Office of the Director, Office of Science Policy, Office of Biotechnology Activities; Notice of Meeting, 18852-18853 [2015-07981]

Download as PDF 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 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. asabaliauskas on DSK5VPTVN1PROD with NOTICES AGENCY: 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 SUMMARY: VerDate Sep<11>2014 17:55 Apr 07, 2015 Jkt 235001 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. The comment period is extended and thus will end at 11:59 p.m., E.D.T. on May 8, 2015. DATES: 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. ADDRESSES: 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. PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 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 E:\FR\FM\08APN1.SGM 08APN1 asabaliauskas on DSK5VPTVN1PROD with NOTICES Federal Register / Vol. 80, No. 67 / Wednesday, April 8, 2015 / Notices 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: https://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 VerDate Sep<11>2014 17:55 Apr 07, 2015 Jkt 235001 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 PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 18853 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 E:\FR\FM\08APN1.SGM 08APN1

Agencies

[Federal Register Volume 80, Number 67 (Wednesday, April 8, 2015)]
[Notices]
[Pages 18852-18853]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-07981]


-----------------------------------------------------------------------

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

[[Page 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: 
https://osp.od.nih.gov/office-biotechnology-activities/biosecurity/nsabb/nsabb-meetings-and-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

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