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 or surveillance improvements 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 improve the understanding of the safety profile of immunizations that are or will be recommended for adults over 65 years old

General information about this opportunity
Last Known Status
Active
Program Number
93.344
Federal Agency/Office
Office of The Assistant Secretary, Department of Health and Human Services
Type(s) of Assistance Offered
B - Project Grants
Program Accomplishments
Fiscal Year 2016 Vaccine Confidence 1 award for $250,000 for FY2016
Fiscal Year 2017 Awardee: Kaiser Foundation Hospitals Project Award: $338,425 Description: This project focuses on adversomics. It aims to identify inherited, immunologic, and clinical factors that may predict the occurrence of febrile seizures after measles vaccination. Awardee: Cincinnati Children's Hospital Medical Center Project Award: $250,000 Description: This project focuses on maternal immunization safety. It aims to validate the Global Alignment of Immunization Safety Assessment in pregnancy (GAIA) maternal and neonatal outcome definitions to standardize the evaluation of the safety of vaccines. Awardee: The Rockefeller University Project Award: $161,575 Description: This project focuses on precision medicine. It aims to analyze the genetic determinants of the immune response following yellow fever vaccination among individuals who experience serious adverse events.
Fiscal Year 2018 unknown at this time
Authorization
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?
Applicant Eligibility
Public (including city, county, regional, and State government) organizations and private nonprofit entities.
Beneficiary Eligibility
Improving vaccine safety for adults.
Credentials/Documentation
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.
What is the process for applying and being award this assistance?
Pre-Application Procedure
Preapplication coordination is not applicable.
Application Procedure
2 CFR 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards applies to this program. OMB Circular No. A-102 applies to this program. OMB Circular No. A-110 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.
Award Procedure
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.
Deadlines
Contact the headquarters or regional location, as appropriate for application deadlines
Approval/Disapproval Decision Time
More than 180 days. from 6 to 9 months
Appeals
Not applicable.
Renewals
Not applicable.
How are proposals selected?
Please see FOA.
How may assistance be used?
The assistance can be applied to improving vaccine safety knowledge, improving the monitoring of adverse events following immunization, including vaccines used by adults over 65 years old. 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 improve the understanding of the safety profile of immunizations that are or will be recommended for adults over 65 years old. There is approximately $500,000 available.
What are the requirements after being awarded this opportunity?
Reporting
Performance Reports: A final performance report is due 90 days following the end of the project period.
Auditing
Not applicable.
Records
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
Statutory formula is not applicable to this assistance listing.

Matching requirements are not applicable to this assistance listing.

MOE requirements are not applicable to this assistance listing.
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: Letter.
Who do I contact about this opportunity?
Regional or Local Office
Karin Bok, MS, PhD 202-690-1191 Karin.Bok@hhs.gov
Headquarters Office
Eric C. West
1101 Wootton Parkway
Tower Building Suite 550
Rockville, MD 20852 US
eric.west@hhs.gov
Phone: (240) 453-8822.
Website Address
http://www.hhs.gov/nvpo
Financial Information
Account Identification
75-0150-0-1-120
Obligations
(Cooperative Agreements) FY 18 Estimate Not Available FY 19 Estimate Not Available FY 20 Estimate Not Available -
Range and Average of Financial Assistance
Estimated Funds Not Available
Regulations, Guidelines and Literature
HHS Grants Policy Statement is available online: http://www.ahrq.gov/funding/policies/hhspolicy/index.html HHS Grants Policies and Regulations are available online: http://www.hhs.gov/grants/grants/grants-policies-regulations/
Examples of Funded Projects
Fiscal Year 2016 Vaccine Confidence 1 award for $250,000 for FY2016 Vaccine Safety Cooperative Agreements; 2 awards each for $250,000 for FY2015 Vaccine Confidence 1 award for $250,000 for FY2016

 



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