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withdrawn by the applicant and for 

which approval has not been withdrawn 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* $56,350 

75 Percent Generic New Animal Drug Sponsor Fee* $42,265 

50 Percent Generic New Animal Drug Sponsor Fee* $28,175 

*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 

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 

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] 

BILLING CODE 4160–01–S 

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, 

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Federal Register / Vol. 73, No. 179 / Monday, September 15, 2008 / Notices 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] 

BILLING CODE 4140–01–M 

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. 

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] 

BILLING CODE 4140–01–M 

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. 

mstockstill on PROD1PC66 with NOTICES