Federal Register / Vol. 76, No. 69 / Monday, April 11, 2011 / Notices 19997 

expertise on BDS and botanical 

ingredients from: (1) The faculty in the 

UM School of Pharmacy, including 

researchers in the Departments of 

Pharmacognosy, Medicinal Chemistry, 

Pharmaceutics, Pharmacology, and the 

Research Institute of Pharmaceutical 

Sciences; (2) research scientists in the 

U.S. Department of Agriculture/ 

Agricultural Research Service’s (USDA/ 

ARS) National Products Utilization 

Research unit who are physically colocated and programmatically integrated 

in the UM–NCNPR; (3) close academic 

links and historical collaborations with 

agriculture and botanical programs and 

facilities within the UM system; (4) 

successful research collaborations with 

the dietary supplement industry; and (5) 

established formal agreements with 

several international academic 

institutions. 

These collaborations give UM– 

NCNPR the unique ability to provide 

essential scientific expertise and 

botanical and chemical resources that 

will continue to assist FDA in its 

mission to ensure the safety of BDS and 

botanical ingredients. 

FDA believes that continued support 

of UM–NCNPR is appropriate because it 

is uniquely qualified to fulfill the 

objectives of the proposed cooperative 

agreement. FDA has determined that 

UM–NCNPR is the only institution with 

the unique capability of providing a 

broad range of highly relevant scientific 

expertise and facilities that are 

physically co-located and singularly 

dedicated to natural products research. 

UM is a comprehensive research 

institution with numerous academic 

programs relevant to natural products. 

II. Award Information/Funds Available 

A. Award Amount 

The estimated amount of support in 

Fiscal Year (FY) 2011 will be for up to 

$2.1 million (direct plus indirect costs), 

with the possibility of 4 additional years 

of support for up to $2.5 million per 

year, subject to the availability of funds. 

Future year amounts will depend on 

annual appropriations and successful 

performance. 

B. Length of Support 

The award will provide 1 year of 

support, with the possibility of 4 

additional years of support, contingent 

upon satisfactory performance in the 

achievement of project and program 

reporting objectives during the 

preceding year and the availability of 

Federal FY appropriations. 

III. Electronic Application, 

Registration, and Submission 

Only electronic applications will be 

accepted. To submit an electronic 

application in response to this FOA, 

applicants should first review the full 

announcement located at http:// 

www.fda.gov/Food/NewsEvents/ 

default.htm or http://grants2.nih.gov/ 

grants/guide. (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.) For all 

electronically submitted applications, 

the following steps are required. 

• Step 1: Obtain a Dun and Bradstreet 

(DUNS) Number. 

• Step 2: Register With Central 

Contractor Registration. 

• Step 3: Obtain Username & 

Password. 

• Step 4: Authorized Organization 

Representative (AOR) Authorization. 

• Step 5: Track AOR Status. 

• Step 6: Register With Electronic 

Research Administration (eRA) 

Commons. 

Steps 1 through 5, in detail, can be 

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

applicants/organization_

registration.jsp. Step 6, in detail, can be 

found at https://commons.era.nih.gov/

commons/registration/

registrationInstructions.jsp. After you 

have followed these steps, submit 

electronic applications to: http:// 

www.grants.gov. 

Dated: April 1, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–8521 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–2010–P–0593] 

Determination That FENTORA 

(Fentanyl Citrate) Buccal Tablet, 300 

Micrograms, Was Not Withdrawn From 

Sale for Reasons of Safety or 

Effectiveness 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

that FENTORA (fentanyl citrate) buccal 

tablet, 300 micrograms (mcg), was not 

withdrawn from sale for reasons of 

safety or effectiveness. This 

determination will allow FDA to 

approve abbreviated new drug 

applications (ANDAs) for fentanyl 

citrate buccal tablet, 300 mcg, if all 

other legal and regulatory requirements 

are met. 

FOR FURTHER INFORMATION CONTACT: 

Reena Raman, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 6238, 

Silver Spring, MD 20993–0002, 301– 

796–7577. 

SUPPLEMENTARY INFORMATION: In 1984, 

Congress enacted the Drug Price 

Competition and Patent Term 

Restoration Act of 1984 (Pub. L. 98–417) 

(the 1984 amendments), which 

authorized the approval of duplicate 

versions of drug products approved 

under an ANDA procedure. ANDA 

applicants must, with certain 

exceptions, show that the drug for 

which they are seeking approval 

contains the same active ingredient in 

the same strength and dosage form as 

the ‘‘listed drug,’’ which is a version of 

the drug that was previously approved. 

ANDA applicants do not have to repeat 

the extensive clinical testing otherwise 

necessary to gain approval of a new 

drug application (NDA). The only 

clinical data required in an ANDA are 

data to show that the drug that is the 

subject of the ANDA is bioequivalent to 

the listed drug. 

The 1984 amendments include what 

is now section 505(j)(7) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

355(j)(7)), which requires FDA to 

publish a list of all approved drugs. 

FDA publishes this list as part of the 

‘‘Approved Drug Products With 

Therapeutic Equivalence Evaluations,’’ 

which is known generally as the 

‘‘Orange Book.’’ Under FDA regulations, 

drugs are removed from the list if the 

Agency withdraws or suspends 

approval of the drug’s NDA or ANDA 

for reasons of safety or effectiveness or 

if FDA determines that the listed drug 

was withdrawn from sale for reasons of 

safety or effectiveness (21 CFR 314.162). 

Under § 314.161(a)(1) (21 CFR 

314.161(a)(1)), the Agency must 

determine whether a listed drug was 

withdrawn from sale for reasons of 

safety or effectiveness before an ANDA 

that refers to that listed drug may be 

approved. FDA may not approve an 

ANDA that does not refer to a listed 

drug. 

FENTORA (fentanyl citrate) buccal 

tablet, 300 mcg, is the subject of NDA 

21–947, held by Cephalon, Inc., and 

initially approved on September 25, 

2006. FENTORA is indicated for the 

management of breakthrough pain in 


srobinson on DSKHWCL6B1PROD with NOTICES
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