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Fragile X Syndrome Cascade Testing and Genetic Counseling Protocols

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Announcement Type: New.

Funding Opportunity Number: AA097.

Catalog of Federal Domestic Assistance Number: 93.283.

Key Dates: Letter of Intent (LOI) Deadline: July 28, 2005.

Application Deadline: August 17, 2005.

I. Funding Opportunity Description

Authority: 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].

Purpose: The purpose of the program is to develop and disseminate cascade testing and genetic counseling protocols for conditions related to changes in the Fragile X Mental Retardation 1 (FMR-1) gene, including Fragile X syndrome, Fragile X-associated Tremor/Ataxia Syndrome (FXTAS), and premature ovarian insufficiency and related fertility problems. 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 one (or more) of the following performance goal(s) for the National Center on Birth Defects and Developmental Disabilities (NCBDDD): Prevent birth defects and developmental disabilities, and improve the health and quality of life of Americans with disabilities.

This announcement is only for non-research activities supported by CDC. 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/​opspoll1.htm.

Activities

  • Using literature review and expert opinion, identify key issues related to cascade testing and genetic counseling for FMR-1 genetic testing.
  • Develop protocols for cascade testing of family members of people identified with a mutation in the FMR-1 gene, including people with mental retardation or developmental delays, males with FXTAS, and females with premature ovarian insufficiency and related fertility problems.
  • Develop protocols for genetic counseling to be used in conjunction with genetic testing for FMR-1 mutations. Protocols will include issues related to the likelihood of repeat allele expansion, impact of mosaicism, and prevalence of mental retardation and developmental delay among individuals with intermediate repeat alleles, premutations or full mutations.
  • Ensure that the protocols address the key issues identified by literature review and expert opinion.
  • Ensure that the protocols are appropriate for consumer needs and scientifically valid.
  • Disseminate protocols to key stakeholders, including pediatricians, family practitioners, obstetricians, gynecologists, neurologists, nurses, clinical geneticists, genetic counselors, and parents.
  • Develop a carefully designed and well-planned evaluation plan to monitor progress on activities and to assess the timeliness, completeness, and success of the project (applicants are encouraged to review the Morbidity and Mortality Weekly Report (MMWR) Recommendations and Reports “Framework for Program Evaluation in Public Health” September 17, 199/50 (RR13); 1-35 available at http://www.cdc.gov/​mmwr/​PDF/​RR/​RR4811.pdf). The plan should be based on a clear rational relating the activities within the cooperative agreement, projects goals, and evaluation measures. Applicants are encouraged to include evaluation plans for both outputs (for Start Printed Page 41228example, number of practitioners reached) and outcomes (for example, changes in genetic testing practices).

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:

  • Assist recipients in monitoring program evaluation/performance, setting and meeting objectives, implementing methods, and complying with cooperative agreement requirements and other funding issues, through various methods including telephone consultation, site visits, and site visit reports.
  • Assist recipients in developing and maintaining working relationships with stakeholder organizations.

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: $250,000 (This amount is an estimate, and is subject to availability of funds.).

Approximate Number of Awards: One.

Approximate Average Award: $250,000 (This amount is for the first 12-month budget period, and includes both direct and indirect costs.).

Floor of Award Range: $200,000.

Ceiling of Award Range: $300,000 (This ceiling is for the first 12-month budget period.).

Anticipated Award Date: August 31, 2005.

Budget Period Length: 12 months.

Project Period Length: One year.

Throughout the project 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

Eligible applicants that can apply for this funding opportunity are listed below:

  • Public nonprofit organizations.
  • Private nonprofit organizations.
  • For profit organizations.
  • Small, minority, women-owned businesses.
  • Universities.
  • Colleges.
  • Research institutions.
  • Hospitals.
  • Community-based organizations.
  • Faith-based organizations.
  • Federally recognized Indian tribal governments.
  • Indian tribes.
  • Indian tribal organizations.
  • State and local governments or their Bona Fide Agents (this includes the District of Columbia, the Commonwealth of Puerto Rico, 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).
  • Political subdivisions of States (in consultation with States).

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 applying as a bona fide agent of a state or local government, a letter from the state or local government as documentation of the status is required. Place this documentation behind the first page of the application form.

III.2. Cost Sharing or Matching

Matching funds are not required for this program.

III.3. Other

A successful applicant must be an organization with a national scope of operations.

If a funding amount greater than the ceiling of the award range is requested, the application will be considered non-responsive and will not be entered into the review process. The applicant will be notified that the application did not meet the submission requirements.

Special Requirements: If the application is incomplete or non-responsive to the special requirements listed in this section, it will not be entered into the review process. The applicant will be notified that the application did not meet submission requirements.

  • Late applications will be considered non-responsive. See section “IV.3. Submission Dates and Times” for more information on deadlines.
  • 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.
  • Assistance will be provided only to a nationally-recognized, independent and objective source of credible information on genetic technologies and genetic policies for health care providers, genetics professionals, the public, media and policymakers.

IV. Application and Submission Information

IV.1. Address To Request Application Package

To apply for this funding opportunity use application form PHS 5161-1.

Electronic Submission

CDC strongly encourages the applicant to submit the application electronically by utilizing the forms and instructions posted for this announcement on http://www.Grants.gov, the official Federal agency wide E-grant Web site. Only applicants who apply on-line are permitted to forego paper copy submission of all application forms.

Paper Submission

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 access to the Internet is not available, or if there is difficulty accessing the forms on-line, contact the CDC Procurement and Grants Office Technical Information Management Section (PGO-TIM) staff at: 770-488-2700 and the application forms can be mailed.

IV.2. Content and Form of Submission

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 the page
  • Written in English, avoid jargon

Your LOI must contain the following information:

  • Name
  • Address
  • Telephone number
  • Principal Investigator
  • Number and title of this program announcement
  • Names of other key personnel
  • Designations of collaborating institutions and entities
  • Recruitment approach
  • Expected Outcomes

Application: A project narrative must be submitted with the application forms. The narrative must be submitted in the following format:

  • Maximum number of pages: 25. 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
  • Double-spacedStart Printed Page 41229
  • 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 narrative should address activities to be conducted over the entire project period, and must include the following items in the order listed:

  • A demonstrated understanding of FMR-1 genetic testing and genetic counseling issues and the justification of the need for establishment cascade testing and genetic counseling protocols.
  • A description of the goals and specific objectives of the project in time-framed, measurable terms.
  • A detailed plan describing the approach to be taken in implementing the project and the methods by which the objectives will be achieved and evaluated, including their sequence. A comprehensive evaluation plan must be outlined.
  • A description of the specific products to be developed and/or disseminated through the project.
  • A description of the cooperative agreement's principal investigator's role and responsibilities.
  • A description of all the project staff, regardless of their funding source. It should include their title, qualifications, experience, percentage of time each will devote to the project, as well as that portion of their salary to be paid by the cooperative agreement.
  • A detailed budget for the cooperative agreement. (Budget justification is not included in narrative page limit).

Additional information may be included in the application appendices. The appendices will not be counted toward the narrative page limit. This additional information includes:

  • Curricula Vitas
  • Letters of Support

The agency or organization is 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/​grantmain.htm. If the application form does not have a DUNS number field, please write the DUNS number at the top of the first page of the application, and/or include the DUNS number in the application cover letter.

Additional requirements that may require submittal of additional documentation with the application are listed in section “VI.2. Administrative and National Policy Requirements.”

IV.3. Submission Dates and Times

LOI Deadline Date: July 28, 2005.

CDC requests that an applicant send an LOI if the applicant intends to apply for this program. Although the LOI is not required, not binding, and does not enter into the review of your subsequent application, it will be used to gauge the level of interest in this program, and to allow CDC to plan the application review.

Application Deadline Date: August 17, 2005.

Explanation of Deadlines: Applications must be received in the CDC Procurement and Grants Office by 4 p.m. Eastern Time on the deadline date.

Applications may be submitted electronically at http://www.grants.gov. Applications completed on-line through Grants.gov are considered formally submitted when the applicant organization's Authorizing Official electronically submits the application to http://www.grants.gov. Electronic applications will be considered as having met the deadline if the application has been submitted electronically by the applicant organization's Authorizing Official to Grants.gov on or before the deadline date and time.

If submittal of the application is done electronically through Grants.gov (http://www.grants.gov), the application will be electronically time/date stamped, which will serve as receipt of submission. Applicants will receive an e-mail notice of receipt when CDC receives the application.

If submittal of the application is by the United States Postal Service or commercial delivery service, the applicant must ensure that the carrier will be able to guarantee delivery by the closing date and time. If CDC receives the submission after the closing date 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, the applicant will be given the opportunity to submit documentation of the carrier's guarantee. If the documentation verifies a carrier problem, CDC will consider the submission as having been received by the deadline.

If a hard copy application is submitted, CDC will not notify the applicant upon receipt of the submission. If questions arise on the receipt of the application, the applicant should first contact the carrier. If the applicant still has questions, contact the PGO-TIM staff at (770) 488-2700. The applicant should wait two to three days after the submission deadline before calling. This will allow time for submissions to be processed and logged.

This announcement is the definitive guide on application content, submission address, and deadline. It supersedes information provided in the application instructions. If the submission does not meet the deadline above, it will not be eligible for review, and will be discarded. The applicant will be notified the application did not meet the submission requirements.

IV.4. Intergovernmental Review of Applications

Executive Order 12372 does not apply to this program.

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 pre-award costs is not allowed.

If requesting indirect costs in the budget, a copy of the indirect cost rate agreement is required. If the 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 the LOI by express mail, delivery service, fax, or e-mail to: Michael Brown, Project Officer, Centers for Disease Control and Prevention (CDC), National Center on Birth Defects and Developmental Disabilities, Division of Human Development and Disability, 1600 Clifton Road NE., Mailstop E-88, Atlanta, GA 30333. Telephone: 404-498-3006. E-mail: MABrown@cdc.gov.

Application Submission Address: Electronic Submission: CDC strongly encourages applicants to submit applications electronically at http://www.Grants.gov. The application package can be downloaded from http://www.Grants.gov. Applicants are able to complete it off-line, and then upload and submit the application via the Grants.gov Web site. E-mail submissions will not be accepted. If the applicant has technical difficulties in Start Printed Page 41230Grants.gov, costumer service can be reached by E-mail at http://www.grants.gov/​CustomerSupport or by phone at 1-800-518-4726 (1-800-518-GRANTS). The Customer Support Center is open from 7 a.m. to 9 p.m. Eastern Time, Monday through Friday.

CDC recommends that submittal of the application to Grants.gov should be early to resolve any unanticipated difficulties prior to the deadline. Applicants may also submit a back-up paper submission of the application. Any such paper submission must be received in accordance with the requirements for timely submission detailed in Section IV.3. of the grant announcement. The paper submission must be clearly marked: “BACK-UP FOR ELECTRONIC SUBMISSION.” The paper submission must conform to all requirements for non-electronic submissions. If both electronic and back-up paper submissions are received by the deadline, the electronic version will be considered the official submission.

It is strongly recommended that the applicant submit the grant application using Microsoft Office products (e.g., Microsoft Word, Microsoft Excel, etc.). If the applicant does not have access to Microsoft Office products, a PDF file may be submitted. Directions for creating PDF files can be found on the Grants.gov Web site. Use of file formats other than Microsoft Office or PDF may result in the file being unreadable by staff; or

Paper Submission

Applicant should submit the original and two hard copies of the application by mail or express delivery service to: Technical Information Management [RFA# AA097], CDC Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341.

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.

The application will be evaluated against the following criteria:

1. Applicant's Understanding of the Problem (25%). The extent to which the applicant demonstrates an understanding of the FMR-1 genetic testing and genetic counseling issues and the need to establish cascade testing and genetic counseling protocols.

2. Goals and Objectives (25%). The extent to which the project goals are clearly stated and the objectives are specific, measurable, and time-phased. Also, the extent to which a plan is presented for evaluating the objectives.

3. Plan of Operation (25%). The extent to which the applicant has provided a full and comprehensive description of the project they propose to undertake and a plan for how it will be accomplished. The applicant must also describe the methods by which the objectives will be achieved and evaluated.

4. Capacity to Conduct Project Activities and Begin Project Operations in a Timely Fashion (25%). The extent to which the applicant has provided information to support its ability to conduct the activities of the cooperative agreement, including documentation of previous relevant experience; documentation of institutional support for the project; demonstrated ability to identify qualified personnel to fill key positions and begin project activities in a timely fashion; and the ability to identify adequate office space for the project. The extent to which the organization demonstrates that it is a nationally-recognized, independent and objective source of credible information on genetic technologies and genetic policies for health care providers, genetics professionals, the public, media and policymakers.

5. 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 (PGO) staff, and for responsiveness by the National Center on Birth Defects and Developmental Disabilities (NCBDDD). 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 process will follow the policy requirements as stated in the GPD 2.04 [http://198.102.218.46/​doc/​gpd204.doc]. The objective review panel will consist of CDC employees outside of the funding division who will be randomly assigned applications to review and score. Applications will be funded in order by score and rank determined by a review panel. CDC will provide justification for any decision to fund out of rank order.

V.3. Anticipated Announcement and Award Dates

Anticipated Announcement date is August 31, 2005 for a September 30, 2005 project start date.

VI. Award Administration Information

VI.1. Award Notices

Successful applicants will receive a Notice of Award (NoA) from the CDC Procurement and Grants Office. The NoA shall be the only binding, authorizing document between the recipient and CDC. The NoA 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

Successful applicants must comply with the administrative requirements outlined in 45 CFR Part 74 and Part 92 as Appropriate. The following additional requirements apply to this project:

  • AR-9 Paperwork Reduction Act Requirements
  • AR-10 Smoke-Free Workplace Requirements
  • AR-11 Healthy People 2010
  • AR-12 Lobbying Restrictions

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.

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

An additional Certifications form from the PHS5161-1 application needs to be included in the Grants.gov electronic submission only. Applicants should refer to http://www.cdc.gov/​od/​pgo/​funding/​PHS5161-1-Certificates.pdf. Once the applicant has filled out the form, it should be attached Start Printed Page 41231to the Grants.gov submission as Other Attachments Form.

VI.3. Reporting Requirements

The applicant must provide CDC with an original, plus two hard copies of the following reports:

1. Interim progress report, due 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. Budget.

e. Measures of Effectiveness.

f. 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.

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, 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: Michael Brown, Project Officer, Centers for Disease Control and Prevention (CDC), National Center on Birth Defects and Developmental Disabilities, Division of Human Development and Disability, 1600 Clifton Road NE., Mailstop E-88, Atlanta, GA 30333. Telephone: 404-498-3006. E-mail: MABrown@cdc.gov.

For financial, grants management, or budget assistance, contact: Nealean Austin, Grants Management Officer, CDC Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341. Telephone: (770) 488-2722. E-mail: nea1@cdc.gov.

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.”

Start Signature

Dated: July 11, 2005.

Alan Kotch,

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

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[FR Doc. 05-14049 Filed 7-15-05; 8:45 am]

BILLING CODE 4163-18-U