An Amendment was made to this announcement on 01.29.08 to the following Sections: Part I. Key Dates; and Section IV. Application and Submission Information, 3.A. Submission, Review, and Anticipated Start Dates.

All modifications are made within the document in red type.

Part I Overview Information

United States Department of Health and Human Services (HHS)

Issuing Organization

Centers for Disease Control and Prevention (NCIRD/CDC), at http://www.cdc.gov/vaccines/about/default.htm

Participating Organizations

Centers for Disease Control and Prevention (CDC), at http://www.cdc.gov

Components of Participating Organizations

National Center for Immunization and Respiratory Diseases (NCIRD) /CDC, at http://www.cdc.gov/vaccines/about/default.htm

Title: Evaluation of the Validity of Coverage Survey Self-Reported Adult Vaccination Status (U01)

The policies, guidelines, terms, and conditions of the HHS Centers for Disease Control and Prevention (CDC) stated in this announcement might differ from those used by the HHS National Institutes of Health (NIH).  If written guidance for completing this application is not available on the CDC website, then CDC will direct applicants elsewhere for that information. 

 
Authority: Section 317 (k) (1) [42 U.S.C. 247b (k) (1)] of the Public Health Service Act, as amended

Announcement Type: New

Instructions for Submission of Electronic Research Applications:

NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide. 

This FOA must be read in conjunction with the application package instructions included with this announcement on Grants.gov/Apply for Grants (hereafter referred to as, Grants.gov/Apply.)

A registration process is necessary before submission, and applicants are strongly encouraged to start the process at least four weeks prior to the grant submission date. See Section IV.

Two steps are required for on time submission:

1) The application must be successfully received by Grants.gov no later than 5:00 p.m. Eastern Time on the application submission receipt date (see “Key Dates” below.)

2) Applicants must complete a verification step in the Electronic Research Administration (eRA Commons) within two business days of notification. Note: Since email can be unreliable, it is the responsibility of the applicant to periodically check on their application status in the eRA Commons.

Funding Opportunity Announcement (FOA) Number: RFA-IP-08-003

Catalog of Federal Domestic Assistance Number(s): 93.185 Immunization Research, Demonstration, Public Information and Education-Training and Clinical Skills Improvement Projects

 

Key Dates

 

Earliest Anticipated Start Date(s): July31, 2008

Additional Information to Be Available Date: none

Due Date for E.O. 12372

Due no later than 60 days after the application receipt date.

Additional Overview Content

Funding Opportunity Announcement Glossary: FOA Glossary Terminology

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
    1. Research Objectives

Section II. Award Information
    1. Mechanism(s) of Support
    2. Funds Available

Section III. Eligibility Information
    1. Eligible Applicants
        A. Eligible Institutions
        
    2.Cost Sharing or Matching
    3.Other - Special Eligibility Criteria

Section IV. Application and Submission Information
    1. Request Application Information
    2. Content and Form of Application Submission
    3. Submission Dates and Times
        A. Receipt and Review and Anticipated Start Dates
            1. Letter of Intent
        B. Submitting an Application to CDC
        C. Application Processing
    4. Intergovernmental Review
    5. Funding Restrictions
    6. Other Submission Requirements

Section V. Application Review Information
    1. Criteria
    2. Review and Selection Process
        A. Additional Review Criteria
        B. Additional Review Considerations
        C. Sharing Research Data
        D. Sharing Research Resources

3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
    1. Award Notices
    2. Administrative and National Policy Requirements  
        A. Cooperative Agreement

            1. Recipient Rights and Responsibilities
            2. HHS/CDC Responsibilities
            3. Collaborative Responsibilities

    3. Reporting

Section VII. Agency Contact(s)
    1. Scientific/Research Contact(s)
    2. Peer Review Contact(s)
    3. Financial/ Grants Management Contact(s)

    4. General Questions Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

The National Center for Immunization and Respiratory Diseases (NCIRD) of CDC within HHS is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010" and to measuring program performance as stipulated by the Government Performance and Review Act (GPRA).  This FOA addresses “Healthy People 2010” priority area(s) of Immunization and Infectious Diseases and is in alignment with to protect people from vaccine-preventable diseases. For more information, www.healthypeople.gov. and

http://intra-apps.cdc.gov/fmo/

The purpose of this FOA is to seek a cooperative agreement for studies to evaluate the validity of self-reported adult vaccination status in the U.S. for the nine most common adult vaccines (Table 1) among populations for which the vaccine is indicated when collected during either a telephone or in-person large population coverage survey. Knowledge gained from this project will help guide future resources and activities associated with monitoring adult vaccination coverage in the U.S.

To measure the level of performance toward achieving national immunization goals it is necessary to conduct large population-based vaccination coverage surveys in the U.S. in which adults are asked to report their vaccination status. These surveys include the National Health Interview Survey (NHIS), the Behavioral Risk Factor Surveillance System (BRFSS) and the National Immunization Survey—Adult (NIS-Adult).  It is quite feasible to collect a fairly valid vaccination history for young children as they receive a number of vaccinations over a relatively short time and from one or two providers. However, finding a ‘gold standard’ in a nationally representative patient population for testing the accuracy of self-reported adult vaccination status is a major challenge and measurement of national vaccination coverage levels among adults is dependent on collecting self-reported vaccination status. A substantial number of adult vaccination records are scattered and incomplete as vaccinations are done at multiple venues and over a number of years, involving too many providers to recall and contact when conducting large population-based surveys. Several of the vaccines tetanus/diphtheria (Td), pneumococcal polysaccharide vaccine (PPV), hepatitis A (HepA), and hepatitis B (HepB) could have been given 10-15 or more years earlier, so receipt may be particularly difficult to recall. In addition, some respondents may be reluctant to name providers of certain vaccines, e.g., HepB, which might reveal risk behaviors.

The validity of adult self-reported vaccination status may be questionable even for vaccines that have been available for many years such as trivalent inactivated influenza vaccine (TIV), PPV, Td and HepB and is unknown for the newer vaccines: HepA licensed in 1995; live, attenuated influenza vaccine (LAIV) licensed in 2003; tetanus/diphtheria/pertussis (Tdap) licensed in 2005; Zoster (shingles) licensed in May 2006; and human papillomavirus (HPV) licensed in June 2006. In one study, self-reported receipt of adult influenza and pneumococcal vaccinations, when compared to what was found in the medical record, were shown to have high sensitivity (0.97 or higher) but lower specificity for influenza (0.71-0.79) and pneumococcal (0.53-0.64) vaccination.  Another study found even lower specificity for influenza vaccination (0.38) as well as lower sensitivity for pneumococcal vaccination (0.85). Respondent recall rates of past Td vaccination status are likely very low. In one recent small study, only 57% of medical record documented Td vaccinations could be recalled by patients.  The accuracy of self-reported vaccination with hepatitis B vaccine has also been studied and found to be low. The goals of the current project are to do a comprehensive assessment of this issue and in addition describe how validity may vary by age for some sub-groups; the applicant is also encouraged to describe how validity may vary by race/ethnicity for some sub-groups.

NCIRD is soliciting research that will determine the accuracy of adult self-reported vaccination status in the U.S. for several age groups and race/ethnic subgroups for nine recommended vaccines (Table 1).  

The Principal Investigator or one of the co-investigators must have conducted immunization-related research and published the findings in a peer-reviewed journal to carry out the proposed project.   The applicant must demonstrate collaboration with participating organizations as evidenced by letters of support from the participating organizations. All letters of support must be placed in the appendix of the application.

The applicants must address all of the following research objectives in the research plan of the application to be considered for funding. 

1.         Identify one or more large study populations with provider-maintained vaccination histories in electronic medical records that are accurate enough to be used as gold standard vaccination records.

2.         Study the accuracy of adult self-reported vaccination status for each of the nine vaccines TIV, LAIV, PPV, Td, HepB, HepA, Tdap, zoster, and HPV, for three age groups, 18-49, 50-64 and 65+ (All three age groups may not be relevant for each vaccine).

3.         Measure the validity of self-reported vaccination status among the populations for which the vaccine has been recommended by CDC/ Advisory Committee on Immunization Practices (ACIP) http://www.cdc.gov/vaccines/.

NOTE: Study samples of patients with indications for HepB and/or HepA may be identified by selected ICD-9 codes and do not need to be representative of the risk profile of the general high-risk-indicated patient population. The sub-group of vaccinated patients should however, be similar in risk profile to those patients in the sub-group without vaccination.

4.         Measure the validity of self-reported vaccinations among defined populations where off-label use is expected to be prevalent, such as the use of HPV vaccination among women over the age of 26 years, nasal spray of LAIV in persons over the age of 49 years and Tdap vaccination among persons older than 64 years.

5.         Use at a minimum the following measures of validity for each of the vaccines in each of the specified age and racial/ethnic subgroups: sensitivity, specificity, positive predictive value, negative predictive value, percent false positive (1-specificity), percent false negative (1- sensitivity) and net bias.

NOTE: A weighted analysis is necessary to accurately calculate positive and negative predictive values in a study population where the prevalence of vaccination is determined by the sampling criteria instead of the base population.

Research and experimental approaches that are being sought:

1.         Recruit one or more providers or provider practices who have electronic medical records and will have adequate patient populations to produce the needed sample sizes in each of the groups shown in the Table 1, and who will have complete and accurate vaccination histories recorded for each respondent selected to be interviewed.

2.         Determine, using established methods, how many medical records with completed interviews will be needed to achieve all of the accuracy estimates with reasonable precision (+/- 5) in all of the age groups and all of the race/ethnic groups for all of the vaccines indicated above and how many records/potential respondents will be needed for attempted contact in order to gain the targeted final sample sizes. At least 200 completed interviews of patients with a medical record status as vaccinated and at least 200 completed interviews of patients with a medical record status as not vaccinated for each vaccine and each target subgroup as shown in the Table 1 are required.  Vaccines with vaccination prevalence rates near 50% will require greater sample sizes to reach the target precision level.

3.         The applicant should follow the following guidelines as closely as possible:

a) At least 80% of respondents found to be eligible to be interviewed should complete the interview;

b) At least 90% who complete the interviews should give consent to look at their medical records at each of the provider locations reported by the respondent; and

c) At least 90% of those provider records should be abstracted. 

The needed sample size, in number of completed interviews coupled with  provider records abstracted, to gain adequate precision around the accuracy estimates, e.g., no more than +/- 5 points, is at least 200 medical records showing receipt of the vaccination and at least 200 records indicating likely non-receipt of the particular vaccination.  This minimum sample size of 200 vaccinated and 200 not vaccinated (Table 2) would apply to each study sub-population for which measures of accuracy shown above are requested by this FOA (Table 1).  

4.         Develop a study protocol and a questionnaire to be administered by telephone and by mail as indicated to collect standard demographic information as well as vaccination histories and risk status. Both the questions and how they are administered should be as similar as possible to what is done for BRFSS, NHIS and NIS-Adult. Explore interviewing by cell phone and land line phone with mail out as a secondary option, if needed to achieve desired response rates. Include a complete follow-up protocol designed to achieve the response rates listed above as well as a monitoring system to track progress toward these targets in real time that will be used to make any needed course corrections and make and make them soon enough to be effective.

5.         Develop a complete comprehensive detailed work plan with time lines including an analysis plan with process and outcome measures to produce the listed estimates above.

Table 1. Accuracy of self reported vaccination study populations and vaccines

*Applicants are encouraged to obtain estimates of accuracy separately for white non-Hispanics, black non-Hispanics and Hispanics, in addition to estimates for the total population in this age group.

^†Obtain estimates of accuracy only among those for which the vaccine is indicated because of risk or occupation.

^¶Obtain estimates of accuracy only among those receiving Td in 2005 or later.

§Obtain estimates of accuracy only among females.

^oObtain estimates of accuracy of reported off-label use among persons outside the licensed age range.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the U01 activity code.

The HHS/CDC U01 is a cooperative agreement assistance instrument. Under the U01 assistance instrument, the Recipient Organization retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, and with HHS/CDC staff is substantially involved as a partner with the Recipient Organization, as described in Section VI.2.A., "Cooperative Agreement”.

2. Funds Available

The participating Centers, Institutes and Offices (CIO)(s) of  NCIRD intends to commit approximately $500,000 including direct and indirect costs in FY2008 to fund one application. The average award amount will be $500,000 for both direct and indirect costs for the first 12-month budget period.  An applicant may request a project period of up to 2 years. An applicant may request up to $500,000 for the first 12-month budget period. The approximate total project period funded amount is $1,000,000 including direct and indirect costs. The anticipated start date for new awards is July 31, 2008.

All estimated funding amounts are subject to availability of funds.

If an applicant requests a funding amount greater than the ceiling of the award range, HHS/CDC will consider the application non-responsive, and it will not enter into the review process. HHS/CDC will notify the applicant that the application did not meet the submission requirements.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

You may submit an application(s) if your organization has any of the following characteristics:

• Public nonprofit organizations
• Private nonprofit organizations
• Universities
• Colleges
• Research institutions
• Hospitals
• Community-based organizations
• Faith-based organizations
• Federally recognized or state-recognized American Indian/Alaska Native tribal governments
• American Indian/Alaska Native tribally designated organizations
• Alaska Native health corporations
• Urban Indian health organizations
• Tribal epidemiology centers
• State and local governments or their Bona Fide Agents (this includes the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, the Commonwealth of the Northern Marianna Islands, American Samoa, Guam, the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau)
• Political subdivisions of States (in consultation with States)

A Bona Fide Agent is an agency/organization identified by the state as eligible to submit an application under the state eligibility in lieu of a state application.  If you are applying as a bona fide agent of a state or local government, you must provide a letter from the state or local government as documentation of your status.  Attach this documentation behind the first page of your application form or for electronic applications, use a PDF file and attach as “Other Documents” and label as appropriate.

2. Cost Sharing or Matching

 

Cost sharing, matching, and cost participation are not required.

The most current HHS Grants Policy Statement is available at: http://www.hhs.gov/grantsnet/docs/HHSGPS_107.doc

3. Other-Special Eligibility Criteria

If your application is incomplete or non-responsive to the special requirements listed in this section, it will not enter into the review process.

Note: Title 2 of the United States Code Section 1611 states that an organization described in Section 501(c)(4) of the Internal Revenue Code that engages in lobbying activities is not eligible to receive Federal funds constituting an award, grant, or loan.