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Cooperative Agreements for the Centers for Birth Defects Research and Prevention; Notice of Availability of Funds

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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 Start Printed Page 16401birth 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 Start Printed Page 16402two, 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 Start Printed Page 16403

(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; Start Printed 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: slh3@cdc.gov.

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: lde2@cdc.gov.

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Dated: April 1, 2002.

Sandra R. Manning,

CGFM, Director, Procurement and Grants Office, Centers for Disease Control and Prevention.

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[FR Doc. 02-8226 Filed 4-4-02; 8:45 am]

BILLING CODE 4163-18-P