Proposed Collection; 60-Day Comment Request, 18853-18854 [2015-07980]
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asabaliauskas on DSK5VPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 67 / Wednesday, April 8, 2015 / Notices
legitimate biological research that generates
information and technologies that could be
misused to pose a biological threat to public
health and/or national security.
The meeting will be open to the public and
will also be webcast as space will be limited.
Persons planning to attend or view via the
webcast may pre-register online using the
link provided below or by calling Palladian
Partners, Inc. (Contact: Monica Barnette at
301–650–8660). Online and telephone
registration will close at 12:00 p.m. Eastern
on May 4, 2015. After that time, attendees
may register onsite on the day of the meeting.
Individuals who plan to attend and need
special assistance, such as sign language
interpretation or other reasonable
accommodations, should indicate these
requirements upon registration.
Please Note: The meeting agenda, proposed
draft framework, and links to the online
registration and webcast will be available at:
https://osp.od.nih.gov/office-biotechnologyactivities/biosecurity/nsabb/nsabb-meetingsand-conferences. Please check this Web site
for updates.
Public Comments: Time will be allotted on
the agenda for oral public comment, with
individual presentations time-limited to
facilitate broad input from multiple speakers.
Any member of the public interested in
presenting comments relevant to the mission
of the NSABB should indicate so upon
registration. Sign-ups for oral comments will
be restricted to one per person or
organization representative per comment
period. In the event that time does not allow
for all attendees interested in presenting oral
comments to do so at the meeting, any
interested person may file written comments
with the Board via an email sent to nsabb@
od.nih.gov or by regular mail sent to the
Contact Person listed on this notice. In
addition, any interested person may submit
written comments to the NSABB at any time
via either of these methods. Comments
received by 5:00 p.m. Eastern on April 28,
2015 will be relayed to the Board prior to the
NSABB meeting. Written statements should
include the name, address, telephone number
and when applicable, the professional
affiliation of the interested person. Any
written comments received after the deadline
will be provided to the Board either before
or after the meeting, depending on the
volume of comments received and the time
required to process them in accordance with
privacy regulations and other applicable
Federal policies.
Please Note: In the interest of security, NIH
has instituted stringent procedures for
entrance onto the NIH campus. All visitor
vehicles, including taxis, hotel, and airport
shuttles will be inspected before being
allowed on campus. Visitors will be asked to
show one form of identification (for example,
a government-issued photo ID, driver’s
license, or passport) and to state the purpose
of their visit.
Dated: April 2, 2015.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2015–07981 Filed 4–7–15; 8:45 am]
BILLING CODE 4140–01–P
VerDate Sep<11>2014
17:55 Apr 07, 2015
Jkt 235001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment
Request
The effectiveness of donor
notification, HIV counseling, and
linkage of HIV positive donors to health
care in Brazil (NHLBI).
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.
DATES: 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: The
effectiveness of donor notification, HIV
counseling, and linkage of HIV positive
donors to health care in Brazil (The
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
18853
Brazil Notification Study), 0925–New,
National Heart, Lung and Blood
Institute (NHLBI).
Need and Use of Information
Collection: The prevention of
transfusion-associated transmission of
HIV is one of the greatest success stories
in the fight against the HIV epidemic;
however, the job is unfinished. In some
middle-and low-income countries,
blood transfusion may account for up to
6% of HIV infections (1). Currently, all
blood donors who test positive or
inconclusive for HIV or other sexually
transmitted diseases are notified (donor
notification) and requested to follow-up
with the blood bank for potential
confirmatory testing and referral to
specific health services, such as
monitoring and treatment. Little is
known about the consequences of blood
donor notification and subsequent
monitoring and counseling on efforts to
control the HIV epidemic in the United
States and internationally. The Brazil
Notification Study team proposed to
addresses this significant information
gap by enrolling all former blood donors
who participated in the REDS–II HIV
case-control study (OMB 0925–0597,
expired on February 29, 2012) and those
enrolled during the REDS–III HIV case
surveillance risk factor study (OMB
0925–0597, expiration date, July 31,
2015), between 2012 and 2014. Donor
enrollees at any of the four blood
centers participating in these studies
completed an audio computer-assisted
structured interview (ACASI) that
elicited responses on demographics, risk
factors/behaviors, and HIV knowledge.
At the same time, a blood sample was
drawn and tested for HIV genotype and
drug resistance. In addition, recent
infection status was determined using
detuned antibody testing of samples
from the original blood donation. All
enrolled participants received
counseling by a blood bank physician
and were referred to HIV counseling and
testing centers (HCT).
New information gathered from these
enrollees will serve the three aims
proposed for this proposed study. The
first aim of this study will be to analyze
the actual percentage of blood donors
who are successfully notified of their
infection testing results. In this aim, we
will expand the notification focus to
include all infections that blood centers
in Brazil test for because differences in
rates of notification by type of infection
are unknown. The second aim will
assess the effectiveness of HIV
notification and counseling. HIVpositive donors will be interviewed to
evaluate their follow-up activities with
regard to HIV infection treatment and
infection transmission prevention
E:\FR\FM\08APN1.SGM
08APN1
18854
Federal Register / Vol. 80, No. 67 / Wednesday, April 8, 2015 / Notices
behavior after notification by the blood
center. This will be accomplished using
a new audio computer-assisted
structured interview (ACASI) (See
Attachment 1, Brazil HIV Follow up
ACASI Survey). The third aim will
consist of asking HIV-positive blood
donors about ways to improve the
disclosure of HIV risks during donor
eligibility assessment to better
understand the motivating factors that
drive higher risk persons to donate
blood.
Because our study will build off the
routine blood donor procedures in four
large blood banks in Brazil, it may lead
to more informed conversations around
and possible changes in donor
screening, notification and counseling
policies in Latin America. Results of
these three aims may also help to better
integrate blood centers within the
context of broader HIV testing,
counseling and treatment sites in Brazil.
Similarly, in the US little is known
about donor behavior after notification
In addition to the traditional route of
scientific dissemination through peer
reviewed scientific publication,
previous REDS and REDS–II study data
were the subject of numerous requested
presentations by Federal and nonFederal agencies, including the FDA
Blood Products Advisory Committee,
the HHS Advisory committee on Blood
Safety and Availability, the AABB
Transfusion-Transmitted Diseases
Committee, and the Americas Blood
Centers (ABC). We anticipate similar
requests for results generated from this
study. Data collected in this proposed
HIV Notification study of donors will be
of practical use to the blood banking
and infectious disease communities in
the U.S. and internationally.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
229.
of testing results by blood centers. The
results from this study can be used to
develop insights and hypotheses
focused on developing improved
strategies for notification and
counseling of HIV-positive (or hepatitis
C or B-positive) donors in the U.S.
This proposed study’s findings will
also yield insights into improved
methods for donor self-selection and
qualification post donation, which will
serve to decrease the frequency of
higher-risk persons acting as donors.
Our findings on improved methods for
Brazilian donor notification and linkage
to health care services may also be
applicable to developed countries,
including the U.S. Results of the Brazil
Notification Study will identify how to
improve notification and counseling
strategies that increase the number of
HIV-positive donors seeking prompt
medical care. This might ultimately
boost strategies to prevent secondary
HIV transmission and reduce the risk of
transfusion-transmission.
ESTIMATED ANNUALIZED BURDEN HOURS
Form name
Type of
respondent
ACASI Questionnaire—Informed Consent ..............
ACASI Questionnaire ...............................................
Adults ........................
Adults ........................
Dated: April 2, 2015.
Lynn Susulske,
NHLBI Project Clearance Liaison, National
Institutes of Health.
[FR Doc. 2015–07980 Filed 4–7–15; 8:45 am]
<FNP>
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
asabaliauskas on DSK5VPTVN1PROD with NOTICES
National Institute of Diabetes and
Digestive and Kidney Diseases; Notice
of Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of meetings of the National
Diabetes and Digestive and Kidney
Diseases Advisory Council.
The meetings will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
VerDate Sep<11>2014
17:55 Apr 07, 2015
Jkt 235001
Number of
respondents
275
275
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 Diabetes and
Digestive and Kidney Diseases Advisory
Council.
Date: May 13, 2015.
Open: 8:30 a.m. to 12:00 p.m.
Agenda: To present the Director’s Report
and other scientific presentations.
Place: National Institutes of Health,
Building 31, 31 Center Drive, Conference
Room 10, Bethesda, MD 20892.
Closed: 4:15 p.m. to 4:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Building 31, 31 Center Drive, Conference
Room 10, Bethesda, MD 20892.
Contact Person: Brent B. Stanfield, Ph.D.,
Director, Division of Extramural Activities,
National Institutes of Diabetes and Digestive
and Kidney Diseases, 6707 Democracy Blvd.,
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
1
1
Average
burden per
response
10/60
40/60
Estimated
total annual
burden hours
requested
46
183
Room 715, MSC 5452, Bethesda, MD 20892,
(301) 594–8843, stanfibr@niddk.nih.gov.
Name of Committee: National Diabetes and
Digestive and Kidney Diseases Advisory
Council; Kidney, Urologic and Hematologic
Diseases Subcommittee.
Date: May 13, 2015.
Open: 1:00 p.m. to 2:00 p.m.
Agenda: To review the Division’s scientific
and planning activities.
Place: National Institutes of Health,
Building 31, 31 Center Drive, Conference
Room 7, Bethesda, MD 20892.
Closed: 2:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Building 31, 31 Center Drive, Conference
Room 7, Bethesda, MD 20892.
Contact Person: Brent B. Stanfield, Ph.D.,
Director, Division of Extramural Activities,
National Institutes of Diabetes and Digestive
and Kidney Diseases, 6707 Democracy Blvd.,
Room 715, MSC 5452, Bethesda, MD 20892,
(301) 594–8843, stanfibr@niddk.nih.gov.
Name of Committee: National Diabetes and
Digestive and Kidney Diseases Advisory
Council; Digestive Diseases and Nutrition
Subcommittee.
Date: May 13, 2015
Open: 1:00 p.m. to 2:30 p.m.
Agenda: To review the Division’s scientific
and planning activities.
E:\FR\FM\08APN1.SGM
08APN1
]]>Agencies
[Federal Register Volume 80, Number 67 (Wednesday, April 8, 2015)]
[Notices]
[Pages 18853-18854]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-07980]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment Request
The effectiveness of donor notification, HIV counseling, and
linkage of HIV positive donors to health care in Brazil (NHLBI).
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.
DATES: 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: The effectiveness of donor notification, HIV
counseling, and linkage of HIV positive donors to health care in Brazil
(The Brazil Notification Study), 0925-New, National Heart, Lung and
Blood Institute (NHLBI).
Need and Use of Information Collection: The prevention of
transfusion-associated transmission of HIV is one of the greatest
success stories in the fight against the HIV epidemic; however, the job
is unfinished. In some middle-and low-income countries, blood
transfusion may account for up to 6% of HIV infections (1). Currently,
all blood donors who test positive or inconclusive for HIV or other
sexually transmitted diseases are notified (donor notification) and
requested to follow-up with the blood bank for potential confirmatory
testing and referral to specific health services, such as monitoring
and treatment. Little is known about the consequences of blood donor
notification and subsequent monitoring and counseling on efforts to
control the HIV epidemic in the United States and internationally. The
Brazil Notification Study team proposed to addresses this significant
information gap by enrolling all former blood donors who participated
in the REDS-II HIV case-control study (OMB 0925-0597, expired on
February 29, 2012) and those enrolled during the REDS-III HIV case
surveillance risk factor study (OMB 0925-0597, expiration date, July
31, 2015), between 2012 and 2014. Donor enrollees at any of the four
blood centers participating in these studies completed an audio
computer-assisted structured interview (ACASI) that elicited responses
on demographics, risk factors/behaviors, and HIV knowledge. At the same
time, a blood sample was drawn and tested for HIV genotype and drug
resistance. In addition, recent infection status was determined using
detuned antibody testing of samples from the original blood donation.
All enrolled participants received counseling by a blood bank physician
and were referred to HIV counseling and testing centers (HCT).
New information gathered from these enrollees will serve the three
aims proposed for this proposed study. The first aim of this study will
be to analyze the actual percentage of blood donors who are
successfully notified of their infection testing results. In this aim,
we will expand the notification focus to include all infections that
blood centers in Brazil test for because differences in rates of
notification by type of infection are unknown. The second aim will
assess the effectiveness of HIV notification and counseling. HIV-
positive donors will be interviewed to evaluate their follow-up
activities with regard to HIV infection treatment and infection
transmission prevention
[[Page 18854]]
behavior after notification by the blood center. This will be
accomplished using a new audio computer-assisted structured interview
(ACASI) (See Attachment 1, Brazil HIV Follow up ACASI Survey). The
third aim will consist of asking HIV-positive blood donors about ways
to improve the disclosure of HIV risks during donor eligibility
assessment to better understand the motivating factors that drive
higher risk persons to donate blood.
Because our study will build off the routine blood donor procedures
in four large blood banks in Brazil, it may lead to more informed
conversations around and possible changes in donor screening,
notification and counseling policies in Latin America. Results of these
three aims may also help to better integrate blood centers within the
context of broader HIV testing, counseling and treatment sites in
Brazil. Similarly, in the US little is known about donor behavior after
notification of testing results by blood centers. The results from this
study can be used to develop insights and hypotheses focused on
developing improved strategies for notification and counseling of HIV-
positive (or hepatitis C or B-positive) donors in the U.S.
This proposed study's findings will also yield insights into
improved methods for donor self-selection and qualification post
donation, which will serve to decrease the frequency of higher-risk
persons acting as donors. Our findings on improved methods for
Brazilian donor notification and linkage to health care services may
also be applicable to developed countries, including the U.S. Results
of the Brazil Notification Study will identify how to improve
notification and counseling strategies that increase the number of HIV-
positive donors seeking prompt medical care. This might ultimately
boost strategies to prevent secondary HIV transmission and reduce the
risk of transfusion-transmission.
In addition to the traditional route of scientific dissemination
through peer reviewed scientific publication, previous REDS and REDS-II
study data were the subject of numerous requested presentations by
Federal and non-Federal agencies, including the FDA Blood Products
Advisory Committee, the HHS Advisory committee on Blood Safety and
Availability, the AABB Transfusion-Transmitted Diseases Committee, and
the Americas Blood Centers (ABC). We anticipate similar requests for
results generated from this study. Data collected in this proposed HIV
Notification study of donors will be of practical use to the blood
banking and infectious disease communities in the U.S. and
internationally.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 229.
Estimated Annualized Burden Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Estimated
Number of Number of Average burden total annual
Form name Type of respondent respondents responses per per response burden hours
respondent requested
--------------------------------------------------------------------------------------------------------------------------------------------------------
ACASI Questionnaire--Informed Consent....... Adults.................................... 275 1 10/60 46
ACASI Questionnaire......................... Adults.................................... 275 1 40/60 183
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dated: April 2, 2015.
Lynn Susulske,
NHLBI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2015-07980 Filed 4-7-15; 8:45 am]
BILLING CODE 4140-01-P
