[Federal Register: May 13, 2004 (Volume 69, Number 93)]
[Notices]
[Page 26606-26610]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13my04-129]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Community Preparation for Tuberculosis (TB) Vaccine Trials
Announcement Type: New.
Funding Opportunity Number: 04086.
Catalog of Federal Domestic Assistance Number: 93.947.
Key Dates:
Application Deadline: June 28, 2004.
I. Funding Opportunity Description
Authority: This program is authorized under Sections 301 and
317E (b) of the Public
[[Page 26607]]
Health Service Act, [42 U.S.C. Sections 241 and 247(b)(6)], as
amended.
Purpose: The purpose of the program is for CDC to test new
Tuberculosis (TB) vaccines that have implemented a large-scale
community-based TB vaccine field trial. CDC plans to award cooperative
agreements to ensure that the agency has the opportunity to provide
technical assistance and guidance to this important partnership,
especially with regard to the design and conduct of epidemiologic
studies leading to field trials of new TB vaccines. This program
addresses the ``Healthy People 2010'' focus areas of HIV testing in TB
patients (aged 25 to 44 years); TB--new cases (per 100,000 population);
and curative therapy for TB.
Measurable outcomes of the program will be in alignment with the
following performance goal for the National Center for HIV, STD and TB
Prevention (NCHSTP): Eliminate TB in the United States.
Project and Research Objectives: Prepare communities for large
(over 5,000 subjects) community-based clinical trials for the
evaluation of new vaccine candidates for TB in multiple, diverse,
global locations.
Activities
To assist in the categorization of the activities as human subjects
research (HSR) and not HSR, activities will be divided into two phases,
which do not necessarily have chronological significance.
Awardee activities for this program are as follows:
Phase I
Develop clinical trials training programs and materials,
including Good Clinical Practice procedures for the full range of staff
needed in a large, community-based TB vaccine trial. This will also
include specialized training for establishing local human subjects
review capacity according to international standards.
Develop laboratory capacity for advanced TB diagnosis and
immunologic assays required for TB vaccine trials.
Develop the logistics and systems needed to conduct a
randomized, controlled TB vaccine trial that will meet regulatory
standards.
Develop capacity or referral systems to treat and cure
patients with TB.
Phase II
Conduct epidemiologic studies to characterize the TB
prevalence and incidence in the proposed study area.
Conduct observational cohort studies that will mimic the
conduct of a vaccine trial.
Develop and refine information on TB prevalence and
incidence in neonatal and adolescent cohorts in the proposed vaccine
trials site.
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:
Phase I
Collaborate in providing epidemiologic and technical
assistance in developing infrastructure by assisting training, hiring
personnel, provision of laboratory equipment, and protocol development
for the observational cohort studies.
Collaborate to provide epidemiologic and technical
assistance in the development of clinical trials training programs that
include good clinical practice (GCP) guidelines and ethical standards
in HSR.
Assist in the development of a research protocol for Human
Subjects Research review by all cooperating institutions participating
in the research project.
Facilitate collaboration among international partners such
as, but not limited to, World Health Organization (WHO), International
Union Against Tuberculosis and Lung Disease, the Royal Netherlands
Tuberculosis Association (KNCV), Ministries of Health (MOH), and other
relevant governmental and nongovernmental organizations doing TB
control and public health activities.
Phase II
Collaborate to provide epidemiologic and other technical
assistance (e.g. consultation in operations research methodology,
assistance with training and capacity building) in conducting the
epidemiologic and cohort studies.
Assist in developing and refining information on TB
prevalence and incidence in neonatal and adolescent cohorts in the
vaccine trials sites.
According to U.S. Federal regulations Title 45 CFR Part 46, project
activities fall into three basic categories: Not HSR, HSR requiring
Institutional Review Board (IRB) review, and HSR exempt from IRB
review. Participation by any Federal employee in project activities as
specified by the above CDC activities requires either a determination
that a component activity of the project is not HSR, or if HSR then
approval from either a full CDC IRB or appropriate CDC Official for IRB
exemption from full review. Approvals are required prior to fund
disbursement for that particular component of the project. IRB approved
components of the project must be reviewed annually for continuation
until project completion (which often extends beyond subject
enrollment). Any change to planned project activities as specified in
application for various HSR approvals may necessitate a redetermination
of not HSR status (in consultation with CDC HSR contacts), whereas IRB
approved HSR components of the project require approved IRB amendments.
II. Award Information
Type of Award: Cooperative Agreement CDC involvement in this
program is listed in the Activities Section above.
Fiscal Year Funds: FY 2004.
Approximate Total Funding: $750,000 to $1,000,000 .
Approximate Number of Awards: One.
Approximate Average Award: $750,000 to $1,000,000 (This amount is
for the first 12-month budget period, and includes both direct and
indirect costs.)
Floor of Award Range: None, award is dependent upon availability of
funds.
Ceiling of Award Range: $1,000,000.
Anticipated Award Date: August 1, 2004.
Budget Period Length: 12 months.
Project Period Length: Three 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
Applications may be submitted by all foundations uniquely qualified
to test new TB vaccines, as demonstrated by the implementation and
conduct of a large-scale community-based TB vaccine field trial.
Eligibility is limited in response to Congressional appropriation
language. Funds are available to both International and domestic
applicants. The limitation of the announcement was restricted by
Congressional directive appropriation language. While the Congressional
intent is not clearly described, it is CDC's understanding that this is
in response to success by foundations in this type of vaccine research,
especially
[[Page 26608]]
in high-burden, endemically impacted countries. It is necessary to find
a foundation with a proven history of experience because vaccine
development for human use is an extremely difficult process and must be
handled with precision.
III.2. Cost Sharing or Matching
Matching funds are not required for this program.
III.3. Other
If you request a funding amount greater than the ceiling of the
award range, your application will be considered non-responsive, and
will not be entered into the review process. You will be notified that
your application did not meet the submission 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.
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
underrepresented racial and ethnic groups as well as individuals with
disabilities are always encouraged to apply for CDC programs.
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.
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. 5/2001). Forms and instructions are
available in an interactive format on the CDC Web site, at the
following Internet address: http://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: http://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. For further assistance with
the PHS 398 application form, contact PGO-TIM staff at 770-488-2700, or
contact GrantsInfo, Telephone (301) 435-0714, E-mail:
GrantsInfo@nih.gov.
Your research plan should address activities to be conducted over
the entire project period.
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 http://www.dunandbradstreet.com
or call 1-866-705-5711. For more information, see the CDC Web site at:
http://www.cdc.gov/od/pgo/funding/pubcommt.htm.
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 Date and Time
Application Deadline Date: June 28, 2004.
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 United States 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 carriers 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 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 application. 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 application deadline. This will allow time for applications to be
processed and logged.
IV.4. Intergovernmental Review of Applications
Your application is subject to Intergovernmental Review of Federal
Programs, as governed by Executive Order (EO) 12372. This order sets up
a system for state and local governmental review of proposed federal
assistance applications. You should contact your state single point of
contact (SPOC) as early as possible to alert the SPOC to prospective
applications, and to receive instructions on your state's process.
Click on the following link to get the current SPOC list: http://www.whitehouse.gov/omb/grants/spoc.html
.
IV.5. Funding Restrictions
Restrictions, which must be taken into account while writing your
budget, are as follows: None.
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 should be less than 12
months of age.
Awards will not allow reimbursement of pre-award costs.
IV.6. Other Submission Requirements
Application Submission Address: Submit the original and five copies
of your application by mail or express delivery service to: Technical
Information Management-PA 04086, CDC Procurement and Grants
Office, 2920 Brandywine Road, Atlanta, GA 30341.
Applications may not be submitted electronically at this time.
V. Application Review Information
V.1. Criteria
You 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
[[Page 26609]]
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 goals of CDC-supported research are to advance the
understanding of biological systems, improve the control and prevention
of disease, and enhance health. 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 (which will include non-Federal
experts) will address and consider each of the following criteria in
assigning the application's 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. For example, an
investigator may propose to carry out important work that by its nature
is not innovative, but is essential to move a field forward.
The criteria are as follows:
Significance: Does this study address an important problem? If the
aims of the application are achieved, how will scientific knowledge be
advanced? What will be the effect of these studies on the concepts or
methods that drive this field?
Approach: Are the conceptual framework, design, methods, and
analyses adequately developed, well-integrated, and appropriate to the
aims of the project? Does the applicant acknowledge potential problem
areas and consider alternative tactics?
Innovation: Does the project employ novel concepts, approaches or
methods? Are the aims original and innovative? Does the project
challenge existing paradigms or develop new methodologies or
technologies?
Investigator: Are the investigators appropriately trained and well
suited to carry out this work? Is the work proposed appropriate to the
experience level of the principal investigator and other researchers
(if any)?
Environment: Does the scientific environment in which the work will
be done contribute to the probability of success? Do the proposed
experiments take advantage of unique features of the scientific
environment or employ useful collaborative arrangements? Is there
evidence of institutional support? Are diverse, geographic locations
and populations being considered?
Additional Review Criteria
In addition to the above criteria, the following items will be
considered in the determination of scientific merit and priority score:
Protection of Human Subjects From Research Risks
Does the application adequately address the requirements of 45 CFR
Part 46 for the protection of human subjects? This 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.
Inclusion of Women and Minorities in Research
Does the application adequately address the CDC Policy requirements
regarding the inclusion of women, ethnic, and racial groups in the
proposed research? This includes: (1) The proposed plan for the
inclusion of both sexes and racial and ethnic minority populations for
appropriate representation; (2) The proposed justification when
representation is limited or absent; (3) A statement as to whether the
design of the study is adequate to measure differences when warranted;
and (4) 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.
Budget
The reasonableness of the proposed budget and the requested period
of support in relation to the proposed research.
V.2. Review and Selection Process
Applications will be reviewed for completeness by the Procurement
and Grants Office (PGO), and for responsiveness by NCHSTP. 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.
Applications that are complete and responsive to the PA will be
evaluated for scientific and technical merit by an appropriate peer
review group or charter study section convened by NCHSTP in accordance
with the review criteria listed above. As part of the initial merit
review, all applications may:
Undergo a process in which only those applications deemed
to have the highest scientific merit, generally the top half of the
applications under review, will be discussed and assigned a priority
score.
Receive a written critique.
Receive a second level review by the CDC/NCHSTP/DTBE
Senior Staff.
Award Criteria: Criteria that will be used to make award decisions
include:
Scientific merit (as determined by peer review)
Availability of funds
Programmatic priorities
V.3. Anticipated Announcement and Award Dates
Award Date: August 1, 2004.
VI. Award Administration Information
VI.1. Award Notices
Successful applicants will receive a Notice of Grant Award (NGA)
from the CDC Procurement and Grants Office. The NGA 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
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: http://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 Requirements for Inclusion of Women and Racial and
Ethnic Minorities in Research
AR-4 HIV/AIDS Confidentiality Provisions
AR-5 HIV Program Review Panel Requirements
AR-6 Patient Care
AR-7 Executive Order 12372
AR-8 Public Health System Reporting Requirements
AR-10 Smoke-Free Workplace Requirements
AR-11 Healthy People 2010
AR-12 Lobbying Restrictions
AR-14 Accounting System Requirements
AR-16 Security Clearance Requirement
AR-22 Research Integrity
AR-25 Release and Sharing of Data
Additional information on these requirements can be found on the
CDC
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Web site at the following Internet address: http://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.
5/2001 as posted on the CDC Web site) no less than 90 days before the
end of the budget period. The progress report will serve as your non-
competing continuation application, and must contain the following
elements:
a. Current Budget Period Activities Objectives.
b. Current Budget Period Financial Progress.
c. New Budget Period Program Proposed Activity Objectives.
d. Budget.
e. Additional Requested Information.
f. Measures of Effectiveness.
2. Financial status report and annual progress 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
For general questions about this announcement, contact: Technical
Information Management Section, CDC Procurement and Grants Office, 2920
Brandywine Road, Atlanta, GA 30341, Telephone: 770-488-2700.
For scientific/research issues, contact: Elsa Villarino, Extramural
Project Officer, CDC, National Center for HIV, STD and TB Prevention,
Division of Tuberculosis Elimination, 1600 Clifton Road, Mail stop E10,
Telephone: 404-639-5340, E-mail: evillarino@cdc.gov.
For questions about peer review, contact: Andrew Vernon, Scientific
Review Administrator, CDC, National Center for HIV, STD and TB
Prevention, Office of the Director, Associate Director for Science
Office, Telephone: 404-639-8000, E-mail: avernon@cdc.gov.
For financial, grants management, or budget assistance, contact:
Jesse Robertson, Grants Management Specialist, CDC Procurement and
Grants Office, 2920 Brandywine Road, Atlanta, GA 30341, Telephone: 770-
488-2747, E-mail: jtr4@cdc.gov.
Dated: May 7, 2004.
William P. Nichols,
Acting Director, Procurement and Grants Office, Centers for Disease
Control and Prevention.
[FR Doc. 04-10856 Filed 5-12-04; 8:45 am]
BILLING CODE 4163-18-P