Part 1. Overview Information

Key Dates

It is critical that applicants follow the Research (R) 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.

Table of Contents

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

Part 2. Full Text of Announcement

 

Section I. Funding Opportunity Description

The Office of Compliance (OC)/Office of Compounding Quality and Compliance (OCQC) in the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) is announcing the availability of a cooperative agreement award. FDA can guarantee one year of funding to one Awardee with the possibility of up to three years of additional, noncompetitive support, depending on performance and continued availability of federal funds.

This cooperative agreement funding opportunity supports the continued development of the Compounding Quality Center of Excellence (CQCOE or COE) Training Program. FDA, using a special Congressional appropriation, established the Compounding Quality Center of Excellence to engage in several initiatives to address challenges faced by the Outsourcing Facility (OF) industry and help the industry meet its intended function of providing high quality drugs needed by patients. The CQCOE Training Program, one of the initiatives, was successfully launched in the fall of 2020 to provide education and training for the OF industry and other stakeholders. The CQCOE Training Program includes the development and provision of practical, virtual, and self-guided online training tailored to the outsourcing facility industry in the realm of Current Good Manufacturing Practice (CGMP). To date, the COE has a portfolio of six live, instructor-led virtual trainings (ILT), ten self-guided online trainings, and two laboratory-based trainings developed prior to the start of the COVID-19 pandemic. These courses have been well attended and are widely utilized by outsourcing facilities.

Drug compounding is generally the practice of combining, mixing, or altering ingredients of a drug or active pharmaceutical ingredient (bulk drug substance) to create a medication tailored to the needs of an individual patient. Although compounded drugs can serve an important medical need for certain patients when an approved drug is not medically appropriate, they also present a risk to patients. Compounded drugs are not FDA-approved. Therefore, they do not undergo premarket review by FDA for safety, effectiveness, and quality. Since compounded drugs are subject to a less stringent regulatory standard than approved drugs, Federal law places conditions on compounding that are designed to protect the public health.

The fungal meningitis outbreak associated with compounded drugs made by the New England Compounding Center (NECC) began in September 2012. In response to the tragic outbreak, in which 64 people died and more than 750 people were sickened, Congress passed the Drug Quality and Security Act (DQSA) in 2013. The legislation affirmed the need for FDA oversight of drug compounders, codified the necessary collaboration between federal and state authorities to advance safer drug compounding practices and established a legal framework to investigate and hold accountable compounding manufacturers that make poor quality compounded drugs.

The Drug Quality and Security Act (DQSA) of 2013 established a sector of compounders, named "outsourcing facilities", under section 503B of the Food, Drug and Cosmetic Act that must meet more stringent quality standards to produce products on a larger scale. This new industry sector of drug compounders is held to higher quality standards to protect patient health. Outsourcing facilities are intended to offer a more reliable supply of compounded drugs needed by hospitals, clinics, and other providers. Ten years since its creation, this domestic industry is still relatively small (approximately 75 entities) and is experiencing growth and market challenges. As this industry continues to experience challenges, and FDA continues to find issues concerning drug quality and safety during inspections, the Agency recognizes the importance of expanding its CQCOE Training Program to address these challenges. This includes the need to develop and deliver new, and revise existing, CGMP training courses and ensure access to CGMP training for all 503B compounding stakeholders (e.g., OFs, compounders, federal and state regulators).

 

The objective of the Cooperative Agreement is to work directly with an established and experienced technical training provider with CGMP compliant facilities and subject matter expertise and experience to continue the existing training program of the Compounding Quality Center of Excellence as well as research and expand the program with new trainings. These trainings help outsourcing facilities and other stakeholders increase technical capabilities and improve facility operations, by gaining an overview of FDA regulatory framework for compounding, identifying insanitary conditions in their facilities, and implementing appropriate corrective actions. Protecting patients from poor-quality compounded drugs is a shared responsibility among the FDA, outsourcing facilities, compounders, state regulators and other stakeholders. The Compounding Quality Center of Excellence, through training and other modalities, engages proactively with these stakeholders to enhance the quality of compounded drugs for human use.

Training formats may include in-person classroom, laboratory, and cleanroom environments; live, in virtual environments; and self-guided, online and be specifically to the CGMP requirements for the outsourcing facility industry (as opposed to customized training or consulting).

The funding opportunity contains three main parts:

1. Instructor-Led, Live In-Person and Virtual Training, 2. Self-guided Online Training, and 3. Registration and Logistical Support.

This Cooperative Agreement seeks support for the following tasks: instructor-led, live in-person and virtual laboratory-based training in CGMP specifically tailored for the entire outsourcing facility industry at or using the firm’s onsite microbiology laboratory and cleanroom facility, self-guided online training tailored specifically for the outsourcing facility industry, and registration and logistical support. Awardee should be able to manage and expand a multi-faceted training program specific to the outsourcing facility industry that includes ongoing administration of multiple in-person, virtual and self-guided online trainings while simultaneously handling all training associated registration/logistics and development and delivery of new in-person, virtual and self-guided online training courses annually.

All three parts will collectively establish the foundation for building a sustainable training program for the FDA Compounding Quality Center of Excellence and its direct technical training partner, the Awardee.

This portion of the funding opportunity includes maintaining and delivering the existing portfolio of instructor-led, live, in person and virtual trainings as specified for Sterile Drug Compounding, Environmental Monitoring, Cleanroom, Investigations and CAPA, Process Validation and Quality Management Systems, and any courses developed in future years. Awardee, through direct ownership or acquiring rights, may use intellectual property for and deliver already existing virtual, instructor-led CGMP trainings tailored specifically to the CGMP requirement for the entire outsourcing facility industry on: Investigations and CAPA, Sterile Drug Compounding, Cleanroom, Environmental Monitoring, Process Validation, and Quality Management Systems including access to SMEs and ownership of intellectual property associated with each existing course.

Under Part 1, the Awardee may engage in activities such as the following:

• Provide training in a virtual format, and courses requiring in person, hands-on laboratory instruction provide them in both virtual and in-person environments (COVID permitting) at the trainer’s onsite classroom and/or microbiology laboratory and cleanroom facilities that align with FDA’s Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing Current Good Manufacturing Practice.
• Research and conduct analyses of existing course content and resource materials to identify instructional gaps in CGMP training content for outsourcing facilities. This may include using accepted instructional design models (i.e., Kemp Design Model, Dick and Carey, etc.) for training outcomes. Existing course content and materials may also be utilized for research focused on improving efficiency and effectiveness of future training delivery, such as studying the effectiveness of virtual training compared to in-person training for firms with barriers to attending in-person trainings. Research may also include analyzing practices for course development and delivery effectiveness to identify best practices and develop instructional designs and approaches that optimize interactive learning of CGMP concepts.
• Develop and deliver instructor-led, live in-person and virtual training (both hands-on and lecture-based).
• Develop virtual courses with companion in-person, hands-on, laboratory-based training courses when applicable to accommodate a diverse range of firm sizes with a broad range of financial capacity for funding training attendance in areas related to CGMP as mutually agreed upon by FDA and the Awardee. Training is tailored specifically to the CGMP requirements for the outsourcing facility industry.
• Revise course content as needed, as indicated, and agreed upon by FDA and the training provider, e.g., in-person laboratory-based trainings for Environmental Monitoring and Sterile Drug Compounding have already been developed and may need minor updates.
• Convert virtual courses (Cleanroom) to an in-person laboratory-based training format, so both virtual and in-person versions of all courses requiring hands-on laboratory training can be provided. Conversion of the Cleanroom course to an in-person format and development of the new course is conducted with direct consultation between Awardee’s subject matter experts (SME) and FDA subject matter experts (SME) without any intermediary.
• Develop at least one new virtual and/or virtual and laboratory-based training course on a CGMP topic mutually agreed upon by FDA and the Awardee tailored specifically to the CGMP requirements for the entire outsourcing facility industry. A primary SME and a back-up SME with expertise relevant to the CGMP topic covered in each course (if they do not already exist) should be available. FDA SMEs will ensure that substantive content aligns with FDA policy for 503Bs.
• In-person laboratory-based courses are held at an onsite microbiology laboratory and cleanroom training facility owned and operated by the Awardee. The onsite microbiology laboratory and cleanroom training facility may not be subcontracted but must be owned by the Awardee. Both the onsite microbiology laboratory and the aseptic processing suite owned by the Awardee must conform to CGMP recommendations and align with FDA’s Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing Current Good Manufacturing Practice and includes:

a) at least two ISO-7 cleanrooms that are certified to be able to meet and maintain ISO-7 specification with no less than 10 appropriately gowned individuals in the ISO-7 cleanroom during aseptic processing;

b) an ISO-8 or better gowning room connected to the ISO-7 via an airlock;

c) ISO-8 or better support rooms, with pass-throughs, that allow for unidirectional flow of supplies, equipment, waste, and finished products into and out of the ISO-7 cleanroom; and

d) ISO-5 devices that generates unidirectional airflow such as an aseptic filling cabinet or restricted access barrier system (RABS) fill line, and isolator for training purposes.

The onsite facility must also have a variety of other types of ISO-5 devices including a laminar flow hood(s), biosafety cabinet(s), and a visual inspection apparatus, for training purposes. The training facility should also have classrooms for lectures.

• Provide laboratory materials and equipment and facility required to conduct the courses.
• Develop a curriculum of CGMP courses for outsourcing facilities utilizing existing courses with plans for future CGMP courses to compliment the curriculum.
• Offer at least one session of the existing instructor-led virtual courses (if development timelines and availability allow) on Sterile Drug Compounding, Environmental Monitoring, Cleanroom, Investigations and CAPA, Process Validation and Quality Management Systems and may offer additional sessions at the Awardee’s discretion based on demand and business needs. Ownership of the courses and course materials will be joint between FDA and the Awardee.
• Recruit pharmaceutical manufacturing, technical, and quality SMEs skilled in their profession to develop and deliver courses.

This portion of the funding opportunity includes developing at least one self-guided online interactive training on a CGMP topic (TBD) tailored specifically to the CGMP requirements for the entire outsourcing facility industry but available to anyone wanting to take the course(s). The trainings are intended for use by outsourcing facilities, compounders, state regulators, and other interested stakeholders and are no cost to trainees with open access, compatible with the TRAIN learning network platform. Under Part 2, the Awardee may engage in activities such as the following:

• Develop public-facing, self-guided online training content in interactive text format for at least one training area tailored specifically to the CGMP requirements for the outsourcing facility industry as opposed to customized training or consulting for individual firms. The self-guided online trainings are developed using the Articulate Rise software and compatible for use with the TRAIN learning network and posted to an FDA designated self-guided online training application.
• Each training session may require multiple modules, as determined by the Awardee and FDA SMEs and be developed using Articulate Rise software to be placed on the TRAIN Learning Network. FDA will provide access to the Awardee for both the Articulate Rise and TRAIN Learning Network. Training work products should comply with 508-compliance regulations and other appropriate access guidelines. Ownership of the courses and course materials will belong jointly to the FDA and Awardee.
• Research and conduct training needs assessments, which may include using accepted Instructional Design Models.
• Develop at least one self-guided online course on mutually agreed upon CGMP topic (TBD) utilizing existing training materials where possible and modifying to accommodate FDA’s regulatory requirements and policies specific to outsourcing facilities.
• Utilize SMEs external to FDA identified with knowledge and experience in the specific technical areas applicable to the course; conduct direct working sessions between FDA staff and these SMEs to develop the course without any intermediary. The Awardee and FDA will have joint decision-making in course development.
• Training courses are up to 2-4 hours in length, interactive and/or video format; recorded narration by SME (voiceovers); graphics; course authorship by external SME.
• Review and pilot test web-based course content (content/functionality testing).
• Recruit pharmaceutical manufacturing, technical, and quality SMEs skilled in their profession to develop and deliver courses. Possess access to multiple SMEs in a wide variety of specialized areas within the realm of CGMP for the outsourcing facility industry to avoid any disruptions in training due to the loss of a single, specialized SME.
• Ensure CE credit is available to participants for the training, prior to any course launch.
• Update existing self-guided online courses owned by the Awardee in conjunction with FDA SMEs as needed.
• Assist with the establishment and assignment of role-based privileges and permissions for each training type.

This portion of the funding opportunity includes oversight and management related to expertly and efficiently handling operational and logistical support such as: executing course registration and logistics; conducting and analyzing course evaluations; collecting course fees; collecting and reporting course-related metrics; and overseeing and managing provision of continuing education credit for all courses. Under Part 3, the Awardee may engage in activities such as the following:

Provide comprehensive operational and logistical support across the training portfolio such as:

• Registration for in-person (including travel arrangements if necessary), virtual and self-guided online courses.
• Logistics associated with the provision of in-person, virtual and self-guided online courses.
• Developing and publicizing a course delivery schedule of in-person and virtual course offerings.
• Metrics associated with course attendance and level of satisfaction with trainings as well as feedback for training improvements (regular basis TBD).
• Providing course evaluations and reports for training courses and sessions to the Agency (regular basis TBD).
• Recommendations for updating course material based on stakeholder feedback.
• Promotion and advertising of trainings to targeted stakeholders, outsourcing facilities, compounding pharmacies, and state regulators and other stakeholders.
• Providing continuing education credit for each course for pharmacists, pharmacy technicians, physicians, nurses, and other professionals. Continuing education credit can be obtained from an external CE provider.
• Charging and collecting fees from training attendees for each instructor-led, live, in-person, and virtual course offering. These fees will be considered Program Income and can be used to further offset allowable costs. Attendees may be charged a fee to attend the trainings commensurate with the fee structure used by the Awardee when providing similar courses. Attendees may also be subject to any group or discount pricing as set by the Awardee.

Section II. Award Information

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

 

Section III. Eligibility Information

Higher Education Institutions

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

The following types of Higher Education Institutions are always encouraged to apply for FDA support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits

• Nonprofits with 501(c)(3) IRS Status
• Nonprofits without 501(c)(3) IRS Status

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations

 

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not 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.

• System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • o   NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • o   Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active SAM registration in order to complete the Grants.gov registration.

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 diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women 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 only one application, without any intermediary.

 

Section IV. Application and Submission Information

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

It is critical that applicants follow the Research (R) 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.

 

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows FDA staff to estimate the potential review workload and plan the review.

 

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), email address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent via electronic mail as a PDF file with the FOA Number and the Institution's Name in the message subject heading to:

Jill Hammond
[email protected]

 

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:

For this specific FOA, the limit is 30 pages.

The following section supplements the instructions found in the SF 424 (R&R) Application Guide and should be used for preparing an application to this FOA. The Required and Optional application components (forms) are listed below.

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.

Specific names provided for Other Attachments must be no more than 50 characters

including spaces.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

• Applications requesting multiple years of support must complete and submit a separate detailed budget breakdown and narrative justification for each year of financial support requested.
• If an applicant is requesting indirect costs as part of their budget, a copy of the most recent Federal indirect cost rate or F&A agreement must be provided as part of the application submission. This agreement should be attached to the RESEARCH & RELATED Other Project Information Component as line #12 'Other Attachments'.
• If the applicant organization has never established an indirect cost rate and/or does not have a negotiated Federal indirect cost rate agreement, a de minimis indirect cost rate of 10 percent (10%) of modified total direct costs (MTDC) will be allowed. MTDC means all direct salaries and wages, applicable fringe benefits, materials and supplies, services, travel, and subaward and subcontracts up to the first $25,000 of each subaward or subcontract. MTDC excludes equipment, capital expenditures, charges for patient care, rental costs, tuition remission, scholarships and fellowships, participant support costs and the portion of each subaward and subcontract in excess of $25,000.
• Indirect/F&A costs under grants to foreign and international organizations will be funded at a fixed rate of 8 percent of modified total direct costs (MTDC), exclusive of tuition and related fees, direct expenditures for equipment, and subawards in excess of $25,000. (With the exception of the American University of Beirut and the World Health Organization, which are eligible for full F&A cost reimbursement). Awards to domestic organizations with a foreign or international consortium participant may include 8 percent of MTDC, exclusive of tuition and related fees, direct expenditures for equipment, and subawards in excess of $25,000.

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, with the following additional requirements:

Resource Sharing Plan:

Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

• Generally, Resource Sharing Plans are expected, but they are not applicable for this FOA.

Appendix:

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

When involving human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

Part I. Overview Information contains information about Key Dates and times. 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, FDA’s 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 and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Late applications will not be accepted for this FOA.

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 and 45 CFR 75, currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

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

Additional funding restrictions may be part of the Notice of Award.

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 How to Apply Application Guide. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. 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 unique entity identifier provided on the application is the same identifier 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 and compliance with application instructions by the assigned Grants Management Specialist and responsiveness by components of participating organizations, FDA. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

 

Post-submission materials are those submitted after submission of the grant application but prior to objective review. They are not intended to correct oversights or errors discovered after submission of the application. FDA accepts limited information between the time of initial submission of the application and the time of objective review. Applicants must contact the assigned Grants Management Specialist to receive approval, prior to submitting any post submission materials. Acceptance and/or rejection of any post submission materials is at the sole discretion of the FDA. Any inquiries regarding post submission materials should be directed to the assigned Grants Management Specialist.

Section V. Application Review Information

Only the review criteria described below will be considered in the review process.

Reviewers will consider each of the review criteria below in the determination of scientific/technical merit.

The Awardee ensure all personnel are adequately trained, possess the requisite experience, and are otherwise fully qualified to provide the high level of support required by this Cooperative Agreement prior to being assigned to this project. The FDA considers the selection of individuals to work on this Cooperative Agreement as critical to the success of the program.

• Is the applicant a technical training firm with at least 10 years of experience providing training to CGMP drug product manufacturers and at least 3 years of experience providing training tailored to meet the needs of the entire Outsourcing Facility industry as opposed to customized training or consulting for individual firms?
• Key personnel and staff should be sufficient to perform the roles and responsibilities for continued development and delivery of CGMP training courses and the development of in-person and virtual training content, such as a Training Project Manager, Primary and back-up SME(s), Graphic/Web Designer, and support personnel.
• Does the applicant describe previous experience and accomplishments with CGMP drug manufacturers and Outsourcing Facilities (OF) providing training tailored to the meet the needs of the entire OF industry (as opposed to an individual OF firm)?
• Does the applicant demonstrate experience with recruiting multiple subject-matter-experts (SMEs) with both CGMP and outsourcing facility expertise and possess existing relationships with these SMEs?
• Does the applicant possess access to multiple SMEs (e.g., primary and back up individuals) in a wide variety of specialized areas within the realm of CGMP for the outsourcing facility industry to avoid any disruptions in training due to the loss of a single, specialized SME?

• Does the applicant possess previous, documented experience in developing and administering in-person, hands-on, laboratory-based courses on CGMP-related topics tailored to the outsourcing facility industry as a whole?
• Does the applicant possess previous, documented experience in developing and administering virtual courses on CGMP-related topics tailored to the outsourcing facility industry as a whole?
• Does the applicant possess previous experience in developing self-guided, online interactive text-based courses on CGMP-related topics tailored to outsourcing facilities?
• Description of a plan of action responding to the scope and complexity of the "Funding Opportunity".
• Description of any previous/current ownership of intellectual property for the training firm’s courses.
• Description of a process/plan to acquire intellectual property for existing courses from another training vendor to provide a course not owned or developed by your firm (if applicable).
• Description of any previous experience in developing online courses utilizing Articulate Rise software.
• Description of any previous experience in developing online courses compatible with the TRAIN learning network.

RFA/PAR only: Additional Questions may be added and should be explained to the applicant in Section IV.2.

• Description of how the applicant will work with the FDA in the continued development and expansion of the CQCOE Training Program, with course development and delivery.
• Description of capability and capacity to manage and expand a multi-faceted training program specific to the outsourcing facility industry that includes ongoing administration of multiple in-person, virtual and self-guided online trainings while simultaneously handling both all training registration/associated logistics and development and delivery of new in-person, virtual and self-guided online courses annually.
• Description of personnel requirements to manage an existing training program and expand a training program.
• Description of a course development process.
• Description of examples of CGMP courses for outsourcing facilities you have developed within the last five years.
• Description of capability to collect and produce training metrics such as attendance and satisfaction.
• Description of capability to evaluate training.
• Description of experience in marketing trainings to targeted stakeholders.
• Description of capability in managing training logistics such as charging fees for courses, handling registration and ongoing communication with registrants, providing continuing education credits, making/facilitating travel arrangements, etc.
• Description of methods proposed in the application to meet accepted methodology in adult training and education approaches.

RFA/PAR only: Additional Questions may be added and should be explained to the applicant in Section IV.2.

• Description of the scientific environment in which the work will be done to contribute to the probability of success.
• Description of the institutional support, equipment, and other physical resources available to the investigators adequate for the project proposed.
• Description of owning and maintaining a facility designed for training purposes, including an onsite microbiology laboratory and cleanroom facility that aligns with FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing Current Good Manufacturing Practice- including: at least two ISO-7 cleanrooms (unidirectional airflow) that are certified to be able to meet and maintain ISO-7 specification with at least 10 appropriately gowned individuals in the ISO-7 cleanroom during aseptic processing instruction, ISO-5 laminar flow hoods, ISO-5 Biosafety cabinet, ISO-5 isolators, RABS, passthrough, a gowning area meeting at least ISO-8 classification connected to the ISO-7 via an airlock, and aseptic processing area.

If so, provide specifications of the equipment and overall facilities. Please provide a facility diagram, describing each functional/operational area. The onsite microbiology laboratory and cleanroom training facility may not be subcontracted but must be owned by the Awardee.

• Description of possessing the proper supplies to provide to course attendees such as all garments/equipment required for sterile gowning, growth plates, sterile filters, cleaning solutions, disinfectants, etc., to ensure for full participation in the training courses.
• Description of the organization providing adequate program infrastructure, organizational resources, administration, professional skill sets, experience, and oversight to manage their application for this RFA.

As applicable for the project proposed, reviewers will evaluate the following additional items but will not give separate scores for these items and should not consider them in providing an overall score.

For research that involves human subjects but does not involve one of the 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 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.

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 individuals of all ages (including children and older adults) 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.

The committee will evaluate the involvement of live vertebrate animals as part of the scientific

assessment according to the following criteria: (1) description of proposed procedures involving

animals, including species, strains, ages, sex, and total number to be used; (2) justifications for

the use of animals versus alternative models and for the appropriateness of the species

proposed; (3) interventions to minimize discomfort, distress, pain, and injury; and (4)

justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia

of Animals.

Reviewers will assess the use of chimpanzees as they would any other application proposing the

use of vertebrate animals. For additional information on review of the Vertebrate Animals section,

please refer to the Worksheet for Worksheet for Review of the Vertebrate Animal Section.

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.

Not Applicable.

Not Applicable.

Not Applicable.

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).

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) Genomic Data Sharing Plan (GDS).

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

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 Objective Review Committee using the stated review criteria.

As part of the objective review, all applications:

• Will receive a written critique.

Appeals of objective review will not be accepted for applications submitted in response to this FOA.

Applications will compete for available funds with all other recommended applications submitted in response to this FOA. The following will be considered in making funding decisions:

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

Successful applicants will be notified of additional information that may be required or other actions leading to an award. The decision not to award a grant, or to award a grant at a particular funding level, is discretionary and is not subject to appeal to any FDA or HHS official or board.

 

Section VI. Award Administration Information

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 recipient’s business official.

Recipients must comply with any funding restrictions described in Section IV.5. Funding Restrictions and in the Notice of Award. 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 terms and conditions found in the HHS Grants Policy Statement, this FOA, and Notice of Award.

Institutional Review Board or Independent Ethics Committee Approval: For projects that involve Human Subjects and/or Clinical Trials Research, Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in FDA-funded studies, the recipient must provide FDA copies of documents related to all major changes in the status of ongoing protocols.

All FDA grant and cooperative agreement awards include the HHS Grants Policy Statement as part of the NoA.

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identify, sexual orientation, and pregnancy).  This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html

 

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to FDA grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.
• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including reasonable accommodations and making services accessible to them, see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about FDA's commitment to supporting a safe and respectful work environment, and what FDA's expectations are for institutions and the individuals supported on FDA-funded awards, please see https://www.fda.gov/science-research/about-science-research-fda/fda-sexual-harassment-policy-concerning-extramural-research.
• For guidance on administering programs in compliance with applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.  

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. 

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), FDA awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants. This provision will apply to all FDA grants and cooperative agreements.

FDA considers the sharing of research resources developed through FDA-sponsored research an important means to enhance the value and further the advancement of research. When research resources have been developed with FDA funds and the associated research findings published, those findings must be made readily available to the scientific community.

Upon acceptance for publication, scientific researchers must submit the author’s final manuscript of the peer-reviewed scientific publication resulting from research supported in whole or in part with FDA funds to the NIH National Library of Medicine's (NLM) PubMed Central (PMC). FDA defines the author's final manuscript as the final version accepted for journal publication, which includes all modifications from the publishing peer review process. The PMC archive is the designated repository for these manuscripts for use by the public, health care providers, educators, scientists, and FDA. Please see the FDA Public Access Policy.

Termination provisions in 2 CFR 200.340 (a) (1-4) are applicable to awards issued under this Notice of Funding Opportunity.

Additional terms and conditions regarding FDA regulatory and OC programmatic requirements may be part of the Notice of Award.

Reporting Requirements:

All FDA grants require both Financial and Performance reporting.

Financial Reporting:

A. Financial Expenditure Reports

A required Federal Financial Report (FFR) must be submitted annually. All annual FFRs must be submitted electronically using the Payment Management System (PMS). This includes all initial FFRs being prepared for submission and any revised FFRs being submitted or re-submitted to FDA. Paper expenditure/FFR reports will not accepted.

Annual FFRs must be submitted for each budget period no later than 90 days after the end of the calendar quarter in which the budget period ended. The reporting period for an annual FFR will be that of the budget period for the particular grant; however, the actual submission date is based on the calendar quarter. If a grant is under expanded authorities, the grantee must indicate the carryover amount in Section 12. Remarks of the annual FFR.

Performance Progress Reporting:

When multiple years (more than one budget period) are involved, Awardees will be required to submit the Research Performance Progress Report (RPPR) annually as required in the Notice of Award. Annual RPPRs must be submitted using the RPPR module in eRA Commons. The annual RPPR must include a detailed budget. Annual RPPRs are due no later than 60 days prior to the start of the next budget period.

Failure to submit timely reports may affect future funding. Additional Financial and Performance Progress reports may be required for this award. Any additional reporting requirements will be listed under Section IV Special Terms and Condition of the Notice of Award.

Salary Caps:

None of the funds in this award shall be used to pay the salary of an individual at a rate in excess

of the current Executive Level II of the Federal Executive Pay Scale.

Certificates of Confidentiality 42 U.S.C. 241(d)

Awardees are responsible for complying with all requirements to protect the confidentiality of identifiable, sensitive information that is collected or used in biomedical, behavioral, clinical, or other research (including research on mental health and research on the use and effect of alcohol and other psychoactive drugs) funded wholly or in part by the Federal Government. See 42 U.S.C. 241(d). All research funded by FDA, in whole or in part, that is within the scope of these requirements is deemed to be issued a Certificate of Confidentiality through these Terms and Conditions. Certificates issued in this manner will not be issued as a separate document.

Awardees are expected to ensure that any investigator or institution not funded by FDA who receives a copy of identifiable, sensitive information protected by these requirements, understand they are also subject to the requirements of 42 U.S.C. 241(d). Awardees are also responsible for ensuring that any subrecipient that receives funds to carry out part of the FDA award involving a copy of identifiable, sensitive information protected by these requirements understand they are also subject to subsection 42 U.S.C. 241(d).

Acknowledgment of Federal Support:

When issuing statements, press releases, publications, requests for proposal, bid solicitations and other documents--such as tool-kits, resource guides, websites, and presentations (hereafter statements )--describing the projects or programs funded in whole or in part with FDA federal funds, the recipient must clearly state:

1. the percentage and dollar amount of the total costs of the program or project funded with federal money; and,

2. the percentage and dollar amount of the total costs of the project or program funded by non-governmental sources.

When issuing statements resulting from activities supported by FDA financial assistance, the recipient entity must include an acknowledgement of federal assistance using one of the following statements.

If the FDA Grant or Cooperative Agreement is NOT funded with other non-governmental sources:

This [project/publication/program/website, etc.] [is/was] supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award [FAIN] totaling $XX with 100 percent funded by FDA]/HHS. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.

If the FDA Grant or Cooperative Agreement IS partially funded with other nongovernmental sources:

This [project/publication/program/website, etc.] [is/was] supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award [FAIN] totaling $XX with XX percentage funded by FDA/HHS and $XX amount and XX percentage funded by non-government source(s). The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.

The federal award total must reflect total costs (direct and indirect) for all authorized funds (including supplements and carryover) for the total competitive segment up to the time of the public statement. Any amendments by the recipient to the acknowledgement statement must be coordinated with FDA. If the recipient plans to issue a press release concerning the outcome of activities supported by FDA financial assistance, it should notify FDA in advance to allow for coordination.

Additional prior approval requirements pertaining to Acknowledgement of Federal Support, publications, press statements, etc. may be required, and if applicable, will be listed under Section IV Special Terms and Condition of the Notice of Award.

Prior Approval:

All prior approval requests must be submitted using the Prior Approval module in eRA Commons. Any requests involving budgetary issues must include a new proposed budget and a narrative justification of the requested changes. If there are any questions regarding the need or requirement for prior approval for any activity or cost, the grantee is to contact the assigned Grants Management Specialist prior to expenditure of funds.

For grant awards not covered under Expanded Authorities, Carryover and No Cost Extension (NCE) requests will require prior approval. All Carryover and NCE requests should be submitted using the Prior Approval module in eRA Commons.

The following activities require prior approval from FDA on all awards:

1. Change in Grantee Organization

2. Significant Rebudgeting

3. Change in Scope or Objectives

4. Deviation from Terms and Conditions of Award

5. Change in Key Personnel which includes replacement of the PD/PI or other key personnel as specified on the NoA.

6. Disengagement from the project for more than three months, or a 25 percent reduction in time devoted to the project, by the approved PD/PI. No individual may be committed to more than 100% professional time and effort. In the event that an individual's commitment exceeds 100%, the grantee must make adjustments to reduce effort. For FDA-sponsored projects, significant reductions in effort (i.e., in excess of 25% of the originally proposed level of effort) for the PD/PI and key personnel named on named on this Notice of Award must receive written prior approval from FDA.

Additional prior approval requirements may be required for this award, and if applicable, will be listed under Section IV Special Terms and Condition of the Notice of Award.

Audits and Monitoring:

Audit Requirements:

1. Recipients of Federal funds are subject to annual audit requirements as specified in 45 CFR 75.501 (https://www.ecfr.gov/cgi-bin/retrieveECFR?gp=1&SID=8040c4036b962cc9d75c3638dedce240&ty=HTML&h=L&r=PART&n=pt45.1.75#se45.1.75_1501). Grantees should refer to this regulation for the current annual Federal fund expenditure threshold level which requires audit.

2. Foreign recipients are subject to the same audit requirements as for-profit organizations (specified in 45 CFR 75.501(h) through 75.501(k).

3. For-profit and foreign entities can email their audit reports to [email protected] or mail them to the following address:

U.S. Department of Health and Human Services
Audit Resolution Division, Room 549D
Attention: Robin Aldridge, Director
200 Independence Avenue, SW
Washington, DC 20201

Monitoring:

Recipients are responsible for managing the day-to-day operations of grant-supported activities using their established controls and policies, as long as they are consistent with Federal, DHHS and FDA requirements. However, to fulfill their role in regard to the stewardship of Federal funds, FDA monitors our grants to identify potential problems and areas where technical assistance might be necessary. This active monitoring is accomplished through review of reports and correspondence from the recipient, audit reports, site visits, and other information available to FDA.

1. Desk review: FDA grants monitoring specialists will periodically reach out to recipients to request information for the completion of desk reviews. Requested information may include:

• Policies and procedures
• List of grant expenditures
• Accounting records
• Supporting documents (e.g., invoices, receipts, paystubs, timesheets, contracts, etc.)
• Financial statements
• Audit reports
• Other related documentation

2. Site visits: FDA will conduct site visits when necessary and will notify the recipient with reasonable advance notice of any such visit(s).

3. Foreign entities: All Foreign entities are subject to the same monitoring requirements as domestic entities. Foreign entities covered under immunity Executive Orders will provide supporting documents for monitoring requirements unless such an action is a violation of the Executive Orders. Recipients may discuss with the FDA to come up with an alternate approach to satisfy the award monitoring requirements.

All recipients will make reasonable efforts to resolve issues found, including audit findings. Successful resolutions to issues are important as they are part of the grant performance review. All recipients are responsible for submitting all requested information in an expeditious manner. Failure to submit timely reports and/or respond to inquiries from FDA may affect future funding or enforcement actions, including withholding, or conversion to a reimbursement payment method.

Financial Conflict of Interest (FCOI):

This award is subject to the Financial Conflict of Interest (FCOI) regulation at 42 CFR Part 50 Subpart F.

Closeout Requirements (when applicable):

A Final Research Performance Progress Report (FRPPR), Final Invention Statement HHS-568 (if applicable), Tangible Personal Property Report SF-428 (if applicable), and Statement of Disposition of Equipment (if applicable) must be submitted within 120 days after the expiration date of the project period. All closeout documents must be submitted electronically in eRA Commons.

The Final Federal Financial Report (FFR SF-425), must be submitted in PMS and indicate the exact balance of unobligated funds and may not reflect unliquidated obligations. There must be no discrepancies between the Final FFR expenditure data and FFR cash transaction data in the Payment Management System (PMS). The expended funds reported on the Final FFR must exactly match the disbursements and the charge advances in PMS. It is the recipient's responsibility to reconcile reports submitted to PMS and to the FDA.

Program Income:

The grantee is required to report any Program Income generated during the Project Period of this grant. Except for royalty income generated from patents and inventions, the amount and disposition of Program Income must be identified on lines 10 (l), (m), (n), and (o) of the grantee s Federal Financial Report (FFR) SF-425.

Examples of Program Income include (but are not limited to): fees for services performed during the grant or sub-grant period, proceeds from sale of tangible personal or real property, usage or rental fees, patent or copyright royalties, and proceeds from the sale of products and technology developed under the grant.

Any Program Income generated during the Project Period of this grant by the grantee or sub-grantee will be treated as identified below.

Treatment of Program Income:

Additional Costs

Prohibition on certain telecommunications and video surveillance services or equipment:

(a) As described in CFR 200.216, recipients and subrecipients are prohibited to obligate or spend grant funds (to include direct and indirect expenditures as well as cost share and program) to:

(1) Procure or obtain,

(2) Extend or renew a contract to procure or obtain; or

(3) Enter into contract (or extend or renew contract) to procure or obtain equipment, services, or systems that use covered telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system. As described in Pub. L. 115-232, section 889, covered telecommunications equipment is telecommunications equipment produced by Huawei Technologies Company or ZTE Corporation (or any subsidiary or affiliate of such entities).

i. For the purpose of public safety, security of government facilities, physical security surveillance of critical infrastructure, and other national security purposes, video surveillance and telecommunications equipment produced by Hytera Communications Corporation, Hangzhou Hikvision Digital Technology Company, or Dahua Technology Company (or any subsidiary or affiliate of such entities).

ii. Telecommunications or video surveillance services provided by such entities or using such equipment.

iii. Telecommunications or video surveillance equipment or services produced or provided by an entity that the Secretary of Defense, in consultation with the Director of the National Intelligence or the Director of the Federal Bureau of Investigation, reasonably believes to be an entity owned or controlled by, or otherwise, connected to the government of a covered foreign country.

Other:

This award is subject to the requirements of 2 CFR Part 25 for institutions to maintain an active registration in the System of Award Management (SAM). Should a consortium/subaward be issued under this award, a requirement for active registration in SAM must be included.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts with cumulative total value greater than $10,000,000 must report and maintain information in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently the Federal Awardee Performance and Integrity Information System (FAPIIS)). Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75.

You must administer your project in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identity, sexual orientation, and pregnancy). This includes taking reasonable steps to provide meaningful access to persons with limited English proficiency and providing programs that are accessible to and usable by persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. See https://www.hhs.gov/civil-rights/for-providers/providerobligations/index.html and https://www.hhs.gov/civil-rights/forindividuals/nondiscrimination/index.html.

• You must take reasonable steps to ensure that your project provides meaningful access to persons with limited English proficiency. For guidance on meeting your legal obligation to take reasonable steps to ensure meaningful access to your programs or activities by limited English proficient individuals, see https://www.hhs.gov/civilrights/for-individuals/special-topics/limited-english-proficiency/fact-sheetguidance/index.html and https://www.lep.gov.
• For information on your specific legal obligations for serving qualified individuals with disabilities, including providing program access, reasonable modifications, and taking appropriate steps to provide effective communication, see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sexdiscrimination/index.html.

For guidance on administering your project in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws, see https://www.hhs.gov/conscience/conscienceprotections/index.html and https://www.hhs.gov/conscience/religiousfreedom/index.html

Expanded authorities do not apply to this cooperative agreement.

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 Part 75, and other DHHS, Public Health Service (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 Awardee’s activities by involvement in and otherwise working jointly with the Awardee 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 Awardee for the project as a whole, although specific tasks and activities may be shared among the Awardee and FDA as outlined below.

Project Director/Principal Investigator primary responsibilities:

The PD/PI will have the primary responsibility for managing the technical and programmatic aspects of the cooperative agreement, and for day-to-day management of the project(s)/ tasks, program and subcontractors as needed. The PD/PI will maintain general oversight for ensuring compliance with the financial and administrative aspects of the award, as well as ensuring that all staff, as needed, has sufficient clearance and/or background checks to work on this project or program. The PD/PI will work closely with designated officials within the Awardee’s 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 also responsible for:

• Participating in a cooperative manner with FDA
• Develop work and project plans in concert with OCQC's work planning outlining course development and delivery initiatives, timelines, review periods, resources utilized, and other criteria as needed
• Timely submission of all training content and/or reviews by subject matter experts (co)authored by members of the grant and/or reviews authored by others working for FDA
• Submitting quarterly progress reports to the FDA Project Officer (PO). These reports will include an update on all progress made on assignments and monies spent to date against the total award. The report will be due by the 15th of the last month in the calendar quarter.
• Provide monthly reporting outlining allocated expenses, funds remaining, initiative progress, and milestone achievement
• Provide mid and yearly progress reports to OCQC and the Office of Acquisition and Grants Services (OAGS) as directed and required
• Travel and preparing materials for meetings with FDA personnel in the Washington, D.C. metro area or other designated area

The Awardee will participate in FDA meetings in a variety of training capacities, as directed by the FDA Team including the Project Officer, Program Leads, Technical Leads, Subject Matter Experts (SME), and other support staff. FDA provides SMEs for FDA centric training content (FDA regulations and policy), project oversight, technical input, content review, and programmatic interaction with Awardee(s) on activities within the scope of this cooperative agreement.

As part of this cooperative agreement, the FDA PO and staff will have substantial programmatic involvement that is above and beyond the normal stewardship of grants. The responsibilities of the designated PO and support staff include activities such as technical assistance, advice, coordination, providing subject matter experts (SMEs) for developing and reviewing training content, and/or assisting with other activities that are above and beyond normal grant program stewardship. As appropriate, the PO and support staff will participate in defining the goals, objectives, and approaches for planning, analyzing, designing, developing, publishing, delivering, and evaluating training and education content. The dominant role and prime responsibility for the projects and activities resides with the Awardee for the project as a whole, but not necessarily for each task. As resources permit, FDA will continue to support the cooperative agreement with input from FDA staff and other SMEs.

Program Income

The Awardee can generate program income, as a result of charging and collecting fees for each Instructor-led training course offering. These fees will be considered program income and can be used to further offset allowable costs. Program income must be reported by the Awardee on a regular basis TBD. Attendees can be charged a fee to attend the instructor-led, live, in-person, and virtual trainings commensurate with the fee structure used by the Awardee when providing similar courses. Attendees can also be subject to any group or discount pricing as set by the Awardee.

Areas of joint responsibility include:

As relevant, the PD/PI will work collaboratively with the designated PO and support staff in evaluating the most appropriate methods, data quality control strategies and implementation, data analysis and interpretation, publication, and dissemination of project activities and results. During performance of the award, the PO, with assistance from other FDA program staff who are designated based on their relevant expertise, may provide appropriate assistance, advice, review, and guidance. The role of the PO will be to facilitate, not direct the activities. It is anticipated that decisions regarding all activities will be reached by consensus between the Awardee and PO, and that selected FDA staff will be given the opportunity to offer input into this process. The PO will facilitate liaison activity for partnerships and provide assistance with access to FDA supported resources and services.

FDA s role:

1. FDA provides oversight, scientific, and programmatic interaction with Awardee in regard to the design, development, delivery, and evaluation of activities within the scope of this cooperative agreement. FDA will be the final approval authority for tasks and will also evaluate courses to assure that instructors are applying the identified instructor competencies and delivering content consistent with the overall purpose of ensuring appropriate training for regulatory stakeholders.

2. FDA will monitor and evaluate the overall performance of the Awardee under this cooperative agreement.

3. FDA will collaborate and work closely with Awardee s continued development.

4. FDA will take any action that may be necessary to ensure compliance with this cooperative agreement.

5. FDA may choose not to have significant input or control on some projects/tasks as it may be deemed more suitable for the Awardee to lead and control the design, methodology, analysis, development and/or delivery of work.

Funding Restrictions:

These awards may only be used for the development and expansion of the Compounding Quality Center of Excellence Training Program and other projects that support the intended outcomes of the cooperative agreement program.

Funding is allocated to cover costs on mutually agreed upon project(s) within the scope of this cooperative agreement such as costs (direct and indirect) associated with course development, course delivery, training instructors, instructor travel, lodging and per diem costs, personnel salaries or wages, course materials and supplies, course material shipping expenses, training need assessments, course certificates and records, etc. Funding is not allocated for course participant travel, lodging, per diem, and salary or wages. Instructor-led course registration fees may be charged for all stakeholders, as program income. Self-guided on-demand courses will be open access with no cost to all stakeholders.

Funds should be requested in the budget for key project personnel to travel to meetings, on-site visits, and audits with FDA program staff to discuss the project. A portion of budgeted travel funds should also be set aside for key personnel to attend an annual face-to-face meeting (as determined by FDA PO). Prior approval from FDA for budget modifications of >10% of the total award of substantial changes to the project proposal is required.

The tasks in this Cooperative Agreement are structured around clearly defined activities but allow for flexibility and innovation to rapidly address new and emerging issues, FDA’s strategic priorities, and priorities of HHS.

Allowable costs include:

1. Audiovisual materials such as promotional materials, etc.

2. Employee salaries wages, and fringe benefits

3. Rental, purchasing, calibration and maintenance of supplies and equipment

4, Indirect costs

5. Course registration fees (generated from program income)

$200,000 of the award funding must be used each year to subsidize course registration fees for Outsourcing Facilities.

6. Purchase or development of IT equipment, software, and support

7. Shipping and mailing of equipment and supplies

8. Travel (including per diem for meals)

9. Instructor fees

Non-allowable costs:

1. No modification or expansion of facility

2.Facilities, work, and training reimbursed under other funding mechanisms must remain distinct and separate from the cooperative agreement. The Awardee must be able to account separately for fund expenditures, including employee salaries, wages, and benefits, under other contracts, other funding mechanisms and these cooperative agreements.

3. Vehicle purchases are not permitted

4. Cooperative agreement funds may not be utilized for new building construction or remodeling of existing facilities.

5. Please also refer to the HHS Grant Policy Statement for additional information regarding costs.

The Awardee will retain custody of, and have primary rights to, the data and software (including all source files) developed under these awards, subject to government rights of access consistent with current DHHS, PHS, and FDA policies. In all cases, FDA must be given a royalty-free, nonexclusive, and irrevocable license for the federal government to reproduce, publish, or otherwise use the material and to authorize others to do so for federal purposes. Curriculum and course content developed under this cooperative agreement such as objectives, learning outcomes, presentations, manuals, scripts, exercises, handouts, reports, documents, or other tangible materials produced by the Awardee must be guaranteed free of copyrights from outside sources and be free domain for use by FDA. Any FDA curriculum or training course content provided by FDA will remain the property of FDA and any proposed changes are not to be made without concurrence from FDA.

The Government, via the PO, will have access to data generated under this cooperative agreement and may periodically review the data, progress reports and/or prepare internal project reports, however Awardees will retain custody of and have primary rights to all data developed under these awards.

FDA retains the right to conduct audits and/or request meetings with the Awardee management to discuss training programs and other related activities. FDA shall be responsible for funding the travel and travel related costs for FDA personnel (or other federal employees). Any travel cost incurred by the Awardee to meet with FDA is the responsibility of the Awardee under this grant.

The Awardee is expected to remain flexible in support of the overall purpose of the cooperative agreement. This may include delivery of training to FDA, state, local, territorial, and tribal regulators as well as academia and regulated industry personnel or the need to reprioritize projects.

Credentials (e.g., certificates, certifications, licenses, continuing education units) should be developed under the appropriate standards such as those found under American National Standards Institute (ANSI).

Exams, assessments, and other security related documents developed for ANSI/ISO/IEC 17024 accredited certification related purposes should be maintained by the Awardee in accordance with the standard. Curriculum, technical reports (e.g., job/task analysis report) and other non-security related certification and curriculum documentation shall remain free of copyright and be free domain for use by FDA.

The Awardee should not previously or presently be involved in legal suits against the federal government.

The Awardee will be expected to participate in monthly progress meetings. At the discretion of FDA, these meetings may be in person, via conference call, or electronic conferencing. The meetings may involve FDA, other grantees, sub/contractors, subject matter experts, and personnel stipulated by FDA, in addition to the PO, together with Awardee personnel knowledgeable of and familiar with the project topic.

The Awardee shall provide a brief financial summary report each quarter (due with quarterly progress report) by categories and/or projects (direct and indirect costs) for funds spent or paid, obligated (but not yet paid for), and remaining funds not yet obligated to a project. Report tallies are to include funding totals on a continuous year-to-date and quarterly basis against the total award.

Delineation of substantive involvement:

1. FDA will monitor and evaluate the overall performance of the Awardee under this cooperative agreement.

2. FDA will collaborate and work closely with Awardee’s continued development.

3. FDA will take any action that may be necessary to ensure compliance with this cooperative agreement.

4. FDA may choose not to have significant input or control on some projects/tasks as it may be deemed more suitable for the Awardee to lead and control the design, methodology, analysis, development and/or delivery of work.

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the Notice of Award.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the terms and conditions of award and the HHS Grants Policy Statement. FDA FOAs outline intended goals and objectives. Post award, FDA will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients 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 the threshold.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 and 2 CFR Part 200 Award Term and Condition for Recipient Integrity and Performance Matters.

 

Section VII. Agency Contacts

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: https://grants.nih.gov/support/index.html (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Jill R. Hammond
CDER/OC/Office of Compounding Quality & Compliance (OCQC)
Food and Drug Administration
Telephone: 301-796-6895
Email: [email protected]

Shashi Malhotra
Office of Acquisitions & Grants Services (OAGS)
Food and Drug Administration
Telephone: 240-402-7592
Email: [email protected]

There must be a contact for all participating ICs.

Shashi Malhotra
Office of Acquisitions & Grants Services (OAGS)
Food and Drug Administration
Telephone: 240-402-7592
Email: [email protected]

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, Notice of Award, and 45 CFR 75, currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions .

Awards are made under the authorization of Section 301 of the Public Health Service Act as amended (42 USC 241) and under Federal Regulations 31 USC 6305, 42 CFR Part 52 and 45 CFR Part 75 and 2 CFR Part 200.