2011-9650. 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: [e-mail]; 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: [e-mail].

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 anti-inflammatory 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.

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.