Proposed Collection; 60-Day Comment Request; HIV Study in Blood Donors From Five Chinese Regions, 33764-33765 [2014-13724]
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33764
Federal Register / Vol. 79, No. 113 / Thursday, June 12, 2014 / Notices
Dated: June 5, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–13637 Filed 6–11–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
rmajette on DSK7SPTVN1PROD with NOTICES
Proposed Collection; 60-Day Comment
Request; HIV Study in Blood Donors
From Five Chinese Regions
Summary: In compliance with the
requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
for opportunity for public comment on
proposed data collection projects, the
National Heart, Lung, and Blood
Institute (NHLBI), the National
Institutes of Health (NIH), will publish
periodic summaries of proposed
projects to the Office of Management
and Budget (OMB) for review and
approval.
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 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 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.
To Submit Comments And For
Further Information: To obtain a copy of
the data collection plans and
instruments, submit comments in
writing, or request more information on
the proposed project, contact: Simone
Glynn, MD, Project Officer/ICD Contact,
Two Rockledge Center, Suite 9142, 6701
Rockledge Drive, Bethesda, MD 20892,
or call 301–435–0065, or Email your
request, including your address to:
glynnsa@nhlbi.nih.gov. Formal requests
for additional plans and instruments
must be requested in writing.
Comment 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.
VerDate Mar<15>2010
21:18 Jun 11, 2014
Jkt 232001
Proposed Collection: HIV Study in
Blood Donors from Five Chinese
Regions, 0925–0596 reinstatement with
change, National Heart, Lung and Blood
Institute (NHLBI).
Need and Use of Information
Collection: This Study is a reinstatement
of OMB Number: 0925–0596 expiration
date, January 31, 2012. To better
understand the diversifying and
changing Human Immunodeficiency
Virus (HIV) epidemic, and
contemporary HIV risk factors,
especially those associated with recent
HIV infections, this HIV risk factor
study in China is proposed as part of the
Recipient Epidemiology and Donor
Evaluation Study-III (REDS–III). The
major objectives of the study will be to
evaluate the proportion of blood donors
in China who test positive for HIV and
have acquired their infection recently or
more remotely; the risk of releasing a
blood product that contains HIV (HIV
residual risk); and the risk factors
associated with HIV infection in China.
The study will also assess the frequency
of distinct HIV–1 viral lineages and drug
resistant mutations among HIV-positive
blood donors. In 2011, there were
780,000 people infected with HIV in
China and it is estimated that over
300,000 HIV infected people in China
are not aware of their infection status.
The large migrating population and the
complexity of HIV transmission routes
in China make it difficult to implement
a comprehensive and effective national
HIV control strategy. Risk factors for
infections can change over time; thus,
identifying factors that contribute to the
recent spread of HIV in a broad crosssection of an otherwise unselected
general population, such as blood
donors, is highly important for
obtaining a complete picture of the
epidemiology of HIV infection in China.
Because the pace of globalization means
infections can cross borders easily, the
study objectives have direct relevance
for HIV control in the U.S. and globally.
Recent years have seen an increase in
blood donations from repeat donors in
most Chinese regions. This increase
permits longer-term follow-up and
testing of repeat donors which allow for
calculation of new HIV infection rates
and residual risks. The HIV data, for
both recently and remotely acquired
infections, from the proposed study will
complement existing data on HIV risks
obtained from general and high risk
populations to provide comprehensive
HIV surveillance data for China. This
study will also monitor genetic
characteristics of recently acquired
infections through genotyping and drug
resistance testing, thus serving a U.S.
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
and global public health imperative to
monitor the genotypes of HIV that have
recently been transmitted. For HIV, the
additional monitoring of drug resistance
patterns in newly acquired infection is
critical to determine if currently
available antiretroviral medicines are
capable of combating infection.
Genotyping and host response
information are scientifically important
not only to China, but to the U.S. and
other nations since they provide a
broader global understanding of how to
most effectively manage and potentially
prevent HIV, for example through
vaccine development. Efforts to develop
vaccines funded by the National
Institutes of Health and other U.S.-based
organizations may directly benefit from
the findings of this study.
Blood donors are tested for
transfusion-transmissible infections
including HIV when they present to
donate, and test result information as
well as demographic data will be
routinely collected in a database at the
five blood centers participating in
REDS–III studies (located in the cities of
Chongqing, Liuzhou, Luoyang,
Mianyang, and Urumqi). These data will
allow for calculation of HIV incidence,
prevalence, and residual risk.
Additionally, a case-control study will
be conducted over a 2 and 1/2 year
period to evaluate the risk factors
associated with HIV infection among
blood donors. Cases will be defined as
potential donors who deny risks on the
donor screening questionnaire but are
found to be positive on HIV testing
(their donation is discarded). HIVpositive donors who gave blood at one
of the five blood centers as stated above
(primary sites) or at blood centers
located in the Guangxi Autonomous
Region (peripheral sites, recruited
through the Guangxi CDC for this study
only but not other REDS–III studies)
will be eligible to participate and
complete a Risk Factor Questionnaire
that will assess general demographic
and risk factor information pertinent to
HIV infection. Controls will be negative
for HIV on confirmatory testing.
Assuming 50% response rate, it is
anticipated that 390 HIV-positive
donors and 960 controls will participate
in the case control study. The results of
this study will contribute to global HIV
surveillance and prevention, provide a
broader global understanding of HIV
epidemiology, and support public
health efforts to most effectively manage
and potentially prevent HIV
transmission both worldwide and in the
U.S.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
E:\FR\FM\12JNN1.SGM
12JNN1
33765
Federal Register / Vol. 79, No. 113 / Thursday, June 12, 2014 / Notices
estimated annualized burden hours are
450.
ESTIMATED ANNUALIZED BURDEN HOURS
Type of
respondents
Form name
HIV Risk factor Q ....
Blood
Blood
Blood
Blood
Blood
Number of
respondents
donors—Case Primary Sites ...........................
donors—Case peripheral sites ........................
donors—Control primary sites .........................
donors—Control—peripheral sites ..................
donors—total ...................................................
Dated: May 29, 2014.
Keith Hoots,
Director, Division of Blood Diseases and
Resources, National Heart, Lung, and Blood
Institute, NIH.
Dated: May 29, 2014.
Lynn Susulske,
NHLBI Project Clearance Liaison, National
Institutes of Health.
[FR Doc. 2014–13724 Filed 6–11–14; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day
Comment Request; The National
Diabetes Education Program (NDEP)
Comprehensive Evaluation Plan
Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institute of Diabetes and Digestive and
Kidney Diseases (NIDDK), the National
Institutes of Health (NIH) has submitted
to the Office of Management and Budget
(OMB) a request for review and
approval of the information collection
listed below. This proposed information
collection was previously published in
the Federal Register on March 19 2014,
pages 15351 and 15351[FR DOC #:
2014–06064], and allowed 60 days for
public comment. There was 1 public
comment received. 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
SUMMARY:
Number of
responses per
respondent
210
180
540
420
1,350
1
1
1
1
1
required to respond to, an information
collection that has been extended,
revised, or implemented on or after
October 1, 1995, unless it displays a
currently valid OMB control number.
Direct Comments To Omb: Written
comments and/or suggestions regarding
the item(s) contained in this notice,
especially regarding the estimated
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: NIH Desk Officer.
DATES: Comment 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.
FOR FURTHER INFORMATION CONTACT: To
obtain a copy of the data collection
plans and instruments or request more
information on the proposed project
contact: Ms. Joanne Gallivan, M.S., R.D.,
Director, National Diabetes Education
Program, OCPL, NIDDK, 31 Center
Drive, MSC 2560, Bethesda, MD 20892,
or call non-toll-free number 301–496–
6110, or Email your request, including
your address to: joanne_gallivan@
nih.gov. Formal requests for additional
plans and instruments must be
requested in writing.
Proposed Collection: The National
Diabetes Education Program (NDEP)
Comprehensive Evaluation Plan, 0925–
0552, Expiration Date 10/31/2015,
REVISION, National Institute of
Diabetes and Digestive and Kidney
Disease (NIDDK), National Institutes of
Health (NIH).
Average
burden per
response
(in hours)
20/60
20/60
20/60
20/60
20/60
Total annual
burden hours
70
60
180
140
450
Need and Use of Information
Collection: The National Diabetes
Education Program (NDEP) is a
partnership of the National Institutes of
Health (NIH) and the Centers for Disease
Control and Prevention (CDC) and more
than 200 public and private
organizations. The long-term goal of the
NDEP is to reduce the burden of
diabetes and pre-diabetes in the United
States, and its territories, by facilitating
the adoption of proven strategies to
prevent or delay the onset of diabetes
and its complications.
The NDEP evaluation will document
the extent to which the NDEP program
has been implemented and how
successful it has been in meeting
program objectives, outlined in the
NDEP Strategic Plan. The evaluation
relies heavily on data gathered from
existing national surveys such as
National Health and Nutrition
Examination Survey (NHANES), the
National Health Interview Survey
(NHIS), the Behavioral Risk Factor
Surveillance System (BRFSS), among
others for this information. This is a
continued collection of additional
primary data from NDEP target
audiences on some key process and
impact measures that are necessary to
effectively evaluate the program. The
audiences targeted by the NDEP include
people at risk for diabetes, people with
diabetes and their families, and the
public.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
841.
rmajette on DSK7SPTVN1PROD with NOTICES
ESTIMATED ANNUALIZED BURDEN HOURS
Estimated
number of
respondents
Type of respondent and instrument
Adults—Pretest surveys ..................................................................................
Adults—Surveys ..............................................................................................
VerDate Mar<15>2010
21:18 Jun 11, 2014
Jkt 232001
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
Estimated
number of
responses per
respondent
25
2500
E:\FR\FM\12JNN1.SGM
1
1
12JNN1
Average time
per response
(in hours)
20/60
20/60
Estimated total
annual burden
hours
8
833
]]>Agencies
[Federal Register Volume 79, Number 113 (Thursday, June 12, 2014)]
[Notices]
[Pages 33764-33765]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-13724]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment Request; HIV Study in Blood
Donors From Five Chinese Regions
Summary: In compliance with the requirement of Section
3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity
for public comment on proposed data collection projects, the National
Heart, Lung, and Blood Institute (NHLBI), the National Institutes of
Health (NIH), will publish periodic summaries of proposed projects to
the Office of Management and Budget (OMB) for review and approval.
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 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 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.
To Submit Comments And For Further Information: To obtain a copy of
the data collection plans and instruments, submit comments in writing,
or request more information on the proposed project, contact: Simone
Glynn, MD, Project Officer/ICD Contact, Two Rockledge Center, Suite
9142, 6701 Rockledge Drive, Bethesda, MD 20892, or call 301-435-0065,
or Email your request, including your address to:
glynnsa@nhlbi.nih.gov. Formal requests for additional plans and
instruments must be requested in writing.
Comment 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.
Proposed Collection: HIV Study in Blood Donors from Five Chinese
Regions, 0925-0596 reinstatement with change, National Heart, Lung and
Blood Institute (NHLBI).
Need and Use of Information Collection: This Study is a
reinstatement of OMB Number: 0925-0596 expiration date, January 31,
2012. To better understand the diversifying and changing Human
Immunodeficiency Virus (HIV) epidemic, and contemporary HIV risk
factors, especially those associated with recent HIV infections, this
HIV risk factor study in China is proposed as part of the Recipient
Epidemiology and Donor Evaluation Study-III (REDS-III). The major
objectives of the study will be to evaluate the proportion of blood
donors in China who test positive for HIV and have acquired their
infection recently or more remotely; the risk of releasing a blood
product that contains HIV (HIV residual risk); and the risk factors
associated with HIV infection in China. The study will also assess the
frequency of distinct HIV-1 viral lineages and drug resistant mutations
among HIV-positive blood donors. In 2011, there were 780,000 people
infected with HIV in China and it is estimated that over 300,000 HIV
infected people in China are not aware of their infection status. The
large migrating population and the complexity of HIV transmission
routes in China make it difficult to implement a comprehensive and
effective national HIV control strategy. Risk factors for infections
can change over time; thus, identifying factors that contribute to the
recent spread of HIV in a broad cross-section of an otherwise
unselected general population, such as blood donors, is highly
important for obtaining a complete picture of the epidemiology of HIV
infection in China. Because the pace of globalization means infections
can cross borders easily, the study objectives have direct relevance
for HIV control in the U.S. and globally. Recent years have seen an
increase in blood donations from repeat donors in most Chinese regions.
This increase permits longer-term follow-up and testing of repeat
donors which allow for calculation of new HIV infection rates and
residual risks. The HIV data, for both recently and remotely acquired
infections, from the proposed study will complement existing data on
HIV risks obtained from general and high risk populations to provide
comprehensive HIV surveillance data for China. This study will also
monitor genetic characteristics of recently acquired infections through
genotyping and drug resistance testing, thus serving a U.S. and global
public health imperative to monitor the genotypes of HIV that have
recently been transmitted. For HIV, the additional monitoring of drug
resistance patterns in newly acquired infection is critical to
determine if currently available antiretroviral medicines are capable
of combating infection. Genotyping and host response information are
scientifically important not only to China, but to the U.S. and other
nations since they provide a broader global understanding of how to
most effectively manage and potentially prevent HIV, for example
through vaccine development. Efforts to develop vaccines funded by the
National Institutes of Health and other U.S.-based organizations may
directly benefit from the findings of this study.
Blood donors are tested for transfusion-transmissible infections
including HIV when they present to donate, and test result information
as well as demographic data will be routinely collected in a database
at the five blood centers participating in REDS-III studies (located in
the cities of Chongqing, Liuzhou, Luoyang, Mianyang, and Urumqi). These
data will allow for calculation of HIV incidence, prevalence, and
residual risk. Additionally, a case-control study will be conducted
over a 2 and 1/2 year period to evaluate the risk factors associated
with HIV infection among blood donors. Cases will be defined as
potential donors who deny risks on the donor screening questionnaire
but are found to be positive on HIV testing (their donation is
discarded). HIV-positive donors who gave blood at one of the five blood
centers as stated above (primary sites) or at blood centers located in
the Guangxi Autonomous Region (peripheral sites, recruited through the
Guangxi CDC for this study only but not other REDS-III studies) will be
eligible to participate and complete a Risk Factor Questionnaire that
will assess general demographic and risk factor information pertinent
to HIV infection. Controls will be negative for HIV on confirmatory
testing. Assuming 50% response rate, it is anticipated that 390 HIV-
positive donors and 960 controls will participate in the case control
study. The results of this study will contribute to global HIV
surveillance and prevention, provide a broader global understanding of
HIV epidemiology, and support public health efforts to most effectively
manage and potentially prevent HIV transmission both worldwide and in
the U.S.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total
[[Page 33765]]
estimated annualized burden hours are 450.
Estimated Annualized Burden Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
Form name Type of respondents Number of responses per per response Total annual
respondents respondent (in hours) burden hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
HIV Risk factor Q.............................. Blood donors--Case Primary Sites....... 210 1 20/60 70
Blood donors--Case peripheral sites.... 180 1 20/60 60
Blood donors--Control primary sites.... 540 1 20/60 180
Blood donors--Control--peripheral sites 420 1 20/60 140
Blood donors--total.................... 1,350 1 20/60 450
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dated: May 29, 2014.
Keith Hoots,
Director, Division of Blood Diseases and Resources, National Heart,
Lung, and Blood Institute, NIH.
Dated: May 29, 2014.
Lynn Susulske,
NHLBI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2014-13724 Filed 6-11-14; 8:45 am]
BILLING CODE 4140-01-P
