[Federal Register Volume 66, Number 206 (Wednesday, October 24, 2001)]
[Notices]
[Pages 53797-53800]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-26743]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement 02011]


Cooperative Agreements for the Development and Improvement of 
Population-Based Birth Defects Surveillance Programs and the 
Integration of Surveillance Data With Public Health Programs; Notice of 
Availability of Funds

A. Purpose

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 2002 funds for a cooperative agreement 
program for developing and improving birth defects surveillance and 
integrating surveillance data with other public health programs. This 
program addresses the ``Healthy People 2010'' focus area of Maternal, 
Infant, and Child Health.
    The purpose of the program is to support: (1) The development, 
implementation, expansion, and evaluation of population-based birth 
defects surveillance systems; (2) the development and implementation of 
population-based programs to prevent birth defects; and (3) the 
development and implementation or expansion of activities to improve 
the access of children with birth defects to health services and early 
intervention programs.

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 Virgin Islands, the Commonwealth of the Northern Mariana Islands, 
American Samoa, Guam, the Federated States of Micronesia, the Republic 
of the Marshall Islands, the Republic of Palau, and federally 
recognized Indian tribal governments.
    Recipients funded under CDC Program Announcement 00094 (Cooperative 
Agreements for the Development of State-Based Birth Defect Surveillance 
Programs and the Use of the Surveillance Data for Public Health 
Programs) and Program Announcement 96043 (Centers of Excellence to 
Provide Surveillance, Research, Services, and Evaluation Aimed at 
Prevention of Birth Defects) are not eligible. See Attachment I in the 
Application Kit for a list of the States currently funded under these 
program announcements.
    The eligible States are: Alabama, Alaska, Colorado, Delaware, 
Florida, Georgia, Hawaii, Idaho, Indiana, Kansas, Kentucky, Maine, 
Maryland, Michigan, Minnesota, Mississippi, Missouri, Montana, 
Nebraska, Nevada, New Hampshire, New Mexico, North Carolina, North 
Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South 
Dakota, Tennessee, Utah, Vermont, Virginia, West Virginia and Wyoming.
    Applicants may apply under one of two categories:
    Category 1--States/territories/tribes with no birth defects 
surveillance systems; or
    Category 2--States/territories/tribes with newly implemented or 
ongoing surveillance systems.

    Note: Title 2 of the United States Code, Section 1611 states 
that an organization described in section 501(c)(4) of the Internal 
Revenue Code that engages in lobbying activities is not eligible to 
receive Federal funds constituting an award, grant, or loan.

C. Availability of Funds

    Approximately $2,400,000 is available in FY 2002 to fund 
approximately 4-8 awards in Category 1, and 8-10 awards in Category 2. 
It is expected that the awards will range from $50,000 to $250,000. The 
average award will be $100,000 for Category 1 States and $200,000 for 
Category 2 States. The awards will begin on or about March 1, 2002, and 
will be made for a 12-month budget period within a project period of up 
to 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.

Use of Funds

    These awards may be used for personnel services, equipment, travel, 
and other costs related to project activities. Project funds may not be 
used to supplant State funds available for birth defects surveillance 
or prevention, health care services, patient care, construction, nor 
lease/purchase of facilities or space.

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 for States with no birth defects surveillance systems; or 2. 
Recipient activities for States with newly implemented or ongoing 
surveillance systems; and CDC will be responsible for the activities 
under 3. CDC activities.
    1. Recipient Activities for States with no birth defects 
surveillance systems:
    a. Develop and begin implementation of a population-based 
surveillance system to ascertain cases and generate timely population-
based data of major birth defects occurring in the State.
    b. Analyze and disseminate the surveillance data generated by the 
system in a timely fashion including rates and trends of major birth 
defects.
    c. Develop and implement a plan to evaluate the surveillance 
methodology used.
    d. Involve the appropriate partners within the State to develop a 
plan and begin implementation of a birth defects prevention program 
(i.e., Neural Tube Defects (NTD) occurrence prevention). Share results 
with appropriate organizations within the State and with other States.
    e. Develop a plan to evaluate the prevention activities.
    f. Involve the appropriate partners within the State to develop a 
plan and begin implementation of activities to improve the access of 
children with birth defects to comprehensive, community-based, family-
centered care (e.g., establish linkages with other programs like 
Children with Special Health Care Needs).
    g. Develop a plan to evaluate the identification of and/or 
timeliness of referral to services among eligible children or families.
    2. Recipient Activities for States with newly implemented or 
ongoing surveillance systems:
    a. Broaden methodologies and approaches which will improve, 
sustain, and expand the capacity of the existing population-based 
surveillance system to ascertain cases and generate timely population-
based data of major birth defects occurring in the State.
    b. Analyze and disseminate the surveillance data generated by the 
system in a timely fashion including rates and trends of major birth 
defects (e.g., publish a report on the surveillance data).

[[Page 53798]]

    c. Evaluate the surveillance methodology used.
    d. Involve the appropriate additional partners within the State to 
expand birth defects prevention programs (i.e., Neural Tube Defects 
(NTD) occurrence prevention). Share results with appropriate 
organizations within the State and with other States.
    e. Evaluate the prevention progress.
    f. Involve the appropriate partners within the State to expand 
activities to improve the access of children with birth defects to 
comprehensive, community-based, family-centered care (e.g., establish 
linkages with other programs like Children with Special Health Care 
Needs).
    g. Evaluate the progress on improving access to services (e.g., 
identification of children and families eligible for services; evaluate 
the timeliness of referral to services).
    3. CDC Activities:
    a. Assist, if requested, in designing, developing, and evaluating 
methodologies and approaches used for population-based birth defects 
surveillance.
    b. Assist, if requested, in analyzing surveillance data related to 
birth defects.
    c. Assist, if requested, in designing plans for prevention programs 
and plans to improve the access of children with birth defects to 
health services and intervention programs.
    d. Provide, if requested, a reference point for sharing regional 
and national data and information pertinent to the surveillance and 
prevention of birth defects.

E. Content

Letter of Intent (LOI)

    A LOI is requested for this program. The LOI will not be used to 
eliminate potential applicants, but it will enable CDC to determine the 
level of interest and plan the review more efficiently. The narrative 
should be no more than two, double-spaced pages, printed on one side, 
with one inch margins and 12 point font. The LOI should include the 
following information: this program announcement number; applicant's 
name and address; project director's name, phone number, and email; 
identification of the category for which the applicant is applying 
(Category 1 or Category 2); a brief description of the number of state-
wide births and current birth defect surveillance system; and a brief 
description of the planned statement of work.

Applications

    Use the information in the Program Requirements, Other 
Requirements, and Evaluation Criteria sections to develop the 
application content. Your application will be evaluated on the criteria 
listed, so it is important to follow them in describing the program 
plan.
    The applicant should provide a detailed description of first-year 
activities and briefly describe future-year objectives and activities. 
The application must contain the following:
    1. Cover Letter: A one page cover letter should indicate whether 
the applicant is applying for Category 1 or Category 2.
    2. A one-page, single-spaced, typed abstract in 12 point font must 
be submitted with the application. The heading should include the title 
of the grant program, project title, organization, name and address, 
project director and telephone number. The abstract should clearly 
state which option the applicant is applying for: Category 1 or 
Category 2. The abstract should briefly summarize the program for which 
funds are requested, the activities to be undertaken, and the 
applicant's organization structure. The abstract should precede the 
program narrative. A table of contents that provides page numbers for 
each of the following sections should be included. All pages must be 
numbered.
    3. Narrative: The narrative should be no more than 25 double-spaced 
pages printed on one side, with one inch margins, and unreduced font 
(12 point). The required detailed budget and detailed budget 
justification are not considered to be part of the program narrative. 
The narrative should specifically address item 1 or 2 in the ``Program 
Requirements'' and should contain the following sections:
    a. Understanding of the Public Health Impact of Birth Defects;
    b. Impact on Population-Based Birth Defects Surveillance;
    c. Use of Surveillance Data for Prevention Activities;
    d. Use of Surveillance Data for Improving Access to Health Services 
and Early Intervention Programs;
    e. Organizational and Program Personnel Capability; and
    f. Human Subjects Review
    4. Budget and Budget Justification--Provide a detailed budget which 
indicates the anticipated costs for personnel, fringe benefits, travel, 
supplies, contractual, consultants, equipment, indirect, and other 
items.

F. Submission and Deadline

Letter of Intent (LOI)

    On or before November 16, 2001, submit the LOI to the officials 
designated for programmatic technical assistance identified in the 
``Where to Obtain Additional Information'' section of this 
announcement.

Application

    Submit the original and two copies of PHS 5161-1 (OMB Number 0937-
0189). Forms are available in the application kit and at the following 
Internet address: www.cdc.gov/od/pgo/forminfo.htm.
    On or before December 7, 2001, submit the application to the Grants 
Management Specialist identified in the ``Where to Obtain Additional 
Information'' section of this announcement.
    Deadline: Applications shall be considered as meeting the deadline 
if they are either:
    (a) Received on or before the deadline date; or
    (b) Sent on or before the deadline date and received in time for 
submission to the independent review group. (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 
(a) or (b) above are considered late applications, will not be 
considered, and will be returned to the applicant.

G. Evaluation Criteria

    Each application will be evaluated individually against the 
following criteria by an independent review group appointed by CDC as 
they relate to the applicant's response to either item 1 or 2 in the 
``Program Requirements'' section.
    1. Applicant's understanding of the public health impact of birth 
defects (5 points):
    The extent to which the applicant has a clear, concise 
understanding of the requirements, objectives, and purpose of the 
cooperative agreement. The extent to which the application reflects an 
understanding of the public health impact of birth defects in their 
State and the purpose and complexities of birth defects surveillance as 
it relates to their State.
    2. Impact on population-based birth defects surveillance (20 
points):
    The extent to which the applicant describes the anticipated level 
of impact this cooperative agreement will have on birth defects 
surveillance activities in the State. The current and proposed 
activities evaluated in this element are specific for Category 1 and 
Category 2.

[[Page 53799]]

    a. Evaluation criteria for Category 1 (States with no birth defects 
surveillance systems):
    (1) Plans for developing population-based birth defects 
surveillance;
    (2) Methods of case ascertainment;
    (3) Timeliness of case ascertainment;
    (4) Level of coverage of the population;
    (5) Specific birth defects ascertained;
    (6) Plans for analyzing and reporting surveillance data to 
appropriate State, local, and federal health officials;
    (7) Plans for evaluating the surveillance methodology and the 
quality of the surveillance data; and
    (8) The degree to which the applicant has met the CDC Policy 
requirements regarding the inclusion of women, ethnic, and racial 
groups in the proposed research. This includes:
    (a) The proposed plan for the inclusion of both sexes and racial 
and ethnic minority populations for appropriate representation.
    (b) The proposed justification when representation is limited or 
absent.
    (c) A statement as to whether the design of the study is adequate 
to measure differences when warranted.
    (d) A statement as to whether the plans for recruitment and 
outreach for study participants include the process of establishing 
partnerships with community(ies) and recognition of mutual benefits.
    b. Evaluation criteria for Category 2 (States with newly 
implemented or ongoing birth defects surveillance systems):
    (1) Ability to improve/expand population-based birth defects 
surveillance;
    (2) Methods of case ascertainment;
    (3) Timeliness of case ascertainment;
    (4) Level of coverage of the population;
    (5) Specific birth defects ascertained;
    (6) Analyzing and reporting surveillance data to appropriate State, 
local, and federal health officials;
    (7) Evaluating the surveillance methodology and quality of the 
surveillance data; and
    (8) The degree to which the applicant has met the CDC Policy 
requirements regarding the inclusion of women, ethnic, and racial 
groups in the proposed research. This includes:
    (a) The proposed plan for the inclusion of both sexes and racial 
and ethnic minority populations for appropriate representation.
    (b) The proposed justification when representation is limited or 
absent.
    (c) A statement as to whether the design of the study is adequate 
to measure differences when warranted.
    (d) A statement as to whether the plans for recruitment and 
outreach for study participants include the process of establishing 
partnerships with community(ies) and recognition of mutual benefits.
    3. Use of the surveillance data for prevention activities (30 
points):
    The extent to which the applicant describes the plans for using 
surveillance data to develop and implement or expand existing programs 
to prevent birth defects. The current and proposed activities evaluated 
in this element are specific for Category 1 and Category 2.
    a. Evaluation criteria for Category 1 (States with no birth defects 
surveillance systems):
    (1) Ability to work with appropriate partners in the State (e.g., 
provide letters of support, Memorandums of Agreement/Understanding); 
and
    (2) Plan for using the surveillance data to develop prevention 
programs; and/or Plan for sharing surveillance data (e.g., personal 
identifiers and contact information) with programs or agencies so that 
children or families can be enrolled in prevention programs.
    b. Evaluation criteria for Category 2 (States with newly 
implemented or ongoing birth defects surveillance systems):
    (1) Ability to work with appropriate partners in the State (e.g., 
provide letters of support, Memorandums of Agreement/Understanding);
    (2) Use of surveillance data to expand prevention programs; and/or 
sharing of surveillance data (e.g., personal identifiers and contact 
information) with programs or agencies so that children or families are 
enrolled in prevention programs; and
    (3) Evaluation of progress made in the prevention of birth defects.
    4. Use of surveillance data for improving access to health services 
and early intervention programs (30 points). The extent to which the 
applicant describes the plans to develop and implement or expand 
existing activities to improve the access of children with birth 
defects to health services and early interventions. The current and 
proposed activities evaluated in this element are specific for Category 
1 and Category 2.
    a. Evaluation criteria for Category 1 (States with no birth defects 
surveillance systems):
    (1) Identification of appropriate programs within the State for 
referral to health services (e.g., provide letters of support, 
Memorandums of Agreement/Understanding);
    (2) Plan for linking programs or developing other approaches to 
increase identification of children or families eligible for health 
services; and
    (3) Plan to evaluate the implementation process.
    b. Evaluation criteria for Category 2 (States with newly 
implemented or ongoing birth defects surveillance systems):
    (1) Ability to integrate programs within the State (e.g., provide 
letters of support, Memorandums of Agreement/Understanding, 
documentation of numbers of eligible children or families referred for 
and percent receiving services);
    (2) Improve and expand approaches to increase identification of 
children or families eligible for health services; and
    (3) Plan for evaluating outcomes of children who receive services.
    5. Organizational and program personnel capability (15 points):
    a. The extent to which the applicant has the experience, skills, 
and ability to develop and improve birth defects surveillance and use 
surveillance data to develop prevention programs and improve access to 
health services or early intervention programs.
    b. The adequacy of the present staff and/or the capability to 
assemble competent staff to either implement or improve upon a birth 
defects surveillance system and develop programs for prevention or 
improving access to health services and early intervention programs. If 
it is necessary to hire staff to conduct program activities, provide 
plans for identifying and hiring qualified applicants on a timely 
basis. Also, provide plans for how work on program activities will be 
conducted prior to hiring necessary staff.
    c. To the extent possible, the applicant shall identify all current 
and potential personnel who will work on this cooperative agreement 
including qualifications and specific experience as it relates to the 
requirements set forth in this announcement.
    6. Human Subjects Review (not scored):
    Does the application adequately address the requirements of Title 
45 CFR Part 46 for the protection of human subjects? (Not scored; 
however, an application can be disapproved if the research risks are 
sufficiently serious and protection against risks are so inadequate as 
to make the entire application unacceptable.)
    7. Budget justification and adequacy of facilities (not scored):
    The budget will be evaluated for the extent to which it is 
reasonable, clearly justified, and consistent with the intended use of 
the cooperative agreement funds. The applicant shall describe and 
indicate the availability of

[[Page 53800]]

facilities and equipment necessary to carry out this project.

H. Other Requirements

Technical Reporting Requirements

    Provide CDC with original plus two copies of:
    1. Semiannual progress reports;
    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 
the ``Where to Obtain Additional Information'' section of this 
announcement.
    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

I. Authority and Catalog of Federal Domestic Assistance Number

    This program is authorized under sections 301(a), 311 and 371 (C) 
of the Public Health Service Act [42 U.S.C. 241(a), 243, and 247 (b-
4)], as amended. The Catalog of Federal Domestic Assistance number is 
93.283.

J. Where To Obtain Additional Information

    This and other CDC announcements can be found on the CDC home page 
Internet address http://www.cdc.gov. Click on ``Funding'' then ``Grants 
and Cooperative Agreements.''
    If you have questions after reviewing the contents of all the 
documents, business management technical assistance may be obtained 
from:
    Virginia Hall-Broadnax, Grants Management Specialist, Grants 
Management Branch, Procurement and Grants Office, Centers for Disease 
Control and Prevention, Announcement 02011, 2920 Brandywine Road, Room 
3000, Atlanta, GA 30341-4146, Telephone: (770) 488-2761, E-mail 
address: [email protected].
    Programmatic technical assistance may be obtained from:
    Larry D. Edmonds or Amanda S. Brown, National Center on Birth 
Defects and Developmental Disabilities, Centers for Disease Control and 
Prevention, 4770 Buford Highway N.E., Atlanta, GA 30341-3724, 
Telephone: (770) 488-7171, E-mail address: [email protected] or 
[email protected].

    Dated: October 18, 2001.
Rebecca B. O'Kelley,
Acting Director, Procurement and Grants Office, Centers for Disease 
Control and Prevention (CDC).
[FR Doc. 01-26743 Filed 10-23-01; 8:45 am]
BILLING CODE 4163-18-P