[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]


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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
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                                                                                                                                             Estimated
                                                                                             Number of       Number of    Average burden   total annual
                  Form name                               Type of respondent                respondents    responses per   per response    burden hours
                                                                                                            respondent                       requested
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ACASI Questionnaire--Informed Consent.......  Adults....................................             275               1           10/60              46
ACASI Questionnaire.........................  Adults....................................             275               1           40/60             183
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    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