[Federal Register Volume 59, Number 124 (Wednesday, June 29, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-15748]


[[Page Unknown]]

[Federal Register: June 29, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Announcement Number 474]
RIN 0905-ZA72

 

1994 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) 1994 for cooperative 
agreements to initiate State-based comprehensive breast and cervical 
cancer early detection programs.
    The Public Health Service (PHS) is committed to achieving the 
health promotion and disease prevention objectives of ``Healthy People 
2000,'' a PHS-led 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 1509 [42 U.S.C. 
300k and 42 U.S.C. 300n-5] of the Public Health Service Act, as amended 
by Pub. L. 101-354, the Breast and Cervical Cancer Mortality Prevention 
Act of 1990.

Smoke-Free Workplace

    The Public Health Service strongly encourages all grant recipients 
to provide a smoke-free workplace and promote the non-use of all 
tobacco products. This is consistent with the PHS mission to protect 
and advance the physical and mental health of the American people.

Eligible Applicants

    Assistance will be provided only to the official health departments 
of States or their bona fide agents or instrumentalities. This includes 
the District of Columbia, American Samoa, the Commonwealth of Puerto 
Rico, the Virgin Islands, the Federated States of Micronesia, Guam, the 
Northern Mariana Islands, the Republic of the Marshall Islands, and the 
Republic of Palau. Excluded are the States of:
    a. Maryland, Missouri, Nebraska, and North Carolina, which were 
funded in January 1992, under Program Announcement 121 entitled Early 
Detection and Control of Breast and Cervical Cancer.
    b. California, Michigan, New Mexico, and Texas, which were funded 
in July 1991, under Program Announcement 121 entitled Early Detection 
and Control of Breast and Cervical Cancer.
    c. Colorado, Minnesota, South Carolina, and West Virginia, which 
were funded in July 1991, under Program Announcement 122 entitled Early 
Detection and Control of Breast and Cervical Cancer.
    d. 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.
    States currently receiving CDC funds under Program Announcement 221 
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 since the activities 
performed under that announcement are duplicated under this 
announcement. If not funded under this announcement, funding will 
continue as stated in the most recent award.

Availability of Funds

    Approximately $8,000,000 is available in FY 1994 to fund 
approximately five states. It is expected that the average award will 
be $1,250,000 ranging from $750,000 to $2,000,000. It is expected that 
the awards will begin on or about September 29, 1994, and will be made 
for 12-month budget periods within a project period of up to 5 years. 
Funding estimates outlined above may vary and are subject to change. 
Continuation awards within the approved project period will be made on 
the basis of satisfactory progress, an acceptable application, 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 these awards is to establish a comprehensive public 
health approach to reduce breast and cervical cancer morbidity and 
mortality through screening, referral and follow-up, public education, 
professional education, quality assurance, surveillance and evaluation, 
coalition-building and cancer plan development, and to pay for the 
screening of women who are unable to afford these services. Special 
attention must be given to ensure the participation of women who are 
low-income, uninsured, underinsured, racial minorities, Native 
American, and coordination with the Health Resources and Services 
Administration (HRSA) primary care centers and Title X Family Planning 
organizations.

Program Requirements

    In accordance with Pub. L. 101-354, an award may not be made unless 
the State 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).
    2. The screening, follow-up and referral services are initiated by 
the end of first budget year with the remaining activities of a 
comprehensive breast and cervical cancer early detection program 
(public education, professional education, quality assurance, 
surveillance and program evaluation, coalition building, and cancer 
plan development) fully operational by the end of the second budget 
year. Section 1503(a)(1) and (3).
    3. Cooperative agreement funds will not be expended to provide 
inpatient hospital or treatment services. Section 1504(g). Treatment is 
defined as any service recommended by a clinician, including medical 
and surgical intervention provided in the management of a diagnosed 
condition.
    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).
    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)(1), (2), and (3).
    6. 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).
    An award may not be made unless the State Medicaid program or plan 
provides coverage for:
    1. In the case of breast cancer, a clinical breast examination and 
screening mammography.
    2. In the case of cervical cancer, both a pelvic examination and 
Pap smear screening. Section 1502A.
    In conducting activities to achieve the purpose of this program the 
recipient shall be responsible for the activities under A., below, and 
CDC shall be responsible for conducting activities under B., below:

A. Recipient Activities

    1. Establish a system for screening women for breast and cervical 
cancer as a preventive health measure. Section 1501(a)(1).
    The intent of this program announcement is to increase the 
utilization of screening services for breast and cervical cancer among 
all groups of women in the State, with special efforts to reach those 
who are age 50 years and older, low-income, uninsured, underinsured, 
racial and ethnic minorities, and Native Americans.
    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).
    Screening services should be made available according to the 
following guidelines:
    (1) Only women age 40 years and older will be eligible for 
screening mammography tests; however, priority for services should be 
given to those age 50 and older because of the proven efficacy of 
screening among these women. At least 75 percent of women screened 
should be age 50 years and older.
    (2) Screening will include a clinical breast examination and 
mammography according to the following guidelines:
    (i) Breast Clinical Examination: Annually for all women.
    (ii) Mammography: Every 2 years for women age 40-49 years. Every 
year for women age 50 years and older.
    (3) All women who are, or who have been sexually active, or who 
have reached age 18 years, should have a pelvic examination and a Pap 
smear test annually.
    (4) After a woman has had three or more consecutive normal annual 
examinations, the Pap smear test may be performed less frequently at 
the discretion of her personal physician.
    (5) For diagnostic services following an abnormal screening result, 
cooperative agreement funds may be expended for the following services 
by using the same eligibility criteria required for screening:
    (i) Cervical Cancer--repeat Pap smear, colposcopy and colposcopy-
directed biopsy.
    (ii) Breast Cancer--repeat screening mammogram, diagnostic 
mammogram, fine needle aspiration, and office visits for clinical 
breast examination and evaluation.
    b. Provide priority for screening, follow-up, and referral services 
to women who are low-income and underserved. Section 1504(a).
    An award may not be made under this announcement unless the State 
involved agrees to give priority to the provision of screening, follow-
up, and referral services to women who are underserved and low income.
    c. Establish breast and cervical cancer screening services 
statewide. Section 1504(c)(1).
    Funds may not be awarded under this announcement, unless the State 
involved agrees that services and activities will be made available 
throughout the State, 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).
    CDC may waive the above requirement if it is determined that 
compliance by the State 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), Section 1504(c)(2).
    d. Provide allowances for items and services reimbursed under other 
programs. Section 1504(d)(1) and (2).
    Funds may not be awarded under this announcement, unless the State 
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 compensation program, insurance policy, or Federal or 
State 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).
    Funds may not be awarded under this announcement, unless the State 
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).
    (2) Adjusted to reflect the income of the woman screened. Section 
1504(b)(2).
    (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 in 
accordance with Section 673(2) of the Omnibus Budget Reconciliation Act 
of 1981. Section 1504(b)(3).
    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). Fees/
charges for services covered by Medicare may vary by location, thus, 
States should determine the appropriate reimbursement rates for their 
areas and use them as the maximum allowance. Fee/charge schedules 
should be developed in accordance with guidelines described in 42 CFR 
Part 405.534 which implements Section 4163 of the Omnibus Budget 
Reconciliation Act of 1990 (Pub. L. 101-508), which provides limited 
coverage for screening mammography services.
    2. Provide appropriate referrals for medical treatment of women 
screened in the program and ensure, to the extent practicable, the 
provision of appropriate follow-up services. Section 1501(a)(2).
    A system for the follow-up and referral of women whose screening 
test results are abnormal or suspicious is an essential component of 
any comprehensive breast and cervical cancer early detection program.
    a. Establish a system for the appropriate follow-up and referral 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 and treatment 
services. Clients needing treatment services should be counseled about 
their eligibility for public-supported third party payment and 
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).
    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 regular screening. A useful tracking system is one that can be 
effectively integrated into the State's health care delivery system for 
the breast and cervical cancer early detection program. The tracking 
system should be capable of documenting the outcome of individual 
screening tests, provide information on needed follow-up, and assure 
confidentiality. Additionally, the capability of monitoring the 
tracking system's timeliness, accuracy, and practical usefulness is 
important.
    To meet the intent of Pub. L. 101-354 in ensuring the appropriate 
follow-up of women with abnormal screening results, the State's 
tracking system must include information on screening location (e.g., 
State, county, city), demographic characteristics (e.g., race, date of 
birth), and, screening procedures and results (e.g., mammography, Pap 
smear) for all women in the program. For women identified with abnormal 
screening results, additional information on diagnostic procedures and 
diagnoses (e.g., colposcopy), and treatment (e.g., date initiated) must 
be included.
    In collaboration with CDC, the currently funded comprehensive 
screening States 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 and education 
programs for the early detection and control of breast and cervical 
cancer. Section 1501(a)(3).
    Public information and education includes the systematic design and 
sustained delivery of clear and consistent health messages, especially 
to older women, using a variety of creative methods that contribute to 
the early detection of breast and cervical cancer. Successful public 
education programs are those that increase the knowledge, attitudes, 
and practices of the targeted population related to breast and cervical 
cancer screening.
    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).
    Health care providers and allied health professionals (including, 
but not limited to, nurse practitioners, physician's assistants, 
registered nurses, radiologists, mammography technicians,) play a 
central and key role in assuring that women are screened at appropriate 
intervals, screening tests are performed optimally, and that women with 
abnormal test results receive timely and appropriate diagnostic follow-
up and treatment. A health care provider education program effectively 
transmits information on the efficacy and appropriate use of screening 
procedures, influences professional practices including the improved 
performance of screening procedures, improves quality of test 
interpretations, and promotes the timely diagnostic and treatment 
follow-up for abnormal results.
    5. Establish mechanisms through which the State can monitor the 
quality of screening procedures for breast and cervical cancer, 
including the interpretation of such procedures. Section 1501(a)(5).
    Cooperative agreement funds may not be awarded under Section 1501, 
Pub. L. 101-354, unless the State involved agrees to assure the 
implementation of quality assurance procedures for mammography and 
cytological screening for breast and cervical cancer. Section 1503 (c) 
and (d).
    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 Health and Human Services. Section 1503(e):
    (1) Facilities shall follow the rules for Medicare coverage of 
screening mammography as promulgated by the HCFA.
    (2) Mammography units shall be accredited by the American College 
of Radiology (ACR) or must have applied for accreditation for the 
unit(s) that will be used for screening or diagnostic mammography. The 
Mammography Quality Standards Act of 1992 requires similar 
accreditation for all mammography units in the United States by October 
1994.
    (3) Facilities shall undergo an annual performance evaluation by a 
medical physicist who is board certified by the American Board of 
Radiology (ABR) or who meets the criteria of the ACR for a medical 
physicist in mammography. The mammography facility must also undergo an 
annual compliance inspection by an individual from the State Radiation 
Control Program.
    (4) Facilities shall use the American College of Radiology Breast 
Imaging Reporting System for reporting the interpretation of 
mammographic examinations.
    (5) A report of the results of a mammography performed on a woman 
screened in the program shall be placed in her permanent medical 
records that are maintained by her health service provider.
    b. Develop and implement a quality assurance system for cervical 
cancer screening.
    The laboratory services provided to women in the program as part of 
cytological screening must be conducted in accordance with the 
following guidelines issued by the Secretary of Health and Human 
Services. Section 1503(e):
    (1) Facilities shall meet the standards and regulations promulgated 
by the HCFA implementing the Clinical Laboratory Improvement Act (CLIA) 
of 1988.
    (2) All cytological screening is required to be done on the 
premises of a qualified laboratory.
    (3) A report of the results of cervical cancer screening performed 
on a woman through this program shall be placed in her permanent 
medical records that are maintained by her health service provider.
    6. Evaluate activities conducted under Recipient Activities 1 
through 5, above, through appropriate surveillance or program-
monitoring activities. Section 1501(a)(6).
    Measuring the impact of program activities on the screening 
behavior of women, and on morbidity and mortality, is important for the 
identification of effective 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 a 
comprehensive program and specific program activities.
    a. Implement a surveillance system to monitor and evaluate program 
activities.
    Monitoring the distribution and determinants of breast and cervical 
cancer incidence and mortality is necessary to effectively evaluate a 
comprehensive early detection program. To do this, a surveillance 
system should:
    (1) Collect statewide, 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's 
tracking system.
    (5) Monitor screening resources, including the number of available 
mammography facilities, cytology laboratories, and providers of 
cytology screening.
    b. Develop and implement an evaluation plan for each program 
component.
    The design of each program component should ensure that there can 
be meaningful process and outcome evaluation. The evaluation plan 
should assess the implementation and effectiveness of each program 
component including:
    (1) screening,
    (2) follow-up and referral,
    (3) public education,
    (4) professional education,
    (5) quality assurance, and
    (6) surveillance and program evaluation.
    At a minimum, the evaluation plan should identify what program 
activities will be evaluated, the process and outcome indicators to be 
measured, how they will be measured, the proposed time lines, and 
resources needed. Specific evaluation activities should include but not 
be limited to:
    (1) An inventory of specific services provided with cooperative 
agreement funds.
    (2) A description of who and how many women received services, 
including 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 services, and the capacity of the system in identifying 
resources in the community and assisting women to access available 
services.
    (4) An assessment of the availability and accessibility of breast 
and cervical cancer screening services and an estimation of the extent 
of unmet needs, particularly for women who are age 50 years and older, 
underserved, low-income, racial and ethnic minorities, and Native 
Americans.
    (5) An assessment of the planning, development, implementation, and 
accomplishment of program activities (e.g., goals, objectives, 
timelines, 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 with respect to screening for 
breast and cervical cancer.
    7. 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).
    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 agrees 
that the services and activities provided in this program are 
coordinated with other Federal, State, and local breast and cervical 
cancer programs. Section 1504(e).
    Linkages should be established with federally funded programs such 
as the HRSA primary care centers and community health centers, Title X 
Family Planning programs, State Offices for Aging and Minority Health, 
the Indian Health Service (IHS), especially in States with Native 
American populations, and appropriate State and local agencies.
    Additionally, 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. 
Coalition members bring valuable knowledge, skills, other expertise, 
and financial resources to the program as well as provide access to 
populations of women who need to be screened. Effective coalitions are 
diverse, include active minority participation and have well-defined 
objectives, roles, responsibilities, and strong leadership.
    Linkages and active collaboration are strongly encouraged with 
public and private sector organizations such as the American Cancer 
Society (ACS), Young Women's Christian Association (YWCA) and the 
American Association of Retired Persons (AARP), and survivors of breast 
and cervical cancer, local women's groups, community leaders, and other 
agencies and businesses in the community that provide health care and 
related support services to women. Interagency agreements to 
collaborate on joint breast and cervical cancer early detection 
activities are encouraged especially with the divisions of ACS located 
in States. The evaluation of coalition activities to ensure the 
effective participation of members is encouraged.
    8. Develop and implement a breast and cervical cancer control plan.
    The success of a comprehensive breast and cervical cancer early 
detection program is increased by the existence of a well-thought-out, 
integrated, and realistic plan to address these disease conditions 
among all women, especially those who are low income, uninsured, 
underinsured, racial and ethnic minorities, and Native Americans. A 
comprehensive breast and cervical cancer early detection program should 
be guided by such a plan, developed with coalition involvement, and 
include an ongoing assessment of disease burden, unmet needs, and 
barriers to screening; measurable objectives; proposed implementation 
strategies; target dates for their achievement; and the identification 
of responsible individuals, organizational units, or agencies.

B. CDC Activities

    1. Convene a meeting of the funded States for information sharing, 
problem solving, and training at least annually.
    2. Provide funded States 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 is defined as advice in the: (a) 
interpretation of current scientific literature related to the early 
detection of breast and cervical cancer; (b) practical application of 
Pub. L. 101-354 and nationally recognized clinical and quality 
assurance guidelines for the assessment and diagnosis of breast and 
cervical cancer including the establishment and maintenance of a 
comprehensive screening program; (c) design and implementation of 
public education, professional education, coalition building, and 
cancer plan development activities; (d) evaluation of each program 
component (process and outcome) through the analysis and interpretation 
of surveillance and other relevant data; and (e) overall program 
management including compliance with cooperative agreement 
requirements.
    3. Conduct site visits to assess program progress and mutually 
resolve problems, as needed.
    4. Provide consultation for effective program management.
    5. At the request of the applicant, assign Federal personnel to a 
project in lieu of a portion of the financial assistance. Section 
1507(b)

Evaluation Criteria (Total 100 Points)

    Applications will be reviewed and evaluated according to the 
following criteria:
1. Background and Need
    The extent of the disease burden and the need among the targeted 
population as measured by: a) the State's breast and cervical cancer 
age-adjusted mortality rates averaged over 2 and 5 years, respectively, 
and ranking nationally;
    b) the incidence rates of these conditions; c) the number of women 
in the State, including minority and Native American women, especially 
those who are low income, uninsured, or underinsured; and d) existing 
access and barriers to early detection services, (e.g., social, 
financial, geographic). (20 points--5 points for each subpart)
2. Operational Plan
    The feasibility and appropriateness of the Operational Plan to 
provide: a) screening services for breast and cervical cancer (15 
points); b) follow-up and referral for medical treatment for women with 
malignant and premalignant conditions, and tracking system (15 points); 
c) public education (5 points); d) professional education (5 points); 
e) a quality assurance system (10 points); and f) a surveillance system 
and evaluation strategies (10 points). (60 points allocated as noted 
above)
3. Coalition and Community Involvement
    The extent to which the applicant proposes to coordinate activities 
with other Federal, State and local cancer programs, other appropriate 
agencies, and private providers as evidenced by letters of support and 
proposed coalition development and coalition participation in program 
planning. (5 points)
4. Breast and Cervical Cancer Control Plan
    The feasibility and appropriateness of the applicant's current 
breast and cervical cancer control plan or their proposal to develop 
such a plan with coalition input and the commitment to use it for 
program development and management. (5 points)
5. Capability
    The extent to which the applicant appears likely to succeed in 
implementing the proposed activities as measured by:
    (a) relevant past experiences; (b) feasible program objectives; (c) 
a realistic timetable for program implementation; (d) a sound 
management structure; and (e) the qualifications of management and 
technical staff, including the appropriateness of their proposed roles 
and responsibilities or job descriptions. (10 points--2 for each 
subpart noted above)
6. Budget and Justification
    The extent to which the proposed budget is adequately justified, 
reasonable, and consistent with this program announcement. (Not 
weighted)

Recipient Financial Participation

    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)(1), (2), and (3).
    The matching funds may be in cash or its equivalent in in-kind or 
donated services and include equipment, fairly evaluated. The 
contributions may be made directly or through donations from public or 
private entities.
    In some States, 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. Non-Federal funds in excess of the average amount 
expended during the 2 years preceding the first fiscal year that a 
State applies for funding may be used as match. Supplantation of 
existing program efforts funded through other Federal or non-Federal 
sources is unallowable. Applicants may also include as State matching 
funds, any non-Federal amounts expended pursuant to Title XIX of the 
Social Security Act for the screening, follow-up and referral of women 
for breast and cervical cancer subject to the limitations of section 
1502(b)(3).
    Matching funds may not include: (1) the payment for treatment 
services or the donation of treatment services (see note below); (2) 
services assisted or subsidized by the Federal government; or (3) the 
indirect or overhead costs of an organization.

    Note: Treatment is defined as any service recommended by a 
clinician including medical and surgical intervention provided in 
the management of a diagnosed condition.

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 and local review of proposed Federal assistance 
applications. Applicants 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. If 
SPOCs have any State process recommendations on applications submitted 
to CDC, they should forward them to Edwin L. Dixon, Grants Management 
Officer, 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, no later than 60 
days after the application due date. The granting agency does not 
guarantee to ``accommodate or explain'' the State 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. 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 Program Announcement and application kit were sent to all 
eligible applicants in June 1994.

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 Gordon R. Clapp, 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.
    Programmatic technical assistance may be obtained from Faye L. 
Wong, M.P.H., R.D, Chief, Program Operations Section, 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 FAX (404) 488-
4727. Please refer to Program Announcement Number 474 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) 783-3238.

    Dated: June 23, 1994.
Ladene H. Newton,
Acting Associate Director for Management and Operations, Centers for 
Disease Control and Prevention (CDC).
[FR Doc. 94-15748 Filed 6-28-94; 8:45 am]
BILLING CODE 4163-18-P