Federal Register / Vol. 80, No. 67 / Wednesday, April 8, 2015 / Notices 18853 

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: 

http://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 

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. HIVpositive donors will be interviewed to 

evaluate their follow-up activities with 

regard to HIV infection treatment and 

infection transmission prevention 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
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 

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 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. 

ESTIMATED ANNUALIZED BURDEN HOURS

Form name Type of 

respondent 

Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

Estimated 

total annual 

burden hours 

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] 

<FNP> 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

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. 

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., 

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. 


asabaliauskas on DSK5VPTVN1PROD with NOTICES