EXPIRED
Participating Organization(s) |
U.S. Food and Drug Administration (FDA) |
Center for Drug Evaluation Research - Office of Generic Drugs |
|
Funding Opportunity Title |
Characterization of Critical Quality Attributes for Semisolid Topical Drug Products (U01) |
Activity Code |
U01 Research Project Cooperative Agreements |
Announcement Type |
New |
Related Notices |
None |
Funding Opportunity Announcement (FOA) Number |
RFA-FD-14-010 |
Companion Funding Opportunity |
None |
Catalog of Federal Domestic Assistance (CFDA) Number(s) |
93.103 |
Funding Opportunity Purpose |
To continue making safe and effective topical semisolid drug products available to the American public, it is essential that FDA's regulatory science, as well as best practices in the pharmaceutical industry, are informed by the most current understanding of the product quality attributes that are potentially critical to the therapeutic performance of topical semisolid dosage forms. The scope of this project is to characterize all measurable physical/chemical qualities of different dosage forms of semisolid topical drug products, identify appropriate methodologies for measuring each of these quality attributes, characterize formulation and manufacturing parameters that alter the arrangement of matter in the dosage form as measured by specific quality attributes, and utilize in vitro and/or in vivo measures of product performance to correlate variations in critical quality attributes with a failure mode for a drug product. |
Posted Date |
March 20, 2014 |
Open Date (Earliest Submission Date) |
April 7, 2014 |
Letter of Intent Due Date(s) |
Not Applicable |
Application Due Date(s) |
June 1, 2014, by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date. |
AIDS Application Due Date(s) |
Not Applicable |
Scientific Merit Review |
|
Advisory Council Review |
September, 2014 |
Earliest Start Date |
September, 2014 |
Expiration Date |
June 2, 2014 |
Due Dates for E.O. 12372 |
Not Applicable |
Required Application Instructions
It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH 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
It can be challenging to evaluate whether a proposed semisolid drug product will be suitable for its intended purpose (i.e. complex product quality assessment). Depending upon formulation and manufacturing processes, even products that are Q1/Q2 equivalent could theoretically have Q3 differences in their arrangement of matter that may have the potential to impact dosage form performance. Furthermore, it can be challenging to evaluate potential failure modes for semisolid drug products, because of the wide variety of complex microstructures that can exist within dosage forms that are non-specifically termed creams, lotions, gels, ointments, etc.
To address these regulatory science challenges, and to advance FDAs mission to make safe and effective drug products available to the American public, it is essential to keep pace with current technologies that can better characterize semisolid dosage forms, to help identify potential risk factors and failure modes in the proposed drug product, and to facilitate an efficient, relevant and comprehensive Q1/Q2/Q3 comparison of a proposed generic drug product with the RLD.
The objective of this work is to support the development of regulatory standards and guidance's for industry regarding the development of semisolid topical drug products, based upon well-defined critical quality and performance attributes that best characterize these products.
A preliminary classification system will be developed to comprehensively inventory the various types of semisolid dosage forms relevant to topical drug products, differentiated based upon their components and anticipated microstructures (e.g. single vs. multi-phase gels, oleaginous suspensions, pluronic lecithin organogels, polyethylene glycol or petrolatum-based ointments, oil-in-water or water-in-oil creams, lotions, pastes, etc., each which may have fully or partially dissolved active pharmaceutical ingredient(s) in one or more phases). A theoretical framework for all potential failure modes for each class of semisolid dosage form will be constructed, and since the product container closure system could be associated with a failure mode, it will be considered as well. A comprehensive set of quality attributes will be identified for each class, which may include such physical/chemical attributes as opacity, smoothness, odor, color, consistency, water content, osmolality, pH, etc. However, while it is of interest to monitor all product quality attributes, not all measurable attributes may be critical to product performance or patient acceptability.
This project will ultimately help to define critical quality and performance attributes that best characterize topical semisolid drug products. At the molecular level, critical quality (Q1, Q2 and particularly Q3) attributes may potentially encompass not only the components, but also the relative proportions and form of the phase state(s) in the semisolid, globule size and distribution, particle size and distribution of the drug substance(s) within the phases of the dosage form, polymorphic forms of the drug substance, and other potentially critical characteristics as relevant. At the macromolecular level, these Q3 attributes may potentially encompass qualities such as rheology, density, homogeneity, and other physical properties. An essential component of this research would be to identify potential failure modes for different topical semisolid drug products, associate those with variations in critical quality attributes (CQAs) and characterize the formulation, manufacturing or stability-related variables that can influence the CQAs and impact a failure mode (e.g. cream homogenization speed may influence globule size which may impact therapeutic performance).
Different classes of semisolid dosage forms will be studied systematically, using formulation or manufacturing alterations to vary different quality attributes, and then using performance tests to identify those attributes that are CQAs. Tests of product performance to evaluate the criticality of quality attributes may be performed with appropriately discriminating in vitro release test (IVRT) methods as described in USP <1724>, or in certain cases with in vitro permeation tests (IVPT) using human skin, or by other methodologies capable of evaluating relative bioavailability.
This project will have several phases as noted below:
1. Comprehensive description of all potentially measurable physical/chemical qualities of semisolid dosage forms comprised of different components and with different anticipated microstructures and potential failure modes.
2. Identification and/or development of appropriate methodologies for measuring each of the quality attributes described for each class of semisolid dosage form.
3. Characterization of formulation/manufacturing variables that impact these quality attributes in each class of semisolid dosage form, and
4. Utilization of in vitro and/or in vivo measures of product performance to identify those quality attributes that may be critical to therapeutic performance, and which may be associated with a failure mode for a drug product.
Funding Instrument |
Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, FDA scientific or program staff will assist, guide, coordinate, or participate in project activities. |
Application Types Allowed |
New |
Funds Available and Anticipated Number of Awards |
The FDA and partner components intend to commit an estimated total of $250,000 to fund 1 award. The number of grants is contingent upon the ability of the applicants to demonstrate their qualification to perform one or more phases of the study. Grants may be awarded to multiple recipients to perform different study phases. FDA/CDER intends to commit $250,000 per award. Future year amounts will depend on annual appropriations, the availability of funds and project performance. |
Award Budget |
Application budgets are not limited but need to reflect the actual needs of the proposed project. Initial Budget period for the 01 and 02 budget years will reflect $250,000 Total costs each year. |
Award Project Period |
The scope of the proposed project should determine the project period. The maximum project period is 5 years depending on a yearly assessment on the availability of funds, and project performance and programmatic relevance. |
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
For-Profit Organizations
Governments
Other
Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to
apply.
Foreign components, as defined in the HHS Grants Policy Statement, are allowed.
Applicant Organizations
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director(s)/Principal
Investigator(s) (PD(s)/PI(s)) 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 SF424 (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 that is essentially the same as one already reviewed within the past thirty-seven months (as described in the HHS Grants Policy Statement), except for submission:
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.
For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
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:
The forms package associated with this FOA includes all applicable components, required and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.
The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
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 SF424 (R&R) Application Guide, with the following modification:
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.
When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.
When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.
Foreign (non-U.S.) institutions must follow policies described in the HHS Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.
Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.
Organizations must submit applications to 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, electronic system for grants administration. eRA Commons and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.
Applicants are responsible for viewing their application before the due date 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 SF424 (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(s)/PI(s) must include their eRA Commons ID in the
Credential field of the Senior/Key Person Profile Component of the
SF424(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. See Section III of this FOA for information on registration requirements.
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 System for Award Management. 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 assigned Grants Management Specialists and responsiveness by components of participating organizations, FDA. 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-13-030.
Only the review criteria described below will be considered in the review process. As part of the FDA Mission, all applications submitted to the FDA in support of biomedical and behavioral research are evaluated for scientific and technical merit through the FDA Ad Hoc Review process.
Reviewers will provide an overall impact 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 are improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Investigator(s)
Are the PD(s)/PI(s), 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?
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 human subjects and/or clinical research, are the plans
to address 1) the protection of human subjects from research risks, and 2) inclusion
(or exclusion) of individuals on the basis of sex/gender, race, and ethnicity,
as well as the inclusion or exclusion of children, justified in terms of the
scientific goals and research strategy proposed?
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?
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 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 Guidelines for the Review of Human Subjects.
Inclusion of Women, Minorities, and Children
When the proposed project involves human subjects and/or clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
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.
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 score.
Applications from Foreign Organizations
Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.
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.
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 convened by CDER, in accordance with FDA Ad Hoc Review Process, using the stated review criteria.
As part of the scientific peer reviews, all applications:
Appeals of initial Ad Hoc Review will not be accepted for applications submitted in response to this FOA.
Following initial Ad Hoc Review, 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:
After the Ad Hoc Review of the application is completed, the PD/PI will receive a copy of his or her Summary Statement (written critique) via e-mail.
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’s 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, SAM
Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.
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
The administrative and funding mechanism used for this program is a cooperative agreement, an "assistance" mechanism in which substantial FDA programmatic involvement with the awardees is anticipated during the performance of the activities.
Under the cooperative agreement, FDA's 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, although specific tasks and activities may be shared among the awardees and FDA as defined below:
a. All awardees are required to participate in a cooperative manner with FDA staff.
b. 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 polices.
c. An agency program official/Project Officer (PO) or a Center program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. FDA staffs have substantial programmatic involvement that is above and beyond the normal stewardship role in award as described below:
Cooperative Agreement - Principal Investigator(s) (PI)/Program Director (PD) responsibility:
The Principal Investigator (PI)/Program Director (PD) will have responsibility for the scientific, technical, and programmatic aspects of the grant, and for the day-to-day management of the project or program. The PD/PI(s) will maintain general oversight for ensuring compliance with the financial and administrative aspects of the award, and ensuring that all staff has sufficient clearance and/or background checks to work on this project or program. This individual will work closely with designated officials within the recipient organization to prepare justifications; appropriately acknowledge Federal support in publications, announcements, news programs, and other media; and ensure compliance with other Federal and organizational requirements.
The awardee is responsible for submitting interim progress reports (e.g. at specified intervals), when requested, to the Office of Generic Drug Project Officer (OGD PO) and the Grants Management Officer (GMO)/Specialist (GMS), listed as a contact on the Notice of Grant Award (NGA/NoA) including summary data on progress and expenses to date.
The awardee is encouraged to publish and publicly release and disseminate results, data and other products of the study, concordant with the study protocol and governance and the approved plan for making data and materials available to the scientific community and FDA. Awardee will work with the appropriate FDA staff to develop and implement an appropriate rapid data release OGD policy.
Manuscripts shall be submitted to OGD PO within two weeks of submission for publication. Publications or oral presentations of work performed under this Cooperative Agreement will require appropriate acknowledgement of FDA support. Timely publication of major findings is encouraged
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 OGD policies.
The awardee is responsible for obtaining prior approval for the development and design of FDA projects prior to execution.
Cooperative Agreement - OGD Responsibility:
The PO will monitor grantees periodically. The monitoring may be in the form of telephone conversations, e-mails, or written correspondence between the PO/GMO/ GMS and the PI. Information including, but not limited to, information regarding study progress, enrollment, problems, adverse events, changes in protocol, and study monitoring activities will be requested. Periodic site visits with officials of the grantee organization may also occur. The scope of the recommendations will consider the following: (1) progress toward enrollment, based on specific circumstances of the study; (2) adequate supply of the product/device; and (3) compliance with applicable FDA and HHS regulatory requirements for the trial.
An OGD PO with scientific/technical expertise and other members of the FDA staff will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
Cooperative Agreement - Collaborative Responsibilities:
The grantee organization must comply with all special terms and conditions of the grant, including those which state that future funding of the study will depend on recommendations from the OGD PO.
As relevant, the PD/PI s, in collaboration with OGD PO, will work collaboratively in evaluating the most appropriate research methods, data quality control strategies, safety issues, study design and implementation, data analysis and interpretation, publication and dissemination of study results.
Projects require FDA approval prior to implementation/initiation.
During performance of the award, the OGD PO, with assistance from other scientific program staff, designated based on their relevant expertise, may provide appropriate assistance, advice and guidance. The role of the OGD PO will be to facilitate and not to direct the activities. It is anticipated that decisions in all activities will be reached by consensus between the PD/PI and the OGD PO and that the FDA programmatic staff will be given the opportunity to offer input into this process. The OGD PO will facilitate liaison activity for partnerships, and provide assistance with access to FDA supported resources and services.
The FDA will work collaboratively to identify and coordinate training, professional development and training-related scientific exchange opportunities.
Cooperative Agreement - Steering Committee (Optional)
If a Steering Committee is determined to be necessary, it should be comprised of the PD(s)/PI(s) of the cooperative agreement, the PI s of additional performance sites, the OGD PO. The steering committee will meet every three to six months, or as dictated by the needs of the project. Each full member of the Steering Committee will have one vote, and all major decisions will be determined by majority vote of the Steering Committee. Awardees will be required to accept and implement OGD policies approved by the Steering Committee.
The primary governing body of the study will be the Steering Committee, which will have responsibility for the final details of project activity and OGD policy decisions and will define the rules regarding access to data and/or product outputs or samples, etc.
Cooperative Agreement - Dispute Resolution Process
Any disagreements that may arise in technical 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 will be convened comprised of (1) a designee of the Steering Committee (if a Steering Committee is not active, a designee of the recipient organization) chosen without FDA staff voting, one FDA designee, and a third designee 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 awardees 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 (Disallowance of Cost).
When multiple years are involved, awardees will be required to submit the annual Non-Competing Progress Report (PHS 2590 or RPPR) 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 HHS 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.
We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.
eRA Commons Help Desk (Questions regarding eRA Commons
registration, submitting and tracking an application, documenting system
problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
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Contact Center Telephone: 800-518-4726
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Sam Raney, Ph.D.
Food and Drug Administration (FDA)
Telephone: 240-276-8514
Email: sameersingh.raney@fda.hhs.gov
Sam Raney, Ph.D.
Food and Drug Administration (FDA)
Telephone: 240-276-8514
Email: sameersingh.raney@fda.hhs.gov
Gladys Melendez (Bohler)
Food and Drug Administration (FDA)
Telephone: 301-515-0642
Email: gladys.bohler@fda.hhs.gov
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH 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 of the Public Health Service Act as amended (42 USC 241) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.
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