[Federal Register Volume 69, Number 168 (Tuesday, August 31, 2004)]
[Notices]
[Pages 53071-53077]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-19799]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Population-Based Birth Defects Surveillance Programs and the 
Utilization of Surveillance Data by Public Health Programs

    Announcement Type: New.
    Funding Opportunity Number: RFA 05009.
    Catalog of Federal Domestic Assistance Number: 93.283.
    Key Dates:
    Letter of Intent Deadline: September 27, 2004.
    Application Deadline: October 20, 2004.

I. Funding Opportunity Description

    Authority: This program is authorized under sections 311, 
317(k)(2), and 317(C) of the Public Health Service Act [42 U.S.C. 
243, 247(k)(2), and 247b-4], as amended.


[[Page 53072]]


    Purpose: The purpose of this 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. This program addresses the ``Healthy 
People 2010'' focus area of Maternal, Infant, and Child Health.
    Measurable outcomes of the program will be in alignment with the 
following performance goal for the National Center on Birth Defects and 
Developmental Disabilities (NCBDDD):
     Increase the number of United States births covered by 
birth defects monitoring programs which use these data to plan services 
for children and evaluate prevention strategies.
    Applicants may apply under one of two categories: Category 1--
States/territories/tribes with nonexistent or less than three year old 
birth defects surveillance systems; or Category 2--States/territories/
tribes with ongoing surveillance systems.
    This announcement is only for non-research activities supported by 
CDC/ATSDR. If research is proposed, the application will not be 
reviewed. For the definition of research, please see the CDC Web site 
at the following Internet address: http://www.cdc.gov/od/ads/opspolll.htm.
    Activities: Awardee activities for this program are as follows: 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 nonexistent or less than three year old 
birth defects surveillance systems; or (2) Recipient activities for 
States with ongoing surveillance systems. CDC will be responsible for 
the activities under (3) CDC activities.
    (1) Recipient Activities for States with nonexistent or less than 
three year old 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, 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 and recurrence 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 and recurrence 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) In a cooperative agreement, CDC staff is substantially involved 
in the program activities, above and beyond routine grant monitoring. 
CDC Activities for this program are as follows:
    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.

II. Award Information

    Type of Award: Cooperative Agreement. CDC involvement in this 
program is listed in the Activities Section above.
    Fiscal Year Funds: 2005.
    Approximate Total Funding: $2,500,000 (This amount is an estimate, 
and subject to the availability of funds.)
    Approximate Number of Awards: Fifteen; Two--Eight Category 1 awards 
and Six--Fourteen Category 2 awards.
    Approximate Average Award: $120,000 for Category 1 awards and 
$190,000 for Category 2 awards (This amount is for the first 12-month 
budget period, and includes both direct and indirect costs.)
    Floor of Award Range: $100,000 for Category 1 awards and $150,000 
for Category 2 awards.
    Ceiling of Award Range: $140,000 for Category 1 awards and $220,000 
for Category 2 awards (This ceiling is for the first 12 month budget 
period.)
    Anticipated Award Date: March 1, 2005.
    Budget Period Length: Twelve months.
    Project Period Length: Five years; 3/1/05-2/28/10. Throughout the 
project

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period, CDC's commitment to continuation of awards will be conditioned 
on the availability of funds, evidence of satisfactory progress by the 
recipient (as documented in required reports), and the determination 
that continued funding is in the best interest of the Federal 
Government.

III. Eligibility Information

III.1. Eligible Applicants

    Applications may be submitted by governments and their agencies, 
such as:
     Federally recognized Indian tribal governments
     Indian tribes
     Indian tribal organizations
     State governments or their Bona Fide Agents (this includes 
the District of Columbia, the Virgin Islands, the Commonwealth of the 
Northern Marianna Islands, American Samoa, Guam, the Federated States 
of Micronesia, the Republic of the Marshall Islands, and the Republic 
of Palau)
    A Bona Fide Agent is an agency/organization identified by the state 
as eligible to submit an application under the state eligibility in 
lieu of a state application. If you are applying as a bona fide agent 
of a state government, you must provide a letter from the state as 
documentation of your status. Place this documentation behind the first 
page of your application form. Applications that fail to submit the 
evidence requested above will be considered non-responsive and returned 
without review.

III.2. Cost Sharing or Matching

    Matching funds are not required for this program. Applicants are 
encouraged to list other sources of funding such as state funds, in-
kind funds, partner funds, etc. that will be used to support this 
program announcement's activities.

III.3. Other

    Special Requirements: If your application is incomplete or non-
responsive to the special requirements listed in this section, it will 
not be entered into the review process. You will be notified that your 
application did not meet the submission requirements.
     If you request a funding amount greater than the ceiling 
of the award range, your application will be considered non-responsive.
     Late applications will be considered non-responsive. See 
section ``IV.3. Submission Dates and Times'' for more information on 
deadlines.
     If you are applying as a bona fide agent of a state 
government, you must provide a letter from the state as documentation 
of your status. Place this documentation behind the first page of your 
application form. Applications that fail to submit the evidence 
requested above will be considered non-responsive.
     Recipients funded under CDC Program Announcement 03019 
(Population-Based Birth Defect Surveillance Programs and the 
Utilization of Surveillance Data by 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 Web site, for 
a list of the States currently funded under these program 
announcements. The eligible States are: Alabama, Alaska, Colorado, 
Connecticut, Delaware, District of Columbia, Georgia, Hawaii, Idaho, 
Indiana, Kansas, Kentucky, Louisiana, Maine, Maryland, Michigan, 
Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New 
Hampshire, New Mexico, North Dakota, Oklahoma, Oregon, Pennsylvania, 
Rhode Island, South Carolina, South Dakota, Tennessee, Virginia, 
Washington, West Virginia, Wisconsin, and Wyoming.

    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.

IV. Application and Submission Information

IV.1. Address To Request Application Package

    To apply for this funding opportunity use application form PHS 
5161. Application forms and instructions are available on the CDC Web 
site, 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 
(PGO-TIM) staff at: 770-488-2700. Application forms can be mailed to 
you.

IV.2. Content and Form of Submission

    Letter of Intent (LOI): Your LOI must be written in the following 
format:
     Maximum number of pages: two
     Font size: 12-point unreduced
     Single spaced
     Paper size: 8.5 by 11 inches
     Page margin size: One inch
     Printed only on one side of page
     Written in English, avoid jargon
    Your LOI must contain the following information:
    1. This program announcement number.
    2. Applicant's legal name and address.
    3. Principal Investigator's name, address, telephone number, and e-
mail address.
    4. Identification of which category applicant is submitting.
    5. A brief description of the number of state-wide births and 
current birth defects surveillance system.
    6. A brief description of the planned statement of work.
    Application: This program announcement is the definitive guide on 
application format, content, and deadlines. It supersedes information 
provided in the application instructions. If there are discrepancies 
between the application form instructions and the program announcement, 
adhere to the guidance in the program announcement.
    You must include a project narrative with your application forms. 
Your narrative must be submitted in the following format:
     Maximum number of pages: 30. If your narrative exceeds the 
page limit, only the first pages which are within the page limit will 
be reviewed.
     Font size: 12 point unreduced
     Paper size: 8.5 by 11 inches
     Page margin size: One inch
     Printed only on one side of page
     Held together only by rubber bands or metal clips; not 
bound in any other way.
    The applicant should provide a detailed description of first-year 
activities and briefly describe future-year objectives and activities. 
Your narrative should address activities to be conducted over the 
entire project period. Your application must include the following 
items in the order listed:
    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

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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 30 double-spaced 
pages, printed on one side, with one-inch margins, and unreduced font 
(12-point). The required detailed budget, detailed budget 
justification, and appendices 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 Improving Access to Health Services 
and Early Intervention Programs.
    b. Use of Surveillance Data for Prevention Activities.
    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 detailed budget and budget justifications for 
each subcontractor/subawardee.
    Additional information may be included in the application 
appendices. The appendices will not be counted toward the narrative 30-
page limit. This additional information can include:
     Birth surveillance legislation
     Most current calendar year birth surveillance data
     International Classification of Diseases codes
     Percent coverage of births
     Memorandums with neighboring states
     Folic acid educational materials
     Curriculum Vitaes/Resumes
     Organizational Charts
     Letters of Support
     Subcontractor/Subawardee budget justification
     Scientific articles and publications
    You are required to have a Dun and Bradstreet Data Universal 
Numbering System (DUNS) number to apply for a grant or cooperative 
agreement from the Federal government. The DUNS number is a nine-digit 
identification number, which uniquely identifies business entities. 
Obtaining a DUNS number is easy and there is no charge. To obtain a 
DUNS number, access http://www.dunandbradstreet.com or call 1-866-705-
5711.
    For more information, see the CDC Web site at: http://www.cdc.gov/od/pgo/funding/pubcommt.htm. If your application form does not have a 
DUNS number field, please write your DUNS number at the top of the 
first page of your application, and/or include your DUNS number in your 
application cover letter.
    Additional requirements that may require you to submit additional 
documentation with your application are listed in section ``VI.2. 
Administrative and National Policy Requirements.''

IV.3. Submission Dates and Times

    LOI Deadline Date: September 27, 2004.
    CDC requests that you send a LOI if you intend to apply for this 
program. Although the LOI is not required, not binding, and does not 
enter into the review of your subsequent application, the LOI will be 
used to gauge the level of interest in this program, and to allow CDC 
to plan the application review.
    Application Deadline Date: October 20, 2004.
    Explanation of Deadlines: Applications must be received in the CDC 
Procurement and Grants Office by 4:00 p.m. Eastern Time on the deadline 
date. If you send your application by the United States Postal Service 
or commercial delivery service, you must ensure that the carrier will 
be able to guarantee delivery of the application by the closing date 
and time. If CDC receives your application 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, you will be given the opportunity to 
submit documentation of the carriers guarantee. If the documentation 
verifies a carrier problem, CDC will consider the application as having 
been received by the deadline.
    This program announcement is the definitive guide on application 
format, content, and deadlines. It supersedes information provided in 
the application instructions. If your application does not meet the 
deadline above, it will not be eligible for review, and will be 
discarded. You will be notified that your application did not meet the 
submission requirements.
    CDC will not notify you upon receipt of your application. If you 
have a question about the receipt of your LOI or application, first 
contact your courier. If you still have a question, contact the PGO-TIM 
staff at: 770-488-2700. Before calling, please wait two to three days 
after the application deadline. This will allow time for applications 
to be processed and logged.

IV.4. Intergovernmental Review of Applications

    Your application is subject to Intergovernmental Review of Federal 
Programs, as governed by Executive Order (EO) 12372. This order sets up 
a system for state and local governmental review of proposed federal 
assistance applications. You should contact your state single point of 
contact (SPOC) as early as possible to alert the SPOC to prospective 
applications, and to receive instructions on your state's process. 
Click on the following link to get the current SPOC list: http://www.whitehouse.gov/omb/grants/spoc.html.

IV.5. Funding Restrictions

    Restrictions, which must be taken into account while writing your 
budget are as follows:
     Funds may not be used for research.
     Reimbursement of preaward costs is not allowed.
     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.
    If you are requesting indirect costs in your budget, you must 
include a copy of your indirect cost rate agreement. If your indirect 
cost rate is a provisional rate, the agreement should be less than 12 
months of age.
    Guidance for completing your budget can be found on the CDC Web 
site, at the following Internet address: http://www.cdc.gov/od/pgo/funding/budgetguide.htm.

IV.6. Other Submission Requirements

    LOI Submission Address: Submit your LOI by mail, express delivery 
service, fax, or E-mail to: (Regular Mail) Bill Paradies, CDC, NCBDDD, 
1600 Clifton Road, M/S E-86, Atlanta, GA 30333, Telephone: 
404.498.3919, Fax: 404.498.3040 or 3550. (Direct/Overnight) Bill 
Paradies, CDC, NCBDDD, 12 Executive Park Drive, Atlanta, GA 30329. E-
mail: [email protected].

[[Page 53075]]

    Application Submission Address: Submit the original and two hard 
copies of your application by mail or express delivery service to: 
Technical Information Management-RFA 05009, CDC Procurement 
and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341.
    Applications may not be submitted electronically at this time.

V. Application Review Information

V.1. 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 stated in the ``Purpose'' section 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.
    Your application will be evaluated against the following criteria:
    1. Use of surveillance data for improving access to health services 
and early intervention programs (30 points): The feasibility of the 
applicant's 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 nonexistent or 
less than 3 year old 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) Evaluate the effectiveness of the referral services and the 
outcomes of children and families who receive services.
    2. Use of the surveillance data for prevention activities (25 
points): The applicant's feasibility and completeness of 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 nonexistent or 
less than 3 year old 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.
    3. Impact on population-based birth defects surveillance (25 
points): The accuracy and completeness of the applicant's description 
of 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 nonexistent or 
less than 3 year old 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 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.

[[Page 53076]]

    4. Organizational and program personnel capability (15 points):
    a. Whether the applicant has the appropriate 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. 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 adequacy of the applicant's description of a 
clear, concise understanding of the requirements, objectives, and 
purpose of the cooperative agreement. This application shall reflect 
the applicant's 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.

V.2. Review and Selection Process

    Applications will be reviewed for completeness by the Procurement 
and Grants Office staff and for responsiveness by the National Center 
on Birth Defects and Developmental Disabilities. Incomplete 
applications and applications that are non-responsive to the 
eligibility criteria will not advance through the review process. 
Applicants will be notified that their application did not meet 
submission requirements. An objective review panel will evaluate 
complete and responsive applications according to the criteria listed 
in the ``V.1. Criteria'' section above. The objective review panel will 
consist of CDC employees who will be randomly assigned applications to 
review and score. Category 1 and Category 2 applications will be funded 
respectively in order by score and rank as determined by the review 
panel. CDC will provide justification for any decision to fund out of 
rank order.

V.3. Anticipated Award Date

    February 2005 for a March 1, 2005 project start date.

VI. Award Administration Information

VI.1. Award Notices

    Successful applicants will receive a Notice of Grant Award (NGA) 
from the CDC Procurement and Grants Office. The NGA shall be the only 
binding, authorizing document between the recipient and CDC. The NGA 
will be signed by an authorized Grants Management Officer, and mailed 
to the recipient fiscal officer identified in the application.
    Unsuccessful applicants will receive notification of the results of 
the application review by mail.

VI.2. Administrative and National Policy Requirements

45 CFR Parts 74 and 92
    For more information on the Code of Federal Regulations, see the 
National Archives and Records Administration at the following Internet 
address: http://www.access.gpo.gov/nara/cfr/cfr-table-search.html.
    The following additional requirements apply to this project:

 AR-7 Executive Order 12372
 AR-9 Paperwork Reduction Act Requirements
 AR-10 Smoke-Free Workplace Requirements
 AR-11 Healthy People 2010
 AR-12 Lobbying Restrictions
 AR-24 Health Insurance Portability and Accountability Act 
Requirements

    Additional information on these requirements can be found on the 
CDC Web site at the following Internet address: http://www.cdc.gov/od/pgo/funding/ARs.htm.

VI.3. Reporting Requirements

    You must provide CDC with an original, plus two copies of the 
following reports:
    1. Interim progress report, no less than 90 days before the end of 
the budget period. The progress report will serve as your non-competing 
continuation application, and must contain the following elements:
    a. Current Budget Period Activities Objectives.
    b. Current Budget Period Financial Progress.
    c. New Budget Period Program Proposed Activity Objectives.
    d. Detailed Line-Item Budget and Justification.
    e. Measures of Effectiveness.
    f. Additional Requested Information.
    2. Financial status report and annual progress 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.
    These reports must be mailed to the Grants Management or Contract 
Specialist listed in the ``Agency Contacts'' section of this 
announcement.

VII. Agency Contacts

    We encourage inquiries concerning this announcement. For general 
questions about this announcement, contact: Technical Information 
Management Section, CDC Procurement and Grants Office, 2920 Brandywine 
Road, Atlanta, GA 30341, Telephone: 770-488-2700.
    For program technical assistance, contact: Cara Mai/Bill Paradies, 
Project Officers, 1600 Clifton Road, Mailstop E-86, Atlanta, GA 30333, 
Telephone: 404-498-3918/3919, Fax: 404-498-3040 or 3550, E-mail: 
[email protected] and [email protected].
    For financial, grants management, or budget assistance, contact: 
Susan B. Kiddoo, Grants Management Officer, CDC Procurement and Grants 
Office, 2920 Brandywine Road, Room 3000, Atlanta, GA 30341, Telephone: 
770-488-2605, Fax: 770-488-2777, E-mail: [email protected].

VIII. Other Information

    This and other CDC funding opportunity announcements can be found 
on the CDC Web site, Internet address http://www.cdc.gov. Click on 
``Funding'' then ``Grants and Cooperative Agreements.''


[[Page 53077]]


    Dated: August 25, 2004.
William P. Nichols,
Acting Director, Procurement and Grants Office, Centers for Disease 
Control and Prevention.
[FR Doc. 04-19799 Filed 8-30-04; 8:45 am]
BILLING CODE 4163-18-P