[Federal Register Volume 64, Number 64 (Monday, April 5, 1999)]
[Notices]
[Pages 16459-16467]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-8207]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention
[Program Announcement 99052]


Cooperative Agreement for 1999 National Breast and Cervical 
Cancer Early Detection Program; Notice of Availability of Funds

A. Purpose

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 1999 funds for a cooperative agreement 
program for the National Breast and Cervical Cancer Early Detection 
Program. This program addresses the ``Healthy People 2000'' priority 
area(s) related to cancer.
    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, tracking, 
follow-up and case management, public education, information, and 
outreach, professional education, quality assurance and improvement, 
surveillance, evaluation, partnership development and community 
involvement. The program is established to eliminate disparity and 
provide comprehensive breast and cervical cancer screening services for 
all women at or below 250 percent of the official poverty line as 
established by the Director of the Office of Management and Budget 
(OMB) and revised by the Secretary of DHHS in accordance with section 
673(2) of the Omnibus Budget Reconciliation Act of 1991 (Section 
1504(b)(3) of the PHS Act, as amended). Criteria for priority 
populations are uninsured or under-insured older women who are racial,

[[Page 16460]]

ethnic and cultural minorities, such as American Indians, Alaska 
Natives, African-Americans, Hispanics, Asian/Pacific Islanders; 
Lesbians; women with disabilities; and for women who live in hard-to-
reach communities in urban and rural areas. Priority populations, as 
defined above, will be used throughout this document.

B. Eligible Applicants

    Assistance will be provided only to the official health departments 
of States and Territories or their bona fide agents or 
instrumentalities and to Indian Tribal governments (including Indian 
Tribes, Tribal organizations, Alaska Natives and Urban Indian 
organizations, hereafter referred to as Tribes). This includes the 
Commonwealth of Puerto Rico, the Federated States of Micronesia, Guam, 
and the Republic of the Marshall Islands, and federally recognized 
tribes.
    1. The following States and territories are excluded:
    a. American Samoa, California, Colorado, Maryland, Michigan, 
Minnesota, Missouri, New Mexico, North Carolina, South Carolina, Texas, 
and West Virginia, which were funded in August 1997, under Program 
Announcement 718 entitled National Breast and Cervical Cancer Early 
Detection Program.
    b. Alabama, Commonwealth of the Northern Mariana Islands, Delaware, 
Hawaii, Idaho, Indiana, Kentucky, Mississippi, Montana, Nevada, New 
Hampshire, North Dakota, 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.
    2. The following Tribes are excluded:
    a. Consolidated Tribal Health Project, Inc., CA, and Southeast 
Regional Health Consortium, AK, which were funded August 1997, under 
Program Announcement 718 entitled National Breast and Cervical Cancer 
Early Detection Program.
    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 321 
and 474, entitled Early Detection and Control of Breast and Cervical 
Cancer, are eligible to apply for funding under this announcement. 
Tribes currently receiving CDC funds under Program Announcement 442, 
entitled Early Detection Program American Indian Initiative, are 
eligible to apply for funding under this announcement.
    Additionally, Puerto Rico, currently funded under Program 
Announcement 425, entitled Capacity Building for Core Components of 
Breast and Cervical Cancer Prevention and Control, is eligible to apply 
under this announcement.

C. Availability of Funds

    1. Approximately $53,000,000 is available in FY 1999 to fund 
approximately 23 States. It is expected that the average award will be 
$2,100,000, ranging from $1,000,000 to $4,500,000.
    2. Approximately $3,500,000 is available in FY 1999 to fund 
approximately 12 Tribes/Territories. It is expected that the average 
award will be $300,000, ranging from $200,000 to $500,000.
    It is expected that the awards will begin on September 30, 1999, 
and will be made for a 12-month budget period within a project period 
of up to five years. Funding estimates may change.
    Continuation awards of funded projects within an approved project 
period will be made on the basis of satisfactory progress and the 
availability of funds.

Direct Assistance

    You may request Federal personnel, equipment, or supplies as direct 
assistance, in lieu of a portion of financial assistance.

Use of Funds

    1. Not less than 60 percent of cooperative agreement funds will be 
expended for screening, tracking, follow-up, and the provision of 
appropriate support services such as case management. The remaining 40 
percent will be expended to support public education, information, and 
outreach; professional education; quality assurance and improvement; 
surveillance; program evaluation; partnership development and community 
involvement. (Section 1503(a)(1) and (4) of the PHS Act, as amended.)
    2. Cooperative agreement funds will not be expended to provide 
inpatient hospital or treatment services. (Section 1504(g) of the PHS 
Act, as amended.) Also, cooperative agreement funds will not be used 
for the specific diagnostic procedure of Loop Electro surgical 
Excisional Procedure (LEEP).
    3. 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.)

    Note: Treatment is defined as any medical or surgical 
intervention recommended by a clinician, and provided for the 
management of a diagnosed condition.

    4. 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.)
    5. 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. (OMB Circular A-
87 ``Cost Principles for State, Local and Indian Tribal Governments'' 
and PHS Grants Policy Statement, Section 6).
    6. All costs used to satisfy matching requirements must be 
documented by the applicant and will be subject to audit.

Recipient Financial Participation

    Recipient financial participation is required for this program in 
accordance with the authorizing legislation. Section 1502(a) and 
(b)(1), (2), and (3) of the PHS Act, as amended, requires matching 
funds from non-Federal sources in an amount not less than $1 for each 
$3 of Federal funds awarded under this program. However, The Omnibus 
Territories Act requires DHHS to waive matching fund requirements for 
Guam, U.S. Virgin Islands, American Samoa and the Commonwealth of the 
Northern Mariana Islands.
    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. Pub. L. 93-638 authorizes tribal organizations 
contracting under the authority of Title I and compacting under the 
authority of Title III to use funds received under the Indian Self-
Determination Act as matching funds.
    In 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)--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

[[Page 16461]]

cervical cancer early detection activities. Supplantation of existing 
program efforts funded through other Federal or non-Federal sources is 
not allowable. 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, tracking, follow-up and 
case management of women for breast and cervical cancer.
    Matching funds may not include: (1) the payment for treatment 
services or the donation of treatment services; (2) services assisted 
or subsidized by the Federal government; or (3) the indirect or 
overhead costs of an organization.

D. Program Requirements

    In accordance with Public Law 101-354:
    1. States, territories and tribes are required to implement all the 
following program components:
    a. States and tribes presently receiving comprehensive funding: All 
program components should be operational at this time.
    b. Territory presently receiving capacity funding: Comprehensive 
breast and cervical cancer screening, follow-up, tracking services and 
other support services such as a case management should be initiated 
within the first twelve months of the first budget year. The capacity 
building program components (not the screening, tracking, follow-up and 
case management systems) should be fully operational 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, 
tracking, follow-up and case management systems should be initiated 
within twelve months of the award date. (Section 1503 (a)(1) and (3) of 
the PHS Act, as amended.)
    2. 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.)
    3. An award may not be made unless the State/Territorial 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)

For those Territorial Departments of Health not receiving Medicaid, 
this program requirement would be non-applicable.
    4. In 1993, Congressional amendments to the National Breast and 
Cervical Cancer Early Detection Program included the following changes:
    a. 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) (Section 1501(b)(3) 
of the PHS Act, as amended).
    b. 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), most 
recently reauthorized and finalized October 31, 1998.
    c. 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.
    5. In 1998, Reauthorization language for the National Breast and 
Cervical Cancer Early Detection Program included the following change:
    a. States/territories/tribes may enter into contracts with public 
and non-profit private entities and through contracts with public and 
private entities to provide screening, tracking, follow-up, and case 
management services, as well as for public education, information, and 
outreach activities, professional education activities, establish 
mechanisms to monitor quality of screening procedures, and to evaluate 
such activities. If a non-profit private entity and a private entity 
that is not a non-profit entity both submit applications to a State/
tribe/territory, the State/tribe/territory may give priority, based on 
a competitive review process, to the application submitted by the non-
profit private entity in any case in which the State/tribe/territory 
determines that the quality of such application is equivalent to the 
quality of the application submitted by the other private entity 
(Section 1501(b) of the PHS Act, as amended).
    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/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 ``Recipient 
Activities'', and CDC will be responsible for conducting activities 
under ``CDC Activities''.

Recipient Activities

    1. Establish a system for screening and rescreening 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 access to and use 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 and rescreening 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:
    (1) Provide priority for screening, tracking, follow-up and other 
support services such as case management to women who are low-income 
and 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, tracking, follow-up, and other support services such as case 
management to low-income women who are underserved or uninsured.

    Note: Low income is defined as at or below 250 percent of the 
official poverty line. The official poverty line is established by 
the Director of the OMB and revised by the Secretary of the DHHS in 
accordance with section 673(2) of the Omnibus Budget Reconciliation 
Act of 1991 (Section 1504(b)(3) of the PHS Act, as amended.)

    (2) 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, or 
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).

[[Page 16462]]

    (3) 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:
    (a) Any State/territory/tribe compensation program, insurance 
policy, or Federal or State/territory/tribe health benefits program.
    (b) An entity that provides health services on a prepaid basis.
    (4) 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 diagnostic evaluation will be:
    (a) Made according to a schedule of fees that is made available to 
the public. (Section 1504(b)(1) of the PHS Act, amended.)
    (b) Adjusted to reflect the income of the woman screened. (Section 
1504(b)(2) of the PHS Act, as amended.)
    (c) Totally waived for any woman with an income of less than 100 
percent of the official poverty line.
    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.
    Breast Health: The most important risk factors for breast cancer 
are being female and older age. Priority for mammograms should be given 
to eligible women 50 years and older not enrolled in Medicare Part B 
previously screened in the NBCCEDP. Specific policies that outline 
eligibility criteria and authorize screening and diagnostic services 
are provided in the NBCCEDP PPM.
    Cervical Health: 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 are higher among younger 
women, older women have higher rates of invasive cancer and cervical 
cancer mortality and are less likely to be screened regularly. Hence, 
programs should provide a balanced distribution in the ages of women 
receiving Pap tests. Women who have had a total hysterectomy that was 
performed for cervical neoplasia are eligible to receive Pap screening. 
Priority for Pap tests should be given to eligible women previously 
screened in the NBCCEDP. The following exception applies: 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.
    For diagnostic services following an abnormal screening result, 
cooperative agreement funds may be expended for colposcopy, colposcopy-
directed biopsy, and endocervical curettage.
    2. Provide appropriate referrals for medical treatment of women 
screened in the program and ensure, to the extent practicable, the 
provision of appropriate and timely diagnostic and treatment services 
(Section 1501(a)(2) of the PHS Act, as amended.)
    A system for providing the appropriate and timely 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 provided a screening procedure by the 
program who have abnormal screening results. The implementation 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. Programs are encouraged to 
use the Screening and Diagnostic Worksheet included in the National 
Breast and Cervical Cancer Early Detection Program (NBCCEDP) Policies 
and Procedures Manual (PPM) to report their projections.
    3. Develop, implement and maintain a proactive system for the 
timely and appropriate tracking, follow-up, and case management of 
women with abnormal or suspicious screening tests (Section 1501(a)(6) 
of the PHS Act, as amended).
    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, as well as treatment 
services. Clients in need of treatment services should be assisted with 
obtaining eligibility for public-supported third party reimbursement 
programs or private donated services.
    Tracking the women screened is essential to identify those women 
who have abnormal results and ensure they receive appropriate and 
timely follow-up for short-interval rescreening, diagnostic procedures, 
and treatment. Tracking also includes reminders and outreach to women 
with normal or benign results to return for timely rescreening. A 
proactive 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 and to document the outcome of individual screening tests, 
regardless of the screening cycle or site. It should also provide 
information on needed diagnostic follow-up. Confidentiality of a 
woman's clinical procedure results 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 and follow-up 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 final diagnoses, treatment (e.g., 
date initiated), and stages of cancer must be included.
    4. 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 information, 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 
information, education, and outreach strategies to the number of women 
screened through the program. The program should develop a plan that

[[Page 16463]]

defines the scope (content, priority populations, methods, strategies 
outcomes, resources) of the public information, education, and outreach 
efforts.
    5. 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.)
    The purpose of professional education activities is to affect 
health care providers' knowledge, attitudes, and behaviors to 
ultimately result in more women, who are identified as priority 
populations as defined in the ``Purpose'' section, in the intended 
audience being screened appropriately.
    Professional education refers to the education of physicians, 
nurses, case managers, cytotechnologists, radiologists, radiologic 
technologists, health educators, outreach workers, support staff 
members, and other health professionals. It includes preprofessional, 
postgraduate, and continuing education. Professional education includes 
developing knowledge, attitudes, and skills to enable professionals to 
perform their jobs more effectively. It involves the identification of 
resources and needs and planning, implementing, and evaluating training 
for the health care provider. Professional education includes promoting 
the development and implementation of systems of health care delivery 
that provide positive clinical outcomes for patients, as well as the 
development and dissemination of clear recommendations and guidelines.
    A plan should be developed that defines the scope (i.e., content, 
provider populations, strategies, methods, outcomes, resources) of 
professional education, including a prioritized list of professional 
groups to be trained.
    Training should be based on adult learning principles with a focus 
on skill-based training.
    6. 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 that the State/territory/
tribe will, in accordance with applicable law, assure the quality of 
screening procedures conducted pursuant to section 1503(c) of the PHS 
Act, as amended.
    a. Develop and implement a quality assurance and improvement 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.
    (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), 
most recently Reauthorized and finalized October 31, 1998.
    (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--additional imaging evaluation needed.
    (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 and improvement 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.
    (1) All facilities providing laboratory services 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) Atypical glandular 
cells; (8) Other.
    In addition to using only MQSA and CLIA certified providers, 
quality assurance and improvement efforts should include use of:
    (1) An active medical advisory group;
    (2) Established clinical guidelines; and,
    (3) A system that assures that abnormal screening results are 
followed-up and that rescreening occurs.
    7. Establish mechanisms which enhance the State/territory/tribe 
cancer surveillance system (i.e., linkage to 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 and coordination with 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 a program's goals and objectives.
    a. To do this, surveillance systems should be established or 
enhanced which will:
    (1) Collect Statewide/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 and follow-up 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 and the effect on morbidity and mortality 
is important for the identification of successful intervention 
strategies for the early detection of breast and cervical

[[Page 16464]]

cancer. Equally important is the 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 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 objectives to be measured, how they will be 
measured, the proposed program time-lines, and resources needed. In 
addition to evaluating progress in meeting goals and objectives, the 
program should develop performance indicators to use as a measure of 
program improvement and resource management and allocation.

    Note: Indicator is defined as a performance measure used to 
track critical processes over time to signify progress toward a 
particular goal or outcome of the program.

    8. Ensure the coordination of services and program activities with 
other similar programs and establish a broad-based coalition 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 health service 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), local medical and 
nursing societies 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.
    9. Develop a work and management plan for the implementation of a 
comprehensive breast and cervical cancer screening.
    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.
    A work plan should include goals, measurable objectives, strategies 
proposed to attain the goals and performance indicators (if 
applicable). The goals in the work plan should relate to the State, 
territory, or tribe Year 2000 Objectives and to the State, territory, 
and tribe Cancer Control Plan.
    The management plan should reflect the development of qualified and 
diverse technical, program, and program/administrative staff, 
appropriate organizational relationships including lines of authority, 
adequate internal and external communication systems, and a system for 
sound fiscal management.
    10. Representation or attendance at CDC sponsored training, 
meetings, site visits, and conferences.

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 at least once a year.
    2. Provide consultation and technical assistance to plan, 
implement, and evaluate each component as described under Recipient 
Activities above, to include:
    a. Practical application of Pub. L. 101-354, including amendments 
to the law;
    b. Design and implementation of each program component (screening, 
tracking, follow-up and support services such as case management; 
public education and outreach; professional education; partnership 
development and community involvement; quality assurance and 
improvement; surveillance; and evaluation);
    c. Interpretation of current scientific literature related to the 
early detection of breast and cervical cancer;
     d. Nationally recognized clinical and quality assurance guidelines 
for the assessment and diagnosis of breast and cervical cancer;
    e. Evaluation of each program component through the analysis and 
interpretation of program outcomes, screening data, and surveillance 
data;
    f. Overall operational planning and program management.
    3. Provide training opportunities 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 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, Georgia.

C. Application Content

    Use the information in the Program Requirements, Other 
Requirements, and Evaluation Criteria sections to develop the 
application content. Your application will be evaluated on the criteria 
listed, so it is important to follow them in laying out your program 
plan. The application, including budget, justification and appendices, 
should be no more than 125 double-spaced unbound pages, printed on one-
side of 8\1/2\ x 11'' paper, suitable for photocopying, with one inch 
margins, and 12 point font.

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 
goals, objectives and activities of the proposed comprehensive breast 
and cervical cancer early detection program; (3) the requested amount 
of Federal funding;

[[Page 16465]]

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) from 
central cancer registries;
    b. Total number of women in the State/territory/tribe;
    c. The number of low income women who are uninsured, by age (18-39; 
40-49; 50-64; 65+) and racial/ethnic distribution;
    d. Unmet screening and rescreening needs of uninsured and 
underinsured women (where available);
    e. Barriers to early detection screening services.

3. Implementation Plan

    The applicant should develop a Work plan that describes the:
    a. Proposed goals, performance indicators related to goals, 
measurable, time-phased, and realistic objectives, and strategies to 
attain the goals for: (1) The overall program and (2) specific program 
components as described under the Recipient Activities. Project the 
number of women to be screened and rescreened annually by age, racial 
and ethnic groups, and areas or locality in the State/territory/tribe. 
(Section 1505(2) of the PHS Act, as amended.) Estimate the number of 
abnormal screening exams expected annually. Applicants are encouraged 
to include a completed Screening and Diagnostic Worksheet (sample 
included in the NBCCEDP PPM) in their application.
    b. Describe the State/territory/tribe's: (1) Health care delivery 
system; (2) proposed Statewide/territorial/tribal screening system; (3) 
proposed proactive tracking and follow-up system for women requiring 
diagnostic procedures and medical treatment not provided by the 
program; and (4) proposed tracking and follow-up system for women 
screened and rescreened by the program; and (5) proposed support 
services such as case management (Section 1501 (a)(1) and (2) of the 
PHS Act, as amended.)
    c. For those applicants previously receiving National Breast and 
Cervical Cancer Early Detection Program Cooperative Agreement funding, 
describe, in detail, the operational plan related to rescreening 
efforts (including staff responsible for oversight, the process to 
monitor rescreening rates and the system to assess the strategies used) 
and rescreening protocol (including a systematic and comprehensive 
reminder system). Include the calculation of mammography and cervical 
cancer rescreening rates for clinical services previously provided to 
eligible enrolled NBCCEDP women.
    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 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); meets the 
standards and regulations of the Clinical Laboratory Improvement Act 
(CLIA) for cervical cancer screening; and, uses the Bethesda System.
    f. Provide a projected timetable for program implementation that 
displays dates for the accomplishment of specific proposed activities.
    g. Describe the current or proposed plan for evaluating (1) the 
program's progress in meeting specific objectives outlined in the 
implementation plan by program component area, and (2) overall success 
based on performance indicators established by the applicant. Describe 
the types of indicators to be used to assess outcomes that will occur 
as a result of this funding. Baseline measures should be identified and 
assessed to allow for comparisons after implementation has begun. 
Specify the kind of data/performance indicator that will be used, how 
the data will be obtained, how information will be used to improve the 
overall efficiency and effectiveness of the program, as well as 
individual program components, who is responsible for each evaluation 
task, and a timeline for accomplishing each evaluation task.
    h. 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. Partnership Development 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 coalitions 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 coalition should be 
described (e.g., Medical Advisory, public information education and 
outreach, and professional education).
    c. Letters of support (dated within the last three months) from key 
partners, participants, and community leaders should be included in the 
application.

5. Management and Organizational Structure

    The applicant should submit a Management plan. This plan should 
include a description of the structure to ensure the implementation of 
a comprehensive breast and cervical cancer program that includes 
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. A copy of the organizational chart indicating the placement of 
the proposed program in the department/organization.
    b. Documentation of 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. 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.)

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:

[[Page 16466]]

    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 cancer age adjusted or age-
group specific; 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 Medicare Part B 
unenrolled women 50 years and older, the timely follow-up of women with 
abnormal screening and diagnostic results, or the use of the American 
College of Radiology BI-RADS by radiologists to report mammogram 
results.
    (2) Territory currently receiving CDC Capacity Building Funds: 
Accomplishments in establishing a comprehensive infrastructure to 
support a breast and cervical cancer screening program including 
screening, tracking, follow-up and case management information, public 
education and outreach, professional education, quality assurance and 
improvement, surveillance, and partnership development and community 
involvement.
    (3) Territories/Tribes not currently Receiving CDC Breast and 
Cervical Cancer Funds: Relevant past experiences of the applicant in 
conducting screening, tracking, follow-up, case management; public 
information, education and outreach; professional education; quality 
assurance and improvement; surveillance; and, partnership development 
and community involvement 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

    a. 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, follow-up and other support services 
such as case management. Not more than 10 percent of Federal funds will 
be expended for administrative expenses. A detailed line-item breakdown 
of the 60/40 distribution should be incorporated into the budget.
    b. The applicant should submit a Screening and Diagnostic Worksheet 
that details the projected number of women screened, the reimbursement 
rate provided for each service, and the overall projected clinical 
costs. A sample Screening and Diagnostic Worksheet is included in the 
NBCCEDP PPM.
    c. To request new direct-assistance assignees, include:
    (1) Number of assignees requested;
    (2) Description of the position and proposed duties;
    (3) Ability or inability to hire locally with financial assistance;
    (4) Justification for request;
    (5) Organizational chart and name of intended supervisor;
    (6) Opportunities for training, education, and work experiences for 
assignees; and
    (7) Description of assignee's access to computer equipment for 
communication with CDC (e.g., personal computer at home, personal 
computer at workstation, shared computer at workstation on site, shared 
computer at a central office).

F. Submission and Deadline

    Submit the original and two copies of the completed application 
Form PHS-5161-1 (OMB Number 0937-0189). Forms are in the application 
kit. On or before May 26, 1999, submit the application to: Mildred S. 
Garner, Grants Management Officer, Grants Management Branch, 
Procurement and Grants Office, Centers for Disease Control and 
Prevention (CDC), 2920 Brandywine Road, Room 3000, Atlanta, GA 30341.
    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 
orderly processing. (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 acceptable 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, will be 
returned to the applicant.

G. Evaluation Criteria (100 Points)

    Each application will be evaluated individually against the 
following criteria by an independent review group appointed by CDC.

1. Background and Need (10 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 18-39, 
40-49, 50-64, 65+ years;
    d. The unmet screening needs of uninsured and under-insured women;
    e. Existing access and barriers to early detection services, (e.g., 
social, financial, geographic).

2. Implementation Plan (50 points)

    The degree of comprehensiveness and quality of the Work Plan in 
relation to:
    a. The applicant's proposed work plan that includes overall goals 
for the program and program components, describes performance 
indicators related to goals and details measurable, time phased and 
realistic objectives for each program component. (10 Points)
    b. Proposed public education, information, and outreach strategies 
that are likely to increase the number of low income, uninsured women 
that are screened and rescreened. (10 points)
    c. Proposed professional education strategies that are likely to 
effect the health care providers knowledge, attitudes, and behaviors in 
such a way that more women in the target audience are screened and 
rescreened appropriately. (10 points)
    d. Proposed a service delivery program that provides quality 
screening, rescreening and diagnostic services,

[[Page 16467]]

according to established standards, and a proactive tracking, follow-up 
and case management system. (10 points)
    e. Proposed surveillance and evaluation strategies that appear 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. Partnership Development and Community Involvement (10 points)

    The feasibility and extent of the applicant's proposal to develop 
and maintain collaborative partnerships with other Federal, State and 
local programs, territories, tribes and voluntary, professional, and 
private-sector agencies. The extent of involvement of a broad-based 
coalition that advises and supports the program. The extent to which 
letters of support reflects assistance from key partners, participants, 
and community leaders.

4. Management and Organizational Structure (15 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 (15 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 and tribes in 
implementing a breast and cervical cancer early detection program as 
required through previous funding agreements. These accomplishments 
should be evaluated in terms of the number of women screened, the 
number of services provided, and the number of cancers detected.
    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.

7. Human Subject (Not Weighted)

    Whether or not exempt from the DHHS regulations, does the 
application adequately address the requirement of 45 CFR part 46 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 risks are inadequate as to make the 
entire application unacceptable.

H. Other Requirements

Technical Reporting Requirements

    Provide CDC with the original plus two copies of:
    1. 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. 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.
    2. An annual financial status report (FSR) must be submitted no 
later than 90 days after the end of each budget period.
    3. The final financial status report and progress report is 
required no later than 90 days after the end of the project period.
    Send all reports to: Nealean K. Austin, Grants Management 
Specialist, Grants Management Branch, Procurement and Grants Office, 
Centers for Disease Control and Prevention (CDC), Room 3000, 2920 
Brandywine Road, Atlanta, GA 30341.
    The following additional requirements are applicable to this 
program. For a complete description of each, see Attachment I in 
application package.

AR-1  Human Subjects Requirement
AR-2  Requirements for Inclusion of Women and Racial and Ethnic 
Minorities in Research
AR-7  Executive Order 12372 Review
AR-9  Paperwork Reduction Act Requirements
AR-10  Smoke-Free Workplace Requirements
AR-11  Healthy People 2000
AR-12  Lobbying Restrictions

I. Authority and Catalog of Federal Domestic Assistance Number

    This program is authorized under sections 1501, 1502, 1507 and 1509 
(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. The Catalog of Federal Domestic 
Assistance number is 93.919.

J. Where To Obtain Additional Information

    To receive additional written information and to request an 
application kit, call 1-888-GRANTS4 (1-888-472-6874). You will be asked 
to leave your name and address and will be instructed to identify the 
Announcement number of interest.
    If you have questions after reviewing the contents of all the 
documents, business management technical assistance may be obtained 
from: Nealean K. Austin, Grants Management Specialist, Grants 
Management Branch, Procurement and Grants Office Announcement 99052, 
Centers for Disease Control and Prevention (CDC), Room 3000, 2920 
Brandywine Road, Atlanta, GA 30341, telephone (770) 488-2754, E-mail 
address [email protected]
    For program technical assistance, contact: Amy Harris, Acting 
Manager, Policy Development and Administrative Coordination, 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 (770) 488-4880, fax 
(770) 488-4727, or
    See also the CDC home page on the Internet: http://www.cdc.gov or 
http://www.cdc.gov/cancer for a copy of the PPM.

    Dated: March 30, 1999.
John L. Williams,
Director, Procurement and Grants Office, Centers for Disease Control 
and Prevention (CDC).
[FR Doc. 99-8207 Filed 4-2-99; 8:45 am]
BILLING CODE 4163-18-P