[Federal Register Volume 69, Number 93 (Thursday, May 13, 2004)]
[Notices]
[Pages 26606-26610]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-10856]


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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

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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: 
[email protected].
    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

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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: [email protected].
    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: [email protected].
    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: [email protected].

    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