Federal Register / Vol. 61, No. 82 / Friday, April 26, 1996 / Notices 18603

1A deceptive act or practice is one that is likely

to mislead consumers acting reasonably under the

circumstances. See Cliffdale Associates, Inc., 103

F.T.C. 110 (1984), reprinting as an appendix letter

dated Oct. 14, 1983, from the Commission to the

Honorable John D. Dingell, Chairman, Committee

on Energy and Commerce, U.S. House of

Representatives (‘‘Deception Statement’’). The

Commission considers a claim deceptive if even a

‘‘significant minority’’ of consumers are misled.

‘‘An interpretation may be reasonable even though

it is not shared by a majority of consumers in the

relevant class, or by particularly sophisticated

consumers. A material practice that misleads a

significant minority of reasonable consumers is

deceptive.’’ Kraft, Inc., 114 F.T.C. 40, 122 (1991),

aff’d 970 F.2d 311 (7th Cir. 1992), cert. denied, 507

U.S. 909 (1993).

2 Commissioner Starek dissented for reasons

previously stated. See 60 FR 53930 (1995).

required that foreign origin be disclosed

if unmarked goods contained a

significant amount of foreign content.

i. Do consumers generally believe that

unlabeled products are domestic? Does

consumer perception of the origin of

unlabeled products vary by type of

product?

ii. Is a failure to disclose foreign

origin for unmarked goods that contain

a significant amount of foreign content

material to consumers? Does the

materiality vary by type of product?

Commenters are urged to limit their

additional comments to clarifying or

rebuttal information, to the

supplemental questions, or to specific

new proposals, and not merely to

resubmitting views or information

previously submitted or expressed

during the workshop. Comments

proposing or addressing a particular

standard should address how it protects

consumers against deception 1 and why

adopting a particular standard is in the

public interest. All written comments

submitted will be available for public

inspection in accordance with the

Freedom of Information Act, 5 U.S.C.

552, and Commission regulations, on

normal business days between the hours

of 8:30 a.m. to 5:00 p.m. at the Public

Reference Room 130, Federal Trade

Commission, 6th and Pennsylvania

Ave., N.W., Washington, D.C. 20580.

In addition, the Commission will

make this notice and, to the extent

technically possible, all comments

received in response to this notice

available to the public through the

Commission’s Home Page on the

Internet. Interested parties can access

the Commission’s Home Page on the

World Wide Web at the following

address: http://www.ftc.gov.

Authority: 15 U.S.C. 41 et seq.

By direction of the Commission,

Commissioner Starek dissenting.2

Donald S. Clark,

Secretary.

[FR Doc. 96–10364 Filed 4–25–96; 8:45 am]

BILLING CODE 6750–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Agency for Toxic Substances and

Disease Registry

[Announcement 607]

Program to Build Capacity to Conduct

Site-Specific Activities

Introduction

The Agency for Toxic Substances and

Disease Registry (ATSDR) announces

the availability of fiscal year (FY) 1996

funds for a cooperative agreement

program for State health agencies to

conduct site-specific health activities to

determine the public health impact of

human exposure to hazardous

substances at hazardous waste sites or

releases. Specifically, funds will be used

to build capacity to conduct ‘‘Core’’ sitespecific activities including public

health assessments, health

consultations, exposure investigations,

community involvement, and

preventive health education; and

‘‘Optional’’ follow-up health

investigations/studies. ATSDR

considers a site as consisting of the

actual boundaries of a release or facility

along with the resident community and

area impacted by the subject release or

facility.

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 under

Sections 104(i) (1)(E), (4), (6), (7), (9),

(14) and (15) of the Comprehensive

Environmental Response,

Compensation, and Liability Act

(CERCLA) of 1980, as amended by the

Superfund Amendments and

Reauthorization Act (SARA) of 1986 [42

U.S.C. 9604(i)(1) (E), (4), (6), (7), (9), (14)

and (15)], and Section 3019 (b) and (c)

of the Resource Conservation and

Recovery Act (RCRA), as amended

(Hazardous and Solid Waste

Amendments of 1984) [42 U.S.C. 6939a

(b) and (c)].

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

Participation is limited to 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.

This program is comprised of Core

activities and Optional activities. All

applicants must compete for Core

Activities (Public Health Assessments/

Consultations, Exposure Investigations,

and Community Involvement and

Preventive Health Education). SiteSpecific Health Investigations/Studies

are considered Optional Activities to the

Core Activities award.

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 cooperative agreement.

It is expected that approximately

$11,500,000 will be available in FY

1996 to fund an estimated 22 awards.

The average new award is expected to

be $300,000, ranging from $100,000 to

$500,000. It is expected that the awards

will begin on or about September 29,

1996, and will be made for a 12-month

budget period within a 5-year project

period. Funding estimates may vary and

are subject to change.

Approximately $10,000,000 of the

$11,500,000 will be available to fund an

estimated 22 Core Activities awards

(range $100,000 to $500,000). Personnel

funded under Core Activities should

include, at a minimum, 1–2 full time

employee (FTE) health assessors and 1–

2 FTE health educators/community

involvement specialists. Funds in the

amount of $1,000,000 will be available

for Optional Activities via the initial
18604 Federal Register / Vol. 61, No. 82 / Friday, April 26, 1996 / Notices

award for epidemiologist or health

scientist personnel. It is anticipated that

$500,000 of supplemental funds may be

made available for conducting sitespecific human health studies after

review of site-specific data, submission

of study protocol with supplemental

budget for proposed study, technical,

objective, and peer review and approval

of study protocols. In years subsequent

to FY 1996, it is anticipated that funds

in the amount of $2,000,000 will be

available for site-specific studies.

The Core Activities Award establishes

the funding for this cooperative

agreement. Only applicants funded for a

Core Activities Award are eligible to

receive awards for Optional Activities.

Applicants who apply and are awarded

for Core Activities only will not be

eligible to add Optional Activities

during the project period.

This program is open to all eligible

applicants, whether or not current

participants in ATSDR grant or

cooperative agreement programs.

Grantees currently funded under

ATSDR’s Program Announcements 227,

415, 325 and 443, can apply and, if

successful, the current award would

replace the previous award (competitive

renewal) for a total project period of up

to 5 years. If a current grantee applies

under this competitive renewal

announcement and is unsuccessful or

chooses not to apply under this

announcement, it will not jeopardize

the current award; ATSDR will honor

the current awards through the

expiration of the project period, subject

to satisfactory progress and the

availability of funds.

Continuation awards within the

project period will be made on the basis

of satisfactory progress and the

availability of funds.

Purpose

The purpose of the program funded

under this cooperative agreement is to

work toward the ultimate goal of

reducing exposures to hazardous

substances and mitigating potential

adverse health effects from such

exposures. The specific purpose of the

Core Activities is to assist public health

agencies to build capacity, in

coordination and cooperation with

ATSDR, to conduct health related

activities under CERCLA and RCRA.

This includes conducting health

consultations, public health

assessments, and exposure

investigations. Core Activities will also

assist recipients to conduct community

involvement activities, and to develop,

disseminate, and evaluate site- specific

preventive health education materials

and other programs related to exposure

to hazardous substances in the

environment.

Optional activities will assist public

health agencies in conducting sitespecific health activities recommended

by the Technical Project Team to assess

the public health impact of human

exposure to hazardous substances in

communities located near hazardous

waste sites or releases.

Program Requirements

ATSDR will assist or work jointly

with the recipient in conducting the

activities of this cooperative agreement

program. The application should be

presented in a manner that

demonstrates the applicant’s ability to

address the health issues in a

collaborative manner with ATSDR.

Note: Recipient activities may not be

conducted with funds from this cooperative

agreement program at any Federal site where

the State is a party to litigation at the site.

Recipient and ATSDR activities are

listed below:

A. Recipient Core Activities

All activities will be conducted via an

annually negotiated work plan,

mutually agreed upon at the time of the

annual budget discussions between

ATSDR and recipient, that complies

with requirements of applicable sections

of CERCLA, as amended.

1. Public Health Assessments

Conduct Public Health Assessments,

including petitions, on National Priority

Lists (NPL), Comprehensive

Environmental Response,

Compensation, and Liability

Information System (CERCLIS), or other

sites or facilities within the recipient’s

territorial boundary in accordance with

the methodology provided in the

ATSDR Public Health Assessment

Guidance Manual, ATSDR’s Review and

Handling Procedures for Public Health

Assessments, and other applicable

guidance. The following activities are

also considered integral in the public

health assessment process: a. Prepare addenda to update public

health assessments.

b. Prepare Site Review and Updates

(SRU) to evaluate current conditions

and determine the need for further

actions.

2. Health Consultations

Prepare a written or verbal response

to a specific question or specific request

for information about health risks posed

by a specific site (including Site

Accelerated Cleanup Model (SACM)),

chemical release, or hazardous material.

Health consultations may also be

written as a follow-up to Public Health

Assessments or SRUs. Consultations

may include the evaluation of

environmental data, community

concerns, health outcome data, and

demographic characterizations, and the

conduct of community outreach and

interaction activities and site

workplans.

3. Exposure Investigations

Exposure Investigations may be

conducted as part of a health assessment

or health consultation response.

Exposure Investigation involves a

collection of data on less than 10

households.

4. Community Involvement

Site-specific community involvement

is designed to develop partnerships

with communities living near hazardous

waste sites in the development,

implementation, and evaluation of sitespecific activities, which may include

needs assessment, site evaluation

activities, participation in community

meetings, and availability to the

community to gather and address health

concerns. The recipient will:

a. Develop a site-specific community

involvement plan which, at a minimum,

should include: (1) A needs assessment

strategy, (2) an implementation strategy,

and (3) an evaluation strategy.

b. Implement the community

involvement plan and, where warranted

based on the needs assessment,

establish Community Assistance Panels.

5. Health Education

Site-specific health education

encompasses a program of education

activities implemented in communities

to enable them to prevent or mitigate the

health impact of exposure to hazardous

substances present at waste sites and

releases. Prevention of exposure is the

focus of community health education.

Prevention of health effects from

exposure is the focus of health

professions education. Based on the

community needs assessment, a

coordinated health education program

to address the needs identified for each

target audience should be developed.

The recipient will:

a. Develop materials that are

appropriate for the target audience

considering such issues as literacy level,

cultural values, and languages spoken.

b. Recipient should give priority to

those sites where specific actions can be

taken to reduce or prevent exposures or

where a significant public health

concern exists.

c. Materials and programs targeted to

a community’s health care providers

should be designed to improve the

knowledge and skill of health care

professionals concerning the potential
Federal Register / Vol. 61, No. 82 / Friday, April 26, 1996 / Notices 18605

exposure to hazardous substances at the

selected sites. Examples include

programs and materials designed to

enhance the ability of health care

providers to communicate risk, counsel

and advise community members

including their patients, recognize and

evaluate potential exposures, obtain

appropriate consultation from

environmental health experts when

needed or diagnose and treat conditions

that may arise from exposure to

hazardous substances.

d. Implement the planned actions

such as distributing materials, and

conducting projects such as Grand

Rounds, short courses, seminars, poster

display sessions, and public availability

sessions.

6. Site-Specific Evaluation

As part of the workplan for Core

Activities (Public Health Assessments/

Health Consultations, Site-specific

Involvement and Health Education),

develop a site- specific evaluation plan

prior to conducting activities. The plan

should contain a component for each

activity undertaken at the site. Conduct

evaluation of activities and projects and

site-specific programs to determine if

community’s needs have been met as

well as intended purpose of the

activities. Both process and impact/

outcome measures should be included

in the evaluation plan.

7. Program Evaluation

An evaluation of effectiveness of

overall capacity building effort in

addressing public health issues in

communities living near hazardous

waste sites will be conducted jointly by

all participants. This evaluation will

focus on outcome and impact

measurements using a standard

evaluation instrument. Both process and

impact/outcome measures will be

included in the evaluation.

B. Recipient Optional Activities

1. For all health assessments and/or

health consultations prior to October 1,

1995, for which a health follow-up

activity was recommended, the

recipient will reassess community,

environmental, and human data and

provide in writing a disposition of their

assessment.

2. For those studies recommended

previously, the recipient will develop a

protocol and conduct the recommended

study. This protocol will undergo

scientific peer review as required by

ATSDR and may require clearance by

the Office of Management and Budget

(OMB) before data collection can begin.

3. The recipient is required to provide

proof by citing a State code or regulation

or other State pronouncement under

authority of law, that medical

information obtained pursuant to the

agreement will be protected from

disclosure when the consent of the

individual to release identifying

information is not obtained.

4. Evaluation

As part of the workplan for Optional

Activities (Public Health Studies/

Investigations), develop a site-specific

evaluation plan, including a standard

evaluation instrument prior to the

conduct of site-specific activities. The

plan should contain a component for

each activity undertaken at the site.

Conduct evaluation of activities,

projects, and site-specific programs to

determine if community’s needs as well

as intended purpose of the activities

have been met. Both process and

impact/outcome measures should be

included in the evaluation plan.

C. Other Activities

1. Participate in Technical Project

team (TPT) review and comply with

established review and handling

procedures for incorporating the results

of recommendations into site evaluation

activities.

2. Provide abstraction overview to

ATSDR on each site for which site

evaluation activities have been

conducted for inclusion in the

HAZDAT.

3. Review and prepare written

comments on EPA’s draft Remedial

Investigation/Feasibility Study (RI/FS),

RI/FS workplans, and Records of

Decision, and site-specific documents of

the State’s environmental department.

4. Workshops

a. Participate in local, State, and

Federal health and environmental

workshops and community meetings to

discuss and respond to questions

concerning a particular site’s impact on

public health.

b. Participate in ATSDR-scheduled

training classes or workshops to

increase knowledge and skills in

environmental public health.

5. Respond to ATSDR’s requests

concerning congressional inquiries/

testimonies, program evaluation, or

other information in carrying out the

purpose of the project.

D. ATSDR Core Activities

All activities will be conducted via an

annually negotiated work plan,

mutually agreed upon at the time of the

annual budget discussions between

ATSDR and recipient, that complies

with requirements of applicable sections

of CERCLA, as amended.

As requested by the recipient, ATSDR

is available to provide the following:

1. Public Health Assessments

Collaborate with and assist recipient

in conducting Public Health Assessment

activities on CERCLIS or other sites or

facilities within the recipient’s

territorial boundary, which includes:

a. Collaborate and assist in preparing

addenda to update public health

assessments.

b. Collaborate and assist in preparing

Site Review and Updates (SRU) to

evaluate current conditions and

determine the need for further actions.

2. Health Consultations

Collaborate and assist recipient in

preparing a written or verbal response to

a specific question or specific request

for information about health risks posed

by a specific site (including SACM),

chemical release, or hazardous material.

3. Exposure Investigations

Collaborate and assist in conducting

Exposure Investigations.

4. Community Involvement

a. Assist in developing effective

methods to conduct needs assessments

in communities living near hazardous

waste sites and in defining goals and

objectives.

b. Assist in development,

implementation, and evaluation of the

community involvement plan.

5. Site-specific Health Education

a. Collaborate in developing and

reviewing all educational materials to

ensure scientific accuracy. Provide

existing materials as requested.

Collaborate in developing projects for

specific target audiences.

c. Collaborate with the State in the

implementation of programs and the

distribution of materials.

6. Evaluation

ATSDR will lead the evaluation of

each recipient’s total program. This

evaluation will focus on outcome and

impact measurements using a standard

evaluation instrument. In addition,

ATSDR will conduct an evaluation of

effectiveness of overall capacity

building effort in addressing public

health issues in communities living near

hazardous waste sites. Both process and

impact/outcome measures will be

included in the evaluation.

E. ATSDR Optional Activities

As requested by the recipient, ATSDR

is available to provide the following:

1. Provide assistance in both the

planning and implementation phases of
18606 Federal Register / Vol. 61, No. 82 / Friday, April 26, 1996 / Notices

the field work called for under the study

protocol.

2. Provide consultation and assist in

monitoring the data and specimen

collection.

3. Participate in the study analysis.

4. Collaborate in interpreting the

study findings.

5. ATSDR will conduct technical and

peer review.

6. Evaluation—ATSDR will evaluate

each recipient’s total program. This

evaluation will focus on outcome and

impact measurements using a standard

evaluation instrument. In addition,

ATSDR will conduct an evaluation of

effectiveness of overall capacity

building effort in addressing public

health issues in communities living near

hazardous waste sites. Both process and

impact/outcome measures will be

included in the evaluation.

F. Other ATSDR Activities

1. Initiate and conduct review by

Technical Project Team.

2. Assist with abstraction overview for

the database on each site for which site

evaluation activities have been

conducted.

3. Assist with recipient’s review and

preparation of written comments on

EPA’s draft Remedial Investigation/

Feasibility Study (RI/FS), RI/FS

workplans, and Records of Decision,

and site-specific documents of the

State’s environmental department.

4. Workshops

a. Assist recipient with participation

in local, State, and Federal health and

environmental workshops and

community meetings to discuss and

respond to questions concerning a

particular site’s impact on public health.

b. Initiate and conduct ATSDRscheduled training classes or workshops

to increase recipients knowledge and

skills in environmental public health.

5. Assist recipient with ATSDR’s

requests concerning congressional

inquiries/testimonies, program

evaluation, or other information in

carrying out the purpose of the project.

Evaluation Criteria

The proposed program, whether made

up of Core Activities or Core Activities

and Optional Activities, will account for

a total of 70% of the score from the

evaluation criteria. Applications will be

reviewed and evaluated according to the

following criteria:

A. Applications for Core Activities Only

1. Proposed Program—70%

Applicant’s ability to address the

following:

a. Ability to respond to specific public

health issues that occur as a result of

actual or potential human exposure to a

hazardous substance including methods

to evaluate and analyze toxicological,

community, and environmental health

data; and to conduct and analyze data

from exposure investigations.

b. Description of involvement with

communities in response to concern

about a particular site’s impact on

public health. Ability to develop and

provide preventive health education in

a timely fashion in response to public

health issues including appropriateness

and thoroughness of the methods used

to evaluate preventive health education;

and the extent to which evaluation plan

includes measures of program outcome

(i.e., effect of participant’s knowledge,

attitudes, skills, behaviors, exposure to

hazardous substances).

2. Program Personnel—15%

The extent to which the proposal has

described or provided biographical data

on the:

a. Manner in which an integrated

‘‘core’’ team will be developed to

address components of this program. A

consistent core team is vital to this

effort. ATSDR recommends that the

team consist of, at minimum, 1–2 FTE

health assessors and 1–2 FTE health

educators/community involvement

specialists for core activities, and 1 FTE

epidemiologist or health scientist for

Optional Activities.

b. Appropriate qualifications,

experience, leadership ability, and

percentage of time project director (or

principle investigator) will commit to

the project.

c. Appropriate qualifications,

experience, and description of how staff

will be utilized in relation to the

activities to be performed to accomplish

the work and their percentage of time to

be spent on the project; CVs should be

provided.

d. Ability of recipient to adhere to

‘‘Third Party Agreements’’ under ‘‘Other

Requirements’’ of this announcement if

contractors are proposed.

3. Capability—15%

Description of the applicant’s

capability to carry out the proposed

project and suitability of facilities and

equipment available or to be purchased

for the project.

4. Program Budget—(not scored)

The extent to which the budget relates

directly to project activities, is clearly

justified, and is consistent with

intended use of funds. The budget

should include funds for one health

assessor, one health educator, and one

epidemiologist or health scientist to

attend the annual training meeting in

Atlanta (five days).

5. Human subjects—(not scored)

Whether or not exempt from the

DHHS regulations, are procedures

adequate for the protection of human

subjects?

Recommendations on the adequacy of

protections include: (1) Protections

appear adequate and there are no

comments to make or concerns to raise,

or (2) protections appear adequate, but

there are comments regarding the

protocol, or (3) protections appear

inadequate and the Objective Review

Group (ORG) has concerns related to

human subjects; or (4) disapproval of

the application is recommended

because the research risks are

sufficiently serious and protection

against the risks are inadequate as to

make the entire application

unacceptable.

6. Continuation Awards

Continuation awards within the

project period will be made on the basis

of the following criteria:

a. Satisfactory progress has been made

in meeting project objectives;

b. Objectives for the new budget

period are realistic, specific, and

measurable;

c. Proposed changes in described

methods of operation, need for financial

support, and/or evaluation procedures

will lead to achievement of project

objectives; and

d. The budget request is clearly

justified and consistent with the

intended use of cooperative agreement

funds.

B. Applications for Core Plus Optional

Activities

1. Proposed Program—70%

Applicant’s ability to address the

following:

a. Ability to respond to specific public

health issues that occur as a result of

actual or potential human exposure to a

hazardous substance including methods

to evaluate and analyze toxicological,

community, and environmental health

data; and to conduct and analyze data

from exposure investigations.

b. Description of involvement with

communities in response to concern

about a particular site’s impact on

public health. Ability to develop and

provide preventive health education in

a timely fashion in response to public

health issues including appropriateness

and thoroughness of the methods used

to evaluate preventive health education;

and the extent to which evaluation plan
Federal Register / Vol. 61, No. 82 / Friday, April 26, 1996 / Notices 18607

includes measures of program outcome

(i.e., effect of participant’s knowledge,

attitudes, skills, behaviors, exposure to

hazardous substances).

c. An understanding of and capability

to conduct human health studies. The

application for Core and Optional

activities should include a protocol for

a human health study from those

previously recommended by ATSDR for

sites in the recipient’s State for which

a study has not commenced. Sitespecific protocol will be reviewed based

on the following: (a) the approach,

feasibility, adequacy, and rationale of

the proposed study design; (b) the

technical merit of the proposed study,

including the methods and procedures

(including quality assurance and quality

control procedures) for the proposed

study; (c) the proposed timeline,

including clearly established objectives

for which progress toward attainment

can and will be measured; and (d) the

proposed method to disseminate the

results of the study to State and local

public health officials, community

residents, and other concerned

individuals and organizations.

2. Program Personnel—15%

The extent to which the proposal has

described or provided biographical data

on the:

a. Manner in which an integrated

‘‘core’’ team will be developed to

address components of this program. A

consistent core team is vital to this

effort. ATSDR recommends that the

team consist of, at minimum, 1–2 FTE

health assessors and 1–2 FTE health

educators/community involvement

specialists for core activities, and 1 FTE

epidemiologist or health scientist for

Optional Activities.

b. Appropriate qualifications,

experience, leadership ability, and

percentage of time project director (or

principle investigator) will commit to

the project.

c. Appropriate qualifications,

experience, and description of how staff

will be utilized in relation to the

activities to be performed to accomplish

the work and their percentage of time to

be spent on the project; CVs should be

provided.

d. Ability of recipient to adhere to

‘‘Third Party Agreements’’ under ‘‘Other

Requirements’’ of this announcement if

contractors are proposed.

3. Capability—15%

Description of the applicant’s

capability to carry out the proposed

project and suitability of facilities and

equipment available or to be purchased

for the project.

4. Program Budget—(not scored)

The extent to which the budget relates

directly to project activities, is clearly

justified, and is consistent with

intended use of funds. The budget

should include funds for one health

assessor, one health educator, and one

epidemiologist or health scientist to

attend the annual training meeting in

Atlanta (five days).

5. Human subjects—(not scored)

Whether or not exempt from the

DHHS regulations, are procedures

adequate for the protection of human

subjects?

Recommendations on the adequacy of

protections include: (1) Protections

appear adequate and there are no

comments to make or concerns to raise,

or (2) protections appear adequate, but

there are comments regarding the

protocol, or (3) protections appear

inadequate and the ORG has concerns

related to human subjects; or (4)

disapproval of the application is

recommended because the research

risks are sufficiently serious and

protection against the risks are

inadequate as to make the entire

application unacceptable.

6. Continuation Awards

Continuation awards within the

project period will be made on the basis

of the following criteria:

a. Satisfactory progress has been made

in meeting project objectives;

b. Objectives for the new budget

period are realistic, specific, and

measurable;

c. Proposed changes in described

methods of operation, need for financial

support, and/or evaluation procedures

will lead to achievement of project

objectives; and

d. The budget request is clearly

justified and consistent with the

intended use of cooperative agreement

funds.

Funding Priorities

Applicants must demonstrate the

ability to address the activities

described in the Program Requirements

section of this announcement. Priority

will be given for the following:

1. Number of proposed and/or listed

National Priorities List (NPL) sites

(Federal and non-Federal) based on

most current listing by EPA.

2. Number of Comprehensive

Environmental Response,

Compensation, and Liability

Information System (CERCLIS) sites

(Federal and non- Federal) based on

most current listing by EPA.

3. Those applicants who apply for

both Core Activities and Optional

Activities in order to develop an

integrated program.

4. Geographic distribution across the

entire United States.

Interested persons are invited to

comment on the proposed funding

priority. All comments received on or

before May 28, 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

receipt of applications.

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 Review

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 should contact

their State Single Point of Contact

(SPOC) as early as possible to alert them

to the prospective applications and to

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., Atlanta, GA

30305, no later than 60 days after the

application deadline date. The granting

agency does not guarantee to

‘‘accommodate or explain’’ State process

recommendations it receives after that

date.

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 ATSDR, 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. This
18608 Federal Register / Vol. 61, No. 82 / Friday, April 26, 1996 / Notices

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 numbers are 93.200, 93.202,

93.203.

Other Requirements

A. Paperwork Reduction Act

Projects that involve the collection of

information from 10 or more individuals

and funded by cooperative agreement

will be subject to review by the Office

of Management and Budget (OMB)

under the Paperwork Reduction Act.

ATSDR has developed standard multiuse interview forms that may be made

available for use by States conducting

investigations and/or studies under this

cooperative agreement.

B. Protection of Human Subjects

If the proposed project involves

research on human subjects, the

applicant must comply with Department

of Health and Human Services

Regulations (45 CFR Part 46) regarding

the protection of human subjects.

Assurances must be provided to

demonstrate that the project will be

subject to initial and continuing review

by appropriate institutional review

committees. In addition to other

applicable committees, Indian Health

Service (IHS) institutional review

committees must also review the project

if any component of IHS will be

involved or will support the research. If

any American Indian community is

involved, its tribal government must

also approve that portion of the project

applicable to it. The applicant will be

responsible for providing assurance in

accordance with the appropriate

guidelines and form provided in the

application kit.

C. Cost Recovery

CERCLA, as amended by SARA,

provides for the recovery of costs

incurred for response actions 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

would also maintain documentation

that describes the site-specific response

actions taken with respect to the site,

e.g., contracts, work assignments,

progress reports, and other documents

that describe the work performed at a

site. The recipient will retain the

documents and records to support these

financial transactions and

documentation of work performed, for

possible use in a cost recovery case, for

a minimum of ten years after

submission of a final financial status

report, unless there is 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.

D. 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

recipient 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 terms of the grant

and/or cooperative agreement, including

requirements concerning technical

review (ATSDR selected reviewers),

ownership of data, and the arrangement

for copyright when publications, data,

or other copyrightable works are

developed under or in the course of

work under a PHS 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 in the course of a grant 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 to be

followed in carrying out the agreement,

and the maximum amount of money for

which the grantee may become liable to

the third party under the agreement.

5. State non-conflict of interest

concerning activities conducted for

ATSDR and site-remediation activities

for other parties.

The written agreement required shall

not relieve the recipient of any part of

its responsibility or accountability to

PHS under the cooperative agreement.

The agreement shall, therefore, retain

sufficient rights and control to the

recipient to enable it to fulfill this

responsibility and accountability.

E. 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.

Application Submission and Deadline

The original and two copies of

application PHS Form 5161–1 (OMB

Number 0937–0189) should 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,

Mailstop E13, Atlanta, GA 30305, on or

before June 14, 1996. (By formal

agreement, the CDC Procurement and

Grants Office will act for and on behalf

of ATSDR on this matter.)

A. Deadline: 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 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.)

B. Late Applications: Applications

which do not meet the criteria in A. 1.

or 2. 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 607. You will receive a

complete program description,

information on application procedures
Federal Register / Vol. 61, No. 82 / Friday, April 26, 1996 / Notices 18609

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- 6630, or

INTERNET address,

mcs9@ops.pgo1.em.cdc.gov.

Programmatic technical assistance

may be obtained from Sharon

Campolucci, Deputy Director, Division

of Health Studies, Agency for Toxic

Substances and Disease Registry, 1600

Clifton Road, NE., Mailstop E–31,

Atlanta, GA 30333, telephone (404)

639–6200, or INTERNET address,

ssc1@atsdhs2.em.cdc.gov.

Please Refer to Announcement Number

607 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 22, 1996.

Claire V. Broome,

Deputy Administrator, Agency for Toxic

Substances and Disease Registry.

[FR Doc. 96–10362 Filed 4–25–96; 8:45 am]

BILLING CODE 4163–70–P

Centers for Disease Control and

Prevention

[INFO–96–14]

Proposed Data Collections Submitted

for Public Comment and

Recommendations

In compliance with the requirement

of Section 3506(c)(2)(A) of the

Paperwork Reduction Act of 1995 for

opportunity for public comment on

proposed data collection projects, the

Centers for Disease Control and

Prevention (CDC) will publish periodic

summaries of proposed projects. To

request more information on the

proposed projects or to obtain a copy of

the data collection plans and

instruments, call the CDC Reports

Clearance Officer on (404) 639–7090.

Comments are invited on: (a) Whether

the proposed collection of information

is necessary for the proper performance

of the functions of the agency, including

whether the information shall have

practical utility; (b) the accuracy of the

agency’s estimate of the burden of the

proposed collection of information; (c)

ways to enhance the quality, utility, and

clarity of the information to be

collected; and (d) ways to minimize the

burden of the collection of information

on respondents, including through the

use of automated collection techniques

for other forms of information

technology. Send comments to Wilma

Johnson, CDC Reports Clearance Officer,

1600 Clifton Road, MS–D24, Atlanta,

GA 30333. Written comments should be

received within 60 days of this notice.

Proposed Projects

1. Studies of Adverse Reproductive

Outcomes in Female Occupational

Groups—(0920–0367)—Revised—An

estimated 50,000 to 60,000 chemicals

are in common use throughout society

today and hundreds of new chemicals

are introduced each year. Yet the list of

environmental chemicals and agents

that have been investigated to determine

whether they have adverse effects on

reproductive health is still limited. With

the growing number of women in the

work force, it is becoming increasingly

important to evaluate the potential

female reproductive health effects of

occupational and physical agents.

In this program, NIOSH is planning to

undertake a series of five studies to

focus on potential reproductive effects

of chemical and physical agents in the

workplace. In the studies planned under

this program, the reproductive health of

a group of female workers exposed to

the agent of interest, will be compared

to the reproductive health of a group of

working women with no occupational

exposure to known or suspected

reproductive toxicants.

For all studies, data from company

personnel records containing

demographic, and work history

information will be used to estimate

workplace exposures. Each woman will

be asked to complete a telephone

questionnaire on reproductive history

and other factors (such as cigarette

smoking) that may influence

reproductive function. Each

questionnaire will take approximately

60 minutes to complete. Medical

records will be requested to confirm

adverse reproductive outcomes reported

by the participants. The risk of adverse

reproductive outcomes between the two

groups of women will then be

compared.

The first study to be conducted under

this program will be a study of

reproductive disorders among female

flight attendants. Approximately 66,000

flight attendants are currently employed

by U.S. commercial airlines and are

potentially exposed to ionizing

radiation and disruption of circadian

rhythms, two exposures that may

adversely affect reproductive function.

The other studies to be conducted under

this program have not yet been

determined. The total cost to

respondents is estimated at 102,000.00

Respondents No. of respondents

No. of responses/respondent

Avg. burden/response

(in hrs.)

Total

burden

(in hrs.)

Workers ............................................................................................................................ 6,200 1 1 6,200

Medical providers ............................................................................................................. 1,200 1 0.5 600

Total ....................................................................................................................... .................... .................... .................... 6,800

2. Coal Mine Dust Personal Sampling Systems—(0920–148)—Extension—This project, mandated under the Federal

Mine Safety and Health Act of 1977 (Pub. L. 91–173, as amended by Pub. L. 95–164), involves conducting evaluations

and tests on coal mine dust personnel sampling units (CMDPSUs) and issuing certifications for those CMDPSUs which

meet or exceed all applicable requirements listed in 30 CFR Part 74. It also requires conducting audits of new ‘‘offthe-shelf’’ CMDPSUs certified under these regulations to determine compliance, evaluating those CMDPSUs sent to NIOSH

as field problems, and responding to technical assistance requests. The total cost to respondents is estimated at $11,000.