National Institute of Dental & Craniofacial Research; Notice of Closed Meetings, 18411-18412 [2015-07739]

Download as PDF 18411 Federal Register / Vol. 80, No. 65 / Monday, April 6, 2015 / Notices for drugs. Dr. Ruth Day, a social scientist researcher at Duke University, has worked as a special government employee on the labeling for drugs. Ron Charnock is CEO of Kwikpoint, which is a visual language developer for instructions for use. His company worked on a Cooperative Research and Development Agreement with the Center for Devices and Radiological Health to determine if visual language could be used in lieu of words on certain portions of device labeling. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN Number of respondents Number of responses per respondent Total annual responses Average burden per response Screener ........................................................................... Health care professionals participating at a hospital ....... Health care professionals participating at FDA ............... 60 24 12 1 1 1 60 24 12 0.08 1.5 3.5 5 36 42 .................... .................... $240 Total .......................................................................... .................... .................... .................... .................... 83 $240 Type of respondent 1 Numbers have been rounded. We plan to screen approximately 60 potential respondents prior to being included in the study. The screener will be done using email. We estimate that the screener will only take approximately 5 minutes per person. We will conduct the studies at three different sites including two area hospitals using their devices, existing labeling, and HCPs. We expect that the maximum time for testing will be 1.5 hours. Given a sample of 6 devices with 2 different labeling types, there will be 12 different labeling types to be tested. We plan to have 24 people test each type of the labeling. We will also conduct the studies on FDA’s campus using medical devices received from medical device industry representatives through a material transfer agreement. To account for travel time we have included 2 additional hours per response in the burden estimate for the 12 health care professionals participating at FDA. Dated: March 31, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–07817 Filed 4–3–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health tkelley on DSK4VPTVN1PROD with NOTICES Center for Scientific Review; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. 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 VerDate Sep<11>2014 Capital costs Total hours 1 18:14 Apr 03, 2015 Jkt 235001 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: Center for Scientific Review Special Emphasis Panel; RFA–OD– 15–001: Building Interdisciplinary Research Careers in Women’s Health K12s. Date: April 28, 2015. Time: 11:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health; 6701 Rockledge Drive; Bethesda, MD 20892; (Virtual Meeting). Contact Person: Suzanne Ryan, Ph.D.; Scientific Review Officer; Center for Scientific Review; National Institutes of Health; 6701 Rockledge Drive, Room 3139, MSC 7770; Bethesda, MD 20892; (301) 435– 1712; ryansj@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Conference and Meetings: Office of Research Infrastructure Programs (ORIP). Date: April 29, 2015. Time: 3:00 p.m. to 4:40 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health; 6701 Rockledge Drive; Bethesda, MD 20892; (Telephone Conference Call). Contact Person: Cathleen L Cooper, Ph.D.; Scientific Review Officer; Center for Scientific Review; National Institutes of Health; 6701 Rockledge Drive, Room 4208, MSC 7812; Bethesda, MD 20892; 301–443– 4512; cooperc@csr.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393–93.396, 93.837–93.844, 93.846–93.878, 93.892, 93.893, National Institutes of Health, HHS) PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 Dated: March 31, 2015. Michelle Trout, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2015–07740 Filed 4–3–15; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Dental & Craniofacial Research; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. 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 Institute of Dental and Craniofacial Research Special Emphasis Panel Review of UH2 grant applications. Date: May 5–6, 2015. Time: 8:00 a.m. to 2:00 p.m. Agenda: To review and evaluate grant applications. Place: Crowne Plaza Washington National Airport, 1489 Jefferson Davis Hwy, Arlington, VA 20220. Contact Person: Savvas C Makrides, Ph.D., Scientific Review Officer, Scientific Review Branch, National Institute of Dental and Craniofacial Research, National Institutes of Health, 6701 Democracy Boulevard, Suite E:\FR\FM\06APN1.SGM 06APN1 18412 Federal Register / Vol. 80, No. 65 / Monday, April 6, 2015 / Notices 672, Bethesda, MD 20892, 301–594–4859, makridessc@mail.nih.gov. Name of Committee: National Institute of Dental and Craniofacial Research; Special Emphasis Panel, Oral Health Disparities in Children: Data Coordinating Center (U01). Date: May 6, 2015. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Crowne Plaza Washington National Airport, 1489 Crystal Drive, Arlington, VA 20220. Contact Person: Jayalakshmi Raman, Ph.D., Scientific Review Officer, Scientific Review Branch, National Institute of Dental and Craniofacial Research, One Democracy Plaza, Room 670, Bethesda, MD 20892–4878, 301– 594–2904, ramanj@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.121, Oral Diseases and Disorders Research, National Institutes of Health, HHS) Dated: March 31, 2015. David Clary, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2015–07739 Filed 4–3–15; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2015–N–0001] Blood Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. tkelley on DSK4VPTVN1PROD with NOTICES ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). At least one portion of the meeting will be closed to the public. Name of Committee: Blood Products Advisory Committee. General Function of the Committee: To provide advice and recommendations to the Agency on FDA’s regulatory issues. Date and Time: The meeting will be held on May 13, 2015, from 8 a.m. to 5:30 p.m. Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm.1503), Silver Spring, MD 20993– 0002. For those unable to attend in person, the meeting will also be available via Web cast. The Web cast will be available at the following link: https://collaboration.fda.gov/bpac2015/. When accessing the Web cast please enter as a guest. Answers to commonly asked questions including information VerDate Sep<11>2014 18:14 Apr 03, 2015 Jkt 235001 regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: https://www.fda.gov/Advisory Committees/AboutAdvisoryCommittees/ ucm408555.htm. Contact Person: Bryan Emery or Joanne Lipkind, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 6132, Silver Spring, MD 20993–0002, 240– 402–8054 or 240–402–8129, or FDA Advisory Committee Information Line, (1–800–741–8138 (301–443–0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency’s Web site at https://www.fda. gov/AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. Agenda: On May 13, 2015, the Blood Products Advisory Committee will meet in open session to discuss strategies for implementation of serological and nucleic acid testing for Babesia microti in blood donors. In the afternoon, the committee will hear update presentations on the following topics: (1) FDA considerations for Hemoglobin S Testing in blood donors; and (2) FDA considerations for a revised blood donor deferral policy for men who have sex with men. Following the update presentations, the committee will hear presentations on the research programs of the Laboratory of Cellular Hematology, Division of Hematology Research and Review, Office of Blood Research and Review, Center for Biologics Evaluation and Research, FDA. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting. Background material is available at https://www.fda.gov/ AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee meeting link. Procedure: On May 13, 2015, from 8:30 a.m. to approximately 5 p.m., the meeting is open to the public. Interested PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before May 6, 2015. Oral presentations from the public on May 13, 2015, will be scheduled between approximately 11:15 a.m. and 12:15 p.m. and 4:30 p.m. until 5 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before April 28, 2015. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by April 29, 2015. Closed Committee Deliberations: On May 13, 2015, from approximately 5 p.m. to 5:30 p.m., the meeting will be closed to the public to permit discussion where disclosure would constitute a clearly unwarranted invasion of personal privacy (5 U.S.C. 552b(c) (6)). The committee will discuss the site visit report of the intramural research programs of the Laboratory of Cellular Hematology and make recommendations regarding personnel staffing decisions. Persons attending FDA’s advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets. Seating for this meeting may be limited, so the public is encouraged to watch the free Web cast if you are unable to attend. The Web cast will be available at 8:30 a.m. on May 13, 2015, at the link provided. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Bryan Emery at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at https://www.fda.gov/Advisory Committees/AboutAdvisoryCommittees/ ucm111462.htm for procedures on public conduct during advisory committee meeting. E:\FR\FM\06APN1.SGM 06APN1

Agencies

[Federal Register Volume 80, Number 65 (Monday, April 6, 2015)]
[Notices]
[Pages 18411-18412]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-07739]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institute of Dental & Craniofacial Research; Notice of 
Closed Meetings

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as 
amended (5 U.S.C. App.), notice is hereby given of the following 
meetings.
    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 Institute of Dental and Craniofacial 
Research Special Emphasis Panel Review of UH2 grant applications.
    Date: May 5-6, 2015.
    Time: 8:00 a.m. to 2:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: Crowne Plaza Washington National Airport, 1489 Jefferson 
Davis Hwy, Arlington, VA 20220.
    Contact Person: Savvas C Makrides, Ph.D., Scientific Review 
Officer, Scientific Review Branch, National Institute of Dental and 
Craniofacial Research, National Institutes of Health, 6701 Democracy 
Boulevard, Suite

[[Page 18412]]

672, Bethesda, MD 20892, 301-594-4859, makridessc@mail.nih.gov.

    Name of Committee: National Institute of Dental and Craniofacial 
Research; Special Emphasis Panel, Oral Health Disparities in 
Children: Data Coordinating Center (U01).
    Date: May 6, 2015.
    Time: 8:00 a.m. to 5:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: Crowne Plaza Washington National Airport, 1489 Crystal 
Drive, Arlington, VA 20220.
    Contact Person: Jayalakshmi Raman, Ph.D., Scientific Review 
Officer, Scientific Review Branch, National Institute of Dental and 
Craniofacial Research, One Democracy Plaza, Room 670, Bethesda, MD 
20892-4878, 301-594-2904, ramanj@mail.nih.gov.

(Catalogue of Federal Domestic Assistance Program Nos. 93.121, Oral 
Diseases and Disorders Research, National Institutes of Health, HHS)

    Dated: March 31, 2015.
David Clary,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2015-07739 Filed 4-3-15; 8:45 am]
BILLING CODE 4140-01-P

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