55588 Federal Register / Vol. 75, No. 176 / Monday, September 13, 2010 / Notices 

CFDA Number: 93.504. 

Justification for the Exception to 

Competition: The former grantee, P2P of 

Vermont, has relinquished all grants 

held under the P2P legal name due to 

an organizational merger with VFN. The 

former grantee has requested that HRSA 

transfer the F2F HIC funds to VFN in 

order to implement and carry out grant 

activities originally proposed under P2P 

of Vermont grant applications. 

A single-source award was made to 

VFN because of the organizational 

merger of P2P into VFN and the 

following program determinations: (1) 

Continuing need for the project; (2) that 

the time required to obtain competition 

would seriously jeopardize the success 

of the project and put at risk the health 

of the people being served by the 

project; (3) that there will be no 

significant change in the scope or 

objectives (including any reduction) of 

the previously approved project or 

activity; (4) that the replacement 

recipient is eligible to receive the award 

and its facilities and resources allow for 

the successful performance of the 

project. 

CYSHCN are defined as ‘‘those 

children and youth who have or are at 

increased risk for a chronic physical, 

developmental, behavioral, or emotional 

condition and who also require health 

and related services of a type or amount 

beyond that required by children 

generally’’ (American Academy of 

Pediatrics, 1998). This is particularly 

relevant since 2006 National survey data 

showed more than 17% of CYSHCN in 

Vermont had problems getting referrals 

to care. Also, because of changes 

occurring in State services and funding 

for CYSHCN, many families and 

providers alike need to be kept up to 

date on these changes so that they can 

access appropriate services. This center 

is urgently needed to address these gaps 

and disparities in information and 

services. 

It is critical that VFN continue 

helping families of CYSHCN gain access 

to information they need to make 

informed health care decisions, be full 

partners in decisionmaking, and access 

needed resources/referrals and 

financing for those services in the state 

of Vermont. It is also imperative that the 

center continues to train and support 

health care providers and other 

professionals in public and private 

agencies who serve Vermont’s CYSHCN, 

helping them better understand the 

needs of children, youth and their 

families. 

VFN 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 the P2P of Vermont. 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 Vermont and in a manner 

which avoids any disruption of services. 

Dated: September 3, 2010. 

Mary K. Wakefield, 

Administrator. 

[FR Doc. 2010–22664 Filed 9–10–10; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Family-to-Family Health Information 

Center Program 

AGENCY: Health Resources and Services 

Administration, HHS. 

ACTION: Notice. 

SUMMARY: The Health Resources and 

Services Administration (HRSA) will be 

transferring the Florida Family-toFamily Health Information Center (F2F 

HIC) grant (H84MC00006) from the 

Florida Institute of Family Involvement 

(FIFI) to the Family Cafe ́ in Tallahassee 

due to financial difficulties resulting in 

closure of FIFI facilities and programs. 

This action ensures the continued 

provision of health resources, financing, 

related services and parent-to-parent 

support for families with children and 

youth with special health care needs 

(CYSHCN) in the state of Florida. 

FOR FURTHER INFORMATION CONTACT: 

LaQuanta Person, Project Officer, 

Integrated Services Branch, Division of 

Services for Children with Special 

Health Needs, Maternal and Child 

Health Bureau, Health Resources and 

Services Administration, 5600 Fishers 

Lane, Room 18A–18, Rockville, MD 

20857; 301.443.2370; lperson@hrsa.gov. 

SUPPLEMENTARY INFORMATION: 

Former Grantee of Record: Florida 

Institute of Family Involvement. 

Original Grant Period: June 1, 2006 to 

May 31, 2011. 

Replacement Awardee: The Family 

Cafe ́. 

Amount of Replacement Award: Up to 

$95,700 for the remaining of the project 

period. 

Period of Replacement Award: The 

period of support for the replacement 

award is June 1, 2010 to May 31, 2011. 

Authority: Section 501(c)(1)(A) of the 

Social Security Act, as amended. 

CFDA Number: 93.504. 

Justification for the Exception to 

Competition: The former grantee, FIFI, 

has relinquished all grants due to 

financial difficulties resulting in closure 

of FIFI facilities and programs. The 

former grantee has requested that HRSA 

transfer the F2F HIC funds to the Family 

Cafe ́ in order to implement and carry 

out grant activities originally proposed 

under FIFI grant applications. 

A single-source award was made to 

the Family Cafe ́ because of the financial 

difficulties of FIFI and the following 

program determinations: (1) Continuing 

need for the project; (2) that the time 

required to obtain competition would 

seriously jeopardize the success of the 

project and put at risk the health of the 

people being served by the project; (3) 

that there will be no significant change 

in the scope or objectives (including any 

reduction) of the previously approved 

project or activity; (4) that the 

replacement recipient is eligible to 

receive the award and its facilities and 

resources allow for the successful 

performance of the project. 

CYSHCN are defined as ‘‘those 

children and youth who have or are at 

increased risk for a chronic physical, 

developmental, behavioral, or emotional 

condition and who also require health 

and related services of a type or amount 

beyond that required by children 

generally’’ (American Academy of 

Pediatrics, 1998). This is particularly 

relevant since 2006 National survey data 

showed more than 26% of CYSHCN in 

Florida had problems getting referrals to 

care. Florida was ranked fourth 

nationally for the highest estimated 

number of CYSHCN in the state 

(551,263). In addition, because of 

changes occurring in state services and 

funding for CYSHCN, many families 

and providers alike need to be kept up 

to date on these changes so that they can 

access appropriate services. This center 

is urgently needed to address these gaps 

and disparities in information and 

services. It is critical that the Family 

Cafe ́ continue helping families of 

CYSHCN gain access to information 

they need to make informed health care 

decisions, be full partners in decisionmaking and access needed resources/ 

referrals and financing for those services 

in the state of Florida. It is also 

imperative that the center continues to 

mstockstill on DSKB9S0YB1PROD with NOTICES

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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