Federal Register / Vol. 65, No. 28 / Thursday, February 10, 2000 / Notices 6607

Federal Coal Mine & Safety Act of 1969),

the Public Health Service has developed

a nationwide autopsy program

(NCWAS) for underground coal miners.

The Consent Release and History Form

is primarily used to obtain written

authorization from the next-of-kin to

perform an autopsy on the deceased

miner. The study is a service program to

aid surviving relatives in establishing

eligibility for black lung compensation.

Because a basic reason for the postmortem exam is research (both

epidemiological and clinical), included

are a minimum of essential information

regarding the deceased miner, his

occupational history, and his smoking

history. The data collected will be used

by the staff at NIOSH for research

purposes in defining the diagnostic

criteria for coal workers’

pneumoconiosis (black lung) and will

be correlated with pathologic changes

and x-ray findings.

It is estimated that only 5 minutes is

required for the pathologist to put a

statement on the invoice affirming that

no other compensation is received for

the autopsy. From past experience, it is

estimated that 15 minutes is required for

the next-of-kin to complete form CDC/

NIOSH 2.6. In as much as an autopsy

report is routinely completed by a

pathologist, the only additional burden

is the specific request of abstract of

terminal illness and final diagnosis

relating to pneumoconiosis. Therefore,

only 5 minutes of additional burden is

estimated for the autopsy report. The

total annual burden hours are 62.5.

Respondents Number of

respondents

Number of

responses/

respondent

Avg. burden

of response

(in hrs.)

Pathologist:

Invoice .............................................................................................................................................. 150 1 5/60

Report ............................................................................................................................................... 150 1 5/60

Next-of-Kin ............................................................................................................................................... 150 1 15/60

Dated: February 2, 2000.

Nancy Cheal,

Acting Associate Director for Policy, Planning

and Evaluation, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 00–3060 Filed 2–9–00; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

[Program Announcement 00033]

Childhood Lead Poisoning Prevention

Programs (CLPPP); Notice of

Availability of Funds

A. Purpose

The Centers for Disease Control and

Prevention (CDC) announces the

availability of fiscal year (FY) 2000

funds for a cooperative agreement

program for new State and competing

continuation State and local programs to

develop and improve Childhood Lead

Poisoning Prevention activities which

include building Statewide capacity to

conduct surveillance of blood lead

levels in children. This program

addresses the ‘‘Healthy People 2000’’

priority area of Environmental Health.

The purpose of this program is to

provide the impetus for the

development, implementation,

expansion, and evaluation of State and

local childhood lead poisoning

prevention program activities which

include Statewide surveillance capacity

to determine areas at high risk for lead

exposure. Also, this cooperative

agreement is to carry out the core public

health functions of Assessment, Policy

Development, and Assurance in

childhood lead poisoning prevention

programs.

Funding for this program will be to:

1. Develop and/or enhance a

surveillance system that monitors all

blood lead levels.

2. Assure screening of children who

are potentially exposed to lead and

follow-up care for children who are

identified with elevated blood lead

levels (BLLs).

3. Assure awareness and action

among the general public and affected

professionals in relation to preventing

childhood lead poisoning.

4. Expand primary prevention of

childhood lead poisoning in high-risk

areas in collaboration with other

government and community-based

organizations.

As programs shift emphasis from

providing direct screening and followup services to the core public health

functions, cooperative agreement funds

may be used to support and emphasize

health department responsibilities to

screen high risk children and provide

appropriate follow-up services. This

includes improving coalitions and

partnerships; conducting better and

more sophisticated assessments;

developing and evaluating policies,

program performance, and effectiveness

based on established goals and

objectives.

B. Eligible Applicants

Applicant eligibility is divided into

Part A (New Applicants), Part B

(Competing Continuation), and Part C

(Supplemental Funding for Alternative

Surveillance Assessment/Screening

Recommendation Evaluation) defined in

the following section. In the future, CDC

plans to shift its program emphasis

toward State funding for childhood lead

poisoning prevention activities.

However, the top five metropolitan

statistical areas (SMSAs)/largest cities

will be eligible for direct funding for

childhood lead poisoning prevention

activities indefinitely. They are New

York City, Los Angeles, Chicago,

Philadelphia, and Houston.

Part A: Eligible applicants are State

health departments or other State health

agencies or departments not currently

funded by CDC and any eligible SMSA

not currently receiving direct funding

from CDC for childhood lead poisoning

prevention activities. Also eligible are

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 federallyrecognized Indian tribal governments.

Please note: Local health departments

are not eligible to apply for cooperative

agreement funding under Part A of this

program announcement.

Applicants encouraged to apply under

Part A are: Alaska; Arkansas; Georgia;

Hawaii; Idaho; Kansas; Kentucky;

Mississippi; Nevada; North Dakota;

Oklahoma; South Dakota; Tennessee;

Texas and Wyoming.

Part B: Eligible applicants are those

currently funded by the Centers for

Disease Control and Prevention whose

project period will expire June 30, 2000.

These applicants are: Alabama; Arizona;

California; Delaware; Detroit, MI;

Houston, TX; Indiana; Iowa; Maine;

Marion County, IN; Michigan; New

Hampshire; Pinellas County, FL; Salt

6608 Federal Register / Vol. 65, No. 28 / Thursday, February 10, 2000 / Notices

Lake City, UT; Virginia and

Westchester, NY. In the future, CDC

plans to shift its program emphasis

towards State and large metropolitan

statistical areas (SMSAs) which

includes Houston, TX funding for

childhood lead poisoning prevention

activities. Consequently, local

applicants eligible for Part B will only

receive funding for a two-year project

period based on satisfactory program

performance. These are Detroit, MI;

Marion County, IN; Pinellas County, FL;

Salt Lake City, UT; and Westchester,

NY.

Part C: Eligible applicants are those

State applicants that apply under Part B.

Funding under Part C will only be

considered if the Part B application: (1)

Is successful and chosen for funding

and (2) has met the program

requirement of submitting data to CDC’s

national surveillance database.

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 (for

example, the State environmental health

agency).

C. Availability of Funds

Part A: New Applicants

Up to $2,500,000 will be available in

FY 2000 to fund up to 8 new applicants.

CDC anticipates that awards for the first

budget year will range from $75,000 to

$800,000.

Part B: Competing Continuations

Up to $8,000,000 will be available in

FY 2000 to fund up to 17 competing

continuation applicants. CDC

anticipates that awards for the first

budget year will range from $75,000 to

$1,500,000.

Part C: Supplemental Studies

Up to $400,000 will be awarded in FY

2000 to fund up to 4 assessment/

evaluation studies with a three-year

project period. These funds will be

awarded to support the development of

alternative surveillance assessments

and/or to conduct evaluation of the

impact of lead screening

recommendations. Awards are expected

to range from $70,000 to $100,000, with

the average award being approximately

$85,000. Funds will be awarded for

assessment/evaluation studies that

address one of the following:

1. Alternative Surveillance

Assessment—Assessment of lead

exposure in a jurisdictional population

or sub-population using an approach to

surveillance that differs from the

Statewide CBLS system described in

this announcement.

2. Screening Recommendation

Evaluation—Evaluation of the impact of

lead screening recommendations on

screening for high-risk children.

Funding for State applicants: To

determine the type of program activities

and the associated level of funding for

an individual State applicant for Part A

or Part B, please refer to the table below.

These are suggested funding guidelines

and should not be regarded as absolute

funding limits. Addendum 2 in the

application package provides an

explanation of the factors used to

develop categorical funding

recommendations. Addendum 3

provides an explanation of the program

activities required for each funding

category.

Suggested Funding Categories Based on

Projected Level of Effort Required To

Provide Prevention and Surveillance

Activies 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

Massasschusette—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.

Funding State Applicants—Part A or

Part B: Determine your funding category

(Category 1, 2, or 3) according to the

table below. The range and average of

awards for each funding category

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

Awards for Local Applicants (under

Part B only): The suggested range of

awards for local applicants is $250,000

to $450,000.

Additional Information on Funding

for all Applicants for Part A, Part B, and

Part C New awards are expected to

begin on or about July 1, 2000, and are

made for 12-month budget periods

within project periods not to exceed 2-

years for local programs or 3-years for

State programs. 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. Awards cannot

supplant existing funding for CLPP or

Supplemental Funding Initiatives.

Funds should be used to enhance the

level of expenditures from State, local,

and other funding sources.

Note: Funds may not be expended for

medical care and treatment or for

environmental remediation of sources 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 cooperative

agreement or contract through the

cooperative agreement may be obligated

for administrative costs. This 10 percent

limitation is in lieu of, and replaces, the

indirect cost rate.

D. Program Requirements

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 Sec. 303 of the

‘‘Preventive Health Amendments of

1992’’ (Public Law 102–531), applicants

AND current grantees must meet the

Federal Register / Vol. 65, No. 28 / Thursday, February 10, 2000 / Notices 6609

following requirements: For CLPP

program services which are Medicaidreimbursable 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.

In order to satisfy this program

requirement, please provide a copy of a

Medicaid provider certificate or

Statement as proof that you meet this

requirement. Failure to include this

information would result in your

application being returned. Please place

this information immediately behind

the budget and budget justification

pages.

Cooperative Activities

Part A and Part B: New and Competing

Continuations

To achieve the purpose of this

cooperative agreement program, the

recipient will be responsible for the

activities listed under 1. Recipient

Activities and CDC will be responsible

for the activities listed under 2. CDC

Activities.

1. Recipient Activities

a. Establish, maintain, or enhance a

Statewide surveillance system in

accordance with CDC guidance. For

local applicants (under Part B), enhance

a data management system that links

with the State’s surveillance system or

develop an automated data management

system to collect and maintain

laboratory data on the results of blood

lead analyses and data on follow-up

care for children with elevated BLLs.

State recipients should ensure receipt of

data from local programs. Local

recipients should transfer relevant data

to the appropriate State entity in a

timely manner for annual submission to

CDC.

b. Manage, analyze and interpret

individual State surveillance data, and

present and disseminate trends and

other important public health findings.

c. Develop, implement and evaluate a

Statewide/jurisdiction-wide 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, participate in the Statewide

planning process. Make screening

recommendations and appropriate local

screening strategies available and

known to health care providers.

d. Assure appropriate follow-up care

is provided for children identified with

elevated blood lead levels.

e. 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; communitybased organizations providing health

and social services in or near public

housing units, as authorized under

Section 330(i) of the PHS Act; State and

local epidemiology programs; State and

local housing rehabilitation programs;

schools of public health and medical

schools; and environmental interest

groups).

f. For State Programs, provide

managerial, technical, analytical, and

program evaluation assistance to local

agencies and organizations in

developing or strengthening their CLPP

programs activities.

2. CDC Activities

a. Provide technical, and scientific

assistance and consultation on program

development, implementation and

operational issues.

b. Provide technical assistance and

scientific consultation regarding the

development and implementation of all

surveillance activities including data

collection methods and analysis of data.

c. Assist with data analysis and

interpretation of individual State

surveillance data and release of national

reports. Reports will include analysis of

national aggregate data as well as Statespecific data.

d. Assist cooperative agreement

recipients with communication and

coordination among Federal agencies,

and other public and private agencies

and organizations.

e. Conduct ongoing assessment of

program activities to ensure the use of

effective and efficient implementation

strategies.

Part C: Supplemental Studies

To achieve the purpose of this

program, the recipient will be

responsible for the activities listed

under 1. Recipient Activities and CDC

will be responsible for the activities

listed under 2. CDC Activities.

1. Recipient Activities

a. Develop and implement a study

protocol to include the following:

methodology, sample selection, field

operation, and statistical analysis.

Applicants must provide a means of

assuring that the results of the study

will be published.

b. Revise, refine, and carry out the

proposed methodology for conducting

Supplemental Funding Studies.

c. Monitor and evaluate all aspects of

the assessment activities.

d. Conduct and evaluate public health

programs and/or have access to

professionals who are knowledgeable in

conducting such activities.

2. CDC Activities

a. Provide technical and scientific

consultation on activities related to

overall program requirements of

supplemental funding activities.

b. Provide technical assistance to

program manager and/or principal

investigator regarding revision,

refinement, and implementation of

study design and proposed methodology

for conducting supplemental funding

activities.

c. Assist program manager and/or

principal investigator with data

interpretation and analysis issues.

E. Application Content

Use the information in the Program

Requirements, Other Requirements, and

Evaluation Criteria sections to develop

the application content. Your

application will be evaluated on the

criteria listed, so it is important to

follow them in laying out your program

plan:

Applications must be developed in

accordance with PHS Form 5161–1.

Part B applicants also competing for

Part C funds must submit separate

applications.

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

unreduced font (10 or 12 point font

only) on 81⁄2′′ 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.

A one-page, single-spaced, typed

abstract must be submitted with the

application. The heading should

include the title of the program, project

title, organization, name and address,

project director, telephone number,

facsimile number, and e-mail address.

6610 Federal Register / Vol. 65, No. 28 / Thursday, February 10, 2000 / Notices

The main body of the CLPP program

application (Parts A or B) must include

the following: budget/budget

justification; Medicaid certification;

progress report (Part B applicants only);

understanding the problem;

surveillance/data-management

activities; Statewide/jurisdiction-wide

planning and collaboration; core public

health functions; goals and objectives;

program management and staffing; and

program evaluation.

The main body of the supplemental

funding project application (Part C)

must include the following: study

protocol, project personnel, and project

management.

Each application should not exceed

75 pages. The abstract, budget narrative,

and budget justification pages are not

included in the 75 page limit.

Supplemental information should be

placed in appendices and is not to

exceed 25 pages.

Part B applicants must submit a

progress report no longer than 10 pages

in their competing continuation

application. This report should be

placed immediately after the budget and

budget justification.

Provide qualified staff, other

resources, and knowledge to implement

the provisions of the program.

Applicants requesting cooperative

agreement supported positions must

provide assurances that such positions

will be authorized to be filled by the

applicant’s personnel system.

F. Submission and Deadline

Submit the original and two copies of

the PHS 5161–1 (OMB Number 0937–

0189) on or before April 12, 1999. Forms

are in the application kit.

Submit the application to: Mattie B.

Jackson, Grants Management Specialist,

Grants Management Branch,

Procurement and Grants Office, Program

Announcement 00033, Centers for

Disease Control and Prevention (CDC),

2920 Brandywine Road, Room 3000,

Atlanta, GA 30341–4146.

Applications shall be considered as

meeting the deadline if they are either:

(1) Received on or before the deadline

date, or (2) sent on or before the

deadline date and received in time for

submission for the review process.

Applicants must request 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.

Applications which do not meet the

criteria above are considered late

applications. Late applications will not

be considered in the current

competition and will be returned to the

applicant.

G. Evaluation Criteria

The review of applications will be

conducted by an objective review panel

as they relate to the applicant’s response

to either Part A, Part B, or Part C. The

applications will be evaluated according

to the following criteria:

Part A: New Applicants

1. Understanding of the Problem (15

points)

The extent to which the applicant’s

description and understanding of the

burden and distribution of childhood

lead exposure or elevated BLLs in their

jurisdiction, using evidence (as

available) of incidence and/or

prevalence and demographic indicators,

including a description of the Medicaid

population.

2. Surveillance Activities (20 points)

The applicant’s ability to develop a

childhood blood lead surveillance

system that includes; (a) a flow chart

that describes data transfer, (b) a

mechanism for tracking lead screening

services to children, especially

Medicaid children, and (c) a mechanism

for reporting data annually to the CDC’s

national surveillance database. The

clarity, feasibility, and scientific

soundness of the surveillance approach.

Also, the extent to which the proposed

time table for accomplishing each

activity and methods for evaluating each

activity are appropriate and clearly

defined. The following elements will be

specifically evaluated:

a. How laboratories report Blood Lead

Levels (BLLs), including ability to

identify and assure reporting from

private laboratories which perform lead

testing.

b. How data will be collected and

managed.

c. How quality of data and

completeness of reporting will be

assured.

d. How and when data will be

analyzed.

e. How summary data will be reported

and disseminated on a regular basis (i.e.,

newsletters, fact sheets, annual reports).

f. Protocols for follow-up of

individuals with elevated BLLs.

g. Provisions to obtain denominator

data (results of all laboratory blood lead

tests, regardless of level).

h. Time line and methods for

evaluating the Childhood Blood Lead

Surveillance (CBLS) approach.

i. Plans to convert paper-based

components of the system to electronic

data manipulation.

j. Use of data including evaluation of

prevention activities, especially to target

screening and prevention efforts.

3. Statewide Planning and Collaboration

(20 points)

The applicant’s ability to develop

Statewide screening recommendations

with appropriate local strategies. The

following elements will be specifically

evaluated:

a. The proposed 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’’.

b. The extent to which the applicant

plans to utilize surveillance and

program data to produce a Statewide

screening recommendation, with

specific attention given to the Medicaid

population.

c. The ability of the applicant to

involve collaborators in the

development of a screening plan and

implementation of strategies to

strengthen childhood lead poisoning

prevention activities.

d. The applicant’s demonstrated

ability to collaborate 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, must be demonstrated by

letters of support, memoranda of

understanding, contracts, or other

documented evidence of relationships.

4. Capacity To Carry Out Public Health

Core Functions (10 points)

The applicant’s ability to describe the

approach and activities necessary to

achieve a balance among health

department roles in CLPP, including

assessment, program and policy

development, and monitoring,

evaluating, and ensuring the provision

of all necessary components of a

comprehensive CLPP activities within

their respective categories.

5. Goals and Objectives (15 points)

The extent to which the applicant’s

goals and objectives relate to the CLPP

activities in their respective categories.

Objectives must be relevant, specific,

measurable, achievable, and timeframed. There must be a formal work

plan with a description of methods, a

timetable and program staff responsible

for accomplishment of each objective,

and the evaluation of each proposed

objective.

6. Project Management and Staffing

(10 points)

The extent to which the applicant has

documented the skills and ability to

develop and carry out a comprehensive

Federal Register / Vol. 65, No. 28 / Thursday, February 10, 2000 / Notices 6611

CLLP program. Specifically, the

applicant should:

a. Describe the proposed health

department staff roles in CLPP, their

specific responsibilities, and their level

of effort and time. Include a plan to

expedite filling of all positions and

assure that requested positions have

been or will be approved by applicant’s

personnel system.

b. Describe the plan to provide

training and technical assistance to

health department personnel and

consultation to collaborators outside the

health department, including proposed

design of information-sharing systems.

7. Program Evaluation (10 points)

The extent to which the applicant

proposes to measure the overall impact

of health department CLPP activities.

Specific criteria should include:

a. The plan for evaluating the impact

or outcome of CLPP activities, including

evaluation design, methods, and

activities.

b. Description of how the project will

assess changes in public policy and

measure the effectiveness of

collaborative activities.

c. Progress made in childhood lead

poisoning prevention which resulted

from planned health department

strategies.

8. Budget justification (not scored)

The extent to which the budget is

reasonable, clearly justified, and

consistent with the intended use of

funds.

Part B: Competing Continuations

1. Understanding of the Problem (15

points)

The extent to which the applicant’s

description and understanding of the

burden and distribution of childhood

lead exposure or elevated BLLs in their

jurisdiction, using evidence (as

available) of incidence and/or

prevalence and demographic indicators,

including a description of the Medicaid

population.

2. Surveillance Activity (20 points)

For State Applicants: The applicant’s

ability to expand its childhood blood

lead surveillance system that includes

tracking lead screening for Medicaid

children, evaluating the existing system,

and reporting data to the CDC’s national

surveillance database. The clarity,

feasibility, and scientific soundness of

the surveillance approach. Also, the

extent to which the proposed time table

for accomplishing each activity are

appropriate and clearly defined. The

following elements will be specifically

evaluated:

a. How laboratories report BLLs,

including ability to identify and assure

reporting from private laboratories

which perform lead testing.

b. How data are collected and

managed.

c. How quality of data and

completeness of reporting are assured.

d. How and when data are analyzed.

e. How summary data are reported

and disseminated on a regular basis (i.e.,

newsletters, fact sheets, annual reports).

f. Protocols for follow-up of

individuals with elevated BLLs.

g. Provisions to obtain denominator

data (results of all laboratory blood lead

tests, regardless of level).

h. Time line and methods for

evaluating the Childhood Blood Lead

Surveillance (CBLS) approach.

i. Process used to convert paper-based

components of the system to electronic

data.

j. Use of data including evaluation of

prevention activities, especially to target

screening and prevention efforts.

For local applicants (Part B only): The

applicant’s ability to expand their data

management system, including the

approach to participating in the State

CBLS, if applicable. The clarity,

feasibility, and scientific soundness of

the approach to data management. Also,

the extent to which the proposed

schedule for accomplishing each

activity and method for evaluating each

activity are clearly defined and

appropriate. The following elements

will be specifically evaluated:

a. How laboratories report Blood Lead

Levels (BLL), including ability to

identify and assure reporting from

private laboratories which perform lead

testing.

b. How data are collected and

managed.

c. How quality of data and

completeness of reporting are assured.

d. How and when data are analyzed.

e. How summary data are reported

and disseminated on a regular basis (i.e.,

newsletters, fact sheets, annual reports).

f. Protocols for follow-up of

individuals with elevated BLLs.

g. Provisions to obtain denominator

data (results of all laboratory blood lead

tests, regardless of level).

h. Time line and methods for

evaluating the Childhood Blood Lead

Surveillance (CBLS) approach.

i. Process used to convert paper-based

components of the system to electronic

data.

j. Use of data including evaluation of

prevention activities, especially to target

screening and prevention efforts.

3. Statewide/Jurisdiction-wide Planning

and Collaboration (20 points)

The applicant’s ability to develop

Statewide/jurisdiction-wide screening

recommendations with appropriate

local strategies. The following elements

will be specifically evaluated:

a. 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’’.

b. The extent to which the applicant

utilized surveillance and program data

to produce Statewide/jurisdiction-wide

screening recommendations and target

the Medicaid population.

c. Description of how collaborations

facilitated the development of a

screening plan and strengthened

childhood lead poisoning prevention

strategies.

d. Evidence of collaboration with

principal partners, including managedcare organizations, State Medicaid

agency, child health-care providers and

provider groups, insurers, communitybased organizations, housing agencies,

and banking, real-estate, and propertyowner interests. These collaborations

must be demonstrated by letters of

support, memoranda of understanding,

contracts, or other documented

evidence of relationships.

Note: For applicants under Part B, describe

progress in developing and implementing the

screening plan based upon each of the

elements listed above.

4. Capacity to Carry Out Public-Health

Core Functions (10 points)

The ability to describe the approach

and activities taken to achieve a balance

among health-department roles in CLPP,

including assessment, program and

policy development, and monitoring,

evaluating, and ensuring the provision

of all CLPP activities within their

respective categories (for example,

Category 3 requires screening plans,

surveillance systems, assure follow-up

care, and evaluation).

5. Goals and Objectives (10 points)

The extent to which the applicant’s

goals and objectives relate to the CLPP

activities in their respective categories

under which they applied. 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

and program staff responsible for

accomplishment of each objective.

6612 Federal Register / Vol. 65, No. 28 / Thursday, February 10, 2000 / Notices

6. Project Management and Staffing (10

points)

The extent to which the applicant has

the skills and ability to develop and

carry out a comprehensive CLLP

program. Specifically the applicant

should:

a. Describe the proposed health

department staff roles in CLPP, their

specific responsibilities, and their level

of effort and time. Include a plan to

expedite filling of all positions and

assure that requested positions have

been or will be approved by the

applicant’s personnel system.

b. Describe the plan to provide

training and technical assistance to

health department personnel and

consultation to collaborators outside the

health department, including proposed

design of information-sharing systems.

7. Program Evaluation (10 points)

The extent to which the applicant

measures the overall impact of health

department CLPP activities. Specific

criteria should include:

a. Description of the progress made to

evaluate the impact and outcome of

collective CLPP activities, including the

evaluation design, methods, and tasks.

b. Description of the changes in the

effectiveness of collaborative activities.

c. Progress made in childhood lead

poisoning prevention which resulted

from planned health department

strategies.

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: Supplemental Funding—Factors

To Be Considered

1. Study Protocol (45 points)

The applicant’s ability to develop a

scientifically sound protocol (including

adequate sample size with power

calculations), quality, feasibility,

consistency with project goals, and

soundness of the evaluation plan (which

should provide sufficient detail

regarding the way the protocol will be

implemented). 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 to include 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 includes

establishing partnerships with

community-based agencies and

organizations. Benefits of the

partnerships should be described.

2. Project Personnel (20 points)

The extent to which personnel

involved in this project are qualified,

including experience in conducting

relevant studies. In addition, the

applicant’s ability to commit

appropriate staff time needed to carry

out the study.

3. Project Management (35 points)

The applicant’s ability to implement

and monitor the proposed study to

include specific, attainable, and realistic

goals and objectives, and evaluation

plan.

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) on the protection of human

subjects.

H. Other Requirements

Technical Reporting Requirements

Provide CDC with the original plus

two copies of:

1. Quarterly progress reports, which

are required of all grantees. The

quarterly report narrative 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.

2. Calendar year surveillance data and

a written surveillance summary report

must be submitted annually to CDC in

the approved OMB format to be

disseminated to State and local public

health officials and congressional

personnel. Data must be submitted to

CDC by March 31st in the required

format for analysis.

3. Financial Status Reports, are due

within 90 days of the end of the budget

period.

4. Final financial reports and

performance reports are due within 90

days after the end of the project period.

Send all reports to the Grants

Management Specialist identified in the

‘‘Where to Obtain Additional

Information’’ section of this

announcement.

Note: Data collection initiated under this

cooperative agreement program has been

approved by the Office of Management and

Budget under OMB number (0920–0337),

‘‘National Childhood Blood Lead

Surveillance System’’, Expiration Date:

March 31, 2001.

The following additional

requirements are applicable to this

program. For a complete description of

each, see Addendum 1 in the

application package.

AR–1 Human Subjects Requirement

AR–2 Requirements for Inclusion of

Women and Racial and Ethnic

Minorities in Research

AR–7 Executive Order 12372 Review

AR–9 Paperwork Reduction Act

Requirements

AR–10 Smoke-Free Workplace

Requirements

AR–11 Healthy People 2000

AR–12 Lobbying Restrictions

I. Authority and Catalog of Federal

Domestic Assistance Number

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. The Catalog of

Federal Domestic Assistance number is

93.197.

J. Pre-Application Workshop for New

and Competing Continuation

Applicants

In addition, for interested applicants,

a telephone conference call for preapplication technical assistance will be

held on Wednesday, February 16, 2000,

from 1:30 p.m. to 3:30 p.m, Eastern

Standard Time. The bridge number for

the conference call is 1–800–311–3437,

and the pass code is 350892. For further

information about all workshops, please

contact Claudette Grant-Joseph at 404–

639–2510.

K. Where To Obtain Additional

Information

This and other CDC announcements

may be downloaded through the CDC

homepage on the Internet at http://

www.cdc.gov. Please refer to program

announcement number 00033 when

requesting information. To receive

additional written information and to

request an application kit, call 1–888–

GRANTS4 (1–888–472–6874). You will

be asked to leave your name, address,

and phone number and will need to

refer to Announcement 00033. You will

receive a complete program description,

information on application procedures,

and application forms. CDC will not

send application kits by facsimile or

express mail.

Federal Register / Vol. 65, No. 28 / Thursday, February 10, 2000 / Notices 6613

If you have questions after reviewing

the contents of all documents, business

management technical assistance may

be obtained from: Mattie B. Jackson,

Grants Management Specialist, Grants

Management Branch, Procurement and

Grants Office, Centers for Disease

Control and Prevention (CDC), 2920

Brandywine Road, Room 3000, Atlanta,

GA 30341–4146, telephone (770) 488–

2718, Internet address mij3.@cdc.gov

For programmatic technical

assistance, contact: Claudette A. GrantJoseph, 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),

1600 Clifton Road, NE, Mailstop E–25,

Atlanta, GA 30333, telephone (404)

639–2510, Internet address

cag4@cdc.gov

Dated: February 4, 2000.

John L. Williams,

Director, Procurement and Grants Office,

Centers for Disease Control and Prevention

(CDC).

[FR Doc. 00–3062 Filed 2–9–00; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 99N–2250]

Agency Information Collection

Activities; Announcement of OMB

Approval; Current Good Manufacturing

Practices for Blood and Blood

Components; Notification of

Consignees Receiving Blood and

Blood Components at Increased Risk

for Transmitting HIV Infection

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that a collection of information entitled

‘‘Current Good Manufacturing Practices

for Blood and Blood Components;

Notification of Consignees Receiving

Blood and Blood Components at

Increased Risk for Transmitting HIV

Infection’’ has been approved by the

Office of Management and Budget

(OMB) under the Paperwork Reduction

Act of 1995.

FOR FURTHER INFORMATION CONTACT:

JonnaLynn P. Capezzuto, Office of

Information Resources Management

(HFA–250), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–4659.

SUPPLEMENTARY INFORMATION: In the

Federal Register of November 4, 1999

(64 FR 60212), the agency announced

that the proposed information collection

had been submitted to OMB for review

and clearance under 44 U.S.C. 3507. An

agency may not conduct or sponsor, and

a person is not required to respond to,

a collection of information unless it

displays a currently valid OMB control

number. OMB has now approved the

information collection and has assigned

OMB control number 0910–0336. The

approval expires on January 31, 2003. A

copy of the supporting statement for this

information collection is available on

the Internet at http://www.fda.gov/

ohrms/dockets.

Dated: February 3, 2000.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 00–3013 Filed 2–9–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 99N–0407]

Agency Information Collection

Activities; Announcement of OMB

Approval; Reclassification Petitions for

Medical Devices

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that a collection of information entitled

‘‘Reclassification Petitions for Medical

Devices’’ has been approved by the

Office of Management and Budget

(OMB) under the Paperwork Reduction

Act of 1995.

FOR FURTHER INFORMATION CONTACT:

Peggy Schlosburg, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–1223.

SUPPLEMENTARY INFORMATION: In the

Federal Register of December 10, 1999

(64 FR 69270), the agency announced

that the proposed information collection

had been submitted to OMB for review

and clearance under 44 U.S.C. 3507. An

agency may not conduct or sponsor, and

a person is not required to respond to,

a collection of information unless it

displays a currently valid OMB control

number. OMB has now approved the

information collection and has assigned

OMB control number 0910–0138. The

approval expires on January 31, 2003. A

copy of the supporting statement for this

information collection is available on

the Internet at http://www.fda.gov/

ohrms/dockets.

Dated: February 3, 2000.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 00–3015 Filed 2–9–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Nonclinical Studies Subcommittee of

the Advisory Committee for

Pharmaceutical Science; Notice of

Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

This notice announces a forthcoming

meeting of a public advisory committee

of the Food and Drug Administration

(FDA). The meeting will be open to the

public.

Name of Committee: Nonclinical Studies

Subcommittee of the Advisory Committee for

Pharmaceutical Science (formerly the

Generic Drugs Advisory Committee).

General Function of the Committee: To

provide advice and recommendations to the

agency on FDA regulatory issues.

Date and Time: The meeting will be held

on March 9, 2000, 8:30 a.m. to 5:30 p.m.

Location: Center for Drug Evaluation and

Research conference room 1066, 5630 Fishers

Lane, Rockville, MD.

Contact Person: Kimberly L. Topper,

Center for Drug Evaluation and Research

(HFD–21), Food and Drug Administration,

5600 Fishers Lane Rockville, MD 20857, 301–

827–7001, e-mail: TOPPERK@cder.fda.gov, or

FDA Advisory Committee Information Line,

1–800–741–8138 (301–443–0572 in the

Washington, DC area), code 12539. Please

call the Information Line for up-to-date

information on this meeting.

Agenda: The subcommittee meeting will

discuss collaborative approaches to scientific

research issues of common interest to the

pharmaceutical industry, universities, the

public, and FDA. Specific areas of focus will

be in the nonclinical studies areas of: (1)

Interspecies biomarkers of toxicity and (2)

noninvasive imaging.

Procedure: Interested persons may present

data, information, or views, orally or in

writing, on issues pending before the

committee. Written submissions may be

made to the contact person by February 25,

2000. Oral presentations from the public will

be scheduled between approximately 1 p.m.

to 2 p.m. Time allotted for each presentation

may be limited. Those desiring to make

formal oral presentations should notify the

contact person before February 25, 2000, and