[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]
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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.
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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.
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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]
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