State and Local Childhood Lead Poisoning Prevention Program and State Childhood Blood Lead Surveillance Program; Notice of Availability of Funds for Fiscal Year 1998

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Announcement 98018]

State and Local Childhood Lead Poisoning Prevention Program and

State Childhood Blood Lead Surveillance Program; Notice of Availability

of Funds for Fiscal Year 1998

Introduction

The Centers for Disease Control and Prevention (CDC) announces the

availability of funds in fiscal year (FY) 1998 for new and competing

continuation State and local childhood lead poisoning prevention (CLPP)

programs, and State childhood blood lead surveillance (CBLS) programs.

The 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 Environmental Health.

(To order a copy of ``Healthy People 2000'', see the Where to Obtain

Additional Information section.)

Authority

This program is authorized under sections 301(a), 317A and 317B of

the Public Health Service Act [42 U.S.C. 241(a), 247b-1, and 247b-3],

as amended. Program regulations are set forth in Title 42, Code of

Federal Regulations, Part 51b.

Smoke-Free Workplace

The CDC strongly encourages all grant recipients to provide a

smoke-free workplace and 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, day care, health care, and early childhood development

services are provided to children.

Eligible Applicants

Eligible applicants for Part A: State and Local CLPP Programs

Eligible applicants are State health departments or other state

health agencies or departments deemed most appropriate by the state to

direct and coordinate the State's childhood lead poisoning prevention

program.

Also eligible are agencies or units of local government that serve

jurisdictional populations greater than 500,000. This eligibility

includes health departments or other official organizational authority

(agency or instrumentality) of the District of Columbia, the

Commonwealth of Puerto Rico, any territory or possession of the United

States, and all Indian tribes.

Applicants for local CLPP program grants from eligible units of

local jurisdictions must either apply directly to CDC or apply as part

of a statewide grant application. Local jurisdictions cannot submit

applications directly to CDC and also apply as part of a statewide

grant application.

Note: An organization described in section 501(c)(4) of the

Internal Revenue Code of 1986 which engages in lobbying activities

[[Page 5549]]

shall not be eligible to receive Federal funds constituting an

award, grant, loan, or any other form.

Eligible Applicants for Part B: CBLS Programs

Eligible applicants are State health departments, the District of

Columbia, the Commonwealth of Puerto Rico, any territory or possession

of the United States, and all Indian tribes, or other State health

agencies or departments deemed most appropriate by the state to direct

and coordinate the state's CBLS program. Eligible applicants must have

a requirement for reporting of blood lead levels (BLLs) by both public

and private laboratories or provide assurances that such a requirement

will be in place within 12 months of awarding the grant.

Eligible Applicants for Part C: Additional Funding for Assessment/

Evaluation Studies

Eligible applicants for supplemental funds are all successful new

and competing-continuation applicants for Part A and Part B, and also

all non-competing continuation applicants for Part A and Part B.

Additional Information for All State Applicants

If a State agency applying for grant funds is other than the

official State health department, written concurrence by the State

health department must be provided. State applicants may apply for

funding from either Part A: CLPP Program or Part B: CBLS Program, but

NOT both. State CLPP Program applicants should note that a CBLS

component is a required part of a comprehensive State CLPP program and

may be funded within the CLPP program grant.

Availability of Funds

Part A: State and Local CLPP Program

Up to $11,000,000 will be available in FY 1998 to fund up to 15 new

and competing continuation grants. CDC anticipates that awards for the

first budget year will range from $75,000 to $1,500,000.

Awards for State applicants

To determine the level of funding for which an individual State

applicant for Part A is eligible, State applicants should refer to the

accompanying table entitled ``State CLPPs Only: Funding Categories

Based on Projected Level of Effort Required to Provide Prevention

Services to a State Population.''

Awards for eligible counties and cities, territories, tribes and

the District of Columbia will range from $250,000-$450,000, with an

average award of $350,000.

Funding for Part B: State CBLS Programs

Up to $700,000 will be available in FY 1998 to fund up to 8 new and

competing-continuation grants to support the development of CBLS

programs. CBLS awards are expected to range from $75,000 to $95,000,

with the average award being approximately $85,000. Funds must be used

to initiate and build capacity for CBLS. Therefore, any applicant that

already has in place a CBLS activity must demonstrate how these grant

funds will be used to enhance, expand, or improve the current activity

in order to remain eligible for funding. CDC funds should be added to

CBLS funding from other sources, if such funding exists. Funds for

these programs may not be used in place of any existing funding for

CBLS.

Funding for Part C: Additional Funds for Assessment/Evaluation Studies

Approximately $150,000 in additional/supplemental funds will be

available in FY 1998 to fund up to 3 assessment/evaluation studies.

Funds will be awarded for assessment/evaluation studies that address

one of the following:

1. Assessment of lead exposure in a jurisdictional population or

subpopulation, using an approach to surveillance that differs from the

complete statewide CBLS system described in this announcement.

2. Evaluation of the impact of lead screening recommendations on

screening for high-risk children.

3. Evaluation of an approach to primary prevention in a high-risk

area.

Additional Information on Funding

For State applicants for Part A: CLPP funding only: Determine your

funding category (Category 1, 2, or 3) according to the table on the

next page. The range and average of awards for each funding category as

follows:

Category 1: $800,000-$1,500,000, average award $1,000,000

Category 2: $250,000-$800,000, average award $520,000

Category 3: $75,000-$250,000, average award $150,000

State CLPPPs Only: Funding Categories Based on Projected Level of Effort

Required to Provide Prevention Services to a State Population

------------------------------------------------------------------------

------------------------------------------------------------------------

Alabama........................................................ 2

Alaska......................................................... 3

Arizona........................................................ 3

Arkansas....................................................... 2

California*.................................................... 1

Colorado....................................................... 3

Connecticut.................................................... 2

Delaware....................................................... 3

Florida*....................................................... 3

Georgia........................................................ 2

Hawaii......................................................... 3

Idaho.......................................................... 3

Illinois....................................................... 1

Indiana*....................................................... 3

Iowa........................................................... 2

Kansas......................................................... 2

Kentucky*...................................................... 3

Louisiana...................................................... 2

Maine.......................................................... 3

Maryland....................................................... 2

Mass........................................................... 2

Michigan*...................................................... 2

Minnesota...................................................... 2

Mississippi.................................................... 2

Missouri....................................................... 2

Montana........................................................ 3

Nebraska....................................................... 2

Nevada......................................................... 3

N. Hampshire................................................... 3

New Jersey..................................................... 2

New Mexico..................................................... 3

New York*...................................................... 2

N. Carolina.................................................... 2

North Dakota................................................... 3

Ohio........................................................... 1

Oklahoma....................................................... 2

Oregon......................................................... 3

Pennsylvania................................................... 1

Rhode Island................................................... 2

S. Carolina.................................................... 2

South Dakota................................................... 2

Tennessee...................................................... 2

Texas*......................................................... 1

Utah........................................................... 3

Vermont........................................................ 3

Virginia....................................................... 2

Washington..................................................... 2

West Virginia.................................................. 2

Wisconsin...................................................... 2

Wyoming........................................................ 3

------------------------------------------------------------------------

* Projected level of effort adjusted to account for currently funded

locales.

Each applicant must use the funding category that is specified for

the applicant's State. CDC will not consider any State application that

contains a funding request, including both direct and indirect costs,

in excess of the funding limit given for the applicant's State. Any

such application will be returned as non-responsive to the program

announcement. However, an applicant may request an amount that is less

than the lower limit of the range given for the applicant's

jurisdiction.

[[Page 5550]]

Additional Information on Funding for All Applicants for Part A and

Part B

New awards are expected to begin on or about July 1, 1998, and are

made for 12-month budget periods within project periods not to exceed 3

years. Estimates outlined above are subject to change based on the

actual availability of funds and the scope and quality of applications

received. Continuation awards within the project period will be made on

the basis of satisfactory progress and availability of funds. Grant

awards cannot supplant existing funding for CLPP or CBLS programs.

Grant funds should be used to increase the level of expenditures from

State, local, and other funding sources. Awards will be made with the

expectation that program activities will continue when grant funds are

terminated.

Additional Information on Funding for All Applicants for Part C.

Additional/supplemental funds are to begin on or about July 1,

1998, and are made for a 12-month budget period in a project period not

to exceed the time period of the main grant.

Note:

Grant funds may not be expended for medical care and

treatment or for environmental remediation of source of lead

exposure. However, the applicant must provide a plan to ensure that

these program activities are carried out.

Not more than 10 percent (exclusive of Direct

Assistance) of any grant may be obligated for administrative costs.

This 10 percent limitation is in lieu of, and replaces, the indirect

cost rate.

Use of Funds--Restrictions on Lobbying

Applicants should be aware of restrictions on the use of HHS funds

for lobbying of Federal or State legislative bodies. Under the

provisions of 31 U.S.C. 1352 (which has been in effect since December

23, 1989), recipients (and their subtier contractors) are prohibited

from using appropriated Federal funds (other than profits from a

Federal contract) for lobbying Congress or any Federal agency in

connection with the award of a particular contract, grant, cooperative

agreement, or loan. This includes grants/cooperative agreements that,

in whole or in part, involve conferences for which Federal funds cannot

be used directly or indirectly to encourage participants to lobby or to

instruct participants on how to lobby.

In addition, the FY 1998 HHS Appropriations Act expressly prohibits

the use of 1998 appropriated funds for indirect or ``grass roots''

lobbying efforts that are designed to support or defeat legislation

pending before State legislatures. Section 503 of Public Law 105-78,

provides as follows:

(a) No part of any appropriation contained in this Act shall be

used, other than for normal and recognized executive-legislative

relationships, for publicity or propaganda purposes, for the

preparation, distribution, or use of any kit, pamphlet, booklet,

publication, radio, television, or video presentation designed to

support or defeat legislation pending before the Congress, or any State

legislature, except in presentation to the Congress or any State

legislative body itself.

(b) No part of any appropriation contained in this Act shall be

used to pay the salary or expenses of any grant or contract recipient,

or agent acting for such recipient, related to any activity designed to

influence legislation or appropriations pending before the Congress or

any State legislature.

Background and Definitions

Background

In the last few years, there have been three major changes in the

context within which CLPP and CBLS programs function. These are:

Changing functions of health departments. Many health

departments have ceased to be major providers of direct screening and

follow-up care services, as Medicaid beneficiaries who formerly

received preventive health care in health departments have enrolled in

managed-care organizations. A decrease in funding has occurred in many

health departments.

Renewed emphasis on accountability of government agencies.

A renewed call for accountability in government agencies requires that

health departments document both the need for and the impact of their

programs.

Continuing declines in BLLs of the entire U.S. population,

resulting in wide variation among jurisdictions with regard to the

magnitude of their childhood lead poisoning problems.

Resource limitations and the demand for public accountability have

made it increasingly important for health departments to perform the

core functions of public health as outlined in The Future of Public

Health (IOM, 1988). These core functions are assessment, policy

development, and assurance. Health department personnel must also

accomplish their missions through others, by deepening relationships

among new and old partners both in and outside of the health

department. Also, the widening disparity among jurisdictions with

regard to the magnitude of the childhood lead poisoning problem has

focused attention on state and local health departments, as opposed to

the Federal government, as the appropriate decision-makers for lead

screening. Taken together, these changes are having a profound impact

on CLPP programs, necessitating a change in programmatic emphasis.

CLPP and CBLS programs are positioned to bring about improved

screening and follow-up care for children with elevated BLLs, improved

public and professional awareness of the problem of childhood lead

poisoning, and improved childhood blood lead surveillance, by

performing the three core public health functions related to childhood

lead poisoning prevention.

Definitions

Assessment: Activities organized by a health department

for the purpose of determining the risk for lead exposure among the

children in its jurisdiction and the adequacy of programmatic

activities to address this risk.

Assurance: Activities organized by a health department for

the purpose of (1) monitoring the provision of CLPP services including

screening, follow-up care, and public and professional education; and

(2) ensuring, as a provider of last resort, the availability of

necessary services.

Care coordination: The monitoring and organizing of

follow-up care for a child with an elevated blood lead level (BLL).

Follow-up care includes both medical and environmental interventions.

High-risk: A term used to designate areas, populations,

and individuals with risk for lead exposure that is assessed or

demonstrated to be higher than average.

Lead hazard: Accessible paint, dust, soil, water, or other

source or pathway that contains lead or lead compounds that can

contribute to or cause elevated BLLs.

Lead hazard remediation: The elimination, reduction, or

containment of known and accessible lead sources.

Policy development: Activities organized by a health

department for the purpose of framing the CLPP problem and establishing

the response to it in its jurisdictions; includes development,

oversight, and evaluation of necessary programs, relationships, and

policies that will support CLPP.

Primary prevention: The prevention of elevated BLLs in an

individual or population, usually by reducing or eliminating lead

hazards in the environment.

[[Page 5551]]

Program: A designated unit within an agency responsible

for implementing and coordinating a systematic and comprehensive

approach to CLPP and CBLS.

Surveillance: A process which (1) systematically collects

information over time about children with elevated BLLs using

laboratory reports as the data source; (2) provides for the follow-up

of cases, including field investigations when necessary; (3) provides

timely and useful analysis and reporting of the accumulated data,

including an estimate of the rate of elevated BLLs among all children

receiving blood tests; and (4) reports data to CDC in the appropriate

format.

Purpose

The purpose of this grant program is to bring about: (1) Screening

for children who are potentially exposed to lead, and follow-up care

for children who are identified with elevated BLLs; (2) awareness and

action among the general public and concerned professionals in relation

to preventing childhood lead poisoning; and (3) collaboration with

other government and community-based organizations for primary

prevention of lead poisoning in high-risk areas. To achieve this

purpose, grant recipients are expected to improve their capacity to

perform core public health functions related to CLPP and, for all state

grant recipients, to develop statewide capacity for conducting CBLS.

These awards should assist State and local health departments in

balancing core public health functions. In some places, achieving this

balance will mean shifting emphasis away from provision of direct

screening and follow-up services and toward improvement of coalitions

and partnerships; providing better and more sophisticated assessment;

and developing and evaluating policies and programs in a manner that is

firmly grounded in improved assessment. In other places where this

balance already exists, the award should help enhance existing

activities.

Program Requirements

Part A: State and Local CLPP Programs

The following are requirements for CLPP Programs:

1. A director/coordinator with authority and responsibility to

carry out the requirements of the program.

2. Provide qualified staff, other resources, and knowledge to

implement the provisions of the program. Applicants requesting grant

supported positions must provide assurances that such positions will be

approved by the applicant's personnel system.

3. For State applicants, commitment to develop a statewide

childhood blood lead surveillance (CBLS) system in accordance with CDC

guidance and to submit surveillance data annually to CDC. For local

applicants, commitment to develop a data management system that is part

of a state CBLS, where applicable; otherwise, local applicants must

develop an automated data management system to collect and maintain

data on the results of blood lead testing and data on follow-up care

for children with elevated BLLs. For both State and local applicants,

commitment to use these systems to monitor adequacy of screening of

high-risk children and of follow-up care for children with elevated

BLLs.

4. For State applicants, commitment to development a statewide

childhood blood lead screening plan consistent with CDC guidance

provided in Screening Young Children for Lead Poisoning: Guidance for

State and Local Public Health Officials. For local applicants,

commitment to participate in the statewide planning process.

5. Establish effective, well-defined working relationships within

public health agencies and with other agencies and organizations at

national, State, and community levels (e.g., housing authorities;

environmental agencies; maternal and child health programs; State

Medicaid Early Periodic Screening, Diagnosis, and Treatment (EPSDT)

programs; community and migrant health centers; community-based

organizations providing health and social services in or near public

housing units, as authorized under Section 340A of the PHS Act; State

epidemiology programs; State and local housing rehabilitation programs;

schools of public health and medical schools; and environmental

interest groups).

6. Assurances that income earned by the CLPP program is returned to

the program for its use.

7. Program maintains a system to monitor the notification and

follow-up of children who are confirmed with elevated BLLs and who are

referred to local Public Housing Authorities.

8. For State CLPP Programs provide managerial, technical,

analytical, and program evaluation assistance to local agencies in

developing or strengthening CLPP programs.

9. SPECIAL REQUIREMENT regarding Medicaid provider-status of

applicants: Pursuant to section 317A of the Public Health Service Act

(42 U.S.C. 247b-1), as amended by Section 303 of the ``Preventive

Health Amendments of 1992'' (Pub. L. 102-531), applicants AND current

grantees must meet the following requirements: For CLPP program

services which are Medicaid-reimbursable in the applicant's State:

Applicants who directly provide these services must be

enrolled with their State Medicaid agency as Medicaid providers.

Providers who enter into agreements with the applicant to

provide such services must be enrolled with their State Medicaid agency

as providers. An exception to this requirement will be made for

providers whose services are provided free of charge and who accept no

reimbursement from any third-party payer. Such providers who accept

voluntary donations may still be exempted from this requirement.

Part B: CBLS Programs

The following are requirements for CBLS Programs:

1. A full-time director/coordinator with authority and

responsibility to carry out the requirements of surveillance program

activities.

2. Provide qualified staff, other resources, and knowledge to

implement the provisions of this program. Applicants requesting grant-

supported positions must provide assurances that such positions will be

approved by the applicant's personnel system.

3. Establish effective, well-defined working relationships with

CLPP programs within the applicant's State.

4. Revise, refine, and carrying out, in collaboration with CDC, the

proposed methodology for conducting CBLS.

5. Evaluate any interim and/or final evaluation of the CBLS

activity in collaboration with CDC.

6. Commitment to development a statewide childhood blood lead

screening plan consistent with CDC guidance provided in Screening Young

Children for Lead Poisoning: Guidance for State and Local Public Health

Officials.

7. Monitoring and evaluation of all major program activities and

services.

8. Conduct and evaluate public health programs or having access to

professionals who are knowledgeable in conducting such activities.

9. Translate data to State and local public health officials,

policy- and decision-makers, and others seeking to strengthen program

efforts.

10. Report CBLS data to CDC in the approved OMB format.

Part C: Assessment/Evaluation Studies

The following are requirements for Assessment/Evaluation Studies:

1. A study director with specific authority and responsibility to

carry out the requirements of the project.

[[Page 5552]]

2. Demonstrated ability to collect and analyze data necessary for

the conduct of the assessment/evaluation study. (OMB Number 0920-0337)

3. Conduct administrative arrangements required by the study.

4. Staff with demonstrated experience in conducting relevant

epidemiologic studies, including publication of original research in

peer-reviewed journals.

5. Establish effective and well-defined working relationships

within the performing organization and with outside entities which will

ensure implementation of the proposed study.

Technical Reporting Requirements

Quarterly progress reports (OMB Number 0920-0282) are required of

all grantees. The quarterly report should not exceed 25 pages. Time

lines for the quarterly reports will be established at the time of

award, but are typically due 30 days after the end of each quarter.

Note that CBLS-only grantees are not required to submit quarterly

quantitative data.

Annual Financial Status Reports (FSRs) are due 90 days after the

end of the budget period. The final progress report and FSR shall be

prepared and submitted no later than 90 days after the end of the

project period. Submit the original and two copies of the reports to

the Grants Management Office indicated in ``Where to Obtain Additional

Information''.

Application Contents

Please refer to the Program Guidance included with the application

package for important information about completing your application.

Applications for CLPP and CBLS Programs must be developed

in accordance with PHS Form 5161-1, and should follow the structure

presented in the Program Guidance document provided by CDC.

Applications for additional funds for assessment/

evaluation studies must be developed in accordance with PHS Form 398.

Application pages must be clearly numbered, and a complete

index to the application and its appendices must be included.

The original and two copies of the application set must be

submitted UNSTAPLED and UNBOUND. All material must be typewritten,

double spaced, printed on one side only, with un-reduced type on 8\1/

2\'' by 11'' paper, and at least 1'' margins and heading and footers.

All graphics, maps, overlays, etc., should be in black and white and

meet the above criteria.

The main body of CLPP and CBLS Program applications should

not exceed 75 pages. Supplemental information may be placed in

appendices and should not exceed 25 pages. Competing continuation

applicants should submit a progress report no longer than 10 pages.

The main body of applications for additional funds for

assessment/evaluation studies should not exceed the page limit set in

``Part C'' of the program guidance document.

Evaluation Criteria

The review of applications will be conducted by an objective review

committee who will review the quality of the application based on the

strength and completeness of the plan submitted. The budget

justification will be used to assess how well the technical plan is

likely to be carried out using available resources. For state CLPP

Programs, funding requests must be consistent with each applicant's

funding category or adjusted funding category. (See section entitled

``Availability of Funds'' for detailed guidance.) The maximum rating

score of an application is 100 points.

Part A: State and Local CLPP Program--Factors To Be considered

------------------------------------------------------------------------

Evaluation criterion Points

------------------------------------------------------------------------

1. Problem statement and evidence of need..................... 15

2. Surveillance activities.................................... 16

State: Development of CBLS

Local: Automated data--management and tracking system

3. Collaboration and statewide planning....................... 15

4. Core public health functions............................... 25

5. Goals and objectives....................................... 15

6. Program management and staffing............................ 14

7. Budget and justificationnot scored......................... (\1\)

---------

Total Maximum Points...................................... 100

------------------------------------------------------------------------

\1\ Not scored.

Part A: State and Local CLPP Programs--Factors To Be Considered

1. Problem statement and evidence of need (15 Points)

a. The applicant's description and understanding of the burden and

distribution of childhood lead exposure or elevated BLLs in the

jurisdiction, using evidence (as available) of incidence and/or

prevalence and demographic indicators. (10 points)

b. The applicant's description of and the extent of current

prevention activities, including need, available resources, gaps, and

use of this award to address gaps. (5 points)

2. Surveillance activities (16 points)

The clarity, feasibility, and scientific soundness of the

surveillance approach. Also, the extent to which a proposed schedule

for accomplishing each activity and methods for evaluating each

activity are clearly defined and appropriate.

For State applicants, the following elements will be specifically

evaluated:

a. How laboratories are identified and data will be transmitted. (2

points)

b. How data will be collected and managed. (2 points)

c. How quality of data and timeliness and completeness of reporting

will be ensured. (2 points)

d. How data will be used by program. (2 points)

e. How summary data will be reported and disseminated. (2 points)

f. How and when data will be analyzed. (2 points)

g. Provisions to obtain denominator data (results of all laboratory

blood lead tests, regardless of level). (2 points)

h. Time line and methods for evaluating CBLS approach. (2 points)

For local applicants, the following elements will be specifically

evaluated:

a. How laboratory reports will be received and data transmitted. (2

points)

b. How data will be collected and managed. (2 points)

c. How quality of data and timeliness and completeness of reporting

will be assured. (2 points)

d. How data will be analyzed and used by the program. (2 points)

[[Page 5553]]

e. How summary data will be reported and disseminated. (2 points)

f. Coordination with state systems. (2 points)

g. Provisions to obtain denominator data (results of all laboratory

blood lead tests, regardless of level). (2 points)

h. Time line and methods for evaluating data-collection approach.

(2 points)

3. Collaboration and statewide planning (15 Points)

a. Evidence of collaboration with principal partners, including

managed-care organizations, state Medicaid agency, child health-care

providers and provider groups, insurers, community-based organizations,

housing agencies, and banking, real-estate, and property-owner

interests, as demonstrated by letters of support, memoranda of

understanding, contracts, or other documented evidence of relationships

with important collaborators. (5 points)

b. The approach to developing and carrying out an inclusive State-

or jurisdiction-wide screening plan as outlined in Screening Young

Children for Lead Poisoning: Guidance for State and Local Health

Officials. (5 points)

c. Description of how collaborations are expected to result in

improved prevention. (5 points)

4. Capacity to carry out public-health core functions (25 Points)

a. The description of the approach and activities necessary to

achieve a balance among health department roles in CLPP, including

assessment, program and policy development, and monitoring, evaluation,

and ensuring provision of all necessary components of comprehensive

CLPP. (5 points)

b. The epidemiologic capacity and structure in place or planned to

provide on-going analysis of: (1) population-based data and (2) program

activities described in the application. (5 points)

c. The health education and health communication capacity in place

or planned to reach out to actual and potential collaborators and

partners to achieve program goals. (5 points)

d. The capacity in place or planned to fill in the gaps in direct

service provision, where gaps have been demonstrated. (5 points)

e. The evaluation capacity in place or planned to examine basic

data on CLPP burden and program activities and make course corrections.

(5 points)

5. Goals and objectives (15 Points)

Evaluation will be based on the quality of goals and objectives

related to the Program Activities listed in the accompanying Program

Guidance. For state applicants, evaluation will assess the soundness of

goals and objectives to bring about all eight elements of a statewide

childhood blood lead surveillance system. Objectives must be relevant,

specific, measurable, achievable, and time-framed. There must be a

formal work plan with a description of methods and a timetable for

accomplishment of each objective.

6. Project management and staffing (14 Points)

a. A description of proposed staffing for health department roles

in CLPP, including the plan to expedite filling of all positions and

written assurances that requested positions have been or will be

approved by applicant's personnel system. (5 points)

b. A description of the responsibilities of individual health

department staff members, including the level of effort and time. (5

points)

c. The plan to provide training to health department personnel and

technical assistance to collaborators outside the health department,

including proposed design of information-sharing systems. (4 points)

7. Budget justification (not scored).

Evaluation will be based on the extent to which the budget is

reasonable, clearly justified, and consistent with the intended use of

funds.

Part B: CBLS Programs--Factors To Be Considered

------------------------------------------------------------------------

Evaluation criterion Points

------------------------------------------------------------------------

1. Problem statement and evidence of need..................... 10

2. Surveillance activities.................................... 30

3. Use of existing resources.................................. 10

4. Collaboration and statewide planning....................... 10

5. Progress toward CBLS....................................... 20

6. Project sustainability..................................... 10

7. Personnel.................................................. 10

8. Budget and justification................................... (\1\)

---------

Total Maximum Points...................................... 100

------------------------------------------------------------------------

\1\ Not scored.

Part B: CBLS Programs--Factors To Be Considered

1. Problem statement and evidence of need (10 Points)

a. The applicant's description and understanding of the burden and

distribution of childhood lead exposure or elevated BLLs in the

jurisdiction, using evidence (as available) of incidence and/or

prevalence and demographic indicators. (5 points)

b. The applicant's description of and the extent of current

prevention activities, including need, available resources, gaps, and

use of this award to address gaps. (5 points)

2. Surveillance activities (30 Points)

The clarity, feasibility, and scientific soundness of the

surveillance approach. Also, the extent to which a proposed schedule

for accomplishing each activity and methods for evaluating each

activity are clearly defined and appropriate. The following points will

be specifically evaluated:

a. How laboratories are identified and data will be transmitted. (3

points)

b. How data will be collected and managed. (3 points)

c. How quality of data and timeliness and completeness of reporting

will be ensured. (3 points)

d. How data will be used by program. (3 points)

e. How summary data will be reported and disseminated. (3 points)

f. How and when data will be analyzed. (3 points)

g. Provisions to obtain denominator data (results of all laboratory

blood lead tests, regardless of level). (3 points)

h. Time line and methods for evaluating CBLS approach. (3 points)

i. Protocols for follow-up of individuals with elevated BLLs. (3

points)

j. Ability of the system to provide data to estimate the burden of

lead exposure in the state and conduct special studies. (3 points)

3. Use of existing resources (10 Points)

The extent to which the proposal would make effective use of

existing resources and expertise within the applicant agency or through

collaboration with other agencies.

4. Collaboration and statewide planning (10 Points)

The approach to developing and carrying out an inclusive statewide

screening plan as outlined in Screening Young Children for Lead

Poisoning: Guidance for State and Local Health Officials.

5. Progress toward complete blood-lead surveillance (20 Points)

a. The extent to which the proposed activities are likely to result

in substantial progress toward establishing a complete statewide

childhood blood lead surveillance activity. (15 points)

b. A description of how data will be used to measure impact of

public policy decisions. (5 points)

6. Project sustainability (10 Points)

The extent to which the proposed activities are likely to result in

the long-term maintenance of a complete statewide CBLS system. In

particular, specific activities that will be undertaken by the state

during the project period to ensure that the surveillance program

continues after completion of the project period.

7. Personnel (10 Points)

The extent to which the qualifications and time commitments of

project

[[Page 5554]]

personnel are clearly documented and appropriate for implementing the

proposal.

8. Budget justification (not scored).

The extent to which the budget is reasonable, clearly justified,

and consistent with the intended use of funds.

Part C: Assessment/Evaluation Studies--Factors To Be Considered

------------------------------------------------------------------------

Evaluation criterion Points

------------------------------------------------------------------------

1. Study protocol............................................. 45

2. Project personnel.......................................... 20

3. Project management......................................... 35

4. Budget and justification................................... (\1\)

5. Human Subjects............................................. (\1\)

---------

Total Maximum Points...................................... 100

------------------------------------------------------------------------

\1\ Not scored.

Part C: Assessment/Evaluation Studies--Factors To Be Considered

1. Study protocol (45 Points)

The protocol's scientific soundness (including adequate sample size

with power calculations), quality, feasibility, consistency with the

project goals, and soundness of the evaluation plan (which should

provide sufficient detail regarding the way in which the program will

be implemented to facilitate replication of the program).

The degree to which the applicant has met the CDC Policy

requirements regarding the inclusion of women, ethnic, and racial

groups in the proposed project. This includes: (a) The proposed plan

for the inclusion of both sexes and racial and ethnic minority

populations for appropriate representation; (b) The proposed

justification when representation is limited or absent; (c) A statement

as to whether the design of the study is adequate to measure

differences when warranted; and (d) A statement as to whether the plans

for recruitment and outreach for study participants include the process

of establishing partnerships with community(ies) and recognition of

mutual benefits will be documented.

2. Project personnel (20 Points)

The qualifications, experience (including experience in conducting

relevant studies), and time commitment of the staff needed to ensure

that the study will be carried out.

3. Project management (35 Points)

Schedule for implementing and monitoring the proposed study. The

extent to which the application documents specific, attainable, and

realistic goals and clearly indicates the performance measures that

will be monitored, how they will be monitored, and with what frequency.

This section should contain enough detail to determine at the end of

each budget year the extent to which the project is on target in

completing the study process and outcome objectives.

4. Budget justification (not scored).

The extent to which the budget is reasonable, clearly justified,

and consistent with the intended use of cooperative agreement funds.

5. Human subjects (not scored).

The extent to which the applicant complies with the Department of

Health and Human Services regulations (45 CFR Part 46) regarding the

protection of human subjects.

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 comments they should be sent 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, GA 30305, no later than 60 days after

the application due date. The Program Announcement Number and Program

Title should be referenced on the document. The granting agency does

not guarantee to ``accommodate or explain'' state process

recommendations it receives after that date.

Public Health System Reporting Requirement

This program is not subject to the Public Health System Reporting

Requirements.

Catalog of Federal Domestic Assistance Number

The Catalog of Federal Domestic Assistance number is 93.197.

Other Requirements

Paperwork Reduction Act

Data collection initiated under this grant has been approved by the

Office of Management and Budget under number 0920-0282, ``Childhood

Lead Prevention Grant Reporting''. Exp. Date 10/98. OMB clearance for

the data collection for the surveillance activities, ``Childhood Blood

Lead Surveillance System OMB No. 0920-0337, Exp. Date 1/98'' is pending

approval by OMB.

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

form provided in the application kit.

Women and Minority Inclusion Policy

It is the policy of the CDC to ensure that women and racial and

ethnic groups will be included in CDC-supported research projects

involving human subjects, whenever feasible and appropriate. Racial and

ethnic groups are defined in OMB Directive No. 15 and include American

Indian or Alaska Native, Asian, Black or African American, Native

Hawaiian or Other Pacific Islander, and Hispanic or Latino. Applicants

shall ensure that women and racial and ethnic minority populations are

appropriately represented in applications for research involving human

subjects. Where a clear and compelling rationale exists that inclusion

is inappropriate or not feasible, this situation must be explained as

part of the application.

In conducting the review of applications for scientific merit,

review groups will evaluate proposed plans for inclusion of minorities

and both sexes as part of the scientific assessment and assigned score.

This policy does not apply to research studies when the investigator

cannot control the race, ethnicity, and/or sex of subjects. Further

guidance to this policy is contained in the Federal Register, Vol. 60,

No. 179, Friday, September 15, 1995, pages 47947-47951.

Application Submission and Deadline

Applicants submitting for Part A (CLPP program) or Part B (CBLS

program) please submit the original and two copies of the PHS 5161-1

(OMB Number 0937-0189).

Applicants submitting for Part C (additional and supplemental

funds) please submit an original and five copies of the PHS 398.

All applications must be submitted to Lisa G. Tamaroff, Grants

Management Specialist, Grants Management Branch,

[[Page 5555]]

Procurement and Grants Office, Centers for Disease Control and

Prevention (CDC), 255 East Paces Ferry Road, NE., Room 300, Atlanta, GA

30305, on or before March 31, 1998.

1. Deadline

Applications shall 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 for the review process. 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 which do not meet the criteria in 1.A. or 1.B. above

are considered late applications. Late applications will not be

considered in the current competition and will be returned to the

applicant.

A one-page, single-spaced, typed abstract must be submitted with

the application. The heading should include the title of the grant

program, project title, organization, name and address, project

director, and telephone number.

Where to Obtain Additional Information

To receive additional written information, call 1-888-GRANTS4. You

will be asked to leave your name, address, and phone number and will

need to refer to Announcement 98018. You will receive a complete

program description, information on application procedures, and

application forms.

If you have questions after reviewing the contents of all

documents, business management technical assistance may be obtained

from 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, Room 300, Mailstop E-

13, Atlanta, GA 30305, telephone (404) 842-6796 (Internet address

[email protected]).

This and other CDC announcements are also available through the CDC

homepage on the Internet. The address for the CDC homepage is http://

www.cdc.gov.

CDC will not send application kits by facsimile or express mail.

Please refer to Announcement Number 98018 when requesting

information and submitting an application.

Technical assistance on CLPP program or Part C. activities may be

obtained from Claudette A. Grant, Acting Chief, Program Services

Section, Lead Poisoning Prevention Branch, Division of Environmental

Hazards and Health Effects, National Center for Environmental Health,

Centers for Disease Control and Prevention (CDC), 4770 Buford Highway,

NE, Mailstop F-42, Atlanta, GA 30341-3724, telephone (770) 488-7330

(Internet address [email protected]).

Technical assistance on CBLS program activities may be obtained

from Sharunda D. Buchanan, Ph.D., Epidemiologist, Surveillance and

Programs Branch, Division of Environmental Hazards and Health Effects,

National Center for Environmental Health, Centers for Disease Control

and Prevention (CDC), 4770 Buford Highway, NE, Mailstop F-47, Atlanta,

GA 30341-3724, telephone (770) 488-7060 (Internet address

[email protected]).

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) through the Superintendent

of Documents, Government Printing Office, Washington, DC 20402-9325,

telephone (202) 512-1800.

Dated: January 27, 1998.

Joseph R. Carter,

Acting Associate Director for Management and Operations, Centers for

Disease Control and Prevention.

Appendix A: Background on CDC's estimate of number and

proportion of children at high risk for lead exposure by state.

To provide states with general guidance about the appropriate

amount of funding to request under this Program Announcement, CDC

estimated the number and percentage of children with EBLLs for each

state. CDC used a logistic-regression model to estimate the

contribution of four major risk factors to the probability that an

individual child would have a blood lead level (BLL) of at least 10

g/dL. The selected risk factors were based on data from

Phase 2 of the Third National Health and Nutrition Examination

Survey (NHANES III, Phase 2) and included the age and race of

children, age of housing, and family income. The model established a

relative contribution or ``coefficient'' for each of these factors.

These coefficients were then applied to the relevant categories of

1990 census data for each state to produce an estimate of both the

number and the percentage of children with elevated BLLs in the

state.

CDC's purpose in estimating the number and percentage of

children with EBLLs in each state is to approximate the level of

effort that may be required to provide prevention services to the

entire population of a state. In accordance with this purpose, CDC

adjusted the level of effort projected for state-level CLPP Programs

in states with one or more locales currently funded under this grant

program.

To derive the funding category for each state, CDC gave twice as

much weight to the estimated percentage of children with elevated

BLLs as to the estimated number of children with elevated BLLs.

Note: The categorization scheme developed for use in this

Program Announcement is likely to be of only limited usefulness for

other purposes. The use of an approximation is necessary because of

the wide variation among states in the extent to which their

pediatric populations are exposed to lead.

[FR Doc. 98-2572 Filed 2-2-98; 8:45 am]

BILLING CODE 4163-18-P