National Institute on Deafness and Other Communication Disorders; Notice of Closed Meetings, 52696-52697 [2016-18864]

Download as PDF asabaliauskas on DSK3SPTVN1PROD with NOTICES 52696 Federal Register / Vol. 81, No. 153 / Tuesday, August 9, 2016 / Notices comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.fda.gov/ regulatoryinformation/dockets/ default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Evella Washington, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1535, Silver Spring, MD 20993–0002, 301–796–6683, Evella.Washington@fda.hhs.gov, 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. SUPPLEMENTARY INFORMATION: Agenda: On September 20 and 21, 2016, the Committee will discuss and make recommendations regarding the classification of certain wound care products containing antimicrobials and other drugs as part of the routine process for device classification. These products are regulated under product code FRO, ‘‘Dressing, Wound, Drug,’’ and are considered ‘‘pre-amendments’’ because they were in commercial distribution prior to May 28, 1976, when the Medical Devices Amendments were enacted, and have not yet been classified under section 513 of the Federal Food, Drug, and Cosmetic Act. As a part of the classification process, FDA is seeking committee input on the indications for use, risks to health, and safety and effectiveness of these wound VerDate Sep<11>2014 20:00 Aug 08, 2016 Jkt 238001 care products, and how they should be classified. They may be classified in class I (general controls), class II (special and general controls), or class III (premarket approval (PMA), requiring demonstration of safety and effectiveness for each product). FDA believes some of these products may meet the definition of class II whereas others may meet the definition of class III in light of their intended use, composition, the extent of evidence of clinical benefit, and the risks they pose. For the subset of the these products that contain antibiotics, FDA appreciates the importance of appropriately addressing the risk of antimicrobial resistance (AMR) in light of the increasingly significant national public health concern posed by AMR. FDA is also aware of differences in the claims made for some products even though they may be regulated in the same manner. FDA intends to make background material available to the public on its Web site at least 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 meeting, and the background material will be posted on FDA’s Web site after the meeting. Background material will be available at https://www.fda.gov/ AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee meeting link. Procedure: Interested 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 September 6, 2016. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. on September 20 and between approximately 9 a.m. and 10:30 a.m. on September 21, 2016. 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 August 26, 2016. 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 PO 00000 Frm 00087 Fmt 4703 Sfmt 4703 notify interested persons regarding their request to speak by August 29, 2016. Persons attending FDA’s advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets. FDA is establishing a docket for public comment on this document. The docket number is FDA–2016–N–2147. The docket will close on October 20, 2016. Comments received on or before September 1, 2016, will be provided to the committee. Comments received after that date will be taken into consideration by the Agency. For press inquiries, please contact the Office of Media Affairs at fdaoma@ fda.hhs.gov or 301–796–4540. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact AnnMarie Williams at AnnMarie.Williams@ fda.hhs.gov, or 301–796–5966 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/ AdvisoryCommittees/ AboutAdvisoryCommittees/ ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: August 3, 2016. Janice M. Soreth, Acting Associate Commissioner, Special Medical Programs. [FR Doc. 2016–18814 Filed 8–8–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Deafness and Other Communication Disorders; 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 E:\FR\FM\09AUN1.SGM 09AUN1 Federal Register / Vol. 81, No. 153 / Tuesday, August 9, 2016 / Notices asabaliauskas on DSK3SPTVN1PROD with NOTICES individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute on Deafness and Other Communication Disorders Special Emphasis Panel; NIDCD Institutional Research Training Grant Application Review. Date: September 7, 2016. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Embassy Suites at the Chevy Chase Pavilion, 4300 Military Road NW., Washington, DC 20015. Contact Person: Shiguang Yang, DVM, Ph.D., Scientific Review Officer Division of Extramural Activities NIDCD, NIH, 6001 Executive Blvd., Room 8349, Bethesda, MD 20892, 301–496–8683, yangshi@ nidcd.nih.gov. Name of Committee: National Institute on Deafness and Other Communication Disorders Special Emphasis Panel; NIDCD Clinical Research Center Grant (P50) Review. Date: September 14, 2016. Time: 11:00 a.m. to 3:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852 (Telephone Conference Call). Contact Person: Katherine Shim, Ph.D., Scientific Review Officer, Division of Extramural Activities, NIH/NIDCD, 6001 Executive Blvd., Room 8351, Bethesda, MD 20892, 301–496–8683, katherine.shim@ nih.gov. Name of Committee: National Institute on Deafness and Other Communication Disorders, Special Emphasis Panel; P50 Review Meeting. Date: September 19, 2016. Time: 2:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852 (Telephone Conference Call). Contact Person: Kausik Ray, Ph.D., Scientific Review Officer, National Institute on Deafness and Other Communication Disorders, National Institutes of Health, Rockville, MD 20850, 301–402–3587, rayk@ nidcd.nih.gov. Name of Committee: National Institute on Deafness and Other Communication Disorders, Special Emphasis Panel; Revised CRC Grant Review. Date: September 20, 2016. Time: 11:00 a.m. to 2:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852 (Telephone Conference Call). Contact Person: Sheo Singh, Ph.D., Scientific Review Officer, Scientific Review Branch, Division of Extramural Activities, 6001 Executive Blvd., Room 8351, Bethesda, VerDate Sep<11>2014 20:00 Aug 08, 2016 Jkt 238001 52697 MD 20892, 301–496–8683, singhs@ nidcd.nih.gov. Name of Committee: National Institute on Deafness and Other Communication Disorders Special Emphasis Panel; VSL Clinical Trial Review. Date: September 22, 2016. Time: 11:00 a.m. to 12:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852 (Telephone Conference Call). Contact Person: Shiguang Yang, DVM, Ph.D., Scientific Review Officer, Division of Extramural Activities, NIDCD, NIH, 6001 Executive Blvd., Room 8349, Bethesda, MD 20892, 301–496–8683, yangshi@ nidcd.nih.gov. Name of Committee: National Institute on Deafness and Other Communication Disorders, Special Emphasis Panel; Synaptopathy R01 Review. Date: October 4, 2016. Time: 1:00 p.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852 (Telephone Conference Call). Contact Person: Kausik Ray, Ph.D., Scientific Review Officer, National Institute on Deafness and Other Communication Disorders, National Institutes of Health, Rockville, MD 20850, 301–402–3587, rayk@ nidcd.nih.gov. Name of Committee: Communication Disorders Review Committee. Date: October 6–7, 2016. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda, MD 20814. Contact Person: Eliane Lazar-Wesley, Scientific Review Officer, Division of Extramural Activities, National Institute on Deafness and other Communication Disorders/NIH, 6001 Executive Blvd., MSC 9670, Bethesda, MD 20892–8401, 301–496– 8683, el6r@nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.173, Biological Research Related to Deafness and Communicative Disorders, National Institutes of Health, HHS) DEPARTMENT OF HEALTH AND HUMAN SERVICES Dated: August 3, 2016. Sylvia L. Neal, Program Analyst, Office of Federal Advisory Committee Policy. DEPARTMENT OF HEALTH AND HUMAN SERVICES [FR Doc. 2016–18864 Filed 8–8–16; 8:45 am] Government-Owned Inventions; Availability for Licensing BILLING CODE 4140–01–P PO 00000 National Institutes of Health Center for Scientific Review; Notice of Closed Meeting 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 meeting. The meeting 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: Center for Scientific Review Special Emphasis Panel; Risk, Prevention, and Health Behavior. Date: August 11, 2016. Time: 10:00 a.m. to 11:00 a.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Martha M. Faraday, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3110, MSC 7808, Bethesda, MD 20892, faradaym@ csr.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. (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) Dated: August 4, 2016. Carolyn Baum, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2016–18865 Filed 8–8–16; 8:45 am] BILLING CODE 4140–01–P National Institutes of Health AGENCY: National Institutes of Health, HHS. ACTION: Frm 00088 Fmt 4703 Sfmt 4703 E:\FR\FM\09AUN1.SGM Notice. 09AUN1

Agencies

[Federal Register Volume 81, Number 153 (Tuesday, August 9, 2016)]
[Notices]
[Pages 52696-52697]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-18864]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institute on Deafness and Other Communication Disorders; 
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

[[Page 52697]]

individuals associated with the grant applications, the disclosure of 
which would constitute a clearly unwarranted invasion of personal 
privacy.

    Name of Committee: National Institute on Deafness and Other 
Communication Disorders Special Emphasis Panel; NIDCD Institutional 
Research Training Grant Application Review.
    Date: September 7, 2016.
    Time: 8:00 a.m. to 5:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: Embassy Suites at the Chevy Chase Pavilion, 4300 Military 
Road NW., Washington, DC 20015.
    Contact Person: Shiguang Yang, DVM, Ph.D., Scientific Review 
Officer Division of Extramural Activities NIDCD, NIH, 6001 Executive 
Blvd., Room 8349, Bethesda, MD 20892, 301-496-8683, 
yangshi@nidcd.nih.gov.

    Name of Committee: National Institute on Deafness and Other 
Communication Disorders Special Emphasis Panel; NIDCD Clinical 
Research Center Grant (P50) Review.
    Date: September 14, 2016.
    Time: 11:00 a.m. to 3:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, Neuroscience Center, 6001 
Executive Boulevard, Rockville, MD 20852 (Telephone Conference 
Call).
    Contact Person: Katherine Shim, Ph.D., Scientific Review 
Officer, Division of Extramural Activities, NIH/NIDCD, 6001 
Executive Blvd., Room 8351, Bethesda, MD 20892, 301-496-8683, 
katherine.shim@nih.gov.

    Name of Committee: National Institute on Deafness and Other 
Communication Disorders, Special Emphasis Panel; P50 Review Meeting.
    Date: September 19, 2016.
    Time: 2:00 p.m. to 5:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, Neuroscience Center, 6001 
Executive Boulevard, Rockville, MD 20852 (Telephone Conference 
Call).
    Contact Person: Kausik Ray, Ph.D., Scientific Review Officer, 
National Institute on Deafness and Other Communication Disorders, 
National Institutes of Health, Rockville, MD 20850, 301-402-3587, 
rayk@nidcd.nih.gov.

    Name of Committee: National Institute on Deafness and Other 
Communication Disorders, Special Emphasis Panel; Revised CRC Grant 
Review.
    Date: September 20, 2016.
    Time: 11:00 a.m. to 2:30 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, Neuroscience Center, 6001 
Executive Boulevard, Rockville, MD 20852 (Telephone Conference 
Call).
    Contact Person: Sheo Singh, Ph.D., Scientific Review Officer, 
Scientific Review Branch, Division of Extramural Activities, 6001 
Executive Blvd., Room 8351, Bethesda, MD 20892, 301-496-8683, 
singhs@nidcd.nih.gov.

    Name of Committee: National Institute on Deafness and Other 
Communication Disorders Special Emphasis Panel; VSL Clinical Trial 
Review.
    Date: September 22, 2016.
    Time: 11:00 a.m. to 12:30 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, Neuroscience Center, 6001 
Executive Boulevard, Rockville, MD 20852 (Telephone Conference 
Call).
    Contact Person: Shiguang Yang, DVM, Ph.D., Scientific Review 
Officer, Division of Extramural Activities, NIDCD, NIH, 6001 
Executive Blvd., Room 8349, Bethesda, MD 20892, 301-496-8683, 
yangshi@nidcd.nih.gov.

    Name of Committee: National Institute on Deafness and Other 
Communication Disorders, Special Emphasis Panel; Synaptopathy R01 
Review.
    Date: October 4, 2016.
    Time: 1:00 p.m. to 4:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, Neuroscience Center, 6001 
Executive Boulevard, Rockville, MD 20852 (Telephone Conference 
Call).
    Contact Person: Kausik Ray, Ph.D., Scientific Review Officer, 
National Institute on Deafness and Other Communication Disorders, 
National Institutes of Health, Rockville, MD 20850, 301-402-3587, 
rayk@nidcd.nih.gov.

    Name of Committee: Communication Disorders Review Committee.
    Date: October 6-7, 2016.
    Time: 8:00 a.m. to 5:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda, 
MD 20814.
    Contact Person: Eliane Lazar-Wesley, Scientific Review Officer, 
Division of Extramural Activities, National Institute on Deafness 
and other Communication Disorders/NIH, 6001 Executive Blvd., MSC 
9670, Bethesda, MD 20892-8401, 301-496-8683, el6r@nih.gov.

(Catalogue of Federal Domestic Assistance Program Nos. 93.173, 
Biological Research Related to Deafness and Communicative Disorders, 
National Institutes of Health, HHS)

    Dated: August 3, 2016.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2016-18864 Filed 8-8-16; 8:45 am]
 BILLING CODE 4140-01-P
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