22404 Federal Register / Vol. 76, No. 77 / Thursday, April 21, 2011 / Notices 

Dated: April 15, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–9651 Filed 4–20–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0012] 

Analgesic Clinical Trials Innovation, 

Opportunities, and Networks (ACTION) 

Initiative 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of grant funds for the 

support of the Analgesic Clinical Trials 

Innovation, Opportunities, and 

Networks (ACTION) Initiative. The goal 

of the ACTION Initiative is to streamline 

the discovery and development process 

for new analgesic drug products for the 

benefit of public health. The ACTION 

Initiative is being developed, in large 

part, through the establishment of a 

cooperative agreement with one or more 

organizations. The ACTION Initiative 

will address major gaps in scientific 

information, which can slow down 

analgesic clinical trials and analgesic 

drug development. FDA will support 

the ACTION Initiative under the 

authority of the Federal Food, Drug, and 

Cosmetic Act. 

DATES: Important dates are as follows: 

1. The application due date is June 8, 

2011. 

2. The anticipated start date is July 14, 

2011. 

3. The opening date is April 22, 2011. 

4. The expiration date is June 9, 2011. 

FOR FURTHER INFORMATION AND

ADDITIONAL REQUIREMENTS CONTACT: Igor 

Cerny, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 22, rm. 3124, Silver Spring, 

MD 20993–0002, 301–796–4273, e-mail: 

Igor.Cerny@fda.hhs.gov; Vieda Hubbard, 

Office of Acquisitions and Grant 

Services, Food and Drug 

Administration, 5630 Fishers Lane 

(HFA–500), Rockville, MD 20857, 301– 

827–7177, e-mail: 

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/ (select the 

‘‘Request for Applications’’ link), 

http://www.grants.gov/ (see ‘‘For 

Applicants’’ section) and/or http:// 

www.fda.gov/AboutFDA/ 

PartnershipsCollaborations/ 

PublicPrivatePartnershipProgram/ 

ucm231130.htm. 

SUPPLEMENTARY INFORMATION: 

I. Funding Opportunity Description 

RFA–FD–11–006 

93.103 

A. Background 

Despite the enormous advances in 

drug development over the past 2 or 3 

decades (e.g., drugs that cure cancer and 

biologic drug products that halt the 

progression of rheumatoid arthritis), the 

development of novel analgesic drug 

products has lagged behind. Indeed, to 

this day, the only analgesic drug 

products that are used widely and 

successfully are opioids, 

acetaminophen, and nonsteroidal antiinflammatory agents, all of which have 

serious, potentially life-threatening 

toxicities, even when used properly. 

While there has been exploration at the 

earliest stages of drug development, 

there has been widespread reluctance 

on the part of the pharmaceutical 

industry to take novel products further 

into development. This is in no small 

part due to the often daunting task of 

demonstrating the efficacy of analgesics 

in clinical trials. Many experts in 

analgesic drug development believe that 

it is the design of the clinical trials that 

is at fault in this situation and that 

better trial designs will yield more 

successful results. This hypothesis is 

certainly supported by the frequent 

failures of clinical efficacy trials of 

opioid drug products, considering the 

well established effectiveness of these 

products from literally thousands of 

years of clinical experience. For these 

reasons, additional studies are needed 

to assess the confounding nature of 

analgesic clinical trials and analgesic 

drug development. 

B. Research Objectives 

Based on collaboration with FDA, key 

stakeholder input, best Government, 

academic, and industry practices, and 

knowledge gained through workshops, 

the Grantee will be responsible for 

developing, defining, and 

recommending projects as described in 

this section. Applicants should, at a 

minimum, address the following three 

overarching research domains in this 

section. The overall study design 

processes within each of these domains 

should be aligned with established 

strategic goals and provide results and 

recommendations in alignment with the 

objectives of the ACTION Initiative. 

1. Data analysis of primarily group 

analgesic clinical trials data (databases) 

for relationships between assay 

sensitivity and metrics including, but 

not limited to, specific research designs 

and methodological features so as to 

inform the future design of analgesic 

clinical trials. 

2. Scientific assessment of FDA’s 

clinical trial databases and development 

of novel and alternative means of 

analyzing various pain scores in a 

manner that effectively considers 

variables, such as bias and 

interindividual variance. 

3. Development of methodologies for 

the execution and transformation of 

pooled trial data from multiple relevant 

analgesic trials. 

C. Eligibility Information 

The following organizations/ 

institutions are eligible to apply: 

• Higher education institutions as 

defined in section 101 of the Higher 

Education Act of 1965 (or a consortium 

of such institutions). 

The following types of higher 

education institutions are always 

encouraged to apply for National 

Institutes of Health support as public or 

private institutions of higher education: 

• Hispanic serving institutions. 

• Historically Black colleges and 

universities. 

• Tribally controlled colleges and 

universities. 

• Alaska Native and Native Hawaiian 

serving institutions. 

Nonprofits other than institutions of 

higher education. 

• A nonprofit organization described 

in section 501(c)(3) of the Internal 

Revenue Code of 1986, which is exempt 

from tax under section 501(a) of that 

code. 

An eligible organization that wishes 

to enter into a collaborative agreement 

must provide an assurance that the 

entity will not accept funding for a 

Critical Path Public-Private Partnership 

project from any organization that 

manufactures or distributes products 

regulated by FDA unless the entity 

provides assurances in its agreement 

with FDA that the results of the Critical 

Path Public-Private Partnership project 

will not be influenced by any source of 

funding. 

II. Award Information/Funds Available 

A. Award Amount 

It is anticipated that no more than 

$1 million will be allocated to this 

cooperative agreement. It is anticipated 

that a single award will be made. 


emcdonald on DSK2BSOYB1PROD with NOTICES
Federal Register / Vol. 76, No. 77 / Thursday, April 21, 2011 / Notices 22405 

B. Length of Support 

The scope of the proposed project will 

determine the project period. The 

maximum period is 5 years. 

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:// 

grants.nih.gov/grants/guide/ (select the 

‘‘Request for Applications’’ link), 

http://www.grants.gov/ (see ‘‘For 

Applicants’’ section) and http:// 

www.fda.gov/AboutFDA/ 

PartnershipsCollaborations/ 

PublicPrivatePartnershipProgram/ 

ucm166082.htm. (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 13, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–9650 Filed 4–20–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0002] 

Cellular, Tissue and Gene Therapies 

Advisory Committee; Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committee: Cellular, Tissue 

and Gene Therapies Advisory 

Committee. 

General Function of the Committee: 

To provide advice and 

recommendations to the Agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on June 29, 2011, from 8 a.m. to 

5 p.m. 

Location: Crowne Plaza Hotel, 8777 

Georgia Ave., Silver Spring, MD 20910. 

Contact Person: Gail Dapolito or 

Sheryl Clark, Center for Biologics 

Evaluation and Research (HFM–71), 

Food and Drug Administration, 1401 

Rockville Pike, Rockville, MD 20852, 

301–827–0314, or FDA Advisory 

Committee Information Line, 1–800– 

741–8138 (301–443–0572 in the 

Washington, DC area), and follow the 

prompts to the desired center or product 

area. Please call the Information Line for 

up-to-date information on this meeting. 

A notice in the Federal Register about 

last minute modifications that impact a 

previously announced advisory 

committee meeting cannot always be 

published quickly enough to provide 

timely notice. Therefore, you should 

always check the Agency’s Web site and 

call the appropriate advisory committee 

hot line/phone line to learn about 

possible modifications before coming to 

the meeting. 

Agenda: On June 29, 2011, the 

committee will discuss cellular and 

gene therapy products for the treatment 

of retinal disorders. Topics to be 

considered include the following: 

(1) Efficacy endpoints in pediatric and 

adult populations, (2) potential safety 

issues related to repeat administration 

or second eye administration, and 

(3) evaluation of product delivery into 

target site. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its Web site prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 

the meeting. Background material is 

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

AdvisoryCommittees/Calendar/ 

default.htm. Scroll down to the 

appropriate advisory committee link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before June 22, 2011. Oral 

presentations from the public will be 

scheduled between approximately 

11:30 a.m. and 12:30 p.m. Those 

individuals interested in making formal 

oral presentations should notify the 

contact person and submit a brief 

statement of the general nature of the 

evidence or arguments they wish to 

present, the names and addresses of 

proposed participants, and an 

indication of the approximate time 

requested to make their presentation on 

or before June 14, 2011. Time allotted 

for each presentation may be limited. If 

the number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by June 15, 2011. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

Agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact Gail Dapolito 

at least 7 days in advance of the 

meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at 

http://www.fda.gov/ 

AdvisoryCommittees/ 

AboutAdvisoryCommittees/ 

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act 

(5 U.S.C. app. 2). 

Dated: April 13, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–9653 Filed 4–20–11; 8:45 am] 

BILLING CODE 4160–01–P 


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