Center for Scientific Review; Notice of Closed Meetings, 45643 [2012-18689]
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Federal Register / Vol. 77, No. 148 / Wednesday, August 1, 2012 / Notices
after taking waivers and reductions into
account. The fee per establishment is
determined by dividing the adjusted
total fee revenue to be derived from
establishments ($239,556,333) by the
estimated 455 establishments, for an
establishment fee rate for FY 2013 of
$526,500 (rounded to the nearest $100).
B. Product Fees
At the beginning of FY 2012, the
product fee was based on an estimate
that 2,365 products would be subject to
and would pay product fees. By the end
of FY 2012, FDA estimates that 2,525
products will have been billed for
product fees, before all decisions on
requests for waivers, reductions, or
exemptions are made. FDA assumes that
there will be 50 waivers and reductions
granted. In addition, FDA estimates that
another 40 product fees will be
exempted this year based on the orphan
drug exemption in FDAAA (see section
736(k) of the FD&C Act). FDA estimates
that 2,435 products will qualify for
product fees in FY 2012, after allowing
for waivers and reductions, including
the orphan drug products eligible under
the FDAAA exemption, and will use
this number for its FY 2013 estimate.
The FY 2013 product fee rate is
determined by dividing the adjusted
total fee revenue to be derived from
product fees ($239,556,333) by the
estimated 2,435 products for a FY 2013
product fee of $98,380 (rounded to the
nearest $10).
V. Fee Schedule for FY 2013
The fee rates for FY 2013 are set out
in Table 7 of this document:
TABLE 7—FEE SCHEDULE FOR FY
2013
Fee category
Fee rates for
FY 2013
Applications:
Requiring clinical data ...
Not requiring clinical
data ............................
Supplements requiring
clinical data ................
Establishments .....................
Products ................................
$1,958,800
979,400
B. Establishment and Product Fees
979,400
526,500
98,380
FDA will issue invoices for
establishment and product fees for FY
2013 under the new fee schedule in
August 2012. Payment will be due on
October 1, 2012. FDA will issue
invoices in November 2013 for any
products and establishments subject to
fees for FY 2013 that qualify for fee
assessments after the August 2012
billing.
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VI. Fee Payment Options and
Procedures
A. Application Fees
The appropriate application fee
established in the new fee schedule
must be paid for any application or
supplement subject to fees under
PDUFA that is received after September
30, 2012. Payment must be made in U.S.
currency by check, bank draft, or U.S.
postal money order payable to the order
VerDate Mar<15>2010
19:53 Jul 31, 2012
of the Food and Drug Administration.
Please include the user fee
identification (ID) number on your
check, bank draft, or postal money
order. Your payment can be mailed to:
Food and Drug Administration, P.O.
Box 979107, St. Louis, MO 63197–9000.
If checks are to be sent by a courier
that requests a street address, the
courier can deliver the checks to: U.S.
Bank, Attention: Government Lockbox
979107, 1005 Convention Plaza, St.
Louis, MO 63101. (Note: This U.S. Bank
address is for courier delivery only.
Contact the U.S. Bank at 314–418–4013
if you have any questions concerning
courier delivery.)
Please make sure that the FDA post
office box number (P.O. Box 979107) is
written on the check, bank draft, or
postal money order.
Wire transfer payment may also be
used. Please reference your unique user
fee ID number when completing your
transfer. The originating financial
institution may charge a wire transfer
fee between $15.00 and $35.00. Please
ask your financial institution about the
fee and include it with your payment to
ensure that your fee is fully paid. The
account information is as follows: New
York Federal Reserve Bank, U.S.
Department of the Treasury, TREAS
NYC, 33 Liberty St., New York, NY
10045, Acct. No.: 75060099, Routing
No.: 021030004, SWIFT: FRNYUS33,
Beneficiary: FDA, 1350 Piccard Dr.,
Rockville, MD.
Application fees can also be paid
online with an electronic check (ACH).
FDA has partnered with the U.S.
Department of the Treasury to utilize
Pay.gov, a Web-based payment
application, for online electronic
payment. The Pay.gov feature is
available on the FDA Web site after the
user fee ID number is generated.
The tax identification number of the
Food and Drug Administration is 53–
0196965.
Jkt 226001
45643
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
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
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; Member
Conflict: AIDS and AIDS Related Research.
Date: August 16–17, 2012.
Time: 10:00 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Virtual Meeting).
Contact Person: Robert Freund, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5216,
MSC 7852, Bethesda, MD 20892, 301–435–
1050, freundr@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Vascular Hematology I.
Date: August 29, 2012.
Time: 1 p.m. to 3 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: Anshumali Chaudhari,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4124,
MSC 7802, Bethesda, MD 20892, (301) 435–
1210, chaudhaa@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)
Dated: July 24, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
Dated: July 26, 2012.
Carolyn A. Baum,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2012–18711 Filed 7–31–12; 8:45 am]
[FR Doc. 2012–18689 Filed 7–31–12; 8:45 am]
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[Federal Register Volume 77, Number 148 (Wednesday, August 1, 2012)]
[Notices]
[Page 45643]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-18689]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
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 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; Member Conflict: AIDS and AIDS Related Research.
Date: August 16-17, 2012.
Time: 10:00 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892, (Virtual Meeting).
Contact Person: Robert Freund, Ph.D., Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 5216, MSC 7852, Bethesda, MD 20892, 301-435-
1050, freundr@csr.nih.gov.
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Member Conflict: Vascular Hematology I.
Date: August 29, 2012.
Time: 1 p.m. to 3 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: Anshumali Chaudhari, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4124, MSC 7802, Bethesda, MD
20892, (301) 435-1210, chaudhaa@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)
Dated: July 26, 2012.
Carolyn A. Baum,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2012-18689 Filed 7-31-12; 8:45 am]
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