Research, Monitoring and Outcomes Definitions for Vaccine Safety
The National Vaccine Program Office (NVPO) collaborates with federal partners to provide strategic direction for the coordination of the vaccine and immunization enterprise for the National Vaccine Plan (NVP) implementation http://www.hhs.gov/nvpo/vacc_plan/2010%20Plan/nationalvaccineplan.pdf
NVPO is looking to partner with an institution or organization to conduct research, monitoring or outcomes definition research related to vaccine safety. The areas of research are specifically, but not limited to, predicting the safety profile of new vaccines during the early development stage, developing or modifying existing vaccines to improve their safety, conducting applied research that will have a direct impact on the current vaccine safety monitoring system, conducting research that will improve the safety profile of currently marketed vaccines, conducting research that will achieve consensus definitions of vaccine safety outcomes that could be utilized to collect consensus data in clinical research conducted globally.
General information about this opportunity
Last Known Status
Agency: Department of Health and Human Services
Office: Office of the Secretary
Type(s) of Assistance Offered
Section 1702(a) [42 U.S.C. 300u-1(a)] and Section 1703(a) and (c) [42 U.S.C. 300u-2(a) and (c)] of the Public Health Service Act, as amended.
Who is eligible to apply/benefit from this assistance?
All children, women (including pregnant women) and adults.
Improving vaccine safety for children, adults and pregnant women.
A nonprofit private entity must provide evidence of its nonprofit status. Allowability of costs charged to the cooperative agreement will be determined in accordance with the following Cost Principles: OMB Circular No. A-21 for educational institutions, OMB Circular No. A-122 for nonprofit organizations. Faith based organizations are eligible to apply. 2 CFR 200, Subpart E - Cost Principles applies to this program.
What is the process for applying and being award this assistance?
Preapplication coordination is not applicable. Environmental impact information is not required for this program. This program is excluded from coverage under E.O. 12372.
2 CFR 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards applies to this program. To apply, access the announcement through www.grants.gov. Enter the CFDA# and follow the website instructions. Applications submitted after the deadline will not be accepted for review. The submission deadline will not be extended. Applications which do not conform to the requirements of the grant announcement will not be accepted for review. Applications may only be submitted electronically via www.grants.gov. Any applications submitted via any other means of electronic communication, including facsimile or electronic mail, will not be accepted for review.
Applications will be screened upon receipt. Those that are judged to be ineligible will not be reviewed. Accepted applications will be reviewed for technical merit in accordance with PHS policies. Applications will be evaluated by a technical review panel composed of experts. Final funding decisions will be determined by the NVPO Office Director; taken into consideration are the recommendations of the review panel; program needs, stated preferences; geographic location. All applicants are notified in writing of actions taken on their applications. A Notice of Award is issued for those applications that are approved and funded.
Contact the headquarters or regional office, as appropriate, for application deadlines.
Approval/Disapproval Decision Time
From 90 to 120 days.
How are proposals selected?
How may assistance be used?
The assistance can be applied to improving vaccine safety knowledge, improving the monitoring of adverse events following immunization, or improving the way vaccine safety data are collected and analyzed in clinical trials. Examples of applicability are predicting the safety profile of new vaccines during the early development stage, developing or modifying existing vaccines to improve their safety, conducting applied research that will have a direct impact on the current vaccine safety monitoring system, conducting research that will improve the safety profile of currently marketed vaccines, conducting research that will achieve consensus definitions of vaccine safety outcomes that could be utilized to collect consensus data in clinical research conducted globally. Funds are restricted from being used for the following: alterations or renovations; construction; fund-raising activities; job training; political education and lobbying; vocational rehabilitation. There is approximately $500,000 available for up to 2 cooperative agreements.
What are the requirements after being awarded this opportunity?
Quarterly and Annual Progress Reports must be submitted each year. A Final Report will be due 90 days after the end of the project period. Federal Financial Reports (FFR) SF425 are required quarterly, 30 days after the end of the quarter, and annually, 90 days after the end of the budget period. A Final FFR will be due 90 days after the end of the project period. Reports must be submitted through the GrantSolutions system. A revised work plan must be submitted each year to indicate any service and/or partnership revisions. Expenditure reports are not applicable. A final performance report is due 90 days following the end of the project period.
In accordance with the provisions of 2 CFR 200, Subpart F - Audit Requirements, non-Federal entities that expend financial assistance of $750,000 or more in Federal awards will have a single or a program-specific audit conducted for that year. Non-Federal entities that expend less than $750,000 a year in Federal awards are exempt from Federal audit requirements for that year, except as noted in 2 CFR 200.503.
HHS and the Comptroller General of the United States or any of their authorized representatives shall have the right of access to any books, documents, papers, or other records of a grantee, sub-grantee, contractor, or subcontractor, which are pertinent to the HHS grant, in order to make audits, examinations, excerpts and transcripts. In accordance with 45 CFR, Part 74.53 and 45 CFR, Part 92, grantees are required to maintain grant accounting records 3 years after the end of a project period. If any litigation, claim, negotiation, audit or other action involving the records has been started before the expiration of the 3-year period, the records shall be retained until completion of the action and resolution of all issues which arise from it, or until the end of the regular 3-year period, whichever is later.
Other Assistance Considerations
Formula and Matching Requirements
This program has no statutory formula.
This program has no matching requirements.
This program does not have MOE requirements.
Length and Time Phasing of Assistance
Cooperative Agreements may not exceed 2 years (subject to the availability of funds). Payment will be made either on a monthly cash request basis or under Electronic Transfer System. Necessary instructions for the appropriate type of payment will be issued at the time an award is made. Method of awarding/releasing assistance: by letter of credit.
Who do I contact about this opportunity?
Regional or Local Office
See Regional Agency Offices. Karin Bok, MS, PhD
Brenda C. Donaldson Tower Building
1101 Wootton Parkway, Suite 550, Rockville, Maryland 20852 Email: Brenda.Donaldson@hhs.gov
(Cooperative Agreements) FY 14 $0; FY 15 est $500,000; and FY 16 Estimate Not Available - New program for FY 2015.
Range and Average of Financial Assistance
It is estimated that $500,000 will be available for up to 2 awards.
Regulations, Guidelines and Literature
HHS Grants Policy Statement is available online: http://www.hhs.gov/asrt/og/aboutog/grantsnet.html
Examples of Funded Projects