2
0.17
0.17
272
105
Total ........................................................................
emcdonald on DSK2BSOYB1PROD with NOTICES
Medical Students ...........................................................
Primary Care Resident Physicians ................................
708
................................
..................................
377
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies are invited
on one or more of the following points:
(1) Whether the proposed collection of
information is necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(2) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (3) ways to enhance the
VerDate Mar<15>2010
16:45 Dec 16, 2010
Jkt 223001
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 or
other forms of information technology.
FOR FURTHER INFROMATION
CONTACT: To request more
information on the proposed projects or
to obtain a copy of the information
collection plans, contact Elisabeth
Davis, Project Officer, National Institute
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
on Drug Abuse, NIDA/NIH/DHHS, 6001
Executive Boulevard, MSC 9591,
Bethesda, MD 20852; or call non-tollfree number (301) 594–6317; fax (301)
480–2485; or e-mail your request,
including your address to:
davise2@nida.nih.gov.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 60 days of the date of
this publication.
E:\FR\FM\17DEN1.SGM
17DEN1
]]>Agencies
[Federal Register Volume 75, Number 242 (Friday, December 17, 2010)]
[Notices]
[Pages 79006-79008]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-31734]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; Comment Request; Transfusion-
Transmitted Retrovirus and Hepatitis Virus Rates and Risk Factors:
Improving the Safety of the U.S. Blood Supply Through Hemovigilance
Summary: Under the provisions of Section 3507(a)(1)(D) of the
Paperwork Reduction Act of 1995, the National Heart, Lung, and Blood
Institute (NHLBI), the National Institutes of Health (NIH) has
submitted to the Office of Management and Budget (OMB) a request to
review and approve the information collection listed below. This
proposed information collection was previously published in the Federal
Register on September 28, 2010, Volume 75, No. 187, pages 59724-59725
and allowed 60 days for public comment. The purpose of this notice is
to allow an additional 30 days for public comment. The National
Institutes of Health may not conduct or sponsor, and the respondent is
not required to respond to, an information collection that has been
extended, revised, or implemented on or after October 1, 1995, unless
it displays a current valid OMB control number.
Proposed Collection: Title: Transfusion-transmitted retrovirus and
hepatitis virus rates and risk factors: Improving the safety of the
U.S. blood supply through hemovigilance. Type of Information Collection
Request: NEW. Need and Use of Information Collection: Information on
current risk factors in blood donors as assessed using analytical study
designs is largely unavailable in the U.S. Studies of risk factor
profiles among HIV-infected donors were funded by the CDC for
approximately 10 years after implementation of serologic screening in
the mid-1980s, whereas studies of HTLV- and HCV-seropositive (and
indeterminate) donors, funded by NIH, were conducted in the early
1990s, but unfortunately, none of these studies is ongoing. Infection
trend analyses have been conducted by the American Red Cross (ARC). The
findings show continued HIV risk with the prevalence of HIV in first
time donors hovering around 10 per 100,000 donations in each of the
last 10 years and the incidence in repeat donors increasing from 1.49
per 100,000 person-years in 1999-2000 to 2.16 per 100,000 persons-years
in 2007-2008. While the prevalence of HCV in first time donors
decreased over this time interval from 345 to 163 per 100,000
donations, the incidence in repeat donors did not decrease and evidence
of incident infection in first time donors increased. Moreover specific
age, gender and race/ethnicity groups were over-represented.
Significantly increased incidence of both HIV and HCV were observed in
2007/2008 compared to 2005/2006. Similar analyses for HBV have shown an
incidence in all donors of 3.4 per 100,000 person-years which is lower
[[Page 79007]]
than earlier estimates, but remains higher than for HIV and HCV.
This project represents a collaborative pilot research study that
will include a comprehensive interview study of viral infection
positive blood donors at the American Red Cross (ARC), Blood Systems
Inc. (BSI) and New York Blood Center (NYBC) in order to identify the
current predominant risk factors for virus positive donations and will
also establish a donor biovigilance capacity that currently does not
exist in the U.S. At this time it is not easy to integrate risk factor
data and disease marker surveillance information within or across
different blood collection organizations because common interview
procedures and laboratory confirmation procedures are not being used
and so we cannot easily tabulate and analyze behavioral risks or viral
infections in U.S. blood donors. This creates the potential for gaps in
our understanding of absolute incidence and prevalence as well as risks
that could lead to transfusion-transmitted disease. Combined data are
critical for appropriate national surveillance efforts. For example,
this information could be used to target educational interventions to
reduce donations from persons with high risk behaviors. This is
particularly important in the case of behaviors associated with
incident (recently acquired) infections because these donations have
the greatest potential transmission risk because they could be missed
during routine testing. As part of the project a comprehensive
research-quality biovigilance database will be created that integrates
existing operational information on blood donors, disease marker
testing and blood components collected by participating organizations
into a research database. The combined database will capture infectious
disease and risk factor information on nearly 60% of all blood donors
and donations in the country. Following successful completion of the
risk factor interviews and research database development, the
biovigilance network pilot can be expanded to include additional blood
centers and/or re-focused on other safety threats as warranted, such as
XMRV. This pilot biovigilance network will thereby establish a
standardized process for integration of information across blood
collection organizations.
The Specific Aims are to:
(1) Define consensus infectious disease testing classification
algorithms for HIV, HCV, HBV, and HTLV that can be used to consistently
classify donation testing results across blood collection organizations
in the U.S. This will allow for better estimates of infection disease
marker prevalence and incidence in the U.S.
(2) Determine current behavioral risk factors associated with
prevalent and incident (when possible) HIV, HCV, HBV and HTLV
infections in blood donors, including parenteral and sexual risks,
across the participating blood collection organizations using a case-
control study design.
(3) Determine nationally-representative infectious disease marker
prevalence and incidence for HIV, HCV, HBV, and HTLV overall and by
demographic characteristics of donors. This will be accomplished by
forming research databases from operational data at BSI and NYBC into
formats that can be combined with the ARC research database.
(4) Analyze integrated risk factor and infectious marker testing
data together because when taken together these may show that blood
centers are not achieving the same degree of success in educational
efforts to prevent donation by donors with risk behaviors across all
demographic groups.
Frequency of Response: Once. Affected Public: Individuals. Type of
Respondents: Adult blood donors. The annual reporting burden is as
follows: Estimated Number of Respondents:4150; Estimated Number of
Responses per Respondent: 1; Average Burden of Hours per Response: 0.58
and Estimated Total Annual Burden Hours Requested: 2407. The annualized
cost to respondents is estimated at: $43,326 (based on $18 per hour).
There are no Capital Costs to report. There are no Operating or
Maintenance Costs to report.
Table 1-1--Estimates of Hour Burden
----------------------------------------------------------------------------------------------------------------
Number of Frequency of Average time Annual hour
Type of respondents respondents response per response burden
----------------------------------------------------------------------------------------------------------------
Cases........................................... 1650 1 0.58 957
Controls........................................ 2500 1 0.58 1450
---------------------------------------------------------------
Total....................................... 4150 .............. .............. 2407
----------------------------------------------------------------------------------------------------------------
Table 1-2--Annualized Cost to Respondents
----------------------------------------------------------------------------------------------------------------
Average time
Type of respondents Number of Frequency of per Hourly wage Respondent
respondents response respondents rate cost
----------------------------------------------------------------------------------------------------------------
Cases........................... 1650 1 0.58 $18 17,226
Controls........................ 2500 1 0.58 18 26,100
-------------------------------------------------------------------------------
Total....................... 4150 .............. .............. .............. 43,326
----------------------------------------------------------------------------------------------------------------
Request for Comments: Written comments and/or suggestions from the
public and affected agencies should address one or more of the
following points: (1) Evaluate 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) Evaluate 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) Enhance the
quality, utility, and clarity of the information to be collected; and
(4) Minimize 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.
Direct Comments to OMB: Written comments and/or suggestions
regarding the item(s) contained in this notice, especially regarding
the estimated
[[Page 79008]]
public burden and associated response time, should be directed to the:
Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: Desk
Officer for NIH. To request more information on the proposed project or
to obtain a copy of the data collection plans and instruments, contact:
Dr. Simone Glynn, Project Officer, NHLBI, Two Rockledge Center, Room
9142, 6701 Rockledge Drive, Bethesda, MD 20892-7950, or call 301-435-
0065, or E-mail your request to glynnsa@nhlbi.nih.gov.
Comments Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 30 days
of the date of this publication.
Dated: December 16, 2010.
Simone Glynn,
Branch Chief, Transfusion Medicine and Cellular Therapeutics Branch,
Division of Blood Diseases and Resources, National Heart, Lung, and
Blood Institute, NIH.
[FR Doc. 2010-31734 Filed 12-16-10; 8:45 am]
BILLING CODE 4140-01-P
