+-----------+---------+----+----------+---+--------------+---------------+
| # P       |         |    |          | # |              |               |
| roject #: |         |    |          |   |              |               |
|           |         |    |          | N |              |               |
|           |         |    |          | 6 |              |               |
|           |         |    |          | 1 |              |               |
+-----------+---------+----+----------+---+--------------+---------------+
|           |         |    |          | # |              |               |
|           |         |    |          |   |              |               |
|           |         |    |          | ( |              |               |
|           |         |    |          | N |              |               |
|           |         |    |          | V |              |               |
|           |         |    |          | P |              |               |
|           |         |    |          | O |              |               |
|           |         |    |          |   |              |               |
|           |         |    |          | u |              |               |
|           |         |    |          | s |              |               |
|           |         |    |          | e |              |               |
|           |         |    |          | ) |              |               |
+-----------+---------+----+----------+---+--------------+---------------+
| ##        |         |    |          |   |              |               |
| Unmet Nee |         |    |          |   |              |               |
| ds FY '04 |         |    |          |   |              |               |
|           |         |    |          |   |              |               |
| **NEW     |         |    |          |   |              |               |
| P         |         |    |          |   |              |               |
| ROPOSAL** |         |    |          |   |              |               |
|           |         |    |          |   |              |               |
| #         |         |    |          |   |              |               |
| ### Appli |         |    |          |   |              |               |
| cation fo |         |    |          |   |              |               |
| r Funding |         |    |          |   |              |               |
+-----------+---------+----+----------+---+--------------+---------------+
| **Title   | Ass     |    |          |   |              |               |
| of        | essment |    |          |   |              |               |
| Pr        | of      |    |          |   |              |               |
| oposal:** | In      |    |          |   |              |               |
|           | fluenza |    |          |   |              |               |
|           | Vaccine |    |          |   |              |               |
|           | Effect  |    |          |   |              |               |
|           | iveness |    |          |   |              |               |
|           | and     |    |          |   |              |               |
|           | Impact  |    |          |   |              |               |
|           | among   |    |          |   |              |               |
|           | Young   |    |          |   |              |               |
|           | C       |    |          |   |              |               |
|           | hildren |    |          |   |              |               |
|           | in      |    |          |   |              |               |
|           | Three   |    |          |   |              |               |
|           | Comm    |    |          |   |              |               |
|           | unities |    |          |   |              |               |
+-----------+---------+----+----------+---+--------------+---------------+
| **        |         | Ma |          |   |              |               |
| Principal |         | ri |          |   |              |               |
| Inve      |         | ka |          |   |              |               |
| stigator\ |         | K. |          |   |              |               |
| (Name,    |         | Iw |          |   |              |               |
| Agency,   |         | an |          |   |              |               |
| Email,    |         | e, |          |   |              |               |
| Phon      |         | CD |          |   |              |               |
| e/Fax):** |         | C/ |          |   |              |               |
|           |         | NI |          |   |              |               |
|           |         | P/ |          |   |              |               |
|           |         | ES |          |   |              |               |
|           |         | D, |          |   |              |               |
|           |         | <  |          |   |              |               |
|           |         | mi |          |   |              |               |
|           |         | wa |          |   |              |               |
|           |         | ne |          |   |              |               |
|           |         | @c |          |   |              |               |
|           |         | dc |          |   |              |               |
|           |         | .g |          |   |              |               |
|           |         | ov |          |   |              |               |
|           |         | >, |          |   |              |               |
|           |         | 40 |          |   |              |               |
|           |         | 4- |          |   |              |               |
|           |         | 63 |          |   |              |               |
|           |         | 9- |          |   |              |               |
|           |         | 87 |          |   |              |               |
|           |         | 69 |          |   |              |               |
+-----------+---------+----+----------+---+--------------+---------------+
| **Coll    |         | NV |          |   |              |               |
| aborators |         | SN |          |   |              |               |
| (list     |         | si |          |   |              |               |
| name &    |         | te |          |   |              |               |
| A         |         | in |          |   |              |               |
| gency):** |         | ve |          |   |              |               |
|           |         | st |          |   |              |               |
|           |         | ig |          |   |              |               |
|           |         | at |          |   |              |               |
|           |         | or |          |   |              |               |
|           |         | s: |          |   |              |               |
|           |         | P  |          |   |              |               |
|           |         | et |          |   |              |               |
|           |         | er |          |   |              |               |
|           |         | S  |          |   |              |               |
|           |         | zi |          |   |              |               |
|           |         | la |          |   |              |               |
|           |         | gy |          |   |              |               |
|           |         | i, |          |   |              |               |
|           |         | U  |          |   |              |               |
|           |         | of |          |   |              |               |
|           |         | Ro |          |   |              |               |
|           |         | ch |          |   |              |               |
|           |         | es |          |   |              |               |
|           |         | te |          |   |              |               |
|           |         | r; |          |   |              |               |
|           |         | A  |          |   |              |               |
|           |         | rd |          |   |              |               |
|           |         | yt |          |   |              |               |
|           |         | he |          |   |              |               |
|           |         | Mo |          |   |              |               |
|           |         | rr |          |   |              |               |
|           |         | ow |          |   |              |               |
|           |         | a  |          |   |              |               |
|           |         | nd |          |   |              |               |
|           |         | Ma |          |   |              |               |
|           |         | ry |          |   |              |               |
|           |         | A. |          |   |              |               |
|           |         | St |          |   |              |               |
|           |         | aa |          |   |              |               |
|           |         | t, |          |   |              |               |
|           |         | Ci |          |   |              |               |
|           |         | nc |          |   |              |               |
|           |         | in |          |   |              |               |
|           |         | na |          |   |              |               |
|           |         | ti |          |   |              |               |
|           |         | Ch |          |   |              |               |
|           |         | il |          |   |              |               |
|           |         | dr |          |   |              |               |
|           |         | en |          |   |              |               |
|           |         | 's |          |   |              |               |
|           |         | Ho |          |   |              |               |
|           |         | sp |          |   |              |               |
|           |         | it |          |   |              |               |
|           |         | al |          |   |              |               |
|           |         | M  |          |   |              |               |
|           |         | ed |          |   |              |               |
|           |         | ic |          |   |              |               |
|           |         | al |          |   |              |               |
|           |         | C  |          |   |              |               |
|           |         | en |          |   |              |               |
|           |         | te |          |   |              |               |
|           |         | r; |          |   |              |               |
|           |         | M  |          |   |              |               |
|           |         | ar |          |   |              |               |
|           |         | ie |          |   |              |               |
|           |         | G  |          |   |              |               |
|           |         | ri |          |   |              |               |
|           |         | ff |          |   |              |               |
|           |         | in |          |   |              |               |
|           |         | a  |          |   |              |               |
|           |         | nd |          |   |              |               |
|           |         | K  |          |   |              |               |
|           |         | at |          |   |              |               |
|           |         | hr |          |   |              |               |
|           |         | yn |          |   |              |               |
|           |         | Ed |          |   |              |               |
|           |         | wa |          |   |              |               |
|           |         | rd |          |   |              |               |
|           |         | s, |          |   |              |               |
|           |         | Va |          |   |              |               |
|           |         | nd |          |   |              |               |
|           |         | er |          |   |              |               |
|           |         | bi |          |   |              |               |
|           |         | lt |          |   |              |               |
|           |         | U  |          |   |              |               |
|           |         | ni |          |   |              |               |
|           |         | ve |          |   |              |               |
|           |         | rs |          |   |              |               |
|           |         | it |          |   |              |               |
|           |         | y; |          |   |              |               |
|           |         | K  |          |   |              |               |
|           |         | ei |          |   |              |               |
|           |         | ji |          |   |              |               |
|           |         | F  |          |   |              |               |
|           |         | uk |          |   |              |               |
|           |         | ud |          |   |              |               |
|           |         | a, |          |   |              |               |
|           |         | CD |          |   |              |               |
|           |         | C/ |          |   |              |               |
|           |         | NC |          |   |              |               |
|           |         | ID |          |   |              |               |
|           |         | /I |          |   |              |               |
|           |         | nf |          |   |              |               |
|           |         | lu |          |   |              |               |
|           |         | en |          |   |              |               |
|           |         | za |          |   |              |               |
|           |         | B  |          |   |              |               |
|           |         | ra |          |   |              |               |
|           |         | nc |          |   |              |               |
|           |         | h; |          |   |              |               |
|           |         | N  |          |   |              |               |
|           |         | or |          |   |              |               |
|           |         | ma |          |   |              |               |
|           |         | A  |          |   |              |               |
|           |         | ll |          |   |              |               |
|           |         | re |          |   |              |               |
|           |         | d, |          |   |              |               |
|           |         | CD |          |   |              |               |
|           |         | C/ |          |   |              |               |
|           |         | NI |          |   |              |               |
|           |         | P/ |          |   |              |               |
|           |         | IS |          |   |              |               |
|           |         | D; |          |   |              |               |
|           |         | C  |          |   |              |               |
|           |         | ar |          |   |              |               |
|           |         | ol |          |   |              |               |
|           |         | yn |          |   |              |               |
|           |         | Br |          |   |              |               |
|           |         | id |          |   |              |               |
|           |         | ge |          |   |              |               |
|           |         | s, |          |   |              |               |
|           |         | CD |          |   |              |               |
|           |         | C/ |          |   |              |               |
|           |         | NI |          |   |              |               |
|           |         | P/ |          |   |              |               |
|           |         | ES |          |   |              |               |
|           |         | D/ |          |   |              |               |
|           |         | VV |          |   |              |               |
|           |         | PD |          |   |              |               |
|           |         | B. |          |   |              |               |
+-----------+---------+----+----------+---+--------------+---------------+
| **Lead    |         | C  |          |   |              |               |
| Org       |         | DC |          |   |              |               |
| anization |         | /N |          |   |              |               |
| (Agency   |         | IP |          |   |              |               |
| /Center/D |         | /E |          |   |              |               |
| ivision/B |         | SD |          |   |              |               |
| ranch):** |         | /V |          |   |              |               |
|           |         | VP |          |   |              |               |
|           |         | DB |          |   |              |               |
+-----------+---------+----+----------+---+--------------+---------------+
|           |         |    |          |   |              |               |
+-----------+---------+----+----------+---+--------------+---------------+
|           |         |    |          |   |              |               |
+-----------+---------+----+----------+---+--------------+---------------+

+--------+-------------------------------------------------------------+
| *      | The proposed study provides a unique opportunity to assess  |
| *Abstr | the effectiveness and impact of influenza vaccination among |
| act:** | young children in 3 large U.S. counties,                    |
|        |                                                             |
|        | under the ACIP encouragement and possibly a full            |
|        | recommendation to vaccinate all 6-23 month old children and |
|        | close contacts of those aged \<2 years. Influenza vaccine   |
|        | efficacy/effectiveness (VE) studies in this age group are   |
|        | very limited and some data suggests lower effectiveness and |
|        | immunogenicity among \<2 year olds versus older children.   |
|        | Even less data are available to assess VE among children    |
|        | with asthma. The proposed study is designed to help fill    |
|        | this gap. We plan to evaluate influenza VE against          |
|        | influenza-associated hospitalizations, emergency department |
|        | (ED) and outpatient clinic visits in community practices    |
|        | with a case-cohort study design during the 2003-04 and      |
|        | 2004-05 influenza seasons for children aged 6-23 months,    |
|        | and those 2-\<5 years old with underlying asthma/high risk  |
|        | conditions.                                                 |
|        |                                                             |
|        | The project will be conducted by the New Vaccine            |
|        | Surveillance Network (NVSN) in 3 counties that include the  |
|        | cities of Rochester NY, Nashville TN, and Cincinnati OH.    |
|        | NVSN will identify lab-confirmed influenza cases though a   |
|        | separately funded multi-year population-based surveillance  |
|        | for hospitalizations, ED visits, and outpatient visits in   |
|        | selected community practices due to respiratory viruses in  |
|        | children aged 0-\<5 years.                                  |
|        |                                                             |
|        | This proposal will estimate influenza vaccination coverage  |
|        | and identify factors associated with coverage in two        |
|        | community cohorts, which will be used to assess VE in       |
|        | children 6-23 months and those 2-\<5 year olds with         |
|        | asthma/high risk conditions. The coverage in these cohorts  |
|        | will be evaluated in relation to the comparable inpatient   |
|        | cases and ED cases. The outpatient cases from selected      |
|        | practices will be evaluated in relation to a comparable     |
|        | cohort from those practices.                                |
|        |                                                             |
|        | -                                                           |
|        | -                                                           |
|        |                                                             |
|        | (1)                                                         |
|        | (2)                                                         |
|        | (3)                                                         |
|        | (4)                                                         |
|        |                                                             |
|        | ```{=html}                                                  |
|        | <!-- -->                                                    |
|        | ```                                                         |
|        | 1.  Influenza vaccine coverage will be accurately assessed  |
|        |     to determine childhood immunization rates at the county |
|        |     level based on chart reviews at primary care practices. |
|        |     All primary care practices that serve children will be  |
|        |     approached, and medical chart reviews conducted equal   |
|        |     to 1250 representative children/community (with         |
|        |     additional sampling to obtain 200 comparison            |
|        |     children/community from the outpatient practices) over  |
|        |     2 seasons to assess vaccination coverage. Immunization  |
|        |     data will be obtained from community practices and      |
|        |     supplemented with information in EDs and immunization   |
|        |     registries. Data will be combined across all practices  |
|        |     and sites (for children using multiple sites) to        |
|        |     determine community coverage rates. Practice            |
|        |     descriptors will be obtained including demographics and |
|        |     approaches to vaccination.                              |
+--------+-------------------------------------------------------------+
| **Sp   | -   To assess influenza VE using a case-cohort design in    |
| ecific |     reducing influenza-related: a) hospitalizations; b) ED  |
| a      |     visits; c) outpatient visits in community practices.    |
| ims:** |                                                             |
|        | -   To determine influenza vaccine coverage levels among    |
|        |     children aged 6-23 months and those 2-\<5 years with    |
|        |     asthma and other high risk conditions                   |
|        |                                                             |
|        | -                                                           |
|        |                                                             |
|        | -                                                           |
|        |                                                             |
|        | -   To assess the association between physician vaccination |
|        |     practices/strategies and influenza vaccine coverage     |
|        |     levels. To assess physician practices regarding         |
|        |     influenza immunization, and the association between     |
|        |     physician use of strategies to improve influenza        |
|        |     vaccinations to actual influenza coverage levels        |
|        |                                                             |
|        | ```{=html}                                                  |
|        | <!-- -->                                                    |
|        | ```                                                         |
|        | -                                                           |
|        | -                                                           |
|        | -                                                           |
+--------+-------------------------------------------------------------+

+-----------+----------------------------------------------------------+
| **Back    | [Vaccine effectiveness:]{.underline} ACIP has encouraged |
| ground:** | influenza vaccination of healthy children aged 6-23      |
|           | months when feasible, in addition to the existing        |
|           | recommendation to vaccinate children with underlying     |
|           | chronic conditions. ACIP is considering a full           |
|           | recommendation for the age group. Despite this, only 1   |
|           | study targeted this age group and showed 66% efficacy    |
|           | against influenza in 1 of 2 years, did not demonstrate   |
|           | efficacy against acute otitis media, and was not powered |
|           | to detect efficacy against medically attended visits in  |
|           | inpatients or outpatients. (Hoberman et al, 2003) Other  |
|           | studies have been underpowered to look at any outcome in |
|           | this age group although some suggest a decrease in       |
|           | clinical effectiveness and immunogenicity with younger   |
|           | age. Additional data are needed to evaluate the          |
|           | encouragement to vaccinate 6-23 month old children. A    |
|           | randomized clinical trial is unlikely to be conducted    |
|           | with the inactivated vaccine. Laboratory confirmation of |
|           | influenza is particularly important in children because  |
|           | of co-circulation of other pathogens causing similar     |
|           | illness, and because less specific outcomes are unlikely |
|           | to accurately assess vaccine benefit.                    |
|           |                                                          |
|           | The NVSN currently conducts active population-based      |
|           | surveillance for hospitalizations due to influenza, and  |
|           | active surveillance for influenza-related outpatient     |
|           | visits in the EDs and selected community practices. This |
|           | study would permit the NVSN to also accurately determine |
|           | influenza vaccination coverage in all 3 communities, and |
|           | in the practices where active disease surveillance is    |
|           | conducted. Using case-cohort techniques, we can then     |
|           | estimate influenza vaccine effectiveness within these    |
|           | communities in reducing hospitalizations, ED visits,     |
|           | and, within community practices, outpatient visits due   |
|           | to laboratory-confirmed influenza.                       |
|           |                                                          |
|           | [Coverage Levels]{.underline}: The "gold standard" means |
|           | to assess coverage levels is medical chart review at all |
|           | participating sites of care. The methods involve medical |
|           | chart reviews at primary care practices for a            |
|           | representative clustered random sample of children from  |
|           | specific birth cohorts, merging of data across practices |
|           | (for children who use multiple sites), and appropriate   |
|           | adjustment for the sampling design. Rochester and        |
|           | Nashville sites have successfully applied these methods  |
|           | in the past. Influenza vaccination rates have been about |
|           | 10-30% among high-risk children for whom vaccine is      |
|           | recommended. At least one of the NVSN sites reports      |
|           | increased vaccination rates among healthy children under |
|           | the ACIP encouragement to vaccinate all 6-23 month old   |
|           | children. Uptake may increase with VFC-coverage, which   |
|           | began in 2003, and if ACIP strengthens its encouragement |
|           | by making a full recommendation.                         |
|           |                                                          |
|           | Little is known about the relationship between influenza |
|           | coverage levels in entire communities and practice       |
|           | characteristics such as patient demographics or          |
|           | approaches to vaccination (e.g., reminder systems,       |
|           | audit/feedback, standing orders, encouraging vaccination |
|           | of parents, siblings, other caretakers). Some of these   |
|           | data will provide covariate measures for analyzing       |
|           | vaccine effectiveness. Understanding these factors may   |
|           | also improve vaccination coverage for both the 6-23      |
|           | month age group and for children with underlying         |
|           | conditions.                                              |
+-----------+----------------------------------------------------------+
| **Study   | This proposal will obtain vaccination coverage and       |
| desig     | practice information needed to evaluate influenza        |
| n/Plan:** | vaccine effectiveness.                                   |
|           |                                                          |
|           | [Setting:]{.underline} 3 NVSN sites: counties that       |
|           | include Rochester NY (11,000 births/yr), Nashville TN    |
|           | (8,000 births/yr), and Cincinnati OH (12,000 births/yr). |
|           |                                                          |
|           | ***[Assess Influenza Vaccination Effectiveness Using     |
|           | Case-Cohort Design]{.underline}***                       |
|           |                                                          |
|           | ####### VE will be                                       |
|           |  estimated by the case-cohort method, which compares vac |
|           | cination rates between inpatient cases and the community |
|           |  cohort, ED cases and the same community cohort, and out |
|           | patient cases with a cohort from the selected practices  |
|           | across the 3 sites participating in active influenza sur |
|           | veillance. The community cohort can include both cases a |
|           | nd non-cases (i.e., VE based on estimate of relative ris |
|           | k, %VE100x\[1-rel risk\]). Through another protocol, NVS |
|           | N will enroll a sample of inpatients, ED, and outpatient |
|           |  visits (in selected practices) and test for influenza b |
|           | y PCR (plus culture for inpatients). Vaccination will be |
|           |  verified by chart review. The community ('cohort') cove |
|           | rage levels will be assessed as described below. In a ty |
|           | pical influenza season, we estimate about 90 inpatients  |
|           | aged 0-\<5 years with influenza would be enrolled at the |
|           |  3 sites, half of which are expected to be 6-23 months o |
|           | ld. This provides \>80% power to detect 60% VE (=0.05, 2 |
|           | -sided) assuming a vaccination rate of 20% for the combi |
|           | ned sites over 2 years for each of the inpatient, ED, an |
|           | d outpatient case-cohort comparisons. Very conservativel |
|           | y, even with mild influenza seasons and half the number  |
|           | of influenza cases, the NVSN would have \>80% power to d |
|           | etect 60% VE for the ED and outpatient case-cohort compa |
|           | risons, and 80% power to detect 80% VE for the inpatient |
|           |  case-cohort comparison over 2 years. Assumptions regard |
|           | ing sample size for the 6-23 month olds and 2-\<5 year o |
|           | ld high risk cases and cohorts are similar. The cohort s |
|           | ample size per community over 2 years is 750 for the 6-2 |
|           | 3 month olds, and 500 for the 2-\<5 yr olds, plus an out |
|           | patient cohort of 200. The sample size accounts for pote |
|           | ntial practice-level clustering and covariates in regres |
|           | sion models. It allows for stratification by risk group  |
|           | or study year if there are a sufficient number of cases. |
|           |                                                          |
|           | ***Influenza Coverage Levels*** ***in the Communities*** |
|           |                                                          |
|           | [Sites]{.underline}: All primary care practices from     |
|           | each community that agree to participate.                |
|           |                                                          |
|           | [Subjects]{.underline}*:* 2 age strata: 6-23 months, and |
|           | those 2-\<5 years with chronic conditions (mostly        |
|           | asthma). A representative set of charts will be selected |
|           | to meet required sample sizes. For 2-\<5 yr olds, an     |
|           | initial chart review will identify children with chronic |
|           | conditions. Cohorts will be sampled from each of 2 study |
|           | years to assess coverage. We will review 1450            |
|           | charts/community (4350 total for 2 years). The           |
|           | half-width of the 95% CI is expected to be 3-5% for      |
|           | 10-20% estimated coverage.                               |
|           |                                                          |
|           | [Data]{.underline} [collection]{.underline}: Chart       |
|           | reviews will be standardized to assess patient           |
|           | demographics, chronic conditions, and dates of receipt   |
|           | of vaccinations. Data for patients from multiple         |
|           | practices, ED, and immunization registries will be       |
|           | merged.                                                  |
|           |                                                          |
|           | Assess Practice Characteristics and Approaches to        |
|           | Influenza Immunization                                   |
|           |                                                          |
|           | ########                                                 |
|           |                                                          |
|           | ######## Primary care practices in the counties wil      |
|           | l be asked about practice characteristics and influenza  |
|           | vaccination strategies/practices. Analyses will evaluate |
|           |  the association between these data and coverage levels. |
+-----------+----------------------------------------------------------+

+-------------+------------------+------------------+------------------+
| **Unmet     |                  |                  |                  |
| Needs**     |                  |                  |                  |
|             |                  |                  |                  |
| ###         |                  |                  |                  |
| # NEW Budge |                  |                  |                  |
| t Worksheet |                  |                  |                  |
|             |                  |                  |                  |
| **FY 2004** |                  |                  |                  |
+-------------+------------------+------------------+------------------+
|             |                  | **Year 1 (FY     | **Year 2 (FY     |
|             |                  | 2004)**          | 2005)**          |
+-------------+------------------+------------------+------------------+
| *           |                  | \$230,546        | \$261,554        |
| *Personnel: |                  |                  |                  |
| (Contra     |                  |                  |                  |
| ctor/FTE)** |                  |                  |                  |
+-------------+------------------+------------------+------------------+
| **          |                  | \$3,000          | \$3,500          |
| Supplies:** |                  |                  |                  |
| (items      |                  |                  |                  |
| needed to   |                  |                  |                  |
| implement   |                  |                  |                  |
| proposal)   |                  |                  |                  |
+-------------+------------------+------------------+------------------+
| **Travel:** |                  | \$3,700          | \$6,600          |
| (Travel     |                  |                  |                  |
| will not be |                  |                  |                  |
| supported   |                  |                  |                  |
| unless it   |                  |                  |                  |
| is central  |                  |                  |                  |
| to the      |                  |                  |                  |
| conduct of  |                  |                  |                  |
| the         |                  |                  |                  |
| proposal,   |                  |                  |                  |
| ju          |                  |                  |                  |
| stification |                  |                  |                  |
| required)   |                  |                  |                  |
+-------------+------------------+------------------+------------------+
| **E         |                  | \$2,000          | \$0              |
| quipment:** |                  |                  |                  |
| (must be    |                  |                  |                  |
| justified)  |                  |                  |                  |
+-------------+------------------+------------------+------------------+
| **          |                  | \$0              | \$0              |
| Printing:** |                  |                  |                  |
+-------------+------------------+------------------+------------------+
| **Overhead  |                  | \$131,488        | \$150,334        |
| amount      |                  |                  |                  |
| (extramural |                  |                  |                  |
| only):**    |                  |                  |                  |
+-------------+------------------+------------------+------------------+
| **Other:**  |                  | \$12,000         | \$14,120         |
+-------------+------------------+------------------+------------------+
| **Total     |                  | \$382,734        | \$436,108        |
| Funds       |                  |                  |                  |
| R           |                  |                  |                  |
| equested:** |                  |                  |                  |
+-------------+------------------+------------------+------------------+
|             |                  |                  |                  |
+-------------+------------------+------------------+------------------+
| **Justific  | The budget       |                  |                  |
| ation(s):** | includes:        |                  |                  |
|             | partial salary   |                  |                  |
|             | for PIs,         |                  |                  |
|             | c                |                  |                  |
|             | o-investigators, |                  |                  |
|             | nurse            |                  |                  |
|             | coordinators,    |                  |                  |
|             | field staff for  |                  |                  |
|             | data collection, |                  |                  |
|             | data             |                  |                  |
|             | managers/data    |                  |                  |
|             | entry staff,     |                  |                  |
|             | administrative   |                  |                  |
|             | support, and     |                  |                  |
|             | statisticians;   |                  |                  |
|             | local travel to  |                  |                  |
|             | hospitals and    |                  |                  |
|             | practice         |                  |                  |
|             | settings, and    |                  |                  |
|             | travel to a      |                  |                  |
|             | study group      |                  |                  |
|             | meeting at one   |                  |                  |
|             | of the sites or  |                  |                  |
|             | Atlanta;         |                  |                  |
|             | supplies         |                  |                  |
|             | (including       |                  |                  |
|             | office and data  |                  |                  |
|             | collection       |                  |                  |
|             | supplies);       |                  |                  |
|             | equipment (a     |                  |                  |
|             | laptop computer  |                  |                  |
|             | at one site for  |                  |                  |
|             | data             |                  |                  |
|             | collection),     |                  |                  |
|             | other costs      |                  |                  |
|             | (compensation to |                  |                  |
|             | provider         |                  |                  |
|             | practices for    |                  |                  |
|             | their effort to  |                  |                  |
|             | pull medical     |                  |                  |
|             | charts for       |                  |                  |
|             | review).         |                  |                  |
+-------------+------------------+------------------+------------------+
| **Total     |                  | \$251,246        | 285,774          |
| Funds       |                  |                  |                  |
| Requested   |                  |                  |                  |
| from        |                  |                  |                  |
| NVPO:**     |                  |                  |                  |
+-------------+------------------+------------------+------------------+
| **Total     |                  | \$131,488        | 150,334          |
| Amount to   |                  |                  |                  |
| be Provided |                  |                  |                  |
| from Other  |                  |                  |                  |
| Sources     |                  |                  |                  |
| (please     |                  |                  |                  |
| list        |                  |                  |                  |
| sour        |                  |                  |                  |
| ces/contact |                  |                  |                  |
| info        |                  |                  |                  |
| rmation):** |                  |                  |                  |
| **C         |                  |                  |                  |
| DC/NIP/ESD, |                  |                  |                  |
| Laurie      |                  |                  |                  |
| Johnson,    |                  |                  |                  |
| Division    |                  |                  |                  |
| Deputy      |                  |                  |                  |
| Director,** |                  |                  |                  |
| **40        |                  |                  |                  |
| 4-639-8772, |                  |                  |                  |
| laj         |                  |                  |                  |
| 1@cdc.gov** |                  |                  |                  |
+-------------+------------------+------------------+------------------+
| **Grand     |                  | \$382,734        | \$436,108        |
| Total:**    |                  |                  |                  |
|             |                  |                  |                  |
| **(NVPO and |                  |                  |                  |
| NON-NVPO    |                  |                  |                  |
| Funds)**    |                  |                  |                  |
+-------------+------------------+------------------+------------------+