[Federal Register Volume 80, Number 67 (Wednesday, April 8, 2015)]
[Notices]
[Pages 18853-18854]
From the Federal Register Online via the Government Publishing 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:
[email protected]. 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