18852 Federal Register / Vol. 80, No. 67 / Wednesday, April 8, 2015 / Notices 

TABLE 2—AREAS OF INTEREST—IN VITRO DIAGNOSTIC AND RADIOLOGICAL DEVICES/TECHNOLOGY—Continued 

Focus area Specific areas of interest 

Antimicrobial susceptibility testing 

(AST).

Visit to a clinical laboratory that employs various AST methodologies for identification of antibiotic resistance. 

B. Site Selection 

CDRH will be responsible for CDRH 

staff travel expenses associated with the 

site visits. CDRH will not provide funds 

to support the training provided by the 

site to this ELP. Selection of potential 

facilities will be based on CDRH’s 

priorities for staff training and resources 

available to fund this program. In 

addition to logistical and other resource 

factors, all sites must have a successful 

compliance record with FDA or another 

Agency with which FDA has a 

memorandum of understanding. If a site 

visit involves a visit to a separate 

physical location of another firm under 

contract with the site, that firm must 

agree to participate in the ELP and must 

also have a satisfactory compliance 

history. 

III. Request for Participation 

Submit proposals for participation 

with the docket number found in the 

brackets in the heading of this 

document. Received requests may be 

seen in the Division of Dockets 

Management (see ADDRESSES) between 9 

a.m. and 4 p.m., Monday through 

Friday. 

Dated: April 2, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–08017 Filed 4–7–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

DEPARTMENT OF AGRICULTURE 

Solicitation of Written Comments on 

the Scientific Report of the 2015 

Dietary Guidelines Advisory 

Committee; Extension of Comment 

Period 

AGENCY: Office of the Assistant 

Secretary for Health, Office of the 

Secretary, Department of Health and 

Human Services; and Food, Nutrition 

and Consumer Services and Research, 

Education, and Economics. U.S. 

Department of Agriculture. 

ACTION: Notice. 

SUMMARY: A notice was published in the 

Federal Register on Monday, February 

23, 2015, Vol. 80, No. 35, pages 9465– 

9466 to announce the availability of the 

Scientific Report of the 2015 Dietary 

Guidelines Advisory Committee 

(Advisory Report) and to solicit written 

comments on the Advisory Report 

(among other things). In the notice dated 

February 23, 2015, it was announced 

that the due date for providing 

comments was April 8, 2015. This 

notice is to announce the extension of 

the solicitation period to allow for 

additional time for written comments to 

be submitted for consideration. 

DATES: The comment period is extended 

and thus will end at 11:59 p.m., E.D.T. 

on May 8, 2015. 

ADDRESSES: The Advisory Report is 

available on the Internet at 

www.DietaryGuidelines.gov. Written 

public comments on the Advisory 

Report can be submitted and/or viewed 

at www.DietaryGuidelines.gov using the 

‘‘Submit Comments’’ and ‘‘Read 

Comments’’ links, respectively. 

FOR FURTHER INFORMATION CONTACT: 

Designated Federal Officer (DFO), 2015 

DGAC, Richard D. Olson, M.D., M.P.H.; 

Office of Disease Prevention and Health 

Promotion, OASH/HHS; 1101 Wootton 

Parkway, Suite LL100 Tower Building; 

Rockville, MD 20852: Telephone: (240) 

453–8280; Fax: (240) 453–8281; 

Alternate DFO, 2015 DGAC, Kellie 

(O’Connell) Casavale, Ph.D., R.D., 

Nutrition Advisor; Office of Disease 

Prevention and Health Promotion, 

OASH/HHS; 1101 Wootton Parkway, 

Suite LL100 Tower Building; Rockville, 

MD 20852: Telephone: (240) 453–8280; 

Fax: (240) 453–8281; Lead USDA CoExecutive Secretary, Colette I. Rihane, 

M.S., R.D., Director, Office of Nutrition 

Guidance and Analysis, Center for 

Nutrition Policy and Promotion, USDA; 

3101 Park Center Drive, Room 1034; 

Alexandria, VA 22302; Telephone: (703) 

305–7600; Fax: (703) 305–3300; and/or 

USDA Co-Executive Secretary, Shanthy 

A. Bowman, Ph.D., Nutritionist, Food 

Surveys Research Group, Beltsville 

Human Nutrition Research Center, 

Agricultural Research Service, USDA; 

10300 Baltimore Avenue, BARC-West 

Bldg. 005, Room 125; Beltsville, MD 

20705–2350; Telephone: (301) 504– 

0619. 

Dated: March 24, 2015. 

Don Wright, 

Deputy Assistant Secretary for Health, Office 

of Disease Prevention and Health Promotion, 

Office of the Assistant Secretary for Health, 

U.S. Department of Health and Human 

Services. 

Dated: March 24, 2015. 

Angela Tagtow, 

Executive Director, Center for Nutrition Policy 

and Promotion, U.S. Department of 

Agriculture. 

Dated: March 23, 2015. 

Steven R. Shafer, 

Associate Administrator, Agricultural 

Research Service, U.S. Department of 

Agriculture. 

[FR Doc. 2015–08049 Filed 4–7–15; 8:45 am] 

BILLING CODE 4150–32–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Office of the Director, Office of Science 

Policy, Office of Biotechnology 

Activities; Notice of Meeting 

Pursuant to section 10(a) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the meeting of the 

National Science Advisory Board for 

Biosecurity (NSABB). 

Name of Committee: National Science 

Advisory Board for Biosecurity. 

Date: May 5, 2015. 

Time: 8:30 a.m.—3:30 p.m. Eastern. 

Agenda: Presentations and discussions 

regarding: (1) NSABB’s proposed framework 

for guiding risk and benefit assessments of 

gain-of-function (GOF) studies involving 

pathogens with pandemic potential; (2) 

overview of conducting the risk and benefit 

assessments; (3) planning for future NSABB 

deliberations on the GOF issue; and (4) other 

business of the Board. 

Place: National Institutes of Health, 9000 

Rockville Pike, Building 31, 6th Floor 

Conference 10, Bethesda, Maryland 20892. 

Contact Person: Carolyn Mosby, NSABB 

Program Assistant, NIH Office of 

Biotechnology Activities, 6705 Rockledge 

Drive, Suite 750, Bethesda, Maryland 20892, 

(301) 435–5504, carolyn.mosby@nih.gov. 

Under authority 42 U.S.C. 217a, Section 

222 of the Public Health Service Act, as 

amended, the Department of Health and 

Human Services established the National 

Science Advisory Board for Biosecurity 

(NSABB) to provide advice regarding federal 

oversight of dual use research, defined as 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
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 


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