18130 Federal Register / Vol. 60, No. 68 / Monday, April 10, 1995 / Notices

C. Determine and manage all

promotional activities (e.g., title, logo,

announcements, mailers, press releases,

etc.). ATSDR must review and approve

all materials with reference to ATSDR

involvement or support.

D. Manage all registrants (e.g., travel,

reservations, correspondence,

conference materials and hand-outs,

badges, registration procedures, etc.).

E. Plan, negotiate, and manage

conference site arrangements, including

all audio-visual needs.

F. Develop and conduct education

and training programs on prevention of

health effects of hazardous substances.

G. Participate in the analysis of data

from conference activities.

H. Collaborate with ATSDR staff in

reporting and disseminating results and

relevant prevention education and

training information to appropriate

Federal, State, and local agencies, and

the general public.

Evaluation Criteria

Applications for support of the types

of conferences listed in the Purpose

section above will be reviewed and

evaluated according to the following

criteria:

A. Proposed Program and Technical

Approach—50%

The description of: (a) the public

health significance of the proposed

conference including the degree to

which the conference can be expected to

influence the prevention of exposure

and adverse human health effects and

diminished quality of life associated

with exposure to hazardous substances

from waste sites, unplanned releases

and other sources of pollution present

in the environment; (b) the feasibility of

the conference in terms of an

operational plan; (c) clearly stated

conference objectives and the potential

for accomplishing those objectives; and

(d) the method of evaluating the

conference.

B. The Qualification of Program

Personnel—30%

Evaluation will be based on the extent

to which the proposal has described: (a)

the qualifications, experience, and

commitment of the principal staff

person, and his/her ability to devote

adequate time and effort to provide

effective leadership, and (b) the

competence of associate staff persons,

discussion leaders, speakers, and

presenters to accomplish the proposed

conference.

C. Applicant Capability—20%

Evaluation will be based on the

description of (a) the adequacy and

commitment of institutional resources

to administer the program, and (b) the

adequacy of the facilities to be used for

the conference.

D. Budget Justification and Adequacy of

Facilities (Not Scored)

The proposed budget will be

evaluated on the basis of its

reasonableness, concise and clear

justification, and consistency with the

intended use of grant funds.

Applications requesting funds in excess

of $30,000 may not be fully funded,

depending upon availability of funds.

The application will also be reviewed as

to the adequacy of existing and

proposed facilities and resources for

conducting conference activities.

Executive Order 12372 Review

Applications are not subject to review

as governed by Executive Order 12372,

Intergovernmental Review of Federal

Programs.

Public Health System Reporting

Requirements

This program is not subject to the

Public Health System Reporting

Requirements.

Catalog of Federal Domestic Assistance

The Catalog of Federal Domestic

Assistance number is 93.161.

Application Submission and Deadline

The original and two copies of the

Application Form PHS 5161–1 (OMB

Number 0937–0189) shall be submitted

to Henry S. Cassell, III, Grants

Management Branch, Procurement and

Grants Office, 255 East Paces Ferry Rd.,

NE., Room 300, Mailstop E–13, Atlanta,

GA 30305, on or before June 13, 1995.

By formal agreement, the CDC

Procurement and Grants Office will act

on behalf of and for ATSDR on this

matter.

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 to

the review committee. (Applicants

should request a legibly dated U.S.

Postal Service postmark or obtain a

legibly dated receipt from a commercial

carrier or the U.S. Postal Service. Private

metered postmarks shall not be

acceptable as proof of timely mailing.)

2. Late Applications

Applications that do not meet the

criteria in 1.a. or 1.b. above are

considered late applications and will be

returned to the applicant.

Where to Obtain Additional

Information

To receive additional written

information call (404) 332–4561. You

will be asked to leave your name,

address, and phone number and will

need to refer to Announcement 516.

You will receive a complete program

description, information on application

procedures and application forms.

If you have questions after reviewing

the contents of all the documents,

business management assistance may be

obtained from Margaret A. Slay, 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,

Atlanta, GA 30305, telephone (404)

842–6797. Programmatic technical

assistance may be obtained from Diana

Cronin, Project Officer, Agency for

Toxic Substances and Disease Registry,

Division of Health Education, 1600

Clifton Road, NE., Mailstop E–33,

Atlanta, GA 30333, telephone (404)

639–6206.

Please refer to Announcement 516

when requesting information and

submitting an application.

Potential applicants may obtain a

copy of ‘‘Healthy People 2000’’ (Full

Report, Stock No. 017–001–00474–0) or

‘‘Healthy People 2000’’ (Summary

Report, Stock No. 017–001–00473–1)

referenced in the Introduction through

the Superintendent of Documents,

Government Printing Office,

Washington, DC 20402–9325, telephone

(202) 512–1800.

Dated: April 4, 1995.

David Satcher,

Administrator, Agency for Toxic Substances

and Disease Registry.

[FR Doc. 95–8716 Filed 4–7–95; 8:45 am]

BILLING CODE 4163–70–P

Centers for Disease Control and

Prevention

Agency for Toxic Substances and

Disease Registry Policy on the

Inclusion of Women and Minorities in

Externally Awarded Research

AGENCY: Centers for Disease Control and

Prevention (CDC) and Agency for Toxic

Substances and Disease Registry

(ATSDR), Public Health Service (PHS),

Department of Health and Human

Services (DHHS).

ACTION: Notice and request for

comments.
Federal Register / Vol. 60, No. 68 / Monday, April 10, 1995 / Notices 18131

1References to CDC also apply to the Agency for

Toxic Substances and Disease Registry (ATSDR).

SUMMARY: This notice is a request for

comments on the CDC1 policy on the

inclusion of women and minorities in

externally awarded research. This

policy is intended to ensure that

individuals of both sexes and the

various racial and ethnic groups will be

included in CDC supported studies

involving human subjects, whenever

feasible and appropriate. Furthermore, it

is CDC policy to proactively identify

significant gaps in knowledge about

health problems that affect women and

racial and ethnic minority populations

and to encourage studies which address

these problems. (NOTE: This policy is

consistent with requirements for CDC

intraagency research.)

DATES: Written comments on the policy

must be received on or before June 9,

1995. This policy, when finalized, will

be applicable for all CDC externally

awarded projects submitted on and after

October 1, 1995.

ADDRESSES: Written comments can be

sent to the Centers for Disease Control

and Prevention, Attention: Office of the

Associate Director for Science, Mailstop

D–39, 1600 Clifton Road, NE., Atlanta,

GA 30333.

FOR FURTHER INFORMATION CONTACT:

Inquiries should be directed to Dixie E.

Snider, Jr., M.D., M.P.H., telephone

(404) 639–3701 or Barbara W.

Kilbourne, R.N., M.P.H., telephone (404)

639–1242.

SUPPLEMENTARY INFORMATION: CDC

Policy on the Inclusion of Women and

Minorities in Externally Awarded

Research.

Table of Contents

I. Introduction

II. Definitions

A. Human Subjects

B. Research

C. Racial and Ethnic Categories

1. Minority Groups

2. Majority Group

III. Policy

Research Involving Human Subjects

IV. Guidance for Applicant Institution

Investigators and Decision Makers in

Complying With This Policy

A. General

B. Studies of Public Health Interventions

V. Implementation

A. Date of Implementation

B. Roles and Responsibilities

1. Applicant Institution Investigators

2. CDC Technical/Peer Review Groups

3. CDC Center/Institute/Office Directors

4. CDC Institutional Review Boards

C. External Award Consideration

D. Recruitment Outreach by Externally

Awarded Investigators

E. Dissemination of Research Results

VI. Evaluation

CDC Inclusion Review Committee

Responsibility and Members

I. Introduction

The Centers for Disease Control and

Prevention (CDC) and the Agency for

Toxic Substances and Disease Registry

(ATSDR) are committed to protecting

the health of all people regardless of

their sex, race, ethnicity, national origin,

religion, sexual orientation,

socioeconomic status, or other

characteristics. To the extent that

participation in research offers direct

benefits to the participants,

underrepresentation of certain

population subgroups denies them the

opportunity to benefit. Moreover, for

purposes of generalizing study results,

investigators must include the widest

possible range of population groups.

A growing body of evidence indicates

that the health conditions and needs of

women are different from those of men.

Some health conditions are unique to

women and others are more prevalent in

women. For some illnesses, there are

marked distinctions, not only in onset

and progression of disease, but also in

the preventive, treatment and

educational approaches necessary to

combat them in women. Furthermore,

initial entry into the health care system

may be different for some subgroups of

women, such as poor and uninsured

women. Lesbians may also enter the

health care system differently because

they may be less likely to seek or receive

prevention services, like cancer

screening, because they may not seek or

receive family planning services. The

Public Health Service Task Force on

Women’s Health Issues published a

report in 1987 stating that it is becoming

more important to note the

environmental, economic, social, and

demographic characteristics that

influence a woman’s health status. The

Task Force focused in on the direct and

indirect effects these factors could have

on the status of a woman’s health and

noted that when a woman is ‘‘outside

the normal range of societal

expectations,’’ that is, she is of an ethnic

or cultural minority or if she is

physically or mentally disabled, her

health status is at greater risk. These

basic observations are not always

recognized or reflected in study

protocols and proposals.

The disparity in health outcomes

between majority and some racial and

ethnic minority groups is now well

documented. Although some minority

populations, e.g., some Asian groups,

have better overall health status than

non-Hispanic whites, many racial and

ethnic minority populations have

dramatically shorter life expectancy,

higher morbidity rates and inadequate

access to quality health care. The

Secretary’s Task Force on Black and

Minority Health issued a report in 1985

noting the underrepresentation of racial

and ethnic minorities in research. This

underrepresentation has resulted in

significant gaps in knowledge about the

health of racial and ethnic minority

populations and their responses to

interventions.

II. Definitions

A. Human Subjects

Under this policy, the definition of

human subjects in Title 45 CFR Part 46,

the Department of Health and Human

Services regulations for the protection of

human subjects applies: ‘‘Human

subject means a living individual about

whom an investigator conducting

research obtains (1) data through

intervention or interaction with the

individual or (2) identifiable private

information.’’

B. Research

Under this policy, the definition of

research in Title 45 CFR Part 46, the

Department of Health and Human

Services regulations for the protection of

human subjects applies: ‘‘Research

means a systematic investigation,

including research development, testing

and evaluation, designed to develop or

contribute to generalizable knowledge.’’

All proposed research involving human

subjects conducted using CDC funding

will be evaluated for compliance with

this policy, including those projects that

are exempt from Institutional Review

Board (IRB) Review (as specified in Title

45 CFR Part 46). However, nothing in

this policy is intended to require IRB

review of protocols which otherwise

would be exempt. This policy applies to

all CDC externally awarded research

regardless of the mechanism of financial

support (e.g., grant, cooperative

agreement, contract, purchase order,

etc.). This policy does not apply to those

projects in which the investigator has no

control over the composition of the

study population (e.g., cohort studies in

which the population has been

previously selected or research followup to outbreak investigations).

C. Racial and Ethnic Categories

1. Minority Groups

This policy shall comply with the

Office of Management and Budget

(OMB) Directive No. 15 and any changes

that may occur as it is reviewed and

revised. OMB Directive No. 15 defines

the minimum standard of basic racial

and ethnic categories, which are used

below. Despite their limitations (as
18132 Federal Register / Vol. 60, No. 68 / Monday, April 10, 1995 / Notices

outlined in the Public Health Reports

‘‘Papers from the CDC/ATSDR

Workshop on the Use of Race and

Ethnicity in Public Health

Surveillance’’), these categories are

useful because they allow comparisons

to many national data bases, especially

Bureau of the Census and national

health data bases. Therefore, the racial

and ethnic categories described below

should be used as basic minimum

guidance, cognizant of their limitations.

American Indian or Alaskan Native:

A person having origins in any of the

original peoples of North America, and

who maintains cultural identification

through tribal affiliation or community

recognition.

Asian or Pacific Islander: A person

having origins in any of the original

peoples of Far East, Southeast Asia, the

Indian subcontinent, or the Pacific

Islands. This area includes, for example,

China, India, Japan, Korea, the

Philippine Islands, and Samoa.

Black, not of Hispanic Origin: A

person having origins in any of the

black racial groups of Africa.

Hispanic: A person of Mexican,

Puerto Rican, Cuban, Central or South

American or other Spanish culture or

origin, regardless of race.

2. Majority Group

White, not of Hispanic Origin: A

person having origins in any of the

original peoples of Europe, North

Africa, or the Middle East.

While investigators should focus

primary attention on the above

categories, CDC recognizes the diversity

of the population. For example, Blacks

describe themselves in several different

ways: African American and Caribbean

(Haitian, Jamaican, West Indian,

Trinidadian). Native Hawaiians have

expressed the desire to be considered a

separate racial/ethnic category exclusive

of the current Asian/Pacific Islander

designation. Therefore, investigators are

encouraged to investigate national or

geographic origin or other cultural

factors (e.g., customs, beliefs, religious

practices, etc.) in studies of race and

ethnicity, and their relationship to

health problems. Furthermore, since

race, ethnicity, and cultural heritage

may serve as markers for other

important characteristics or conditions

associated with a health problem or

outcome, investigators should actively

seek to identify these other

characteristics or conditions.

III. Policy

Research Involving Human Subjects

Applicant institutions must ensure

that women and racial and ethnic

minority populations are appropriately

represented in their proposals for

research. Women and members of racial

and ethnic minority groups should be

adequately represented in all CDCsupported studies involving human

subjects, unless a clear and compelling

rationale and justification establishes to

the satisfaction of the CDC that

inclusion is inappropriate or clearly not

feasible. This policy does not apply to

studies when the investigator cannot

control the race, ethnicity, and sex of

subjects; however, women and racial

and ethnic minority populations must

not be routinely and/or arbitrarily

excluded from such investigations.

Women of childbearing potential should

also not be routinely and/or arbitrarily

excluded from participation; however,

there are ethical/risk issues to consider

for exclusion. Information on

differences in outcome or risk profiles

should be further reason for exclusion.

Therefore, pregnancy status may need to

be determined prior to enrollment for

some studies and, if necessary, during

an intervention to safeguard the

participants’ health.

IV. Guidance for Applicant Institution

Investigators and Decision Makers in

Complying With This Policy

A General

In determining whether special efforts

should be made to set specific

enrollment goals for women and

members of racial and ethnic minority

groups in research or whether to design

special studies to specifically address

health problems in such populations,

principal investigators should consider

the following points:

• Is the disease or condition under

study unique to, or is it relatively rare

in men, women or one or more racial

and ethnic minority populations?

• What are the characteristics of the

population to which the protocol results

will be applied? Does it include both

men and women? Does it include

specific racial and ethnic minority

populations?

• Are there scientific reasons to

anticipate significant differences

between men and women and among

racial and ethnic minority populations

with regard to the hypothesis under

investigation?

• Are there study design or

recruitment limitations in the protocol

that could result, unnecessarily, in

underrepresentation of one sex or

certain racial and ethnic minority

populations?

• Could such underrepresentation

cause an adverse impact on the

generalizability and application of

results?

• Is the underrepresentation

correctable?

• Does racial and ethnic

characterization of study subjects serve

a bona fide purpose or might it serve

only to stigmatize a group?

Inclusion of women and/or racial and

ethnic minority groups in research can

be addressed either by including all

appropriate groups in one single study

or by conducting multiple studies. In

general, protocols and proposals for

support of studies involving human

subjects should employ a design with

sex and/or minority representation

appropriate to the scientific objectives.

It is not an automatic requirement that

the study design provide sufficient

statistical power to answer the questions

posed for men and women and racial

and ethnic groups separately; however,

whenever there are scientific reasons to

anticipate differences between men and

women and/or racial and ethnic groups,

with regard to the hypothesis under

investigation, investigators should

include an evaluation of these sex and

minority group differences in the study

proposal. If adequate inclusion of one

sex and/or minority group is impossible

or inappropriate with respect to the

purpose of the proposed study, or if in

the only study population available,

there is a disproportionate

representation of one sex or minority/

majority group, the rationale for the

study population must be well

explained and justified. The cost of

inclusion of women and/or racial and

ethnic minority groups shall not be a

permissible consideration for exclusion

from a given study unless data regarding

women and/or racial and ethnic

minority groups have been or will be

obtained through other means that

provide data of comparable quality.

Acceptable reasons for exclusion are as

follows:

(1) Inclusion is inappropriate with

respect to the health of the subjects;

(2) Inclusion is inappropriate with

respect to the purpose of the study;

(3) There is substantial scientific

evidence that there is no significant

difference between the effects that the

variables to be studied have on women

and/or racial and ethnic minority

groups;

(4) There are already substantial

scientific data on the effects that

variables have on the excluded

population;

(5) Inclusion is inappropriate under

other circumstances determined

acceptable by the CDC.

In each protocol or proposal, the

composition of the proposed study
Federal Register / Vol. 60, No. 68 / Monday, April 10, 1995 / Notices 18133

population must be described in terms

of sex and racial and ethnic group

together with a rationale for its choices.

Sex and racial and ethnic issues should

be addressed in developing a study

design and sample size appropriate for

the scientific objectives of the

investigation. The proposal should

contain a description of the proposed

outreach programs, if necessary, for

recruiting women and racial and ethnic

minorities as participants. Investigators

must safeguard the consent process by

promoting open and free

communication with the study

participants. Investigators must seek to

understand cultural differences and

variety of languages inherent in the

population to be enrolled. The

possibility of non-proficiency of

speaking and/or reading English by a

potential study participant must be

considered and assurances given that

adequate provision has been made for

appropriate translation of the consent

document or the availability of

translators to ensure an adequate

understanding of the research.

B. Studies of Public Health Interventions

Investigators must consider the

following when planning an

intervention trial:

• If the data from prior studies

strongly indicate the existence of

significant differences of clinical or

public health importance in

intervention effect between the sexes or

among racial and ethnic populations,

the primary question(s) to be addressed

by the scientific investigation and the

design of that study must specifically

accommodate this. For example, if men,

women, and racial and ethnic minority

groups are thought to respond

differently to an intervention, then the

study should be designed to answer

separate primary questions that apply to

men, women, and/or specific racial and

ethnic groups with adequate sample size

for each.

• If the data from prior studies

strongly support no significant

differences of clinical or public health

importance in intervention effect

between subgroups, then sex and race

and ethnicity are not required as subject

selection criteria. However, the

inclusion of sex and racial and ethnic

subgroups is still strongly encouraged.

• If the data from prior studies

neither support nor negate the existence

of significant differences of clinical or

public health importance in

intervention effect, then the study

should include sufficient and

appropriate entry of men and women

and racial and ethnic minority

populations so that valid analysis of the

intervention effect in each subgroup can

be performed.

• If women of childbearing potential

are to be included and if there is a

reason to suspect that there may be

adverse events in pregnant women,

pregnancy status may need to be

determined prior to enrollment for some

intervention trials.

V. Implementation

A. Date of Implementation

This policy applies to all CDC

externally awarded projects submitted

on and after October 1, 1995.

B. Roles and Responsibilities

Certain individuals and groups have

special roles and responsibilities with

regard to the implementation of these

guidelines.

1. Applicant Institution Investigators

Applicant institution investigators

should assess the theoretical and/or

scientific linkages between sex and race

and ethnicity and their topic of study.

Following this assessment, the applicant

institution investigator will address the

policy in each protocol, application and

proposal, providing the required

information on inclusion of women and

minorities in studies, and any required

justifications for exceptions to the

policy.

2. CDC Technical/Peer Review Groups

In conducting technical/peer review

of contract, grant, or cooperative

agreement applications for scientific

and technical merit, CDC Center/

Institute/Office (C/I/O) Directors will

ensure that CDC technical/peer review

groups, to the extent possible, should

include women and racial and ethnic

minorities and will do the following:*

• Evaluate the proposed plan for the

inclusion of both sexes and racial and

ethnic minority populations for

appropriate representation or evaluate

the proposed justification when

representation is limited or absent.

• Evaluate the proposed exclusion of

a certain racial and ethnic minority

population and males or females on the

basis that a requirement for inclusion is

inappropriate.

*C/I/O Directors may waive this

requirement if it is clearly inappropriate

or clearly not feasible.

• Determine whether the design of

the study is adequate to measure

differences when warranted.

• Evaluate the plans for recruitment

and outreach for study participants

including whether the process of

establishing partnerships with

community(ies) and recognition of

mutual benefits will be documented.

• Include these criteria as part of the

technical assessment and assign a score.

3. CDC Center/Institute/Office Directors

CDC C/I/O Directors are responsible

for ensuring that CDC externally

awarded research involving human

subjects meet the requirements of these

guidelines. CDC C/I/O Directors will

also inform externally awarded

investigators concerning this policy and

monitor its implementation during the

development, review, award, and

conduct of research.

4. CDC Institutional Review Boards

(IRBs)

CDC IRBs are responsible for ensuring

that CDC investigators have adequately

addressed the inclusion of women and

racial and ethnic minorities in research

protocols that require CDC IRB

approval.

C. External Award Consideration

CDC project officers shall design their

Requests for Contracts and Requests for

Assistance in compliance with this

policy. CDC C/I/O Directors shall ensure

this policy is fully considered and

implemented prior to the release of the

Request for Contract and Request for

Assistance to the CDC Procurement and

Grants Office. CDC funding components

will not award any grant, cooperative

agreement, or contract nor support any

externally funded project to be

conducted or funded in fiscal year 1996

and thereafter which does not comply

with this policy.

D. Recruitment Outreach by Externally

Awarded Investigators

Externally awarded investigators and

their staff(s) are urged to develop

appropriate and culturally sensitive

outreach programs and activities

commensurate with the goals of the

research. The purpose should be to

establish a relationship between the

investigator(s), populations, and

community(ies) of interest so that

mutual benefit is achieved by all groups

participating in the study. Investigators

should document the process for

establishing a partnership with the

community(ies) and the mutual benefits

of the study and ensure that any factors

(e.g., educational level, nonproficiency

in English, low socioeconomic status)

are accounted for and handled

appropriately. In addition,

investigator(s) and staff(s) should take

precautionary measures to ensure that

ethical concerns are clearly noted, such

that there is minimal possibility of

coercion or undue influence in the

incentives or rewards offered in
18134 Federal Register / Vol. 60, No. 68 / Monday, April 10, 1995 / Notices

recruiting into or retaining participants

in scientific studies.

E. Dissemination of Research Results

Externally awarded investigators are

urged to make special efforts to

disseminate relevant research results to

the communities who participated in

the studies and to the populations to

which they pertain, especially racial

and ethnic minority populations which

may have cultural, language, and

socioeconomic barriers to the easy

receipt of such information.

VI. Evaluation

CDC Inclusion Review Committee

Responsibility and Members

A CDC Inclusion Review Committee

(IRC) with representatives from the CDC

Office of the Associate Director for

Science, the CDC Office of the Associate

Director for Minority Health, and the

CDC Office of the Associate Director for

Women’s Health will review any

questions, issues, or comments

pertaining to this policy and

recommend necessary changes or

modifications to the Director, CDC. This

committee will meet regularly to review

compliance with this policy and

evaluate the impact of this policy on

research activities at CDC. The CDC IRC

may periodically conduct random

audits of research protocols to assess

compliance with this policy.

Dated: March 30, 1995.

Claire V. Broome,

Deputy Director, Centers for Disease Control

and Prevention (CDC) and Deputy

Administrator, Agency for Toxic Substances

and Disease Registry (ATSDR).

[FR Doc. 95–8718 Filed 4–7–95; 8:45 am]

BILLING CODE 4163–18–P

[Announcement 525]

Continuation of the Development of

Technology for the Measurement of

Lead in Blood; Notice of Availability of

Funds for Fiscal Year 1995

Introduction

The Centers for Disease Control and

Prevention (CDC) announces the

availability of fiscal year (FY) 1995

funds for a grant program for the

continuation of the development of new

and innovative technology, or

significant improvement of existing

technology, for the measurement of lead

in blood. CDC has supported such

development efforts under a grant

program since FY 1992 and under

Cooperative Research and Development

Agreements (CRADAs) since 1991.

State, community and physician officebased childhood lead poisoning

prevention programs have a need for

reasonably priced, accurate, precise,

portable, rugged, and easy-to-operate

instruments or analytical techniques to

measure the concentration of lead in

blood. Such programs screen large

numbers of infants and young children

and identify those with lead poisoning.

The Public Health Service (PHS) is

committed to achieving the health

promotion and disease prevention

objectives of ‘‘Healthy People 2000,’’ a

PHS-led national activity to reduce

morbidity and mortality and improve

the quality of life. This announcement

is related to the priority area of

Environmental Health. (For ordering a

copy of ‘‘Healthy People 2000,’’ see the

section Where To Obtain Additional

Information.)

Authority

This program is authorized under

sections 301(a) [42 U.S.C. 241(a)] and

317B(b) [42 U.S.C. 247b-3(b)] of the

Public Health Service Act, as amended.

Smoke-Free Workplace

PHS strongly encourages all grant

recipients to provide a smoke-free

workplace and to promote the nonuse 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 are limited to

those organizations which are currently

developing innovative technology for

the measurement of lead in blood,

funded under CDC grant Announcement

269 (included in the application

package), or organizations which have a

current CDC Cooperative Research and

Development Agreement (CRADA)

dealing with blood lead measurement

technology. However, if funded, the

CDC CRADA dealing with blood lead

will be terminated.

Note: Eligible applicants are encouraged to

enter into contracts, including consortia

agreements, as necessary to meet the

requirements of the program and strengthen

the overall application.

Availability of Funds

Approximately $800,000 is available

in FY 1995 to fund up to three grants.

It is expected that the average award

will be $250,000, ranging from $100,000

to $500,000. It is expected that the

awards will begin on or about June 30,

1995, and will be made for a 12-month

budget period within a project period of

up to one year. Funding estimates may

vary and are subject to change.

Purpose

State and community health agencies

are the principal delivery points for

childhood lead screening and related

medical and environmental

management activities. Universal

screening of children is recommended

in ‘‘Preventing Lead Poisoning in Young

Children—a Statement by the Centers

for Disease Control,’’ (October 1991);

however, the lack of analytical systems

(methods plus instrumentation) which

are easy-to-operate, rugged, and suitable

for field use in screening programs have

made it difficult and costly for agencies

to develop programs for the elimination

of this totally preventable disease. This

program will provide financial support

for the continuation and possible

completion of the development and

validation of new and innovative

technology leading to better blood lead

measurement systems.

Program Requirements

The following are essential

requirements of the Grantee:

1. Provide a principal investigator

with the authority, responsibility, and

research experience to carry out the

objectives of the grant.

2. Provide qualified staff, laboratory

and/or production facilities, equipment,

and other resources necessary to carry

out the objectives of the grant.

3. Conduct a scientifically sound,

goal-oriented research and development

program which will yield all or portions

of practical analytical systems which

measure one or more chemicals in

complex solutions. Understand and

address the difficult analytical problem

presented by a blood sample matrix.

4. Publish the results of the research

effort in the peer-reviewed scientific

literature, or otherwise make the

research findings available for objective

evaluation and use.

5. Provide evidence of significant

progress under the previous grant or

CRADA for blood lead measurement

technology consistent with the goals

and objectives of the original grant or

CRADA, and clearly show that

successful completion could be

reasonably expected within the one year

project period.

Evaluation Criteria

The applications will be reviewed and

evaluated according to the following

criteria:

1. Understanding of the Problem (30%)

By progress under previous grant or

CRADA agreement, the Applicant has