[Federal Register Volume 62, Number 47 (Tuesday, March 11, 1997)]
[Notices]
[Pages 11202-11211]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-5956]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Announcement 718]
Cooperative Agreement for 1997 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) 1997 for cooperative
agreements to develop State, territorial, 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, 1502 and 1507 (42
U.S.C. 300k, 42 U.S.C. 300l, 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
Pub. L. 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 American Samoa, the Commonwealth
of Puerto Rico, the Federated States of Micronesia, Guam, the Republic
of the Marshall Islands, 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 and territories are excluded:
a. Alabama, Delaware, Hawaii, Idaho, Indiana, Kentucky,
Mississippi, Montana, New Hampshire, Nevada, North Dakota, Northern
Mariana Islands, Republic of Palau, South Dakota, Tennessee, Virgin
Islands, Virginia, Washington, DC, and Wyoming, which were funded in
September of 1996, under Program Announcement 623 entitled ``1996
National Breast and Cervical Cancer Early Detection Program.''
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:
a. Arctic 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; and
Southcentral Foundation, AK, which were funded under the American
Indian Initiative Program Announcement 442.
[[Page 11203]]
b. Hopi Tribe, AZ; Native American Rehabilitation Association of
the NW, OR; Indian Community Health Service; AZ; and the Navajo
Division of Health, AZ, which were funded in September of 1996, under
Program Announcement 623 entitled ``1996 National Breast and Cervical
Cancer Early Detection Program.''
States currently receiving CDC funds under Program Announcement 121
and 122, entitled ``Early Detection and Control of Breast and Cervical
Cancer,'' are eligible to apply for funding under this announcement.
Additionally, those programs currently funded under Program
Announcement 425 (Puerto Rico and American Samoa) are eligible to apply
under this announcement. If currently funded under Program Announcement
425, no additional new funding will be available at the end of the
current 12-month budget period. Thereafter, a 12-month no-cost
extension may be approved to complete capacity-building activities that
have been initiated.
Availability of Funds
Approximately $37 million is available in FY 1997 to fund
approximately fourteen awards to States/territories/tribes. It is
expected that the average award will be $1,500,000 ranging from
$200,000 to $3,000,000.
It is expected that these awards will begin on August 15, 1997, 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.
Recipient Financial Participation
Section 1502 (a) and (b)(1), (2), and (3) of the PHS Act, as
amended, states that 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.
The matching funds may be in cash or its equivalent in-kind or
donated services, including equipment, fairly evaluated. The
contributions may be made directly or through donations from public or
private entities.
In some States/territories/tribes, non-Federal funds from a variety
of sources may presently be used to support one or more of the breast
and cervical cancer early detection activities described in this
program announcement. Maintenance of Effort (MOE)--Non-Federal funds in
excess of the average amount expended during the two years preceding
the first fiscal year that a State/territory/tribe applies for funding
may be used as match. Supplantation of existing program efforts funded
through other Federal or non-Federal sources is unallowable. Applicants
may also include, as State/territory/tribe matching funds, any non-
Federal amounts expended pursuant to Title XIX of the Social Security
Act for the screening, follow-up and referral of women for breast and
cervical cancer.
Matching funds may not include: (1) The payment for treatment
services or the donation of treatment services (see note below); (2)
services assisted or subsidized by the Federal Government; or (3) the
indirect or overhead costs of an organization.
Note: Treatment is defined as any service recommended by a
clinician including medical and surgical intervention provided in
the management of a diagnosed condition.
Background
Breast Cancer
In the United States, approximately 500,000 women will die this
decade from breast and cervical cancer. Among women, breast cancer
accounts for 29 percent of all new cancer cases and is the second
leading cause of cancer related deaths. An estimated one of every eight
women in the United States will develop breast cancer in her lifetime.
The American Cancer Society estimated that in 1996, 184,300 women would
be diagnosed with invasive breast cancer and 44,300 women would die of
this disease. Death rates from the disease are highest among women aged
40 or more years, and among black women as compared to white women for
those aged less than 70 years.
It is not currently known how to prevent breast cancer from
occurring. Thus, detecting carcinoma of the breast at an early stage is
the key to more treatment options, improved survival, and decreased
mortality. Research has shown that the use of mammography can reduce
the mortality due to breast cancer among women 50 years and older by 30
percent.
The percent of women who are regularly screened for breast cancer
decreases with age. The baseline data on mammography use from the 1987
National Health Interview Survey show that only 23 percent of women 50
years and older reported having received a mammogram within the past
three years. This proportion was lower for racial and ethnic minority
women, for women who had less than a high school education, for women
who were over age 75 years, and for women who were living below the
poverty level. In Healthy People 2000, the Public Health Service (PHS)
recommended that by the year 2000, 60 percent of women aged 50 years
and older should receive a mammogram every two years.
Cervical Cancer
The overall incidence of invasive cervical cancer has decreased
steadily over the last several decades, but in recent years, this rate
has increased among women who are less than 50 years old. In 1996,
invasive cervical cancer was diagnosed in approximately 15,700 women,
and carcinoma in situ was diagnosed in about 65,000 women, and about
4,900 women died of cervical cancer.
The primary goal of cervical cancer screening is to increase
detection and treatment of precancerous cervical lesions and thus
prevent the occurrence of cervical cancer. Although no clinical trials
have studied the efficacy of Papanicolaou (Pap) test in reducing
cervical cancer mortality, experts agree that it is an effective
technology. Since the introduction of the Pap test in the 1940s,
cervical cancer mortality rates have decreased by 75 percent.
In 1991, the PHS established that by the year 2000, 85 percent of
women should be receiving a Pap test within the preceding one to three
years. Baseline data on the use of the Pap test from the 1987 National
Health Interview Survey (NHIS) showed that only 65 percent of women
aged 18 years and older reported having received a Pap test within the
past three years. As with mammography screening, this proportion was
lower for racial and ethnic minority women, for women who had less than
a high school education, for women who were over age 75 years, and for
women who had low incomes.
National Breast and Cervical Cancer Early Detection Program
In 1990, the U.S. Congress passed ``The Breast and Cervical Cancer
Mortality Prevention Act,'' Pub. L. 101-354. This legislation enables
CDC, in partnership with State health agencies and territories, to make
breast and cervical cancer screening, referral, tracking and follow-up
services available and accessible to women, with priority for services
given to low income, and uninsured and under-insured women. Many women
do not have access to a well-coordinated and integrated health care
system that provides screening, follow-up, and
[[Page 11204]]
treatment services because of social, financial, and geographic
barriers.
In accordance with Pub. L. 101-354, a comprehensive program
includes the following program components: (1) Breast and cervical
cancer screening; (2) referral and follow-up; (3) public education; (4)
professional education; (5) quality assurance; (6) surveillance and
program evaluation; and (7) partnership development and community
involvement. The importance of these program components and a
systematic, coordinated approach is universally appreciated as
necessary to ensure maintenance of quality, comprehensive, state/
territory-/tribe-wide services. This comprehensive effort offers an
opportunity to build a State/territorial/tribal infrastructure for
breast and cervical cancer control.
Program success is enhanced when State/territorial/tribal resources
and efforts are combined with those of other State/territorial/tribal
programs, voluntary organizations, private sector organizations, and
community-based organizations through partnership development. State/
territorial/tribal comprehensive breast and cervical cancer control
programs can make a vital contribution to the nationwide effort to
reduce morbidity and mortality and improve quality of life.
Purpose
The purpose of this program is to establish a State/territorial/
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, evaluation, partnership development
and community involvement. The program is established to provide for
comprehensive breast and cervical cancer screening services for all
women who are unable to afford them. Criteria for priority populations
are uninsured or under-insured older women who are racial, ethnic and
cultural minorities, such as American Indians, Alaskan Natives,
African-Americans, Hispanics, Asian/Pacific Islanders, Lesbians, women
with disabilities, or women who live in hard-to-reach communities in
urban and rural areas. Priority populations, as defined above, will be
used throughout this document.
Program Requirements
In accordance with Pub. L. 101-354, an award may not be made unless
the State/territory/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, partnership development and community involvement,
and related program activities. (Section 1503(a) (1) and (4) of the PHS
Act, as amended.) Of the proportion of funds required for screening and
diagnostic services, the majority should be directed toward breast
health. Refer to the most current CDC National Breast and Cervical
Cancer Early Detection Program Administrative Requirements and
Guidelines for more information.
2. States, territories, and tribes are required to implement all
program components by the schedule that follows:
a. States presently receiving comprehensive funding:
All program components should be operational at this time.
b. Territories/tribes presently receiving capacity funding:
Comprehensive breast and cervical cancer screening, referral,
follow-up and tracking services should be initiated within the first
twelve months of the first budget year. The capacity building program
components (not the screening, referral, follow-up and tracking system)
should be fully operational by the end at this time.
c. Territories/tribes not presently receiving capacity funds and
applying for comprehensive funding:
The application should outline plans for the operation of all
program components. The screening, follow-up and referral services
should be initiated within twelve months of the award date. (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 (OMB) 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 will 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
will 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/territories/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/territory/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 will 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
[[Page 11205]]
services/activities if it is determined that compliance by the State/
territory/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 with emphasis being
given to identified priority populations as described under the
``Purpose'' section.
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).)
b. 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.
a. Provide priority for screening, referral, tracking, and follow-
up services to women who are uninsured or under-insured. (Section
1504(a) of the PHS Act, as amended.)
An award may not be made under this announcement unless the State/
territory/tribe involved agrees to give priority to the provision of
screening, follow-up, and referral services to women who are
underserved and low-income.
b. Establish breast and cervical cancer screening services
throughout the State/territory/tribe. (Section 1504(c)(1) of the PHS
Act, as amended.)
Funds may not be awarded under this announcement, unless the State/
territory/tribe involved agrees that services and activities will be
made available throughout the State/territory/ 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).
c. 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/
territory/ 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/territory/tribe compensation program, insurance
policy, or Federal or State/territory/tribe health benefits program.
(2) An entity that provides health services on a prepaid basis.
d. 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/
territory/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
[[Page 11206]]
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/territory/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/
territory/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 stages of disease must be included.
In collaboration with CDC, States/territories/tribes 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, territories, and tribes
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 include 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, and ultimately have an impact on attitudes and screening
behavior.
Public education and outreach activities should increase the number
of women screened especially those who are identified as priority
populations as defined in the ``Purpose'' section. State/territory/
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/territory/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/
territory/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 will 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 will 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 will 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 will be placed in the woman's permanent medical records that
are maintained by her health care provider.
(4) Pathologists participating in the program will 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.
[[Page 11207]]
6. Establish mechanisms which enhance the State/territory/tribe
cancer surveillance system (i.e., the 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/territory/tribe
vital statistics, the Central Cancer Registry, the Behavioral Risk
Factor Surveillance System and other State/territory/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/territory/tribe
program screening data, cancer staging, morbidity, mortality).
a. To do this, surveillance systems should be established or
enhanced which will:
(1) Collect State/territory/tribal 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/
territory/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 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/
territory/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) 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 broad-based 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/
territory/tribe agrees that the services and activities provided in
this program are coordinated with other Federal, State/territory/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 an operational and management plan for the
implementation of a comprehensive breast and cervical cancer screening
program.
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 emphasis given to women identified as priority populations
under the ``Purpose'' section. All program components of the
comprehensive program should be addressed.
[[Page 11208]]
A comprehensive breast and cervical cancer screening operational
plan should relate to the State/territory/tribe Year 2000 Objectives
and to the State/territory/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.
9. Representation or attendance at CDC sponsored trainings,
meetings, site visits, and conferences.
B. CDC Activities
1. Convene a workshop of the funded programs every one to two years
for information-sharing and problem-solving and hold a Program
Director's meeting twice a year.
2. Provide funded States/territories/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 self-study educational packets on selected topics to State,
territorial, and tribal program staff through the National Center for
Chronic Disease Prevention and Health Promotion, Division of Cancer
Prevention and Control's (DCPC's) 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.)
Technical Reporting Requirements
Semiannual progress reports are required and must be submitted no
later than 30 days after each semiannual reporting period. The
semiannual progress reports must summarize the following: (1) Major
accomplishments including information on women screened; (2) problems
encountered in program implementation; and (3) efforts or proposed
strategies to resolve problems. The final progress report is required
no later than 90 days after the end of the project period. All
manuscripts published as a result of the work supported in part or
whole by the cooperative agreement will be submitted with the progress
reports.
An annual financial status report (FSR) must be submitted no later
than 90 days after the end of each budget period. The final financial
status report is due no later than 90 days after the end of the project
period.
An original and two copies of all reports should be submitted to
the Grants Management Branch, Procurement and Grants Office, CDC.
Application Content
All applicants must develop their applications in accordance with
information contained in this program announcement and the instructions
below. Applications should not exceed 100 pages including budget and
justification; this does not include appendices.
1. Executive Summary
The applicant should provide a clear, concise one or two page
written summary to include: (1) The need for the program; (2) the major
objectives and activities of the proposed comprehensive breast and
cervical cancer early detection program; (3) the requested amount of
Federal funding; and (4) capability to implement the program.
2. Background and Need
The applicant should describe:
a. The disease burden by age and race/ethnicity: (1) The State/
territory/tribe breast and cervical cancer age-adjusted mortality rates
averaged over five years and their ranking nationally, (2) the
incidence rates for these diseases (where available);
b. Total number of women in the State/territory/ tribe, including
those women who are uninsured, by age and racial/ethnic distribution;
c. Unmet screening and rescreening needs of uninsured and
underinsured women (where available);
d. Barriers to early detection screening services;
e. State/territory/tribe's relevant experiences in the development
and implementation of a breast and cervical cancer early detection
program.
3. Implementation Plan
The applicant should:
a. Propose measurable, time-phased, and realistic objectives for:
(1) The overall program, and (2) specific program components as
described under the ``Recipient Activities'' section, including a
projection of the number of women to be screened by age, racial and
ethnic groups, and areas or locality in the State/territory/tribe.
(Section 1505(2) of the PHS Act, as amended.)
b. Describe the State/territory/tribe's: (1) Health care delivery
system; (2) proposed State/ territorial/tribal screening system; (3)
proposed follow-up and referral system for women requiring diagnostic
procedures and medical treatment not provided by the program; and (4)
proposed tracking system for women screened and rescreened by the
program. (Section 1501(a) (1) and (2) of the PHS Act, as amended.)
c. Proposed specific outreach strategies to reach women who are
identified as priority populations as defined under the ``Purpose''
section. (Section 1504 (a) of the PHS Act, as amended.)
d. Document available resources in the State/territory/tribe for
the payment or reimbursement of breast and cervical cancer screening,
including the Medicaid Program. [Section 1504 (d) of the PHS Act, as
amended.]
e. Describe, in detail, the current or proposed: (1) Professional
education; (2) public education and outreach activities; and (3) and
surveillance activities for breast and cervical control. (Section
1501(a)(3), (4), (5), and (6) of the PHS Act, as amended.) Information
provided should include program objectives, proposed activities and
evaluation.
f. Describe the ability to establish a screening program that meets
FDA regulations for mammography screening; uses the American College of
Radiology Breast Imaging Reporting and Data System (BI-RADS); and meet
the standards and regulations of the Clinical Laboratory Improvement
Act (CLIA) for cervical cancer screening.
g. Provide a projected timetable for program implementation that
displays
[[Page 11209]]
dates for the accomplishment of specific proposed activities.
h. Describe process and outcome evaluation strategies for each
program component, including how the information will be used to plan,
develop, and manage the program on an ongoing basis. (Section 1501
(a)(6) of the PHS Act, as amended.)
i. Describe how the State/territory/tribe will assure that funds
will be used in a cost-effective manner. (Section 1505 (4) of the PHS
Act, as amended.)
4. Collaborative Partnership and Community Involvement
The applicant should describe:
a. How the program will develop linkages and coordinate with other
Federal, State, and local programs, voluntary and professional
organizations, private physicians, and mammography facilities and other
groups, agencies, and businesses in the community that provide health
care and related support services to women. (Section 1504(e) of the PHS
Act, as amended.)
b. The current or proposed broad-based council that will advise and
support the breast and cervical cancer early detection program,
including the identification of current members or proposed
representatives, their charge, and their proposed roles and
responsibilities. Specific subcommittees of the council should be
described (e.g., clinical services, public education and outreach, and
professional education).
5. Management and Organizational Structure
The applicant should submit a description of the structure to
ensure the implementation of a breast and cervical cancer program 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. The information should also include the
following:
a. Provide a copy of the organizational chart indicating the
placement of the proposed program in the department/organization.
b. Document available resources in the State/territory/tribe for
the payment or reimbursement of breast and cervical cancer screening,
including the Medicaid and Medicare Programs. (Section 1504 (d) of the
PHS Act, as amended.)
c. Submit the proposed schedule of fees and charges for breast and
cervical cancer screening and diagnostic services, consistent with
maximum Medicare reimbursement rates, and include a description of its
use in the program. In States/territories/tribes where there are
multiple Medicare rates and a single reimbursement rate is being
proposed, the applicant must provide justification for approval.
(Section 1504 (b) of the PHS Act, as amended.)
d. Letters of support (dated within the last three months) from key
partners, participants, and community leaders should be included in the
application.
6. Capability for Program Implementation
The applicant should describe proposed activities as measured by:
(a) Accomplishments of an existing breast and cervical cancer early
detection program funded by CDC or relevant past experiences funded by
other sources:
(1) States Currently Receiving CDC Comprehensive Funds:
Accomplishments in establishing a comprehensive breast and cervical
cancer early detection program, including the total number, age and
racial/ethnic distribution of women screened; percent of abnormal
findings by age and race/ethnicity; rate of cancers identified by age;
follow-up time between screening and diagnosis and between diagnosis
and treatment initiation; and, percent of women who are routinely
rescreened by the program.
Accomplishments in establishing an infrastructure to support a
breast and cervical cancer screening program and in resolving program
challenges, such as mammography screening for women 50 years and older,
the timely follow-up of women with abnormal screening and diagnostic
results, or the use of the ACR Lexicon final reporting categories by
radiologists to report mammogram results.
(2) Territories/Tribes Currently Receiving CDC Capacity Building
Funds:
Accomplishments in establishing a comprehensive infrastructure to
support a breast and cervical cancer screening program including
screening, referral, tracking, and follow-up, public education and
outreach, professional education, quality assurance, surveillance, and
partnership activities.
(3) Territories/Tribes Not Currently Receiving CDC Breast and
Cervical Cancer Funds:
Relevant past experiences of the applicant in conducting screening,
referral, tracking, and follow-up, public education and outreach,
professional education, quality assurance, surveillance, partnership
activities for cancer control, chronic disease control or other
relevant areas.
7. Source Data for Matching Requirement
Identify and describe:
a. Maintenance of Effort (MOE)--The average amount of non-Federal
dollars expended for breast and cervical cancer programs and activities
made by a State/territory/tribe for the two year period preceding the
first Federal fiscal year of the program funding for breast and
cervical cancer early detection activities. This amount will be used to
establish the maintenance of effort baseline for current and future
match requirements;
b. State/territory/tribe allowable sources of matching funds for
the program and the estimated amounts from each;
c. Procedures for documenting the value of non-cash matching funds;
d. Procedures for documenting the actual amount of match received.
8. Budget with Justification
Provide a detailed budget request and complete line item
justification (for both Federal and non-Federal funds) of all proposed
operating expenses consistent with the program activities described in
this announcement. Not less than 60 percent of Federal funds will be
expended for screening, tracking, and follow-up services. Not more than
10 percent of Federal funds will be expended for administrative
expenses.
The applicant should submit a chart showing the expected funding
levels and the number of women to be screened by mammography and Pap
tests by contract, county, or locality in the State/territory/tribe.
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/territorial/tribal breast and cervical cancer age-
adjusted mortality rates averaged more than 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, 50-64 years, and the number of women eligible for Medicare;
(d) The unmet screening needs of uninsured and under-insured women;
[[Page 11210]]
(e) Existing access and barriers to early detection services,
(e.g., social, financial, geographic).
2. Implementation 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, re-screening, and surveillance programs, and compliance with
Federal requirements (i.e., screening guidelines, FDA mammography
certification requirements, BI-RAD reporting, and CLIA regulations).
(20 Points).
b. The extent to which proposed public education activities appear
likely to increase the number of women screened, especially women
identified in priority populations (see ``Purpose'). (15 Points)
c. The extent to 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, territories, tribes and voluntary, professional, and private-
sector agencies, and to establish and maintain a broad-based council of
partners at State, territory, tribe and local levels.
4. Management and Organizational Structure (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 comprehensive-funded States in implementing a
breast and cervical cancer early detection program as required through
previous funding agreements.
b. Accomplishments by capacity-funded States in establishing a
comprehensive public health infrastructure to support a breast and
cervical cancer early detection program.
c. 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.
Non-competing Continuation Application Content
In compliance with 45 CFR 74.51(d) and 92.10(b)(4), as applicable,
non-competing continuation applications submitted within the project
period need only include:
A. A brief progress report describing the accomplishments of the
previous budget period.
B. Any new or significantly revised items or information
(objectives, scope of activities, operational methods, evaluation,
etc.) not included in the 01 Year application.
C. An annual budget and justification. Existing budget items that
are unchanged from the previous budget period do not need
rejustification. Simply list the items in the budget and indicate that
they are continuation items. Supporting justification should be
provided where appropriate.
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/territory/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 territories 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 reference
this Announcement Number 718 and forward recommendations 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 305, Mailstop E-18, Atlanta, GA
30305, no later than 60 days after the application deadline date. The
Program Announcement Number and Program Title should be referenced on
the document. 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.
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 305, Mailstop E-18, Atlanta, GA 30305
on or before May 9, 1997.
1. Deadline: Applications will 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 will 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
[[Page 11211]]
competition and will be returned to the applicant.
Where To Obtain Additional Information
To receive additional written information, call (404) 332-4561. You
will be asked to leave your name, address, and telephone number. Please
refer to Announcement #718. You will receive a complete program
description, information on application procedures and application
forms. If you have questions after reviewing the contents of all the
documents, business management technical assistance may be obtained
from Gladys T. Gissentanna, 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) 842-6801, fax (404)
842-6513. Programmatic technical assistance may be obtained from Kevin
Brady, MPH, Assistant Branch Chief, 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) 488-4343, fax (404) 488-4727. You may also
obtain this announcement, and other CDC announcements, from one of two
Internet sites on the actual publication date: CDC's homepage at http:/
/www.cdc.gov or the Government Printing Office homepage (including free
on-line access to the Federal Register at http://www.access.gpo.gov).
Please refer to Announcement Number 718 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'' section through the Superintendent of Documents,
Government Printing Office, Washington, DC 20402-9325, telephone (202)
512-1800.
Dated: March 5, 1997.
Joseph R. Carter,
Acting Associate Director for Management and Operations, Centers for
Disease Control and Prevention (CDC).
[FR Doc. 97-5956 Filed 3-10-97; 8:45 am]
BILLING CODE 4163-18-P
