[Federal Register Volume 61, Number 90 (Wednesday, May 8, 1996)]
[Notices]
[Pages 20825-20831]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-11443]



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[[Page 20826]]


DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Announcement Number 612]
RIN: 0905-ZA97


Academic Medical Center/Community Health Network Childhood 
Immunization Demonstration Projects; Notice of Availability of Funds 
for Fiscal Year 1996

Introduction

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 1996 funds for cooperative agreement 
demonstration projects to improve the delivery of immunizations to 
preschool children in urban and rural areas. The purposes of this 
program are to (1) increase immunization coverage among children 
receiving care in academic medical centers networks of primary care 
providers and/or in community health networks, (2) improve immunization 
delivery by other providers working in specified Target Communities, 
and (3) develop innovative methods that increase immunization coverage 
among difficult-to-reach children without separating immunizations from 
primary care.
    CDC is committed to achieving the health promotion and disease 
prevention objectives of Healthy People 2000, a national activity to 
reduce morbidity and mortality and improve the quality of life. This 
announcement is related to the priority area of Immunization. (For 
ordering a copy of Healthy People 2000, see the section Where to Obtain 
Additional Information.)

Authority

    This program is authorized under sections 317 (42 U.S.C. 247b) and 
311 (42 U.S.C. 243) of the Public Health Service Act as amended, and 
the National Childhood Vaccine Injury Act (42 U.S.C. 300aa-1, et seq.).

Smoke-Free Workplace

    CDC strongly encourages all grant recipients to provide a smoke-
free workplace and to promote the non-use of all tobacco products, and 
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in 
certain facilities that receive Federal funds in which education, 
library, child care, health care, and early childhood development 
services are provided to children.

Definitions

    Academic Medical Center (AMC)--A medical school, hospital, or 
center that is a participating institution in an accredited residency 
program in pediatrics or family medicine, and that may be part of a 
managed care organization serving Medicaid- eligible children.
    Community Health Network (CHN)--A network of health care providers 
which provides primary health care services to needy children with low 
immunization coverage levels, but which does not necessarily include an 
AMC, as defined above.
    Health Professional Shortage Area (HPSA)--HPSAs are urban and rural 
geographic areas, population groups, and facilities experiencing a 
shortage of health professionals. The current designated HPSAs of 
concern to this project are those relating to primary medical care and 
are identified by the Health Resources and Services Administration, 
Department of Health and Human Services in the Federal Register of 
October 2, 1995 (60 FR 51518).
    Immunization Action Plan (IAP)--An initiative first funded in 1992 
for communities to develop and implement a broad-based plan to achieve 
national immunization coverage goals by involving all interested groups 
concerned with children's health.
    Urban Area--For the purposes of this program, one of the 29 cities 
originally funded, either directly or indirectly, by CDC as an IAP 
area. Their IAP designation was based on a combination of factors 
(i.e., magnitude of population, proportion of racial/ethnic minorities, 
and internal areas or ``pockets'' of chronic low immunization coverage) 
which most clearly corresponds to the intent of this demonstration 
program. In alphabetical order, these cities are Atlanta, Georgia; 
Baltimore, Maryland; Birmingham, Alabama; Boston, Massachusetts; 
Chicago, Illinois; Cleveland, Ohio; Columbus, Ohio; Dallas, Texas; 
Detroit, Michigan; El Paso, Texas; Houston, Texas; Indianapolis, 
Indiana; Jacksonville, Florida; Los Angeles, California; Memphis, 
Tennessee; Miami, Florida; Nashville, Tennessee; Milwaukee, Wisconsin; 
Newark, New Jersey; New Orleans, Louisiana; New York, New York; 
Philadelphia, Pennsylvania; Phoenix, Arizona; San Antonio, Texas; San 
Diego, California; San Jose, California; San Juan, Puerto Rico; 
Seattle, Washington; and Washington D.C.
    Rural Area--For the purposes of this program, a HPSA 
nonmetropolitan area, as specified by HRSA in the Federal Register of 
October 2, 1995. HRSA notes that all HPSA nonmetropolitan areas are 
beyond the boundary of a Metropolitan Statistical Area as established 
by the Office of Management and Budget (OMB Bulletin 95-04 dated June 
30, 1995).
    Target Community--A geographic area (for urban areas having at 
least 100,000 population) which the applicant defines by census tracts, 
and which includes a designated HPSA and any contiguous census tract 
areas to that HPSA in which, as the applicant must establish, a 
majority of residing children <2 years old are from Medicaid-eligible 
families.
    Project Collaborator--A primary health care provider with clinic 
facilities serving Target Community children which joins with the 
applying AMC/CHN at the outset to carry out each task of this 
demonstration project.
    AMC/CHN Primary Care Clinic--A facility managed by, or affiliated 
with, an AMC/CHN, or which is a Project Collaborator's clinic facility, 
and which provides comprehensive primary care (immunizations, other 
preventive care, and acute care) to children in a Target Community.
    AMC Network of Children's Primary Care Providers--A collection of 
geographically disbursed AMC Primary Care Clinics in which all serving 
health care providers work under the facility's standards of care (and 
which does not include private physicians with admitting privileges).
    Clinic Assessment Software Application (CASA)--A software tool from 
the National Immunization Program, CDC, for conducting immunization 
clinic audits. It encompasses a standardized sampling methodology for 
obtaining medical charts for abstractions. Immunization and utilization 
``events'' are recorded in CASA, and CASA calculates various measures 
of immunization status and practice.
    Racial and Ethnic Minority Populations--Groups recognized as racial 
and ethnic minority populations are: African-Americans, Alaska Natives, 
American Indians, Asian Americans, Pacific Islanders, and Latinos/
Hispanics.

Eligible Applicants

    Eligible applicants are Academic Medical Centers/Community Health 
Networks which:
    A. Provide immunization services for children in the context of 
comprehensive primary care.
    B. Have significant experience in delivering health care services 
to underserved children in urban populations, or rural populations.
    C. Are able to effect primary care policy in each of their own AMC/
CHN Primary Care Clinics, plus those of their project collaborators, 
within each designated Target Community.

[[Page 20827]]

    To be considered eligible applicants, AMCs must have an AMC network 
of children's primary care providers, as defined in this program 
announcement. To be considered eligible applicants, Community Health 
Networks also must provide evidence of linkage to an AMC, as defined in 
this program announcement, at least to the extent that an AMC agrees to 
accept responsibility for the clinic-based process and outcome 
evaluation of the CHN's proposed demonstration program.
    Urban area applicants must designate one or more Target Communities 
wherein collectively lives a minimum current annual birth cohort (all 
children born in the same calendar year) of 8,000; and from which the 
applicant currently serves a minimum of 4,000 from that birth cohort in 
its network of AMC/CHN Primary Care Clinics. (NOTE: The headquarters of 
the AMC/CHN, its Project Collaborators, or the project's designated 
AMC/CHN Primary Care Clinics, need not be physically located within the 
Target Community(ies), but the AMC/CHN Primary Care Clinics, 
collectively, must be serving the specified minimum birth cohort from 
the Target Community.)
    Separate applications from an eligible applicant may be accepted 
for review if aspects of one application do not depend on CDC 
supporting any other application. Dependent applications will be 
returned to the applicant without further consideration because CDC 
intends to make only one award to any eligible applicant.

Availability of Funds

    Approximately $5,400,000 is available in FY 1996 to fund 
approximately four cooperative agreements, three in urban areas and one 
in a rural area. Only one urban area award will be made in a State, but 
this will not affect the award of the single rural area cooperative 
agreement. It is expected that the average award will be $1,350,000 per 
year (including direct and indirect costs), ranging from $1,000,000 to 
$1,500,000, with awards being made on or before September 30, 1996. The 
awards will be made for 12-month budget periods within a project period 
of up to 5 years. Funding estimates may vary and are subject to change 
based on the availability of funds.
    Cooperative agreement applications which exceed the $1,500,000 
(including direct and indirect costs) per year will be returned to the 
applicant as non- responsive.
    Continuation awards within the project period will be made on the 
basis of satisfactory progress and the availability of funds.
    At the request of the applicant, Federal personnel with skills in 
immunization program operations may be assigned to a project in lieu of 
a portion of the financial assistance provided for the initial budget 
period(s) of this project.

Use of Funds

Allowable Uses

    Funds should be targeted for implementation, management, and 
evaluation of the project. Funds can support personnel and the purchase 
of modest amounts of hardware and software to (1) create and operate 
systems that track and improve the immunization status of children, (2) 
link with the USDA Special Supplemental Nutrition Program for Women, 
Infants, and Children (WIC), and (3) conduct clinic assessments of 
immunization coverage levels with feedback to the providers. Funds may 
be used to support direct medical care, e.g., new or expanded primary 
care services designed to increase immunization coverage levels, but it 
is expected that this will be limited to the final task of the project. 
Applicants may enter into contractual arrangements for goods or 
services, or to support collaborative activities, but must retain 
direct control of all tasks of the project.

Prohibited Uses

    Cooperative agreement funds through this project cannot be used for 
(1) construction, (2) renovation, (3) the purchase or lease of 
passenger vehicles or vans, or (4) hiring or contracting personnel to 
conduct interventions such as special remote vaccination clinics or 
other vaccination-only activities that promote vaccination outside the 
context of delivering primary medical care, or (5) supplanting any 
current applicant expenditures.

Purpose

    The purpose of these projects is for AMCs/CHNs to demonstrate 
increases in immunization coverage levels (above the baseline percent) 
of at least 25 percentage points in the AMC's/CHN's network of Primary 
Care Clinics, at least 20 percentage points among other Target 
Community health care providers, and at least 15 percentage points in 
the overall population of each Target Community (attainment of the 
latter to be determined by an independent evaluator under contract to 
CDC), over a 5-year period through the use of conventional and 
innovative practices. (A paper summarizing methods for improving 
immunization practices in primary care settings is provided with each 
application kit.) The projects have three specific tasks:
    Task I--the AMC/CHN is to increase immunization coverage among 
children already receiving care in the AMC's/CHN's network of Primary 
Care Clinics. Concurrently, the AMC/CHN is asked to perform a community 
needs assessment to adjust approaches to achieving Task I and to 
prepare for carrying out Tasks II and III.
    Task II--The AMC/CHN is to translate its experience with the 
successful methods used to carry out Task I to other providers of 
children's primary care within the Target Community(ies), resulting in 
measurable changes in immunization practices and measurable 
improvements in the immunization coverage among the children served by 
the other providers.
    Task III--The AMC/CHN is to use innovative or experimental 
methodologies to improve immunization coverage levels in the Target 
Community(ies). Task I focuses on children who receive care in the AMC/
CHN Primary Care Clinics. Task II focuses on children who receive care 
from other Target Community health care providers. Task III requires 
that the successful parts of Tasks I and II, along with any other 
population-based strategies used, have an overall impact on 
immunization coverage for the Target Community(ies).
    Most AMCs/CHNs will initiate these three tasks in sequence, but 
some AMCs/CHNs may be sufficiently advanced to initiate Tasks I and II 
simultaneously. By midway into the project period, most AMCs/CHNs 
probably will be conducting these three tasks concurrently.

Program Requirements

    The following are application requirements:
    A. Is your organization an Academic Medical Center or a Community 
Health Network, as each is defined in this program announcement (if so, 
please specify which)?
    B. Does your AMC/CHN provide comprehensive primary care and 
immunization services?
    C. Does your AMC/CHN have experience in delivering services to 
underserved child populations in the setting (urban area or rural area) 
for which you intend to apply?
    D. Have your AMC/CHN and each of your Project Collaborators been 
providing primary medical care to infants and children for at least the 
past 12 months?
    E. Does your AMC/CHN have the ability to effect primary care policy 
in each of the AMC/CHN Primary care

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clinics in the Target Communities you would propose for this project?
    F. If you are an AMC, does your institution have a network of 
primary care providers for children, as defined in this program 
announcement?
    G. If you are a CHN, do you have linkages with an AMC, as defined 
in this program announcement, at least to the extent that an AMC has 
agreed to accept responsibility for the clinic-based process and 
outcome evaluation of the CHN's proposed demonstration program?
    H.1. If you are applying for an urban area award, do you have at 
least one AMC/CHN Primary Care Clinic serving at least one urban Target 
Community with <gr-thn-eq>100,000 population, as those terms are 
defined in this program announcement?
    H.2. If you are applying for an urban area award, do you have a 
collective current annual birth cohort of at least 8,000 residing in 
your proposed Target Community(ies)?
    H.3. If you are applying for an urban area award, do your AMC/CHN 
Primary Care Clinics serving the population from your proposed Target 
Community(ies) collectively serve a current annual birth cohort of at 
least 4,000?
    H.4. If you are applying for a rural area award, do you have at 
least one AMC/CHN Primary Care Clinic in at least one rural Target 
Community, as those terms are defined in this program announcement?
    I. Do each of the Target Communities you would select for this 
project have at least one additional primary care provider, other than 
an AMC/CHN Primary Care Clinic participating in this project, serving 
children from the Target Community population?
    J. Is there a commitment at the highest levels of your AMC/CHN that 
the project manager, within reasonable limits, will be given sufficient 
direct authority and institutional backing to make those decisions 
necessary to ensure success of the project, even if those decisions may 
affect other domains, such as clinic/provider policies and practices?
    K. Do each of your AMC/CHN Primary Care Clinics in the Target 
Community(ies) have an existing and proven patient information system 
(automated or manual) capable of recording demographic information 
about your enrolled population, and utilization information about 
patient encounters and immunizations administered?
    L. Are you able to identify a populations, preferably within your 
MSA (if applying for an urban area award) or your State (if applying 
for a rural area award), to serve as a control for CDC's population-
based evaluation of your project? (i.e., a population from an area 
which includes a HPSA and which has a racial/ethnic composition and 
Medicaid proportion which approximates (<plus-minus>15 percent for each 
population group and for the Medicaid proportion) their distribution 
when the selected Target Communities are taken as a collective).
    Provide a succinct but informative response to each application 
requirement. Respond with ``N/A'' whenever a requirement does not 
relate to your type of eligible applicant organization (AMC or CHN) or 
the type of award (urban area or rural area) for which you are 
applying. Your response must not exceed 4 pages or have independent 
attachments, although you are encouraged to reference appropriate text 
in, or attachments to, the application. Your response must appear as 
the first 1-4 pages of the text of your application and be titled, 
``Program Requirements.'' An affirmative response to each applicable 
question (A-L) is required to qualify for further review. All responses 
should provide adequate explanation and clarification of any 
exceptions.

Cooperative Activities

    In conducting activities of this program, the recipient shall be 
responsible for the activities under A., below and CDC shall be 
responsible for conducting activities under B., below.

A. Recipient Activities

    1. Task I activities include:
    a. A Target Community needs assessment--To ensure effective program 
planning, a recipient is expected to conduct a community needs 
assessment in collaboration with the organizations/agencies serving the 
Target Community populations. The intent is for recipients to obtain 
information about these populations and to involve their 
representatives actively in the development of the program plan. 
Recipients are expected to: (1) use a participatory process that 
includes relevant community organizations, State and local health 
departments, and other local agencies; (2) identify and assess the 
unmet immunization and primary care needs of the targeted 
population(s); and, (3) document the available resources for supporting 
an effort to raise immunization coverage levels in the Target 
Community. Based on the results of the needs assessment, and in 
coordination with CDC, a recipient is expected to develop a program and 
community-specific plan for Task II and Task III. The needs assessment 
should determine, describe, and document:
    (1) Access to, and availability of, immunization and primary care 
services for the population(s) of the Target Community(ies), barriers 
to obtaining services, and specific unmet primary care needs; and;
    (2) Technical assistance needs of providers and organizations 
serving, or proposing to serve, Target Community populations.
    The needs assessment should include the procedures used to identify 
and assess immunization and primary care needs, the actual unmet 
immunization and primary care needs, and any recent, current, or 
proposed actions to be taken within the Target Community(ies) to 
address them. This documentation also should include lessons learned 
through the needs assessment process and the technical assistance 
services planned (for Task II and Task III), so this information can be 
shared with other organizations, agencies, and recipients.
    b. Application of interventions in the AMC's/CHN's network of 
primary care providers in the Target Community(ies)--In each AMC/CHN 
Primary Care Clinic that operates in each Target Community selected for 
this demonstration project, a recipient is expected to apply practices 
that have been shown to improve and sustain immunization coverage. A 
recipient is expected to document the efforts made, including successes 
and failures and outcomes resulting from these activities. At a 
minimum, these practices must be consistent with the Standards for 
Pediatric Immunization Practices, with particular emphasis on the 
following interventions:
    (1) Reminder/recall systems--Each AMC/CHN Primary Care Clinic or 
network of Primary Care Clinics should establish a reminder/recall 
system conditioned on the immunization status of the enrolled patients.
    (2) Provider immunization record assessment and feedback--The 
recipient must ensure that a semiannual immunization record assessment 
is conducted using software approved by CDC (such as CASA) for each 
provider within each AMC/CHN Primary Care Clinic. The recipient may 
perform CASA-type assessments of Task I, either through its own 
resources or by engaging other expertise, such as the State or local 
health department. (A paper on the supportive potential of public 
health departments for this project is provided with each application 
kit.) Depending on the expertise residing at the AMC chosen to take 
responsibility for the clinic-based process and outcome evaluation of 
its

[[Page 20829]]

program, a CHN may want to insist that the AMC engage the State or 
local health department, or another expert entity, to assist in 
conducting its CASA-type clinic assessment. The data obtained through 
these assessments should be used by the recipient in conjunction with 
CDC to identify problems in immunization service delivery and to 
formulate and implement solutions.
    (3) Administration of vaccines--Target Community AMC/CHN Primary 
Care Clinics should ensure that all providers administer all 
appropriate vaccines at the appropriate time.
    (4) Observance of the most current Recommended Immunization 
Schedule, approved by the Advisory Committee on Immunization Practices 
(ACIP), the American Academy of Pediatrics (AAP), and the American 
Academy of Family Physicians (AAFP), or accelerated schedule, as 
appropriate to an individual child.
    (5) Observance of true immunization contraindications--AMC/CHN 
Primary Care Clinics should practice only true contraindications to 
vaccination, as stated in the most current ACIP recommendations.
    c. Task I clinic-based process evaluation--A recipient is expected 
to ensure the ongoing process evaluation of various Task I activities 
to identify delivery problems. At a minimum, the quarterly process 
indicators for each Target Community AMC/CHN Primary Care Clinic should 
include:
    (1) CASA-type utilization indicators.
    (2) Enrollment status for each Target Community AMC/CHN Primary 
Care Clinic.
    (3) Appointment and reminder/recall process data.
    d. Task I clinic-based outcome evaluation--On a semiannual basis, a 
recipient is expected to ensure the gathering, analysis, and reporting 
of immunization outcome indicators for each Target Community AMC/CHN 
Primary Care Clinic relating to two age groups of children: 12-15 and 
24-27 months of age. A recipient is expected to ensure that a baseline 
CASA-type assessment is performed for each Target Community AMC/CHN 
Primary Care Clinic and is repeated at 6-month intervals. Sampling 
should be consistent with the CASA methodology.
    2. Task II activities--The purpose of Task II is to improve the 
immunization practices of other Target Community primary medical care 
providers. This includes:
    a. Continuing Task I activities in each AMC/CHN Primary Care 
Clinic;
    b. Exporting successful Task I activities to other AMC/CHN Primary 
Care Clinic(s) serving the Target Community(ies); and,
    c. Exporting successful Task I activities to other primary health 
care providers serving the Target Community(ies).
    d. Clinic-based process and outcome evaluations--As with Task I, 
the recipient is responsible in performing Task II for ensuring that a 
CASA-type assessment is periodically performed for each participating 
primary health care provider in the Target Community(ies). Also, as 
with Task I, the recipient may discharge this responsibility by using 
its own resources or by engaging other expertise, such as the State or 
local health department.
    3. Task III activities--The purpose of Task III is to design and 
test creative approaches to raising the immunization coverage level of 
remaining Target Community children. Task III includes:
    a. Continuing all Task I and Task II activities in the Target 
Community(ies);
    b. Developing creative, practical strategies for bringing all 
infants into the primary health care delivery system for the earliest 
recommended well-child-care visit, and retaining them in the system; 
and developing protocols based on conventional scientific methods for 
rigorously evaluating the feasibility of these strategies;
    c. Developing creative, practical strategies for returning and 
retaining children who have dropped out of the health delivery system, 
and develop protocols based on conventional scientific methods for 
rigorously evaluating the feasibility of these strategies;
    d. Collaborating with CDC on the design of all Task III 
investigations;
    e. Implementing investigations to test Task III strategies.
    f. Task III Evaluation--Procedures and parameters for the 
evaluation of Task III activities will be described as part of the 
individual protocols approved and implemented and on the schedule 
specified in those protocols.
    Although the projects resulting from this announcement are 
demonstrations rather than research studies, valuable new knowledge 
will be gained that can help other areas improve the immunization 
status of children. It is expected that the recipients will publish 
their methods and results. Data from individual projects belong to the 
recipients but must be shared with the CDC, and CDC reserves the right 
to publish scientific papers from data that are aggregated across 
projects. Publication of individual project data in the same manuscript 
with these aggregate data will be a shared responsibility with the 
standard rules of authorship applying. Thus, all authors must have 
participated in the creation, conduct, analysis, and interpretation of 
results.

B. CDC Activities

    1. Provide medical, epidemiologic, programmatic, and educational 
consultation and technical assistance in planning, operating, 
improving, and evaluating the demonstration project.
    2. Provide technical assistance in community coalition development 
to increase the potential for achieving Task II and Task III.
    3. Provide oversight for the rigorous scientific approach to be 
taken in Task III to increase the use of primary care by underserved 
families of underimmunized children.
    4. Ensure that recipients are provided population-based 
immunization coverage data for their respective urban area or rural 
area Target Community(ies) as such data become available from the 
independent evaluation contractor.
    5. Coordinate the dissemination of findings from the demonstration 
project and collaborate with recipients on specific publications 
involving data collected.

Evaluation Criteria

    Upon receipt, applications will be screened by CDC staff for 
completeness and responsiveness as outlined under the previous heading, 
``Program Requirements'' (A-L). Incomplete applications and 
applications which are not responsive will be returned to the applicant 
without further consideration. Applications which are complete and 
responsive may be subjected to a preliminary evaluation by a peer 
review group to determine if the application is of sufficient technical 
and scientific merit to warrant further review (triage); the CDC will 
withdraw from further consideration applications judged to be 
noncompetitive and promptly notify the principal investigator/program 
director and the official signing for the applicant organization.
    Applications accepted for full review will be reviewed and 
evaluated according to the following criteria:
    A.1. For Urban Area Applicants--The extent to which need for the 
program is justified by the applicant's documentation of: (1) the 
magnitude of unmet primary care needs and underimmunization (if 
available) of urban inner city and other underserved populations in the 
proposed Target Community(ies); and (2) the existence of the current 
annual birth cohort residing in the proposed Target Community(ies)--10 
Points.

[[Page 20830]]

    A.2. For Rural Area Applicants--The extent to which need for the 
program is justified by the applicant's documentation of the magnitude 
of unmet primary care needs and underimmunization (if available) of the 
underserved populations living in the proposed Target Community(ies)--
10 Points.
    B. The extent to which the applicant's documentation establishes: 
(1) experience in delivering children's primary care and immunization 
services to underserved child populations in the Target Community(ies); 
(2) knowledge of the population in the Target Community(ies), as 
reflected by the cultural appropriateness of services that the 
applicant is providing; and (3) existence of the current annual birth 
cohort collectively served by AMC/CHN Primary Care Clinics 
participating as part of the proposed Target Community(ies)--10 Points.
    C. The extent to which the proposed program framework is 
comprehensive, specific, reasonable, and realistic--20 Points.
    D. The quality and feasibility of a narrative program proposal that 
includes: (1) detailed plans for: (a) implementing all Task I and Task 
II activities and general preparations for Task III; (b) program 
management; (c) documenting the process, including successes and 
failures, of implementing the activities of the three tasks; (d) 
resolving problems that might be encountered in designing and 
implementing program activities, (e.g., problems in recruiting, hiring, 
or retaining staff; training of staff; monitoring and ensuring staff 
performance; and monitoring and ensuring provider performance in Task 
II and Task III); and (e) completing and submitting progress reports; 
and (2) the extent to which: (a) the applicant's proposed Target 
Community(ies) are visually represented on a census tract map; (b) data 
regarding the applicant's proposed Target Community(ies) and AMC/CHN 
Primary Care Clinics appear to document the infrastructure needed to 
successfully conduct and evaluate this demonstration project; (c) the 
plan to ensure the sustainability of the results of carrying out the 
project's tasks is realistic; and (d) the plan is feasible in relation 
to the size of the current annual birth cohort, both residing in the 
Target Community(ies) and being served by AMC/CHN Primary Care Clinics 
in the selected Target Community(ies)--20 Points.
    E. The extent to which: (1) the evaluation plan, either of an 
applying AMC or of a CHN through the AMC which will be responsible for 
the clinic-based process and outcome evaluation for the CHN's project, 
will measure the achievement of the applicant's stated goals and 
objectives, quality assure services, and support the ongoing management 
of the project; (2) the evaluation capability of an applying AMC, or of 
a CHN through the AMC which will be responsible for clinic-based 
process and outcome evaluation of the CHN's proposed demonstration 
program; and (3) the proposed control population is visually 
represented on a census tract map and meets the specifications for HPSA 
inclusion, racial/ethnic group composition, and Medicaid proportion set 
forth in subsection E. Evaluation Plan of the Application Contents 
section--20 Points.
    F. The extent to which the applicant's description of a patient 
information system indicates a conclusion that the system is adequate 
to support an effective program--10 Points.
    G. The extent to which the applicant proposes and properly 
documents potentially effective coordination, collaboration, and 
working relationships with State/local health departments--5 Points.
    H. The extent to which the applicant documents effective prior 
working relationships with project collaborators, and the extent to 
which the applicant will coordinate and collaborate with providers 
(private and public), relevant community organizations, coalitions, and 
other agencies serving the populations in the Target Community(ies). 
For applying CHNs, the extent to which there is documentation showing 
the details of an formal agreement whereby a collaborating AMC agrees 
to assume responsibility for the clinic-based process and outcome 
evaluation of the CHN's project activities--5 Points.

Funding Priorities

    During the selection process of urban area demonstration projects, 
CDC will make every effort to ensure that funded applications reflect a 
geographic distribution, as well as racial/ethnic diversity of the 
target populations; however, consistent with consideration of technical 
merit, at least one urban area award will be made to an applicant 
serving a predominantly African-American population, and at least one 
award will be made to an applicant serving a predominantly Hispanic 
population. No more than one urban area project will be funded in a 
State. The award of a rural area project will not be affected by the 
geographic distribution or ethnic/racial diversity of urban area 
projects. Therefore, it is possible that an urban area project and the 
single rural area project could be awarded in the same State, but not 
to the same recipient.
    Interested persons are invited to comment on the proposed funding 
priority. All comments received on or before June 7, 1996 will be 
considered before the final funding priority is established. If the 
funding priority should change as a result of any comments received, a 
revised announcement will be published in the Federal Register prior to 
the final selection of awards. Written comments should be addressed to: 
Ron Van Duyne, Grants Management Officer, Grants Management Branch, 
Procurement and Grants Office, Centers for Disease Control and 
Prevention (CDC), 255 East Paces Ferry Road, Room 321, Atlanta, Georgia 
30305.

Executive Order 12372 Review

    Applications are subject to Intergovernmental Review of Federal 
Programs as governed by Executive Order (E.O.) 12372. E.O. 12372 sets 
up a system for State and local government review of proposed Federal 
assistance applications. Applicants should contact their State Single 
Point of Contact (SPOC) as early as possible to alert them to the 
prospective applications and receive any necessary instructions on the 
State process. For proposed projects serving more than one State, the 
applicant is advised to contact the SPOC for each affected State. A 
current list of SPOCs is included in the application kit. If the SPOCs 
have any State process recommendations on applications submitted to 
CDC, they should send them to Lisa G. Tamaroff, Grants Management 
Specialist, Grants Management Branch, Procurement and Grants Office, 
Centers for Disease Control and Prevention (CDC), 255 East Paces Ferry 
Road, NE., Atlanta, Georgia 30305, no later than 60 days after the 
application due date. Please include the Program Announcement Number 
and Program Title on the letter.

Public Health System Reporting Requirement

    This program is subject to the Public Health System Reporting 
Requirements. Under these requirements, all community-based non-
governmental applicants must prepare and submit the items identified 
below to the head of the appropriate State and/or local health 
agency(s) in the program area(s) that may be impacted by the proposed 
project no later than the receipt date of the Federal application. The 
appropriate State and/or local health agency is determined by the 
applicant. The

[[Page 20831]]

following information must be provided:
    A. A copy of the face page of the application (SF 424).
    B. A summary of the project that should be titled ``Public Health 
System Impact Statement'' (PHSIS), not to exceed one page, and include 
the following:
    1. A description of the population to be served;
    2. A summary of the services to be provided; and
    3. A description of the coordination plans with the appropriate 
State and/or local health agencies.
    If the State and/or local health official should desire a copy of 
the entire application, it may be obtained from the State Single Point 
of Contact (SPOC) or directly from the applicant.

Catalog of Federal Domestic Assistance Number

    The Catalog of Federal Domestic Assistance number is 93.268.

Other Requirements

Human Subjects

    If the proposed project involves research on human subjects, the 
applicant must comply with the Department of Health and Human Services 
Regulations, 45 CFR Part 46, regarding the protection of human 
subjects. Assurance must be provided to demonstrate that the project 
will be subject to initial and continuing review by an appropriate 
institutional review committee. The applicant will be responsible for 
providing assurance in accordance with the appropriate guidelines and 
forms provided in the application kit.

Application Submission and Deadline

A. Preapplication Letter of Intent

    Although not a prerequisite of application, a non-binding letter of 
intent-to-apply is requested from potential applicants. The letter 
should be submitted to the Grants Management Specialist (whose address 
is reflected in section B, ``Applications''). It should be postmarked 
no later than one month prior to the planned submission deadline, 
(e.g., June 12 for a July 12 submission). The letter should identify 
the announcement number, the name of the applicant AMC or CHN and its 
Project Collaborators, as defined in this announcement, and the 
geographic type (urban or rural) of program which the intended 
application will address. The letter of intent does not influence 
review or funding decisions, but it will enable CDC to plan the review 
more efficiently and thereby potentially benefit all applicants.

B. Application

    The application should be carefully completed, following the 
directions provided in this program announcement. The original and two 
copies of the application PHS Form 5161-1 must be submitted to Lisa G. 
Tamaroff, Grants Management Specialist, Grants Management Branch, 
Procurement and Grants Office, Centers for Disease Control and 
Prevention (CDC), 255 East Paces Ferry Road, Room 300, Mailstop E-13, 
Atlanta, Georgia 30305, on or before July 12, 1996.
1. Deadline
    Applications will be considered as meeting the deadline if they are 
either:
    a. Received on or before the deadline date; or
    b. Sent on or before the deadline date and received in time for 
submission to the triage process, if it is employed, or the objective 
review process if it is not. (Applicants must request a legibly dated 
U.S. Postal Service postmark or obtain a legibly dated receipt from a 
commercial carrier or U.S. Postal Service. Private metered postmarks 
shall not be acceptable as proof of timely mailing.)
2. Late Applications
    Applications that do not meet the criteria in 1.a. or 1.b. above 
are considered late applications. Late applications will not be 
considered and will be returned to the applicant.

Where To Obtain Additional Information

    To receive additional written information call (404) 332-4561. You 
will be asked to leave your name, address, and phone number and will 
need to refer to Announcement #612. You will receive a complete program 
description. The program announcement is also available on through the 
CDC homepage on the Internet. The address for the CDC homepage is 
http://www.cdc.gov. CDC will not send program announcements by 
facsimile or express mail. If you have any questions after reviewing 
the contents of all the documents, business management technical 
assistance may be obtained from Lisa Tamaroff, Grants Management 
Specialist, Grants Management Branch, Procurement and Grants Office, 
Centers for Disease Control and Prevention (CDC), 255 East Paces Ferry 
Road, NE., Room 300, Mailstop E-13, Atlanta, Georgia 30305, telephone 
(404) 842-6796, Internet address: <a href="/cdn-cgi/l/email-protection#214d465510614e515251464e100f444c0f4245420f464e57"><span class="__cf_email__" data-cfemail="b5d9d2c184f5dac5c6c5d2da849bd0d89bd6d1d69bd2dac3">[email protected]</span></a>.
    Programmatic technical assistance may be obtained from Russ Havlak, 
Immunization Services Division, National Immunization Program, Centers 
for Disease Control and Prevention (CDC), Building 12, Corporate Square 
Boulevard, Mailstop E-52, Atlanta, Georgia 30329, telephone (404) 639-
8569, Internet address: <a href="/cdn-cgi/l/email-protection#5c3b2e346d1c3f2c2f283e6d723931723f383f723b332a"><span class="__cf_email__" data-cfemail="1572677d24557665666177243b70783b7671763b727a63">[email protected]</span></a>.
    Please refer to Announcement Number 612 when requesting information 
and submitting an application.
    There may be delays in mail delivery as well as difficulty in 
reaching the CDC Atlanta offices during the 1996 Summer Olympics (July 
19-August 4). Therefore, CDC suggests the following to get more timely 
responses to any questions: using internet/email, following all 
instructions in this announcement, and leaving messages on the contact 
person's voice mail.
    Potential applicants may obtain a copy of Healthy People 2000 (Full 
Report, Stock No. 017-001-00474-0) or Healthy People 2000 (Summary 
Report, Stock No. 017-001-00473-1) referenced in the Introduction 
through the Superintendent of Documents, Government Printing Office, 
Washington, D.C. 20402-9325, telephone: 202-512-1800.

    Dated: May 2, 1996.
Joseph R. Carter,
Acting Associate Director for Management and Operations Centers for 
Disease Control and Prevention (CDC).
[FR Doc. 96-11443 Filed 5-7-96; 8:45 am]
BILLING CODE 4163-18-P

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