[Federal Register: July 18, 2005 (Volume 70, Number 136)]
[Notices]
[Page 41227-41231]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18jy05-62]
=======================================================================
-----------------------------------------------------------------------
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: 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
[[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 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-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 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
[[Page 41230]]
Grants.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
[[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: http://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