[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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