Participating Organization(s)	U.S. Food and Drug Administration (FDA)
Components of Participating Organizations	Center for Drug Evaluation and Research)
Funding Opportunity Title	Data Concepts and Terminology Standards for Clinical Research and Drug Development (R24)
Activity Code	R24 Resource-Related Research Projects
Announcement Type	New
Related Notices	June 6, 2013 - See Notice NOT-FD-13-011. Notice to Terminate this Funding Opportunity Announcement. June 1, 2012 - Notice of Supplemental Funds for FDA PAR 11-209. See Notice NOT-FD-12-012.
Funding Opportunity Announcement (FOA) Number	PAR-11-209
Companion FOA	None
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.103
FOA Purpose	The FDA Center for Drug Evaluation and Research is encouraging grant applications for programs to expedite development of data concepts and terminology to support human drug development and evaluation. The primary objective is to support the development of non-proprietary, consensus-based, national data standards for use in clinical studies of human drugs and biologics. Projects may focus on solutions to general data standards development and implementation challenges or on specific clinical concepts or domains where standardization is needed.

Posted Date	April 28, 2011
Letter of Intent Due Date	None
Application Due Date(s)	June 1, 2011; November 15, 2011; June 1, 2012; November 15, 2012, June 1,2013; November 15, 2013
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	June and November, 2011; June and November 2012; June and November 2013
Advisory Council Review	September, 2011; February, 2012, September, 2012;;February, 2013; September, 2013
Earliest Start Date(s)	September, 2011; February, 2012 and September, 2012; February, 2013 and September, 2013
Expiration Date	(Now Expired June 6, 2013 per NOT-FD-13-011), Originally November 16, 2013
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS398 Application Guide except where instructed to do otherwise (in this FOA). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. While some links are provided, applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

NOTE: The policies, guidelines terms and conditions stated in this announcement may differ from those used by the NIH.

Part 1. Overview Information
Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Purpose/Research Objectives: The purpose of this funding opportunity announcement is to encourage applications for the development of data concepts and terminology standards to support human drug development and evaluation. The primary objective is to support the development of non-proprietary, consensus-based, national data standards for use in clinical studies of human drugs and biologics. Projects may focus on solutions to general data standards development and implementation challenges or on specific clinical concepts or domains where standardization is needed.

The Food and Drug Administration’s Center for Drug Evaluation and Research (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 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. Standardized data will allow reviewers to increase review consistency and perform evaluations across the drug lifecycle. The lack of standardized data also impacts the U.S. and global drug development industry. Standardized data will facilitate clinical research design, implementation and analyses. Projects funded under this funding opportunity announcement will focus on data standards activities applicable to regulatory and industry data needs.

To ensure that useful, publicly-available data standards exist for all key data needed for regulatory decisions, CDER must develop clear processes that will facilitate standards development, adoption and implementation within reasonable timeframes. Current standards development processes often span many years. A more agile approach that creates useful data standards at an accelerated pace while enhancing stakeholder participation and industry adoption is needed. Preference will be given to projects that seek to develop best practices for efficient and timely development of standards that enhance stakeholder participation.

In accordance with the Office of Management and Budget (OMB) Circular A-119, the FDA will: use voluntary, consensus-based standards development processes in place of government unique standards unless such standards are inconsistent with law or otherwise impractical; advocate to align these standards with existing health information technology initiatives, laws, regulations, and mandates; and promote coordination with other standards currently in use. The projects selected under this funding opportunity must adhere to these principles.

Harmonization of terminology used within clinical research and healthcare delivery domains is essential for interoperability of data systems and efficient data analyses throughout the product lifecycle, i.e., pre-market and post-market. Currently, multiple standards developing organizations (SDOs) operate in these realms. These SDOs tend to work independently; each focuses on particular use cases and constituent needs and follows its distinct processes. The potential for divergent terminology adoption and repeated efforts to maintain semantic interoperability exist. Moreover, these processes are lengthy taking years to establish a standard. A clear, effective pathway for developing and maintaining harmonization of terminology across established standards is needed. Preference will be given to projects that seek to develop best practices for ensuring semantic interoperability among and integration into multiple standards, including Clinical Data Interchange Standards Consortium (CDISC) and Health Level 7 (HL7) standards.

Specific Areas of Research Interest: FDA/CDER is specifically interested in projects to develop standardized clinical research concepts and terminology for therapeutic areas with significant drug development pipeline activity, emerging or complex analytical challenges, and/or are of significant public health concern.

Funding Instrument	Grant
Application Types Allowed	New The OER Glossary and the PHS398 Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	The number of awards is contingent upon available funding, and the submission of a sufficient number of meritorious applications. FDA intends to fund an estimate of up to 5 awards, corresponding to a total of up to $300,000, for fiscal year 2011. Future year amounts will depend on the availability of funds.
Award Budget	Application budgets are limited up to $150,000 for fiscal year 2011 but need to reflect actual needs of the proposed project.
Award Project Period	These are one year awards.

FDA grants policies as described in the HHS Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Higher Education Institutions:

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

Foreign (non-U.S.) components of U.S. Organizations are not allowed

Applicant organizations must complete the following registrations as described in the PHS398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

• Central Contractor Registration (CCR) must maintain an active registration, to be renewed at least annually
• eRA Commons

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

This FOA does not require cost sharing as defined in the HHS Grants Policy Statement.

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

FDA will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. FDA will not accept any application that is essentially the same as one already reviewed.

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

It is critical that applicants follow the instructions in the PHS398 Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, in one package to:

Gladys M. Bohler
Food and Drug Administration
Office of Acquisitions and Grants Support
5630 Fishers Lane; Rm. 1078 MSC 500
Rockville, MD 20857

At the time of submission, three additional paper copies of the application and all copies of the appendix files must be sent to:

Catherine Jansto
Food and Drug Administration
Center for Drug Evaluation and Research
10903 New hampshire Avenue, Building 51, Room 1160
Silver Spring, MD 20993
Telephone: 301-796-5104
Email: catherine.jansto@fda.hhs.gov

The FDA does not follow the NIH Page Limitation Guidelines or the Enhanced Peer Review Scoring Criteria. Applicants are encouraged to consult with FDA Agency Contacts for additional information regarding page limits and the FDA Peer Review Process.

All page limitations described in the PHS398 Application Guide must be followed, with the following exceptions or additional requirements:

• Research Strategy section is limited to 30 pages.

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions:

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS) as provided in the PHS398 Application Guide, with the following modifications:

• Reviewers will comment on whether the Data Sharing Plan is reasonable.

Appendix

Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS398 Application Guide.

Part I. Overview Information contains information about Key Dates.

Information on the process of receipt and determining if your application is considered on-time is described in detail in the PHS398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

This initiative is not subject to intergovernmental review.

All FDA awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement

Pre-award costs are allowable only as described in the HHS Grants Policy Statement.

Applications must be received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described below:

Acceptable post-submission materials include:

Revised budget page(s) (e.g., change in budget request due to new funding or institutional acquisition of equipment)

Biographical sketches (e.g., change in senior/key personnel due to the hiring, replacement, or loss of an investigator)

Letters of support or collaboration resulting from a change in senior/key personnel due to the hiring, replacement, or loss of an investigator

Adjustments resulting from natural disasters (e.g., loss of an animal colony)

Adjustments resulting from change of institution (e.g., PD/PI moves to another university)

News of an article accepted for publication (a copy of the article should not be sent)

All post-submission materials must conform to NIH policy on font size, margins, and paper size as referenced in Part I.2.6 of the applicable application instructions. NIH additional form pages such as budget, biographical sketches, and other required forms must follow application form standards for required form pages.

If post-submission material is not required on a form page, each explanation or letter is limited to one page (see Acceptable Late Materials above).

If the application has subprojects or cores, each subproject or core is allowed explanations or letters (see Acceptable Late Materials above), but each explanation or letter is limited to one page.

Unacceptable post-submission materials (for all applications except those listed under Exceptions below) include:

Updated Specific Aims or Research Strategy pages;

Late-breaking research findings;

New letters of support or collaboration that do not result from a change in senior/key personnel due to the hiring, replacement, or loss of an investigator.

Only the review criteria described below will be considered in the review process. As part of the FDA mission http://www.fda.gov/, all applications submitted to the FDA are evaluated for scientific and technical merit through the FDA Ad Hoc review system.

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or data standardization need? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical research be improved? How will successful completion of the aims impact data acquisition, analysis, storage, and reporting of clinical regulatory data? How will the project complement existing data standards?

Investigator(s)

Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? If the Program Directors/Principal Investigators have prior data standards development experience, is there evidence that their efforts resulted in successful achievement of practical results in an efficient manner?

Innovation

Does the application challenge and seek to shift data standards development paradigms by utilizing novel approaches or methodologies? Is a refinement, improvement, or new application of data standards development concepts, approaches or methodologies proposed?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

Is the project plan clear and appropriate for efficient achievement of the purpose? Are the progress metrics appropriate? Is the plan for stakeholder inclusion well-reasoned and appropriate for development of robust data standards?

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protections section in the HHS Grants Policy Statement.

Inclusion of Women, Minorities, and Children

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the HHS Grants Policy Statement

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable.

Renewals

Not Applicable.

Revisions

Not Applicable.

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact/priority score.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the Resource Sharing Plans, or the rationale for not sharing the data sharing plans are reasonable.

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Applications will be evaluated for scientific and technical merit by (an) appropriate Ad Hoc Review Group Group(s), in accordance with FDA review policy and procedures, using the stated review criteria.

As part of the Ad Hoc review, all applications:

• Will receive a written critique.

Applications will be assigned to the appropriate FDA Center and will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial Ad Hoc Review by the FDA, recommended applications will receive a second level of review by the National Cancer Institute, National Cancer Advisory Board. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

Information regarding the disposition of applications is available in the HHS Grants Policy Statement.

If the application is under consideration for funding, FDA will request "just-in-time" information from the applicant as described in the HHS Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements. The Individual awards are based on the application submitted to, and as approved by, the FDA and are subject to the terms and conditions incorporated either directly or by reference in the following:

The grant program legislation and program regulation cited in the Notice of Award.

Conditions on activities and expenditure of funds in other statutory requirements, such as those included in appropriation acts, 45 CFR Part 74 or 45 CFR Part 92, as applicable.

The HHS Grants Policy Statement, including addenda in effect as of the beginning date of the budget period. The Notice of Award including all terms and conditions cited on the document or attachments.

All FDA grant and cooperative agreement awards include the HHS Grants Policy Statement.

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the HHS Grants Policy Statement for additional information on this reporting requirement.

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

GrantsInfo (Questions regarding application instructions and process, finding FDA grant resources)
Telephone 301-827-7175
TTY 301-480-0434
Email: gladys.bohler@fda.hhs.gov

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Catherine Jansto
Food and Drug Administration
Center for Drug Evaluation and Research
10903 New Hampshire Ave. Building 51, Room 1160
Silver Spring, MD 20993 Telephone: 301-796-5104
Email: catherine.jansto@fda.hhs.gov

Catherine Jansto
Food and Drug Administration
Center for Drug Evaluation and Research
10903 New Hampshire Ave. Building 51, Room 1160
Silver Spring, MD 20993 Telephone: 301-796-5104
Email: catherine.jansto@fda.hhs.gov

Gladys M. Bohler
Food and Drug Administration
Office of Acquisitions and Grant Support
5630 Fishers Lane, Rm. 1078; HFA 500
Telephone: 301-827-7175
Email: gladys.bohler@fda.hhs.gov

All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.

Awards are made under the authorization of Sections 301 of the Public Health Service Act as amended (42 USC 241) and under Federal Regulation.