Part I Overview Information
Department of Health and Human Services
Food and Drug Administration (FDA)
NOTE: The policies, guidelines, terms, and conditions stated in this announcement may differ from those used by the NIH. Where this Funding Opportunity Announcement (FOA) provides specific written guidance that may differ from the general guidance provided in the grant application form, please follow the instructions given in this FOA
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.
Components of Participating Organizations
Center for Food Safety and Applied Nutrition (CFSAN)
Funding Opportunity Title
University of Mississippi National Center for Natural Products Research (U01)
U01 Research Project – Cooperative Agreements
Announcement Type: New
Related Notices: None
Funding Opportunity Announcement (FOA) Number: RFA-FD-11-004
Companion FOA: None
Number of Applications
Only one application is allowed, as defined in Section III. 3. Additional Information on Eligibility
Catalog of Federal Domestic Assistance (CFDA) Number(s)
The Food and Drug Administration (FDA) is announcing its intention to receive and consider an application for this cooperative agreement from the University of Mississippi (UM) to support the National Center for Natural Products Research (NCNPR). The purpose of this partnership with UM-NCNPR is to promote the efficient development and dissemination of natural products research and science and the programs developed under the agreement will complement the diverse activities of both the public and private sectors.
Specifically, this cooperative agreement will provide continued support so that UM-NCNPR can:(1) assist in the identification and development of a list of botanical dietary supplements and botanical ingredients based on safety concerns, trends, and knowledge of botanicals being marketed in the U.S., to prioritize for further research; (2) acquire, validate, and characterize authenticated reference materials, including raw and processed plant materials and purified natural products of relevance to FDA, for evaluation of their safety; (3) exchange technical and scientific information, analytical methods, and reference material with FDA scientists and other stakeholders; (4) collaborate with FDA scientists in research areas of mutual interest; (5) coordinate scientific workshops and conferences on BDS-related topics of public health relevance to address high priority science and research needs.
Open Date (Earliest Submission Date): April 11, 2011
Letters of Intent Due Date: Not Applicable
Application Due Dates(s): May 11, 2011, by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s):Not Applicable
Scientific Merit Review: May 18, 2011
Advisory Council Review: Not Applicable
Earliest Start Date(s): June 1, 2011
Expiration Date: May 12, 2011.
Due Dates for E.O. 12372: Not Applicable
Required Application Instructions
It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the FDA Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. 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.
Table of Contents
- Eligible Applicants
- Cost Sharing
- Other - Special Eligibility Criteria
- Requesting an Application Package
- Content and Form of Application Submission
- Submission Dates and Time
- Intergovernmental Review (E.O. 12372)
- Funding Restrictions
- Other Submission Requirements and Information
- Review and Selection Process
- Anticipated Announcement and Award Dates
- Award Notices
- Administrative and National Policy Requirements
- Scientific/Research Contact(s)
- Financial/ Grants Management Contact(s)
Part II - Full Text of Announcement
Section I. Funding Opportunity Description
The primary focus of the UM-NCNPR/FDA collaborative agreement is to develop and disseminate botanical natural product research with an emphasis on public safety according to the needs of the FDA. The cooperative research, education, and outreach programs developed by UM-NCNPR will address scientific issues related to the safety of botanical dietary supplements (BDS) and botanical ingredients and will complement the diverse activities of both the public and private sectors.
This cooperative agreement will define the research projects, workshops, conferences, partnerships with academia, industry, non-governmental organizations, and international organizations and other activities on which the FDA and UM-NCNPR will collaborate.
Specifically, this cooperative agreement will provide continued support so that UM-NCNPR can:
- Assist in the identification and development of a list of BDS and botanical ingredients, based on safety concerns, trends, and knowledge of botanicals being marketed in the U.S., to prioritize for further research.
- Acquire, validate, and characterize authenticated reference materials, including raw and processed plant materials and purified natural products of relevance to FDA, for evaluation of their safety.
- Exchange technical and scientific information, analytical methods, and reference material with FDA scientists and other stakeholders.
- RCollaborate with FDA scientists in research areas of mutual interest.
- Coordinate scientific workshops and conferences on BDS-related topics of public health relevance to address high priority science and research needs.
In an effort to enhance collaborative interactions and communication between both institutions, FDA and DISL will collaborate in the development of regular workshops where faculty from all the institutions within the DISL and FDA scientists and staff share information about on going research, education and outreach efforts of mutual interest.
See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.
Section II. Award Information
Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, scientific or program staff will assist, guide, coordinate, or participate in project activities.
Application Types Allowed
The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards
CFSAN intends to fund one award, for up to $2,100,000.00, for FY2011. Future year amounts will depend on annual appropriations and successful performance.
The estimated amount of support in FY11 will be for up to $ 2.1 million (direct plus indirect costs), with the possibility of four additional years of support for up to $ 2.5 million per year, subject to the availability of funds. Future year amounts will depend on annual appropriations and successful performance.
Award Project Period
The award will provide one year of support, with the possibility of four additional years of support, contingent upon satisfactory performance in the achievement of project and program reporting objectives during the preceding year and the availability of Federal fiscal year appropriations.
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.
Section III. Eligibility Information
1. Eligible Applicants
University of Mississippi, National Center for Natural Products Research
Competition is limited to UM-NCNPR because it has the unique capability to bring together diverse scientific expertise on BDS and botanical ingredients from: (1) The faculty in the UM School of Pharmacy, including researchers in the Departments of Pharmacognosy, Medicinal Chemistry, Pharmaceutics, Pharmacology, and the Research Institute of Pharmaceutical Sciences; (2) research scientists in the US Department of Agriculture/Agricultural Research Service's (USDA/ARS) National Products Utilization Research unit who are physically co-located and programmatically integrated in the UM-NCNPR; (3) close academic links and historical collaborations with agriculture and botanical programs and facilities within the UM system; (4) successful research collaborations with the dietary supplement industry; and (5) established formal agreements with several international academic institutions.
These collaborations give UM-NCNPR the unique ability to provide essential scientific expertise and botanical and chemical resources which will continue to assist FDA in its mission to ensure the safety of BDS and botanical ingredients.
Applicant organizations must complete the following registrations as described in the SF 424 (R&R) 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.
Eligible Individuals (Program Director/Principal Investigator)
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 FDA support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.
2. Cost Sharing or Matching
This FOA does not require cost sharing as defined in the HHS Grants Policy Statement.
3. Additional Information on Eligibility
Number of Applications
Only one application is allowed.
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.
Section IV. Application and Submission Information
Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.
2. Content and Form of Application Submission
It is critical that applicants follow the instructions in the SF424 (R&R) 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.
Required and Optional Components
The forms package associated with this FOA includes all applicable components, mandatory and optional. Please note that some components marked optional in the application package are required for application submission. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate "optional" components.
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:
- Research Strategy section is limited to 30 pages.
PHS 398 Research Plan Component
All instructions in the SF424 (R&R) 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) as provided in the SF424 (R&R Application Guide). with the following modifications:
- All applications, regardless of the amount of direct costs requested for any one year, should include a Data Sharing Plan.
Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide,
Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide, with the following modifications:
- No publications or other printed material, with the exception of pre-printed questionnaires or surveys, may be included in the Appendix
3. Submission Dates and Times
Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.
Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.
Applicants are responsible for viewing their application in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
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.
6. Other Submission Requirements and Information
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.
Important reminders: All PD/PIs must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to FDA.
The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the Central Contractor Registration (CCR). Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness by the FDA Grants Office and responsiveness by components of participating organizations. Applications that are incomplete and/or nonresponsive will not be reviewed.
Post Submission Materials
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115, with the following modifications:
Section V. Application Review Information
Overall Impact. 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).
Scored Review Criteria. 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 a critical barrier to progress in the field? If the aims of the program are achieved, how will scientific knowledge and technical capability be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Do the PD/PIs, collaborators, and other researchers understand the purpose and objectives of the cooperative agreement regarding the collaborative research, education, and outreach programs?
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?
Innovation. Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? Has UM-NCNPR used appropriate technologies to advance the understanding of the chemistry of botanical ingredients, including those relevant to dietary supplements?
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?
If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?
Does UM-NCNPR develop and use a research paradigm that considers the chemical complexity of botanical products?
Environment. Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
Additional Review Criteria. 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 Protection and Inclusion Guidelines.
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 Human Subjects Protection and Inclusion Guidelines.
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. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
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.
Resubmission Applications: Not Applicable.
Renewal Applications. Not Applicable
Revisions. Not Applicable
Additional Review Considerations. 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.
The application will receive a merit description (outstanding, acceptable, or unacceptable) that reflects the progress of the FDA program at the UM-NCNPR as a whole evaluated on:
Have past research outcomes at UM-NCNPR demonstrated the ability to continue to achieve the research objectives outlined in Section I of the original FOA?
Has UM-NCNPR demonstrated success in promoting the development of collaborative interactions/research with non-FDA scientists and other scientists?
Has there been any development of additional resources?
What is the evidence of institutional support?
Were results from past projects/experiments used in the design and interpretation of other experiments?
Applications from Foreign Organizations. Not Applicable.
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 following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).
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.
2. Review and Selection Process
As part of the review, all applications:
- Will receive a written critique.
Applications will be assigned to the appropriate FDA Center
3. Anticipated Announcement and Award Dates
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.
Section VI. Award Administration Information
1. Award Notices
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 as noted on the Award Conditions and Information for FDA Grants website.
2. Administrative and National Policy Requirements
All FDA grant and cooperative agreement awards include the HHS Grants Policy Statement as part of the NoA
Cooperative Agreement Terms and Conditions of Award
If this FOA is not a cooperative agreement, make no changes to this section. If it IS a cooperative agreement, fill out the template “Cooperative Agreement Terms and Conditions of Award” as appropriate. THEN, copy and paste all the text from that template into this section, replacing “Not Applicable” (below) with your text.
The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMS administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and FDA grant administration policies.
The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an “acquisition mechanism"), in which substantial FDA programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the FDA purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role of activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the FDA as defined below.
2. A.1. Principal Investigator Rights and Responsibilities
The Principal Investigator will have the primary responsibility for and dominant role in planning, directing, and executing the proposed project, with the FDA staff being substantially involved as a partner with the PI.
Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and FDA policies.
2. A.2. FDA Responsibilities
An FDA Project Officer will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
The program project officer will monitor the grantee periodically. The monitoring may be in the form of telephone conversations, emails, or written correspondence between the project officer/grants management officer and the Principal Investigator. Periodic site visits with officials of the grantee organization may also occur. The results of these monitoring activities will be recorded in the official grant file and will be available to the grantee upon request, consistent with applicable disclosure statutes and with FDA disclosure regulations. Also, the grantee organization must comply with all special terms and conditions of the grant, including those that state that future funding will depend on recommendations from the project officer. In addition,
- FDA will have prior approval of the appointment of all key administrative and scientific personnel proposed by the grantee.
- FDA will be directly involved in the guidance and development of the program.
FDA scientists will participate, with the grantee, in determining and carrying out scientific and technical activities. Collaboration will also include data analysis, interpretation of findings and, where appropriate, co-authorship of publications
When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in 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 FDA 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.
Section VII. Agency Contacts
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
Application Submission Contacts
GrantsInfo (Questions regarding application instructions and process, finding FDA grant resources)
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)
Jeanne I. Rader, Project Officer
Center for Food Safety and Applied Nutrition (CFSAN)
Telephone: 301-436-1786 (Updated contact number: 240-402-1786)
Steven L. Robbs, Liaison
Center for Food Safety and Applied Nutrition (CFSAN)
Telephone: 301-436-2146 (Updated contact number: 240-402-2146)
LaQuia S. Geathers, Extramural Resource Specialist
Center for Food Safety and Applied Nutrition (CFSAN)
Telephone: 301-436-2821 (Updated contact number: 240-402-2821)
Financial/Grants Management Contact(s)
Office of Acquisition and Grant Services (OAGS)
Section VIII. Other Information
All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.
Authority and Regulations
1. Required Federal Citations
1.A. Clinical Trials Data Bank
The Food and Drug Administration Amendments Act of 2007 (FDAAA) contains provisions that expand the current database known as ClinicalTrials.gov to include additional requirements for individuals and entities, including grantees, who are involved in conducting clinical trials that involve products regulated by FDA or that are funded by the Department of Health and Human Services (HHS), including FDA. These additional requirements include mandatory registration of certain types of clinical trials, as well as reporting of results for certain trials for inclusion in the ClinicalTrials.gov database. ClinicalTrials.gov, which was created after the Food and Drug Administration Modernization Act of 1997, provides patients, family members, healthcare providers, researchers, and members of the public easy access to information on clinical trials for a wide range of diseases and conditions. The U.S. National Library of Medicine (NLM) has developed this site in collaboration with NIH and FDA. ClinicalTrials.gov is available to the public through the Internet at http://clinicaltrials.gov.
ClinicalTrials.gov contains information about certain clinical trials, both federally and privately funded, of drugs (including biological products) and medical devices. The types of trials that are required to be registered, and for which results must be reported, are known as "applicable clinical trials." FDAAA defines the types of clinical trials that are "applicable clinical trials" and, therefore, are subject to the registration and results reporting requirements. The registry listing for each trial includes information such as descriptive information about the trial, patient eligibility criteria, recruitment status, location information on the clinical trial sites, and points of contact for those wanting to enroll in the trial. The database also contains information on the results of clinical trials. More detailed information on the definition of "applicable clinical trial" and the registry and results reporting requirements can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-014.html and http://prsinfo.clinicaltrials.gov/fdaaa.html.
FDAAA also added new requirements concerning clinical trials supported by grants from HHS, including FDA. Under these provisions, any grant or progress report forms required under a grant from any part of HHS, including FDA, must include a certification that the person responsible for entering information into ClinicalTrials.gov (the "responsible party") has submitted all required information to the database. There are also provisions regarding when agencies within HHS, including FDA, are required to verify compliance with the database requirements before releasing funding to grantees.
Program staff will provide additional information on these requirements, including the appropriate means by which to certify that a grantee has complied with the database requirements.
1.B. Data and Safety Monitoring Plan
Data and Safety monitoring may be required for certain types of clinical trials. The establishment of Data and Safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risk to the participants, and generally for Phase 3 clinical trials. Although Phase 1 and Phase 2 clinical trials may also use DSMBs, smaller clinical trials may not require this oversight format, and alternative monitoring plans may be appropriate.
1.C. Access to Research Data through the Freedom of Information Act (FOIA)
The Freedom of Information Act (FOIA), 5 U.S.C. 552, provides individuals with a right to access certain records in the possession of the Federal government, subject to certain exemptions. The government may withhold information pursuant to the exemptions and exclusions contained in the FOIA. The exact language of the exemptions can be found in the FOIA. Additional guidance on the exemptions and how they apply to certain documents can be found in the HHS regulations implementing the FOIA (45 CFR part 5) and FDA regulations implementing the FOIA (21 CFR part 20). Also, see the HHS Web site http://www.hhs.gov/foia/ and FDA Web site at http://www.fda.gov/RegulatoryInformation/FOI/default.htm.
Data included in the application may be considered trade secret or confidential commercial information within the meaning of relevant statutes and implementing regulations. FDA will protect trade secret or confidential commercial information to the extent allowed under applicable law.
1.D. Use of Animals in Research
Recipients of PHS support for activities involving live vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals as applicable (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf), as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm) and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm).
1.E Human Subjects Protection
Federal regulations (45 CFR 46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
1.F. Inclusion of Women And Minorities in Clinical Research (Adopted by the FDA)
It is the policy of the NIH/DHHS that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research” (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the SF424 (R&R) application; and updated roles and responsibilities of NIH/DHHS staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.
1.G. Inclusion of Children as Participants in Clinical Research (Adopted by the FDA)
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 of the Public Health Service Act as amended (42 USC 241) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement in the following link: http://www.hhs.gov/grantsnet/adminis/gpd/index.htm.
1.H. Required Education on the Protection of Human Subject Participants (Adopted by the FDA)
NIH/DHHS policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
1.I. Standards for Privacy of Individually Identifiable Health Information
HHS issued final modification to the Standards for Privacy of Individually Identifiable Health Information, the Privacy Rule, on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) that governs the protection of individually identifiable health information, and is administered and enforced by the HHS Office for Civil Rights (OCR).
Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR Web site (http://www.hhs.gov/ocr/) provides information on the Privacy Rule.
1.J. Healthy People 2010
PHS is committed to achieving the health promotion and disease prevention objectives of Healthy People 2010, a PHS-led national activity for setting priority areas. This Funding Opportunity Announcement is related to one or more of the priority areas. Potential applicants may obtain a copy of Healthy People 2010 at http://www.health.gov/healthypeople.
1.K. Smoke-Free Workplace
The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.
1.L. Authority and Regulation
This program is not subject to the intergovernmental review requirements of Executive Order 12372. FDA's research program is described in the Catalog of Federal Domestic Assistance (CFDA), No. 93.103 (http://www.cfda.gov/).
FDA will support the clinical studies covered by this notice under the authority of section 301 of the Public Health Service Act (the PHS Act) as amended (42 U.S.C. 241) and under applicable regulations at 42 CFR Part 52 and 45 CFR Parts 74 and 92. All grant awards are subject to applicable requirements for clinical investigations imposed by sections 505, 512, and 515 of the act (21 U.S.C. 355, or 360e) or safety, purity, and potency for licensing under section 351 of the PHS Act (42 U.S.C. 262), section 351 of the PHS Act, including regulations issued under any of these sections.
All human subject research regulated by FDA is also subject to FDA's regulations regarding the protection of human subjects (21 CFR Parts 50 and 56). Applicants are encouraged to review the regulations, guidance, and information sheets on human subject protection and Good Clinical Practice available on the Internet at http://www.fda.gov/oc/gcp/.
The applicant is referred to HHS regulations at 45 CFR 46.116 and 21 CFR 50.25 for details regarding the required elements of informed consent.
All awards will be subject to all policies and requirements that govern the research grant programs of the PHS as incorporated in the HHS Grants Policy Statement, dated January 1, 2007 (http://www.hhs.gov/grantsnet/adminis/gpd/index.htm).