80 FR 55123 - Anesthetic and Analgesic Drug Products Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 177 (September 14, 2015)

Page Range		55123-55124
FR Document		2015-22984

Federal Register, Volume 80 Issue 177 (Monday, September 14, 2015)

[Federal Register Volume 80, Number 177 (Monday, September 14, 2015)]
[Notices]
[Pages 55123-55124]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-22984]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0001]


Anesthetic and Analgesic Drug Products Advisory Committee; Notice 
of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of a public advisory 
committee of the Food and Drug Administration (FDA). The meeting will 
be open to the public.
    Name of Committee: Anesthetic and Analgesic Drug 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 November 6, 2015, from 8 
a.m. to 5 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. Answers to commonly asked questions including information 
regarding special accommodations due to a disability, visitor parking, 
and transportation may be accessed at: http://www.fda.gov/
AdvisoryCommittees/

[[Page 55124]]

AboutAdvisoryCommittees/ucm408555.htm.
    Contact Person: Stephanie L. Begansky, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-796-9001, FAX: 
301-847-8533, [email protected], 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 http://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: The committee will discuss new drug application (NDA) 
022225, sugammadex sodium injection, submitted by Organon USA Inc., a 
subsidiary of Merck & Co., Inc., for the proposed indication of 
reversal of moderate or deep neuromuscular blockade (NMB) induced by 
rocuronium or vecuronium.
    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 http://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 
October 23, 2015. Oral presentations from the public will be scheduled 
between approximately 1 p.m. and 2 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 October 15, 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 October 16, 2015.
    Persons attending FDA's advisory committee meetings are advised 
that the Agency is not responsible for providing access to electrical 
outlets.
    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 Stephanie L. Begansky 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 http://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: September 8, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2015-22984 Filed 9-11-15; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 80, No. 177 / Monday, September 14, 2015 / Notices 55123

investigational new drug review costs III. Fee Schedule for FY 2016 for courier delivery only.) The FDA post
are included in this amount.) Twenty- The fee rate for FY 2016 is set out in office box number (P.O. Box 979107)
nine of these applications (20 NDAs and table 1: must be written on the check. The tax
9 BLAs) received priority review, which identification number of FDA is 53–
would mean that the remaining 19 TABLE 1—TROPICAL DISEASE PRI- 0196965.
received standard reviews. Because a Wire transfer payments may also be
ORITY REVIEW SCHEDULE FOR FY
priority review compresses a review that used. Please reference your unique user
2016 fee ID number when completing your
ordinarily takes 10 months into 6
months, FDA estimates that a multiplier transfer. The originating financial
Fee rate for
Fee category institution may charge a wire transfer
of 1.67 (10 months divided by 6 months) FY 2016
should be applied to non-priority fee. Please ask your financial institution
review costs in estimating the effort and Application submitted with a about the fee and include it with your
cost of a priority review as compared to
tropical disease priority re- payment to ensure that your fee is fully
view voucher in addition to paid. The account information is as
a standard review. This multiplier is the normal PDUFA fee ......... $2,727,000
consistent with published research on follows: New York Federal Reserve
Bank, U.S. Dept. of Treasury, TREAS
this subject. In the article ‘‘Developing IV. Implementation of Tropical Disease NYC, 33 Liberty St., New York, NY
Drugs for Developing Countries,’’ Priority Review User Fee 10045, Account Number: 75060099,
published in ‘‘Health Affairs,’’ Volume
Under section 524(c)(4)(A) of the Routing Number: 021030004, SWIFT:
25, Number 2, in 2006, the comparison FRNYUS33, Beneficiary: FDA, 8455
of historical average review times by FD&C Act, the priority review user fee
is due upon submission of a human Colesville Rd., Silver Spring, MD
David B. Ridley, Henry G. Grabowski, 20993–0002.
drug application for which the priority
and Jeffrey L. Moe, supports a priority
review voucher is used. Section Dated: September 8, 2015.
review multiplier in the range of 1.48 to
524(c)(4)(B) of the FD&C Act specifies Leslie Kux,
2.35. The multiplier derived by FDA
that the application will be considered Associate Commissioner for Policy.
falls well below the midpoint of this incomplete if the priority review user
range. Using FY 2014 figures, the costs [FR Doc. 2015–23006 Filed 9–11–15; 8:45 am]
fee and all other applicable user fees are
of a priority and standard review are not paid in accordance with FDA
BILLING CODE 4164–01–P
estimated using the following formula: payment procedures. In addition, FDA
(29 a × 1.67) + (19 a) = $268,974,000 may not grant a waiver, exemption, DEPARTMENT OF HEALTH AND
reduction, or refund of any fees due and HUMAN SERVICES
where ‘‘a’’ is the cost of a standard payable under this section of the FD&C
review and ‘‘a × 1.67’’ is the cost of a Act and FDA may not collect priority Food and Drug Administration
priority review. Using this formula, the review voucher fees prior to a relevant
cost of a standard review for NME NDAs appropriation for fees for that fiscal [Docket No. FDA–2015–N–0001]
and BLAs is calculated to be $3,989,000 year. Beginning with FDA’s
(rounded to the nearest thousand Anesthetic and Analgesic Drug
appropriation for FY 2009, the annual
dollars) and the cost of a priority review Products Advisory Committee; Notice
appropriation language states
for NME NDAs and BLAs is 1.67 times of Meeting
specifically that ‘‘priority review user
that amount, or $6,662,000 (rounded to fees authorized by 21 U.S.C. 360n AGENCY: Food and Drug Administration,
the nearest thousand dollars). The (section 524 of the FD&C Act) may be HHS.
difference between these two cost credited to this account, to remain ACTION: Notice.
estimates, or $2,673,000, represents the available until expended.’’ (Pub. L.
incremental cost of conducting a 111–8, Section 5, Division A, Title VI). This notice announces a forthcoming
priority review rather than a standard The tropical disease priority review meeting of a public advisory committee
review. fee established in the new fee schedule of the Food and Drug Administration
For the FY 2016 fee, FDA will need must be paid for any application that is (FDA). The meeting will be open to the
received on or after October 1, 2015, and public.
to adjust the FY 2014 incremental cost
submitted with a priority review Name of Committee: Anesthetic and
by the average amount by which FDA’s
voucher. This fee must be paid in Analgesic Drug Products Advisory
average costs increased in the 3 years
addition to any other fee due under Committee.
prior to FY 2015, to adjust the FY 2014
PDUFA. Payment must be made in U.S. General Function of the Committee:
amount for cost increases in FY 2015. currency by check, bank draft, or U.S. To provide advice and
That adjustment, published in the postal money order payable to the order recommendations to the Agency on
Federal Register on August 3, 2015 (see of the Food and Drug Administration. FDA’s regulatory issues.
80 FR 46028 at 46029), setting FY 2016 The user fee identification (ID) number Date and Time: The meeting will be
PDUFA fees, is 2.0266 percent for the should be included on the check, held on November 6, 2015, from 8 a.m.
most recent year, not compounded. followed by the words ‘‘Tropical to 5 p.m.
Increasing the FY 2014 incremental Disease Priority Review.’’ Payments can Location: FDA White Oak Campus,
priority review cost of $2,673,000 by be mailed to: Food and Drug 10903 New Hampshire Ave., Bldg. 31
2.0266 percent results in an estimated Administration, P.O. Box 979107, St. Conference Center, the Great Room (Rm.
cost of $2,727,000 (rounded to the
tkelley on DSK3SPTVN1PROD with NOTICES

Louis, MO 63197–9000. 1503), Silver Spring, MD 20993–0002.
nearest thousand dollars). This is the If checks are sent by a courier that Answers to commonly asked questions
priority review user fee amount for FY requests a street address, the courier can including information regarding special
2016 that must be submitted with a deliver the checks to: U.S. Bank, accommodations due to a disability,
priority review voucher in FY 2016, in Attention: Government Lockbox 979107, visitor parking, and transportation may
addition to any PDUFA fee that is 1005 Convention Plaza, St. Louis, MO be accessed at: http://www.fda.gov/
required for such an application. 63101. (Note: This U.S. Bank address is AdvisoryCommittees/

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Document Created: 2018-02-26 10:14:58
Document Modified: 2018-02-26 10:14:58

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
Action		Notice.
FR Citation		80 FR 55123

80 FR 55123 - Anesthetic and Analgesic Drug Products Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 177 (September 14, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration