[Federal Register Volume 67, Number 66 (Friday, April 5, 2002)]
[Notices]
[Pages 16400-16404]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-8226]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement 02081]


Cooperative Agreements for the Centers for Birth Defects Research 
and Prevention; 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 state based Centers for Birth Defects Research and 
Prevention (CBDRP). 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 enhancement and/
or expansion of population-based birth defects surveillance systems; 
(2) the development and expansion of the epidemiological research 
capability of the state CBDRP; (3) the participation of the state 
CBDRPs in the National Birth Defects Prevention Study (NBDPS); and (4) 
the utilization, implementation, and evaluation of the surveillance 
data for local and collaborative studies into birth defects research 
including environmental exposures, gene-gene interactions, and gene-
environment interactions. Quantifiable and measurable outcomes of the 
cooperative agreement will be measured against the ``Government 
Performance Results Act'' performance goal to find causes and risk 
factors for birth defects in order to develop prevention strategies.

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.
    Current awardees funded under Program Announcement (PA) 96043 are 
also eligible. To be considered eligible, applicants should have 
ongoing access to data generated from a state-based

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birth defects surveillance (ascertainment) program based on a 
population of not less than 35,000 live births per year within the 
State or defined region. The surveillance data will provide the source 
of the birth defect research cases from one or two defined regions, 
preferably contiguous geographic areas, with a minimum of 35,000 live 
births and a maximum of 75,000 live births. Applicants should not 
utilize sampling as a means of including a larger geographic area (e.g. 
should not select a sample of cases from an area with 100,000 live 
births.) Applicants should also have a suitable source for obtaining 
controls from the same population from which cases are derived. 
Applicants should have the capability of contributing approximately 400 
interviews (300 cases and 100 controls) per year to the NBDPS. 
Additionally, the applicant must provide a letter from the appropriate 
State health agency designating the applicant as a bona fide agent if 
applicable. This information should be placed directly behind the face 
page of the application. Applications that fail to submit the evidence 
requested above will be considered non-responsive and returned without 
review.

    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 $6,500,000 is available in FY 2002 to fund seven to 
nine awards. It is expected that the awards will range from $750,000 to 
$1,000,000 with the average award around $900,000. The awards will 
begin on or about September 1, 2002, 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.

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 the activities under 2. CDC 
Activities.
1. Recipient Activities
    a. Develop and implement methods and approaches which will improve 
or expand the capacity of the applicant's existing surveillance system 
to ascertain cases and generate timely population-based data of birth 
defects including, if possible, the integration of prenatal diagnoses 
into the birth defects registry. Make any necessary modifications to 
the birth defect surveillance system to comply with NBDPS case 
definitions. The NBDPS case definitions and other information developed 
by the current grantees may be obtained from the programmatic technical 
assistance point-of-contact in the ``Where to Obtain Additional 
Information'' section.
    b. Analyze and disseminate the surveillance data generated by the 
surveillance system on an annual basis including rates and trends of 
major birth defects to any interested parties.
    c. Evaluate the surveillance methodology used including, but not 
limited to such factors as improvement or expansion of case 
ascertainment, improvement in timeliness, etc.
    d. Develop the epidemiological research capability, including 
infrastructure, of each CBDRP to support future birth defects research.
    e. Develop and implement local studies. Examples of local study 
topics include but are not limited to the following:
    (1) An evaluation of the methods related to the primary prevention 
of birth defects;
    (2) An evaluation of the potential teratogenicity of drugs related 
to the possible causes of birth defects;
    (3) An evaluation of the potential environmental causes of birth 
defects;
    (4) An evaluation of the genetic factors influencing the occurrence 
of birth defects;
    (5) An evaluation of the behavioral causes of birth defects;
    (6) An evaluation of effects of twinning and multiple birth 
pregnancies;
    (7) An evaluation of the medical and other costs associated with 
birth defects; and
    (8) An evaluation of the costs associated with birth defects 
prevention programs and estimated human and fiscal savings.
    f. As part of the NBDPS, conduct approximately 400 maternal 
interviews (300 cases and 100 controls) per year using the 
collaboratively agreed-upon computer-assisted-telephone-interview 
(CATI) questionnaire. Contribute the data to the NBDPS collaborative 
study for inclusion in the combined Centers database for dissemination 
to all Centers. The NBDPS methods and protocols should be 
collaboratively agreed-upon by all of the cooperative agreement 
awardees. The awardees should use all of the agreed-upon methods and 
protocols including the CATI, clinical, and biologics database formats 
to input, maintain, and backup all data in the NBDPS databases. Use the 
NBDPS databases for birth defects research. Use generally accepted 
epidemiological methods to evaluate and publish the results in peer-
reviewed journals.
    g. As part of NBDPS, obtain buccal samples or other biologics, as 
agreed-upon or specified in the future, from the case and control 
infants and their parents. In a timely manner, send half of the 
collected genetic material from each subject (mother, father, infant) 
to a central facility for long-term storage. Demonstrate quality 
control/quality assurance by participating in NBDPS exercises to 
evaluate each laboratory. Utilize the genetic material for birth 
defects research. Analyze and publish the results in peer-reviewed 
journals.
2. CDC Activities
    a. Participate in designing, developing, and evaluating 
methodologies and approaches used for population-based birth defects 
surveillance.
    b. Participate in the collection, management, and analysis of 
surveillance data related to birth defects.
    c. Participate with the quality assurance/quality control exercises 
of each applicant's laboratory.
    d. Participate in the development, implementation, and conduct of 
study protocol.
    e. Participate in the sharing of information between the Centers 
such as abstract format, telephone interview, clinical, and biologic 
databases, potential research issues, etc.
    f. Serve as a resource for sharing State, regional, and national 
data and information pertinent to the surveillance, research, 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

[[Page 16402]]

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 e-mail address; a brief description 
of the number of births in the defined geographic region and the 
current birth defect surveillance system; on-going or proposed birth 
defect research topics; and a brief description of the planned 
cooperative agreement activities.

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 with the Principal 
Investigator and business office representative signatures.
    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 briefly 
summarize the goals and 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 35 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 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. Organizational and Program Personnel Capability;
    d. Utilizing Surveillance Data for Birth Defects Research--
Participation in NBDPS;
    e. Utilizing Surveillance Data for Birth Defects Research--Local 
Studies; 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. Please provide a copy of the 
appropriate indirect rate agreement letter or cost allocation plan.

F. Submission and Deadline

Letter of Intent (LOI)

    On or before May 6, 2002, submit the LOI to the official 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 at the following Internet address: 
www.cdc.gov/od/pgo/forminfo.htm.
    On or before June 4, 2002, 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

    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 ``A. Purpose'' of 
this announcement. Measures must be objective/quantitative and must 
measure the intended outcome. These Measures of Effectiveness shall be 
submitted with the application and shall be an element of evaluation.
    Each application will be evaluated individually against the 
following criteria by an independent review group appointed by CDC. For 
the cooperative agreement awards under PA 02081, these evaluation 
criteria will be used as performance measures to evaluate grantee 
progress in the semiannual progress reports and the future budget year 
continuation awards.
    1. Applicant's Understanding of the Public Health Impact of Birth 
Defects (5 points):
    a. The extent to which the applicant has a clear, concise 
understanding of the requirements, objectives, and purpose of the 
cooperative agreement.
    b. The extent to which the application reflects an understanding of 
the public health impact of birth defects in their State, the purpose 
and complexities of birth defects surveillance as it relates to their 
State, and the importance of birth defect research.
    2. Impact on Population-Based Birth Defects Surveillance (15 
points):
    The extent to which the applicant describes the anticipated level 
of impact that this cooperative agreement will have on birth defects 
surveillance activities in the State. This includes:
    a. Ability to improve/expand population-based birth defects 
surveillance;
    b. Methods and assessment of the completeness of case 
ascertainment;
    c. Timeliness of case ascertainment including information on any 
changes in timeliness in recent years or plans to improve timeliness;
    d. Describe the level of coverage of the population;
    e. Specific birth defects ascertained including the ability to 
comply with the standard NBDPS case definitions for all birth defects 
included in the study;
    f. Analyzing and reporting surveillance data to appropriate State, 
local, and federal health officials;
    g. Evaluating the surveillance methodology and quality of the 
surveillance data; and
    h. 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:
    (1) The proposed plan for the inclusion of both sexes and racial 
and ethnic minority populations for appropriate representation;
    (2) The proposed justification when representation is limited or 
absent;
    (3) A statement as to whether the design of the study is adequate 
to measure differences when warranted; and

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    (4) 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. Organizational and Program Personnel Capability (25 points):
    a. The extent to which the applicant has the experience, skills, 
and ability to improve birth defects surveillance and use surveillance 
data for birth defects research.
    b. The adequacy of the present staff and/or the capability to 
assemble competent staff to improve upon a birth defects surveillance 
system, and conduct birth defects research. Existing grantees under PA 
96043 should demonstrate how their epidemiological research capability 
increased over the PA 96043 project period. If it is necessary for new 
applicants or existing grantees under PA 96043 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 the 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. The resumes/curricula 
vitae of key personnel such as the Principal Investigator, Study 
Coordinator, Clinical Geneticist, Epidemiologists, Biologics personnel, 
Information Technology personnel, etc. should be included in the 
application.
    4. Utilizing Surveillance Data for Birth Defects Research--
Participation in NBDPS (35 points).
    The evaluation criteria is different for a new applicant and an 
applicant with an award under PA 96043.
    a. Evaluation Criteria--New Applicant: The extent to which the 
applicant describes their:
    (1) Ability to identify birth defects research topics, conduct 
epidemiological studies, and publish the findings;
    (2) Ability to collaborate on research projects;
    (3) Ability to prepare human subjects protocol and obtain and 
maintain Institutional Review Board approval;
    (4) Ability to participate in ongoing activities that include 
interviews, clinical, and biologics data collection;
    (5) Ability to maintain, update, and send data in a timely manner 
to a central, off-site location;
    (6) Ability to perform timely interviews of cases and controls;
    (7) Ability to adhere to the NBDPS biologics protocol and the 
ability to perform timely processing and quality assurance/quality 
control measures for biologics samples. Meet proficiency standards for 
biologic sample processing;
    (8) Ability to obtain high case and control interview and/or 
biologic participation rates of research projects similar to the one 
listed in this program announcement;
    (9) Ability to comply with the established NBDPS case definitions 
by having available the necessary clinical information and expertise; 
and
    (10) Ability to define a geographic area with 35,000-75,000 live 
births per year for selection of cases and controls.
    b. Evaluation Criteria--Applicant who has an award under PA 96043: 
The extent to which the applicant describes their:
    (1) Ability to identify birth defects research topics, conduct 
epidemiological studies, and publish the findings. List the birth 
defects research letters of intent and proposals submitted for NBDPS 
under PA 96043 with the applicant's Principal Investigator or 
collaborators as a lead investigator;
    (2) Ability to collaborate on research projects under PA 96043 and 
other collaborations;
    (3) Compliance with the approved CDC Institutional Review Board 
(IRB) human subjects protocol (except for protocol changes required by 
local IRBs) and a history of obtaining and maintaining IRB approvals in 
a timely manner;
    (4) Ability to utilize computer-assisted-telephone-interview 
(CATI), clinical, and biologics databases for research, including 
consistently maintaining, updating, and sending data in a timely manner 
to a central, off-site location;
    (5) History of timely interviews of NBDPS cases and controls;
    (6) Ability to adhere to the NBDPS biologics protocol and the 
ability to perform quality assurance/quality control measures and meet 
proficiency standards for biologic sample processing;
    (7) Ability to obtain a minimum case and control interview 
participation rate of 70 percent and a minimum biologic participation 
rate of 50 percent for mothers and infants. Higher participation rates 
are desirable. Demonstrate improvements in the participation rates;
    (8) Consistent participation in PA 96043 working groups, committee 
activities, CATI evaluation, and data sharing activities;
    (9) Compliance with the established NBDPS case definitions and the 
availability of the necessary clinical information and expertise;
    (10) Ability to define a geographic area with 35,000-75,000 live 
births per year for selection of cases and controls; and
    (11) Technological ability, capability, and information technology 
support to consistently utilize the NBDPS standard software, formats, 
timely replication of data, etc.
    5. Utilizing Surveillance Data for Birth Defects Research--Local 
Studies (20 points):
    The evaluation criteria is different for a new applicant and an 
applicant with an award under PA 96043.
    a. Evaluation Criteria--New Applicant: The extent to which the 
applicant describes their:
    (1) Ability to identify birth defects research topics, conduct 
epidemiological studies, and publish the findings. Describe prior 
accomplishments and future plans for local birth defects research;
    (2) Ability to collaborate on research projects;
    (3) Ability to prepare human subjects protocol and obtain 
Institutional Review Board approval;
    (4) Use of birth defects surveillance data to address local areas 
of concern;
    (5) Ability to perform quality assurance/quality control measures 
and meet proficiency standards for biologic sample processing;
    (6) Ability to obtain adequate case and control interview and/or 
biologic participation rates of research projects similar to the one 
listed in this program announcement; and
    (7) Dissemination of local research findings at national scientific 
meetings and in peer-reviewed journals.
    b. Evaluation Criteria--Applicant who has an award under PA 96043: 
The extent to which the applicant describes their:
    (1) Ability to identify birth defects research topics, conduct 
epidemiological studies, and publish the findings. List the local birth 
defects research projects in progress and completed under PA 96043. 
Describe prior accomplishments and future plans for local birth defects 
research;
    (2) Ability to collaborate on research projects under PA 96043 and 
other collaborations;
    (3) Compliance with the approved CDC Institutional Review Board 
(IRB) human subjects protocol (except for protocol changes required by 
local IRBs) and a history of obtaining and maintaining IRB approvals in 
a timely manner;

[[Page 16404]]

    (4) Use of birth defects surveillance data to address local areas 
of concern;
    (5) Ability to perform quality assurance/quality control measures 
and meet proficiency standards for biologic sample processing; and
    (6) Dissemination of local research findings at national scientific 
meetings and in peer-reviewed journals.
    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.

H. Other Requirements

Technical Reporting Requirements

    Provide CDC with original plus two copies of:
    1. Semiannual progress reports which should include:
    a. A brief project description;
    b. A comparison of the actual accomplishments to the goals and 
objectives established for the period;
    c. The progress report will include a data requirement that 
demonstrates measures of effectiveness. In the case that established 
goals and objectives may not be accomplished or are delayed, 
documentation of both the reason for the deviation and the anticipated 
corrective action or a request for deletion of the activity from the 
project;
    d. Other pertinent information, including preliminary findings from 
the analysis of available data.
    e. Financial recap of obligated dollars to date as a percentage of 
total available funds.
    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 I 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 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.

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:
    Sheryl L. Heard, Grants Management Specialist, Acquisition and 
Assistance Branch B, Centers for Disease Control and Prevention, 
Announcement 02081, 2920 Brandywine Road, Room 3000, Atlanta, GA 30341-
4146, Telephone: (770) 488-2723, Email address: [email protected].
    Programmatic technical assistance and copies of NBDPS guideline and 
protocol information may be obtained from:
    Larry D. Edmonds, 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, Email address: [email protected].

    Dated: April 1, 2002.
Sandra R. Manning,
CGFM, Director, Procurement and Grants Office, Centers for Disease 
Control and Prevention.
[FR Doc. 02-8226 Filed 4-4-02; 8:45 am]
BILLING CODE 4163-18-P