Fragile X Syndrome Cascade Testing and Genetic Counseling Protocols, 41227-41231 [05-14049]

Agencies

• Centers for Disease Control and Prevention
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 70, Number 136 (Monday, July 18, 2005)]
[Notices]
[Pages 41227-41231]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-14049]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Fragile X Syndrome Cascade Testing and Genetic Counseling 
Protocols

    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: https://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 https://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

[[Page 41228]]

example, 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 https://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: https://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-spaced

[[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 https://www.dunandbradstreet.com or call 1-
866-705-5711.
    For more information, see the CDC Web site at: https://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 https://
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 https://
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 (https://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: https://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 https://
www.Grants.gov. The application package can be downloaded from https://
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

[[Page 41230]]

Grants.gov, costumer service can be reached by E-mail at https://
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 [https://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: https://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: https://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 https://www.cdc.gov/od/pgo/funding/PHS5161-1-
Certificates.pdf. Once the applicant has filled out the form, it should 
be attached

[[Page 41231]]

to 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: https://www.cdc.gov. Click on 
``Funding'' then ``Grants and Cooperative Agreements.''

    Dated: July 11, 2005.
Alan Kotch,
Acting Director, Procurement and Grants Office, Centers for Disease 
Control and Prevention.
[FR Doc. 05-14049 Filed 7-15-05; 8:45 am]
BILLING CODE 4163-18-U