and Human Services (HHS)
EXPIRED
Participating Organization(s) |
U.S. Food and Drug Administration (FDA) 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. |
Center for Drug Evaluation and Research (CDER) |
|
Funding Opportunity Title |
Novel Interventions and Collaborations to Improving the Safe Use of Medications (U01) |
Activity Code |
U01 Research Project Cooperative Agreements |
Announcement Type |
New |
Related Notices |
None |
Funding Opportunity Announcement (FOA) Number |
RFA-FD-11-024 |
Companion FOA |
U01 Research Project Cooperative Agreements |
Catalog of Federal Domestic Assistance (CFDA) Number(s) |
93.103 |
FOA Purpose |
As part of FDA's Safe Use Initiative: Collaborating to Reduce Preventable Harm, FDA will identify drug/drug classes or therapeutic areas associated with preventable harm. The mission of the Safe use Initiative is to seek solutions to preventable harm associated with suboptimal use of regulated prescription and over the counter medications. The approach is to involve cross sector collaborations with other parts of healthcare committed to medication safety. This Funding Opportunity Announcement (FOA), issued by FDA, will provide resources for research to characterize preventable harm associated with specific FDA regulated drugs, identify sources (root causes) of the preventable harm and for the development and implementation of interventions to reduce the preventable harm. |
Posted Date |
June 17, 2011 |
Open Date (Earliest Submission Date) |
June 17, 2011 |
Letter of Intent Due Date |
Not Applicable |
Application Due Date(s) |
July 18, 2011, by 5:00 PM local time of applicant organization. |
AIDS Application Due Date(s) |
Not Applicable |
Scientific Merit Review |
August 5, 2011 |
Advisory Council Review |
September 13, 2011 |
Earliest Start Date(s) |
|
Expiration Date |
July 19, 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.
Part 1. Overview Information
Part 2. Full Text of the 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
FDA is announcing an FOA for research to identify preventable harm associated with FDA-regulated medications. This FOA will also cover studies to investigate root causes of preventable harm, such as suboptimal prescribing, dispensing, administration or other ways in which patients receive/take prescription and over the counter medications. It also covers research to develop test and measure the effectiveness of interventions to improve the safe use of prescription and over-the-counter medications.
According to the Institute of Medicine, up to 50% of the harm from medications is preventable. This translates into about 1.5 million preventable adverse drug events each year. The research conducted under this FOA offers the potential to enhance public health by reducing the healthcare burden associated with preventable adverse drug events.
This FOA is through the FDA's Safe Use Initiative's (SUI), one component of the FDA's Center for Drug' Evaluation and Research comprehensive Drug Safety Plan. This plan encompasses premarket review and the Agency's expanded and strengthened postmarketing activities, as set forth in 2007 FDA Amendments Act. The SUI complements these more traditional regulatory activities. The SUI mission is to engage stakeholders from all sectors of healthcare: public, private, government, (including at the state and local level), non-government organizations (NGOs), professional, and consumer based organizations, etc. FDA, as part of the SUI, will collaborate with these partners to identify drug, drug classes or therapeutic areas associated with preventable harm and to develop and implement feasible harm reduction measures.
Preventable harm is a result of one or more of the following: 1) medication errors, 2) unintended exposures, 3) intentional misuse, abuse, or self-harm 4) drug quality defects. A medication error can result from a procedural error such as prescribing an incorrect dose of a drug, administration via the wrong route, or dispensing the wrong drug because of look alike/sound alike names. Another type of medication error is an error because of incomplete information about the patient, the medication, and or the underlying condition, such as consuming more than the recommended dose of a medication. Children are particularly vulnerable to accidental (unintentional) exposures when, for example, they have access to unsecured medications. Each year, unintentional ingestions in children under age 12 result in more than 60,000 visits to emergency departments. The harm from intentional misuse, abuse or self-harm, perhaps the most difficult to quantify and remedy, constitute a large burden to healthcare. In 2006, drug-related suicides resulted in an estimated 180,000 visits to emergency departments. This FOA covers the first 3 types of preventable harm. Drug quality defects are managed through FDA's traditional review and oversight functions and will not be part of this FOA.
The risk management model, as articulated in FDA's 1999 report entitled "Managing Risks from Medical Product Use: Creating a Risk Management Framework. Report to the FDA Commissioner from the Task Force on Risk Management" is a relevant paradigm to address preventable harm from medications. The report outlines a framework that involves healthcare stakeholders and partners throughout all steps of an iterative process. The process begins with identifying and characterizing the problem, quantifying the extent of harm, conducting a root cause analysis(es), identifying options to address the problem, selecting a strategy(ies) or intervention(s). Implementation and evaluation follows, and the cycle repeats and continues.
It will not be possible to develop a single strategy that addresses all safe medication use issues. Any risk reduction strategy needs to consider the healthcare delivery setting and the affected population(s). It must involve key stakeholders to assure the approach is relevant feasible and sustainable. FDA is aware of several promising approaches to harm reduction. These include but are not limited to expanded pharmacy services for medication therapy management, academic detailing to prescribers, enhancing information exchange to reduce impact of reduced health literacy, and harnessing the power of health information technology. Risk reduction strategies often require a multi-pronged approach, consisting of combinations of education and outreach, engineering and technological improvements, and/or enforcement and oversight such as via standard setting organizations.
The November 2010 Safe Use public meeting provided an opportunity to highlight Safe Use Project Collaborations (see public meeting website). The projects represented a spectrum of issues and stages of development. This FOA may address and expand on topics presented at the public meeting, or may be directed to new areas of preventable harm.
The research developed under this FOA should involve a drug/drug class or therapeutic area associated with preventable harm; it can cover prescription and/or over the counter medications. The research should lead to one or more of the following:
Funding Instrument |
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 |
New The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types. |
Funds Available and Anticipated Number of Awards |
FDA intends to fund an estimate of range awards, corresponding to a total of $250,000 for fiscal year 2012. Future year amounts are subject to the availability of funds. |
Award Budget |
FDA anticipates providing approximately $250,000 in support of this program in fiscal year 2011. It is anticipated that up to five (5) awards will be made, not to exceed 50,000 in total costs (direct plus indirect) per award, per year. The length of support will be one (1) year from date of award, with the possibility of two additional years of support (see below). Because the nature and scope of the proposed activities will vary from application to application, it is anticipated that size and the duration of each award will also vary. The total amount awarded and the number of awards will ultimately depend upon the number of applications, quality, duration, and cost of the applications received and the availability of funds. |
Award Project Period |
The award will provide one year of support, with the possibility of two additional years of support, contingent upon satisfactory performance in the achievement of project and program report 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.
Higher Education Institutions:
The following types of Higher Education Institutions are always encouraged to apply for FDA support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
Governments
Other
Non-domestic (non-U.S.) Entities
(Foreign Organizations) are not eligible to apply.
Foreign (non-U.S.) components of U.S. Organizations are not allowed.
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.
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.
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.
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. Resubmission applications may be submitted, according to the FDA Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.
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.
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.
Not Applicable
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 must be followed, with the following exceptions or additional requirements:
All instructions in the SF424 (R&R) Application Guide must be followed.
Appendix
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:
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, FDA’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.
Applications must be submitted electronically following the instructions described in the SF 424 (R&R) Application Guide. Paper applications will not be accepted.
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.
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.
Only the review criteria described below will be considered in the review process. As the Safe Use mission, all applications submitted to the FDA in support of behavioral research are evaluated for scientific and technical merit through the FDA peer 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 a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Does the research address an important area of regulatory science and will it inform future safe use of FDA regulated drugs? If the project aims are achieved, how will technological advances, clinical practice, and/or health be improved? Will the new approach/methodology have a competitive advantage over existing/alternate approaches? Does the proposed research address an unmet area in regulatory science?
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? Does the applicant have the necessary ability to address regulatory issues? Do project team members and/or associated collaborators have prior experience and/or necessary qualifications to successfully execute and implement the proposed research including, where appropriate, the ability to partner and collaborate with other scientists or organizations? Are the relationships of the key personnel to the applicant organization and, if applicable, to other partnering organizations (e.g., Contract Research Organizations (CROs), Contract Manufacturing Organizations (CMOs), academic laboratories, clinical sites and/or strategic partners) appropriate for the work?
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? Does the research outcome have the potential to solve the identified problem and create significant value in informing the drug safety and the medication use process? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies?
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? Are the technologies or experimental approaches state of the art?
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? Is the applicant organization concentrating on its core competencies to maximize its chances of success? Has the applicant established alliances/collaborative partnerships where they are appropriate or needed to facilitate achievement of the research goals?
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.
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.
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.
Applications will be evaluated for scientific and technical
merit by (an) appropriate Scientific Review Group(s), in accordance with HHS peer
review policy and procedures, using the stated review
criteria. Review assignments will be shown in the eRA Commons.
As part of the scientific peer review, all applications:
Applications will be assigned on the basis of established PHS referral guidelines to the appropriate FDA Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the FDA peer review committee. The following will be considered in making funding decisions:
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 as noted in the HHS Grants
Policy Statement.
All FDA grant and cooperative agreement awards include the HHS Grants Policy Statement as part of the NoA. For these terms of award, see the HHS Grants Policy Statement Part II: Terms and Conditions of FDA Grant Awards, Subpart A: General and Part II: Terms and Conditions of FDA Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for FDA Grants.
Cooperative Agreement Terms and Conditions of Award
The following special terms of award are in addition to, and
not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB)
administrative guidelines, U.S. Department of Health and Human Services (DHHS)
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 NIH 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 NIH programmatic
involvement with the awardees is anticipated during the performance of the
activities. Under the cooperative agreement, the NIH 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 in the 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 NIH as defined below.
The PD(s)/PI(s) will have the primary responsibility for:
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 DHHS, PHS, and FDA policies.
As part of a cooperative agreement applicants must be transparent in their activities and be willing to provide information and to discuss their protocols, data and findings with FDA on at least a quarterly basis. Each award will be assigned to an FDA Project Scientist (PS). The PS will have substantial programmatic involvement that is above and beyond the normal stewardship role of the assigned Project Officer (PO) as described below:
In addition to the involvement of the PS, each recipient will be assigned to an FDA Project Officer (PO) to monitor programmatic stewardship of the award.
Areas of Joint Responsibility include:
Dispute Resolution:
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the FDA may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members; one FDA staff member, [OCC10] one FDA designee, and a third designee[w11] with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.
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 the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.
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.
FDA encourages inquiries concerning this funding opportunity
and welcomes the opportunity to answer questions from potential applicants.
For questions please contact:
Sharon Bakayoko, M.B.A.
Project Manager Safe Use Initiative
[email protected]
Or
Tamara Ford
Office of Executive Programs
[email protected]
Grants.gov
Customer Support (Questions regarding Grants.gov registration and
submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: [email protected]
GrantsInfo (Questions regarding application instructions and
process, finding FDA grant resources)
Telephone: 301-827-6802
TTY 301-480-0434
Email: [email protected]
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: [email protected]
Karen Weiss, MD, MPH
Safe Use
Initiative
Office of the Center Director, CDER
Food and Drug Administration
10902 New Hampshire Avenue
Bldg. 51, Rm. 1348
Silver Spring, MD 20993
Phone: 301-796-1348
Fax: 301-847-8614
Email: [email protected]
Dale Slavin, Ph.D.
Safe Use Initiative
Office of the Center Director, CDER
Food and Drug Administration
10902 New Hampshire Avenue
Bldg. 51, Rm. 1352
Silver Spring, MD 20993
Phone: 301-796-3757
Fax: 301-847-8614
Email: [email protected]
Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).
Stephanie D. Bogan
Division of Acquisition Support and Grants
Office of Acquisitions & Grants Service
Food and Drug Administration
FHSL Rm 1095, HFA-500
5630 Fishers Lane
Rockville, MD 20857
Phone: 301-827-6802
Fax: 301-827-7101
Email: [email protected]
Recently issued trans-FDA policy notices may affect your application submission. A full list of policy notices published by FDA is provided in the FDA Guide for Grants and Contracts. 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 and
405 of the Public Health Service Act as amended (42 USC 241 and 284) 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. The HHS Grants Policy Statement
can be found at http://www.hhs.gov/asfr/ogapa/grantinformation/hhsgps107.pdf.
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. 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. OPD program staff will be providing 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
See Section VI.3.A. for more detail and other FDA monitoring
requirements. 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 (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) as applicable.
1. E. Inclusion of Women And Minorities in Clinical Research
Applicants for PHS clinical research grants are encouraged to include minorities and women in study populations so research findings can be of benefit to all people at risk of the disease or condition under study. It is recommended that applicants place special emphasis on including minorities and women in studies of diseases, disorders, and conditions that disproportionately affect them. This policy applies to research subjects of all ages. If women or minorities are excluded or poorly represented in clinical research, the applicant should provide a clear and compelling rationale that shows inclusion is inappropriate.
1.F. Inclusion of Children as Participants in Clinical Research
FDA regulations at 21 CFR part 50, subpart D contain additional requirements that must be met by IRBs reviewing clinical investigations regulated by FDA and involving children as subjects. FDA is part of HHS; accordingly, the research project grants under this program are supported by HHS, and HHS regulations at 45 CFR part 46, subpart D also apply to research involving children as subjects.
1.G. 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 (HIPAA) of 1996 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.H. 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.I. 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.J. 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 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 Public Health Service Act (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).
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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