80_FR_58451 80 FR 58264 - National Institute on Deafness and Other Communication Disorders; Notice of Meeting

80 FR 58264 - National Institute on Deafness and Other Communication Disorders; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 80, Issue 187 (September 28, 2015)

Page Range58264-58265
FR Document2015-24545

Federal Register, Volume 80 Issue 187 (Monday, September 28, 2015) 
[Federal Register Volume 80, Number 187 (Monday, September 28, 2015)]
[Notices]
[Pages 58264-58265]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-24545]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institute on Deafness and Other Communication Disorders; 
Notice of Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as 
amended (5 U.S.C. App.), notice is hereby given of a meeting of the 
Board of Scientific Counselors, NIDCD.
    The meeting will be open to the public as indicated below, with 
attendance limited to space available. Individuals who plan to attend 
and need special assistance, such as sign language interpretation or 
other reasonable accommodations, should notify the Contact Person 
listed below in advance of the meeting.
    The meeting will be closed to the public in accordance with the 
provisions set forth in sections 552b(c)(6), title 5 U.S.C., as amended 
for the review, discussion, and evaluation of individual intramural 
programs and projects conducted by the NATIONAL INSTITUTE ON DEAFNESS 
AND OTHER COMMUNICATION DISORDERS, including consideration of personnel 
qualifications and performance, and the competence of individual 
investigators, the disclosure of which would constitute a clearly 
unwarranted invasion of personal privacy.

    Name of Committee: Board of Scientific Counselors, NIDCD.
    Date: October 26-27, 2015.
    Closed: October 26, 2015, 8:00 a.m. to 8:30 a.m.
    Agenda: To review and evaluate personal qualifications and 
performance, and competence of individual investigators.

[[Page 58265]]

    Place: National Institutes of Health, Porter Neuroscience 
Research Center, Room 610, Building 35A Convent Drive, Bethesda, MD 
20892.
    Open: October 26, 2015, 8:30 a.m. to 8:45 a.m.
    Agenda: Reports from the Institute staff.
    Place: National Institutes of Health, Porter Neuroscience 
Research Center, Room 610, Building 35A Convent Drive, Bethesda, MD 
20892.
    Closed: October 26, 2015, 8:45 a.m. to 4:40 p.m.
    Agenda: To review and evaluate personal qualifications and 
performance, and competence of individual investigators.
    Place: National Institutes of Health, Porter Neuroscience 
Research Center, Room 610, Building 35A Convent Drive, Bethesda, MD 
20892.
    Closed: October 27, 2015, 8:00 a.m. to 2:15 p.m.
    Agenda: To review and evaluate personal qualifications and 
performance, and competence of individual investigators.
    Place: National Institutes of Health, Porter Neuroscience 
Research Center, Room 610, Building 35A Convent Drive, Bethesda, MD 
20892.
    Contact Person: Andrew J. Griffith, Ph.D., MD, Director, 
Division of Intramural Research, National Institute on Deafness and 
Other Communication Disorders, 35A Convent Drive, GF 103, Rockville, 
MD 20892, 301-496-1960, [email protected].

    Any interested person may file written comments with the 
committee by forwarding the statement to the Contact Person listed 
on this notice. The statement should include the name, address, 
telephone number and when applicable, the business or professional 
affiliation of the interested person.
    In the interest of security, NIH has instituted stringent 
procedures for entrance onto the NIH campus. All visitor vehicles, 
including taxicabs, 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.
    Information is also available on the Institute's/Center's home 
page: http://www.nidcd.nih.gov/about/groups/bsc/, where an agenda 
and any additional information for the meeting will be posted when 
available.

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

    Dated: September 23, 2015.
Melanie J. Gray,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2015-24545 Filed 9-25-15; 8:45 am]
BILLING CODE 4140-01-P

58264 Federal Register / Vol. 80, No. 187 / Monday, September 28, 2015 / Notices $268,974,000. (Note: These numbers III. Fee Schedule for FY 2016 FDA’s normal procedures for timely exclude the President’s Emergency Plan The fee rate for FY 2016 is set out in payment of the PDUFA fee for the for AIDS Relief NDAs; no table 1: human drug application. investigational new drug (IND) review IV. Reference costs are included in this amount.) TABLE 1—RARE PEDIATRIC DISEASE Twenty-nine of these applications (20 The following reference has been PRIORITY REVIEW SCHEDULE FOR placed on display in the Division of NDAs and 9 BLAs) received priority FY 2016 review, which would mean that the Dockets Management (see ADDRESSES), remaining 19 received standard reviews. and may be seen by interested person Fee rate for Because a priority review compresses a Fee category FY 2016 between 9 a.m. and 4 p.m., Monday review schedule that ordinarily takes 10 through Friday. months into 6 months, FDA estimates Application submitted with a $2,727,000 1. Ridley, D. B., H. G. Grabowski, and J. L. rare pediatric disease priority Moe, ‘‘Developing Drugs for Developing that a multiplier of 1.67 (10 months review voucher in addition to Countries,’’ Health Affairs, vol. 25, no. 2, divided by 6 months) should be applied the normal PDUFA Fee. pp. 313–324, 2006. to non-priority review costs in estimating the effort and cost of a Dated: September 22, 2015. IV. Implementation of Rare Pediatric priority review as compared to a Leslie Kux, Disease Priority Review User Fee standard review. This multiplier is Associate Commissioner for Policy. consistent with published research on Under section 529(c)(4)(A) of the [FR Doc. 2015–24508 Filed 9–25–15; 8:45 am] this subject which supports a priority FD&C Act, the priority review user fee BILLING CODE 4164–01–P review multiplier in the range of 1.48 to is due (i.e. the obligation to pay the fee is incurred) when a sponsor notifies 2.35 (Ref. 1). The multiplier derived by FDA of its intent to use the voucher. DEPARTMENT OF HEALTH AND FDA falls well below the midpoint of Section 529(c)(4)(B) of the FD&C Act HUMAN SERVICES this range. Using FY 2014 figures, the specifies that the application will be costs of a priority and standard review considered incomplete if the priority National Institutes of Health are estimated using the following review user fee and all other applicable formula: user fees are not paid in accordance National Institute on Deafness and (29 a × 1.67) + (19 a) = $268,974,000 with FDA payment procedures. In Other Communication Disorders; addition, section 529(c)(4)(C) specifies Notice of Meeting Where ‘‘a’’ is the cost of a standard that FDA may not grant a waiver, review and ‘‘a times 1.67’’ is the cost of Pursuant to section 10(d) of the exemption, reduction, or refund of any a priority review. Using this formula, Federal Advisory Committee Act, as fees due and payable under this section the cost of a standard review for NME amended (5 U.S.C. App.), notice is of the FD&C Act. Beginning with FDA’s NDAs and BLAs is calculated to be hereby given of a meeting of the Board appropriation for FY 2015, the annual $3,989,000 (rounded to the nearest of Scientific Counselors, NIDCD. appropriation language states The meeting will be open to the thousand dollars) and the cost of a specifically that priority review user priority review for NME NDAs and public as indicated below, with fees authorized by 21 U.S.C. 360n and attendance limited to space available. BLAs is 1.67 times that amount, or 360ff (section 529 of the FD&C Act) Individuals who plan to attend and $6,662,000 (rounded to the nearest shall be credited to this account, to need special assistance, such as sign thousand dollars). The difference remain available until expended.’’ (Pub. language interpretation or other between these two cost estimates, or L. 113–235, Section 5, Division A, Title reasonable accommodations, should $2,673,000, represents the incremental VI). notify the Contact Person listed below cost of conducting a priority review The rare pediatric disease priority in advance of the meeting. rather than a standard review. review fee established in the new fee The meeting will be closed to the For the FY 2016 fee, FDA will need schedule must be paid for any public in accordance with the to adjust the FY 2014 incremental cost application that is received on or after provisions set forth in sections October 1, 2015. In order to comply 552b(c)(6), title 5 U.S.C., as amended for by the average amount by which FDA’s with this requirement, the sponsor must the review, discussion, and evaluation average costs increased in the 3 years contact FDA before providing official of individual intramural programs and prior to FY 2015, to adjust the FY 2014 notification of its intent to use the projects conducted by the NATIONAL amount for cost increases in FY 2015. voucher. That adjustment, published in the INSTITUTE ON DEAFNESS AND FDA will issue an invoice to the OTHER COMMUNICATION Federal Register on August 3, 2015 (see sponsor who has incurred a rare 80 FR 46028 at 46029), is 2.0266 percent DISORDERS, including consideration of pediatric disease priority review personnel qualifications and for the most recent year, not voucher fee when it receives the compounded. Increasing the FY 2014 performance, and the competence of sponsor’s notification of intent to use individual investigators, the disclosure incremental priority review cost of the voucher. The invoice will include $2,673,000 by 2.0266 percent results in of which would constitute a clearly instructions on how to pay the fee via unwarranted invasion of personal an estimated cost of $2,727,000 wire transfer or check. (rounded to the nearest thousand privacy. As noted in section II, if a sponsor dollars). This is the rare pediatric Name of Committee: Board of Scientific tkelley on DSK3SPTVN1PROD with NOTICES uses a rare pediatric disease priority disease priority review user fee amount review voucher for a human drug Counselors, NIDCD. for FY 2016 that must be submitted with Date: October 26–27, 2015. application, the sponsor would incur Closed: October 26, 2015, 8:00 a.m. to 8:30 a priority review voucher for a human the rare pediatric disease priority review a.m. drug application in FY 2016, in addition voucher fee in addition to any PDUFA Agenda: To review and evaluate personal to any PDUFA fee that is required for fee that is required for the application. qualifications and performance, and such an application. The sponsor would need to follow competence of individual investigators. VerDate Sep<11>2014 17:19 Sep 25, 2015 Jkt 235001 PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 E:\FR\FM\28SEN1.SGM 28SEN1

Federal Register / Vol. 80, No. 187 / Monday, September 28, 2015 / Notices 58265 Place: National Institutes of Health, Porter DEPARTMENT OF HEALTH AND as amended. The grant applications and Neuroscience Research Center, Room 610, HUMAN SERVICES the discussions could disclose Building 35A Convent Drive, Bethesda, MD confidential trade secrets or commercial 20892. National Institutes of Health property such as patentable material, Open: October 26, 2015, 8:30 a.m. to 8:45 and personal information concerning a.m. National Heart, Lung, and Blood individuals associated with the grant Agenda: Reports from the Institute staff. Institute; Notice of Closed Meeting applications, the disclosure of which Place: National Institutes of Health, Porter would constitute a clearly unwarranted Pursuant to section 10(d) of the Neuroscience Research Center, Room 610, invasion of personal privacy. Federal Advisory Committee Act, as Building 35A Convent Drive, Bethesda, MD 20892. amended (5 U.S.C. App.), notice is Name of Committee: Center for Scientific hereby given of the following meeting. Review Special Emphasis Panel; SBIB Closed: October 26, 2015, 8:45 a.m. to 4:40 Clinical Pediatric and Fetal Applications. p.m. The meeting will be closed to the public in accordance with the Date: October 21, 2015. Agenda: To review and evaluate personal Time: 11:00 a.m. to 5:00 p.m. qualifications and performance, and provisions set forth in sections Agenda: To review and evaluate grant competence of individual investigators. 552b(c)(4) and 552b(c)(6), title 5 U.S.C., applications. Place: National Institutes of Health, Porter as amended. The grant applications and Place: National Institutes of Health, 6701 Neuroscience Research Center, Room 610, the discussions could disclose Rockledge Drive, Bethesda, MD 20892. Building 35A Convent Drive, Bethesda, MD confidential trade secrets or commercial Contact Person: John Firrell, Ph.D., 20892. property such as patentable material, Scientific Review Officer, Center for and personal information concerning Scientific Review, National Institutes of Closed: October 27, 2015, 8:00 a.m. to 2:15 individuals associated with the grant Health, 6701 Rockledge Drive, Room 5118, p.m. MSC 7854, Bethesda, MD 20892, 301–435– Agenda: To review and evaluate personal applications, the disclosure of which 2598, firrellj@csr.nih.gov. qualifications and performance, and would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Healthcare Delivery competence of individual investigators. and Methodologies Integrated Review Group; Place: National Institutes of Health, Porter Name of Committee: National Heart, Lung, Biostatistical Methods and Research Design Neuroscience Research Center, Room 610, and Blood Institute Special Emphasis Panel; Study Section. Building 35A Convent Drive, Bethesda, MD NHLBI Summer Training R25 Review. Date: October 23, 2015. 20892. Date: October 20, 2015. Time: 8:00 a.m. to 5:00 p.m. Contact Person: Andrew J. Griffith, Ph.D., Time: 8:30 a.m. to 5:00 p.m. Agenda: To review and evaluate grant MD, Director, Division of Intramural Agenda: To review and evaluate grant applications. Research, National Institute on Deafness and applications. Place: Marriott Courtyard Gaithersburg Place: Hilton Garden Inn Bethesda, 7301 Washingtonian Ctr, 204 Boardwalk Place, Other Communication Disorders, 35A Waverly Street, Bethesda, MD 20814. Gaithersburg, MD 20878. Convent Drive, GF 103, Rockville, MD 20892, Contact Person: YingYing Li-Smerin, MD, Contact Person: Peter J. Kozel, Ph.D., 301–496–1960, griffita@nidcd.nih.gov. Ph.D., Scientific Review Officer, Office of Scientific Review Officer, Center for Any interested person may file written Scientific Review/DERA, National Heart, Scientific Review, National Institutes of comments with the committee by forwarding Lung, and Blood Institute, 6701 Rockledge Health, 6701 Rockledge Drive, Room 3139, the statement to the Contact Person listed on Drive, Room 7184, Bethesda, MD 20892– Bethesda, MD 20892, 301–435–1116, kozelp@ this notice. The statement should include the 7924, 301–435–0277, lismerin@nhlbi.nih.gov. mail.nih.gov. name, address, telephone number and when (Catalogue of Federal Domestic Assistance Name of Committee: Center for Scientific applicable, the business or professional Program Nos. 93.233, National Center for Review Special Emphasis Panel; RFA–CA– affiliation of the interested person. Sleep Disorders Research; 93.837, Heart and 15–006: Big Data to Knowledge (BD2K) In the interest of security, NIH has Vascular Diseases Research; 93.838, Lung Advancing Biomedical Science Using Diseases Research; 93.839, Blood Diseases Crowdsourcing and Interactive Digital Media instituted stringent procedures for entrance and Resources Research, National Institutes (UH2). onto the NIH campus. All visitor vehicles, Date: October 23, 2015. of Health, HHS) including taxicabs, hotel, and airport shuttles Time: 8:30 a.m. to 5:00 p.m. will be inspected before being allowed on Dated: September 22, 2015. Agenda: To review and evaluate grant campus. Visitors will be asked to show one Michelle Trout, applications. form of identification (for example, a Program Analyst, Office of Federal Advisory Place: Courtyard by Marriott, 5520 government-issued photo ID, driver’s license, Committee Policy. Wisconsin Avenue, Chevy Chase, MD 20815. or passport) and to state the purpose of their [FR Doc. 2015–24482 Filed 9–25–15; 8:45 am] Contact Person: Kee Hyang Pyon, Ph.D., visit. BILLING CODE 4140–01–P Scientific Review Officer, Center for Information is also available on the Scientific Review, National Institutes of Institute’s/Center’s home page: http:// Health, 6701 Rockledge Drive, Room 5148, MSC 7806, Bethesda, MD 20892, pyonkh2@ www.nidcd.nih.gov/about/groups/bsc/, DEPARTMENT OF HEALTH AND csr.nih.gov. where an agenda and any additional HUMAN SERVICES information for the meeting will be posted Name of Committee: Center for Scientific National Institutes of Health Review Special Emphasis Panel; Virology. when available. Date: October 26, 2015. (Catalogue of Federal Domestic Assistance Time: 1:00 p.m. to 3:00 p.m. Center for Scientific Review; Notice of Program Nos. 93.173, Biological Research Agenda: To review and evaluate grant Related to Deafness and Communicative Closed Meetings applications. Disorders, National Institutes of Health, HHS) Pursuant to section 10(d) of the Place: Renaissance Washington DC, Dupont Circle, 1143 New Hampshire Avenue tkelley on DSK3SPTVN1PROD with NOTICES Dated: September 23, 2015. Federal Advisory Committee Act, as NW., Washington, DC 20037. Melanie J. Gray, amended (5 U.S.C. App.), notice is Contact Person: John C. Pugh, Scientific hereby given of the following meetings. Review Officer, Center for Scientific Review, Program Analyst, Office of Federal Advisory The meetings will be closed to the Committee Policy. National Institutes of Health, 6701 Rockledge public in accordance with the Drive, Room 1206, MSC 7808, Bethesda, MD [FR Doc. 2015–24545 Filed 9–25–15; 8:45 am] provisions set forth in sections 20892, (301) 435–2398, pughjohn@ BILLING CODE 4140–01–P 552b(c)(4) and 552b(c)(6), title 5 U.S.C., csr.nih.gov. VerDate Sep<11>2014 17:19 Sep 25, 2015 Jkt 235001 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 E:\FR\FM\28SEN1.SGM 28SEN1


Document Created: 2018-02-26 10:21:35
Document Modified: 2018-02-26 10:21:35
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
DatesOctober 26-27, 2015.
FR Citation80 FR 58264 
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