19998 Federal Register / Vol. 76, No. 69 / Monday, April 11, 2011 / Notices 

patients with cancer who are already 

receiving and who are tolerant to 

around-the-clock opioid therapy for 

their underlying persistent cancer pain. 

FENTORA (fentanyl citrate) buccal 

tablet, 300 mcg, is currently listed in the 

‘‘Discontinued Drug Product List’’ 

section of the Orange Book. 

Watson Laboratories, Inc., submitted a 

citizen petition dated November 16, 

2010 (Docket No. FDA–2010–P–0593), 

under 21 CFR 10.30, requesting that the 

Agency determine whether FENTORA 

(fentanyl citrate) buccal tablet, 300 mcg, 

was withdrawn from sale for reasons of 

safety or effectiveness. 

After considering the citizen petition 

and reviewing Agency records, FDA has 

determined under § 314.161 that 

FENTORA (fentanyl citrate) buccal 

tablet, 300 mcg, was not withdrawn for 

reasons of safety or effectiveness. The 

petitioner has identified no data or other 

information suggesting that FENTORA 

(fentanyl citrate) buccal tablet, 300 mcg, 

was withdrawn for reasons of safety or 

effectiveness. We have carefully 

reviewed our files for records 

concerning the withdrawal of 

FENTORA (fentanyl citrate) buccal 

tablet, 300 mcg, from sale. We have also 

independently evaluated relevant 

literature and data for possible 

postmarketing adverse events and have 

found no information that would 

indicate that this product was 

withdrawn from sale for reasons of 

safety or effectiveness. 

Accordingly, the Agency will 

continue to list FENTORA (fentanyl 

citrate) buccal tablet, 300 mcg, in the 

‘‘Discontinued Drug Product List’’ 

section of the Orange Book. The 

‘‘Discontinued Drug Product List’’ 

delineates, among other items, drug 

products that have been discontinued 

from marketing for reasons other than 

safety or effectiveness. ANDAs that refer 

to FENTORA (fentanyl citrate) buccal 

tablet, 300 mcg, may be approved by the 

Agency as long as they meet all other 

legal and regulatory requirements for 

the approval of ANDAs. If FDA 

determines that labeling for this drug 

product should be revised to meet 

current standards, the Agency will 

advise ANDA applicants to submit such 

labeling. 

Dated: April 6, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–8524 Filed 4–8–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0012] 

Supplemental Funding Under the Food 

and Drug Administration Pediatric 

Device Consortia Grant Program 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of supplemental grant funds 

for the Pediatric Device Consortia Grant 

Program. The goal of this announcement 

is to allow an existing active grantee to 

compete for further funds listed under 

RFA–FD–11–002. 

DATES: Important dates are as follows: 

1. The supplemental application due 

date is May 2, 2011. 

2. The anticipated start date is in 

September 2011. 

3. The opening date is April 11, 2011. 

4. The expiration date is May 3, 2011. 

FOR FURTHER INFORMATION AND

ADDITIONAL REQUIREMENTS CONTACT: 

Linda C. Ulrich, Office of Orphan 

Products Development, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, rm. 5271, Silver Spring, 

MD 20993–0002, 301–796–8686. e-mail: 

Linda.Ulrich@fda.hhs.gov; or Vieda 

Hubbard, Office of Acquisitions & 

Grants Service (HFA–500), Food and 

Drug Administration, 5630 Fishers 

Lane, rm.1079, Rockville, MD 20857, 

301–827–7177, FAX: 301–827–7039, email: Vieda.Hubbard@fda.hhs.gov. 

For more information on this funding 

opportunity announcement (FOA) and 

to obtain detailed requirements, please 

refer to the full FOA located at: http:// 

grants.nih.gov/grants/guide/rfa-files/ 

RFA–FD–11–002.html. 

SUPPLEMENTARY INFORMATION: 

I. Funding Opportunity Description 

RFA–FD–11–025; 93.103 

The purpose of this Federal Register 

notice is to allow an existing grantee to 

compete to receive a competitive 

supplement under a previous funding 

opportunity announcement. 

A. Background 

The development of pediatric medical 

devices currently lags 5 to 10 years 

behind the development of devices for 

adults. Children differ from adults in 

terms of their size, growth, 

development, and body chemistry, 

adding to the challenges of pediatric 

device development. There currently 

exists a great need for medical devices 

designed specifically with children in 

mind. Such needs include the original 

development of pediatric medical 

devices, as well as the specific 

adaptation of existing adult devices for 

children. Thus, as part of the Food and 

Drug Administration Amendments Act 

of 2007 (FDAAA) legislation, Congress 

passed the Pediatric Medical Device 

Safety and Improvement Act of 2007 

(PMDSI Act). Section 305 of the PMDSI 

Act requires the Secretary of Health and 

Human Services to provide 

demonstration grants or contracts to 

nonprofit consortia to promote pediatric 

device development. 

B. Research Objectives 

The goal of FDA’s Pediatric Device 

Consortia Grant Program is to promote 

pediatric device development by 

providing grants to nonprofit consortia. 

The consortia will facilitate the 

development, production, and 

distribution of pediatric medical devices 

by: 

(1) Encouraging innovation and 

connecting qualified individuals with 

pediatric device ideas with potential 

manufacturers; 

(2) Mentoring and managing pediatric 

device projects through the 

development process, including product 

identification, prototype design, device 

development, and marketing; 

(3) Connecting innovators and 

physicians to existing Federal and nonFederal resources; 

(4) Assessing the scientific and 

medical merit of proposed pediatric 

device projects; and 

(5) Providing assistance and advice as 

needed on business development, 

personnel training, prototype 

development, postmarketing needs, and 

other activities. 

C. Eligibility Information 

This supplement is only available to 

a current, existing, ongoing grant 

recipient. 

II. Award Information/Funds Available 

A. Award Amount 

The maximum amount of this 

supplement would be $1,000,000 in 

total cost (direct costs plus indirect 

costs) per year. 

B. Length of Support 

The supplement may be awarded on 

a competitive basis for up to 2 years. 

III. Paper Application, Registration, 

and Submission Information 

To submit a paper application in 

response to this FOA, the applicant 

should first review the full 


srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 76, No. 69 / Monday, April 11, 2011 / Notices 19999 

announcement located at http:// 

grants.nih.gov/grants/guide/rfa-files/ 

RFA–FD–11–002.html. (FDA has 

verified the Web site addresses 

throughout this document, but FDA is 

not responsible for any subsequent 

changes to the Web sites after this 

document publishes in the Federal 

Register.) Persons interested in applying 

for a grant may obtain an application at 

http://grants.nih.gov/grants/guide/rfafiles/RFA–FD–11–002.html. 

For all paper application submissions, 

the following steps are required: 

• Step 1: Obtain a Dun and Bradstreet 

(DUNS) Number 

• Step 2: Register With Central 

Contractor Registration 

Steps 1 and 2, in detail, can be found 

at http://www07.grants.gov/applicants/ 

organization_registration.jsp. After you 

have followed these steps, submit paper 

applications to: Division of Acquisition 

Support and Grants, Office of 

Acquisition & Grant Services, 5630 

Fishers Lane, Rm. 1079, Rockville, MD 

20857, 301–827–7177. 

Dated: April 6, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–8513 Filed 4–8–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Eunice Kennedy Shriver National 

Institute of Child Health & Human 

Development; Notice of Closed 

Meeting 

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 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 

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 

Child Health and Human Development 

Special Emphasis Panel, Cognitive 

Development. 

Date: April 27, 2011. 

Time: 2:30 p.m. to 4 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6100 

Executive Boulevard, Rockville, MD 20852 

(Telephone Conference Call). 

Contact Person: Carla Walls, PhD, 

Scientific Review Officer, Division of 

Scientific Review, National Institute of Child 

Health and Human Development, 6100 

Executive Boulevard, Rockville, MD 20892– 

9304, (301) 435–6898, wallsc@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.864, Population Research; 

93.865, Research for Mothers and Children; 

93.929, Center for Medical Rehabilitation 

Research; 93.209, Contraception and 

Infertility Loan Repayment program, National 

Institutes of Health, HHS) 

Dated: April 5, 2011. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2011–8606 Filed 4–8–11; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

In compliance with Section 

3506(c)(2)(A) of the Paperwork 

Reduction Act of 1995 concerning 

opportunity for public comment on 

proposed collections of information, the 

Substance Abuse and Mental Health 

Services Administration (SAMHSA) 

will publish periodic summaries of 

proposed projects. To request more 

information on the proposed projects or 

to obtain a copy of the information 

collection plans, call the SAMHSA 

Reports Clearance Officer on (240) 276– 

1243. 

Comments are invited on: (a) Whether 

the proposed collections of information 

are necessary for the proper 

performance of the functions of the 

agency, including whether the 

information shall have practical utility; 

(b) the accuracy of the agency’s estimate 

of the burden of the proposed collection 

of information; (c) ways to enhance the 

quality, utility, and clarity of the 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques or 

other forms of information technology. 

Proposed Project: Unified Application 

for the Community Mental Health 

Services Block Grant and Substance 

Abuse and Prevention Treatment Block 

Grant FY 2012–2013 Application 

Guidance and Instructions (OMB No. 

0930–0168)—Revision 

The Substance Abuse and Mental 

Health Services Administration 

(SAMHSA), is requesting approval from 

the Office of Management and Budget 

(OMB) for a revision of the 2012 and 

2013 Community Mental Health 

Services Block Grant (MHSBG) and 

Substance Abuse Prevention and 

Treatment Block Grant (SAPTBG) 

Guidance and Instructions into one 

unified block grant application. To 

minimize the burden, the two separate 

clearances for the block grant 

applications will be merged into one. 

Currently, the SAPTBG and the 

MHSBG differ on a number of their 

practices (e.g., data collection at 

individual or aggregate levels) and 

statutory authorities (e.g., method of 

calculating MOE, stakeholder input 

requirements for planning, set asides for 

specific populations or programs, etc.). 

Historically, the Centers within 

SAMHSA that administer these Block 

Grants have had different approaches to 

application requirements and reporting. 

To compound this variation, States have 

different structures for accepting, 

planning, and accounting for the Block 

Grants and the Prevention Set Aside 

within the SAPTBG. As a result, how 

these dollars are spent and what is 

known about the services and clients 

that receive these funds varies by Block 

Grant and by State. 

In addition, between 2012 and 2015, 

32 million individuals who are 

uninsured will have the opportunity to 

enroll in Medicaid or private health 

insurance. This expansion of health 

insurance coverage will have a 

significant impact on how State Mental 

Health Authorities (SMHAs) and State 

Substance Abuse Authorities (SSAs) use 

their limited resources. Many 

individuals served by these authorities 

are funded through Federal Block Grant 

funds. SAMHSA proposes that Block 

Grant funds be directed toward four 

purposes: (1) To fund priority treatment 

and support services for individuals 

without insurance or who cycle in and 

out of health insurance coverage; (2) to 

fund those priority treatment and 

support services not covered by 

Medicaid, Medicare or private insurance 

offered through the exchanges and that 

demonstrate success in improving 

outcomes and/or supporting recovery; 

(3) to fund universal, selective and 

targeted prevention activities and 


srobinson on DSKHWCL6B1PROD with NOTICES