[Federal Register Volume 66, Number 132 (Tuesday, July 10, 2001)]
[Notices]
[Pages 35984-35988]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-17039]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement 01098]


Well-Integrated Screening and Evaluation for Women Across the 
Nation (WISEWOMAN); Notice of Availability of Funds

A. Purpose

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 2001 funds for a cooperative agreement 
program for Well-Integrated Screening and Evaluation for Women Across 
the Nation (WISEWOMAN). This program addresses the ``Healthy People 
2010'' focus areas of Nutrition and Overweight, Physical Activity and 
Fitness, Tobacco Use, Heart Disease and Stroke, Diabetes, and Access to 
Quality Health Services.
    The purpose of this program is to use scientifically rigorous 
methods to test the effectiveness of a behavioral or lifestyle 
intervention aimed at preventing cardiovascular disease (CVD) and other 
chronic diseases. The target population consists of women participating 
in the National Breast and Cervical Cancer Early Detection Program 
(NBCCEDP). The major long-term goal is to demonstrate a successful 
behavioral or lifestyle intervention for the population targeted by the 
NBCCEDP. Recipients are also expected to work with existing health care 
systems to identify free or discounted medication for women who require 
such therapy.

B. Eligible Applicants

    Assistance will be provided only to the health departments of 
States or their bona fide agents, including the District of Columbia, 
the Commonwealth of Puerto Rico, the Virgin Islands, the Commonwealth 
of the Northern Mariana Islands, American Samoa, Guam, federally 
recognized Indian tribal governments, the Federated States of 
Micronesia, the Republic of the Marshall Islands, and the Republic of 
Palau. NBCCEDP grantees who are currently receiving grants under 
Program Announcements 99135 and 00115 are not eligible.

C. Availability of Funds

    Approximately $2,000,000 is available in FY 2001 to fund two 
awards. It is expected that the average amount per award is between 
$750,000 to $1,250,000. It is expected that the awards will begin on or 
about September 30, 2001, and will be made for a 12-month budget period 
within a project period of three years. Funding estimates may change.
    Continuation awards within an approved project period will be made 
on the basis of satisfactory progress as evidenced by required reports 
and the availability of funds.

1. Use of Funds

    In accordance with Public Law 101-354, an award may not be made 
unless the State/Territory/Tribe involved agrees that:
    a. At least 60 percent of cooperative agreement funds will be 
expended for screening, lifestyle intervention, public

[[Page 35985]]

health case management, appropriate referral for medical treatment, and 
to ensure, to the extent practicable, the provision of appropriate 
follow-up services and support services such as medical case management 
for women with extremely high values. The remaining 40 percent or less 
will be expended for public education programs, for training of health 
professionals, for mechanisms to monitor screening procedures, and to 
evaluate activities conducted under this cooperative agreement through 
appropriate program surveillance or program-monitoring activities 
(Sections 1501(a) and 1503(a) (42 U.S.C. 300k(a) and 300m(a)) of the 
Public Health Service Act (PHS Act), as amended).
    b. Use of federal funds for medical care case management of women 
without alert values is strongly discouraged (see VI. below for 
definition of alert values). As stated above funds should be expended 
for screening, appropriate referral for medical treatment, and, to 
ensure, to the extent practicable, the provision of appropriate follow-
up services and support services such as case management (see 
definitions below). Therefore, it is not required that funds be used to 
provide follow-up services and support services such as case 
management. However, programs are encouraged to use funds for screening 
and intervention case management. When funds must be used for medical 
care case management, priority is to be given to women with extremely 
high values (i.e. those with alert values which are defined in Section 
E.4.e). Because 60-80% of women will have abnormal screening values, 
the cost of providing medical care case management to women with non-
alert screening values is not practicable or cost-efficient.
    Case Management: A term for all activities that a physician or 
other health care professional normally performs to insure the 
coordination of the public health services or medical services required 
by a patient.
    WISEWOMAN Screening and Intervention Case Management: A term for 
all activities that a public health professional performs to ensure the 
coordination of the public health screening, intervention, and referral 
services required by a client.
    WISEWOMAN Medical Care Case Management: A term for all activities 
that a physician, health care professional, or public health 
professional performs to ensure the coordination of the medical 
services required by a patient.
    c. All blood pressure, cholesterol, and other preventive health 
screenings, intervention, referral, follow-up, case management, and 
evaluation should be initiated by the end of any second fiscal year of 
payments pursuant to the grant (i.e, by the end of the second year in 
the budget period). (Section 1503 (a)(3) (42 U.S.C. 300m(a)(3)) of the 
PHS Act, as amended.)
    d. Cooperative agreement funds will not be expended to provide 
inpatient hospital or treatment services. (Section 1504(g) (42 U.S.C. 
300n(g)) of the PHS Act, as amended.) Treatment is defined as any 
medical, pharmaceutical, or surgical service prescribed by a clinician 
in the management of a diagnosed condition. Lifestyle and behavioral 
interventions are included in the definition of case-management but are 
not considered treatment.
    e. Not more than 10 percent of funds will be expended annually for 
administrative expenses (Section 1504(f) (42 U.S.C. 300n(f)) of the PHS 
Act, as amended.)
    f. 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) 
(42 U.S.C. 300k(b)(3))) of the PHS Act, as amended. These may vary by 
location and grantee should determine appropriate reimbursement rates.
    In accordance with section 1504 (c)(2) (42 U.S.C. 300n(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 an 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.

2. Recipient Financial Participation

    Recipient financial participation is required for this program in 
accordance with the authorizing legislation. Section 1502 (42 U.S.C. 
300) of the PHS Act states that matching funds are required from non-
Federal sources in an amount not less than $1 for each $3 of Federal 
funds awarded under this program. The non-Federal contributions may be 
made directly in cash or equivalent in-kind or donated services, 
including equipment, fairly evaluated, through donations from public or 
private entities. 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. In some 
States/Territories/Tribes, non-Federal funds from a variety of sources 
may presently be used to support one or more of the WISEWOMAN early 
detection activities described in this program announcement.

D. Program Requirements

    In conducting activities to achieve the purpose of this program, 
the recipient will be responsible for the activities under 1. 
(Recipient Activities), and CDC will be responsible for conducting 
activities under 2. (CDC Activities).

1. Recipient Activities

    a. Build a chronic disease screening and intervention program with 
priority on preventing cardiovascular disease (i.e. WISEWOMAN program 
that includes hypertension and cholesterol screening). This program 
should target populations that have not been previously well-studied.
    b. Work collaboratively with other WISEWOMAN programs and partners 
to develop methods which have the potential to be implemented in other 
WISEWOMAN programs.
    c. Develop program and research protocols (see Attachment I in the 
application kit).
    d. Implement screening, referral, and follow-up according to the 
recommendations of the NationalCholesterol Education Program (NCEP)of 
the National Heart, Lung, and Blood Institute (NHLBI) for cholesterol 
screening; and the recommendations set forth for hypertension screening 
by the sixthJoint National Report on the Detection, Evaluation and 
Treatment of High Blood Pressure. Laboratories that perform the 
screening for cholesterol must be accredited and meet all applicable 
Federal and State quality assurance standards in the provision of any 
test performed.
    e. Establish cardiovascular disease prevention as the primary focus 
of interventions, with interventions addressing one or more risk 
factors for cardiovascular disease: overweight, physical inactivity, 
inadequate intake of fruit and vegetables and excessive calories and 
dietary fat. Cigarette smoking, and undiagnosed diabetes may also be 
addressed as secondary priorities. Some interventions available to the 
grantee are: strength training programs, culturally-appropriate 
modifications of the five-day diet, or combined physical activity and 
nutrition counseling tools. To obtain the statistical power to evaluate 
the intervention, the program should add cholesterol and blood pressure 
screenings to a sufficiently large number of NBCCEDP sites. After 
demonstration

[[Page 35986]]

of an effective lifestyle intervention to reduce the risk of 
cardiovascular disease, recipients may develop a number of other 
preventive services to be delivered.
    f. Implement program/research protocols as developed.
    g. Develop abstracts and publications in collaboration with other 
partners that inform the public, scientific community, and Congress as 
to the progress and program results.
    h. Grantees are expected to use a public health approach in 
designing an efficient intervention delivery system.
    i. If the intervention will be assigned at the level of the site, 
it is extremely important to provide power calculations justifying the 
number of sites selected. A method of collecting information for the 
purpose of program evaluation should be developed and implemented.

2. CDC Activities

    a. Assist as needed in the development demonstration project 
protocols and forms.
    b. Participate in workshops and/or teleconferences of the 
recipients for information-sharing and problem-solving.
    c. Provide ongoing consultation and technical assistance to plan, 
implement, and evaluate program activities.
    d. Assist recipients as requested with the analysis of their data 
and in the development of their abstracts and publications.

E. 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 
evaluation criteria listed, so it is important to follow them in laying 
out your program plan. The narrative should be no more than 35 double-
spaced pages, printed on one side, with one inch margins, and unreduced 
font.
    Provide a realistic time-phased work plan that addresses the points 
below. If the first year of the program will be used for planning, the 
application should detail how each of the preliminary plans will be 
finalized by detailing the process used and the time line to a final 
plan.

1. Background and Need

    Provide a brief description of the extent of the disease burden. 
Also describe the background of the health care system to include:
    a. The current health care system in whichBCCEDP sites operate and 
the appropriateness of the health care system for implementing 
standardized effective interventions, adhering to program protocols, 
tracking difficult to reach women, and providing timely information on 
women who have high values of cholesterol and blood pressure;
    b. Explanation of all non-cancer-related services currently being 
provided within the context of the BCCEDP (i.e., are heights and 
weights measured, is blood pressure routinely taken, is a smoking 
history obtained, etc.? Are the results of these services recorded so 
that they are accessible to the BCCEDP?)
    c. Describe the current medical care safety network for uninsured 
persons and how it will be utilized to provide discounted medical care 
and discounted medications.

2. Infrastructure

    Document the current BCCEDP infrastructure including:
    a. The number of BCCEDP sites in operation as of January, 2001;
    b. The total number of political subdivisions(e.g., counties) and 
the percentage of these subdivisions that had a BCCEDP site in January, 
2001; and
    c. During the most recent program year: (1) The average number of 
women served in the State/Territory/Tribal Service Area each month 
during the past BCCEDP project year;
    (2) The racial/ethnic characteristics of the population served;
    (3) The percentage of women with a positive mammogram or pap test 
who did not go on for further diagnostics and reasons why women did not 
go on; and
    (4) The average length of time between a positive mammogram or pap 
test and the receipt of a diagnostic test.

3. Collaborative Efforts

    Provide a concise collaboration plan, which addresses program 
methods and analyzing and publishing data. The following areas should 
be addressed:
    a. Meeting and teleconference attendance for the purpose of 
developing, to the degree possible, scientifically sound protocols, 
forms, tracking systems, measurements, etc.;
    b. Analyzing data and developing abstracts and publications; and
    c. Extent of collaboration with university personnel including 
public or community health experts.

4. Program Planning

    Describe how the program will decide the following:
    a. Site selection, approximate number, characteristics of and the 
proportion that will receive WISEWOMAN services and an annual estimate 
of women served;
    b. Public health screening and intervention services to be provided 
along with a time line for determining and implementing screening and 
intervention services (allowable screening and diagnostic procedures 
for the demonstration programs include resting pulse, blood pressure, 
serum total cholesterol (nonfasting), HDL-cholesterol (nonfasting), 
height and weight measurements, automated blood chemistry (to assess 
blood glucose, potassium, calcium, creatinine, uric acid, triglyceride, 
or micronutrient levels), urine analysis(including urine cotinine), and 
paper and pencil tests, interviews, or computerized methods that 
measure level of physical activity, dietary intake, smoking, 
osteoporosis risk status, immunization status, or other chronic disease 
risk factors or preventable health problems). Tests that require the 
participant to fast should be considered diagnostic tests and not 
public health screening tests. One fasting LDL-C test or fasting 
lipoprotein profile will be allowed when ordered as a diagnostic test. 
The use of program funds for other diagnostic tests will require 
substantial justification by the program;
    c. Letters of support for WISEWOMAN from a number of State/
Territorial/Tribal BCCEDP site directors, medical staff involved in 
diagnostic testing and provision of discounted medications, and 
university personnel;
    d. A staffing plan that appoints at least two professional staff 
members to work full-time on WISEWOMAN, or a plan for hiring such staff 
members and describe the WISEWOMAN evaluation team with information on 
their experience and academic degrees;
    e. A method for tracking women through the system and after they 
leave the system (for the purpose of bringing them back for further 
screening, intervention, and behavioral follow-up), for case management 
that includes assurances that women will have access to medical care 
facilities, for flagging women who need immediate referral (i.e. those 
with alert values) because of extremely high blood pressure (180 
systolic blood pressure or 110 diastolic blood pressure), cholesterol 
(>400 mg/dL), or glucose levels (>375 mg/dL); and
    f. How the program will track women, the number and types of 
standardized lifestyle interventions received, and the costs of the 
intervention.

5. Screening and Intervention

    Document the ability of the program to screen and intervene upon 
women enrolled in the WISEWOMAN program including implementation of 
WISEWOMAN screening activities, the rationale and guidelines for 
implementing WISEWOMAN

[[Page 35987]]

intervention activities, methods for reaching women for this and the 
use of staff such as outreach workers to address differing barriers.

6. Evaluation

    Submit a preliminary evaluation design to examine the impact of 
chronic disease risk factors intervention(s) on lowering blood pressure 
and improving cholesterol profiles at six and 12 months after 
intervention. The plan should include:
    a. The extent to which a university or prevention research center 
at a university will be involved in the evaluation design;
    b. The preliminary evaluation questions to be answered;
    c. The type of evaluation design (e.g. randomized controlled 
design) and rationale for using this type of design;
    d. Length of follow-up and measurement intervals;
    e. Protocol used to ensure that the maximum number of women will 
return for each evaluation;
    f. Statistical techniques that will be used to analyze the data 
with preliminary estimates of the sample size needed to achieve 
adequate statistical power; and
    g. A plan for pilot testing the methods outlined in the initial 
research protocols, including methods of screening, proposed lifestyle 
interventions, delivery system for lifestyle interventions, 
availability of discounted care and medications, and program 
evaluation.
    One type of evaluation might from a number of sites, compare blood 
pressure and cholesterol, and risk behaviors for CVD in those assigned 
to a ``usual care'' (e.g., hypertension and cholesterol screening, 
referral, and follow-up with minimal intervention) group with those 
assigned to ``special intervention'' (e.g., added screening for 
overweight, poor dietary habits, physical inactivity, cigarette 
smoking, or undiagnosed diabetes followed up by interventions such as 
special classes, support groups, physician prescriptions, extra follow-
up efforts, and/or community programs such as food co-ops, walking 
clubs, or smoking cessation programs) group. In this case, a discussion 
of the method that will be used to keep the usual care group from 
knowing and adopting the interventions that are being implemented in 
other areas of the clinic is extremely important. Other designs may be 
proposed given sufficient justification of the scientific method. 
Special interventions should assure more intensive and frequent 
behavioral follow-up consistent with counseling recommendations. 
Assignments to ``usual care'' or ``special intervention'' groups could 
be at the clinic or individual level. Random assignment to level of 
intervention is preferred.

7. Budget and Justification

    Provide a detailed budget and line-item justification that is 
consistent with the stated objectives, purpose, and planned activities 
of the project. Identify the required 60/40 cost distribution of 
program funds in the requested itemized budget by using separate 
columns for each. CDC WISEWOMAN requires use of funds in accordance 
with Pub. L. 101-354.
    Budget for the following travel:
    a. Up to two persons to attend one training session during the year 
(two to three days). Topic and place to be determined.
    b. Up to two persons to Atlanta, GA to participate in the 2002 
NCCDPHP Annual Chronic Disease Conference(four days).
    c. One person to attend the Physical Activity and Public Health 
Course that is held at Sea Pines, South Carolina in September 2002 
[Cost for seven to eight day package is $1150 for the registration, 
lodging, and meals. Airfare is not included] or one person to 
participate in a non-CDC sponsored professional meeting directly 
relevant to the program.
    Budget for collecting and reporting cost data and minimum data 
elements. Section 1505 (42 U.S.C. 300n-1) requires that applicants 
provide assurances that the grant funds be used in the most cost-
effective manner.

8. Human Subjects

    State whether or not Human subjects are involved in this proposal. 
CDC Institutional Review Board approval is required.

9. Women, Ethnic, and Racial Groups

    Describe how the CDC/ATSDR policy requirements will be met 
regarding the inclusion of women, ethnic, and racial groups in the 
proposed research. (See Women, Racial, and Ethnic Minorities in the 
Evaluation Criteria and Other Requirements sections.)

F. Submission and Deadline

    Submit the original and two copies of CDC form 0.1246. Forms are 
available in the application kit and at the following Internet address: 
www.cdc.gov/od/pgo/forminfo.htm.
    On or before August 20, 2001, submit the application to the Grants 
Management Specialist identified in Section J., ``Where to Obtain 
Additional Information''.
    Deadline: Applications shall be considered as meeting the deadline 
if they are either:
    1. Received on or before the deadline date; or
    2. Sent on or before the deadline date. (Applicants must request a 
legibly dated U.S. Postal Service postmark or obtain a legibly dated 
receipt from a commercial carrier or U.S. Postal Service. Private 
metered postmarks shall not be acceptable as proof of timely mailing.)
    Late Applications: Applications which do not meet the criteria in 
1. or 2. above are considered late applications, will not be 
considered, and 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; Women, Racial, and Ethnic Groups (15 Points)

    The extent of the disease burden and the need among the priority 
populations, including a description of gaps in the scientific 
knowledge with regard to preventing cardiovascular disease or other 
chronic diseases in the selected priority populations. (10 points); The 
extent to which the applicant has met the CDC Policy requirements 
regarding the inclusion of women, ethnic, and racial groups in the 
proposed research (5 points).

2. Infrastructure (10 Points)

    The strength of the State/Territorial/Tribal BCCEDP program as 
evidenced by the number of BCCEDP sites and the percentage of 
subdivisions (e.g., counties) within the State/Territory/Tribal Service 
Area that had a BCCEDP site in January, 2000; the average number of 
women served each month during the past BCCEDP project year; the 
racial/ethnic characteristics of the population served; the percentage 
of women with a positive mammogram or pap test who did not go on for 
further diagnostics and reasons why they didn't; and the average length 
of time between a positive test and the receipt of a diagnostic test.

3. Collaborative Efforts (5 Points)

    Ability to collaborate and extent of proposed collaboration with 
other WISEWOMAN projects to develop joint program methods and analyze 
data.

4. Program Plan (30 Points)

    The adequacy and appropriateness of the preliminary program plan as 
indicated by:

[[Page 35988]]

    a. The likelihood that program plans and protocols will be 
finalized within the first year;
    b. Proposed site selection, the approximate number of sites to 
receive WISEWOMAN services, the characteristics of the sites, the 
proportion of State/Territorial/Tribal BCCEDP sites that will receive 
WISEWOMAN services, and estimated number of women who are expected to 
receive such services in the first, second, and subsequent years;
    c. Letters of support for WISEWOMAN from the State/Territorial/
Tribal BCCEDP site directors and medical staff;
    d. A staffing plan;
    e. A proposed tracking system for women for referral and follow up 
and the number and types of interventions provided; and

5. Screening and Interventions (15 Points)

    Proposed public health screening and intervention services to be 
provided along with a time line for determining and implementing 
screening and intervention services. The adequacy and quality of the 
proposed rationale and guidelines for implementing eachWISEWOMAN 
screening and intervention activity; the methods for reaching women 
from the State/Territorial/Tribal BCCEDP for the purpose of WISEWOMAN 
screening and intervention; the extent and use of outreach workers to 
address barriers to program involvement, behavioral change, and 
maintaining contact for future health screenings and interventions.

6. Evaluation Plan (25 Points)

    The extent to which the preliminary evaluation plan provides an 
appropriate design to examine the impact of chronic disease risk factor 
intervention(s) on lowering blood pressure and improving cholesterol 
profiles; collaboration with partners including university partners; 
evaluation; and data analysis.

7. Budget and Justification (Not Scored)

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

8. Human Subjects (Not Weighted)

    Does the application adequately address the requirements of Title 
45 CFR part 46 for the protection of human subjects?

H. Other Requirements

    Technical Reporting Requirements:
    Provide CDC with original plus two copies of--
    1. Progress reports on a quarterly basis;
    2. Financial status report, no more than 90 days after the end of 
the budget period; and
    3. Final financial status and performance reports, no more than 90 
days after the end of the project period.
    Send all reports to the Grants Management Specialist identified in 
Section J., ``Where to Obtain Additional Information''. The following 
additional requirements are applicable to this program. For a complete 
description of each, see Attachment II in the application kit.

AR-1  Human Subjects Requirements
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 2010
AR-12  Lobbying Restrictions
AR-22  Research Integrity

I. Authority and Catalog of Federal Domestic Assistance Number

    This program is authorized by sections 1501-1509 (42 U.S.C. 300k-
300n-4a) of the Public Health Service Act, as amended. This program is 
also authorized by the Consolidated Appropriations Act, 2000, Pub. L. 
106-113. The Catalogue of Federal Domestic Assistance (CFDA) number is 
93.283.

J. Where To Obtain Additional Information

    This and other CDC announcements can be found on the CDC home page 
on the Internet: http://www.cdc.gov. Click on ``Funding'' then ``Grants 
and Cooperative Agreements''.
    Should you have questions after reviewing the contents of all the 
documents, business management assistance may be obtained from: Glynnis 
Taylor, Grants Management Specialist, Grants Management Branch, 
Procurement and Grants Office, Centers for Disease Control and 
Prevention (CDC), Announcement 01098, 2920 Brandywine Road, Room 3000, 
Atlanta, GA 30341-4146, Telephone: (770) 488-2752, E-mail address: 
[email protected].
    For program technical assistance, contact: Julie C. Will, Division 
of Nutrition and Physical Activity, National Center for Chronic Disease 
Prevention and Health Promotion, Centers for Disease Control and 
Prevention (CDC), 4770 Buford Hwy, NE., Atlanta, Georgia 30341-4146, 
Telephone: (770) 488 6024, E-mail address: [email protected].

    Dated: July 2, 2001.
John L. Williams,
Director, Procurement and Grants Office Centers for Disease Control and 
Prevention (CDC).
[FR Doc. 01-17039 Filed 7-9-01; 8:45 am]
BILLING CODE 4163-18-P