Federal Register / Vol. 61, No. 90 / Wednesday, May 8, 1996 / Notices 20821

fact that are in dispute, summarizing the

evidence that would be presented at a

hearing, and indicating how the party

commenting would be aggrieved by

approval of the proposal.

Unless otherwise noted, comments

regarding the applications must be

received at the Reserve Bank indicated

or the offices of the Board of Governors

not later than May 22, 1996.

A. Federal Reserve Bank of

Richmond (Lloyd W. Bostian, Jr., Senior

Vice President) 701 East Byrd Street,

Richmond, Virginia 23261:

1. Allied Irish Banks, p.l.c., Dublin,

Ireland, and First Maryland Bancorp,

Baltimore, Maryland; to acquire ZirkinCutler Investments, Inc., Washington,

D.C., and thereby engage in serving as

investment adviser to investment

companies registered under the

Investment Company Act of 1940,

including sponsoring, organizing, and

managing closed-end investment

companies; providing portfolio

investment advice to any other person;

and, furnishing general economic

information and advice, general

economic statistical forecasting services

and industry studies, pursuant to §§

225.25(b)(4)(ii), (iii), and (iv) of the

Board’s Regulation Y.

B. Federal Reserve Bank of Atlanta

(Zane R. Kelley, Vice President) 104

Marietta Street, N.W., Atlanta, Georgia

30303:

1. Barnett Banks, Inc., Jacksonville,

Florida; to engage de novo through its

subsidiary, Barnett Community

Development Corporation, Jacksonville,

Florida, in community development

activities, pursuant to § 225.25(b)(6) of

the Board’s Regulation Y.

C. Federal Reserve Bank of Dallas

(Genie D. Short, Vice President) 2200

North Pearl Street, Dallas, Texas 75201-

2272:

1. Outsource Capital Group, Inc.,

Lubbock, Texas, and Outsource

Delaware Capital Group, Inc., Dover,

Delaware (both in formation); to acquire

Rall Mortgage Corporation, Lubbock,

Texas, and thereby engage in mortgage

lending, pursuant to § 225.25(b)(1) of

the Board’s Regulation Y.

Board of Governors of the Federal Reserve

System, May 2, 1996.

Jennifer J. Johnson,

Deputy Secretary of the Board.

[FR Doc. 96–11414 Filed 5–7–96; 8:45 am]

BILLING CODE 6210–01–F

Sunshine Act Meeting

AGENCY HOLDING THE MEETING: Board of

Governors of the Federal Reserve

System.

TIME AND DATE: 11:00 a.m., Monday, May

13, 1996.

PLACE: Marriner S. Eccles Federal

Reserve Board Building, C Street

entrance between 20th and 21st Streets,

NW., Washington, DC 20551.

STATUS: Closed.

MATTERS TO BE CONSIDERED:

1. Personnel actions (appointments,

promotions, assignments,

reassignments, and salary actions)

involving individual Federal Reserve

System employees.

2. Any items carried forward from a

previously announced meeting.

CONTACT PERSON FOR MORE INFORMATION:

Mr. Joseph R. Coyne, Assistant to the

Board; (202) 452–3204. You may call

(202) 452–3207, beginning at

approximately 5 p.m. two business days

before this meeting, for a recorded

announcement of bank and bank

holding company applications

scheduled for the meeting.

Dated: May 3, 1996.

Jennifer J. Johnson,

Deputy Secretary of the Board.

[FR Doc. 96–11559 Filed 5–3–96; 4:56 am]

BILLING CODE 6210–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Agency for Toxic Substances and

Disease Registry

[Announcement 608]

Human Health Studies; Applied

Research and Development

Introduction

The Agency for Toxic Substances and

Disease Registry (ATSDR) announces

the availability of fiscal year (FY) 1996

funds for a grant program designed to

answer public health questions arising

from situations commonly encountered

at hazardous waste sites. The objective

of this program is to fill gaps in

knowledge, including data needs and

health conditions, by conducting

applied research and development

studies related to human exposure to

hazardous substances and to the

ATSDR’s health assessments,

consultations, and health studies on

hazardous substances prioritized by

ATSDR. These Priority Health

Conditions are identified under the

Purpose section of this notice. Priority

data needs are identified by ATSDR in

its toxicological profiles.

ATSDR 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. (For

ordering a copy of ‘‘Healthy People

2000,’’ see the Section Where to Obtain

Additional Information.)

Authority

This program is authorized in sections

104(i)(1)(E), (6), (7), (9), and (15) of the

Comprehensive Environmental

Response, Compensation, and Liability

Act (CERCLA), as amended by the

Superfund Amendments and

Reauthorization Act (SARA) [42 U.S.C.

9604(i)(1)(E), (6), (7), (9), and (15)].

Smoke-Free Workplace

ATSDR strongly encourages all grant

and cooperative agreement 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 are the official

public health agencies of States or their

bona fide agents or instrumentalities.

This includes the District of Columbia,

American Samoa, the Commonwealth of

Puerto Rico, the Virgin Islands, the

Federated States of Micronesia, Guam,

the Northern Mariana Islands, the

Republic of the Marshall Islands, the

Republic of Palau, and federally

recognized Indian tribal governments.

State organizations, including State

universities, State colleges, and State

research institutions, must establish that

they meet their respective State’s

legislature definition of a State entity or

political subdivision to be considered

an eligible applicant.

Availability of Funds

The Government’s obligation under

this grant project is contingent upon the

availability of appropriated funds from

which payment for grant purposes can

be made. No legal liability on the part

of the government for any obligation

may arise until funds are made available

to the grantee through the formal award

of a grant/cooperative agreement.

It is expected that $500,000 will be

available in FY 1996 to fund

approximately 2 awards. Awards are

funded for a 12-month budget period

within a project period of up to 3 years.

Continuation awards within the project

period will be made on the basis of
20822 Federal Register / Vol. 61, No. 90 / Wednesday, May 8, 1996 / Notices

satisfactory progress and the availability

of funds.

Purpose

The purpose of this announcement is

to solicit scientific proposals designed

to answer public health questions

arising from situations commonly

encountered at hazardous waste sites.

The objective of this research program is

to fill gaps in knowledge regarding

human health effects of hazardous

substances identified during the

conduct of ATSDR’s health assessments,

consultations, toxicological profiles, and

health studies, including but not limited

to those health conditions prioritized by

ATSDR. The ATSDR Priority Health

Conditions are (in alphabetical order):

1. birth defects and reproductive

disorders,

2. cancers (selected anatomic sites),

3. immune function disorders,

4. kidney dysfunction,

5. liver dysfunction,

6. lung and respiratory diseases and

7. neurotoxic disorders.

Substance-specific research needs are

identified in ATSDR toxicological

profiles.

Program Requirements

Grants funded under this program

will focus on one or more of the

following:

1. Human Populations,

2. Use of innovative methodologies to

fill data gaps identified through

ATSDR’s public health assessments and

consultations at hazardous waste sites,

3. Ecologic studies using data from

multiple sites to assess the health status

of several communities, or

4. Analytical studies, including metaanalysis of existing sets of human data.

Research activities may include, but

not be limited to the following:

1. Epidemiological studies,

2. Health outcomes studies,

3. Further analysis of existing human

data sets,

4. Identification, validation, and

development of biomarkers of exposure,

susceptibility, and effect,

5. Further evaluating the link or lack

of linkage between specific chemicals

and specific health effects,

6. Developing innovative

methodologies to fill data gaps on the

health effects associated with exposure

to chemicals frequently found at

hazardous waste sites,

7. Relationship of environmental fate

and transport of chemicals to human

health effects,

8. Developing innovative health

education methodologies to prevent

exposure and/or adverse human health

effects,

9. Psychological effects associated

with exposure to hazardous substances,

10. Health effects associated with

incineration, and

11. Improving human risk assessment.

This program is designed for grant

applications only. In a grant, the

recipient is required to conduct the

proposed study without substantial

programmatic involvement from the

funding agency.

Evaluation Criteria

The review for scientific and

technical merit by an objective review

group will be based on the following

criteria:

A. Scientific and Technical Review

Criteria of New Applications

1. Appropriateness and Knowledge of

Study Design—25%

The extent to which the applicant’s

proposal addresses the:

a. Scientific merit of the proposed

project, including the novelty,

originality and feasibility of the

approach and the adequacy of the

design,

b. Technical merit of the proposed

project, including the degree to which

the project can be expected to yield or

demonstrate results that will be useful

and desirable in furthering the program

objective as described in the Purpose

section of this announcement, and

c. Proposed project schedule,

including clearly established and

obtainable project objectives for which

progress toward attainment can and will

be measured.

2. Proposed Study—25%

The adequacy of the proposal relevant

to the:

a. Study purpose, objectives, and

rationale,

b. Quality of program objectives in

terms of specificity, measurability, and

feasibility,

c. Specificity and feasibility of the

applicant’s timetable for implementing

program activities and timely

completion of the study, and

d. Likelihood of the applicant agency

completing proposed program activities

and attaining proposed objectives based

on the thoroughness and clarity of the

overall program.

In addition, the degree to which the

applicant has met the CDC/ATSDR

policy requirements regarding the

inclusion of women, ethnic, and racial

groups in the proposed research. This

includes:

a. The proposed plan for the inclusion

of both sexes and racial and ethnic

minority populations for appropriate

representation.

b. The appropriateness of the

proposed justification when

representation is limited or absent.

c. Whether the design of the study is

adequate to measure differences when

warranted.

d. Whether the plans for recruitment

and outreach for study participants

include the process of establishing

partnerships with community(ies) and

recognition of mutual benefits.

3. Relationship to Initiative—15%

The extent to which the application

addresses the areas of investigation

outlined by ATSDR.

4. Quality of Data Collection—15%

The extent to which the:

a. Study ascertains the information

necessary to meet the objectives,

including (but not limited to)

information on pathways of exposure,

confounding factors, and biomedical

testing,

b. Quality control and quality

assurance of questionnaire data are

provided, including (but not limited to)

interviewer training and consistency

checks of data,

c. Laboratory tests (if applicable) are

sensitive and specific for the analyte or

disease outcome of interest, and

d. Quality control, quality assurance,

precision and accuracy of information

for the proposed tests are provided and

acceptable.

5. Applicant Capability and

Coordination Efforts—10%

The extent to which the proposal has

described the:

a. Capability of the applicant’s

administrative structure to foster

successful scientific and administrative

management of a study,

b. Capability of the applicant to

demonstrate an appropriate plan for

interaction with the community, and

c. Suitability of facilities and

equipment available or to be purchased

for the project.

6. Program Personnel—10%

The extent to which the proposed

program staff is qualified and

appropriate, and the time allocated for

them to accomplish program activities is

adequate.

7. Program Budget—(Not Scored)

The extent to which the budget is

reasonable, clearly justified, and

consistent with intended use of

cooperative agreement/grant funds.

B. Review of Continuation Applications

Continuation awards within the

project period will be made on the basis

of the following criteria:
Federal Register / Vol. 61, No. 90 / Wednesday, May 8, 1996 / Notices 20823

1. Satisfactory progress has been made

in meeting project objectives.

2. Objectives for the new budget

period are realistic, specific, and

measurable.

3. Proposed changes in described

long-term objectives, methods of

operation, need for grant support, and/

or evaluation procedures will lead to

achievement of project objectives.

4. The budget request is clearly

justified and consistent with the

intended use of grant/cooperative

agreement funds.

Funding Priorities

Priority will be given for studies

which address one or more of the

following areas of investigation:

A. Evaluate the occurrence of adverse

health effects in a population. This will

include the evaluation of the incidence

or prevalence of a disease, disease

symptoms, self-reported health

concerns, or biological markers of

disease, susceptibility, or exposure.

B. Identify risk factors for adverse

health effects in populations. This will

include hypothesis generating cohort or

case-control studies on potentially

impacted populations to identify

linkages between exposure and adverse

health effects and those risk factors

which may be impacted by prevention

actions.

C. Develop methods to diagnose

adverse health effects in populations.

This includes medical research to

evaluate currently available biological

tests (biomarkers) and disease

occurrence in potentially impacted

populations.

D. Develop health education methods

applicable to the hazardous substances

and their exposure pathways most

commonly found at hazardous waste

sites. These may include demonstration

projects to investigate the effectiveness

of these methods.

Interested persons are invited to

comment on the proposed funding

priority. All comments received on or

before June 7, 1996, will be considered

before the final funding priority is

established. If the funding priority

should change as a result of any

comments received, a revised

announcement will be published in the

Federal Register prior to the final

selection of awards.

Written comments should be

addressed to Ron S. Van Duyne, Grants

Management Officer, 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.

Executive Order 12372

Applications are subject to the

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 (other than

federally recognized Indian tribal

governments) 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

SPOCs have any State process

recommendations on applications

submitted to CDC, they should forward

them to Ron S. Van Duyne, Grants

Management Officer, 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, no

later than 60 days after the application

deadline date. (By formal agreement, the

CDC Procurement and Grants Office will

act on behalf of and for ATSDR on this

matter.)

Indian tribes are strongly encouraged

to request tribal government review of

the proposed application.

If tribal governments have any tribal

process recommendations on

applications submitted to CDC, they

should forward them to Ron S. Van

Duyne, Grants Management Officer,

Grants Management Branch,

Procurement and Grants Office, Centers

for Disease Control and Prevention

(CDC), 255 East Paces Ferry Road, NE.,

Mailstop E13, Atlanta, GA 30305. This

should be done no later than 60 days

after the application deadline date. The

granting agency does not guarantee to

‘‘accommodate or explain’’ for tribal

process recommendations it receives

after that date.

Public Health System Reporting

Requirements

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 93.161, Health

Programs for Toxic Substances and

Disease Registry.

Other Requirements

A. Protection of Human Subjects

This program requires research on

human subjects, therefore, all applicants

must comply with 45 CFR Part 46

regarding the protection of human

subjects. Assurances must be provided

that the project or activity will be

subject to initial and continuing review

by an appropriate institutional review

committee. The applicant will be

responsible for providing evidence of

this assurance in accordance with the

appropriate guidelines and forms

provided in the application kit.

B. Women, Racial, and Ethnic

Minorities

It is the policy of CDC and ATSDR to

ensure that individuals of both sexes

and the various racial and ethnic groups

will be included in CDC/ATSDRsupported research projects involving

human subjects, whenever feasible and

appropriate. Racial and ethnic groups

are those defined in OMB Directive No.

15 and include American Indian,

Alaskan Native, Asian, Pacific Islander,

Black and Hispanic. Applicants shall

ensure that women, racial and ethnic

minority populations are appropriately

represented in applications for research

involving human subjects. Where clear

and compelling rationale exist that

inclusion is inappropriate or not

feasible, this situation must be

explained as part of the application. In

conducting review for scientific merit,

review groups will evaluate proposed

plans for inclusion of minorities and

both sexes as part of the scientific

assessment and scoring.

This policy does not apply to research

studies when the investigator cannot

control the race, ethnicity and/or sex of

subject. Further guidance to this policy

is contained in the Federal Register,

Vol. 60, No. 179, pages 47947–47951,

Friday, September 15, 1995.

A copy of the CDC/ATSDR policy is

included in the application kit.

C. Disclosure

Recipient is required to provide proof

by way of citation to State code or

regulation or other State pronouncement

given the authority of law, that medical

information obtained pursuant to the

agreement, pertaining to an individual,

and therefore considered confidential,

will be protected from disclosure when

the consent of the individual to release

identifying information is not obtained.

D. Cost Recovery

CERCLA, as amended by SARA,

provides for the recovery of costs

incurred for health assessments and
20824 Federal Register / Vol. 61, No. 90 / Wednesday, May 8, 1996 / Notices

health effects studies at each Superfund

site from potentially responsible parties.

The recipient would agree to maintain

an accounting system that will keep an

accurate, complete, and current

accounting of all financial transactions

on a site-specific basis, i.e., individual

time, travel, and associated cost

including indirect cost, as appropriate

for the site. The recipient will retain the

documents and records to support these

financial transactions, for possible use

in a cost recovery case, for a minimum

of 10 years after submission of a final

Financial Status Report (FSR), unless

there is a litigation, claim, negotiation,

audit, or other action involving the

specific site, then the records will be

maintained until resolution of all issues

on the specific site.

E. Third Party Agreements

Project activities which are approved

for contracting pursuant to the prior

approval provisions shall be formalized

in a written agreement that clearly

establishes the relationship between the

grantee and the third party.

The written agreement shall at a

minimum:

1. State or incorporate by reference all

applicable requirements imposed on the

contractors under the grant by the terms of

the grant, including requirements concerning

peer review and technical review, release of

data, ownership of data, and the arrangement

for copyright when publications, data or

other copyrightable works are developed in

the course of work under an ATSDR grant

supported project or activity.

2. State that any copyrighted or

copyrightable works shall be subject to a

royalty-free, nonexclusive, and irrevocable

license to the Government to reproduce,

publish, or otherwise use them, and to

authorize others to do so for Federal

Government purposes.

3. State that whenever any work subject to

this copyright policy may be developed by a

contractor under a grant, the written

agreement (contract) must require the

contractor to comply with these requirements

and can in no way diminish the

Government’s right in that work.

4. State the activities to be performed, the

time schedule for those activities, the

policies and procedures for carrying out the

agreement, and the maximum amount of

money for which the grantee may become

liable to the third party.

The written agreement required shall

not relieve the grantee of any part of its

responsibility or accountability to

ATSDR under the grant. The agreement

shall, therefore, retain sufficient rights

and control to the grantee to enable it

to fulfill this responsibility and

accountability.

Application and Submission Deadline

A. Preapplication Letter of Intent

Although not a prerequisite of

application, a non-binding letter of

intent-to-apply is requested from

potential applicants. The letter should

be submitted to the Grants Management

Branch, CDC (see address below) and

should be postmarked no later than June

8, 1996. The letter should include the

following:

1. Announcement Number,

2. Title of the proposed area or areas

of research,

3. Name of the principal

investigator/s and

4. Identification of any other

participating institutions.

The letter of intent does not influence

review or funding decisions, but it will

enable ATSDR to more efficiently plan

the objective review.

The original and two copies of the

application PHS Form 5161–1 (OMB

Number 0937–0189) must be submitted

to Ron S. Van Duyne, Grants

Management Officer, Grants

Management Branch, Procurement and

Grants Office, Centers for Disease

Control and Prevention (CDC), 255 East

Paces Ferry Road, NE., Room 300, Mail

Stop E–13, Atlanta, GA 30305, on or

before July 8, 1996 (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 objective review group. (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.

Where To Obtain Additional

Information

To receive additional information call

(404) 332–4561. You will be asked to

leave your name, address and phone

number and will need to refer to

Announcement 608. You will receive a

complete program description,

information on application procedures

and application forms. The

announcement is also available through

the CDC home page on the Internet. The

address for the CDC home page is http:/

/www.cdc.gov.

If you have questions after reviewing

the contents of all the documents,

business management assistance may be

obtained from Maggie 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,

Mailstop E–13, Atlanta, GA 30305,

telephone (404) 842–6797, or

INTERNET address,

mcs9@opspgo1.em.cdc.gov.

Programmatic assistance may be

obtained from Dr. Jeffrey A. Lybarger,

Director, Division of Health Studies,

telephone, (404) 639–6200, or

INTERNET address,

jal2@atsdhs2.em.cdc.gov., or Dr. John

Andrews, Associate Administer for

Science, telephone (404) 639–0708, or

INTERNET address,

jsa1@atsoaa1.em.cdc.gov., Agency for

Toxic Substances and Disease Registry,

1600 Clifton Road, NE., Mailstop E–31,

Atlanta, GA 30333.

Please refer to announcement number

608 when requesting information and

submitting an application.

There may be delays in mail delivery

as well as difficulty in reaching the CDC

Atlanta offices during the 1996 Summer

Olympics (July 19 - August 4).

Therefore, in order to receive more

timely response to questions please use

INTERNET/E- Mail, follow all

instructions in this announcement, and

leave messages on the contact person’s

voice mail.

Potential applicants may obtain a

copy of ‘‘Healthy People 2000’’ (Full

Report, Stock No. 017–001–00474–0) or

‘‘Healthy People 2000’’ (Summary

Report, Stock No. 017–001–00473–1)

referenced in the Introduction through

the Superintendent of Documents,

Government Printing Office,

Washington, DC 20402–9325, telephone,

(202) 512–1800.

Dated: May 1, 1996.

Claire V. Broome,

Deputy Administrator, Agency for Toxic

Substances and Disease Registry.

[FR Doc. 96–11444 Filed 5–7–96; 8:45 am]

BILLING CODE 4163–70–P