Federal Register / Vol. 61, No. 85 / Wednesday, May 1, 1996 / Notices 19299

Reeves, 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–09, Atlanta, GA

30305, Telephone (404) 842–6596.

For Programmatic/Technical

Assistance: Bruce Granoff, Resource

Analysis Specialist, Public Health

Practice Program Office, Centers for

Disease Control and Prevention (CDC),

1600 Clifton Road, NE., Mailstop E–42,

Atlanta, GA 30333, Telephone (404)

639–0425.

Please refer to Announcement

Number 703 when requesting

information and when submitting your

Letter of Intent and application in

response to the announcement.

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 25, 1996.

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. 96–10783 Filed 4–30–96; 8:45 am]

BILLING CODE 4163–18–P

[Announcement 623]

1996 National Breast and Cervical

Cancer Early Detection Program

Introduction

The Centers for Disease Control and

Prevention (CDC) announces the

availability of funds in fiscal year (FY)

1996 for cooperative agreements to

develop State and Tribal comprehensive

breast and cervical cancer early

detection programs.

CDC is committed to achieving the

health promotion and disease

prevention objectives of ‘‘Healthy

People 2000,’’ a national activity to

reduce morbidity and mortality and to

improve the quality of life. This

announcement is related to the priority

area of Cancer. (To order a copy of

‘‘Healthy People 2000,’’ see the section

‘‘Where To Obtain Additional

Information.’’)

Authority

This program is authorized by

Sections 1501 and 1507 [42 U.S.C. 300k

and 42 U.S.C. 300n–3] of the Public

Health Service Act, as amended.

Smoke-Free Workplace

CDC strongly encourages all grant

recipients to provide a smoke-free

workplace and to 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

Assistance will be provided only to

the official health departments of States

or their bona fide agents or

instrumentalities and to American

Indian Tribes. 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 includes Indian

Tribes, Tribal organizations, and Urban

Indian organizations, hereby referred to

as Tribes).

1. The following States are excluded:

a. California, Colorado, Maryland,

Michigan, Minnesota, Missouri,

Nebraska, New Mexico, North Carolina,

South Carolina, Texas, and West

Virginia, which were funded in 1991,

under Program Announcements 121 and

122 entitled Early Detection and Control

of Breast and Cervical Cancer.

b. New York, Pennsylvania, Ohio,

Wisconsin, Massachusetts, and

Washington, which were funded in

September 1993, under Program

Announcement 321 entitled Early

Detection and Control of Breast and

Cervical Cancer.

c. Florida, Oklahoma and Utah, which

were funded in September 1994, under

Program Announcement 321 entitled

Early Detection and Control of Breast

and Cervical Cancer.

d. Alaska, Georgia, Maine, Oregon,

and Rhode Island, which were funded

in September 1994, under Program

Announcement 474 entitled Early

Detection and Control of Breast and

Cervical Cancer.

e. Arizona, Arkansas, Connecticut,

Iowa, Illinois, Kansas, Louisiana, New

Jersey, and Vermont, which were

funded in March 1995, under Program

Announcement 474 entitled Early

Detection and Control of Breast and

Cervical Cancer.

2. The following Tribes are excluded:

Artic Slope Native Association, Limited,

AK; Cherokee Nation, OK; Cheyenne

River Sioux Tribe, SD; Eastern Band of

Cherokee Indians, NC; Maniilaq

Association, AK; Pleasant Point

Passamaquoddy, ME; Poarch Band of

Creek Indians, AL; South Puget

Planning Agency, WA; Southcentral

Foundation, AK, which were funded

under the American Indian Initiative

Program Announcement 442.

States currently receiving CDC funds

under Program Announcement 221 and

425, entitled Breast and Cervical Cancer

Core Capacity, are eligible to apply for

funding under this announcement.

However, if funded under this

announcement, funding under Program

Announcement 221 will cease at the

end of the current 12-month budget

period. These grantees are currently in

a 12-month extension and will not be

eligible for an additional extension.

Under Program Announcement 425, a

no-cost extension may be approved to

complete capacity-building activities. If

not funded under this announcement,

funding will continue as stated in the

most recent award.

Availability of Funds

1. Approximately $15 million is

available in FY 1996 to fund

approximately 19 States/Territories. It is

expected that the average award will be

$750,000, ranging from $500,000 to

$1,500,000.

2. Approximately $1 million is

available to fund approximately 5

Tribes. It is expected that the average

award will be $200,000 ranging from

$150,000 to $350,000.

It is expected that these awards will

begin on September 30, 1996, and will

be made for 12-month budget periods

within a project period of up to five

years. Funding estimates may vary and

are subject to change.

Continuation awards within the

project period will be made on the basis

of satisfactory progress and the

availability of funds.

At the request of the applicant,

Federal personnel may be assigned to a

project in lieu of a portion of the

financial assistance.

Purpose

The purpose of this program is to

establish a State/Tribal comprehensive

public health approach to reduce breast

and cervical cancer morbidity and

mortality through screening, referral and

follow-up, public education and

outreach, professional education,

quality assurance, surveillance and

evaluation. The program will pay for

screening of women who are unable to

afford these services. Priority for

provision of services will be given to

women who are low-income, uninsured
19300 Federal Register / Vol. 61, No. 85 / Wednesday, May 1, 1996 / Notices

and under-insured, racial and ethnic

minorities including American Indians,

and women who live in hard-to- reach

communities in urban and rural

America.

Program Requirements

In accordance with Pub. L. 101–354,

an award may not be made unless the

State/Tribe involved agrees that:

1. Not less than 60 percent of

cooperative agreement funds will be

expended for screening, appropriate

referral for medical treatment, and, to

the extent practicable, the provision of

appropriate follow-up services. The

remaining 40 percent will be expended

to support public education,

professional education, quality

assurance, surveillance, program

evaluation, and related program

activities. [Section 1503(a) (1) and (4) of

the PHS Act, as amended.]

2. States and Tribes are required to

implement all program components, i.e.,

the screening, follow-up and referral

services must be initiated by the end of

the first budget year, and the remaining

activities of a comprehensive breast and

cervical cancer early detection program

(public education, professional

education, quality assurance,

surveillance and program evaluation)

must be fully operational by the end of

the second budget year. [Section 1503

(a) (1) and (3) of the PHS Act, as

amended.]

3. Cooperative agreement funds will

not be expended to provide inpatient

hospital or treatment services. [Section

1504(g) of the PHS Act, as amended.]

Treatment is defined as any service

recommended by a clinician, including

medical and surgical intervention

provided in the management of a

diagnosed condition. Also, cooperative

agreement funds will not be used for the

specific diagnostic procedures of breast

biopsy and Loop Electrosurgical

Excisional Procedure (LEEP).

4. Not more than 10 percent of funds

will be expended annually for

administrative expenses. These

administrative expenses are in lieu of

and replace indirect costs. [Section

1504(f) of the PHS Act, as amended.]

5. Matching funds are required from

non-Federal sources in an amount not

less than $1 for each $3 of Federal funds

awarded under this program. [Section

1502 (a) and (b) of the PHS Act, as

amended.]

6. Costs used to satisfy matching

requirements are subject to the same

prior approval requirements and rules of

allowability as those which govern

project costs supported by Federal

funds. (Office of Management and

Budget, Circular A–87, ‘‘Cost Principles

for State, Local and Indian Tribal

Governments’’ and PHS Grants Policy

Statement, Section 6.)

7. All costs used to satisfy matching

requirements must be documented by

the applicant and shall be subject to

audit.

8. If a new, or improved, and superior

screening procedure becomes widely

available and is recommended for use,

this superior procedure shall be utilized

in the program. [Section 1503(b) of the

PHS Act, as amended.]

9. An award may not be made unless

the State Medicaid Program provides

coverage for:

a. In the case of breast cancer, a

clinical breast examination and

screening mammography.

b. In the case of cervical cancer, both

a pelvic examination and Pap test

screening. [Section 1502A of the PHS

Act, as amended.]

10. In 1993, congressional

amendments to the National Breast and

Cervical Cancer Early Detection Program

included the following changes:

a. States/Tribes may enter into

contracts with private for-profit entities

to provide screening and diagnostic

services only. Contracts for other kinds

of services with for-profit agencies are

not allowed.

b. The amount paid by a State/Tribe

for a screening procedure may not

exceed the amount that would be paid

under part B of title XVIII of the Social

Security Act (Medicare).

c. All facilities conducting

mammography screening procedures

funded by the Program must meet the

regulations for mammography quality

assurance developed by the Food and

Drug Administration (FDA).

d. For cervical cancer activities,

facilities shall meet the standards and

regulations developed by the Health

Care Financing Administration (HCFA)

implementing the Clinical Laboratory

Improvement Amendments (CLIA) of

1988.

In accordance with Section 1504 (c)(2)

of the PHS Act, as amended, CDC may

waive the requirements for specific

services/activities if it is determined

that compliance by the State/Tribe

would result in an inefficient allocation

of resources with respect to carrying out

a comprehensive breast and cervical

cancer early detection program as

described in Section 1501(a). A request

from the recipient outlining appropriate

and detailed justification would be

required before the waiver is approved.

In conducting activities to achieve the

purpose of this program, the recipient

will be responsible for the activities

under A. (Recipient Activities), and

CDC will be responsible for conducting

activities under B. (CDC Activities).

A. Recipient Activities

1. Establish a system for screening

women for breast and cervical cancer as

a preventive health measure. [Section

1501(a)(1) of the PHS Act, as amended.]

This program is to increase the

utilization of screening services for

breast and cervical cancer among all

women in States/Tribes, with priority

given to those women who are lowincome, uninsured, underinsured, racial

and ethnic minorities.

a. Ensure that screening procedures

are available for both breast and cervical

cancer and provided to women

participating in the program, including

a clinical breast exam, mammography,

pelvic exam, and Pap smear. [Section

1503(a)(2) (A) and (B) of the PHS Act,

as amended.]

Screening services should be made

available according to the following

guidelines:

Breast Health: (1) The most important

risk factors for breast cancer are being

female and older age. Programs should

place emphasis on screening women 50

years and older. Specific screening

guidelines that outline age eligibility are

provided in the Official Program

Guidelines Age Eligibility for

Mammography Screening (included in

the application kit). Eligible women can

receive an annual clinical breast

examination and screening

mammogram.

The following exceptions apply:

(a) Women who have an abnormal

clinical breast exam may be referred for

a physician consultation, diagnostic

mammogram and/or other diagnostic

procedures reimbursed by the program

(see ‘‘b.’’ below).

(b) Among asymptomatic women ages

40–49 who are screened for the first

time by the program, priority should be

given to those who have a personal

history of breast cancer or a first-degree

relative with pre-menopausal breast

cancer.

(2) For diagnostic services following

an abnormal screening result,

cooperative agreement funds may be

expended for additional mammogram

views, fine-needle aspiration,

ultrasound, and office visits for

evaluation of abnormal clinical breast

examinations.

b. Provide priority for screening,

referral, tracking, and follow-up services

to women who are uninsured or underinsured. [Section 1504(a) of the PHS

Act, as amended.]

An award may not be made under this

announcement unless the State/Tribe

involved agrees to give priority to the
Federal Register / Vol. 61, No. 85 / Wednesday, May 1, 1996 / Notices 19301

provision of screening, follow-up, and

referral services to women who are

underserved and low-income.

c. Establish breast and cervical cancer

screening services throughout the State/

Tribe. [Section 1504(c)(1) of the PHS

Act, as amended.]

Funds may not be awarded under this

announcement, unless the State/Tribe

involved agrees that services and

activities will be made available

throughout the State/Tribe, including

availability to members of any Indian

Tribe or tribal organization (as such

terms are defined in Section 4 of the

Indian Self-Determination and

Education Assistance Act).

d. Provide allowances for items and

services reimbursed under other

programs. [Section 1504(d) (1) and (2) of

the PHS Act, as amended.]

Funds may not be awarded under this

announcement, unless the State/Tribe

involved agrees that funds will not be

expended to make payment for any item

or service that will be paid or can

reasonably be expected to be paid by:

(1) Any State/Tribe compensation

program, insurance policy, or Federal or

State/Tribe health benefits program.

(2) An entity that provides health

services on a prepaid basis.

e. Establish a schedule of fees/charges

for services. [Section 1504(b) (1), (2),

and (3) of the PHS Act, as amended.]

Funds may not be awarded under this

announcement unless the State/Tribe

involved agrees that if charges are to be

imposed for the provision of services or

program activities, the fees/charges for

allowable screening and follow-up

services will be:

(1) Made according to a schedule of

fees that is made available to the public.

[Section 1504(b)(1) of the PHS Act, as

amended.]

(2) Adjusted to reflect the income of

the woman screened. [Section

1504(b)(2) of the PHS Act, as amended.]

(3) Totally waived for any woman

with an income of less than 100 percent

of the official poverty line as established

by the Director of the Office of

Management and Budget and revised by

the Secretary of the Department of

Health and Human Services in

accordance with Section 673(2) of the

Omnibus Budget Reconciliation Act of

1981. [Section 1504(b)(3) of the PHS

Act, as amended.]

Additionally, the schedule of fees/

charges should not exceed the

maximum allowable charges established

by the Medicare Program administered

by the Health Care Financing

Administration (HCFA). Fee/charge

schedules should be developed in

accordance with guidelines described in

the interim final rule (42 CFR Parts 405

and 534) which implements Section

4163 of the Omnibus Budget

Reconciliation Act of 1990 (Pub. L. 101-

508) which provides limited coverage

for screening mammography services.

Cervical Health: (1) Women who are

18 years and older, with an intact

cervix, are eligible for an annual Pap

test and pelvic examination. While the

incidence of precancerous lesions and

cancer are higher among younger

women, older women have higher

mortality rates and are less likely to be

screened regularly. Hence, programs

should provide a balanced distribution

in the ages of women receiving Pap

tests.

The following exceptions apply:

(a) After a woman has had three

consecutive, normal, annual

examinations, the Pap test may be

performed less frequently at the

discretion of her health care provider.

(b) Women who have had a total

hysterectomy that was performed for

cervical neoplasia are eligible to receive

Pap screening.

(2) For diagnostic services following

an abnormal screening result,

cooperative agreement funds may be

expended for colposcopy and

colposcopy-directed biopsy.

2. Provide appropriate referrals for

medical treatment of women screened

in the program and ensure, to the extent

practicable, the provision of appropriate

diagnostic and treatment services.

[Section 1501(a)(2) of the PHS Act, as

amended.]

A system for providing the

appropriate diagnostic and treatment

services for women whose screening test

results are abnormal or suspicious is an

essential component of any

comprehensive breast and cervical

cancer early detection program. Priority

for diagnostic services should be given

to women participating in the screening

program who have abnormal screening

results. The operational plan and budget

for diagnostic services should reflect the

projected number of women to be

screened by the program annually and

the estimated number of abnormal

screening exams expected.

a. Establish and maintain a system for

the timely and appropriate referral and

follow-up of women with abnormal or

suspicious screening tests.

Referral systems should include the

regular updating of information on local

resources available in the community to

which health care providers can refer

women for additional diagnostic

procedures not paid for by the program,

as well as treatment services. Health

care providers should assist clients in

need of treatment services in obtaining

eligibility for public-supported third

party reimbursement programs.

b. Develop and implement a tracking

system for women screened in the breast

and cervical cancer early detection

program. [Section 1501(a)(6) of the PHS

Act, as amended.]

Tracking the women screened is

essential to ensure that those who have

abnormal results receive appropriate

and timely follow-up for repeat

screening, diagnostic procedures, and

treatment. Tracking also includes

reminders and outreach to women with

normal results to return for timely

rescreening. A useful tracking system is

one that can be effectively integrated

into the State/Tribe health care delivery

system. The tracking system should

provide women with a unique

identification number to document the

outcome of individual screening tests,

regardless of the screening cycle or site.

It should also provide information on

needed follow-up. Confidentiality must

be assured.

To meet the intent of Pub. L. 101–354

in ensuring the appropriate follow-up of

women with abnormal screening results,

the State/Tribe tracking system must

include information on screening

location (e.g., county, city),

demographic characteristics (e.g., race,

date of birth), and screening procedures

and results (e.g., mammography, Pap

tests) for all women in the program. For

women identified with abnormal

screening results, information on

diagnostic procedures (e.g.,colposcopy)

and diagnoses, treatment (e.g., date

initiated), and stage of disease must be

included.

In collaboration with CDC, States with

currently funded comprehensive

programs have compiled a list of some

of the information necessary to ensure

the appropriate follow-up of women.

This list is available for the use of States

awarded new funding under this

announcement.

3. Develop and disseminate public

information, education and outreach

programs for the early detection and

control of breast and cervical cancer.

[Section 1501 (a)(3) of the PHS Act, as

amended.]

Public information, education, and

outreach includes the systematic design

and sustained delivery of clear and

consistent health messages to women

using a variety of methods and strategies

that contribute to the early detection of

breast and cervical cancer. Successful

public education and outreach programs

are those that increase women’s

knowledge, attitudes, and ultimately

have an impact on screening behavior.

Public education and outreach

activities should increase the number of
19302 Federal Register / Vol. 61, No. 85 / Wednesday, May 1, 1996 / Notices

women screened especially those who

are low-income, uninsured, underinsured, older women of a racial or

ethnic minority, and women who reside

in hard-to-reach urban or rural

communities. State/Tribe and local

programs should clearly demonstrate,

through evaluation, the relationship of

public education and outreach strategies

to the number of women screened

through the program.

4. Improve the education, training,

and skills of health professionals

(including allied health professionals)

in the detection and control of breast

and cervical cancer. [Section 1501(a)(4)

of the PHS Act, as amended.]

Health care providers (including, but

not limited to, primary care physicians,

radiologists, cytopathologists, surgeons,

gynecologists, nurse practitioners,

physician’s assistants, registered nurses,

radiologic technologists, health

educators, and outreach workers) play a

key role in assuring that women are

screened at appropriate intervals, that

screening tests are performed optimally,

and that women with abnormal test

results receive timely and appropriate

diagnostic follow-up and treatment.

Professional education strategies can be

focused in two directions. One direction

could provide direct educational

opportunities to those health care

professionals who provide breast and

cervical cancer screening. A second

focus is to develop clinical systems of

practice that promote ongoing

appropriate screening.

5. Establish mechanisms through

which the State/Tribe can monitor the

quality of screening procedures for

breast and cervical cancer, including the

interpretation of such procedures.

[Section 1501(a)(5) of the PHS Act, as

amended.]

Cooperative agreement funds may not

be awarded under Section 1501 of the

PHS Act, as amended, Pub. L. 101–354

unless the State/Tribe involved agrees to

assure the implementation of quality

assurance procedures for mammography

and cervical cytology. [Section 1503(c)

and (d) of the PHS Act, as amended.]

a. Develop and implement a quality

assurance system for breast cancer

screening. The mammography services

provided to women screened in the

program must be conducted in

accordance with the following

guidelines issued by the Secretary of the

Department of Health and Human

Services. [Section 1503(e) of the PHS

Act, as amended]:

(1) All facilities conducting

mammography screening procedures

funded by the program must meet the

requirements for mammography quality

assurance developed by the Food and

Drug Administration (FDA).

(2) Radiologists participating in the

program shall record their findings

using the second edition American

College of Radiology (ACR) Breast

Imaging Reporting and Data System (BI–

RADS). The BI–RADS’ reporting

categories are as follows: (1) Negative;

(2) Benign finding; (3) Probably benign

finding—short interval follow-up

suggested; (4) Suspicious finding; (5)

Highly suggestive of malignancy; (6)

Assessment incomplete.

(3) A report of the results of a

mammogram performed through this

program shall be placed in a woman’s

permanent medical records that are

maintained by her health care provider.

b. Develop and implement a quality

assurance system for cervical cancer

screening. The laboratory services

provided to women for cytological

screening must be conducted in

accordance with the following

guidelines issued by the Secretary of the

Department of Health and Human

Services. [Section 1503(e) of the PHS

Act, as amended]:

(1) Facilities shall meet the standards

and regulations promulgated by the

Health Care Financing Administration

(HCFA) under the Clinical Laboratory

Improvement Act (CLIA) of 1988.

(2) All cervical cytology interpretation

is required to be done on the premises

of a qualified laboratory.

(3) A report of the results of a Pap test

performed through this program shall be

placed in the woman’s permanent

medical records that are maintained by

her health care provider.

(4) Pathologists participating in the

program shall record their Pap test

findings using the Bethesda System

which specifies specimen adequacy and

incorporates these categories: (1) Within

Normal Limits; (2) Infection/

Inflammation/Reactive Changes; (3)

Atypical squamous cells; (4) Low Grade

Squamous Intra epithelial Neoplasia

(SIL); (5) High Grade SIL; (6) Squamous

Cell Carcinoma; (7) Other.

6. Establish mechanisms which

enhance the State/Tribe cancer

surveillance system (i.e., the Statewide

Central Cancer Registry and other

databases) and facilitate program

planning and evaluation. [Section

1501(a)(5) of the PHS Act, as amended.]

Monitoring the distribution and

determinants of breast and cervical

cancer incidence and mortality is

necessary to effectively plan,

implement, and evaluate a

comprehensive early detection program.

Linkages with, and in some cases

enhancements of, State/Tribe vital

statistics, the Central Cancer Registry,

the Behavioral Risk Factor Surveillance

System and other State/Tribe and local

surveys are needed to evaluate the

status of program process (i.e.,

management, professional education,

public education and outreach), impact

(i.e., changes in participant screening

behavior or screening practices of

providers) and outcome (i.e., State/Tribe

program screening data, cancer staging,

morbidity, mortality).

a. To do this, surveillance systems

should be established or enhanced

which will:

(1) Collect Statewide/Tribe

population-based information on the

demographics, incidence, staging at

diagnosis, and mortality from breast and

cervical cancer.

(2) Identify segments of the

population at higher risk for disease and

for the failure to be screened.

(3) Identify factors contributing to the

disease burden, such as behavioral risk

factors and limited or inequitable access

to early detection and treatment

services.

(4) Monitor the number and

characteristics of women screened in

the program and the outcome of

screening by analyzing data from the

State/Tribe tracking system.

(5) Monitor screening resources,

including the number of available

mammography facilities, cytology

laboratories, and providers of cervical

cancer screening.

(6) When appropriate, develop

linkages between the above-mentioned

data bases.

b. Measuring the effectiveness of

program activities to modify the

screening behavior of women (impact

evaluation) and on morbidity and

mortality (outcome evaluation) is

important for the identification of

successful intervention strategies for the

early detection of breast and cervical

cancer. Equally important is process

evaluation or the assessment of factors

that contributed to the successful or

unsuccessful establishment and

implementation of program activities.

The design of each program

component should ensure that there can

be meaningful process, impact, and

outcome evaluation. The evaluation

plan should assess the implementation

and effectiveness of each program

component. At a minimum, the

evaluation plan should identify those

program activities that will be

evaluated, the process, impact, and

outcome indicators to be measured, how

they will be measured, the proposed

program time-lines, and resources

needed. Activities could include:

(1) An inventory of specific services

provided and a systematic description
Federal Register / Vol. 61, No. 85 / Wednesday, May 1, 1996 / Notices 19303

of the infrastructure developed with

cooperative agreement funds;

(2) A description of the women who

received services, including the number

of women and demographic information

such as age, race and ethnicity;

(3) An assessment of the referral

system including the number of women

referred for diagnostic and treatment

services, number who received these

services, and the capacity of the system

to identify community resources to

assist women in obtaining access to

available services;

(4) An assessment of the availability

and accessibility of breast and cervical

cancer screening services and an

estimation of the number of uninsured

women by age and racial/ethnic

distribution in the State/Tribe to be

served by the program;

(5) An assessment of the planning,

development, implementation, and

accomplishment of program activities

(e.g., goals, objectives, time lines,

recruiting, hiring, and retaining staff;

training staff; establishing and

maintaining contracts with provider

agencies, and assuring the quality of

contractor performance);

(6) An assessment of changes in

participant and provider knowledge,

attitudes, behaviors, and practices

related to screening for breast and

cervical cancer;

(7) And an assessment of the quality

of screening tests provided by the

program.

7. Ensure the coordination of services

and program activities with other

similar programs and establish a broadbased council to advise and support the

program. [Section 1504(e) of the PHS

Act, as amended.] Coordination with

other similar programs maximizes the

availability of services and program

activities, promotes consistency in

screening procedures and educational

messages, and reduces duplication. An

award may not be made under this

program announcement unless the

State/Tribe agrees that the services and

activities provided in this program are

coordinated with other Federal, State/

Tribe, and local breast and cervical

cancer early detection programs through

the development of collaborative

partnerships. [Section 1504(e) of the

PHS Act, as amended.]

The success of a comprehensive

breast and cervical cancer early

detection program is improved by

broad-based support in the community

and active public and private sector

involvement. Partnership development

with a broad range of stakeholders,

including consumers, brings valuable

knowledge, skills, and financial

resources to the program, and provides

access to, and information about,

populations of women who have been

missed by traditional screening systems.

Linkages should be established with

federally funded programs such as the

Regional Offices of the National Cancer

Institute/Cancer Information Service

(NCI/CIS), the Health Resources and

Services Administration (HRSA)

community/migrant health centers, Title

X Family Planning programs, State

Offices for Aging and Minority Health,

the Indian Health Service (IHS) and the

Medicare Program of the Health Care

Financing Administration (HCFA).

Linkages and active collaboration are

strongly encouraged with private sector

organizations such as the American

Cancer Society (ACS), the Young

Women’s Christian Association

(YWCA), the Susan G. Komen Breast

Cancer Foundation, the National Breast

Cancer Coalition (NBCC), the National

Alliance of Breast Cancer Organizations

(NABCO), the American Association of

Retired Persons (AARP), professional

organizations, private physicians,

survivors of breast and cervical cancer,

local women’s support groups,

community leaders, managed care

organizations, and other agencies and

businesses in the community that

provide health care and related support

services to women.

8. Develop and implement a breast

and cervical cancer control plan for

program management and operations.

The success of a comprehensive

breast and cervical cancer early

detection program is increased by the

existence of a comprehensive,

integrated, and realistic plan to address

these diseases among all women, with

priority to uninsured and underinsured

women and racial and ethnic minorities.

All program components of the

comprehensive program should be

addressed.

A comprehensive breast and cervical

cancer screening operational plan

should relate to the State/Tribe Year

2000 Objectives and to the State/Tribe

Cancer Control Plan. The operational

and management plan should also

reflect the development of qualified and

diverse technical, program, and

administrative staff, appropriate

organizational relationships including

lines of authority, adequate internal and

external communication systems, and a

system for sound fiscal management.

B. CDC Activities

1. Convene a workshop of the funded

States/Tribes every one to two years for

information-sharing and problemsolving and hold a Program Director’s

meeting twice a year.

2. Provide funded States/Tribes with

ongoing consultation and technical

assistance to plan, implement, and

evaluate each component of the

comprehensive program as described

under Recipient Activities above.

Consultation and technical assistance

will be provided in the following areas:

a. Interpretation of current scientific

literature related to the early detection

of breast and cervical cancer;

b. Practical application of Pub. L.

101–354, including amendments to the

law;

c. Nationally recognized clinical and

quality assurance guidelines for the

assessment and diagnosis of breast and

cervical cancer;

d. Design and implementation of each

program component (screening, referral,

tracking, and follow-up; public

education and outreach; professional

education; collaborative partnerships;

quality assurance; surveillance; and

evaluation);

e. Evaluation of each program

component (process, impact, and

outcome) through the analysis and

interpretation of program outcomes,

screening data, and surveillance data;

f. Overall operational planning and

program management.

3. Provide two training opportunities

and a video teleconference with selfstudy educational packets on selected

topics to State and Tribal program staff

through the National Center for Chronic

Disease and Prevention, Division of

Cancer Prevention and Control’s (DCPC)

National Training Center.

4. Conduct site visits to assess

program progress and mutually resolve

problems, as needed, and/or coordinate

reverse site visits to CDC in Atlanta, GA.

5. At the request of the applicant, and

if available, assign Federal personnel to

a project in lieu of a portion of the

financial assistance. [Section 1507(b) of

the PHS Act, as amended.]

Evaluation Criteria (Total 100 Points)

Applications will be reviewed and

evaluated according to the following

criteria:

1. Background and Need (5 Points)

The extent of the disease burden and

the need among the priority populations

as measured by:

a. The State/Tribal breast and cervical

cancer age-adjusted mortality rates

averaged over five years and ranking

nationally;

b. The disease burden, including the

incidence rates of breast and cervical

cancer by age, race and ethnicity (where

available);

c. The number of uninsured women

by race/ethnicity who are 18–49 years,
19304 Federal Register / Vol. 61, No. 85 / Wednesday, May 1, 1996 / Notices

50–64 years, and the number of women

eligible for Medicare;

d. The unmet screening needs of

uninsured women;

e. Existing access and barriers to early

detection services, (e.g., social,

financial, geographic).

2. Operational Plan (60 Points)

The degree of comprehensiveness and

quality of the Operational Plan in

relation to:

a. The number of women projected for

screening, quality of screening, rescreening, and surveillance programs,

and compliance with Federal

requirements (i.e., screening guidelines,

FDA mammography certification

requirements, BI–RAD reporting, and

CLIA requlations.) (20 Points)

b. The extent in which proposed

public education activities appear likely

to increase the number of women

screened, especially those women

identified as a priority for services. (15

Points)

c. The extent in which proposed

professional education activities

provide training options and

educational opportunities to improve

the quality of care of women. (15 Points)

d. The extent to which proposed

surveillance and evaluation appears to

use reliable data and program results to

measure program effectiveness and to

facilitate program planning,

development, and implementation, and

to enhance program goals and

objectives. (10 Points)

3. Collaborative Partnerships and

Community Involvement (15 Points)

The feasibility and extent of the

applicant’s proposal to develop

collaborative partnerships with other

Federal, State and local programs,

Tribes, and voluntary, professional, and

private-sector agencies, and to establish

and maintain a broad-based council of

partners at State, Tribe, and local levels.

4. Breast and Cervical Cancer Control

Plan (10 Points)

The feasibility and appropriateness of

the applicant’s management plan that

describes the development of qualified

and diverse technical, program, and

administrative staff, organizational

relationships including lines of

authority, internal and external

communication systems, and a system

for sound fiscal management.

5. Capability for Program

Implementation (10 points)

The extent to which the applicant

appears likely to be successful in

implementing the proposed activities as

measured by:

a. Accomplishments by capacityfunded States in establishing a

comprehensive public health

infrastructure to support a breast and

cervical cancer early detection.

b. Relevant past experiences of

unfunded applicants in conducting

breast and cervical cancer early

detection programs.

6. Budget and Justification (Not

Weighted)

The extent to which the proposed

budget is adequately justified,

reasonable, and consistent with this

program announcement.

7. Human Subject (Not Weighted)

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.

Executive Order 12372 Review

Applications are subject to

Intergovernmental Review of Federal

Programs as governed by Executive

Order 12372. This order sets up a

system for State/Tribe and local 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 expected

announcements of cooperative

agreement funds 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 of each

State. A current list of SPOCs is

included in the application kit. Indian

Tribes are strongly encouraged to

request tribal government review of the

proposed application. If Tribal

governments have any Tribal process

recommendations or if SPOCs have any

State process recommendations on

applications submitted to CDC, they

should send them to Sharron P. Orum,

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–09, Atlanta, GA 30305, no

later than 60 days after the application

deadline date. The granting agency does

not guarantee to ‘‘accommodate or

explain’’ the State or 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 93.919.

Other Requirements

Paperwork Reduction Act

Projects which involve the collection

of information from ten 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.

Human Subjects

If the proposed project involves

research on human subjects, the

applicant must comply with the

Department of Health and Human

Services Regulations (45 CFR Part 46)

regarding the protection of human

subjects. Assurance must be provided to

demonstrate that the project will be

subject to initial and continuing review

by an appropriate institutional review

committee. In addition to other

applicable committees, Indian Health

Service (IHS) institutional review

committees also must 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.

Application Submission and Deadline

The original and two copies of the

completed application Form

PHS–5161–1 (OMB Number 0937–0189)

must be submitted to Sharron P. Orum,

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–09, Atlanta, GA 30305, on or

before July 1, 1996.
Federal Register / Vol. 61, No. 85 / Wednesday, May 1, 1996 / Notices 19305

1The NTP uses five categories of evidence of

carcinogenic activity observed in each animal

study: two categories for positive results (‘‘clear

evidence’’ and ‘‘some evidence’’), one category for

uncertain findings (‘‘equivocal evidence’’), one

category for no observable effect (‘‘no evidence’’)

and one category for studies that cannot be

evaluated because of major flaws (‘‘inadequate

study’’).

1. Applications shall be considered as

meeting the deadline if they are either:

a. Received on or before the stated

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 the U.S. Postal Service. Private

metered postmarks shall not be accepted

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

A complete program description,

information on application procedures,

an application package, and business

management technical assistance may

be obtained from Nealean K. Austin,

Grants Management Specialist, Grants

Management Branch, Procurement and

Grants Office, Centers for Disease

Control and Prevention (CDC), 255 East

Paces Ferry Road, NE., Room 314,

Mailstop E–18, Atlanta, GA 30305,

telephone (404) 842–6508; by fax (404)

842–6513; by Internet or CDC WONDER

electronic mail at

nea1@opspgo1.em.cdc.gov.

Programmatic technical assistance

may be obtained from Kevin Brady,

MPH, Acting Assistant Branch Chief for

Management and Operations, Program

Services Branch, Division of Cancer

Prevention and Control, National Center

for Chronic Disease Prevention and

Health Promotion, Centers for Disease

Control and Prevention (CDC), 4770

Buford Highway, NE., Mailstop K–57,

Atlanta, GA 30341–3724, telephone

(404) 488–4880 and by fax (404) 488–

4727; by Internet or CDC WONDER

electronic mail at

KBB2@ccdpcp1.em.cdc.gov.

Please refer to Program

Announcement Number 623 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.

There may be delays in mail delivery

and difficulty in reaching the CDC

Atlanta offices during the 1996 Summer

Olympics. Therefore, CDC suggests

using Internet, following all instructions

in this announcement and leaving

messages on the contact person’s voice

mail for more timely responses to any

questions.

Dated: April 24, 1996.

Joseph R. Carter,

Acting Associate Director for Management

and Operations, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 96–10778 Filed 4–30–96; 8:45 am]

BILLING CODE 4163–18–P

Public Health Service

National Toxicology Program;

Availability of Technical Report on

Toxicology and Carcinogenesis

Studies of t-Butyl Alcohol

The HHS’ National Toxicology

Program announces the availability of

the NTP Technical Report on the

toxicology and carcinogenesis studies of

t-butyl alcohol. t-Butyl alcohol is widely

used in the manufacture of perfumes

and a variety of cosmetics.

Toxicology and carcinogenicity

studies were conducted by

administration of t-butyl alcohol, in

drinking water to groups of 60 F344/N

rats of each sex at doses of 0, 1.25, 2.5,

or 5 mg/mL for males and 0, 2.5, 5, or

10 mg/mL for females. Groups of 60

B6C3F1 mice of each sex received t-butyl

alcohol in drinking water at does of 0,

5, 10, or 20 mg/mL.

Under the conditions of these 2-year

drinking water studies, there was some

evidence of carcinogenic activity 1 of tbutyl alcohol in male F344/N rats based

on increased incidences of renal tubule

adenoma or carcinoma (combined).

There was no evidence of carcinogenic

activity of t-butyl alcohol in female

F344/N rats receiving 2.5, 5 or 10 mg/

mL. There was equivocal evidence of

carcinogenic activity in male B6C3F1

mice based on marginally increased

incidences of follicular cell adenoma or

carcinoma (combined) of the thyroid

gland. There was some evidence of

carcinogenic activity of t-butyl alcohol

in female B6C3F1 mice based on

increased incidences of follicular cell

adenoma of the thyroid gland.

Questions or comments about the

Technical Report should be directed to

Central Data Management at P.O. Box

12233, Research Triangle Park, NC

27709 or telephone (919) 541–3419.

Copies of Toxicology and

Carcinogenesis Studies of t-Butyl

Alcohol (CAS No. 75–65–0) (TR–436)

are available without charge from

Central Data Management, NIEHS, MD

E1–02, P.O. Box 12233, Research

Triangle Park, NC 27709; telephone

(919) 541–3419.

Dated: April 27, 1996.

Kenneth Olden,

Director, National Toxicology Program.

[FR Doc. 96–10832 Filed 4–30–96; 8:45 am]

BILLING CODE 4140–01–M

National Toxicology Program;

Availability of Technical Report on

Toxicology and Carcinogenesis

Studies of Diethylphthalate with

Dermal Initiation/Promotion Study of

Diethylphthalate and

Dimethylphthalate

The HHS’ National Toxicology

Program announces the availability of

the NTP Technical Report on the

toxicology and carcinogenesis studies of

Diethylphthalate. Diethylphthalate and

Dimethylphthalate are used as phthalte

plasticizers in an extensive array of

products.

Toxicology and carcinogenicity

studies were conducted by dermal

administration of diethylphthalate to

groups of 60 F344/N rats of each sex at

doses of 0, 100, or 300 μL and to groups

of 60 B6C3F1 mice of each sex at doses

of 0, 7.5, 15, or 30 μL. Neat chemical

was applied to rats for 5 days per week

for 103 weeks and up to 10 animals per

group were evaluated after 15 months.

Mice received doses in 100 μL of

acetone for 5 days per week for 103

weeks with a 1 week recovery period,

and up to 10 animals per group were

evaluated after 15 months.

An additional group of 50 male Swiss

(CD–1) mice were dosed dermally with

diethylphthalate of dimethylphthalate

to study their effect as initiators and

promoters. They were tested as

initiators with and without 12–

Otetradecanoylphorbol and they were

tested as promoters with and without

the known skin tumor initiator 7,12-

dimethylbenzanthrancene.

Under the conditions of these 2-year

dermal studies, there was no evidence

of carcinogenic activity 1 of