Single Gene Disorders Resource Network, 41401-41406 [05-14166]
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Federal Register / Vol. 70, No. 137 / Tuesday, July 19, 2005 / Notices
2038, Rockville, Maryland 20850, telephone
(301) 427–1554.
Agenda items for this meeting are
subject to change as priorities dictate.
Dated: July 11, 2005.
Carolyn M. Clancy,
Director.
[FR Doc. 05–14183 Filed 7–18–05; 8:45 am]
BILLING CODE 4160–10–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Single Gene Disorders Resource
Network
Announcement Type: New.
Funding Opportunity Number: AA092.
Catalog of Federal Domestic Assistance
Number: 93.283.
Key Dates:
Letter of Intent (LOI) Deadline: July 29,
2005.
Application Deadline: August 18, 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].
Background: There are over 6000
known single gene disorders, including
over 1650 with identified genes. Single
gene disorders occur in about one in 300
births, and account for 13 percent of inpatients in pediatric hospital and three
to five percent of pediatric deaths. The
National Center on Birth Defects and
Developmental Disabilities (NCBDDD)
seeks to ensure the optimal outcome of
people with disabling or potential
disabling pediatric single gene
conditions and their families, by
developing surveillance systems that
meet challenges of single gene
disorders, improving screening and
diagnosis, and improving services to
patients and families. Genetic disorders
raise different issues for health care
providers and families than do nongenetic disorders because genetic
disorders have implications for other
family members, and raise psychosocial
issues (such as guilt, blame and
stigmatization). Lessons learned from
public health activities in single gene
disorders can be applied to complex
disorders as their etiologies become
elucidated.
This cooperative agreement will fund
the development of a national resource
network for single gene disorders. Initial
funding will support projects related to
Duchenne and Becker Muscular
Dystrophy (DBMD) and Fragile X
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syndrome (FXS). The proposed National
Network will have the capacity to
expand to other single gene disorders.
Purpose: The purpose of the program
is to develop, implement, and evaluate
a Network for Single Gene Disorders,
focusing specifically on DBMD and
FXS. This program addresses the
‘‘Healthy People 2010’’ focus areas of
Disability and Secondary Conditions;
Mental Health and Mental Health
Disorders; and 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 nonresearch activities supported by CDC/
ATSDR. 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:
Applicants may apply for funding
under part A and/or part B. Please note
that if applicants choose to apply for
both part A and part B, applicants may
submit consolidated applications
addressing the requirements of both part
A and part B under one application.
Awardee activities for part A of this
program are as follows:
• Increase access to accurate and
scientifically valid information on the
etiology, diagnosis, and treatment of
DBMD for end users including families,
educators, health professionals, allied
health caregivers, and the general
public. The awardee will specifically
assemble and/or develop informational
materials that: (1) Reflect expert
opinion, evidence-based knowledge and
current clinical practice, and (2)
respond to the needs of individuals and
families affected by DBMD. These
informational materials will be
disseminated to the target populations.
• Assess current educational and
outreach materials related to DBMD
targeted at families with DBMD and the
general public. Develop and/or modify,
implement and evaluate educational
materials for families with DBMD and
the general public, including
information on the etiology, clinical
course, treatment options, and available
services (including services supported
by Health Resources and Services
Administration, the Administration for
Children and Families/Administration
on Developmental Disabilities, and
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other DHHS-supported efforts that target
families of children with disabilities).
Content of materials includes issues
specific to single gene disorders, such as
genetic counseling.
• Assess current educational and
outreach materials related to DBMD
targeted at health care providers.
Develop and/or modify, implement and
evaluate educational materials for
providers and students, focusing on
recognition, diagnosis, referral and
treatment. Content of materials includes
current diagnostic and treatment
standards or guidelines; and issues
specific to single gene disorders, such as
genetic counseling.
• Disseminate the information on
DBMD widely within the targeted group
including families, educators, health
professionals, allied health caregivers,
and the general public. This may be new
or existing materials in a variety of
formats including written, video, CD,
and World Wide Web. Ensure the
dissemination plan for the materials is
developed, methods for reaching underserved and minority communities are
described and justified; and accurate
information about diagnosis and
treatment of DBMD is available to
various stakeholders, i.e., practitioners,
families, teachers, and other caregivers.
• Coordinate educational activities
with other community-based and
community-wide providers and
organizations that offer services or
direct education messages to U.S.
residents that have DBMD and their
providers.
• Hire and train staff as necessary to
implement education and outreach
activities for DBMD.
• Increase opportunities for regular
and ongoing DBMD training and
education available to persons within
the targeted audiences.
• Identify core competencies about
DBMD for medical and allied health
students.
• Evaluate the core competencies for
appropriateness and validity based on
needs of the audiences and on scientific
research.
• Develop methods to ensure that
materials and resources for DBMD
education and training are easily
accessible.
• Coordinate activities with other
awardees.
Awardee activities for part B of this
program are as follows:
• Increase access to accurate and
scientifically valid information on the
etiology, diagnosis, and treatment of
FXS for end users including health
professionals, allied health caregivers,
and students. The awardee will
specifically assemble and/or develop
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informational materials that: (1) reflect
expert opinion, evidence-based
knowledge and current clinical practice;
and (2) respond to the needs of
individuals and families affected by
FXS. These informational materials will
be disseminated to the target
populations.
• Assess current educational and
outreach materials related to FXS
targeted at health care providers.
Develop and/or modify, implement and
evaluate educational materials for
providers and students, focusing on
recognition, diagnosis, referral and
treatment. Content of materials includes
current diagnostic and treatment
standards or guidelines; and issues
specific to single gene disorders, such as
genetic counseling.
• Disseminate the information on
FXS widely within the targeted group
including health professionals, allied
health caregivers, and students. This
may be new or existing materials in a
variety of formats including written,
video, CD and World Wide Web. Ensure
the dissemination plan for the materials
is developed, methods for reaching
under-served and minority communities
are described and justified, and accurate
information about diagnosis and
treatment of FXS is available to various
stakeholders, i.e., practitioners,
teachers, and other caregivers.
• Coordinate educational activities
with other community-based and
community-wide providers and
organizations that offer services or
direct education messages to U.S.
residents who have FXS and their
providers.
• Hire and train staff as necessary to
implement education and outreach
activities for FXS.
• Increase opportunities for regular
and ongoing FXS training and education
available to persons within the targeted
audiences.
• Identify core competencies about
FXS for medical and allied health
students.
• Evaluate the core competencies for
appropriateness and validity based on
needs of the audiences and on scientific
research.
• Develop methods to ensure that
materials and resources for FXS
education and training are easily
accessible.
• Coordinate activities with other
awardees.
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;
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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 coordination of
activities where possible.
• Assist recipients in coordination of
activities with those of related partner
organizations, including HRSA maternal
and child health, Community Health
Centers and OPA family planning.
• Assist recipients in developing and
maintaining working relationships with
stakeholder organizations.
• Provide technical assistance in
assessing and prioritizing training and
educational needs and in planning,
implementing, and evaluating training
and educational activities.
• Provide technical assistance in
developing and evaluating innovative
curriculum approaches, instructional
strategies, and materials.
II. Award Information
Part A: Duchenne and Becker Muscular
Dystrophy
Type of Award: Cooperative
Agreement. CDC involvement in this
program is listed in the Activities
Section above.
Fiscal Year Funds: 2005.
Approximate Total Funding: $600,000
(This amount is an estimate, and is
subject to availability of funds.)
Approximate Number of Awards:
One.
Approximate Average Award:
$600,000 (This amount is for the first
12-month budget period, and includes
both direct and indirect costs).
Floor of Award Range: $500,000.
Ceiling of Award Range: $600,000
(This ceiling is for the first 12-month
budget period.)
Anticipated Award Date: August 30,
2005.
Budget Period Length: 12 months.
Project Period Length: Five years.
Part B: Fragile X Syndrome
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).
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Floor of Award Range: $200,000.
Ceiling of Award Range: $250,000
(This ceiling is for the first 12-month
budget period.)
Anticipated Award Date: August 30,
2005.
Budget Period Length: 12 months.
Project Period Length: Five years.
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.
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If a funding amount greater than the
ceiling of the award range is requested,
the application will be considered nonresponsive 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 well-established non-profit
organization with experience in: (1)
Assisting parents and families of people
with genetic disorders; (2) conducting a
national medical and public education
agenda that focuses on producing
valuable literature for families with
genetic disorders, health care providers,
and allied health caregivers; and (3)
communicating research findings
effectively to national, regional, state
and local level media outlets in
coordination with partners.
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.
Application forms and instructions are
available on the CDC web site, at the
following Internet address: https://
www.cdc.gov/od/pgo/forminfo.htm.
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
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accessing the forms on-line, contact the
CDC Procurement and Grants Office
Technical Information Management
Section (PGO–TIM) staff at: 770–488–
2700. Application forms can be mailed.
IV.2. Content and Form of Application
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
• Intent to apply under part A and/or
part B of this 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 for
part A or part B, 30 for parts A and B
combined. 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
• 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
the problem of single gene disorders
including DBMD and/or FXS and the
justification of the need for
establishment of the Single Gene
Disorders Resource Network.
• A description of the goals and
specific objectives of the project in timeframed, 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.
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• 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 description of relationships with
voluntary health organizations and
other organizations that offer services or
direct education messages to U.S.
residents that have single gene disorders
including DBMD and/or FXS and their
providers dedicated; and a description
of a plan to involve these organizations
in the development, implementation
and evaluation of this project.
• A detailed first year’s budget for the
cooperative agreement with future
annual projections. Awards will be
made for a project period of up to five
years. (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 Vitae
• 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
Letter of Intent (LOI) Deadline Date:
July 29, 2005.
CDC requests that you send a LOI if
you intend to apply for this program.
The LOI will be used to gauge the level
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of interest in this program, and to allow
CDC to plan the application review.
Application Deadline Date: August
18, 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,
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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 your
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
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
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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:
Applicants should submit the original
and two hard copies of the application
by mail or express delivery service to:
Technical Information Management
[RFA# AA092], 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. Capacity to Conduct Project
Activities and Begin Project Operations
in a Timely Fashion (30%)
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 as
well as facilities for conducting
training/educational sessions. The
extent to which the organization has
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with experience in: (1) Assisting parents
and families of people with genetic
disorders (2) conducting a national
medical and public education agenda
that focuses on producing valuable
literature for families with genetic
disorders, health care providers, and
allied health caregivers (3)
communicating research findings
effectively to national, regional, state
and local level media outlets in
coordination with partners.
2. Applicant’s Understanding of the
Problem (20%)
The extent to which the applicant
demonstrates an understanding of the
resource needs related to single gene
disorders, including DBMD and/or FXS,
and the importance of educating
medical and allied health students and
practitioners about these conditions.
3. Goals and Objectives (20%)
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.
4. Collaboration with Voluntary
Health and Related Organizations
(15%)
The extent to which the applicant has
provided a full and comprehensive
description of partnerships with
voluntary health organizations and
other organizations that offer services or
direct education messages to U.S.
residents that have genetic disorders
including DBMD and/or FXS and their
providers; and a description of a plan to
involve these organizations in the
development, implementation and
evaluation of this project.
5. Plan of Operation (15%)
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.
6. 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.
7. Human Subjects Review (not
scored)
Does the application adequately
address the requirements of Title 45
CFR Part 46 for the protection of human
subjects?
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V.2. Review and Selection Process
VI. Award Administration Information
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 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
the review panel. Applicants that apply
under both part A and part B will
receive separate scores for each part.
CDC will provide justification for any
decision to fund out of rank order.
Subsequent to the formal review of all
competitive applications, a second level
of review will be conducted by senior
CDC program staff. This review will not
revisit the scientific merit of the
applications, but will evaluate the
overall budget implications of the
applications against funding ceilings;
they may not make recommendations as
to the final ordering of the top ranked
applications for part A and part B, and
they may not actually change the
ranking order (or scores). It is possible
that the second level of review may
recommend funding the highest ranked
proposal under part A (or part B) and
also funding that same organization
under its application for the other part
of the announcement. That could occur
in the event that an organization with
the highest ranking in one part ranks
among the highest three applicants in
the other part. This would be done to
take into account economies of scale
and establish the capacity to conduct
non-redundant programs to best meet
the purposes of this announcement. In
such a case, the total approved budget
may be less than the sum of the two
applications due to staff time
commitment duplications and other
considerations.
VI.1. Award Notices
V.3. Anticipated Announcement and
Award Dates
August 31,2005 for a September 30,
2005 project start date.
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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 NGA 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-tablesearch.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
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.
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Federal Register / Vol. 70, No. 137 / Tuesday, July 19, 2005 / Notices
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: Mildred
Garner, Grants Management Officer,
CDC Procurement and Grants Office,
2920 Brandywine Road, Atlanta, GA
30341; Telephone: (770) 488–2745; Email: mqg4@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 13, 2005.
Alan A. Kotch,
Acting Director, Procurement and Grants
Office, Centers for Disease Control and
Prevention.
[FR Doc. 05–14166 Filed 7–18–05; 8:45 am]
Control and Prevention (CDC)
announces the following meeting:
Name: Disease, Disability, and Injury
Prevention and Control Special Emphasis
Panel (SEP): Intervention for Individuals
with Fetal Alcohol Syndrome: Transitioning
Science to Community Project, Request for
Application (RFA) #DD 05–079 and
Implementing Community-Level Strategies
for Fetal Alcohol Syndrome Prevention and
Surveillance in South Africa, RFA #DD 05–
118.
Times and Dates: 1 p.m.–5 p.m., August 3,
2005 (Closed).
Place: Teleconference.
Status: The meeting will be closed to the
public in accordance with provisions set
forth in Section 552b(c)(4) and (6), Title 5
U.S.C., and the Determination of the Director,
Management Analysis and Services Office,
CDC, pursuant to Public Law 92–463.
Matters To Be Discussed: The meeting will
include the review, discussion, and
evaluation of applications received in
response to: Intervention for Individuals with
Fetal Alcohol Syndrome: Transitioning
Science to Community Project, Request for
Application (RFA) #DD 05–079 and
Implementing Community-Level Strategies
for Fetal Alcohol Syndrome Prevention and
Surveillance in South Africa, RFA #DD 05–
118.
For Further Information Contact: Pamela J.
Wilkerson, MPA, Scientific Review
Administrator, 24 Executive Park Drive, NE.,
Mailstop E74, Atlanta, GA 30333, Telephone
(404) 498–2556.
The Director, Management Analysis and
Services Office, has been delegated the
authority to sign Federal Register notices
pertaining to announcements of meetings and
other committee management activities, for
both CDC and the Agency for Toxic
Substances and Disease Registry.
Dated: July 12, 2005.
Alvin Hall,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 05–14162 Filed 7–18–05; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
BILLING CODE 4163–18–P
[Docket No. 2003D–0167] (formerly Docket
No. 03D–0167)
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Guidance for Industry on Dispute
Resolution Procedures for ScienceBased Decisions on Products
Regulated by the Center for Veterinary
Medicine; Availability
Centers for Disease Control and
Prevention
Food and Drug Administration,
Meetings: Disease, Disability, and
Injury Prevention and Control Special
Emphasis Panel
AGENCY:
In accordance with Section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
VerDate jul<14>2003
17:15 Jul 18, 2005
Jkt 205001
HHS.
ACTION:
Notice.
SUMMARY:
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(#79) entitled ‘‘Guidance for Industry:
Dispute Resolution Procedures for
Science-Based Decisions on Products
Regulated by the Center for Veterinary
Medicine (CVM).’’ This guidance
document describes dispute resolution
procedures by which sponsors,
applicants, or manufacturers of FDAregulated products for animals may
request review of science-based
decisions. This guidance does not
address procedures for handling issues
associated with FDA’s new initiative to
enhance pharmaceutical good
manufacturing practices (GMPs).
DATES: Submit written or electronic
comments on agency guidances at any
time.
ADDRESSES: Submit written requests for
single copies of the guidance to the
Communications Staff (HFV–12), Center
for Veterinary Medicine, Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855. Send one selfaddressed adhesive label to assist that
office in processing your requests.
Submit written comments on this
guidance to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https:///
www.fda.gov/dockets/ecomments.
Comments should be identified with the
full title of the guidance and the docket
number found in brackets in the
heading of this document. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the guidance
document.
FOR FURTHER INFORMATION CONTACT:
Marcia Larkins, Center for Veterinary
Medicine (HFV–7), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 301–827–4535, email: mlarkins@cvm.fda.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of May 19,
2003 (68 FR 27094), FDA published a
notice of availability for a draft guidance
for industry entitled ‘‘Dispute
Resolution Procedures for ScienceBased Decisions on Products Regulated
by the Center for Veterinary Medicine
(CVM)’’ giving interested persons until
August 4, 2003, to submit comments on
the draft guidance and until July 18,
2003, to comment on the information
collection. FDA considered all
comments received and, where
appropriate, made changes in the
guidance.
II. Significance of Guidance
This level 1 guidance is being issued
consistent with FDA’s good guidance
E:\FR\FM\19JYN1.SGM
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Agencies
[Federal Register Volume 70, Number 137 (Tuesday, July 19, 2005)]
[Notices]
[Pages 41401-41406]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-14166]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Single Gene Disorders Resource Network
Announcement Type: New.
Funding Opportunity Number: AA092.
Catalog of Federal Domestic Assistance Number: 93.283.
Key Dates:
Letter of Intent (LOI) Deadline: July 29, 2005.
Application Deadline: August 18, 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].
Background: There are over 6000 known single gene disorders,
including over 1650 with identified genes. Single gene disorders occur
in about one in 300 births, and account for 13 percent of in-patients
in pediatric hospital and three to five percent of pediatric deaths.
The National Center on Birth Defects and Developmental Disabilities
(NCBDDD) seeks to ensure the optimal outcome of people with disabling
or potential disabling pediatric single gene conditions and their
families, by developing surveillance systems that meet challenges of
single gene disorders, improving screening and diagnosis, and improving
services to patients and families. Genetic disorders raise different
issues for health care providers and families than do non-genetic
disorders because genetic disorders have implications for other family
members, and raise psychosocial issues (such as guilt, blame and
stigmatization). Lessons learned from public health activities in
single gene disorders can be applied to complex disorders as their
etiologies become elucidated.
This cooperative agreement will fund the development of a national
resource network for single gene disorders. Initial funding will
support projects related to Duchenne and Becker Muscular Dystrophy
(DBMD) and Fragile X syndrome (FXS). The proposed National Network will
have the capacity to expand to other single gene disorders.
Purpose: The purpose of the program is to develop, implement, and
evaluate a Network for Single Gene Disorders, focusing specifically on
DBMD and FXS. This program addresses the ``Healthy People 2010'' focus
areas of Disability and Secondary Conditions; Mental Health and Mental
Health Disorders; and 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/ATSDR. 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:
Applicants may apply for funding under part A and/or part B. Please
note that if applicants choose to apply for both part A and part B,
applicants may submit consolidated applications addressing the
requirements of both part A and part B under one application.
Awardee activities for part A of this program are as follows:
Increase access to accurate and scientifically valid
information on the etiology, diagnosis, and treatment of DBMD for end
users including families, educators, health professionals, allied
health caregivers, and the general public. The awardee will
specifically assemble and/or develop informational materials that: (1)
Reflect expert opinion, evidence-based knowledge and current clinical
practice, and (2) respond to the needs of individuals and families
affected by DBMD. These informational materials will be disseminated to
the target populations.
Assess current educational and outreach materials related
to DBMD targeted at families with DBMD and the general public. Develop
and/or modify, implement and evaluate educational materials for
families with DBMD and the general public, including information on the
etiology, clinical course, treatment options, and available services
(including services supported by Health Resources and Services
Administration, the Administration for Children and Families/
Administration on Developmental Disabilities, and other DHHS-supported
efforts that target families of children with disabilities). Content of
materials includes issues specific to single gene disorders, such as
genetic counseling.
Assess current educational and outreach materials related
to DBMD targeted at health care providers. Develop and/or modify,
implement and evaluate educational materials for providers and
students, focusing on recognition, diagnosis, referral and treatment.
Content of materials includes current diagnostic and treatment
standards or guidelines; and issues specific to single gene disorders,
such as genetic counseling.
Disseminate the information on DBMD widely within the
targeted group including families, educators, health professionals,
allied health caregivers, and the general public. This may be new or
existing materials in a variety of formats including written, video,
CD, and World Wide Web. Ensure the dissemination plan for the materials
is developed, methods for reaching under-served and minority
communities are described and justified; and accurate information about
diagnosis and treatment of DBMD is available to various stakeholders,
i.e., practitioners, families, teachers, and other caregivers.
Coordinate educational activities with other community-
based and community-wide providers and organizations that offer
services or direct education messages to U.S. residents that have DBMD
and their providers.
Hire and train staff as necessary to implement education
and outreach activities for DBMD.
Increase opportunities for regular and ongoing DBMD
training and education available to persons within the targeted
audiences.
Identify core competencies about DBMD for medical and
allied health students.
Evaluate the core competencies for appropriateness and
validity based on needs of the audiences and on scientific research.
Develop methods to ensure that materials and resources for
DBMD education and training are easily accessible.
Coordinate activities with other awardees.
Awardee activities for part B of this program are as follows:
Increase access to accurate and scientifically valid
information on the etiology, diagnosis, and treatment of FXS for end
users including health professionals, allied health caregivers, and
students. The awardee will specifically assemble and/or develop
[[Page 41402]]
informational materials that: (1) reflect expert opinion, evidence-
based knowledge and current clinical practice; and (2) respond to the
needs of individuals and families affected by FXS. These informational
materials will be disseminated to the target populations.
Assess current educational and outreach materials related
to FXS targeted at health care providers. Develop and/or modify,
implement and evaluate educational materials for providers and
students, focusing on recognition, diagnosis, referral and treatment.
Content of materials includes current diagnostic and treatment
standards or guidelines; and issues specific to single gene disorders,
such as genetic counseling.
Disseminate the information on FXS widely within the
targeted group including health professionals, allied health
caregivers, and students. This may be new or existing materials in a
variety of formats including written, video, CD and World Wide Web.
Ensure the dissemination plan for the materials is developed, methods
for reaching under-served and minority communities are described and
justified, and accurate information about diagnosis and treatment of
FXS is available to various stakeholders, i.e., practitioners,
teachers, and other caregivers.
Coordinate educational activities with other community-
based and community-wide providers and organizations that offer
services or direct education messages to U.S. residents who have FXS
and their providers.
Hire and train staff as necessary to implement education
and outreach activities for FXS.
Increase opportunities for regular and ongoing FXS
training and education available to persons within the targeted
audiences.
Identify core competencies about FXS for medical and
allied health students.
Evaluate the core competencies for appropriateness and
validity based on needs of the audiences and on scientific research.
Develop methods to ensure that materials and resources for
FXS education and training are easily accessible.
Coordinate activities with other awardees.
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 coordination of activities where
possible.
Assist recipients in coordination of activities with those
of related partner organizations, including HRSA maternal and child
health, Community Health Centers and OPA family planning.
Assist recipients in developing and maintaining working
relationships with stakeholder organizations.
Provide technical assistance in assessing and prioritizing
training and educational needs and in planning, implementing, and
evaluating training and educational activities.
Provide technical assistance in developing and evaluating
innovative curriculum approaches, instructional strategies, and
materials.
II. Award Information
Part A: Duchenne and Becker Muscular Dystrophy
Type of Award: Cooperative Agreement. CDC involvement in this
program is listed in the Activities Section above.
Fiscal Year Funds: 2005.
Approximate Total Funding: $600,000 (This amount is an estimate,
and is subject to availability of funds.)
Approximate Number of Awards: One.
Approximate Average Award: $600,000 (This amount is for the first
12-month budget period, and includes both direct and indirect costs).
Floor of Award Range: $500,000.
Ceiling of Award Range: $600,000 (This ceiling is for the first 12-
month budget period.)
Anticipated Award Date: August 30, 2005.
Budget Period Length: 12 months.
Project Period Length: Five years.
Part B: Fragile X Syndrome
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: $250,000 (This ceiling is for the first 12-
month budget period.)
Anticipated Award Date: August 30, 2005.
Budget Period Length: 12 months.
Project Period Length: Five years. 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.
[[Page 41403]]
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 well-established
non-profit organization with experience in: (1) Assisting parents and
families of people with genetic disorders; (2) conducting a national
medical and public education agenda that focuses on producing valuable
literature for families with genetic disorders, health care providers,
and allied health caregivers; and (3) communicating research findings
effectively to national, regional, state and local level media outlets
in coordination with partners.
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. Application
forms and instructions are available on the CDC web site, at the
following Internet address: https://www.cdc.gov/od/pgo/forminfo.htm.
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. Application forms can be mailed.
IV.2. Content and Form of Application 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
Intent to apply under part A and/or part B of this
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 for part A or part B, 30 for
parts A and B combined. 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
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 the problem of single gene
disorders including DBMD and/or FXS and the justification of the need
for establishment of the Single Gene Disorders Resource Network.
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 description of relationships with voluntary health
organizations and other organizations that offer services or direct
education messages to U.S. residents that have single gene disorders
including DBMD and/or FXS and their providers dedicated; and a
description of a plan to involve these organizations in the
development, implementation and evaluation of this project.
A detailed first year's budget for the cooperative
agreement with future annual projections. Awards will be made for a
project period of up to five years. (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 Vitae
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
Letter of Intent (LOI) Deadline Date: July 29, 2005.
CDC requests that you send a LOI if you intend to apply for this
program. The LOI will be used to gauge the level
[[Page 41404]]
of interest in this program, and to allow CDC to plan the application
review.
Application Deadline Date: August 18, 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 your 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 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:
Applicants should submit the original and two hard copies of the
application by mail or express delivery service to: Technical
Information Management [RFA AA092], 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. Capacity to Conduct Project Activities and Begin Project
Operations in a Timely Fashion (30%)
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 as well as facilities for
conducting training/educational sessions. The extent to which the
organization has
[[Page 41405]]
with experience in: (1) Assisting parents and families of people with
genetic disorders (2) conducting a national medical and public
education agenda that focuses on producing valuable literature for
families with genetic disorders, health care providers, and allied
health caregivers (3) communicating research findings effectively to
national, regional, state and local level media outlets in coordination
with partners.
2. Applicant's Understanding of the Problem (20%)
The extent to which the applicant demonstrates an understanding of
the resource needs related to single gene disorders, including DBMD
and/or FXS, and the importance of educating medical and allied health
students and practitioners about these conditions.
3. Goals and Objectives (20%)
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.
4. Collaboration with Voluntary Health and Related Organizations
(15%)
The extent to which the applicant has provided a full and
comprehensive description of partnerships with voluntary health
organizations and other organizations that offer services or direct
education messages to U.S. residents that have genetic disorders
including DBMD and/or FXS and their providers; and a description of a
plan to involve these organizations in the development, implementation
and evaluation of this project.
5. Plan of Operation (15%)
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.
6. 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.
7. Human Subjects Review (not scored)
Does the application adequately address the requirements of Title
45 CFR Part 46 for the protection of human subjects?
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 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 the review panel. Applicants that apply
under both part A and part B will receive separate scores for each
part. CDC will provide justification for any decision to fund out of
rank order. Subsequent to the formal review of all competitive
applications, a second level of review will be conducted by senior CDC
program staff. This review will not revisit the scientific merit of the
applications, but will evaluate the overall budget implications of the
applications against funding ceilings; they may not make
recommendations as to the final ordering of the top ranked applications
for part A and part B, and they may not actually change the ranking
order (or scores). It is possible that the second level of review may
recommend funding the highest ranked proposal under part A (or part B)
and also funding that same organization under its application for the
other part of the announcement. That could occur in the event that an
organization with the highest ranking in one part ranks among the
highest three applicants in the other part. This would be done to take
into account economies of scale and establish the capacity to conduct
non-redundant programs to best meet the purposes of this announcement.
In such a case, the total approved budget may be less than the sum of
the two applications due to staff time commitment duplications and
other considerations.
V.3. Anticipated Announcement and Award Dates
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 NGA 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 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.
[[Page 41406]]
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:
Mildred Garner, Grants Management Officer, CDC Procurement and Grants
Office, 2920 Brandywine Road, Atlanta, GA 30341; Telephone: (770) 488-
2745; E-mail: mqg4@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 13, 2005.
Alan A. Kotch,
Acting Director, Procurement and Grants Office, Centers for Disease
Control and Prevention.
[FR Doc. 05-14166 Filed 7-18-05; 8:45 am]
BILLING CODE 4163-18-P