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

credit: causesofchildhoodobesity.org
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.

Agency - Department of Health and Human Services

The Department of Health and Human Services is the Federal government's principal agency for protecting the health of all Americans and providing essential human services, especially to those who are least able to help themselves.

Office - See Regional Agency Offices.

Karin Bok, MS, PhD
202-690-1191
Karin.Bok@hhs.gov.

Relevant Nonprofit Program Categories




Program Accomplishments

Not Applicable.

Uses and Use Restrictions

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.

Eligibility Requirements

Applicant Eligibility

All children, women (including pregnant women) and adults.

Beneficiary Eligibility

Improving vaccine safety for children, adults and pregnant women.

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. OMB Circular No. A-87 applies to this program.

Aplication and Award Process

Preapplication Coordination

Preapplication coordination is not applicable.

Environmental impact information is not required for this program.

This program is excluded from coverage under E.O.

12372.

Application Procedures

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 Procedures

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 office, as appropriate, for application deadlines.

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.

Range of Approval/Disapproval Time

From 90 to 120 days.

Appeals

Not Applicable.

Renewals

Not Applicable.

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.

Post Assistance Requirements

Reports

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.

Audits

In accordance with the provisions of OMB Circular No. A-133 (Revised, June 27, 2003), "Audits of States, Local Governments, and Non-Profit Organizations," nonfederal entities that expend financial assistance of $500,000 or more in Federal awards will have a single or a program-specific audit conducted for that year. Nonfederal entities that expend less than $500,000 a year in Federal awards are exempt from Federal audit requirements for that year, except as noted in Circular No. A-133.

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.

Financial Information

Account Identification

75-0150-0-1-120.

Obigations

(Cooperative Agreements) FY 13 $0; FY 14 est $0; and FY 15 est $500,000 - 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

Information Contacts

Regional or Local Office

See Regional Agency Offices. Karin Bok, MS, PhD
202-690-1191
Karin.Bok@hhs.gov.

Headquarters Office

Brenda C. Donaldson Tower Building
1101 Wootton Parkway, Suite 550, Rockville, Maryland 20852 Email: Brenda.Donaldson@hhs.gov Phone: 2404538442

Criteria for Selecting Proposals

Not Applicable.



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