81 FR 52696 - National Institute on Deafness and Other Communication Disorders; Notice of Closed Meetings
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 81, Issue 153 (August 9, 2016)
National Institutes of Health
Federal Register Volume 81, Issue 153 (August 9, 2016)
| Page Range | 52696-52697 | |
| FR Document | 2016-18864 |
[Federal Register Volume 81, Number 153 (Tuesday, August 9, 2016)] [Notices] [Pages 52696-52697] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-18864] ----------------------------------------------------------------------- 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
![52696 Federal Register / Vol. 81, No. 153 / Tuesday, August 9, 2016 / Notices
comments and you must identify this care products, and how they should be notify interested persons regarding their
information as ‘‘confidential.’’ Any classified. They may be classified in request to speak by August 29, 2016.
information marked as ‘‘confidential’’ class I (general controls), class II (special Persons attending FDA’s advisory
will not be disclosed except in and general controls), or class III committee meetings are advised that the
accordance with 21 CFR 10.20 and other (premarket approval (PMA), requiring Agency is not responsible for providing
applicable disclosure law. For more demonstration of safety and access to electrical outlets.
information about FDA’s posting of effectiveness for each product). FDA is establishing a docket for
comments to public dockets, see 80 FR FDA believes some of these products public comment on this document. The
56469, September 18, 2015, or access may meet the definition of class II docket number is FDA–2016–N–2147.
the information at: http://www.fda.gov/ whereas others may meet the definition The docket will close on October 20,
regulatoryinformation/dockets/ of class III in light of their intended use, 2016. Comments received on or before
default.htm. composition, the extent of evidence of September 1, 2016, will be provided to
Docket: For access to the docket to clinical benefit, and the risks they pose. the committee. Comments received after
read background documents or the For the subset of the these products that that date will be taken into
electronic and written/paper comments contain antibiotics, FDA appreciates the consideration by the Agency.
received, go to http:// importance of appropriately addressing For press inquiries, please contact the
www.regulations.gov and insert the the risk of antimicrobial resistance Office of Media Affairs at fdaoma@
docket number, found in brackets in the (AMR) in light of the increasingly fda.hhs.gov or 301–796–4540.
heading of this document, into the significant national public health FDA welcomes the attendance of the
‘‘Search’’ box and follow the prompts concern posed by AMR. FDA is also public at its advisory committee
and/or go to the Division of Dockets aware of differences in the claims made meetings and will make every effort to
Management, 5630 Fishers Lane, Rm. for some products even though they accommodate persons with disabilities.
1061, Rockville, MD 20852. may be regulated in the same manner. If you require accommodations due to a
FOR FURTHER INFORMATION CONTACT: FDA intends to make background disability, please contact AnnMarie
Evella Washington, Center for Devices material available to the public on its Williams at AnnMarie.Williams@
and Radiological Health, Food and Drug Web site at least 2 business days before fda.hhs.gov, or 301–796–5966 at least 7
Administration, 10903 New Hampshire the meeting. If FDA is unable to post the days in advance of the meeting.
Ave., Bldg. 66, Rm. 1535, Silver Spring, background material on its Web site FDA is committed to the orderly
MD 20993–0002, 301–796–6683, prior to the meeting, the background conduct of its advisory committee
Evella.Washington@fda.hhs.gov, or FDA material will be made publicly available meetings. Please visit our Web site at
Advisory Committee Information Line, at the location of the meeting, and the http://www.fda.gov/
1–800–741–8138 (301–443–0572 in the background material will be posted on AdvisoryCommittees/
Washington, DC area). FDA’s Web site after the meeting. AboutAdvisoryCommittees/
A notice in the Federal Register about Background material will be available at ucm111462.htm for procedures on
last minute modifications that impact a http://www.fda.gov/ public conduct during advisory
previously announced advisory AdvisoryCommittees/Calendar/ committee meetings.
committee meeting cannot always be Notice of this meeting is given under
default.htm. Scroll down to the
published quickly enough to provide the Federal Advisory Committee Act (5
appropriate advisory committee meeting
timely notice. Therefore, you should U.S.C. app. 2).
link.
always check the Agency’s Web site at Procedure: Interested persons may Dated: August 3, 2016.
http://www.fda.gov/ present data, information, or views, Janice M. Soreth,
AdvisoryCommittees/default.htm and orally or in writing, on issues pending Acting Associate Commissioner, Special
scroll down to the appropriate advisory before the committee. Written Medical Programs.
committee meeting link, or call the submissions may be made to the contact [FR Doc. 2016–18814 Filed 8–8–16; 8:45 am]
advisory committee information line to person on or before September 6, 2016. BILLING CODE 4164–01–P
learn about possible modifications Oral presentations from the public will
before coming to the meeting. be scheduled between approximately 1
SUPPLEMENTARY INFORMATION: p.m. and 2 p.m. on September 20 and DEPARTMENT OF HEALTH AND
Agenda: On September 20 and 21, between approximately 9 a.m. and 10:30 HUMAN SERVICES
2016, the Committee will discuss and a.m. on September 21, 2016. Those
make recommendations regarding the individuals interested in making formal National Institutes of Health
classification of certain wound care oral presentations should notify the
National Institute on Deafness and
products containing antimicrobials and contact person and submit a brief
Other Communication Disorders;
other drugs as part of the routine statement of the general nature of the
Notice of Closed Meetings
process for device classification. These evidence or arguments they wish to
products are regulated under product present, the names and addresses of Pursuant to section 10(d) of the
code FRO, ‘‘Dressing, Wound, Drug,’’ proposed participants, and an Federal Advisory Committee Act, as
and are considered ‘‘pre-amendments’’ indication of the approximate time amended (5 U.S.C. App.), notice is
because they were in commercial requested to make their presentation on hereby given of the following meetings.
distribution prior to May 28, 1976, or before August 26, 2016. Time allotted The meetings will be closed to the
asabaliauskas on DSK3SPTVN1PROD with NOTICES
when the Medical Devices Amendments for each presentation may be limited. If public in accordance with the
were enacted, and have not yet been the number of registrants requesting to provisions set forth in sections
classified under section 513 of the speak is greater than can be reasonably 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
Federal Food, Drug, and Cosmetic Act. accommodated during the scheduled as amended. The grant applications and
As a part of the classification process, open public hearing session, FDA may the discussions could disclose
FDA is seeking committee input on the conduct a lottery to determine the confidential trade secrets or commercial
indications for use, risks to health, and speakers for the scheduled open public property such as patentable material,
safety and effectiveness of these wound hearing session. The contact person will and personal information concerning
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![Federal Register / Vol. 81, No. 153 / Tuesday, August 9, 2016 / Notices 52697
individuals associated with the grant MD 20892, 301–496–8683, singhs@ DEPARTMENT OF HEALTH AND
applications, the disclosure of which nidcd.nih.gov. HUMAN SERVICES
would constitute a clearly unwarranted Name of Committee: National Institute on
invasion of personal privacy. Deafness and Other Communication National Institutes of Health
Name of Committee: National Institute on Disorders Special Emphasis Panel; VSL
Clinical Trial Review. Center for Scientific Review; Notice of
Deafness and Other Communication
Disorders Special Emphasis Panel; NIDCD Date: September 22, 2016. Closed Meeting
Institutional Research Training Grant Time: 11:00 a.m. to 12:30 p.m. Pursuant to section 10(d) of the
Application Review. Agenda: To review and evaluate grant
Federal Advisory Committee Act, as
Date: September 7, 2016. applications.
Time: 8:00 a.m. to 5:00 p.m.
amended (5 U.S.C. App.), notice is
Place: National Institutes of Health,
Agenda: To review and evaluate grant hereby given of the following meeting.
Neuroscience Center, 6001 Executive
applications. The meeting will be closed to the
Boulevard, Rockville, MD 20852 (Telephone
Place: Embassy Suites at the Chevy Chase public in accordance with the
Conference Call).
Pavilion, 4300 Military Road NW.,
Contact Person: Shiguang Yang, DVM,
provisions set forth in sections
Washington, DC 20015.
Ph.D., Scientific Review Officer, Division of
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
Contact Person: Shiguang Yang, DVM, as amended. The grant applications and
Ph.D., Scientific Review Officer Division of Extramural Activities, NIDCD, NIH, 6001
Executive Blvd., Room 8349, Bethesda, MD the discussions could disclose
Extramural Activities NIDCD, NIH, 6001 confidential trade secrets or commercial
Executive Blvd., Room 8349, Bethesda, MD 20892, 301–496–8683, yangshi@
nidcd.nih.gov. property such as patentable material,
20892, 301–496–8683, yangshi@
nidcd.nih.gov. and personal information concerning
Name of Committee: National Institute on
individuals associated with the grant
Name of Committee: National Institute on Deafness and Other Communication
Deafness and Other Communication
applications, the disclosure of which
Disorders, Special Emphasis Panel;
Disorders Special Emphasis Panel; NIDCD would constitute a clearly unwarranted
Synaptopathy R01 Review.
Clinical Research Center Grant (P50) Review. Date: October 4, 2016.
invasion of personal privacy.
Date: September 14, 2016. Time: 1:00 p.m. to 4:00 p.m. Name of Committee: Center for Scientific
Time: 11:00 a.m. to 3:00 p.m. Agenda: To review and evaluate grant Review Special Emphasis Panel; Risk,
Agenda: To review and evaluate grant Prevention, and Health Behavior.
applications.
applications. Date: August 11, 2016.
Place: National Institutes of Health, Place: National Institutes of Health,
Time: 10:00 a.m. to 11:00 a.m.
Neuroscience Center, 6001 Executive Neuroscience Center, 6001 Executive
Agenda: To review and evaluate grant
Boulevard, Rockville, MD 20852 (Telephone Boulevard, Rockville, MD 20852 (Telephone applications.
Conference Call). Conference Call). Place: National Institutes of Health, 6701
Contact Person: Katherine Shim, Ph.D., Contact Person: Kausik Ray, Ph.D., Rockledge Drive, Bethesda, MD 20892
Scientific Review Officer, Division of Scientific Review Officer, National Institute (Telephone Conference Call).
Extramural Activities, NIH/NIDCD, 6001 on Deafness and Other Communication Contact Person: Martha M. Faraday, Ph.D.,
Executive Blvd., Room 8351, Bethesda, MD Disorders, National Institutes of Health, Scientific Review Officer, Center for
20892, 301–496–8683, katherine.shim@ Rockville, MD 20850, 301–402–3587, rayk@ Scientific Review, National Institutes of
nih.gov. nidcd.nih.gov. Health, 6701 Rockledge Drive, Room 3110,
Name of Committee: National Institute on MSC 7808, Bethesda, MD 20892, faradaym@
Name of Committee: Communication
Deafness and Other Communication csr.nih.gov.
Disorders, Special Emphasis Panel; P50 Disorders Review Committee. This notice is being published less than 15
Review Meeting. Date: October 6–7, 2016. days prior to the meeting due to the timing
Date: September 19, 2016. Time: 8:00 a.m. to 5:00 p.m. limitations imposed by the review and
Time: 2:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant funding cycle.
Agenda: To review and evaluate grant applications. (Catalogue of Federal Domestic Assistance
applications. Place: Residence Inn Bethesda, 7335 Program Nos. 93.306, Comparative Medicine;
Place: National Institutes of Health, Wisconsin Avenue, Bethesda, MD 20814. 93.333, Clinical Research, 93.306, 93.333,
Neuroscience Center, 6001 Executive Contact Person: Eliane Lazar-Wesley, 93.337, 93.393–93.396, 93.837–93.844,
Boulevard, Rockville, MD 20852 (Telephone Scientific Review Officer, Division of 93.846-93.878, 93.892, 93.893, National
Conference Call). Extramural Activities, National Institute on Institutes of Health, HHS)
Contact Person: Kausik Ray, Ph.D.,
Deafness and other Communication
Scientific Review Officer, National Institute Dated: August 4, 2016.
on Deafness and Other Communication Disorders/NIH, 6001 Executive Blvd., MSC
9670, Bethesda, MD 20892–8401, 301–496– Carolyn Baum,
Disorders, National Institutes of Health,
8683, el6r@nih.gov. Program Analyst, Office of Federal Advisory
Rockville, MD 20850, 301–402–3587, rayk@
Committee Policy.
nidcd.nih.gov. (Catalogue of Federal Domestic Assistance
Program Nos. 93.173, Biological Research [FR Doc. 2016–18865 Filed 8–8–16; 8:45 am]
Name of Committee: National Institute on
Deafness and Other Communication Related to Deafness and Communicative BILLING CODE 4140–01–P
Disorders, Special Emphasis Panel; Revised Disorders, National Institutes of Health, HHS)
CRC Grant Review.
Date: September 20, 2016. Dated: August 3, 2016. DEPARTMENT OF HEALTH AND
Time: 11:00 a.m. to 2:30 p.m. Sylvia L. Neal, HUMAN SERVICES
Agenda: To review and evaluate grant
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Program Analyst, Office of Federal Advisory
applications. Committee Policy. National Institutes of Health
Place: National Institutes of Health,
[FR Doc. 2016–18864 Filed 8–8–16; 8:45 am]
Neuroscience Center, 6001 Executive Government-Owned Inventions;
Boulevard, Rockville, MD 20852 (Telephone BILLING CODE 4140–01–P Availability for Licensing
Conference Call).
Contact Person: Sheo Singh, Ph.D., AGENCY: National Institutes of Health,
Scientific Review Officer, Scientific Review HHS.
Branch, Division of Extramural Activities, ACTION: Notice.
6001 Executive Blvd., Room 8351, Bethesda,
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Document Created: 2016-08-09 01:10:04
Document Modified: 2016-08-09 01:10:04
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Dates | September 7, 2016. | |
| FR Citation | 81 FR 52696 |
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