[Federal Register Volume 76, Number 77 (Thursday, April 21, 2011)]
[Notices]
[Pages 22404-22405]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-9650]


-----------------------------------------------------------------------

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: [email protected]; 
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: [email protected].
    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.

[[Page 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