80 FR 37277 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 80, Issue 125 (June 30, 2015)

Page Range		37277-37278
FR Document		2015-15841

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.

Federal Register, Volume 80 Issue 125 (Tuesday, June 30, 2015)

[Federal Register Volume 80, Number 125 (Tuesday, June 30, 2015)]
[Notices]
[Pages 37277-37278]
From the Federal Register Online  [www.thefederalregister.org]
[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
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                     Number of                          Estimated total
                Form name                         Type of respondent              Number of        responses per      Average burden     annual burden
                                                                                 respondents         respondent        per response     hours requested
--------------------------------------------------------------------------------------------------------------------------------------------------------
ACASI Questionnaire--Informed Consent...  Adults............................                275                  1              10/60                 46
ACASI Questionnaire.....................  Adults............................                275                  1              40/60                183
--------------------------------------------------------------------------------------------------------------------------------------------------------


    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

37278 Federal Register / Vol. 80, No. 125 / Tuesday, June 30, 2015 / Notices

drive higher risk persons to donate This proposed study’s findings will previous REDS and REDS–II study data
blood. also yield insights into improved were the subject of numerous requested
Because our study will build off the methods for donor self-selection and presentations by Federal and non-
routine blood donor procedures in four qualification post donation, which will Federal agencies, including the FDA
large blood banks in Brazil, it may lead serve to decrease the frequency of Blood Products Advisory Committee,
to more informed conversations around higher-risk persons acting as donors. the HHS Advisory committee on Blood
and possible changes in donor Our findings on improved methods for Safety and Availability, the AABB
screening, notification and counseling Brazilian donor notification and linkage Transfusion-Transmitted Diseases
policies in Latin America. Results of to health care services may also be Committee, and the Americas Blood
these three aims may also help to better applicable to developed countries, Centers (ABC). We anticipate similar
integrate blood centers within the including the US. Results of the Brazil requests for results generated from this
context of broader HIV testing, Notification Study will identify how to study. Data collected in this proposed
counseling and treatment sites in Brazil. improve notification and counseling HIV Notification study of donors will be
Similarly, in the US little is known strategies that increase the number of of practical use to the blood banking
about donor behavior after notification HIV-positive donors seeking prompt and infectious disease communities in
of testing results by blood centers. The medical care. This might ultimately
results from this study can be used to the US and internationally.
boost strategies to prevent secondary
develop insights and hypotheses HIV transmission and reduce the risk of OMB approval is requested for 3
focused on developing improved transfusion-transmission. years. There are no costs to respondents
strategies for notification and In addition to the traditional route of other than their time. The total
counseling of HIV-positive (or hepatitis scientific dissemination through peer estimated annualized burden hours are
C or B-positive) donors in the U.S. reviewed scientific publication, 229.

ESTIMATED ANNUALIZED BURDEN HOURS
Number of Estimated total
Type of Number of Average burden
Form name responses per annual burden
respondent respondents per response
respondent hours requested

ACASI Questionnaire—Informed Con- Adults ................... 275 1 10/60 46
sent.
ACASI Questionnaire ............................ Adults ................... 275 1 40/60 183

Dated: June 16, 2015. Date: July 6, 2015. (Catalogue of Federal Domestic Assistance
Valery Gheen, Time: 9:00 a.m. to 2:00 p.m. Program Nos. 93.306, Comparative Medicine;
NHLBI Project Clearance Liaison, National Agenda: To review and evaluate grant 93.333, Clinical Research, 93.306, 93.333,
Institutes of Health. applications. 93.337, 93.393–93.396, 93.837–93.844,
Place: National Institutes of Health, 6701 93.846–93.878, 93.892, 93.893, National
[FR Doc. 2015–15841 Filed 6–29–15; 8:45 am] Institutes of Health, HHS)
Rockledge Drive, Bethesda, MD 20892,
BILLING CODE 4140–01–P (Virtual Meeting). Dated: June 24, 2015.
Contact Person: Lawrence E. Boerboom, David Clary,
Ph.D., Chief, CVRS IRG, Center for Scientific
DEPARTMENT OF HEALTH AND Review, National Institutes of Health, 6701 Program Analyst, Office of Federal Advisory
HUMAN SERVICES Rockledge Drive, Room 4130, MSC 7814, Committee Policy.
Bethesda, MD 20892, (301) 435–8367, [FR Doc. 2015–15945 Filed 6–29–15; 8:45 am]
National Institutes of Health boerboom@nih.gov. BILLING CODE 4140–01–P
This notice is being published less than 15
Center for Scientific Review; Notice of days prior to the meeting due to the timing
Closed Meetings limitations imposed by the review and DEPARTMENT OF HEALTH AND
Pursuant to section 10(d) of the
funding cycle. HUMAN SERVICES
Federal Advisory Committee Act, as Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member National Institutes of Health
amended (5 U.S.C. App.), notice is
Conflicts: Asthma, Pulmonary Fibrosis and
hereby given of the following meetings. Center for Scientific Review; Notice of
Inflammation.
The meetings will be closed to the Date: July 6–7, 2015. Closed Meetings
public in accordance with the Time: 9:00 a.m. to 5:00 p.m.
provisions set forth in sections Agenda: To review and evaluate grant Pursuant to section 10(d) of the
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., applications. Federal Advisory Committee Act, as
as amended. The grant applications and Place: National Institutes of Health, 6701 amended (5 U.S.C. App.), notice is
the discussions could disclose Rockledge Drive, Bethesda, MD 20892, hereby given of the following meetings.
confidential trade secrets or commercial (Virtual Meeting). The meetings will be closed to the
property such as patentable material, Contact Person: Bradley Nuss, Ph.D., public in accordance with the
asabaliauskas on DSK5VPTVN1PROD with NOTICES

and personal information concerning Scientific Review Officer, Center for provisions set forth in sections
individuals associated with the grant Scientific Review, National Institutes of
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
Health, 6701 Rockledge Drive, Room 4142,
applications, the disclosure of which as amended. The grant applications and
MSC7814, Bethesda, MD 20892, 301–451–
would constitute a clearly unwarranted 8754, nussb@csr.nih.gov. the discussions could disclose
invasion of personal privacy. This notice is being published less than 15 confidential trade secrets or commercial
Name of Committee: Center for Scientific days prior to the meeting due to the timing property such as patentable material,
Review Special Emphasis Panel; Member limitations imposed by the review and and personal information concerning
Conflict: Respiratory Sciences. funding cycle. individuals associated with the grant

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Document Created: 2018-02-22 11:16:50
Document Modified: 2018-02-22 11:16:50

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
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.
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,
FR Citation		80 FR 37277

80 FR 37277 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 80, Issue 125 (June 30, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health