Federal Register / Vol. 75, No. 176 / Monday, September 13, 2010 / Notices 55589 

train and support health care providers 

and other professionals in public and 

private agencies who serve Florida’s 

CYSHCN, helping them better 

understand the needs of children, youth 

and their families. 

The Family Cafe ́ will receive funding 

through May 31, 2011 to continue the 

same state-wide services as previously 

outlined in the originally competed and 

approved grant application submitted 

by FIFI. This replacement award will 

maintain Congress’ mandate under the 

2005 Budget Deficit Reduction Act/ 

Family Opportunity Act and the Patient 

Protection and Affordable Care Act 

(Pub. L. 111–148) that there shall be an 

F2F HIC in all 50 states and the District 

of Columbia by June 2009. It will also 

ensure that an F2F HIC will be 

accessible to families and professionals 

to continue providing essential 

information, referral and support 

services to families with CYSHCN 

throughout Florida and in a manner 

which avoids any disruption of services. 

Dated: September 3, 2010. 

Mary K. Wakefield, 

Administrator. 

[FR Doc. 2010–22663 Filed 9–10–10; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0463] 

Fee for Using a Priority Review 

Voucher in Fiscal Year 2011 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

fee rates for using a tropical disease 

priority review voucher for fiscal year 

(FY) 2011. The Federal Food, Drug, and 

Cosmetic Act (the FD&C Act), as 

amended by title XI of the Food and 

Drug Administration Amendments Act 

of 2007 (FDAAA), authorizes FDA to 

determine and collect priority review 

user fees for certain applications for 

approval of drug or biological products 

when those applications use a priority 

review voucher awarded by the 

Secretary of Health and Human 

Services. These vouchers are awarded to 

the sponsor of certain tropical disease 

product applications, submitted after 

September 27, 2007, upon FDA 

approval of such applications. The 

amount of the fee to be submitted to 

FDA with applications using a priority 

review voucher is determined each 

fiscal year (FY) based on the average 

cost incurred by FDA in the review of 

a human drug application subject to 

priority review in the previous FY. 

This notice establishes the priority 

review fee rate for FY 2011. 

FOR FURTHER INFORMATION CONTACT: 

David Miller, Office of Financial 

Management (HFA–100), Food and Drug 

Administration, 1350 Piccard Dr., 

Rockville, MD 20850, 301–796–7103. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 1102 of FDAAA added new 

section 524 to the FD&C Act (21 U.S.C. 

360n). In section 524, Congress 

encouraged development of new drug 

and biological products for prevention 

and treatment of certain tropical 

diseases by offering additional 

incentives for obtaining FDA approval 

of such products. Under section 524, the 

sponsor of an eligible human drug 

application submitted after September 

27, 2007, for a qualified tropical disease 

(as defined in section 524(a)(3)), shall 

receive a priority review voucher upon 

approval of the tropical disease product 

application. The recipient of a priority 

review voucher may either use the 

voucher with a future submission to 

FDA under section 505(b)(1) of the 

FD&C Act (21 U.S.C. 355(b)(1)) or 

section 351 of the Public Health Service 

Act (21 U.S.C. 262), or transfer 

(including by sale) the voucher to 

another party that may then use it. A 

priority review is a review conducted 

with a Prescription Drug User Fee Act 

(PDUFA) goal date of 6 months. 

The applicant that uses a priority 

review voucher is entitled to a priority 

review but must pay FDA a priority 

review user fee in addition to any other 

fee required by PDUFA. FDA has 

published a draft guidance on its Web 

site about how this priority review 

voucher program will operate (available 

at: http://www.fda.gov/downloads/

Drugs/GuidanceComplianceRegulatory

Information/Guidances/

ucm080599.pdf). 

This notice establishes the priority 

review fee rate for 2011 of $4,582,000, 

and outlines FDA’s process for 

implementing the collection of the 

priority review user fees. This rate is 

effective on October 1, 2010, and will 

remain in effect through September 30, 

2011, for applications submitted with a 

priority review voucher, and the 

payment of this priority review user fee 

is required in addition to the payment 

of any other fee that would normally 

apply to such an application under 

PDUFA before FDA considers the 

application complete and acceptable for 

filing. 

II. Priority Review User Fee for FY 

2011 

Under section 524(c)(2) of the FD&C 

Act, the amount of the priority review 

user fee is to be determined each FY 

based on the average cost incurred by 

FDA in the review of a human drug 

application subject to priority review in 

the previous FY. 

A priority review is a review 

conducted with a PDUFA goal date of 6 

months. Normally, an application for a 

Center for Drug Evaluation and Research 

(CDER) product will qualify for a 

priority review if FDA determines that 

the product, if approved, would provide 

safe and effective therapy where no 

satisfactory alternative therapy exists or 

would be a significant improvement 

compared to marketed products, 

including non-drug products and/or 

therapies, in the treatment, diagnosis, or 

prevention of a disease. A Center for 

Biologics Evaluation and Research 

(CBER) product will qualify for a 

priority review if FDA determines that 

the product, if approved, would be a 

significant improvement in the safety or 

effectiveness of the treatment, diagnosis, 

or prevention of a serious or lifethreatening disease. FDA has committed 

to a goal to review and act on 90 percent 

of the applications that have been 

granted priority review status no later 

than 6 months after receipt. An 

application that does not receive a 

priority designation will receive a 

‘‘standard’’ review. Under the goals 

identified in the letters referenced in 

section 101(c) of FDAAA, FDA commits 

to a goal to review and act on 90 percent 

of ‘‘standard’’ applications within 10 

months of the date of receipt. A priority 

review involves a more intensive level 

of effort and a higher level of resources 

than a standard review. 

Section 524 of the FD&C Act specifies 

that the fee amount should be based on 

the average cost incurred by the Agency 

for a priority review in the previous FY. 

Because FDA has never tracked the cost 

of reviewing applications that get 

priority review as a separate cost subset, 

FDA estimated this cost based on other 

data that the Agency has tracked and 

kept. FDA started by using data that the 

Agency estimates and publishes on its 

Web site each year—standard costs for 

review. FDA does not publish a 

standard cost for ‘‘the review of a human 

drug application subject to priority 

review in the previous fiscal year.’’ 

However, we expect all such 

applications would contain clinical 

data. The standard cost application 

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55590 Federal Register / Vol. 75, No. 176 / Monday, September 13, 2010 / Notices 

categories with clinical data that FDA 

does publish each year are as follows: 

(1) New drug applications (NDAs) for 

a new molecular entity (NME) with 

clinical data and 

(2) Biologic license applications 

(BLAs). 

The worksheets for standard costs for 

FY 2009, the latest year for which 

standard cost data are available, show a 

standard cost of $4,021,000 (rounded to 

the nearest thousand dollars) for an 

NDA with clinical data and $3,530,000 

(rounded to the nearest thousand 

dollars) for a BLA. Based on these 

standard costs, the total cost to review 

the 55 applications in these 2 categories 

in FY 2009 (24 BLAs and 31 NDAs with 

clinical data) was $209,371,000. (Note: 

no investigational new drug (IND) 

review costs are included in this 

amount; they will be calculated 

separately and added in the next 

paragraph.) Records acquired from 

CDER and CBER by the Office of Policy, 

Planning and Budget (OPPB), 

Economics Staff, indicate that a total of 

17 of these applications (8 NDAs 

[excluding the President’s Emergency 

Plan for Aids Relief NDAs] and 9 BLAs) 

received priority review, which would 

mean that the remaining 38 received 

standard reviews. Because a priority 

review compresses a review that 

ordinarily takes 10 months into 6 

months, OPPB estimates that a 

multiplier of 1.67 (10 months divided 

by 6 months) should be applied to nonpriority review costs in estimating the 

effort and cost of a priority review as 

compared to a standard review. This 

multiplier is consistent with published 

research on this subject. In the article 

‘‘Developing Drugs for Developing 

Countries,’’ published in Health Affairs, 

vol. 25, Number 2, in 2006, the analysis 

by David B. Ridley, Henry G. 

Grabowski, and Jeffrey L. Moe supports 

a priority review multiplier in the range 

of 1.48 to 2.35. The multiplier derived 

by FDA falls well below the midpoint of 

this range. Using FY 2009 figures, the 

costs of a priority and standard review 

are estimated using the following 

formula: 

(17a x 1.67) + (38a) = $209,371,000 

where ‘‘a’’ is the cost of a standard 

review and ‘‘a’’ times 1.67 is the cost of 

a priority review. Using this formula, 

the cost of a standard review for NMEs 

is calculated to be $3,154,000 (rounded 

to the nearest thousand dollars) and the 

cost of a priority review for NMEs is 

1.67 times that amount, or $5,267,000 

(rounded to the nearest thousand 

dollars). 

Next, the cost of the IND review phase 

for these applications is calculated. The 

standard lifetime cost of reviewing a 

drug IND in FY 2009 was $291,000 

(rounded to the nearest thousand 

dollars). The standard lifetime cost of a 

biologic IND review in FY 2009 was 

$860,000 (rounded to the nearest 

thousand dollars). Because there were 8 

priority NDAs and 9 priority BLAs 

received in FY 2009, the following 

formula estimates the average cost of the 

IND review phase of an application: 

(8 NDAs x $291,000) + (9 BLAs x 

$860,000) = $10,068,000 

This is the full cost of the IND review 

associated with the 17 priority review 

applications received in FY 2009. 

Dividing $10,068,000 by 17 (the total 

number of priority review applications 

received in FY 2009), yields an average 

IND review phase cost of $592,000 

(rounded to the nearest thousand 

dollars) per priority review application. 

Adding the cost of the NDA/BLA 

priority review calculated previously, 

$5,267,000, to the cost of the IND review 

phase of $592,000, results in an 

estimated average cost for priority 

review for an application received in FY 

2009 of $5,859,000. 

Section 524 of the FD&C Act specifies 

that the fee amount should be based on 

the average cost incurred by the Agency 

for a priority review in the previous FY. 

FDA is setting fees for FY 2011, and the 

previous FY is FY 2010. However, the 

FY 2010 submission cohort has not been 

closed out yet, and the cost data for FY 

2010 are not complete. The latest year 

for which FDA has data is FY 2009. 

Accordingly, FDA will adjust the 

previously mentioned FY 2009 cost 

figure by the average amount by which 

FDA’s average salary and benefit costs 

increased in the 5 years prior to FY 

2011, to adjust the FY 2009 amount for 

cost increases in FY 2010. That figure, 

published in the Federal Register of 

August 4, 2010 (75 FR 46952 at 46954), 

which set Prescription Drug User Fees 

for FY 2011, is 4.53 percent. Increasing 

the FY 2009 average priority review cost 

figure of $5,859,000 by 4.53 percent 

results in an estimated cost of 

$6,124,000 (rounded to the nearest 

thousand dollars). 

FDA will deduct from this amount the 

PDUFA fee that must also be paid in 

addition to the priority review fee when 

an NDA or BLA with clinical data is 

submitted in FY 2011. That amount, 

also published in the Federal Register 

of August 4, 2010 (75 FR 46952 at 

46957), which set PDUFA fees for FY 

2011, is $1,542,000. The difference, 

rounded to the nearest thousand dollars, 

is $4,582,000. This is the priority review 

user fee amount for FY 2011 that must 

be submitted with a priority review 

voucher in FY 2011, in addition to any 

PDUFA fee that is required for such an 

application. 

III. Priority Review Fee Schedule for 

FY 2011 

The fee rate for FY 2011 is set out in 

table 1 of this document. 

TABLE 1. 

FEE CATEGORY FEE RATE FOR 

FY 2011 

APPLICATIONS SUBMITTED WITH A PRIORITY REVIEW VOUCHER 

In addition to the normal PDUFA Fee $4,582,000 

IV. Implementation of Priority Review 

Fee 

Under section 524(c)(4)(A) of the 

FD&C Act, the priority review user fee 

is due upon submission of the 

application for which the priority 

review voucher is used. Section 

524(c)(4)(B) specifies that the 

application will be considered 

incomplete if the priority review user 

fee and all other applicable user fees are 

not paid in accordance with FDA 

payment procedures. FDA may not grant 

a waiver, exemption, reduction, or 

refund of any fees due and payable 

under this section of the FD&C Act, and 

FDA may not collect priority review 

voucher fees prior to a relevant 

appropriation for fees for that FY. 

Beginning with FDA’s appropriation for 

FY 2009, the annual appropriation 

language states specifically that ‘‘priority 

review user fees authorized by 21 U.S.C. 

360n (section 524 of the FD&C Act) may 

be credited to this account, to remain 

available until expended.’’ (Public Law 

111–8, Section 5, Division A, Title VI). 

The priority review fee established in 

the new fee schedule must be paid for 

any application that is received after 

September 30, 2010, and submitted with 

a priority review voucher. This fee must 

be paid in addition to any other fee due 

under PDUFA. 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. The user fee 

identification (ID) number should be 

included on the check, followed by the 

words ‘‘Priority Review’’. Payments can 

be mailed to: Food and Drug 

Administration, P.O. Box 70963, 

Charlotte, NC 28272–0963. 

If checks are sent by a courier that 

requests a street address, the courier can 

deliver the checks to: Wells Fargo QLP 

Lockbox D1113–022, Attn: Food and 

Drug Administration Lockbox 70963, 

1525 West WT Harris Blvd., Charlotte, 

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Federal Register / Vol. 75, No. 176 / Monday, September 13, 2010 / Notices 55591 

NC 28262. (Note: This Wells Fargo 

address is for courier delivery only.) 

The FDA post office box number (P.O. 

Box 70963) must be written on the 

check. The tax identification number of 

the Food and Drug Administration is 

53–0196965. 

Wire transfer payments 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. 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. Dept. of 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 20850. 

Application fees can also be paid 

online with an electronic check (ACH). 

FDA has partnered with the U.S. 

Department of Treasury to utilize 

Pay.gov, a Web-based payment 

application, for online electronic 

payment. The Pay.gov feature is 

available on FDA’s Web site after the 

user fee ID number is generated. 

Dated: September 7, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–22760 Filed 9–10–10; 8:45 am] 

BILLING CODE 4160–01–S 

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: Prions, HCV and Beta-Lactams. 

Date: September 23–24, 2010. 

Time: 10 a.m. to 3 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Rolf Menzel, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3196, 

MSC 7808, Bethesda, MD 20892, 301–435– 

0952, menzelro@csr.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: Center for Scientific 

Review Special Emphasis Panel; Dental and 

Oral Sciences. 

Date: October 4, 2010. 

Time: 2 p.m. to 5 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: Yi-Hsin Liu, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4214, 

MSC 7814, Bethesda, MD 20892, 301–435– 

1781, liuyh@csr.nih.gov. 

Name of Committee: Musculoskeletal, Oral 

and Skin Sciences Integrated Review Group; 

Oral, Dental and Craniofacial Sciences Study 

Section. 

Date: October 6, 2010. 

Time: 8 a.m. to 6 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Embassy Suites at the Chevy Chase 

Pavilion, 4300 Military Road, NW., 

Washington, DC 20015. 

Contact Person: Yi-Hsin Liu, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4214, 

MSC 7814, Bethesda, MD 20892, 301–435– 

1781, liuyh@csr.nih.gov. 

Name of Committee: Molecular, Cellular 

and Developmental Neuroscience Integrated 

Review Group; Neurodifferentiation, 

Plasticity, and Regeneration Study Section. 

Date: October 6–7, 2010. 

Time: 8 a.m. to 4 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Savoy Suites Hotel, 2505 Wisconsin 

Avenue, NW., Washington, DC 20007. 

Contact Person: Joanne T. Fujii, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4184, 

MSC 7850, Bethesda, MD 20892, 301–435– 

1178, fujiij@csr.nih.gov. 

Name of Committee: Molecular, Cellular 

and Developmental Neuroscience Integrated 

Review Group; Neurogenesis and Cell Fate 

Study Section. 

Date: October 7, 2010. 

Time: 8 a.m. to 6 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Melrose Hotel, 2430 Pennsylvania 

Avenue, NW., Washington, DC 20037. 

Contact Person: Joanne T. Fujii, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4184, 

MSC 7850, Bethesda, MD 20892, 301–435– 

1178, fujiij@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel Fellowship: 

Biomedical Imaging and Bioengineering. 

Time: 11:30 a.m. to 4 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: Dharam S Dhindsa, DVM, 

PhD, Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5110, 

MSC 7854, Bethesda, MD 20892,(301) 435– 

1174, dhindsad@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel PAR09–057: 

Improving Interventions for Communication 

Disorders. 

Date: October 18, 2010. 

Time: 1 p.m. to 4 p.m. 

Agenda: To review and evaluate grant 

applications, JW Marriott San Francisco 

Union Square, 500 Post Street corner of Post 

and Mason, San Francisco, CA 94102. 

Contact Person: Eugene Carstea, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5194, 

MSC 7846, Bethesda, MD 20892, (301) 408– 

9756, carsteae@csr.nih.gov. 

Name of Commitee: Center for Scientific 

Review Special Emphasis Panel PAR09–056: 

Improving Intervention Possibilities for 

Communication Disorders. 

Date: October 18, 2010. 

Time: 12 p.m. to 1 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: JW Marriott San Francisco Union 

Square, 500 Post Street corner of Post and 

Mason, San Francisco, CA 94102. 

Contact Person: Eugene Carstea, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5194, 

MSC 7846, Bethesda, MD 20892, (301) 408– 

9756, carsteae@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel Member 

Conflict: Old mice. 

Date: October 18, 2010. 

Time: 12 p.m. to 1:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Room 3222, Bethesda, MD 

20892 (Telephone Conference Call). 

Contact Person: James Harwood, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5168, 

MSC 7840, Bethesda, MD 20892, 301–435– 

1256, harwoodj@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel PAR–08– 

076: Community Participation Research. 

Date: October 19, 2010. 

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

Agenda: To review and evaluate grant 

applications. 

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