[Federal Register Volume 80, Number 125 (Tuesday, June 30, 2015)]
[Notices]
[Pages 37277-37278]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-15841]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Review; 30-Day Comment Request; The 
Effectiveness of Donor Notification, HIV Counseling, and Linkage of HIV 
Positive Donors to Health Care in Brazil

AGENCY: National Heart, Lung and Blood Institute (NHLBI), National 
Institutes of Health (NIH), Department of Health and Human Services.

SUMMARY: Under the provisions of the Paperwork Reduction Act of 1995, 
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 April 8, 
2015, page 18853 and allowed 60-days for public comment. No public 
comments were received. The purpose of this notice is to allow an 
additional 30 days for public comment. The National Institutes of 
Health (NIH) 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 currently valid OMB control number.

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.

ADDRESSES: 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, [email protected] or by fax to 202-395-6974, 
Attention: NIH Desk Officer.

FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data 
collection plans and instruments 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.

SUPPLEMENTARY INFORMATION:
    Proposed Collection: The effectiveness of donor notification, HIV 
counseling, and linkage of HIV positive donors to health care in 
Brazil, 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 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

[[Page 37278]]

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 US. 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 US 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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                                                                                                     Number of                          Estimated total
                Form name                         Type of respondent              Number of        responses per      Average burden     annual burden
                                                                                 respondents         respondent        per response     hours 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: June 16, 2015.
Valery Gheen,
NHLBI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2015-15841 Filed 6-29-15; 8:45 am]
 BILLING CODE 4140-01-P