Interventions for Individuals With Fetal Alcohol Syndrome: Transitioning Science to Community Projects, 18400-18405 [05-7147]
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Secretary, ACMH, prior to close of
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Dated: April 5, 2005.
Garth N. Graham,
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Health, Executive Secretary, ACMH.
[FR Doc. 05–7206 Filed 4–8–05; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Interventions for Individuals With Fetal
Alcohol Syndrome: Transitioning
Science to Community Projects
Announcement Type: New.
Funding Opportunity Number: RFA
DD05–079.
Catalog of Federal Domestic
Assistance Number: 93.283.
Key Dates:
Application Deadline: May 26, 2005.
I. Funding Opportunity Description
Authority: This program is authorized
under Sections 317(k)(2) and 317C of the
Public Health Service Act, (42 U.S.C.
247b(k)(2) and 247b–(4), as amended.
Purpose:
The purpose of this cooperative
agreement is to implement the
continuation of a directive within the
Children’s Health Act of 2000 to
develop and scientifically evaluate
interventions for children and
adolescents affected by Fetal Alcohol
Syndrome (FAS) or other conditions
resulting from prenatal alcohol exposure
and their families. Interventions were
developed to (1) improve developmental
outcomes, (2) prevent secondary
conditions, and (3) provide education
and support to caregivers and families.
The primary objective of this program is
to translate successful or promising
scientifically evaluated interventions for
children with FAS to community
settings.
This program addresses the ‘‘Healthy
People 2010’’ focus areas of Substance
Abuse and Maternal, Infant, and Child
Health.
Measurable outcomes of the program
will be in alignment with FAS-related
performance goals for the National
Center on Birth Defects and
Developmental Disabilities that include
establishing new, or enhancing existing
prevention programs designed to reduce
the prevalence of FAS, reduce prenatal
exposure to alcohol, and improve and/
or link children currently affected by
FAS to health services.
Research Objectives and Background
Development of interventions and
public health programs often occur in
large research-oriented medical schools
and universities. These settings provide
a large number of intellectual and
logistical resources that facilitate
development of state-of-the-art
interventions and programs. Frequently
however, developed programs are
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simply released to community agencies
who must determine how best to adapt
and implement the programs; otherwise
the interventions languish in scientific
journals without community
implementation. This program seeks to
bridge the transition between researchbased development of interventions and
community implementation of these
interventions.
The benefit of intervention, especially
early intervention, for individuals with
developmental disabilities has long
been proven in the scientific and
community programs literatures. Until
recently, information and strategies for
interventions specific to individuals
with FAS has been gleaned from other
disabilities, and the wisdom gained by
parents has been achieved through trial
and error and shared through informal
networks. Although informative to a
limited degree, such treatments have
been implemented without being
evaluated systematically or
scientifically.
To increase scientific understanding
of the spectrum of disorders associated
with prenatal alcohol exposure,
recipients should develop mechanisms
to obtain neuro-development
assessment data from children
participating in the community-based
interventions, and estimate and
compare economic costs and benefits of
prescribed interventions in the
community setting.
Hence, the approach of the current
cooperative agreement (RFA DD05–079)
will be for each funded site to work
with a community agency to adapt their
program to the community setting. In
the later stages of the program, each site
will document the intervention process
such as through a working manual or
guidance, and initiate a train-the-trainer
type program to facilitate even broader
dissemination of these scientifically
evaluated interventions for children
with FAS.
In 2001, CDC provided the first
federal funding to develop systematic,
specific, and scientifically evaluated
interventions appropriate for children
with FAS and their families.
Under that competitive
announcement, awards were made to
five recipients to conduct interventions
with the aim of improving the
developmental outcomes of individuals
with FAS, reducing secondary
conditions, and improving the lives of
families affected by FAS.
For each site, children in both
treatment and control groups received
comprehensive multi-disciplinary
assessments that guided referrals for
standard care and services as indicated
(e.g., speech therapy, special education).
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Beyond assessment and standard care,
children in the treatment groups also
received interventions specifically
designed to focus on one of the core
vulnerabilities associated with FAS:
mathematical skills, social
communication, peer relations, foster
care stability, compliance, learning
readiness, and challenging behaviors.
All sites included specific instruction
and training for parents and caregivers
as part of the treatment process. Final
analyses and submission of articles to
scientific journals is anticipated in late
2005.
Thus, this announcement seeks to
build upon previous activities and
foundation building in partnering with
community agencies, employing a study
design to include outcome assessment
data and documenting performance
toward process and time-bounded
objectives, and implementing a
dissemination program to publicize
approaches, collaborations, and results.
In effect, these five recipients should
have completed or be nearing
completion of intervention research that
has: Concluded data collection;
completed or is advanced in data
analysis; measured behavioral and/or
health outcomes related to
intervention(s) for individuals with
prenatal alcohol exposure; collected
pre- and post-test data, used treatment
and control/comparison groups with
random assignment; and evaluated the
effectiveness of intervention(s) using
quantitative statistics.
4. Develop mechanisms to identify
core elements of intervention necessary
to ensure fidelity of implementation;
5. Disseminate these scientifically
evaluated and proven credible
interventions for children with FAS by
development of a train-the-trainer or
other similar programs to be offered to
appropriate professionals (e.g., medical
and allied health, education, case
managers, etc);
6. Facilitate definition of the full
spectrum of neuro-developmental
disabilities associated with prenatal
exposure to alcohol and its
consequences by development of a
cross-site collaborative database
including: (a) Neuro-developmental
testing results for children with FAS or
other prenatal alcohol exposure related
conditions in the community setting;
and (b) outcomes;
7. Subsequent to definition of
variables to be included in development
of the database and the convening of
investigators from other funded projects,
discuss and develop a common protocol
that could be implemented for obtaining
assessment data from children, and in
determining outcomes, costs and
benefits of each intervention;
8. Prepare scientific reports for
publication that document the
translated research study findings. The
dissemination effort should seek to
convert interventions into packages of
‘‘how to’’ materials for use in
community settings for implementing
the target intervention.
Activities
Project activities should focus on
tailoring and adapting a proven
intervention to community settings and
facilitating start-up activities. Awardee
activities for this program are as follows:
1. Translate scientifically evaluated
interventions for children with a Fetal
Alcohol Syndrome Disorder (FASD) for
use in community settings through
partnership with a community agency
(e.g., school, health department, state
service organization) and to adapt each
intervention to the resources;
infrastructure, and personnel of their
partner;
2. Demonstrate the utility and
scientific credibility of developed
materials and training of community
agencies for implementing these
interventions toward enhancing
cognitive, developmental, or behavioral
outcomes for children with FASD;
3. Work with partner agency to
develop outreach and recruitment
procedures for identification of affected
children and their families from
multiple sources to maximize the
possibility of ascertaining participants;
CDC Responsibilities
In a cooperative agreement, CDC staff
is substantially involved in the program
activities, above and beyond routine
grant monitoring. In this cooperative
agreement, CDC Scientists (Scientific
Collaborator) within the National Center
on Birth Defects and Developmental
Disabilities (NCBDDD) are an equal
partner with scientific and
programmatic involvement during the
conduct of the project through technical
assistance, advice, and coordination.
Scientific Collaborators will:
1. Use their experience in studies of
this nature to advise the project on
specific questions regarding the projectdeveloped protocol;
2. As requested, assist the project in
responding to inquiries regarding such
areas as data management, data analysis,
intervention design, family dynamics,
formats for presenting research findings,
and in comparing project-developed
evaluation formats with other research
projects and activities known to CDC;
3. Provide scientific consultation and
technical assistance as requested on
questions related to epidemiology,
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statistical and power calculations, and
data storage and tracking formats used
in other CDC sponsored research that
could be advantageous to the project;
and
4. Suggest to the project upon request;
processes for analysis, interpretation,
and reporting of findings in the
literature that can serve a broad range of
scientific interests.
CDC Scientific Program Administrator
(SPA)
The CDC NCBDDD will appoint an
SPA, apart from the NCBDDD Scientific
Collaborator who will:
1. Serve as the Program Official for
the funded research institutions.
2. Carry out continuous review of all
activities to ensure objectives are being
met.
3. Attend Coordinating Committee
meetings for purposes of assessing
overall progress and for program
evaluation purposes.
4. Provide scientific consultation and
technical assistance in the conduct of
the project as requested.
5. Conduct site visits to recipient
institutions to determine the adequacy
of the research and to monitor
performance against approved project
objectives.
Collaborative Responsibilities
The planning and implementation of
the cooperative aspects of the study will
be effected by a coordinating committee
consisting of the Principal Investigator
from the organizations receiving awards
under this program and the CDC
Scientific Collaborator. Organizations
serving as sub-contractors under
awarded projects are not considered
members of the coordinating committee.
This coordinating committee will
formulate a plan for cooperative
research and address issues of common
concern throughout the life of the
project.
At periodic coordination committee
meetings, the group will: (1) Make
recommendations on the study protocol
and data collection approaches; (2)
discuss common protocols as they relate
to neuro-development assessment data
from children participating in
community-based interventions,
development of a cross-site
collaborative database of testing results,
and collecting cost estimates for each
intervention; (3) discuss the target
populations that have been or will be
recruited; (4) identify and recommend
solutions to unexpected study problems;
and (5) discuss ways to efficiently
coordinate study activities and best
practices.
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II. Award Information
Type of Award: Cooperative
agreement.
CDC involvement in this program is
listed in the Activities Section above.
Mechanism of Support: U84 (The
Administrative Code for FAS
cooperative agreements).
Fiscal Year Funds: 2005.
Approximate Total Funding:
$1,500,000. The estimated funding
amount is pending availability of FY
2005 funds, and is subject to change.
Approximate Number of Awards:
Five.
Approximate Average Award:
$300,000. This amount is for the first
12-month budget period for each of the
five awarded projects, and includes both
direct and indirect costs.
Floor of Award Range: $300,000.
Ceiling of Award Range: $300,000.
Anticipated Award Date: August 1,
2005.
Budget Period Length: 12 months.
Project Period Length: Four 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.I. Eligible Applicants
Eligibility is limited to those projects
previously funded under CDC Program
Announcement Number 01074; FAS
Neuro-development Disorders in
Children and/or Adolescents. They
include the University of California, Los
Angeles; Children’s Research Triangle,
Chicago, IL; Kennedy Krieger Institute,
Baltimore, MD (with the project located
at the Marcus Institute in Atlanta, GA);
University of Oklahoma Health Sciences
Center; and the University of
Washington. This limited eligibility is
based on sustaining support to wellestablished projects, and to take
advantage of the foundation and
multiple systems developed over time
and now in place to identify and impact
on the lives of individuals with FAS
and their families.
III.2. Cost Sharing or Matching
Matching funds are not required for
this program.
III.3. Other
If you request a funding level greater
than the upper threshold, your
application will not be eligible for
review. You will be notified that you
did not meet submission requirements.
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Special Requirements
If your application is incomplete or
non-responsive to the requirements
listed below, it will not be entered into
the review process. You will be notified
that your application did not meet
submission requirements.
Applicants must document their
present infrastructure, capacity,
expertise, and experience (within
organization or within organizations of
collaborators) in conducting research
directly related to the awardee activities
cited in this announcement.
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.
Individuals Eligible to Become
Principal Investigators: Any individual
with the skills, knowledge, and
resources necessary to carry out the
proposed research is invited to work
with their institution to develop an
application for support. Individuals
from under-represented racial and
ethnic groups as well as individuals
with disabilities are always encouraged
to apply for CDC programs.
IV. Application and Submission
Information
IV.1 Address To Request Application
Package
To apply for this funding opportunity,
use application form PHS 398 (OMB
number 0925–0001 rev. 11/2004). Forms
and instructions are available in an
interactive format on the CDC Web site,
at the following Internet address:
https://www.cdc.gov/od/pgo/
forminfo.htm.
Forms and instructions are also
available in an interactive format on the
National Institutes of Health (NIH) Web
site at the following Internet address:
https://grants.nih.gov/grants/funding/
phs398/phs398.html.
If you do not have access to the
Internet, or if you have difficulty
accessing the forms on-line, you may
contact the CDC Procurement and
Grants Office Technical Information
Management Section (PGO–TIM) staff
at: 770–488–2700. Application forms
can be mailed to you.
IV.2. Content and Form of Application
Submission
Application: Follow the PHS 398
application instructions for content and
formatting of your application. If the
instructions in this announcement differ
in any way from the PHS 398
instructions, follow the instructions in
this announcement. For further
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assistance with the PHS 398 application
form, contact PGO-TIM staff at (770)
488–2700, or contact Grants Info,
Telephone (301) 435–0714, E-mail:
GrantsInfo@nih.gov.
You are 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. Your DUNS
number must be entered on line 11 of
the face page of the PHS 398 application
form. 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 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/
pubcommt.htm.
This announcement uses the nonmodular budgeting format. See: https://
grants.nih.gov/grants/funding/modular/
modular.htm.
The PHS 398 grant application form
requires the applicant to enter the
project title on page 1 (Form AA, ‘‘Face
Page’’) and the project description
(abstract on page 2).
The main body of the application
narrative should not exceed 25 singlespaced pages. This narrative research
plan should address activities to be
conducted over the entire project
period.
Additional information may be
included in the application appendices.
The appendices will not be counted
toward the narrative page limit. This
additional information may include
´
´
curriculum vitae and resumes for key
project staff, organizational charts,
letters of commitment and support,
graphic work plan with time intervals
related to goals and objectives, etc.; and
should be limited to those items
relevant to the requirements of this
announcement. Applicants must
provide a graphic work plan that
outlines major goals and objectives with
timelines established for each calendar
quarter covering the entire project
period.
All material must be typewritten, with
10 characters per inch type (12 point) on
8 -1⁄2 by 11 inch white paper with one
inch margins, no headers or footers
(except for applicant-produced forms
such as organizational charts, c. vitae,
graphs and tables, etc). Applications
must be held together only by rubber
bands or metal clips, and not bound
together in anyway (including
attachments/appendices).
Additional requirements that may
require you to submit additional
documentation with your application
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are listed in section ‘‘VI.2.
Administrative and National Policy
Requirements.’’
IV.3. Submission Dates and Time
Application Deadline Date: May 26,
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. If you send your application by the
appropriate postal service or
commercial delivery service, you must
ensure that the carrier will be able to
guarantee delivery of the application by
the closing date and time. If CDC
receives your application after closing
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, you will be
given the opportunity to submit
documentation of the carrier’s
guarantee. If the documentation verifies
a carrier problem, CDC will consider the
application as having been received by
the deadline.
This announcement is the definitive
guide on the application submission
address and deadline. It supersedes
information provided in the application
instructions. If your application does
not meet the deadline above, it will not
be eligible for review, and will be
discarded. You will be notified that
your application did not meet the
submission requirements.
CDC will not notify you upon receipt
of your submission. If you have a
question about the receipt of your
application, first contact your courier. If
you still have a question, contact the
PGO-TIM staff at: 770–488–2700. Before
calling, please wait two to three days
after the submission deadline. This will
allow time for submissions to be
processed and logged.
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:
• Project funds cannot be used to
supplant other available applicant or
collaborating agency funds for
construction or for lease or purchase of
facilities or space.
• Funds may be spent for reasonable
program purposes, including personnel,
travel, supplies, and services.
Equipment may be purchased if deemed
necessary to accomplish program
objectives, however, prior approval by
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CDC officials must be requested in
writing.
• The applicant may contract with
other organizations under this program;
however the applicant must perform a
substantial portion of the activities
(including program management and
operations, and delivery of prevention
services for which funds are required).
• If you are requesting indirect costs
in your budget, you must include a copy
of your indirect cost rate agreement. If
your indirect cost rate is a provisional
rate, the agreement must be less than 12
months from the application due date.
IV.6. Other Submission Requirements
Application Submission Address:
Submit the original and one hard copy
of your application by mail or express
delivery service to: Technical
Information Management—RFA DD05–
079, CDC Procurement and Grants
Office, 2920 Brandywine Road, Atlanta,
Georgia 30341.
At the time of submission, four
additional copies of the application, and
all appendices must be sent via
overnight commercial carrier to: Dr.
Kathleen Madden, Office of Public
Health Research (OPHR), 1 West Court
Square, Suite 7000, Room 7008,
Mailstop D–72, Decatur, Georgia 30030,
E-mail address: kmn0@cdc.gov.
V. Application Review Information:
V.1. Criteria
You are required to provide measures
of outcome and effectiveness that will
demonstrate the accomplishment of the
various identified objectives for each
stage 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.
In the written comments, reviewers
will be asked to evaluate the application
in order to judge the likelihood that the
proposed research will have a
substantial impact on the pursuit of
these goals. The scientific review group
will address the applications’ overall
score, weighting them as appropriate for
each application. The application does
not need to be strong in all categories to
be judged likely to have major scientific
impact and thus deserve a high priority
score.
Under the evaluation criteria noted
below, applicants must describe how
they will address the program
components as they relate to the
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Purpose and Research Objectives, and
Recipient Activities as cited in this
Announcement.
Your application will be evaluated
against the following criteria. Please
ensure that your narrative describes not
only what will be done, but how and
through what tasks and activities the
work will be undertaken:
1. Resources and Organizational
Capacity, including but not limited to
applicant experience, within its
organization and with collaborating
partners to meet all the requirements of
this announcement; and a demonstrated
ability to assemble a team with the
experience and time commitments to
dedicate full attention to all planning,
implementation, and outcome
assessment components of the project.
2. Methods and Activities, including
but not limited to ensuring that
proposed methods and activities
convincingly and comprehensively meet
the intention and goals of the
announcement; that the methods and
activities are feasible within scientific,
programmatic and fiscal constraints and
will produce accurate, valid and reliable
data; that the calculated statistical
power and the potential capacity of the
research design is adequate to generate
meaningful results during the study
period; and that the design can be easily
replicated for future use by sponsoring
organizations including the
dissemination of findings and
recommendations for the benefit of
other agencies.
3. Management, Staffing, and
Objectives, including evidence that the
applicant has sufficient scientific and
management resources for project
planning and data management/
analysis; that the proposed staffing, staff
qualifications, experience, and project
organization are sufficient to
accomplish the objectives of the
program; and that the project goals and
objectives can be accomplished through
the proposed methods and within the
proposed timeline.
4. Evaluation Plan, including that the
evaluation components described in the
announcement have been addressed in
the proposal; that the measurable
objectives included in the methods
proposed are appropriate for the
measurable objectives; and that the
evaluation plan includes a process for
overall evaluation of sub-components
and the entire project, including the
assignment of responsibility for ongoing
review of all specified components.
5. Budget Description and
Justification, including the
comprehensiveness and adequacy of the
proposed budget in relation to program
operations, collaborations, and services;
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and the extent to which the budget is
reasonable, clearly justified, accurate,
and consistent with the purposes of this
research.
6. Protections: Does the application
adequately address the requirements of
45 CFR Part 46 for the protection of
human subjects? This criteria will not
be scored; however, an application can
be disapproved if the research risks are
sufficiently serious and protection
against risks is so inadequate as to make
the entire application unacceptable.
7. Inclusion: Does the application
adequately address the CDC policy
requirements regarding the inclusion of
women, ethnic, and racial groups in the
proposed research? This includes:
a. The proposed plan for the inclusion
of both sexes and racial and ethnic
minority populations for appropriate
representation.
b. The proposed justification when
representation is limited or absent.
c. A statement as to whether the
design of the study is adequate to
measure differences when warranted.
d. A statement as to whether the plans
for recruitment and outreach for study
participants include the process of
establishing partnerships with
community(ies) and recognition of
mutual benefits.
V.2. Review and Selection Process
Applications will be reviewed for
completeness by the Procurement and
Grants Office (PGO) and for
responsiveness by OPHR. Incomplete
applications and applications that are
non-responsive as to the eligibility
criteria and other eligibility
requirements will not advance through
the review process. Applicants will be
notified that their application did not
meet submission requirements and will
not receive further consideration.
Applications, which are complete and
responsive, will be subjected to a
preliminary evaluation (triage) by the
scientific review group (Special
Emphasis Panel—SEP) composed of
external (non-CDC) peer reviewers to
determine if the application is of
sufficient technical and scientific merit
to warrant further review by the SEP.
Applications that are determined to be
non-competitive will not be considered.
Subsequent to the review meeting CDC
will notify the investigator/program
director and the official signing for the
applicant organization of that
determination.
Applications determined to be
competitive will then be reviewed and
scored under the formal SEP peer
review process. The review of these
fully competitive applications will
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result in the determination of the score
and ranking for those applications.
Subsequent to the formal peer review
by the SEP, a second level of review will
be conducted by senior CDC program
staff. This review is not intended to
revisit the scientific merit of the
applications. It is designed to review
and discuss issues related to the
adequacy and justification of the
proposed budgets and funding ceilings,
and to review the overall rating and
ranking of all recommended
applications. This will be done in order
to prepare recommendations for funding
based on the scientific merit as
determined by the SEP; and to ensure
that the recommendations are consistent
and compatible with the Review and
Selection section of the original program
announcement.
V.3. Anticipated Award Date:
August 1, 2005.
VI. Award Administration Information
VI.1. Award Notices: If your
application is to be funded, you 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
45 CFR Parts 74 and 92.
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. The following additional
requirements apply to this project:
• AR–1: Human Subjects
Requirements
• AR–2: Requirement for Inclusion of
Women and Racial and Ethnic
Minorities in Research
• AR–10: Smoke-Free Workplace
Requirements
• AR–11: Healthy People 2010
• AR–12: Lobbying Restrictions
• AR–22: Research Integrity
• AR–25: Release and Sharing of Data
Projects that involve the collection of
information from 10 or more individuals
and funded by cooperative agreement
will be subject to review by the Office
of Management and Budget under the
Paperwork Reduction Act.
Additional information on these
requirements can be found on the CDC
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11APN1
Federal Register / Vol. 70, No. 68 / Monday, April 11, 2005 / Notices
web site at the following Internet
address: https://www.cdc.gov/od/pgo/
funding/ARs.htm.
VI.3. Reporting
You must provide CDC with an
original, plus two copies of the
following reports:
1. Interim progress report, (PHS 2590,
OMB Number 0925–0001, rev. 11/2004),
on a date to be determined for your
project for each subsequent budget year.
The progress report will serve as your
non-competing continuation
application, and must contain the
following elements:
a. Current Budget Period Activities
and Objectives.
b. Current Budget Period Financial
Progress.
c. New Budget Period Program
Proposed Activities and Objectives.
d. Budget.
e. Additional Requested Information.
f. Measures of Effectiveness.
2. Financial status report and annual
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 sent to the
Grants Management 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 (PGO–
TIM), CDC Procurement and Grants
Office, 2920 Brandywine Road, Atlanta,
Georgia 30341, Telephone: 770–488–
2700.
For program technical assistance,
contact: Don Lollar, Ed.D., National
Center on Birth Defects and
Developmental Disabilities, CDC, 1600
Clifton Road, Mailstop E–87, Atlanta,
Georgia 30333, E-Mail Address:
dlollar@cdc.gov. Telephone: 404–498–
3041.
For budget assistance, contact:
Nealean Austin, Grants Management
Specialist, CDC Procurement and Grants
Office, 2920 Brandywine Road, Atlanta,
Georgia 30341, Telephone: 770–488–
2814, E-mail: naustin@cdc.gov.
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.’’
17:45 Apr 08, 2005
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel: Mining Occupational
Safety and Health Research, Request
for Application OH–05–005; Correction
Correction: This notice was published
in the Federal Register on March 31,
2005, Volume 70, Number 61, page
16505. The meeting location has been
changed.
Meeting Location: Hyatt Regency
Baltimore, 300 Light Street, Baltimore,
MD 21202.
FOR FURTHER INFORMATION CONTACT:
George Bockosh, MS, Scientific Review
Administrator, National Institute for
Occupational Safety and Health, CDC,
National Personal Protective
Technology Laboratory, 626 Cochrans
Mill Road, Pittsburgh, PA 15236,
Telephone (412) 386–6465.
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: April 5, 2005.
Alvin Hall,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 05–7148 Filed 4–8–05; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Antiviral Drugs Advisory Committee;
Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
VIII. Other Information
VerDate jul<14>2003
Dated: April 5, 2005.
William P. Nichols,
Director, Procurement and Grants Office,
Centers for Disease Control and Prevention.
[FR Doc. 05–7147 Filed 4–8–05; 8:45 am]
Jkt 205001
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
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18405
Name of Committee: Antiviral Drugs
Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on May 19, 2005, from 8 a.m. to 5
p.m.
Location: Hilton Washington DC
North/Gaithersburg, Salons A, B, and C,
620 Perry Pkwy., Gaithersburg, MD.
Contact Person: Anuja Patel, Center
for Drug Evaluation and Research (HFD–
21), Food and Drug Administration,
5600 Fishers Lane (for express delivery,
5630 Fishers Lane, rm. 1093), Rockville,
MD 20857, 301–827–7001, FAX: 301–
827–6776, e-mail: patela@cder.fda.gov,
or FDA Advisory Committee
Information Line, 1–800–741–8138
(301–443–0572 in the Washington, DC
area), code 3014512531. Please call the
Information Line for up-to-date
information on this meeting.
Agenda: The committee will discuss
new drug application (NDA) 021–814,
proposed trade name APTIVUS
(Tipranavir) 250 milligram capsules,
Boehringer Ingelheim Pharmaceuticals,
Inc., indicated for the treatment of
patients with human immunodeficiency
virus (HIV).
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person by May 6, 2005. Oral
presentations from the public will be
scheduled between approximately 1
p.m. and 2 p.m. Time allotted for each
presentation may be limited. Those
desiring to make formal oral
presentations should notify the contact
person before May 6, 2005, and submit
a brief statement of the general nature of
the evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
requested to make their presentation.
Persons attending FDA’s advisory
committee meetings are advised that the
agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Angie
Whitacre at 301–827–7001, at least 7
days in advance of the meeting.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
E:\FR\FM\11APN1.SGM
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Agencies
[Federal Register Volume 70, Number 68 (Monday, April 11, 2005)]
[Notices]
[Pages 18400-18405]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-7147]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Interventions for Individuals With Fetal Alcohol Syndrome:
Transitioning Science to Community Projects
Announcement Type: New.
Funding Opportunity Number: RFA DD05-079.
Catalog of Federal Domestic Assistance Number: 93.283.
Key Dates:
Application Deadline: May 26, 2005.
I. Funding Opportunity Description
Authority: This program is authorized under Sections 317(k)(2)
and 317C of the Public Health Service Act, (42 U.S.C. 247b(k)(2) and
247b-(4), as amended.
Purpose:
The purpose of this cooperative agreement is to implement the
continuation of a directive within the Children's Health Act of 2000 to
develop and scientifically evaluate interventions for children and
adolescents affected by Fetal Alcohol Syndrome (FAS) or other
conditions resulting from prenatal alcohol exposure and their families.
Interventions were developed to (1) improve developmental outcomes, (2)
prevent secondary conditions, and (3) provide education and support to
caregivers and families. The primary objective of this program is to
translate successful or promising scientifically evaluated
interventions for children with FAS to community settings.
This program addresses the ``Healthy People 2010'' focus areas of
Substance Abuse and Maternal, Infant, and Child Health.
Measurable outcomes of the program will be in alignment with FAS-
related performance goals for the National Center on Birth Defects and
Developmental Disabilities that include establishing new, or enhancing
existing prevention programs designed to reduce the prevalence of FAS,
reduce prenatal exposure to alcohol, and improve and/or link children
currently affected by FAS to health services.
Research Objectives and Background
Development of interventions and public health programs often occur
in large research-oriented medical schools and universities. These
settings provide a large number of intellectual and logistical
resources that facilitate development of state-of-the-art interventions
and programs. Frequently however, developed programs are
[[Page 18401]]
simply released to community agencies who must determine how best to
adapt and implement the programs; otherwise the interventions languish
in scientific journals without community implementation. This program
seeks to bridge the transition between research-based development of
interventions and community implementation of these interventions.
The benefit of intervention, especially early intervention, for
individuals with developmental disabilities has long been proven in the
scientific and community programs literatures. Until recently,
information and strategies for interventions specific to individuals
with FAS has been gleaned from other disabilities, and the wisdom
gained by parents has been achieved through trial and error and shared
through informal networks. Although informative to a limited degree,
such treatments have been implemented without being evaluated
systematically or scientifically.
To increase scientific understanding of the spectrum of disorders
associated with prenatal alcohol exposure, recipients should develop
mechanisms to obtain neuro-development assessment data from children
participating in the community-based interventions, and estimate and
compare economic costs and benefits of prescribed interventions in the
community setting.
Hence, the approach of the current cooperative agreement (RFA DD05-
079) will be for each funded site to work with a community agency to
adapt their program to the community setting. In the later stages of
the program, each site will document the intervention process such as
through a working manual or guidance, and initiate a train-the-trainer
type program to facilitate even broader dissemination of these
scientifically evaluated interventions for children with FAS.
In 2001, CDC provided the first federal funding to develop
systematic, specific, and scientifically evaluated interventions
appropriate for children with FAS and their families.
Under that competitive announcement, awards were made to five
recipients to conduct interventions with the aim of improving the
developmental outcomes of individuals with FAS, reducing secondary
conditions, and improving the lives of families affected by FAS.
For each site, children in both treatment and control groups
received comprehensive multi-disciplinary assessments that guided
referrals for standard care and services as indicated (e.g., speech
therapy, special education). Beyond assessment and standard care,
children in the treatment groups also received interventions
specifically designed to focus on one of the core vulnerabilities
associated with FAS: mathematical skills, social communication, peer
relations, foster care stability, compliance, learning readiness, and
challenging behaviors. All sites included specific instruction and
training for parents and caregivers as part of the treatment process.
Final analyses and submission of articles to scientific journals is
anticipated in late 2005.
Thus, this announcement seeks to build upon previous activities and
foundation building in partnering with community agencies, employing a
study design to include outcome assessment data and documenting
performance toward process and time-bounded objectives, and
implementing a dissemination program to publicize approaches,
collaborations, and results.
In effect, these five recipients should have completed or be
nearing completion of intervention research that has: Concluded data
collection; completed or is advanced in data analysis; measured
behavioral and/or health outcomes related to intervention(s) for
individuals with prenatal alcohol exposure; collected pre- and post-
test data, used treatment and control/comparison groups with random
assignment; and evaluated the effectiveness of intervention(s) using
quantitative statistics.
Activities
Project activities should focus on tailoring and adapting a proven
intervention to community settings and facilitating start-up
activities. Awardee activities for this program are as follows:
1. Translate scientifically evaluated interventions for children
with a Fetal Alcohol Syndrome Disorder (FASD) for use in community
settings through partnership with a community agency (e.g., school,
health department, state service organization) and to adapt each
intervention to the resources; infrastructure, and personnel of their
partner;
2. Demonstrate the utility and scientific credibility of developed
materials and training of community agencies for implementing these
interventions toward enhancing cognitive, developmental, or behavioral
outcomes for children with FASD;
3. Work with partner agency to develop outreach and recruitment
procedures for identification of affected children and their families
from multiple sources to maximize the possibility of ascertaining
participants;
4. Develop mechanisms to identify core elements of intervention
necessary to ensure fidelity of implementation;
5. Disseminate these scientifically evaluated and proven credible
interventions for children with FAS by development of a train-the-
trainer or other similar programs to be offered to appropriate
professionals (e.g., medical and allied health, education, case
managers, etc);
6. Facilitate definition of the full spectrum of neuro-
developmental disabilities associated with prenatal exposure to alcohol
and its consequences by development of a cross-site collaborative
database including: (a) Neuro-developmental testing results for
children with FAS or other prenatal alcohol exposure related conditions
in the community setting; and (b) outcomes;
7. Subsequent to definition of variables to be included in
development of the database and the convening of investigators from
other funded projects, discuss and develop a common protocol that could
be implemented for obtaining assessment data from children, and in
determining outcomes, costs and benefits of each intervention;
8. Prepare scientific reports for publication that document the
translated research study findings. The dissemination effort should
seek to convert interventions into packages of ``how to'' materials for
use in community settings for implementing the target intervention.
CDC Responsibilities
In a cooperative agreement, CDC staff is substantially involved in
the program activities, above and beyond routine grant monitoring. In
this cooperative agreement, CDC Scientists (Scientific Collaborator)
within the National Center on Birth Defects and Developmental
Disabilities (NCBDDD) are an equal partner with scientific and
programmatic involvement during the conduct of the project through
technical assistance, advice, and coordination. Scientific
Collaborators will:
1. Use their experience in studies of this nature to advise the
project on specific questions regarding the project-developed protocol;
2. As requested, assist the project in responding to inquiries
regarding such areas as data management, data analysis, intervention
design, family dynamics, formats for presenting research findings, and
in comparing project-developed evaluation formats with other research
projects and activities known to CDC;
3. Provide scientific consultation and technical assistance as
requested on questions related to epidemiology,
[[Page 18402]]
statistical and power calculations, and data storage and tracking
formats used in other CDC sponsored research that could be advantageous
to the project; and
4. Suggest to the project upon request; processes for analysis,
interpretation, and reporting of findings in the literature that can
serve a broad range of scientific interests.
CDC Scientific Program Administrator (SPA)
The CDC NCBDDD will appoint an SPA, apart from the NCBDDD
Scientific Collaborator who will:
1. Serve as the Program Official for the funded research
institutions.
2. Carry out continuous review of all activities to ensure
objectives are being met.
3. Attend Coordinating Committee meetings for purposes of assessing
overall progress and for program evaluation purposes.
4. Provide scientific consultation and technical assistance in the
conduct of the project as requested.
5. Conduct site visits to recipient institutions to determine the
adequacy of the research and to monitor performance against approved
project objectives.
Collaborative Responsibilities
The planning and implementation of the cooperative aspects of the
study will be effected by a coordinating committee consisting of the
Principal Investigator from the organizations receiving awards under
this program and the CDC Scientific Collaborator. Organizations serving
as sub-contractors under awarded projects are not considered members of
the coordinating committee. This coordinating committee will formulate
a plan for cooperative research and address issues of common concern
throughout the life of the project.
At periodic coordination committee meetings, the group will: (1)
Make recommendations on the study protocol and data collection
approaches; (2) discuss common protocols as they relate to neuro-
development assessment data from children participating in community-
based interventions, development of a cross-site collaborative database
of testing results, and collecting cost estimates for each
intervention; (3) discuss the target populations that have been or will
be recruited; (4) identify and recommend solutions to unexpected study
problems; and (5) discuss ways to efficiently coordinate study
activities and best practices.
II. Award Information
Type of Award: Cooperative agreement.
CDC involvement in this program is listed in the Activities Section
above.
Mechanism of Support: U84 (The Administrative Code for FAS
cooperative agreements).
Fiscal Year Funds: 2005.
Approximate Total Funding: $1,500,000. The estimated funding amount
is pending availability of FY 2005 funds, and is subject to change.
Approximate Number of Awards: Five.
Approximate Average Award: $300,000. This amount is for the first
12-month budget period for each of the five awarded projects, and
includes both direct and indirect costs.
Floor of Award Range: $300,000.
Ceiling of Award Range: $300,000.
Anticipated Award Date: August 1, 2005.
Budget Period Length: 12 months.
Project Period Length: Four 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.I. Eligible Applicants
Eligibility is limited to those projects previously funded under
CDC Program Announcement Number 01074; FAS Neuro-development Disorders
in Children and/or Adolescents. They include the University of
California, Los Angeles; Children's Research Triangle, Chicago, IL;
Kennedy Krieger Institute, Baltimore, MD (with the project located at
the Marcus Institute in Atlanta, GA); University of Oklahoma Health
Sciences Center; and the University of Washington. This limited
eligibility is based on sustaining support to well-established
projects, and to take advantage of the foundation and multiple systems
developed over time and now in place to identify and impact on the
lives of individuals with FAS and their families.
III.2. Cost Sharing or Matching
Matching funds are not required for this program.
III.3. Other
If you request a funding level greater than the upper threshold,
your application will not be eligible for review. You will be notified
that you did not meet submission requirements.
Special Requirements
If your application is incomplete or non-responsive to the
requirements listed below, it will not be entered into the review
process. You will be notified that your application did not meet
submission requirements.
Applicants must document their present infrastructure, capacity,
expertise, and experience (within organization or within organizations
of collaborators) in conducting research directly related to the
awardee activities cited in this announcement.
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.
Individuals Eligible to Become Principal Investigators: Any
individual with the skills, knowledge, and resources necessary to carry
out the proposed research is invited to work with their institution to
develop an application for support. Individuals from under-represented
racial and ethnic groups as well as individuals with disabilities are
always encouraged to apply for CDC programs.
IV. Application and Submission Information
IV.1 Address To Request Application Package
To apply for this funding opportunity, use application form PHS 398
(OMB number 0925-0001 rev. 11/2004). Forms and instructions are
available in an interactive format on the CDC Web site, at the
following Internet address: https://www.cdc.gov/od/pgo/forminfo.htm.
Forms and instructions are also available in an interactive format
on the National Institutes of Health (NIH) Web site at the following
Internet address: https://grants.nih.gov/grants/funding/phs398/
phs398.html.
If you do not have access to the Internet, or if you have
difficulty accessing the forms on-line, you may contact the CDC
Procurement and Grants Office Technical Information Management Section
(PGO-TIM) staff at: 770-488-2700. Application forms can be mailed to
you.
IV.2. Content and Form of Application Submission
Application: Follow the PHS 398 application instructions for
content and formatting of your application. If the instructions in this
announcement differ in any way from the PHS 398 instructions, follow
the instructions in this announcement. For further
[[Page 18403]]
assistance with the PHS 398 application form, contact PGO-TIM staff at
(770) 488-2700, or contact Grants Info, Telephone (301) 435-0714, E-
mail: GrantsInfo@nih.gov.
You are 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. Your DUNS number must be entered
on line 11 of the face page of the PHS 398 application form. 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 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/pubcommt.htm.
This announcement uses the non-modular budgeting format. See:
https://grants.nih.gov/grants/funding/modular/modular.htm.
The PHS 398 grant application form requires the applicant to enter
the project title on page 1 (Form AA, ``Face Page'') and the project
description (abstract on page 2).
The main body of the application narrative should not exceed 25
single-spaced pages. This narrative research plan should address
activities to be conducted over the entire project period.
Additional information may be included in the application
appendices. The appendices will not be counted toward the narrative
page limit. This additional information may include curriculum vitae
and r[eacute]sum[eacute]s for key project staff, organizational charts,
letters of commitment and support, graphic work plan with time
intervals related to goals and objectives, etc.; and should be limited
to those items relevant to the requirements of this announcement.
Applicants must provide a graphic work plan that outlines major goals
and objectives with timelines established for each calendar quarter
covering the entire project period.
All material must be typewritten, with 10 characters per inch type
(12 point) on 8 -\1/2\ by 11 inch white paper with one inch margins, no
headers or footers (except for applicant-produced forms such as
organizational charts, c. vitae, graphs and tables, etc). Applications
must be held together only by rubber bands or metal clips, and not
bound together in anyway (including attachments/appendices).
Additional requirements that may require you to submit additional
documentation with your application are listed in section ``VI.2.
Administrative and National Policy Requirements.''
IV.3. Submission Dates and Time
Application Deadline Date: May 26, 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. If you send your application by the appropriate postal service or
commercial delivery service, you must ensure that the carrier will be
able to guarantee delivery of the application by the closing date and
time. If CDC receives your application after closing 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, you will be given the opportunity to
submit documentation of the carrier's guarantee. If the documentation
verifies a carrier problem, CDC will consider the application as having
been received by the deadline.
This announcement is the definitive guide on the application
submission address and deadline. It supersedes information provided in
the application instructions. If your application does not meet the
deadline above, it will not be eligible for review, and will be
discarded. You will be notified that your application did not meet the
submission requirements.
CDC will not notify you upon receipt of your submission. If you
have a question about the receipt of your application, first contact
your courier. If you still have a question, contact the PGO-TIM staff
at: 770-488-2700. Before calling, please wait two to three days after
the submission deadline. This will allow time for submissions to be
processed and logged.
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:
Project funds cannot be used to supplant other available
applicant or collaborating agency funds for construction or for lease
or purchase of facilities or space.
Funds may be spent for reasonable program purposes,
including personnel, travel, supplies, and services. Equipment may be
purchased if deemed necessary to accomplish program objectives,
however, prior approval by CDC officials must be requested in writing.
The applicant may contract with other organizations under
this program; however the applicant must perform a substantial portion
of the activities (including program management and operations, and
delivery of prevention services for which funds are required).
If you are requesting indirect costs in your budget, you
must include a copy of your indirect cost rate agreement. If your
indirect cost rate is a provisional rate, the agreement must be less
than 12 months from the application due date.
IV.6. Other Submission Requirements
Application Submission Address: Submit the original and one hard
copy of your application by mail or express delivery service to:
Technical Information Management--RFA DD05-079, CDC Procurement and
Grants Office, 2920 Brandywine Road, Atlanta, Georgia 30341.
At the time of submission, four additional copies of the
application, and all appendices must be sent via overnight commercial
carrier to: Dr. Kathleen Madden, Office of Public Health Research
(OPHR), 1 West Court Square, Suite 7000, Room 7008, Mailstop D-72,
Decatur, Georgia 30030, E-mail address: kmn0@cdc.gov.
V. Application Review Information:
V.1. Criteria
You are required to provide measures of outcome and effectiveness
that will demonstrate the accomplishment of the various identified
objectives for each stage 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.
In the written comments, reviewers will be asked to evaluate the
application in order to judge the likelihood that the proposed research
will have a substantial impact on the pursuit of these goals. The
scientific review group will address the applications' overall score,
weighting them as appropriate for each application. The application
does not need to be strong in all categories to be judged likely to
have major scientific impact and thus deserve a high priority score.
Under the evaluation criteria noted below, applicants must describe
how they will address the program components as they relate to the
[[Page 18404]]
Purpose and Research Objectives, and Recipient Activities as cited in
this Announcement.
Your application will be evaluated against the following criteria.
Please ensure that your narrative describes not only what will be done,
but how and through what tasks and activities the work will be
undertaken:
1. Resources and Organizational Capacity, including but not limited
to applicant experience, within its organization and with collaborating
partners to meet all the requirements of this announcement; and a
demonstrated ability to assemble a team with the experience and time
commitments to dedicate full attention to all planning, implementation,
and outcome assessment components of the project.
2. Methods and Activities, including but not limited to ensuring
that proposed methods and activities convincingly and comprehensively
meet the intention and goals of the announcement; that the methods and
activities are feasible within scientific, programmatic and fiscal
constraints and will produce accurate, valid and reliable data; that
the calculated statistical power and the potential capacity of the
research design is adequate to generate meaningful results during the
study period; and that the design can be easily replicated for future
use by sponsoring organizations including the dissemination of findings
and recommendations for the benefit of other agencies.
3. Management, Staffing, and Objectives, including evidence that
the applicant has sufficient scientific and management resources for
project planning and data management/analysis; that the proposed
staffing, staff qualifications, experience, and project organization
are sufficient to accomplish the objectives of the program; and that
the project goals and objectives can be accomplished through the
proposed methods and within the proposed timeline.
4. Evaluation Plan, including that the evaluation components
described in the announcement have been addressed in the proposal; that
the measurable objectives included in the methods proposed are
appropriate for the measurable objectives; and that the evaluation plan
includes a process for overall evaluation of sub-components and the
entire project, including the assignment of responsibility for ongoing
review of all specified components.
5. Budget Description and Justification, including the
comprehensiveness and adequacy of the proposed budget in relation to
program operations, collaborations, and services; and the extent to
which the budget is reasonable, clearly justified, accurate, and
consistent with the purposes of this research.
6. Protections: Does the application adequately address the
requirements of 45 CFR Part 46 for the protection of human subjects?
This criteria will not be scored; however, an application can be
disapproved if the research risks are sufficiently serious and
protection against risks is so inadequate as to make the entire
application unacceptable.
7. Inclusion: Does the application adequately address the CDC
policy requirements regarding the inclusion of women, ethnic, and
racial groups in the proposed research? This includes:
a. The proposed plan for the inclusion of both sexes and racial and
ethnic minority populations for appropriate representation.
b. The proposed justification when representation is limited or
absent.
c. A statement as to whether the design of the study is adequate to
measure differences when warranted.
d. A statement as to whether the plans for recruitment and outreach
for study participants include the process of establishing partnerships
with community(ies) and recognition of mutual benefits.
V.2. Review and Selection Process
Applications will be reviewed for completeness by the Procurement
and Grants Office (PGO) and for responsiveness by OPHR. Incomplete
applications and applications that are non-responsive as to the
eligibility criteria and other eligibility requirements will not
advance through the review process. Applicants will be notified that
their application did not meet submission requirements and will not
receive further consideration.
Applications, which are complete and responsive, will be subjected
to a preliminary evaluation (triage) by the scientific review group
(Special Emphasis Panel--SEP) composed of external (non-CDC) peer
reviewers to determine if the application is of sufficient technical
and scientific merit to warrant further review by the SEP. Applications
that are determined to be non-competitive will not be considered.
Subsequent to the review meeting CDC will notify the investigator/
program director and the official signing for the applicant
organization of that determination.
Applications determined to be competitive will then be reviewed and
scored under the formal SEP peer review process. The review of these
fully competitive applications will result in the determination of the
score and ranking for those applications.
Subsequent to the formal peer review by the SEP, a second level of
review will be conducted by senior CDC program staff. This review is
not intended to revisit the scientific merit of the applications. It is
designed to review and discuss issues related to the adequacy and
justification of the proposed budgets and funding ceilings, and to
review the overall rating and ranking of all recommended applications.
This will be done in order to prepare recommendations for funding based
on the scientific merit as determined by the SEP; and to ensure that
the recommendations are consistent and compatible with the Review and
Selection section of the original program announcement.
V.3. Anticipated Award Date:
August 1, 2005.
VI. Award Administration Information
VI.1. Award Notices: If your application is to be funded, you 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
45 CFR Parts 74 and 92.
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. The
following additional requirements apply to this project:
AR-1: Human Subjects Requirements
AR-2: Requirement for Inclusion of Women and Racial and Ethnic
Minorities in Research
AR-10: Smoke-Free Workplace Requirements
AR-11: Healthy People 2010
AR-12: Lobbying Restrictions
AR-22: Research Integrity
AR-25: Release and Sharing of Data
Projects that involve the collection of information from 10 or more
individuals and funded by cooperative agreement will be subject to
review by the Office of Management and Budget under the Paperwork
Reduction Act.
Additional information on these requirements can be found on the
CDC
[[Page 18405]]
web site at the following Internet address: https://www.cdc.gov/od/pgo/
funding/ARs.htm.
VI.3. Reporting
You must provide CDC with an original, plus two copies of the
following reports:
1. Interim progress report, (PHS 2590, OMB Number 0925-0001, rev.
11/2004), on a date to be determined for your project for each
subsequent budget year. The progress report will serve as your non-
competing continuation application, and must contain the following
elements:
a. Current Budget Period Activities and Objectives.
b. Current Budget Period Financial Progress.
c. New Budget Period Program Proposed Activities and Objectives.
d. Budget.
e. Additional Requested Information.
f. Measures of Effectiveness.
2. Financial status report and annual 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 sent to the Grants Management 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 (PGO-TIM),
CDC Procurement and Grants Office, 2920 Brandywine Road, Atlanta,
Georgia 30341, Telephone: 770-488-2700.
For program technical assistance, contact: Don Lollar, Ed.D.,
National Center on Birth Defects and Developmental Disabilities, CDC,
1600 Clifton Road, Mailstop E-87, Atlanta, Georgia 30333, E-Mail
Address: dlollar@cdc.gov. Telephone: 404-498-3041.
For budget assistance, contact: Nealean Austin, Grants Management
Specialist, CDC Procurement and Grants Office, 2920 Brandywine Road,
Atlanta, Georgia 30341, Telephone: 770-488-2814, E-mail:
naustin@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: April 5, 2005.
William P. Nichols,
Director, Procurement and Grants Office, Centers for Disease Control
and Prevention.
[FR Doc. 05-7147 Filed 4-8-05; 8:45 am]
BILLING CODE 4163-18-P