National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings, 53260-53261 [E8-21169]
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53260
Federal Register / Vol. 73, No. 179 / Monday, September 15, 2008 / Notices
abbreviated application for a generic
new animal drug, that has not been
withdrawn by the applicant and for
which approval has not been withdrawn
by the Secretary of Health and Human
Services, or has submitted an
investigational submission for a generic
new animal drug that has not been
terminated or otherwise rendered
inactive; and (2) had an abbreviated
application for a generic new animal
drug, supplemental abbreviated
application for a generic new animal
drug, or investigational submission for a
generic new animal drug pending at
FDA after September 1, 2008 (see 21
U.S.C. 379j–21(k)(7) and 379j–21(a)(3)).
A generic new animal drug sponsor is
subject to only one such fee each fiscal
year (see 21 U.S.C. 379j–21(a)(3)(B)).
Applicants with more than six approved
abbreviated applications will pay 100
percent of the sponsor fee, applicants
with two to six approved abbreviated
applications will pay 75 percent of the
sponsor fee, and applicants with one or
fewer approved abbreviated
applications will pay 50 percent of the
sponsor fee (see 21 U.S.C. 379j–
21(a)(3)(B)). The sponsor fees are to be
set so that they will generate $1,691,000
in fee revenue for FY 2009. This is the
amount set out in the statute and no
adjustments are required for FY 2009.
To set generic new animal drug
sponsor fees to realize $1,691,000, FDA
must make some assumptions about the
number of sponsors who will pay these
fees in FY 2009. Based on the number
of firms that would have met this
definition in each of the past 5 years,
FDA estimates that in FY 2009 11
sponsors will pay 100 percent (full) fees,
11 sponsors will pay 75 percent fees,
and 28 sponsors will pay 50 percent
fees. That totals the equivalent of 33.25
full sponsor fees (11 times 100 percent
or 11, plus 11 times 75 percent or 8.25,
plus 28 times 50 percent or 14).
FDA estimates that about 10 percent
of all of these sponsors, or 3.25, may
qualify for a minor use/minor species
waiver or reduction.
Accordingly, the agency estimates
that the equivalent of 30 full sponsor
fees (33.25 minus 3.25) are likely to be
paid in FY 2009.
B. Sponsor Fee Rates for FY 2009
FDA must set the fee rates for FY 2009
so that the estimated equivalent of 30
full sponsor fees will generate a total of
$1,691,000. To generate this amount
will require the 100-percent fee for a
generic new animal drug sponsor,
rounded to the nearest fifty dollars, to
be $56,350. Accordingly, the fee for
those paying 75 percent of the full
sponsor fee, rounded to the nearest five
dollars, will be $42,265, and the fee for
those paying 50 percent of the full
sponsor fee will be $28,175.
VI. Fee Schedule for FY 2009
The fee rates for FY 2009 are
summarized in table 1 of this document.
TABLE 1—FY 2009 FEE RATES
Generic New Animal Drug User Fee Category
Fee Rate for FY 2009
Abbreviated Application for Generic New Animal Drug Fee
$41,400
Generic New Animal Drug Product Fee
$3,005
100 Percent Generic New Animal Drug Sponsor Fee*
75 Percent Generic New Animal Drug Sponsor Fee*
50 Percent Generic New Animal Drug Sponsor Fee*
* An
animal drug sponsor is subject to only one such fee each fiscal year
VII. Procedures for Paying FY 2009
Generic New Animal Drug User Fees
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$56,350
$42,265
$28,175
FDA may not collect user fees for
abbreviated applications, for generic
new animal drug products, and for
generic new animal drug sponsors until
an appropriation of fees is provided by
Congress (see 21 U.S.C. 379j–21(g)(1)).
For this reason FDA may not begin to
collect these fees at this time.
Fees for generic new animal drug
products and sponsors will be invoiced
at the rates published in this notice on
the later of December 31, 2008, or 30
days after appropriation of generic new
animal drug user fees by Congress.
Invoices for fees for abbreviated
applications for generic new animal
drugs submitted on or after July 1, 2008,
will be issued 30 days after
appropriation of generic new animal
drug user fees by Congress. After that
time, FDA will not consider an
abbreviated application for a generic
abbreviated new animal drug complete
unless the application fee for that
application has been paid in advance.
Within 30 days after appropriation of
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generic new animal drug user fees by
Congress, FDA will publish another
notice in the Federal Register providing
payment instructions so that these fees
may be paid in advance of the
submission of such abbreviated
applications from that time forward.
Dated: September 3, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–21453 Filed 9–12–08; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of the following
meetings.
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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: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; Application of Platform
Technologies for the Development of
Therapeutics for Biodefense-A.
Date: October 16–17, 2008.
Time: 8:30 a.m. to 5:30 p.m.
Agenda: To review and evaluate contract
proposals.
Place: Gaithersburg Marriott
Washingtonian Center, 9751 Washingtonian
Boulevard, Gaithersburg, MD 20878.
Contact Person: Alec Ritchie, PhD,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
National Institutes of Health/NIAID/DHHS,
6700 B Rockledge Drive, MSC 7616,
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mstockstill on PROD1PC66 with NOTICES
Bethesda, MD 20892–7616, 301–435–1614,
aritchie@niaid.nih.gov.
Name of Committee: National Institute of
Allergy and Infectious Diseases, Special
Emphasis Panel, Application of Platform
Technologies for the Development of
Therapeutics for Biodefense-B.
Date: October 20–21, 2008.
Time: 8:30 a.m. to 5:30 p.m.
Agenda: To review and evaluate contract
proposals.
Place: Washingtonian Center Courtyard,
204 Boardwalk Place, Gaithersburg, MD
20878.
Contact Person: Alec Ritchie, PhD,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
National Institutes of Health/NIAID/DHHS,
6700 B Rockledge Drive, MSC 7616,
Bethesda, MD 20892–7616, 301–435–1614,
aritchie@niaid.nih.gov.
Name of Committee: National Institute of
Allergy and Infectious Diseases, Special
Emphasis Panel, Application of Platform
Technologies for the Development of
Therapeutics for Biodefense-C.
Date: October 23–24, 2008.
Time: 8:30 a.m. to 5:30 p.m.
Agenda: To review and evaluate contract
proposals.
Place: Gaithersburg Marriott
Washingtonian Center, 9751 Washingtonian
Boulevard, Gaithersburg, MD 20878.
Contact Person: Alec Ritchie, PhD,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
National Institutes of Health/NIAID/DHHS,
6700 B Rockledge Drive, MSC 7616,
Bethesda, MD 20892–7616, 301–435–1614,
aritchie@niaid.nih.gov.
Name of Committee: Allergy, Immunology,
and Transplantation Research Committee.
Date: October 29, 2008.
Time: 11 a.m. to 5:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge Drive, 3128, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Katrin Eichelberg, PhD,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities
NIAID/NIH/DHHS, 6700B Rockledge Drive,
MSC 7616, Bethesda, MD 20892, (301) 496–
0818, keichelberg@niaid.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: September 5, 2008.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E8–21169 Filed 9–12–08; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), 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: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; Cooperative Research
Partnerships for Biodefense and Emerging
Infectious Diseases SEP 6.
Date: October 3, 2008.
Time: 11 a.m. to 4 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6700B
Rockledge Drive, 3257, Bethesda, MD 20817,
(Telephone Conference Call).
Contact Person: Michelle M Timmerman,
PhD, Scientific Review Officer, Scientific
Review Program NIH/NIAID/DHHS, Room
3147, 6700B Rockledge Drive, MSC–7616,
Bethesda, MD 20892–7616, 301–451–4573,
timmermanm@niaid.nih.gov.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; HIV Vaccines Research and
Development (HIVRAD).
Date: October 6–8, 2008.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Crowne Plaza Washington DC/Silver
Spring, 8777 Georgia Avenue, Silver Spring,
MD 20910.
Contact Person: Eleazar Cohen, PhD,
Scientific Review Officer, Division of
Extramural Activities, National Institutes of
Health/NIAID, 6700B Rockledge Drive, Room
3129, Bethesda, MD 20892, 301–435–3564,
ec17w@nih.gov.
Name of Committee: Microbiology,
Infectious Diseases and AIDS Initial Review
Group; Microbiology and Infectious Diseases
Research Committee; Microbiology and
Infectious Diseases Research Committee.
Date: October 9, 2008.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: The Crowne Plaza—Silver Spring,
8777 Georgia Avenue, Silver Spring, MD
20910.
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53261
Contact Person: Annie Walker-Abbey, PhD,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
NIH/NIAID/DHHS, 6700B Rockledge Drive,
RM. 3126, Bethesda, MD 20892–7616, 301–
451–2671, aabbey@niaidnih.gov.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; Hematopoietic Cell
Transplantation.
Date: October 16, 2008.
Time: 11 a.m. to 2:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6700B
Rockledge Drive, Bethesda, MD 20817,
(Telephone Conference Call).
Contact Person: Sujata Vijh, PhD, Scientific
Review Officer, Scientific Review Program,
Division of Extramural Activities, NIAID/
NIH/DHHS, 6700B Rockledge Drive, MSC
7616, Bethesda, MD 20892, 301–594–0985,
vijhs@niaid.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: September 5, 2008.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E8–21170 Filed 9–12–08; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Mental Health;
Notice of Meeting
Pursuant to section 10(a) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of a meeting of the
Services Subcommittee of the
Interagency Autism Coordinating
Committee (IACC).
The purpose of the Services
Subcommittee is to review the current
state of services and supports for
individuals with Autism Spectrum
Disorder (ASD) and their families in
order to improve these services. The
Subcommittee meeting will be
conducted as a telephone conference
call with presentations on the web. This
meeting is open for the public to call in
to listen and to access the web
presentations. The Subcommittee will
report on its meeting at the next meeting
of the IACC on November 21, 2008.
Name of Committee: Interagency Autism
Coordinating Committee (IACC).
Type of Meeting: Services Subcommittee
Conference Call and Webinar.
Date: October 10, 2008.
Time: 9:30 a.m. to 11:30 a.m. Eastern Time.
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Agencies
[Federal Register Volume 73, Number 179 (Monday, September 15, 2008)]
[Notices]
[Pages 53260-53261]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-21169]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of
Closed Meetings
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), 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: National Institute of Allergy and Infectious
Diseases Special Emphasis Panel; Application of Platform
Technologies for the Development of Therapeutics for Biodefense-A.
Date: October 16-17, 2008.
Time: 8:30 a.m. to 5:30 p.m.
Agenda: To review and evaluate contract proposals.
Place: Gaithersburg Marriott Washingtonian Center, 9751
Washingtonian Boulevard, Gaithersburg, MD 20878.
Contact Person: Alec Ritchie, PhD, Scientific Review Officer,
Scientific Review Program, Division of Extramural Activities,
National Institutes of Health/NIAID/DHHS, 6700 B Rockledge Drive,
MSC 7616,
[[Page 53261]]
Bethesda, MD 20892-7616, 301-435-1614, aritchie@niaid.nih.gov.
Name of Committee: National Institute of Allergy and Infectious
Diseases, Special Emphasis Panel, Application of Platform
Technologies for the Development of Therapeutics for Biodefense-B.
Date: October 20-21, 2008.
Time: 8:30 a.m. to 5:30 p.m.
Agenda: To review and evaluate contract proposals.
Place: Washingtonian Center Courtyard, 204 Boardwalk Place,
Gaithersburg, MD 20878.
Contact Person: Alec Ritchie, PhD, Scientific Review Officer,
Scientific Review Program, Division of Extramural Activities,
National Institutes of Health/NIAID/DHHS, 6700 B Rockledge Drive,
MSC 7616, Bethesda, MD 20892-7616, 301-435-1614,
aritchie@niaid.nih.gov.
Name of Committee: National Institute of Allergy and Infectious
Diseases, Special Emphasis Panel, Application of Platform
Technologies for the Development of Therapeutics for Biodefense-C.
Date: October 23-24, 2008.
Time: 8:30 a.m. to 5:30 p.m.
Agenda: To review and evaluate contract proposals.
Place: Gaithersburg Marriott Washingtonian Center, 9751
Washingtonian Boulevard, Gaithersburg, MD 20878.
Contact Person: Alec Ritchie, PhD, Scientific Review Officer,
Scientific Review Program, Division of Extramural Activities,
National Institutes of Health/NIAID/DHHS, 6700 B Rockledge Drive,
MSC 7616, Bethesda, MD 20892-7616, 301-435-1614,
aritchie@niaid.nih.gov.
Name of Committee: Allergy, Immunology, and Transplantation
Research Committee.
Date: October 29, 2008.
Time: 11 a.m. to 5:30 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Rockledge Drive, 3128,
Bethesda, MD 20892, (Telephone Conference Call).
Contact Person: Katrin Eichelberg, PhD, Scientific Review
Officer, Scientific Review Program, Division of Extramural
Activities NIAID/NIH/DHHS, 6700B Rockledge Drive, MSC 7616,
Bethesda, MD 20892, (301) 496-0818, keichelberg@niaid.nih.gov.
(Catalogue of Federal Domestic Assistance Program Nos. 93.855,
Allergy, Immunology, and Transplantation Research; 93.856,
Microbiology and Infectious Diseases Research, National Institutes
of Health, HHS)
Dated: September 5, 2008.
Jennifer Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. E8-21169 Filed 9-12-08; 8:45 am]
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