[Federal Register Volume 78, Number 166 (Tuesday, August 27, 2013)]
[Notices]
[Pages 52933-52934]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-20823]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0972]
Strengthening the Operating Framework and Furthering the
Objectives of Coalition for Accelerating Standards and Therapies
Initiative (U24)
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 Center for Drug
Evaluation and Research (CDER) Data Standards Program. The goal of the
CDER Data Standards Program is to strengthen and support the Coalition
for Accelerating Standards and Therapies (CFAST) Initiative in its
efforts to establish and maintain clinical data standards that will
enable FDA reviewers to more efficiently perform efficacy analysis of
potential new drugs in therapeutic areas that are important to public
health.
DATES: Important dates are as follows:
1. The application due date is August 26, 2013.
2. The anticipated start date is September 15, 2013.
3. The expiration date is August 27, 2013.
ADDRESSES: Submit the paper application to: Kimberly Pendleton-Chew,
Grants Management (HFA-500), 5630 Fishers Lane, Rm. 2031, Rockville, MD
20857, and a copy to Fatima Frye, Center for Drug Evaluation and
Research, 10903 New Hampshire Ave., Bldg. 51, Rm. 1195, Silver Spring,
MD 20993. For more information, see section III of the SUPPLEMENTARY
INFORMATION.
FOR FURTHER INFORMATION CONTACT: Fatima Frye, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1195, Silver Spring, MD 20993, 301-796-
4863; or Kimberly Pendleton-Chew, Office of Acquisition Support and
Grants, Food and Drug Administration, 5630 Fishers Lane, Rm. 2031,
Rockville, MD 20857, 301-827-9363, email:
[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://www.fda.gov/Drugs/DevelopmentApprovalProcess/
[[Page 52934]]
FormsSubmissionRequirements/ElectronicSubmissions/ucm364432.htm.
SUPPLEMENTARY INFORMATION:
I. Funding Opportunity Description
RFA-FD-13-039
93.103
A. Background
CDER receives an enormous and growing amount of data in a variety
of regulatory submissions from a multitude of sources and in a variety
of formats. This wealth of data holds great potential to advance CDER's
regulatory and scientific work, but the present lack of standardized
data creates significant challenges to realizing that potential. The
volume and complexity of drug-related information submitted to CDER for
regulatory review is creating significant challenges to the Center's
ability to efficiently and effectively perform its critical public
health mission.
The lack of standardized data affects CDER's review processes by
curtailing a reviewer's ability to perform integral tasks such as rapid
acquisition, analysis, storage, and reporting of regulatory data.
Improved data quality, accessibility, and predictability will give
reviewers more time to carry out complex analyses, ask in-depth
questions, and address late-emerging issues. Standardized data will
allow reviewers to increase review consistency and perform evaluations
across the drug lifecycle. This will enhance the Center's performance
across key drug regulatory functions and ongoing business operations,
including premarket review, post-market safety, oversight of drug
quality, and oversight of drug promotion.
Standardized data elements that are common to all clinical trials,
such as age and gender, have been established through Clinical Data
Interchange Standards Consortium standards. However, data elements that
are unique for a particular disease or therapeutic area still need to
be developed so that the data are consistent and consistently
understood for efficacy analysis, and that data from multiple trials
can be more easily grouped for reporting and meta-analysis.
In short, establishing common standards for data reporting will
provide new opportunities to transform the massive amount of data from
drug studies on specific diseases into useful information to
potentially speed the delivery of new therapies to patients.
B. Research Objectives
The CFAST Initiative aims to accelerate clinical research and
medical product development by establishing and maintaining data
standards, tools, and methods for conducting research in therapeutic
areas that are important to public health. It is established as a
public-private partnership (PPP) involving multiple stakeholders. The
Grantee funded through this announcement would be expected to
accomplish activities such as, but not limited to:
Maintenance of the scientific and administrative
infrastructure of the PPP to support a series of projects under the
CFAST Initiative.
Coordination and management of therapeutic area standards
development projects with key experts in the specific therapeutic
areas, including stakeholders from industry, professional
organizations, academia, and Government agencies.
Identification and engagement with key experts in the
therapeutic areas, including stakeholders from industry, professional
organizations, academia, and Government agencies.
Development of therapeutic area data standards, initially
proposed for diabetes, QT studies, lipid lowering/altering drugs, and
hepatitis C. Additional or different areas can be considered as well.
Identification and implementation of continuous quality
improvements with respect to the data standards development process and
product(s) to facilitate timely and sustainable standards.
C. Eligibility Information
The following organization is eligible to apply: The Critical Path
Institute (C-Path).
Over the past 7 years, C-Path has become an international leader in
forming and leading/managing collaborations globally. They currently
lead 7 very active scientific consortia across multiple disease areas.
C-Path consortia include more than 1,000 scientists from Government,
academia, patient advocacy organizations, and 41 major pharmaceutical
companies. C-Path has a proven process, capability, and institutional
knowledge critical to successfully leading scientific consortia and
rapid therapeutic area standards development projects through an open,
transparent process as identified by the Prescription Drug User Fee Act
V.
II. Award Information/Funds Available
A. Award Amount
Total amount of funding available is $2,000,000. Anticipate one
award.
B. Length of Support
Scope of the proposed project should determine the project period.
The maximum period is 3 years.
III. Paper Application, Registration, and Submission Information
To submit a paper application in response to this FOA, applicants
should first review the full announcement located at http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm364432.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.) Persons interested in
applying for a grant may obtain an application at http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm364432.htm. For all the paper application
submissions, the following steps are required:
Step 1: Obtain a Dun and Bradstreet (DUNS) Number
Step 2: Register With System for Award Management (SAM)
Step 3: Register With Electronic Research Administration
(eRA) Commons
Steps 1 and 2, in detail, can be found at http://www07.grants.gov/applicants/organization_registration.jsp. Step 3, in detail, can be
found at https://commons.era.nih.gov/commons/registration/registrationInstructions.jsp. After you have followed these steps,
submit paper applications to: Kimberly Pendleton-Chew, 5630 Fishers
Lane, Rm. 2031, Rockville, MD 20857, 301-827-9363, email:
[email protected].
Dated: August 21, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-20823 Filed 8-26-13; 8:45 am]
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