[Federal Register Volume 61, Number 85 (Wednesday, May 1, 1996)]
[Notices]
[Pages 19299-19305]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-10778]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Announcement 623]


1996 National Breast and Cervical Cancer Early Detection Program

Introduction

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of funds in fiscal year (FY) 1996 for cooperative 
agreements to develop State and Tribal comprehensive breast and 
cervical cancer early detection programs.
    CDC is committed to achieving the health promotion and disease 
prevention objectives of ``Healthy People 2000,'' a national activity 
to reduce morbidity and mortality and to improve the quality of life. 
This announcement is related to the priority area of Cancer. (To order 
a copy of ``Healthy People 2000,'' see the section ``Where To Obtain 
Additional Information.'')

Authority

    This program is authorized by Sections 1501 and 1507 [42 U.S.C. 
300k and 42 U.S.C. 300n-3] of the Public Health Service Act, as 
amended.

Smoke-Free Workplace

    CDC strongly encourages all grant recipients to provide a smoke-
free workplace and to promote the non-use of all tobacco products, and 
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in 
certain facilities that receive Federal funds in which education, 
library, day care, health care, and early childhood development 
services are provided to children.

Eligible Applicants

    Assistance will be provided only to the official health departments 
of States or their bona fide agents or instrumentalities and to 
American Indian Tribes. This includes the District of Columbia, 
American Samoa, the Commonwealth of Puerto Rico, the Virgin Islands, 
the Federated States of Micronesia, Guam, the Northern Mariana Islands, 
the Republic of the Marshall Islands, the Republic of Palau, and 
federally recognized Indian tribal governments (this includes Indian 
Tribes, Tribal organizations, and Urban Indian organizations, hereby 
referred to as Tribes).
    1. The following States are excluded:
    a. California, Colorado, Maryland, Michigan, Minnesota, Missouri, 
Nebraska, New Mexico, North Carolina, South Carolina, Texas, and West 
Virginia, which were funded in 1991, under Program Announcements 121 
and 122 entitled Early Detection and Control of Breast and Cervical 
Cancer.
    b. New York, Pennsylvania, Ohio, Wisconsin, Massachusetts, and 
Washington, which were funded in September 1993, under Program 
Announcement 321 entitled Early Detection and Control of Breast and 
Cervical Cancer.
    c. Florida, Oklahoma and Utah, which were funded in September 1994, 
under Program Announcement 321 entitled Early Detection and Control of 
Breast and Cervical Cancer.
    d. Alaska, Georgia, Maine, Oregon, and Rhode Island, which were 
funded in September 1994, under Program Announcement 474 entitled Early 
Detection and Control of Breast and Cervical Cancer.
    e. Arizona, Arkansas, Connecticut, Iowa, Illinois, Kansas, 
Louisiana, New Jersey, and Vermont, which were funded in March 1995, 
under Program Announcement 474 entitled Early Detection and Control of 
Breast and Cervical Cancer.
    2. The following Tribes are excluded: Artic Slope Native 
Association, Limited, AK; Cherokee Nation, OK; Cheyenne River Sioux 
Tribe, SD; Eastern Band of Cherokee Indians, NC; Maniilaq Association, 
AK; Pleasant Point Passamaquoddy, ME; Poarch Band of Creek Indians, AL; 
South Puget Planning Agency, WA; Southcentral Foundation, AK, which 
were funded under the American Indian Initiative Program Announcement 
442.
    States currently receiving CDC funds under Program Announcement 221 
and 425, entitled Breast and Cervical Cancer Core Capacity, are 
eligible to apply for funding under this announcement. However, if 
funded under this announcement, funding under Program Announcement 221 
will cease at the end of the current 12-month budget period. These 
grantees are currently in a 12-month extension and will not be eligible 
for an additional extension. Under Program Announcement 425, a no-cost 
extension may be approved to complete capacity-building activities. If 
not funded under this announcement, funding will continue as stated in 
the most recent award.

Availability of Funds

    1. Approximately $15 million is available in FY 1996 to fund 
approximately 19 States/Territories. It is expected that the average 
award will be $750,000, ranging from $500,000 to $1,500,000.
    2. Approximately $1 million is available to fund approximately 5 
Tribes. It is expected that the average award will be $200,000 ranging 
from $150,000 to $350,000.
    It is expected that these awards will begin on September 30, 1996, 
and will be made for 12-month budget periods within a project period of 
up to five years. Funding estimates may vary and are subject to change.
    Continuation awards within the project period will be made on the 
basis of satisfactory progress and the availability of funds.
    At the request of the applicant, Federal personnel may be assigned 
to a project in lieu of a portion of the financial assistance.

Purpose

    The purpose of this program is to establish a State/Tribal 
comprehensive public health approach to reduce breast and cervical 
cancer morbidity and mortality through screening, referral and follow-
up, public education and outreach, professional education, quality 
assurance, surveillance and evaluation. The program will pay for 
screening of women who are unable to afford these services. Priority 
for provision of services will be given to women who are low-income, 
uninsured

[[Page 19300]]

and under-insured, racial and ethnic minorities including American 
Indians, and women who live in hard-to- reach communities in urban and 
rural America.

Program Requirements

    In accordance with Pub. L. 101-354, an award may not be made unless 
the State/Tribe involved agrees that:
    1. Not less than 60 percent of cooperative agreement funds will be 
expended for screening, appropriate referral for medical treatment, 
and, to the extent practicable, the provision of appropriate follow-up 
services. The remaining 40 percent will be expended to support public 
education, professional education, quality assurance, surveillance, 
program evaluation, and related program activities. [Section 1503(a) 
(1) and (4) of the PHS Act, as amended.]
    2. States and Tribes are required to implement all program 
components, i.e., the screening, follow-up and referral services must 
be initiated by the end of the first budget year, and the remaining 
activities of a comprehensive breast and cervical cancer early 
detection program (public education, professional education, quality 
assurance, surveillance and program evaluation) must be fully 
operational by the end of the second budget year. [Section 1503 (a) (1) 
and (3) of the PHS Act, as amended.]
    3. Cooperative agreement funds will not be expended to provide 
inpatient hospital or treatment services. [Section 1504(g) of the PHS 
Act, as amended.] Treatment is defined as any service recommended by a 
clinician, including medical and surgical intervention provided in the 
management of a diagnosed condition. Also, cooperative agreement funds 
will not be used for the specific diagnostic procedures of breast 
biopsy and Loop Electrosurgical Excisional Procedure (LEEP).
    4. Not more than 10 percent of funds will be expended annually for 
administrative expenses. These administrative expenses are in lieu of 
and replace indirect costs. [Section 1504(f) of the PHS Act, as 
amended.]
    5. Matching funds are required from non-Federal sources in an 
amount not less than $1 for each $3 of Federal funds awarded under this 
program. [Section 1502 (a) and (b) of the PHS Act, as amended.]
    6. Costs used to satisfy matching requirements are subject to the 
same prior approval requirements and rules of allowability as those 
which govern project costs supported by Federal funds. (Office of 
Management and Budget, Circular A-87, ``Cost Principles for State, 
Local and Indian Tribal Governments'' and PHS Grants Policy Statement, 
Section 6.)
    7. All costs used to satisfy matching requirements must be 
documented by the applicant and shall be subject to audit.
    8. If a new, or improved, and superior screening procedure becomes 
widely available and is recommended for use, this superior procedure 
shall be utilized in the program. [Section 1503(b) of the PHS Act, as 
amended.]
    9. An award may not be made unless the State Medicaid Program 
provides coverage for:
    a. In the case of breast cancer, a clinical breast examination and 
screening mammography.
    b. In the case of cervical cancer, both a pelvic examination and 
Pap test screening. [Section 1502A of the PHS Act, as amended.]
    10. In 1993, congressional amendments to the National Breast and 
Cervical Cancer Early Detection Program included the following changes:
    a. States/Tribes may enter into contracts with private for-profit 
entities to provide screening and diagnostic services only. Contracts 
for other kinds of services with for-profit agencies are not allowed.
    b. The amount paid by a State/Tribe for a screening procedure may 
not exceed the amount that would be paid under part B of title XVIII of 
the Social Security Act (Medicare).
    c. All facilities conducting mammography screening procedures 
funded by the Program must meet the regulations for mammography quality 
assurance developed by the Food and Drug Administration (FDA).
    d. For cervical cancer activities, facilities shall meet the 
standards and regulations developed by the Health Care Financing 
Administration (HCFA) implementing the Clinical Laboratory Improvement 
Amendments (CLIA) of 1988.
    In accordance with Section 1504 (c)(2) of the PHS Act, as amended, 
CDC may waive the requirements for specific services/activities if it 
is determined that compliance by the State/Tribe would result in an 
inefficient allocation of resources with respect to carrying out a 
comprehensive breast and cervical cancer early detection program as 
described in Section 1501(a). A request from the recipient outlining 
appropriate and detailed justification would be required before the 
waiver is approved.
    In conducting activities to achieve the purpose of this program, 
the recipient will be responsible for the activities under A. 
(Recipient Activities), and CDC will be responsible for conducting 
activities under B. (CDC Activities).

A. Recipient Activities

    1. Establish a system for screening women for breast and cervical 
cancer as a preventive health measure. [Section 1501(a)(1) of the PHS 
Act, as amended.]
    This program is to increase the utilization of screening services 
for breast and cervical cancer among all women in States/Tribes, with 
priority given to those women who are low-income, uninsured, 
underinsured, racial and ethnic minorities.
    a. Ensure that screening procedures are available for both breast 
and cervical cancer and provided to women participating in the program, 
including a clinical breast exam, mammography, pelvic exam, and Pap 
smear. [Section 1503(a)(2) (A) and (B) of the PHS Act, as amended.]
    Screening services should be made available according to the 
following guidelines:
    Breast Health: (1) The most important risk factors for breast 
cancer are being female and older age. Programs should place emphasis 
on screening women 50 years and older. Specific screening guidelines 
that outline age eligibility are provided in the Official Program 
Guidelines Age Eligibility for Mammography Screening (included in the 
application kit). Eligible women can receive an annual clinical breast 
examination and screening mammogram.
    The following exceptions apply:
    (a) Women who have an abnormal clinical breast exam may be referred 
for a physician consultation, diagnostic mammogram and/or other 
diagnostic procedures reimbursed by the program (see ``b.'' below).
    (b) Among asymptomatic women ages 40-49 who are screened for the 
first time by the program, priority should be given to those who have a 
personal history of breast cancer or a first-degree relative with pre-
menopausal breast cancer.
    (2) For diagnostic services following an abnormal screening result, 
cooperative agreement funds may be expended for additional mammogram 
views, fine-needle aspiration, ultrasound, and office visits for 
evaluation of abnormal clinical breast examinations.
    b. Provide priority for screening, referral, tracking, and follow-
up services to women who are uninsured or under-insured. [Section 
1504(a) of the PHS Act, as amended.]
    An award may not be made under this announcement unless the State/
Tribe involved agrees to give priority to the

[[Page 19301]]

provision of screening, follow-up, and referral services to women who 
are underserved and low-income.
    c. Establish breast and cervical cancer screening services 
throughout the State/Tribe. [Section 1504(c)(1) of the PHS Act, as 
amended.]
    Funds may not be awarded under this announcement, unless the State/
Tribe involved agrees that services and activities will be made 
available throughout the State/Tribe, including availability to members 
of any Indian Tribe or tribal organization (as such terms are defined 
in Section 4 of the Indian Self-Determination and Education Assistance 
Act).
    d. Provide allowances for items and services reimbursed under other 
programs. [Section 1504(d) (1) and (2) of the PHS Act, as amended.]
    Funds may not be awarded under this announcement, unless the State/
Tribe involved agrees that funds will not be expended to make payment 
for any item or service that will be paid or can reasonably be expected 
to be paid by:
    (1) Any State/Tribe compensation program, insurance policy, or 
Federal or State/Tribe health benefits program.
    (2) An entity that provides health services on a prepaid basis.
    e. Establish a schedule of fees/charges for services. [Section 
1504(b) (1), (2), and (3) of the PHS Act, as amended.]
    Funds may not be awarded under this announcement unless the State/
Tribe involved agrees that if charges are to be imposed for the 
provision of services or program activities, the fees/charges for 
allowable screening and follow-up services will be:
    (1) Made according to a schedule of fees that is made available to 
the public. [Section 1504(b)(1) of the PHS Act, as amended.]
    (2) Adjusted to reflect the income of the woman screened. [Section 
1504(b)(2) of the PHS Act, as amended.]
    (3) Totally waived for any woman with an income of less than 100 
percent of the official poverty line as established by the Director of 
the Office of Management and Budget and revised by the Secretary of the 
Department of Health and Human Services in accordance with Section 
673(2) of the Omnibus Budget Reconciliation Act of 1981. [Section 
1504(b)(3) of the PHS Act, as amended.]
    Additionally, the schedule of fees/charges should not exceed the 
maximum allowable charges established by the Medicare Program 
administered by the Health Care Financing Administration (HCFA). Fee/
charge schedules should be developed in accordance with guidelines 
described in the interim final rule (42 CFR Parts 405 and 534) which 
implements Section 4163 of the Omnibus Budget Reconciliation Act of 
1990 (Pub. L. 101- 508) which provides limited coverage for screening 
mammography services.
    Cervical Health: (1) Women who are 18 years and older, with an 
intact cervix, are eligible for an annual Pap test and pelvic 
examination. While the incidence of precancerous lesions and cancer are 
higher among younger women, older women have higher mortality rates and 
are less likely to be screened regularly. Hence, programs should 
provide a balanced distribution in the ages of women receiving Pap 
tests.
    The following exceptions apply:
    (a) After a woman has had three consecutive, normal, annual 
examinations, the Pap test may be performed less frequently at the 
discretion of her health care provider.
    (b) Women who have had a total hysterectomy that was performed for 
cervical neoplasia are eligible to receive Pap screening.
    (2) For diagnostic services following an abnormal screening result, 
cooperative agreement funds may be expended for colposcopy and 
colposcopy-directed biopsy.
    2. Provide appropriate referrals for medical treatment of women 
screened in the program and ensure, to the extent practicable, the 
provision of appropriate diagnostic and treatment services. [Section 
1501(a)(2) of the PHS Act, as amended.]
    A system for providing the appropriate diagnostic and treatment 
services for women whose screening test results are abnormal or 
suspicious is an essential component of any comprehensive breast and 
cervical cancer early detection program. Priority for diagnostic 
services should be given to women participating in the screening 
program who have abnormal screening results. The operational plan and 
budget for diagnostic services should reflect the projected number of 
women to be screened by the program annually and the estimated number 
of abnormal screening exams expected.
    a. Establish and maintain a system for the timely and appropriate 
referral and follow-up of women with abnormal or suspicious screening 
tests.
    Referral systems should include the regular updating of information 
on local resources available in the community to which health care 
providers can refer women for additional diagnostic procedures not paid 
for by the program, as well as treatment services. Health care 
providers should assist clients in need of treatment services in 
obtaining eligibility for public-supported third party reimbursement 
programs.
    b. Develop and implement a tracking system for women screened in 
the breast and cervical cancer early detection program. [Section 
1501(a)(6) of the PHS Act, as amended.]
    Tracking the women screened is essential to ensure that those who 
have abnormal results receive appropriate and timely follow-up for 
repeat screening, diagnostic procedures, and treatment. Tracking also 
includes reminders and outreach to women with normal results to return 
for timely rescreening. A useful tracking system is one that can be 
effectively integrated into the State/Tribe health care delivery 
system. The tracking system should provide women with a unique 
identification number to document the outcome of individual screening 
tests, regardless of the screening cycle or site. It should also 
provide information on needed follow-up. Confidentiality must be 
assured.
    To meet the intent of Pub. L. 101-354 in ensuring the appropriate 
follow-up of women with abnormal screening results, the State/Tribe 
tracking system must include information on screening location (e.g., 
county, city), demographic characteristics (e.g., race, date of birth), 
and screening procedures and results (e.g., mammography, Pap tests) for 
all women in the program. For women identified with abnormal screening 
results, information on diagnostic procedures (e.g.,colposcopy) and 
diagnoses, treatment (e.g., date initiated), and stage of disease must 
be included.
    In collaboration with CDC, States with currently funded 
comprehensive programs have compiled a list of some of the information 
necessary to ensure the appropriate follow-up of women. This list is 
available for the use of States awarded new funding under this 
announcement.
    3. Develop and disseminate public information, education and 
outreach programs for the early detection and control of breast and 
cervical cancer. [Section 1501 (a)(3) of the PHS Act, as amended.]
    Public information, education, and outreach includes the systematic 
design and sustained delivery of clear and consistent health messages 
to women using a variety of methods and strategies that contribute to 
the early detection of breast and cervical cancer. Successful public 
education and outreach programs are those that increase women's 
knowledge, attitudes, and ultimately have an impact on screening 
behavior.
    Public education and outreach activities should increase the number 
of

[[Page 19302]]

women screened especially those who are low-income, uninsured, under-
insured, older women of a racial or ethnic minority, and women who 
reside in hard-to-reach urban or rural communities. State/Tribe and 
local programs should clearly demonstrate, through evaluation, the 
relationship of public education and outreach strategies to the number 
of women screened through the program.
    4. Improve the education, training, and skills of health 
professionals (including allied health professionals) in the detection 
and control of breast and cervical cancer. [Section 1501(a)(4) of the 
PHS Act, as amended.]
    Health care providers (including, but not limited to, primary care 
physicians, radiologists, cytopathologists, surgeons, gynecologists, 
nurse practitioners, physician's assistants, registered nurses, 
radiologic technologists, health educators, and outreach workers) play 
a key role in assuring that women are screened at appropriate 
intervals, that screening tests are performed optimally, and that women 
with abnormal test results receive timely and appropriate diagnostic 
follow-up and treatment. Professional education strategies can be 
focused in two directions. One direction could provide direct 
educational opportunities to those health care professionals who 
provide breast and cervical cancer screening. A second focus is to 
develop clinical systems of practice that promote ongoing appropriate 
screening.
    5. Establish mechanisms through which the State/Tribe can monitor 
the quality of screening procedures for breast and cervical cancer, 
including the interpretation of such procedures. [Section 1501(a)(5) of 
the PHS Act, as amended.]
    Cooperative agreement funds may not be awarded under Section 1501 
of the PHS Act, as amended, Pub. L. 101-354 unless the State/Tribe 
involved agrees to assure the implementation of quality assurance 
procedures for mammography and cervical cytology. [Section 1503(c) and 
(d) of the PHS Act, as amended.]
    a. Develop and implement a quality assurance system for breast 
cancer screening. The mammography services provided to women screened 
in the program must be conducted in accordance with the following 
guidelines issued by the Secretary of the Department of Health and 
Human Services. [Section 1503(e) of the PHS Act, as amended]:
    (1) All facilities conducting mammography screening procedures 
funded by the program must meet the requirements for mammography 
quality assurance developed by the Food and Drug Administration (FDA).
    (2) Radiologists participating in the program shall record their 
findings using the second edition American College of Radiology (ACR) 
Breast Imaging Reporting and Data System (BI-RADS). The BI-RADS' 
reporting categories are as follows: (1) Negative; (2) Benign finding; 
(3) Probably benign finding--short interval follow-up suggested; (4) 
Suspicious finding; (5) Highly suggestive of malignancy; (6) Assessment 
incomplete.
    (3) A report of the results of a mammogram performed through this 
program shall be placed in a woman's permanent medical records that are 
maintained by her health care provider.
    b. Develop and implement a quality assurance system for cervical 
cancer screening. The laboratory services provided to women for 
cytological screening must be conducted in accordance with the 
following guidelines issued by the Secretary of the Department of 
Health and Human Services. [Section 1503(e) of the PHS Act, as 
amended]:
    (1) Facilities shall meet the standards and regulations promulgated 
by the Health Care Financing Administration (HCFA) under the Clinical 
Laboratory Improvement Act (CLIA) of 1988.
    (2) All cervical cytology interpretation is required to be done on 
the premises of a qualified laboratory.
    (3) A report of the results of a Pap test performed through this 
program shall be placed in the woman's permanent medical records that 
are maintained by her health care provider.
    (4) Pathologists participating in the program shall record their 
Pap test findings using the Bethesda System which specifies specimen 
adequacy and incorporates these categories: (1) Within Normal Limits; 
(2) Infection/Inflammation/Reactive Changes; (3) Atypical squamous 
cells; (4) Low Grade Squamous Intra epithelial Neoplasia (SIL); (5) 
High Grade SIL; (6) Squamous Cell Carcinoma; (7) Other.
    6. Establish mechanisms which enhance the State/Tribe cancer 
surveillance system (i.e., the Statewide Central Cancer Registry and 
other databases) and facilitate program planning and evaluation. 
[Section 1501(a)(5) of the PHS Act, as amended.]
    Monitoring the distribution and determinants of breast and cervical 
cancer incidence and mortality is necessary to effectively plan, 
implement, and evaluate a comprehensive early detection program. 
Linkages with, and in some cases enhancements of, State/Tribe vital 
statistics, the Central Cancer Registry, the Behavioral Risk Factor 
Surveillance System and other State/Tribe and local surveys are needed 
to evaluate the status of program process (i.e., management, 
professional education, public education and outreach), impact (i.e., 
changes in participant screening behavior or screening practices of 
providers) and outcome (i.e., State/Tribe program screening data, 
cancer staging, morbidity, mortality).
    a. To do this, surveillance systems should be established or 
enhanced which will:
    (1) Collect Statewide/Tribe population-based information on the 
demographics, incidence, staging at diagnosis, and mortality from 
breast and cervical cancer.
    (2) Identify segments of the population at higher risk for disease 
and for the failure to be screened.
    (3) Identify factors contributing to the disease burden, such as 
behavioral risk factors and limited or inequitable access to early 
detection and treatment services.
    (4) Monitor the number and characteristics of women screened in the 
program and the outcome of screening by analyzing data from the State/
Tribe tracking system.
    (5) Monitor screening resources, including the number of available 
mammography facilities, cytology laboratories, and providers of 
cervical cancer screening.
    (6) When appropriate, develop linkages between the above-mentioned 
data bases.
    b. Measuring the effectiveness of program activities to modify the 
screening behavior of women (impact evaluation) and on morbidity and 
mortality (outcome evaluation) is important for the identification of 
successful intervention strategies for the early detection of breast 
and cervical cancer. Equally important is process evaluation or the 
assessment of factors that contributed to the successful or 
unsuccessful establishment and implementation of program activities.
    The design of each program component should ensure that there can 
be meaningful process, impact, and outcome evaluation. The evaluation 
plan should assess the implementation and effectiveness of each program 
component. At a minimum, the evaluation plan should identify those 
program activities that will be evaluated, the process, impact, and 
outcome indicators to be measured, how they will be measured, the 
proposed program time-lines, and resources needed. Activities could 
include:
    (1) An inventory of specific services provided and a systematic 
description

[[Page 19303]]

of the infrastructure developed with cooperative agreement funds;
    (2) A description of the women who received services, including the 
number of women and demographic information such as age, race and 
ethnicity;
    (3) An assessment of the referral system including the number of 
women referred for diagnostic and treatment services, number who 
received these services, and the capacity of the system to identify 
community resources to assist women in obtaining access to available 
services;
    (4) An assessment of the availability and accessibility of breast 
and cervical cancer screening services and an estimation of the number 
of uninsured women by age and racial/ethnic distribution in the State/
Tribe to be served by the program;
    (5) An assessment of the planning, development, implementation, and 
accomplishment of program activities (e.g., goals, objectives, time 
lines, recruiting, hiring, and retaining staff; training staff; 
establishing and maintaining contracts with provider agencies, and 
assuring the quality of contractor performance);
    (6) An assessment of changes in participant and provider knowledge, 
attitudes, behaviors, and practices related to screening for breast and 
cervical cancer;
    (7) And an assessment of the quality of screening tests provided by 
the program.
    7. Ensure the coordination of services and program activities with 
other similar programs and establish a 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/Tribe 
agrees that the services and activities provided in this program are 
coordinated with other Federal, State/Tribe, and local breast and 
cervical cancer early detection programs through the development of 
collaborative partnerships. [Section 1504(e) of the PHS Act, as 
amended.]
    The success of a comprehensive breast and cervical cancer early 
detection program is improved by broad-based support in the community 
and active public and private sector involvement. Partnership 
development with a broad range of stakeholders, including consumers, 
brings valuable knowledge, skills, and financial resources to the 
program, and provides access to, and information about, populations of 
women who have been missed by traditional screening systems.
    Linkages should be established with federally funded programs such 
as the Regional Offices of the National Cancer Institute/Cancer 
Information Service (NCI/CIS), the Health Resources and Services 
Administration (HRSA) community/migrant health centers, Title X Family 
Planning programs, State Offices for Aging and Minority Health, the 
Indian Health Service (IHS) and the Medicare Program of the Health Care 
Financing Administration (HCFA). Linkages and active collaboration are 
strongly encouraged with private sector organizations such as the 
American Cancer Society (ACS), the Young Women's Christian Association 
(YWCA), the Susan G. Komen Breast Cancer Foundation, the National 
Breast Cancer Coalition (NBCC), the National Alliance of Breast Cancer 
Organizations (NABCO), the American Association of Retired Persons 
(AARP), professional organizations, private physicians, survivors of 
breast and cervical cancer, local women's support groups, community 
leaders, managed care organizations, and other agencies and businesses 
in the community that provide health care and related support services 
to women.
    8. Develop and implement a breast and cervical cancer control plan 
for program management and operations.
    The success of a comprehensive breast and cervical cancer early 
detection program is increased by the existence of a comprehensive, 
integrated, and realistic plan to address these diseases among all 
women, with priority to uninsured and underinsured women and racial and 
ethnic minorities. All program components of the comprehensive program 
should be addressed.
    A comprehensive breast and cervical cancer screening operational 
plan should relate to the State/Tribe Year 2000 Objectives and to the 
State/Tribe Cancer Control Plan. The operational and management plan 
should also reflect the development of qualified and diverse technical, 
program, and administrative staff, appropriate organizational 
relationships including lines of authority, adequate internal and 
external communication systems, and a system for sound fiscal 
management.

B. CDC Activities

    1. Convene a workshop of the funded States/Tribes every one to two 
years for information-sharing and problem- solving and hold a Program 
Director's meeting twice a year.
    2. Provide funded States/Tribes with ongoing consultation and 
technical assistance to plan, implement, and evaluate each component of 
the comprehensive program as described under Recipient Activities 
above. Consultation and technical assistance will be provided in the 
following areas:
    a. Interpretation of current scientific literature related to the 
early detection of breast and cervical cancer;
    b. Practical application of Pub. L. 101-354, including amendments 
to the law;
    c. Nationally recognized clinical and quality assurance guidelines 
for the assessment and diagnosis of breast and cervical cancer;
    d. Design and implementation of each program component (screening, 
referral, tracking, and follow-up; public education and outreach; 
professional education; collaborative partnerships; quality assurance; 
surveillance; and evaluation);
    e. Evaluation of each program component (process, impact, and 
outcome) through the analysis and interpretation of program outcomes, 
screening data, and surveillance data;
    f. Overall operational planning and program management.
    3. Provide two training opportunities and a video teleconference 
with self-study educational packets on selected topics to State and 
Tribal program staff through the National Center for Chronic Disease 
and Prevention, Division of Cancer Prevention and Control's (DCPC) 
National Training Center.
    4. Conduct site visits to assess program progress and mutually 
resolve problems, as needed, and/or coordinate reverse site visits to 
CDC in Atlanta, GA.
    5. At the request of the applicant, and if available, assign 
Federal personnel to a project in lieu of a portion of the financial 
assistance. [Section 1507(b) of the PHS Act, as amended.]

Evaluation Criteria (Total 100 Points)

    Applications will be reviewed and evaluated according to the 
following criteria:

1. Background and Need (5 Points)

    The extent of the disease burden and the need among the priority 
populations as measured by:
    a. The State/Tribal breast and cervical cancer age-adjusted 
mortality rates averaged over five years and ranking nationally;
    b. The disease burden, including the incidence rates of breast and 
cervical cancer by age, race and ethnicity (where available);
    c. The number of uninsured women by race/ethnicity who are 18-49 
years,

[[Page 19304]]

50-64 years, and the number of women eligible for Medicare;
    d. The unmet screening needs of uninsured women;
    e. Existing access and barriers to early detection services, (e.g., 
social, financial, geographic).

2. Operational Plan (60 Points)

    The degree of comprehensiveness and quality of the Operational Plan 
in relation to:
    a. The number of women projected for screening, quality of 
screening, re-screening, and surveillance programs, and compliance with 
Federal requirements (i.e., screening guidelines, FDA mammography 
certification requirements, BI-RAD reporting, and CLIA requlations.) 
(20 Points)
    b. The extent in which proposed public education activities appear 
likely to increase the number of women screened, especially those women 
identified as a priority for services. (15 Points)
    c. The extent in which proposed professional education activities 
provide training options and educational opportunities to improve the 
quality of care of women. (15 Points)
    d. The extent to which proposed surveillance and evaluation appears 
to use reliable data and program results to measure program 
effectiveness and to facilitate program planning, development, and 
implementation, and to enhance program goals and objectives. (10 
Points)

3. Collaborative Partnerships and Community Involvement (15 Points)

    The feasibility and extent of the applicant's proposal to develop 
collaborative partnerships with other Federal, State and local 
programs, Tribes, and voluntary, professional, and private-sector 
agencies, and to establish and maintain a broad-based council of 
partners at State, Tribe, and local levels.

4. Breast and Cervical Cancer Control Plan (10 Points)

    The feasibility and appropriateness of the applicant's management 
plan that describes the development of qualified and diverse technical, 
program, and administrative staff, organizational relationships 
including lines of authority, internal and external communication 
systems, and a system for sound fiscal management.

5. Capability for Program Implementation (10 points)

    The extent to which the applicant appears likely to be successful 
in implementing the proposed activities as measured by:
    a. Accomplishments by capacity-funded States in establishing a 
comprehensive public health infrastructure to support a breast and 
cervical cancer early detection.
    b. Relevant past experiences of unfunded applicants in conducting 
breast and cervical cancer early detection programs.

6. Budget and Justification (Not Weighted)

    The extent to which the proposed budget is adequately justified, 
reasonable, and consistent with this program announcement.

7. Human Subject (Not Weighted)

    Whether or not exempt from the DHHS regulations, are procedures 
adequate for the protection of human subjects? Recommendations on the 
adequacy of protections include: (1) protections appear adequate and 
there are no comments to make or concerns to raise, or (2) protections 
appear adequate, but there are comments regarding the protocol, or (3) 
protections appear inadequate and the Objective Review Group (ORG) has 
concerns related to human subjects; or (4) disapproval of the 
application is recommended because the research risks are sufficiently 
serious and protection against the risks are inadequate as to make the 
entire application unacceptable.

Executive Order 12372 Review

    Applications are subject to Intergovernmental Review of Federal 
Programs as governed by Executive Order 12372. This order sets up a 
system for State/Tribe and local review of proposed Federal assistance 
applications. Applicants (other than federally recognized Indian tribal 
governments) should contact their State Single Point of Contact (SPOC) 
as early as possible to alert them to expected announcements of 
cooperative agreement funds and receive any necessary instructions on 
the State process. For proposed projects serving more than one State, 
the applicant is advised to contact the SPOC of each State. A current 
list of SPOCs is included in the application kit. Indian Tribes are 
strongly encouraged to request tribal government review of the proposed 
application. If Tribal governments have any Tribal process 
recommendations or if SPOCs have any State process recommendations on 
applications submitted to CDC, they should send them to Sharron P. 
Orum, Grants Management Officer, Grants Management Branch, Procurement 
and Grants Office, Centers for Disease Control and Prevention (CDC), 
255 East Paces Ferry Road, NE., Room 300, Mailstop E-09, Atlanta, GA 
30305, no later than 60 days after the application deadline date. The 
granting agency does not guarantee to ``accommodate or explain'' the 
State or Tribal process recommendations it receives after that date.

Public Health System Reporting Requirements

    This program is not subject to the Public Health System Reporting 
Requirements.

Catalog of Federal Domestic Assistance Number

    The Catalog of Federal Domestic Assistance Number is 93.919.

Other Requirements

Paperwork Reduction Act

    Projects which involve the collection of information from ten or 
more individuals and funded by cooperative agreement will be subject to 
review by the Office of Management and Budget (OMB) under the Paperwork 
Reduction Act.

Human Subjects

    If the proposed project involves research on human subjects, the 
applicant must comply with the Department of Health and Human Services 
Regulations (45 CFR Part 46) regarding the protection of human 
subjects. Assurance must be provided to demonstrate that the project 
will be subject to initial and continuing review by an appropriate 
institutional review committee. In addition to other applicable 
committees, Indian Health Service (IHS) institutional review committees 
also must review the project if any component of IHS will be involved 
or will support the research. If any American Indian community is 
involved, its Tribal government must also approve that portion of the 
project applicable to it. The applicant will be responsible for 
providing assurance in accordance with the appropriate guidelines and 
form provided in the application kit.

Application Submission and Deadline

    The original and two copies of the completed application Form
PHS-5161-1 (OMB Number 0937-0189) must be submitted to Sharron P. Orum, 
Grants Management Officer, Grants Management branch, Procurement and 
Grants Office, Centers for Disease control and Prevention (CDC), 255 
East Paces Ferry Road, NE., Room 300, Mailstop E-09, Atlanta, GA 30305, 
on or before July 1, 1996.

[[Page 19305]]

    1. Applications shall be considered as meeting the deadline if they 
are either:
    a. Received on or before the stated deadline date; or
    b. Sent on or before the deadline date and received in time for 
submission to the objective review group. (Applicants must request a 
legibly dated U.S. Postal Service postmark or obtain a legibly dated 
receipt from a commercial carrier or the U.S. Postal Service. Private 
metered postmarks shall not be accepted as proof of timely mailing.)
    2. Late Applications:
    Applications which do not meet the criteria in 1.a. or 1.b., above, 
are considered late applications. Late applications will not be 
considered in the current competition and will be returned to the 
applicant.

Where To Obtain Additional Information

    A complete program description, information on application 
procedures, an application package, and business management technical 
assistance may be obtained from Nealean K. Austin, Grants Management 
Specialist, Grants Management Branch, Procurement and Grants Office, 
Centers for Disease Control and Prevention (CDC), 255 East Paces Ferry 
Road, NE., Room 314, Mailstop E-18, Atlanta, GA 30305, telephone (404) 
842-6508; by fax (404) 842-6513; by Internet or CDC WONDER electronic 
mail at [email protected].
    Programmatic technical assistance may be obtained from Kevin Brady, 
MPH, Acting Assistant Branch Chief for Management and Operations, 
Program Services Branch, Division of Cancer Prevention and Control, 
National Center for Chronic Disease Prevention and Health Promotion, 
Centers for Disease Control and Prevention (CDC), 4770 Buford Highway, 
NE., Mailstop K-57, Atlanta, GA 30341-3724, telephone (404) 488-4880 
and by fax (404) 488-4727; by Internet or CDC WONDER electronic mail at 
KBB[email protected].
    Please refer to Program Announcement Number 623 when requesting 
information and submitting an application.
    Potential applicants may obtain a copy of ``Healthy People 2000'' 
(Full Report, Stock No. 017-001-00474-0) or ``Healthy People 2000'' 
(Summary Report, Stock No. 017-001-00473-1) referenced in the 
Introduction through the Superintendent of Documents, Government 
Printing Office, Washington, DC 20402- 9325, telephone (202) 512-1800.
    There may be delays in mail delivery and difficulty in reaching the 
CDC Atlanta offices during the 1996 Summer Olympics. Therefore, CDC 
suggests using Internet, following all instructions in this 
announcement and leaving messages on the contact person's voice mail 
for more timely responses to any questions.

    Dated: April 24, 1996.
Joseph R. Carter,
Acting Associate Director for Management and Operations, Centers for 
Disease Control and Prevention (CDC).
[FR Doc. 96-10778 Filed 4-30-96; 8:45 am]
BILLING CODE 4163-18-P