[Federal Register Volume 68, Number 46 (Monday, March 10, 2003)]
[Notices]
[Pages 11399-11403]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-5584]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement 03019]


Population-Based Birth Defects Surveillance Programs and the 
Utilization of Surveillance Data by Public Health Programs; Notice of 
Availability of Funds

    Application Deadline: April 30, 2003.

A. Authority and Catalog of Federal Domestic Assistance Number

    This program is authorized under sections 301, 311 and 317(C) of 
the Public Health Service Act (42 U.S.C. 241, 243, and 247b-4), as 
amended. The Catalog of Federal Domestic Assistance number is 93.283.

B. Purpose

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 2003 funds for a cooperative agreement 
program for developing, implementing, and improving state's birth 
defects surveillance data and utilizing the surveillance data by 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 state's population-based 
birth defects surveillance systems; (2) the development and 
implementation of population-based programs to prevent birth defects; 
(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; and (4) the evaluation of the 
effectiveness of the referral activities and the impact on the affected 
children and families.
    Measurable outcomes of the program will be in alignment with one or 
more of the following performance goals for the National Center on 
Birth Defects and Developmental Disabilities:
    [sbull] Improve the data on the prevalence of birth defects and 
developmental disabilities.
    [sbull] Find causes and risk factors for birth defects and 
developmental disabilities in order to develop prevention strategies.

C. Eligible Applicants

    Assistance will be provided only to the health departments of 
States or their bona fide agents, including the Commonwealth of Puerto 
Rico, 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 02011 (Cooperative 
Agreements for the Development and Improvement of Population-Based 
Birth Defect Surveillance Programs and the Integration of Surveillance 
Data with Public Health Programs) and Program Announcement 02081 
(Centers for Birth Defects Research and Prevention) are not eligible. 
See Attachment I, as posted on the CDC website, for a list of the 
States currently funded under these program announcements. 
Additionally, if the applicant is not the State health agency, the 
applicant must provide a letter from the appropriate State health 
agency designating the applicant as a bona fide agent. This information 
should be placed directly behind the cover letter of the application. 
Applications that fail to submit the evidence requested above will be 
considered non-responsive and returned without review.
    The eligible States are: Arizona, Connecticut, Delaware, Florida, 
Georgia, Idaho, Illinois, Kansas, Louisiana, Maryland, Mississippi, 
Nebraska, Nevada, New Jersey, New York, North Dakota, Ohio, Oregon, 
Pennsylvania, Rhode Island, South Dakota, Tennessee, Vermont, 
Washington, Wisconsin, 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 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.

D. Availability of Funds

    Approximately $1,900,000 is available in FY 2003 to fund 
approximately 2-4 awards in Category 1, and 6-10 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 September 1, 2003, 
and will be made for a 12-month budget period within a project period 
of up to five years. Funding estimates may change.
    Continuation awards 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, nor construction.
    Award recipients agree to use cooperative agreement funds for 
travel by project staff selected by CDC to participate in CDC-sponsored 
workshops, or other called meetings such as regional or annual 
meetings.

E. 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 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

[[Page 11400]]

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, including the 
State's organization receiving title V Federal funds, 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 your 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 ongoing surveillance 
systems:
    a. Broaden methodologies and approaches which will improve 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).
    c. Evaluate the surveillance methodology used.
    d. Involve the appropriate additional partners within the State, 
including the State's organization receiving title V Federal funds, 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).
    h. Evaluate the effectiveness of the referral activities and the 
benefit/impact on the affected children and families.
    3. CDC Activities:
    a. Provide technical assistance such as presenting the need, 
benefits, and description of a birth defects surveillance, prevention, 
and intervention program, reviewing draft legislation, etc. to state 
agencies and interested parties.
    b. Assist in designing, developing, and evaluating methodologies 
and approaches used for population-based birth defects surveillance. 
Discuss the advantages and disadvantages of different case 
ascertainment methods.
    c. Assist in analyzing surveillance data related to birth defects.
    d. Assist in designing, developing, and evaluating plans for 
prevention programs.
    e. Assist in designing, developing, and evaluating plans to improve 
the access of children with birth defects to health services and 
intervention programs.
    f. Provide a reference point for sharing regional and national data 
and information pertinent to the surveillance and prevention of birth 
defects.

F. Content

    Letter of Intent (LOI): A LOI is requested for this program. The 
Program Announcement title and number must appear in the LOI. 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 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 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: The Program Announcement title and number must appear 
in the application. 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. Additionally, 
if the applicant is not the State health agency, the applicant must 
provide a letter from the appropriate State health agency designating 
the applicant as a bona fide agent. This information should be placed 
directly behind the cover letter of the application.
    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. Use of Surveillance Data for Prevention Activities.
    b. Use of Surveillance Data for Improving Access to Health Services 
and Early Intervention Programs.
    c. Impact on Population-Based Birth Defects Surveillance.
    d. Organizational and Program Personnel Capability.
    e. Understanding of the Public Health Impact of Birth Defects.
    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. Please provide a copy of the appropriate indirect rate agreement 
letter or cost allocation plan.

[[Page 11401]]

G. Submission and Deadline

    Letter of Intent (LOI) Submission: On or before March 7, 2003, 
submit the LOI to Larry Edmonds, Project Officer, at the address 
designated for programmatic technical assistance identified in the 
``Where to Obtain Additional Information'' section of this 
announcement.
    Application Forms: Submit the original and two copies of PHS 5161-1 
(OMB Number 0937-0189). Forms are available at the following Internet 
address: http://www.cdc.gov/od/pgo/forminfo.htm. If you do not have 
access to the internet, or if you have difficulty accessing the forms 
on-line, you may contact the CDC Procurement and Grants Office 
Technical Information Management Section at telephone number (770) 488-
2700. Application forms can be mailed to you.
    Submission Date, Time, and Address: The application must be 
received by 4 p.m. eastern time on April 30, 2003. Submit the 
application to: Technical Information Management--PA 03019, 
Procurement and Grants Office, Centers for Disease Control and 
Prevention, 2920 Brandywine Rd., Room 3000, Atlanta, GA 30341-4146.
    Applications may not be submitted electronically.
    CDC Acknowledgment of Application Receipt: A postcard will be 
mailed by PGO-TIM, notifying you that CDC has received your 
application.
    Deadline: Letters of intent and applications will be considered as 
meeting the deadline if they are received before 4 p.m. eastern time on 
the deadline date. Applicants sending applications by the United States 
Postal Service or commercial delivery services must ensure that the 
carrier will be able to guarantee delivery of the application by the 
closing date and time. If an application is received after closing due 
to: (1) carrier error (when the carrier accepted the package with a 
guarantee for delivery by the closing date and time) or (2) significant 
weather delays or natural disasters, CDC will upon receipt of proper 
documentation, consider the application as having been received by the 
deadline.
    Applications which do not meet the above criteria will not be 
eligible for competition and will be discarded. Applicants will be 
notified of their failure to meet the submission requirements.

H. Evaluation Criteria

    Applicants are required to provide measures of effectiveness that 
will demonstrate the accomplishment of the various identified 
objectives of the cooperative agreement. Measures of effectiveness must 
relate to the performance goals as stated in section ``B. Purpose'' of 
this announcement. Measures must be objective and quantitative and must 
measure the intended outcome. These measures of effectiveness must be 
submitted with the application and will be an element of evaluation.
    An independent review group appointed by CDC will evaluate each 
application against the applicant's response to either item 1. or 2. in 
the ``Program Requirements'' section.
    1. 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).
    (2) Plan for using the surveillance data to develop prevention 
programs.
    (3) 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.
    (4) Letter from the State's organization receiving title V Federal 
funds that describe the data linkages and other collaborative 
activities with the applicant.
    b. Evaluation criteria for Category 2 (States with 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.
    (3) Sharing the surveillance data (e.g., personal identifiers and 
contact information) with programs or agencies so that children or 
families are enrolled in prevention programs.
    (4) Evaluation of progress made in the prevention of birth defects.
    (5) Letter from the State's organization receiving title V Federal 
funds that describe the data linkages and other collaborative 
activities with the applicant.
    2. 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.
    (3) Plan to evaluate the implementation process.
    b. Evaluation criteria for Category 2 (States with 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.
    (3) Plan for evaluating the effectiveness of the referral services 
and the outcomes of children and families who receive services.
    3. 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.
    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.
    (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

[[Page 11402]]

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 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.
    (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.
    4. 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.
    5. 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.
    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 facilities and equipment necessary to 
carry out this project.

I. Other Requirements

Technical Reporting Requirements

    Provide CDC with original plus two copies of:
    1. Interim progress report, no less than 90 days before the end of 
the budget period. The interim progress report will serve as your non-
competing continuation application and must include the following 
elements:
    a. Current Budget Period Activities Objectives.
    b. Current Budget Period Financial Progress.
    c. New Budget Period Proposed Activity Objectives.
    d. Detailed Line-Item Budget and Justification.
    e. Additional Requested Information.
    2. Financial status report, no more than 90 days after the end of 
the budget period.
    3. Final financial 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 of the 
program announcement as posted on the CDC website.

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

J. Where To Obtain Additional Information

    This and other CDC announcements, the necessary applications, and 
associated forms can be found on the CDC website, Internet address 
http://www.cdc.gov. Click on ``Funding'' then ``Grants and Cooperative 
Agreements.''
    For general questions about this announcement, contact: Technical 
Information Management, CDC Procurement and Grants Office, 2920 
Brandywine Rd., Room 3000, Atlanta, GA 30341-4146. Telephone: 770-488-
2700.
    For business management and budget assistance, contact: Sheryl L. 
Heard, Grants Management Specialist, Procurement and Grants Office, 
Centers for Disease Control and Prevention, Announcement 03019, 2920 
Brandywine Road, Atlanta, GA 30341-4146. Telephone: (770) 488-2723. E-
mail address: [email protected].
    For business management and budget assistance in the territories, 
contact: Charlotte Flitcraft, Grants Management Officer, CDC 
Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341-
4146. Telephone: (770) 488-2632. E-mail address: [email protected].
    For program technical assistance, contact: Larry D. Edmonds, 
Project Officer, National Center on Birth Defects and Developmental 
Disabilities, Centers for Disease Control and Prevention, 4770 Buford 
Highway, NE., Atlanta, GA 30341-3724. Telephone: (770) 488-7171. E-mail 
address: [email protected].


[[Page 11403]]


    Dated: March 3, 2003.
Sandra R. Manning,
CGFM, Director, Procurement and Grants Office, Centers for Disease 
Control and Prevention.
[FR Doc. 03-5584 Filed 3-7-03; 8:45 am]
BILLING CODE 4163-18-P