This announcement has been amended to extend the deadline to Wednesday August 15, 2007. Please make note of this change.
All amendments are marked by red font.
Billing Code: 4163-18-P
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Immunization Grants and Vaccines for Children Program
Announcement Type: Competing Continuation
Opportunity Number: CDC-RFA-IP08-803
Catalog of Federal Domestic Assistance Number: 93.268
Application Deadline: August 15, 2007
Authority: This program is authorized under section 317 of the Public Health Service Act, [42 U.S.C. section 247b], as amended.
The Vaccines for Children (VFC) program is authorized under Section 1902(a)(62) of the Social Security Act, 42 U.S.C. section 1396a(a)(62). The VFC Program was established under the authority of Section 1928(a) of the Social Security Act, 42 U.S.C. 1396s(a).
Purpose: The purpose of this grant program is to support efforts to plan, develop, and maintain a public health infrastructure that helps assure high immunization coverage levels and low incidence of vaccine-preventable diseases. As a part of this effort, the purpose of the VFC program is to increase access to vaccines for eligible children by supplying federal government-purchased pediatric vaccines to public and private health care providers registered with the program. Eligible children include newborns through 18 years of age who are Medicaid-eligible, not insured, American Indian/Alaska Natives, and children who are uninsured with respect to the vaccine and who are served by a Federally Qualified Health Center or a Rural Health Clinic.
This program addresses the “Healthy People 2010” focus area of immunization:
Increase the proportion of young children who receive all vaccines that have been recommended for universal administration for at least five years.
Increase the proportion of providers who have measured the vaccination coverage levels among children in their practice population within the past two years.
Increase the proportion of children who participate in fully operational population-based immunization registries.
Increase routine vaccination coverage levels of adolescents.
Increase hepatitis B vaccine coverage among high-risk groups.
Measurable outcomes of the program will be in alignment with the following performance goal for the National Center for Immunization and Respiratory Diseases:
Ensure that two-year olds are appropriately vaccinated.
Increase the proportion of adults who are vaccinated annually against influenza and ever vaccinated against pneumococcal disease.
This announcement is only for non-research activities supported by CDC. If research is proposed, the application will not be reviewed. For the definition of research, please see the CDC Web site at the following Internet address:
Program Requirements:
The Program Requirements are as follows:
Vaccine Accountability and Management
Maintain, implement and submit to CDC written vaccine accountability policies, procedures and protocols that include formal policies on fraud and abuse and assuring that VFC vaccine is administered only to VFC-eligible children. Policies, procedures and protocols should be reviewed regularly, updated as needed and updated policies should be submitted to CDC.
Conduct site visits in public and private VFC provider settings to assure vaccine accountability and appropriate vaccine storage and handling at the provider level.
Collect data sufficient to accurately account for all publicly purchased vaccine; monitor this information using standardized protocols to assure that provider vaccine orders are appropriate, to determine the amount of vaccine lost or wasted, to provide technical assistance to providers when problems are identified, and to implement corrective action plans as needed.
After transition to centralized distribution assure appropriate apportionment of VFC vaccine purchases based on VFC-eligible population for direct-shipped vaccines..
Adhere to VFC requirements for vaccine storage and handling and vaccine incident and wastage reporting.
Return wasted vaccine for a refund of the federal excise tax following procedures outlined at the following website: http://www.cdc.gov/nip/vfc/st_immz_proj/forms/excise_tax_credit.htm
Perinatal Hepatitis B Prevention
Establish a mechanism to identify all HBsAg-positive pregnant women.
Conduct case management of all identified infants at risk of acquiring perinatal hepatitis B infection which includes:
a. Administration of appropriate immunoprophylaxis to all infants born to HBsAg-positive women [including hepatitis B immune globulin (HBIG), hepatitis B vaccine birth dose, and complete vaccine series].
b. Completion of post-vaccination serologic testing of all infants born to HBsAg-positive women and reporting of all HBsAg-positive infants to CDC through the National Notifiable Disease Surveillance System (NNDSS).
Evaluate completeness of identification of HBsAg-positive pregnant women, case management, reporting of HBsAg-positive infants, and appropriate care of infants born to HBsAg-unknown status mothers based on the methodology provided in Managing a Perinatal Hepatitis B Prevention Program-A Guide to Life as a Program Coordinator and found at http://www.cdc.gov/ncidod/diseases/hepatitis/resource/perinatalhepB.htm
Develop and examine feasibility to implement a state plan to put into practice a universal reporting mechanism with documentation of maternal HBsAg test results for all births.
Work with hospitals to achieve universal birth dose coverage and documentation of the birth dose in an immunization information system (IIS) that complies with the National Vaccine Advisory Committee’s functional recommendations/standards of operation.
Provider Quality Assurance
1. Demonstrate achievement of the Level I Assessment/Feedback/Incentives/eXchange (AFIX) Standards by December 31, 2008.
2. Develop a methodology to use the IIS to assess immunization coverage levels.
Immunization Information Systems (IIS)
Strive to achieve the program goal of enrolling at least 95 percent of children under six years of age in a fully operational grantee IIS.
Produce an annual detailed report that documents how each immunization program component demonstrates the grantee IIS data use to support immunization program activities. At a minimum, the report should describe the use of IIS data to identify areas where immunization coverage is low, assess immunization practices and coverage status, document IIS vaccination histories used to assist with the investigation of vaccine-preventable disease, describe IIS data caveats such as participation rate limitations, document number of children one dose away from being up to date, use of vaccine inventory and control data, and number of AFIX assessments done with IIS data.
Conduct an evaluation of the grantee immunization information systems’ operations and subject data to an independent objective analysis (e.g. review of grantee IIS operations and data by third party assessments to certify readiness, evaluate selected measures of data quality, or use of the data in a regional or national analysis.)
Update and implement a business plan for the grantee IIS.
Implement and maintain the grantee immunization information systems in accordance with the National Vaccine Advisory Committee functional recommendation/standards of operation. (NVAC reports are published at http://www.hhs.gov/nvpo/nvac/reports.html)
Population Assessment
Identify and monitor groups of under-immunized children, adolescents and adults at higher risk for vaccine-preventable diseases using immunization coverage estimates (e.g., the National Immunization Survey (NIS), retrospective analysis of school immunization surveys, provider coverage assessments, immunization information system data, Medicare billing data, Behavioral Risk Factor Surveillance System (BRFSS) and cluster surveys).
Use a CDC-approved sample survey methodology to annually estimate program-wide immunization coverage and exemption rates among children entering kindergarten; report data and assessment methods to CDC annually by April 30. These data will be used to monitor progress toward Healthy People objective 14.23, and will be available annually on CDC's website and published periodically in the MMWR.
Monitor changes to state immunization requirements for child care centers and schools. Include updated information on state immunization requirements as part of the annual report to CDC on school data and assessment methods. This information will be available annually on CDC's website and published periodically.
Epidemiology and Surveillance
1. Implement and maintain surveillance systems to investigate and document cases and outbreaks of vaccine-preventable diseases (VPDs) in accordance with CDC’s “Manual for Surveillance of Vaccine-Preventable Diseases.” http://www.cdc.gov/nip/publications/surv-manual/default.htm
2. For routine reporting, collaborate with appropriate staff to submit timely and complete electronic case/death reports to CDC for cases of VPDs designated as reportable by the Council of State and Territorial Epidemiologists (CSTE) http://www.cdc.gov/epo/dphsi/nndsshis.htm, including cases as described in the case confirmation status print criteria approved by CSTE http://www.cdc.gov/epo/dphsi/phs/infdis.htm, applying guidance as provided in the “Manual for Surveillance of Vaccine-Preventable Diseases.” http://www.cdc.gov/nip/publications/surv-manual/default.htm Outbreaks may require additional reporting elements as deemed necessary by CDC.
Evaluate timeliness and completeness of case/death investigation and reporting, in accordance with CDC’s “Manual for Surveillance of Vaccine-Preventable Diseases.” http://www.cdc.gov/nip/publications/surv-manual/default.htm
4. Coordinate reporting and monitor the Vaccine Adverse Event Reporting System mandated by the National Childhood Vaccine Injury Act of 1986. The Vaccine Adverse Event Reporting System (VAERS) web site now accepts adverse event reports in an encrypted and secure electronic transmission format and can be found at www.vaers.hhs.gov
5. Follow up on all reports of serious adverse events received by the state agency (e.g. death, life-threatening illness, hospitalization and permanent disability) following immunization.
Adolescent Immunization
1. Work with partners to support the establishment of the adolescent platform for
adolescent immunizations.
2. Provide, with guidance from CDC, information regarding the VFC program to
appropriate medical providers and institutions that provide care for adolescents.
3. Identify juvenile correctional facilities and/or social services agencies serving adolescent
populations, and foster partnerships to promote increased coverage for recommended
vaccines.
Adult Immunization
Work with partners (e.g., Quality Improvement Organizations, medical professional societies, hospital infection control nurses) to promote the adoption of evidence-based approaches to increasing vaccination such as the use of immunization information systems (IIS) for client and provider reminder/recall; standing orders; and assessment/feedback in settings including hospitals, long term care facilities, and outpatient clinical settings.
Work with partners (e.g., Joint Commission on Accreditation of Healthcare Organizations) to increase influenza vaccination of healthcare workers.
As 317 funds permit, increase access to vaccines for high risk adults.
Information, Education, Training, and Partnerships
Provide orientation for grantee immunization staff that includes the role of CDC and how it relates to grantee activities.
Distribute Vaccine Information Statements (VIS) and CDC's online instructions for their use to ensure proper use of VIS in accordance with the National Childhood Vaccine Injury Act (section 2126 of the Public Health Service Act, 42 U.S.C. section 300aa-26).
Program Planning and Evaluation
Document the process used by the state health department to meaningfully engage American Indian tribal governments, tribal organizations representing those governments, tribal epidemiology centers, or Alaska Native Villages and Corporations located within their boundaries in immunization activities. Grantees must coordinate immunization program planning and implementation with tribal/638 health clinics , the Indian Health Service, and other entities that provide medical services to American Indian/Alaska Native (AI/AN) populations. This may include the sharing of resources awarded under this grant.
2. All grantees will actively engage in self-evaluation to ensure that their findings guide the program in making necessary changes to more effectively carry out their mission of achieving and sustaining high immunization rates and maximizing programmatic outcomes. CDC will provide feedback on the appropriateness of the proposed framework and focus. In addition, CDC will review proposed evaluation questions, and provide technical assistance, and develop training to increase grantee capacity in program evaluation.
3. As part of the submission of the continuing grant application for 2009, all grantees will be required to submit to CDC an evaluation plan that explains their framework or system for program assessment, defines the methods used for program self-evaluation, and describes how findings will be used to guide the program in making necessary changes to more effectively carry out their mission and maximize programmatic outcomes.
4. As part of the submission of the continuing grant application for 2009, grantees will submit their proposed evaluation focus, and their list of stakeholders. Evaluations should focus on one or more of the nine program components [adolescent immunization, adult immunization, education/training, Immunization Information Systems (IIS), Perinatal hepatitis B, Population assessment, Provider Quality Assurance, Surveillance, and Vaccine Accountability and Management].
5. Annually, thereafter, grantees will submit, as part of the continuation grant application, progress report data supporting progress toward conducting program evaluation activities.
All systems funded through CDC grants, contracts, and cooperative agreements must comply
with the Public Health Information Network (PHIN) standards and specifications. http://www.cdc.gov/phin/overview.html.
Type of Award: Grant
Award Mechanism: H23
Fiscal Year Funds: 2008
II 1. Immunization and Vaccines for Children Grants
Approximate Total Project Period Funding:
317: $959,603,345 (This amount is an estimate, and is subject to availability of funds.) This includes direct and/or indirect costs.
VFC: $350,089,695 (This amount is an estimate, and is subject to availability of funds.)
Approximate Number of Awards: 64
Approximate Average Award:
317: $2,998,760 (This amount is for the first 12-month budget period and includes both direct and indirect costs. This amount is an estimate, and is subject to availability of funds.)
VFC: $1,094,030 (This amount is for the first 12-month budget period and includes both direct and indirect costs. This amount is an estimate, and is subject to availability of funds.)
Floor of Individual Award Range:
317: $111,000
VFC: $0
Ceiling of Individual Award Range:
317: $23,937,000. (This ceiling is for the first 12-month budget period and includes indirect costs.)
VFC: $5,656,276. (This ceiling is for the first 12-month budget period and includes indirect costs.)
Anticipated Award Date: January 1, 2008
Budget Period Length: 12 months
Project Period Length: 5 years
II2. Immunization Information Systems (IIS) Sentinel Site Funding
Funds are available to grantees for development of IIS Sentinel Site Projects. These projects promote the population-based analysis and quality improvement of IIS data for immunization program assessment, evaluation, and to assist in disease surveillance activities. Sentinel sites are smaller geographic areas of the grantee IIS that have most of the children and provider sites in that area participating in the IIS. Vaccination data in the sentinel site area should be comprehensive so as to represent the vaccination practices and patterns of the area represented. Sentinel sites are divided into two categories—“capacity building” or “implementation level”-- based on the level of funding received and size of the sentinel site population. Applicants can apply for either capacity-level funding or implementation funding but not both.
The purpose of the sentinel site project is to:
a. Maintain a population-based active vaccination surveillance system for all administered vaccines in a specific geographic area.
b. Enhance the data quality and scope of the IIS in the surveillance area.
c. Enhance the analytic capacity of the IIS in support of the immunization program for evaluation and epidemiologic activities.
Approximate Current Fiscal Year Funding: $1,400,000
Approximate Total Project Period Funding: $7,000,000. (This amount is an estimate, and is subject to availability of funds.) This includes direct and/or indirect costs.
Approximate Number of Awards: 10
Floor of Individual Award Range: $50,000 (capacity applications)
Ceiling of Individual Award Range: $200,000 (implementation applications) (This ceiling is for the first 12-month budget period and includes indirect costs.)
Anticipated Award Date: January 1, 2008
Budget Period Length: 12 months
1. Project Period Length: 5 years
Throughout the project period, CDC’s commitment to continuation of awards will be based on the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports), and the determination that continued funding is in the best interest of the Federal government.
II 3. Enhancing perinatal hepatitis B case management
Funds are available to grantees to evaluate and enhance perinatal hepatitis B case management.
The purpose of the enhanced perinatal hepatitis B case management is to:
a. Optimize perinatal case management
1. To develop a case management data collection system in collaboration with CDC that includes a comprehensive, expanded set of core data elements useful for both case management and evaluation of case management activities.
2. To implement and use enhanced case management data systems and assess the feasibility of collecting new core data elements.
3. To retrospectively evaluate the effectiveness of participating perinatal hepatitis B prevention/case management programs in vaccinating and providing prophylaxis to infants born to HBsAg-positive mothers as recommended by the Advisory Committee on Immunization Practices to prevent perinatal infections over a 2-year period.
b. Assess completeness of identification of HBsAg-positive pregnant women
1. To evaluate perinatal program success in identifying births to HBsAg-positive women, including women with no prenatal care, quantifying numbers of women with unknown HBsAg status at the time of delivery, using limited medical record reviews (as needed) and laboratory data to validate program records.
2. To develop a mechanism for laboratories to indicate pregnancy status of individuals tested for HBsAg.
3. To evaluate the accuracy and utility of universal reporting mechanisms through cross-checking of these records with perinatal program data, laboratory records, and if needed, a sample of maternal and infant medical records.
c. Optimize secondary prevention activities
Approximate Current Fiscal Year Funding: $500,000
Approximate Total Project Period Funding: $800,000. (This amount is an estimate, and is subject to availability of funds.) This includes direct and/or indirect costs
Approximate Number of Awards: 5
Floor of Individual Award Range: $50,000
Ceiling of Individual Award Range: $100,000 (This ceiling is for the first 12-month budget period and includes indirect costs.)
Anticipated Award Date: January 1, 2008
Budget Period Length: 12 months
Project Period Length: 2 years
Throughout the project period, CDC’s commitment to continuation of awards will be conditioned on the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports), and the determination that continued funding is in the best interest of the Federal government.
Direct Assistance
Applicants may request Federal personnel as Direct Assistance (DA). Grantees may also access Federal contracts for equipment, supplies, and services needed for IIS development by requesting these costs as DA.
III.1. Eligible Applicants for Immunization and Vaccines for Children Grants
Limited Competition
Assistance will be provided only to the current 64 grantees because they have the necessary infrastructure in place to perform the activities required and have the experience needed to successfully complete the required functions. Included among these grantees are the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, the Commonwealth of the Northern Mariana Islands, American Samoa, Guam, the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau. The Federated States of Micronesia, the Republic of Palau and the Republic of the Marshall Islands are not eligible for funding through the VFC Program. Competition is limited to the entities listed above because they have the primary responsibility for carrying out the public health assurance functions required to achieve the desired outcomes and performance goals established by CDC.
III.2 Eligibility for Immunization Information Systems (IIS) Sentinel Sites
To meet the purpose of the IIS sentinel site project, eligibility for this funding opportunity is restricted to applicants described below because they have the minimum levels of data quality and population representation to ensure reliable results that can be used for immunization programmatic decision-making:
Applicants who meet eligibility criteria of Section III.1 who have a population-based (e.g., download of Vital Records birth records or access to birth records from birthing hospitals) IIS in the geographic areas served.
Applicants identifying a sentinel site sub-population of their IIS geographic area for evaluation purposes (i.e., estimating vaccination coverage, intense IIS data quality interventions and assessments) that includes:
i. contiguous census tracts, zip codes, or counties where
ii. at least 85% vaccine provider sites are enrolled in the IIS and
iii. at least 85% of the children <19 years of age are participating in the IIS. Participation is defined as a child having at least two doses of vaccine recorded in the IIS.
iv. At least 70% of the doses administered from this sentinel site area should be submitted to and processed by the IIS within 30 days of vaccine administration.
v. Capacity-level applicants: applicants seeking funding at this level should have at least 20,000 children <19 years of age in their sentinel site area with at least two doses of vaccine recorded in the IIS as well as the criteria listed above in sections i, ii, iii, iv.
vi. Implementation-level applicants: applicants seeking funding at this level should have at least 200,000 children <19 years of age in their sentinel site area with at least two doses of vaccine recorded in the IIS as well as the criteria listed above in sections i, ii, iii, iv.
III 3. Eligibility for enhancing perinatal hepatitis B case management
Eligibility for this funding opportunity is restricted to applicants described in III.1 with perinatal hepatitis B case loads of > 200 identified HBsAg-positive births. Programs with perinatal hepatitis B caseloads of ≥200 identified HBsAg-positive births account for project areas with the highest fraction of births to HBsAg-positive women in the United States.
III.4. Cost Sharing or Matching
Matching funds are not required for this program.
III.5. Other
Special Requirements:
If the application is incomplete or non-responsive to the special requirements listed in this section, it will not be entered into the review process. The applicant will be notified the application did not meet submission requirements.
Late applications will be considered non-responsive. See section “IV.3. Submission Dates and Times” for more information on deadlines.
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 a grant, loan, or an award.
Grantees may purchase federal-contract vaccine with grantee funds either in advance of use or after use. A positive balance results when the grantee purchases in advance of use. When purchasing in advance of use, the grantee will have a “credit” against which they may draw, i.e. there will be no need to replenish in arrears. When purchasing after use, the grantee will have a “debit” which must be satisfied by replenishing vaccines used. CDC will purchase enough 317-funded vaccine to enable grantee-funded purchases after use. Grantees must commit to replenishing in arrears any 317-funded vaccine purchased to cover the grantee-funded portion of vaccine need. The grantee’s 317 budget will be reduced by the amount of the grantee’s replenishment commitment if the commitment is not fulfilled by the grantee.
This grant will require documentation in the application and in progress reports that demonstrates the state health department has meaningfully engaged American Indian tribal governments, tribal organizations representing those governments, tribal epidemiology centers, or Alaska Native Villages and Corporations located within their boundaries in the planning, implementation and evaluation of immunization activities.
IV.1. Address to Request Application Package
To apply for this funding opportunity use application form PHS 5161-1.
Electronic Submission:
CDC requires the applicant to submit the application electronically by utilizing the forms and instructions posted for this announcement on www.Grants.gov, the official Federal agency wide E-grant Web site.
Registering your organization through www.Grants.gov is the first step in submitting applications online. Registration information is located in the “Get Started” screen of www.Grants.gov. While application submission through www.Grants.gov is optional, we strongly encourage you to use this online tool.
Please visit www.Grants.gov at least 30 days prior to filing your application to familiarize yourself with the registration and submission processes. Under “Get Started,” the one-time registration process will take three to five days to complete. We suggest submitting electronic applications prior to the closing date so if difficulties are encountered, you can submit a hard copy of the application prior to the deadline.
If access to the Internet is not available, or if there is difficulty accessing the forms on-line, contact the CDC Procurement and Grants Office Technical Information Management Section (PGO-TIM) staff at 770-488-2700 and the application forms can be mailed.
IV.2. Content and Form of Submission
Application:
A Project Abstract must be submitted with the application forms. The abstract must be submitted in the following format:
Maximum of one page.
Font size: 12 point unreduced, Times New Roman
Single spaced
Paper size: 8.5 by 11 inches
Page margin size: One inch
The Project Abstract must contain a summary of the proposed activity suitable for dissemination to the public. It should be a self-contained description of the project and should contain a statement of objectives and methods to be employed. It should be informative to other persons working in the same or related fields and insofar as possible understandable to a technically literate lay reader. This abstract must not include any proprietary/confidential information.
A project narrative must be submitted with the application forms. The narrative must be submitted in the following format:
Maximum number of pages: 75. If your narrative exceeds the page limit, only the first pages which are within the page limit will be reviewed.
Font size: 12 point unreduced, Times New Roman
Double spaced
Paper size: 8.5 by 11 inches
Page margin size: One inch
Number all pages of the application sequentially from page 1 (Application Face Page) to the end of the application, including charts, figures, tables, and appendices.
The narrative should address activities to be conducted over the entire project period and must include the following items in the order listed.
For each of the requirements listed in Section I of this Announcement and for eligible applicants applying for funds under Enhancing Perinatal Hepatitis B Case Management, provide:
Plan
One or more objectives that address the required activity. Each objective must be specific, measurable, achievable, realistic and one that can be achieved in the funding period. For each objective, provide:
The activities to be undertaken to accomplish each objective
The timeline for reaching each objective
The method of evaluating the success or accomplishment of each objective
A staffing plan that demonstrates an understanding of the labor needed to accomplish each activity. Identify staff members by name and title.
Budget justification (not counted in the 75-page limit); see section IV.5 of this Announcement
Additional information may be included in the application appendices. The appendices will not be counted toward the narrative page limit. This additional information includes:
Organizational Charts
For applicants applying for funding for Immunization Information Sentinel Site funding (Section III.2 of this Announcement), provide:
A project narrative in the following format:
Maximum number of pages: 25. If your narrative exceeds the page limit, only the first pages which are within the page limit will be reviewed.
Font size: 12 point unreduced, Times New Roman
Double spaced
Paper size: 8.5 by 11 inches
Page margin size: One inch
Number all pages of the application sequentially from page 1 (Application Face Page) to the end of the application, including charts, figures, tables, and appendices.
The narrative should address activities to be conducted over the entire project period and must include the following items in the order listed.
Description of the sentinel site population of interest and how this population meets the eligibility criteria for the application.
- Describe the geographic area of the proposed sentinel site and compare this area to the rest of the state (i.e., how well this area represents the vaccination patterns of the IIS geographic area). Provide an estimate of the annual stability/mobility of the sentinel group, the race/ethnicities represented, the percentage that is below the poverty level, what percentage of the population in the sentinel area participates in the IIS (provide estimates for the following age groups: 0-5 years, 6-10 years, 11-12 years, 13-15 years, 16-18 years; provide numerators and denominators) and indicate how percentages were determined. Use the 2005 U.S. Census data for the denominators.
- Provide provider site enrollment numbers for provider sites that are enrolled in the IIS in the sentinel site area. A provider site is a vaccine service delivery location (public or private) that maintains permanent records (excluding temporary or mobile immunization clinics, health fairs, etc.). Well-child and immunization-only clinics in the same location should be counted as separate sites only if each maintains separate sets of vaccination records and separate vaccine inventories. Provide enrollment rates for
§ the public sector,
§ the private sector, and
§ both sectors combined
Provide numerators and denominators and describe how percentages were determined.
Indicate if this sentinel site area coincides with an active/enhanced disease surveillance site (e.g., varicella, pertussis, a children’s hospital, the CDC/NCIRD New Vaccine Surveillance Network) or some other type of external partnership with vaccine-preventable disease surveillance.
- Provide a general overview of the overall IIS, including a list of all data elements in the IIS database (includes elements beyond the National Vaccine Advisory Committee’s (NVAC) core data elements) and whether these fields are optional or required.
One or more objectives that address the three IIS functional standards, evaluation activities, meetings, and publications outlined below. Each objective must be specific, measurable, achievable, realistic and one that can be achieved in the funding period. For each objective provide:
1) The activities to be undertaken to accomplish each objective
2) The timeline for reaching each objective
3) The method of evaluating the success or accomplishment of each objective. Define the process/frequency for monitoring achievement and provide baseline measures where indicated.
4) Identify the staff or agency designee who will be conducting the activities
IIS Functional Standard #1: Electronically store data on all NVAC-approved core data elements (including vaccine lot number and manufacturer).
Definition: Data elements and mechanisms should be in place for populating NVAC-approved core data fields and routinely monitoring how accurately, completely, and frequently the data fields are populated. The NVAC core data elements are: patient name (first, middle, and last); patient birth date; patient sex; patient birth state/country; mother’s name (first, middle, last, and maiden); vaccine type; vaccine manufacturer; vaccination date; and vaccine lot number. Patient race/ethnicity and patient birth order for multiple births are expected to be approved as required NVAC core elements in 2007.
Goal: At least 25% completeness of each NVAC core data element; vaccine lot number and vaccine manufacturer fields should be complete for >50% of immunization records by the end of the project period.
The plan should include creation of NVAC core data elements fields if they do not currently exist and activities to populate these data elements to meet the goal within the project period.
For baseline measures for your data quality improvement plan, review the records as of December 31, 2006, for 100% of the sentinel population of children born from January-March 2006. Historical data may be excluded.[1] Generate a query to confirm the value/percentage of each NVAC core data element or anticipated NVAC required core data element field. Review the fields in the database to ensure that entries do not contain codes for “unknown” or “filler” data (non-relevant data entered to force the computer past a NVAC core data element field). Please refer to the Technical Working Group Immunization Registry Certification Recommendations for this functional standard at the following website for further guidance (and alternative methods) on measuring this goal: http://www.cdc.gov/nip/registry/st_terr/tech/tech.htm#certif.
IIS Functional Standard #4: Receive and process immunization information within one month (30 days) of vaccine administration
Definition: The IIS receives and processes immunization information within 1 month (30 days) of vaccine(s) administration.
Goal: >90% of immunization events are in the IIS within 1 month (30 days) of the immunization event by the end of the project period.
The applicant must describe its plans/processes to accurately measure and calculate this standard (e.g., date stamp record entry into the IIS, flag historical shot records to exclude them from timeliness calculations) and improve their timeliness. Improvements in timeliness can result from provider outreach, improvements to reporting methods, and/or other methods. A baseline measure as of December 31, 2006 must be provided for the sentinel site population that describes the percentage of records received and processed within 30 days, >30 days and ≤ 60 days, and > 60 days of vaccine administration. Logic guidance: For sentinel site children born and vaccinated between January 1, 2006, and December 31, 2006, where vaccine shot date – date vaccine recorded in the IIS= ≤ 30 days, >30 days and ≤ 60 days, and > 60 days.
IIS Functional Standard #12: Promote accuracy and completeness of IIS data.
Definition: The IIS has developed and implemented data quality procedures and can produce a written data quality protocol that addresses the goal below.
Goal: 90% of records/data elements are accurate and complete (without filler/nonsense data); a de-duplication algorithm with a sensitivity score of at least 90% and a specificity score of 100%; <5% data errors at the patient and vaccine level; IIS-derived vaccination coverage estimates fall within the 95% confidence interval of a comparable estimate derived from the National Immunization Survey (NIS) or another source by the end of the project period.
The applicant must provide baseline measures of the 4:3:1:3:3 and 4:3:1:3:3:1 vaccination series for the sentinel site population children 19-35 months of age from the IIS as of May 31, 2007, and compare these results to comparable results according to the most recent NIS or another source (i.e., random chart pull from provider offices in the sentinel site area of 30 charts/site to verify accuracy and completeness of IIS data for this population). The grantee should describe activities that will take place during the project period to minimize the difference between the IIS-derived estimate and the NIS-derived or alternate estimate.
With this application, applicants must also provide baseline measures reporting the percentage of IIS records requiring manual resolution for patient matching (e.g., if an applicant processes 100 records and 60 records automatically load into the database but 40 require human resolution to de-duplicate, the answer would be 40%) and provide results from using the CDC’s de-duplication test cases to measure the accuracy of the applicants de-duplication algorithm. For more information, please refer to (http://www.cdc.gov/nip/registry/st_terr/tech/dedup.htm). Grantees should describe in this element their current data quality procedures and the activities they will conduct in order to meet the goals of this data quality element. Grantees should also describe their current business rules to reduce duplicates at not only the patient level, but also the vaccine level. If business rules do not exist, the grantee should develop business rules or implement the AIRA-MIROW vaccine de-duplication business rules during this project period. Please refer to http://www.immregistries.org/pubs/mirow.phtml.
Activities should also be described to capture seasonal vaccines (e.g., pediatric influenza vaccine), adolescent vaccines, and non-routine vaccines completely by the IIS. These activities could include, but are not limited to, provider education about entering influenza vaccinations into the IIS, recruiting OB/GYN practices, schools, universities, STD clinics, and juvenile detention centers, and travel clinics to become IIS participants.
d) Evaluation activities
Definition: The IIS demonstrates the ability to conduct IIS data analysis and produce complete quarterly and ad-hoc reports by the report deadline. Quarterly reports measure vaccination coverage levels and timeliness measures for the sentinel site population. Ad-hoc reports evaluate the uptake of new vaccines, the uptake of new ACIP recommendations on vaccination practices, vaccine safety issues, and other topics of programmatic interest at the state and/or federal level. De-identified data sets are included in the ad-hoc reporting requirement.
Goal: Reports must be generated by the report deadline (see page 38). All questions will be complete. Sites must describe in the request activities meet this goal and identify staff who will be analyzing the data.
Activities to meet this goal could include, but are not limited to, adding analytic features to the IIS to improve the efficiency of analyzing IIS data, hiring staff or designating contractor time, and developing/improving IIS business rules to account for children who have moved or gone elsewhere (MOGE) in vaccination coverage estimates (for guidance on MOGE business rules, please refer to http://www.immregistries.org/pubs/mirow.phtml). Applicants are encouraged to describe activities that demonstrate the usefulness of IIS data that go beyond vaccination coverage assessment. Activities could include, but are not limited to, activities described in the Programmatic Registry Operations Workgroup Project (PROW) Registry Standards of Excellence (http://www.immregistries.org/about/GET_PROW.phtml) such as use of the IIS with disease surveillance (e.g., outbreaks, vaccine storage and handling errors, partnering with external partners such as active/enhanced disease surveillance sites), linking to other databases and facilities that target special populations (e.g., Indian Health Services, children’s hospitals, schools, juvenile detention centers), and activities for vaccine utilization/accountability ( e.g., vaccine management system, evaluating VFC populations).
e) Meetings, Conferences, and Discussions
Goals: At least one key sentinel site staff will attend a face-to-face sentinel site meeting at annual National Immunization Conferences and participate on conference calls. Sentinel site staff will submit at least one abstract for presentation at a national public health or informatics conference based on an ad-hoc query generated by their public health program for public health decision making. Staff should attend and funds should be designated for travel to conferences that have accepted the submitted abstract.
f) Publications (for applicants at the implementation funding level only)
Recipients of implementation funding should dedicate staff or contractors to write one new article for a peer-reviewed journal based on sentinel site data or recent IIS efforts to demonstrate an important aspect of the use of IIS data for immunization program activities for each budget period. Articles should originate from IIS or immunization program staff or their designees, including data analysis, data interpretation, and manuscript preparation.
3. Budget justification (not counted in the 25 page limit); see section IV.5 of this announcement. Financial Assistance (FA) or Direct Assistance (DA) funds may be allocated.
Additional information submitted via Grants.gov should be labeled clearly with the name of the document or a clear descriptive title when uploaded into Grants.gov.
No more than 5 electronic attachments should be uploaded per application.
The agency or organization is required to have a Dun and Bradstreet Data Universal Numbering System (DUNS) number to apply for a grant or cooperative agreement from the Federal government. The DUNS number is a nine-digit identification number, which uniquely identifies business entities. Obtaining a DUNS number is easy and there is no charge. To obtain a DUNS number, access http://www.dunandbradstreet.com or call 1-866-705-5711.
Additional requirements that may request submittal of additional documentation with the application are listed in section “VI.2. Administrative and National Policy Requirements.”
Application Deadline Date: August 15, 2007
Explanation of Deadlines: Applications must be received in the CDC Procurement and Grants Office by 4:00 p.m. Eastern Time on the deadline date.
Applications must be submitted electronically at www.Grants.gov. Applications completed on-line through Grants.gov are considered formally submitted when the applicant organization’s Authorizing Official electronically submits the application to www.Grants.gov. Electronic applications will be considered as having met the deadline if the application has been submitted electronically by the applicant organization’s Authorizing Official to Grants.gov on or before the deadline date and time.
When the application is submitted electronically through Grants.gov (http://www.grants.gov), the application will be electronically time/date stamped, which will serve as receipt of submission. Applicants will receive an e-mail notice of receipt when HHS/CDC receives the application.
This announcement is the definitive guide on application content, submission address, and deadline. It supersedes information provided in the application instructions. If the application submission does not meet the deadline above, it will not be eligible for review, and will be discarded by HHS/CDC. The applicant will be notified the application did not meet the submission requirements.
IV.4. Intergovernmental Review of Applications
The application is subject to Intergovernmental Review of Federal Programs, as governed by Executive Order (EO) 12372. This order sets up a system for state and local governmental review of proposed federal assistance applications. Contact the state single point of contact (SPOC) as early as possible to alert the SPOC to prospective applications and to receive instructions on the State’s process. Visit the following Web address to get the current SPOC list:
IV.5. Funding Restrictions