Federal Register / Vol. 61, No. 90 / Wednesday, May 8, 1996 / Notices 20825

Centers for Disease Control and

Prevention

[30DAY–09]

Agency Forms Undergoing Paperwork

Reduction Act Review

The Centers for Disease Control and

Prevention (CDC) publishes a list of

information collection requests under

review, in compliance with the

Paperwork Reduction Act (44 U.S.C.

Chapter 35). To request a copy of these

requests, call the CDC Reports Clearance

Office on (404) 639–7090.

The following request have been

submitted for review since the last

publication date on March 21, 1996.

Proposed Project

1. Phase 2, 1996 National Health

Interview Survey, Basic Module (0920–

0214). The annual National Health

Interview Survey (NHIS) is a basic

source of general statistics on the health

of the U.S. population. Due to the

integration of health surveys in the

Department of Health and Human

Services, the NHIS also has become the

sampling frame and first stage of data

collection for other major surveys,

including the Medical Expenditure

Panel Survey, the National Survey of

Family Growth, and the National Health

and Nutrition Examination Survey. By

linking to the NHIS, the analysis

potential of these surveys increases. The

NHIS has long been used by

government, university, and private

researchers to evaluate both general

health and specific issues, such as

cancer, AIDS, and childhood

immunizations. Journalists use its data

to inform the general public. It will

continue to be a leading source of data

for the Congressionally-mandated

‘‘Health US’’ and related publications,

as well as the single most important

source of statistics to track progress

toward the National Health Promotion

and Disease Prevention Objectives,

‘‘Healthy People 2,000.’’

Because of survey integration and

changes in the health and health care of

the U.S. population, demands on the

NHIS have changed and increased,

leading to a major redesign. Improved

information technology is planned,

especially computer assisted personal

interviewing (CAPI.) This clearance is

for a one-time data collection, to

introduce, test, and evaluate the

redesigned NHIS data system. This data

collection, planned for July–December

1996, is also expected to produce data

of sufficient quality to allow publication

of national estimates and release of

public use micro data files. The

resulting new NHIS data system is

expected to be in the field for at least

10 years, beginning in January, 1997.

Separate clearance will be requested for

the post-1996 period.

Respondents Number of

respondents

Number of

respondents/respondents

Avg. burden/

responses

(in hours)

Total burden

(in hrs.)

Family ............................................................................................................................. 10,500 1 0.5 5,250

Sample Adult .................................................................................................................. 10,500 1 0.5 5,250

Sample child ................................................................................................................... 4,500 1 0.25 1,125

Total ..................................................................................................................... .................... .................... ...................... 11,625

The total annual burden is 11,625. Send comments to Desk officer, CDC; Human Resources and Housing Branch,

New Executive Office Building, Room 10235; Washington, DC 20503.

2. Ethnographic Study of Tuberculosis Outreach Worker Activities - New - This data collection will generate descriptive

data from those directly involved and responsible for providing outreach to identified TB patients to gain an understanding

of outreach activities, how they occur, and their level of effectiveness. Three interview guides have been developed

for use with TB outreach workers, their supervisor and a small number of outreach patients. This effort will result

in a more comprehensive picture of effective and efficient TB outreach activities. The major product of this effort

will be a descriptive analytical report detailing the ‘‘lessons learned’’.

Respondents Number of

respondents

Number of

responses/

respondents

Avg. Burden

(in hrs.)

Outreach Workers .................................................................................................................................... 36 1 0.75

Outreach Workers’ Supervisor ................................................................................................................. 36 1 0.75

TB Patients ............................................................................................................................................... 72 1 0.33

The total annual burden is 78.00. Send comments to Desk officer, CDC; Human Resources and Housing Branch,

New Executive Office Building, Room 10235; Washington, DC 20503.

Dated: May 1, 1996.

Wilma G. Johnson,

Acting Associate Director for Policy Planning And Evaluation, Centers for Disease Control and Prevention (CDC).

[FR Doc. 96–11446 Filed 5–7–96; 8:45 am]

BILLING CODE 4163–18–P
20826 Federal Register / Vol. 61, No. 90 / Wednesday, May 8, 1996 / Notices

[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 difficultto-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.
Federal Register / Vol. 61, No. 90 / Wednesday, May 8, 1996 / Notices 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 nonresponsive.

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
20828 Federal Register / Vol. 61, No. 90 / Wednesday, May 8, 1996 / Notices

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 ≥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 (±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
Federal Register / Vol. 61, No. 90 / Wednesday, May 8, 1996 / Notices 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-childcare 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.
20830 Federal Register / Vol. 61, No. 90 / Wednesday, May 8, 1996 / Notices

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 clinicbased 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 clinicbased 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 AfricanAmerican 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
Federal Register / Vol. 61, No. 90 / Wednesday, May 8, 1996 / Notices 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: lgt1@opspgo1.em.cdc.gov.

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:

grh1@cpstb1.em.cdc.gov.

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

Food and Drug Administration

Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: This notice announces a

forthcoming meeting of a public

advisory committee of the Food and

Drug Administration (FDA). This notice

also summarizes the procedures for the

meeting and methods by which

interested persons may participate in

open public hearings before FDA’s

advisory committees.

FDA has established an Advisory

Committee Information Hotline (the

hotline) using a voice-mail telephone

system. The hotline provides the public

with access to the most current

information on FDA advisory committee

meetings. The advisory committee

hotline, which will disseminate current

information and information updates,