45022 Federal Register / Vol. 73, No. 149 / Friday, August 1, 2008 / Notices 

TABLE 6—FEE-PAYING FULL APPLICATION EQUIVALENT—5-YEAR AVERAGE

Fiscal Year 2004 2005 2006 2007 2008 5-Year 

Average 

Fee-Paying FAEs 145.1 121.5 136.7 134.4 144.7 136.5 

The FY 2009 application fee is 

estimated by dividing the average 

number of full applications that paid 

fees over the latest 5 years, 136.5, into 

the fee revenue amount to be derived 

from application fees in FY 2009, 

$170,222,000. The result, rounded to the 

nearest $100, is a fee of $1,247,200 per 

full application requiring clinical data, 

and $623,600 per application not 

requiring clinical data or per 

supplement requiring clinical data. 

IV. Fee Calculations for Establishment 

and Product Fees 

A. Establishment Fees 

At the beginning of FY 2008, the 

establishment fee was based on an 

estimate that 390 establishments would 

be subject to, and would pay, fees. By 

the end of FY 2008, FDA estimates that 

435 establishments will have been 

billed for establishment fees, before all 

decisions on requests for waivers or 

reductions are made. As in previous 

years, FDA again estimates that a total 

of 25 establishment fee waivers or 

reductions will be made for FY 2008. In 

addition, FDA estimates that another 10 

full establishment fees will be exempted 

this year based on the orphan drug 

exemption in the Food and Drug 

Administration Amendments Act of 

2007 (FDAAA) (see section 736(k) of the 

act). Subtracting 35 establishments (25 

plus the estimated 10 establishments 

under the orphan exemption) from 435 

leaves a net of 400 fee-paying 

establishments. FDA will use 400 for its 

FY 2009 estimate of establishments 

paying fees, 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 

($170,222,000) by the estimated 400 

establishments, for an establishment fee 

rate for FY 2009 of $425,600 (rounded 

to the nearest $100). 

B. Product Fees 

At the beginning of FY 2008, the 

product fee was based on an estimate 

that 2,355 products would be subject to, 

and would pay, product fees. By the end 

of FY 2008, FDA estimates that 2,450 

products will have been billed for 

product fees, before all decisions on 

requests for waivers or reductions are 

made. FDA assumes that there will be 

about 40 waivers and reductions 

granted, the same amount estimated last 

year. In addition, FDA estimates that 

another 30 product fees will be 

exempted this year based on the orphan 

drug exemption in FDAAA (see section 

736(k) of the act). FDA estimates that 

2,380 products will qualify for product 

fees in FY 2008, after allowing for 

waivers and reductions, including the 

orphan drug products eligible under the 

FDAAA exemption, and will use this 

number for its FY 2009 estimate. 

Accordingly, the FY 2009 product fee 

rate is determined by dividing the 

adjusted total fee revenue to be derived 

from product fees ($170,222,000) by the 

estimated 2,380 products for a FY 2009 

product fee of $71,520 (rounded to the 

nearest $10). 

V. Fee Schedule for FY 2009 

The fee rates for FY 2009 are set out 

in Table 7 of this document. 

TABLE 7 

Fee Category Fee Rates for 

FY 2009 

APPLICATIONS 

Requiring clinical data $1,247,200 

Not requiring clinical data $623,600 

Supplements requiring 

clinical data 

$623,600 

ESTABLISHMENTS $425,600 

PRODUCTS $71,520 

VI. Implementation of Adjusted Fee 

Schedule 

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, 2008. Payment must be made in U.S. 

currency by check, bank draft, or U.S. 

postal money order payable to the order 

of the Food and Drug Administration. 

Please include the user fee ID number 

on your check. Your payment can be 

mailed to: Food and Drug 

Administration, P.O. Box 70963, 

Charlotte, NC 28272–0963. 

If checks are to be sent by a courier 

that requests a street address, the 

courier can deliver the checks to: 

Wachovia Bank, Attn: Food and Drug 

Administration Lockbox 70963, 1525 

West WT Harris Blvd., rm. NC0810, 

Charlotte, NC 28262. (Note: This 

Wachovia Bank address is for courier 

delivery only.) 

Please make sure that the FDA post 

office box number (P.O. Box 70963) is 

written on the check. The tax 

identification number of the Food and 

Drug Administration is 53–0196965. 

Wire transfer payment may also be 

used. The routing and transit number is 

021030004 and the account number is 

75060099. 

B. Establishment and Product Fees 

FDA will issue invoices for 

establishment and product fees for FY 

2009 under the new fee schedule in 

August 2008. Payment will be due on 

October 1, 2008. FDA will issue 

invoices in November 2009 for any 

products and establishments subject to 

fees for FY 2009 that qualify for fees 

after the August 2008 billing. 

Dated: July 28, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–17738 Filed 7–31–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Alcohol Abuse 

and Alcoholism; Notice of Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of a meeting of the 

National Advisory Council on Alcohol 

Abuse and Alcoholism. 

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)(4) and 552b(c)(6), Title 5 U.S.C., 

mstockstill on PROD1PC66 with NOTICES

Federal Register / Vol. 73, No. 149 / Friday, August 1, 2008 / Notices 45023 

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 Advisory 

Council on Alcohol Abuse and Alcoholism. 

Date: September 17–18, 2008. 

Closed: September 17, 2008, 5:30 p.m. to 

7:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 5635 

Fishers Lane, Bethesda, MD 20892. 

Open: September 18, 2008, 9 a.m. to 3:30 

p.m. 

Agenda: Program reports and 

presentations. 

Place: National Institutes of Health, 5635 

Fishers Lane, Bethesda, MD 20892. 

Contact Person: Abraham P. Bautista, PhD, 

Executive Secretary, National Institute on 

Alcohol Abuse & Alcoholism, National 

Institutes of Health, 5635 Fishers Lane, Rm 

3039, Rockville, MD 20852, 301–443–9737, 

bautistaa@mail.nih.gov. 

Information is also available on the 

Institute’s/Center’s home page: http:// 

silk.nih.gov/silk/niaaa1/about/roster.htm, 

where an agenda and any additional 

information for the meeting will be posted 

when available. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.271, Alcohol Research 

Career Development Awards for Scientists 

and Clinicians; 93.272, Alcohol National 

Research Service Awards for Research 

Training; 93.273, Alcohol Research Programs; 

93.891, Alcohol Research Center Grants, 

National Institutes of Health, HHS) 

Dated: July 25, 2008. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E8–17583 Filed 7–31–08; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Biomedical 

Imaging and Bioengineering; Notice of 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of a meeting of the 

National Advisory Council for 

Biomedical Imaging and Bioengineering. 

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)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications 

and/or contract proposals 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 and/or contract proposals, 

the disclosure of which would 

constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Advisory 

Council for Biomedical Imaging and 

Bioengineering; NACBIB September 2008. 

Date: September 16, 2008. 

Open: 9 a.m. to 12:30 p.m. 

Agenda: Report from the Institute Director, 

other Institute staff and presentations of 

working group reports. 

Place: Bethesda Marriott Suites, 6711 

Democracy Boulevard, Bethesda, MD 20817. 

Closed: 1:30 p.m. to 4:30 p.m. 

Agenda: To review and evaluate grant 

applications and/or proposals. 

Place: Bethesda Marriott Suites, 6711 

Democracy Boulevard, Bethesda, MD 20817. 

Contact Person: Anthony Demsey, PhD, 

Director, National Institute of Biomedical 

Imaging and Bioengineering, 6701 

Democracy Blvd., Room 241, Bethesda, MD 

20892. 

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. 

Information is also available on the 

Institute’s/Center’s home page: http:// 

www.nibib1.nih.gov/about/NACBIB/ 

NACBIB.htm, where an agenda and any 

additional information for the meeting will 

be posted when available. 

Dated: July 25, 2008. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E8–17586 Filed 7–31–08; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Eye Institute; 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 Eye Institute 

Special Emphasis Panel; K08, K23, K99–NEI 

Research Training Applications. 

Date: August 8, 2008. 

Time: 8:30 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Hyatt Regency Bethesda, One 

Bethesda Metro Center, 7400 Wisconsin 

Avenue, Bethesda, MD 20814. 

Contact Person: Samuel Rawlings, PhD, 

Chief, Scientific Review Branch, Division Of 

Extramural Research, National Eye Institute, 

5635 Fishers Lane, Suite 1300 Msc 9300, 

Bethesda, MD 20892–9300, 301–451–2020, 

rawlings@nei.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

Name of Committee: National Eye Institute 

Special Emphasis Panel; NEI Conference 

Grant Review. 

Date: August 26, 2008. 

Time: 12 p.m. to 2 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 5635 

Fishers Lane, Bethesda, MD 20892 

(Telephone Conference Call). 

Contact Person: Samuel Rawlings, PhD, 

Chief, Scientific Review Branch, Division Of 

Extramural Research, National Eye Institute, 

5635 Fishers Lane, Suite 1300 Msc 9300, 

Bethesda, MD 20892–9300, 301–451–2020, 

rawlings@nei.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.867, Vision Research, 

National Institutes of Health, HHS) 

Dated: July 25, 2008. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E8–17584 Filed 7–31–08; 8:45 am] 

BILLING CODE 4140–01–M 

mstockstill on PROD1PC66 with NOTICES