[Federal Register: May 10, 2005 (Volume 70, Number 89)]
[Notices]
[Page 24594-24598]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10my05-90]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Poliovirus Antibody Seroprevalence Among Inner City Preschool
Children, Post-OPV Era
Announcement Type: New.
Funding Opportunity Number: RFA IP05-103.
Catalog of Federal Domestic Assistance Number: 93.185.
Dates:
Letter of Intent Deadline: June 9, 2005.
Application Deadline: June 24, 2005.
I. Funding Opportunity Description
Authority: Section 317(k)(1) of the Public Health Service Act,
42 U.S.C. 247b(k)(1).
Background: The U.S. transitioned from reliance on oral poliovirus
vaccine (OPV) to exclusive use of inactivated poliovirus vaccine (IPV)
in 2000. To date, no studies have assessed the poliovirus
seroprevalence status of children since the implementation of the all-
IPV schedule in the U.S. Previous studies, done prior to total
cessation of OPV, have been affected by circulating OPV. In 2005, all
children aged 19-35 months, born and raised in
[[Page 24595]]
the U.S. should have received three doses of IPV. Measurement of
poliovirus antibodies is important to determine the risk for a
poliovirus outbreak in the U.S. Should seroprevalence be less than 90
percent of sampled children, efforts can be directed toward prevention
of reintroduction of paralytic poliomyelitis in the U.S.
Purpose: The purpose of the program is to assess susceptibility to
poliovirus among preschool-aged children in the United States in two
inner city communities in an all-IPV era. This program addresses the
``Healthy People 2010'' focus area(s) of Immunization and Infectious
Diseases.
Measurable outcomes of the program will be in alignment with one
(or more) of the following performance goal(s) for the National
Immunization Program (NIP): Reduce the number of, or prevent,
indigenous cases of vaccine-preventable diseases.
Research Objectives:
To assess poliovirus antibody seroprevalence among
preschool children in a population at risk for not being up to date
with poliovirus vaccinations in an all-IPV era.
To determine in this population risk factors for not being
adequately protected against poliovirus in an inner city community.
Activities: Awardee activities for this program are as follows:
Conduct a cross sectional study of serum neutralizing
antibodies for poliovirus types 1, 2, and 3 among 600 children aged 19
months-35 months receiving medical care in an inner city healthcare
system. Children eligible for recruitment are those admitted to the
hospital as a non-critically ill inpatient, or receiving care in an
outpatient clinic emergency department, and having blood drawn for
other indication in an outpatient emergency department; or whose
parents give permission to having blood drawn for the purpose of this
study. Children who have received OPV, or have resided or traveled to
an OPV country, will be excluded. Two cubic centimeters (ccs) of blood
from each child will be collected in a red-top tube or microtainer, and
labeled with a unique identification number. After clotting, all blood
samples will be centrifuged and the sera collected and labeled with the
child's study number. Sera will be stored at -20 degrees C until
transported refrigerated to the Centers for Disease Control and
Prevention.
A sample size of 600 children will provide a precision of
plus or minus 4 percent (assuming simple random sampling) for
estimation of a poliovirus seroprevalence of 90 percent at alpha equal
to 0.05. Precision will be greater for higher actual levels of
seroprevalence. This same sample size has a 99 percent power to detect
a change in prevalence from 95 percent to 80 percent, and a 75 percent
power to detect a change from 90 percent to 80 percent. Eligible
children will be sampled consecutively during predetermined days/time
periods until the target of 600 children is reached.
A standardized questionnaire will be administered to
collect history of vaccination and potential secondary exposure to OPV
through travel or contact with traveler(s). Although poliovirus
vaccination status is the key variable for this analysis, information
on health care coverage and Women, Infants, Children's Supplemental
Feeding Program (WIC) status will be collected to evaluate the
representativeness of the study population. Vaccination status of each
child will be provider verified whenever possible. The questionnaire
should take approximately five minutes to complete.
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:
Provide CDC investigators to monitor the cooperative
agreement as protocol investigators and project officers.
Provide consultation, scientific, and technical assistance
in designing and conducting the project.
Provide laboratory testing of sera specimens.
Assist in the development of Institutional Review Boards
(IRB) approval review by all cooperating institutions and CDC.
Participate in data analysis and interpretation, and co-
authoring manuscripts.
Participate in publication and dissemination of findings.
II. Award Information
Type of Award: Cooperative Agreement.
CDC involvement in this program is listed in the Activities Section
above.
Mechanism of Support: R01.
Fiscal Year Funds: 2005.
Approximate Total Funding: $140,620. (This amount is an estimate
and includes direct and indirect costs, and is subject to availability
of funds.)
Approximate Number of Awards: One.
Approximate Average Award: $140,620 (includes direct and indirect
costs).
Floor of Award Range: None.
Ceiling of Award Range: $140,620 (includes direct and indirect
costs).
Anticipated Award Date: August 31, 2005.
Budget Period Length: 12 months.
Project Period Length: 1 Year.
Throughout the project period, CDC's commitment to continuation of
awards will be conditioned on the availability of funds, evidence of
satisfactory progress by the recipient (as documented in required
reports), and the determination that continued funding is in the best
interest of the Federal Government.
III. Eligibility Information
III.1. Eligible applicants
Applications may be submitted by public and private nonprofit
organizations and by governments and their agencies, such as:
Public nonprofit organizations.
Private nonprofit organizations.
Universities.
Colleges.
Research institutions.
Hospitals.
Community-based organizations.
Faith-based organizations.
Federally recognized Indian tribal governments.
Indian tribes.
Indian tribal organizations.
State and local governments or their Bona Fide Agents
(this includes the District of Columbia, the Commonwealth of Puerto
Rico, the Virgin Islands, the Commonwealth of the Northern Marianna
Islands, American Samoa, Guam, the Federated States of Micronesia, the
Republic of the Marshall Islands, and the Republic of Palau).
Political subdivisions of States (in consultation with
States).
A Bona Fide Agent is an agency/organization identified by the state
as eligible to submit an application under the state eligibility in
lieu of a state application. If you are applying as a bona fide agent
of a state or local government, you must provide a letter from the
state or local government as documentation of your status. Place this
documentation behind the first page of your application form.
III.2. Cost Sharing or Matching
Matching funds are not required for this program.
III.3. Other
CDC will accept and review applications with budgets greater than
the ceiling of the award range.
Special Requirements: If your application is incomplete or non-
[[Page 24596]]
responsive to the requirements listed in this section, it will not be
entered into the review process. You will be notified that your
application did not meet submission requirements.
Late applications will be considered non-responsive. See
section ``IV.3. Submission Dates and Times'' for more information on
deadlines.
Note: Title 2 of the United States Code Section 1611 states that
an organization described in Section 501(c)(4) of the Internal
Revenue Code that engages in lobbying activities is not eligible to
receive Federal funds constituting an award, grant, or loan.
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
encouraged to apply for CDC programs.
Additional Principal Investigator qualifications are as follows:
Previous demonstration of ability to conduct and
successfully complete published peer-reviewed epidemiologic/clinical
studies among a pediatric population on vaccine preventable diseases.
Submission of letters of support.
Be able to initiate and conclude the study in the project
period while fulfilling recruitment goals.
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. 9/2004). 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
Letter of Intent (LOI): Your LOI must be written in the following
format:
Maximum number of pages: Two.
Font size: 12-point unreduced, Single spaced.
Paper size: 8.5 by 11 inches.
Page margin size: One inch. Printed only on one side of page.
Written in plain language, avoid jargon.
Your LOI must contain the following information: Descriptive title
of the proposed research; Name, address, E-mail address, telephone
number, and FAX number of the Principal Investigator; Names of other
key personnel; Participating institutions; Number and title of this
Announcement.
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 Grants Info, 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/pubcommt1.htm.
This announcement uses the modular budgeting as well as non-modular
budgeting formats. See: http://grants.nih.gov/grants/funding/modular/modular.htm
for additional guidance on modular budgets. Specifically,
if you are submitting an application with direct costs in each year of
$250,000 or less, use the modular budget format. Otherwise, follow the
instructions for non-modular budget research grant applications.
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 Times
LOI Deadline Date: June 9, 2005.
CDC requests that you send a LOI if you intend to apply for this
program. Although the LOI is not required, not binding, and does not
enter into the review of your subsequent application, the LOI will be
used to gauge the level of interest in this program, and to allow CDC
to plan the application review.
Application Deadline Date: June 24, 2005.
Explanation of Deadlines: LOIs must be received in the CDC Office
of Public Health Research (OPHR) and applications must be received in
the CDC Procurement and Grants Office by 4 p.m. eastern time on the
deadline date. If you submit your application by the United States
Postal Service or commercial delivery service, you must ensure that the
carrier will be able to guarantee delivery by the closing date and
time. If CDC receives your submission 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 submission as having
been received by the deadline.
This announcement is the definitive guide on LOI and application
content, 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 you 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 LOI or application, first
contact your courier. If you still have a question concerning your LOI,
contact the OPHR staff at 404-371-5277. If you still have a question
concerning your application, 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
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
[[Page 24597]]
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:
Construction.
Real estate lease or purchase.
Vehicle purchase.
Vehicle lease or rental.
Funds relating to the conduct of research will not be
released until the appropriate assurances and IRB approvals are in
place.
Reimbursement of pre-award costs is not allowed.
Awarded funds may not be used for any of the above restrictions
with the exception of vehicle rental associated with necessary travel
directly to accomplish the requirements and for incidental expenses
associated with travel to meetings directly relating to the
requirements.
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.
IV.6. Other Submission Requirements
LOI Submission Address: Submit your LOI by express mail or delivery
service to: Mary Lerchen, DrPH, Scientific Review Administrator, CDC/
Office of Public Health Research, One West Court Square, Suite 7000, MS
D-72. Telephone: 404-371-5277. Fax: 404-371-5215. E-mail:
MLerchen@cdc.gov.
Application Submission Address: Submit the original and one hard
copy of your application by mail or express delivery service to:
Technical Information Management Section-RFA IP05-103, CDC Procurement
and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341.
At the time of submission, four additional copies of the
application and all appendices must be sent to: Mary Lerchen, DrPH,
Scientific Review Administrator, CDC/Office of Public Health Research,
One West Court Square, Suite 7000, MS D-72. Telephone: 404-371-5277.
Fax: 404-371-5215. E-mail: MLerchen@cdc.gov.
Applications may not be submitted electronically at this time.
V. Application Review Information
V.1. Criteria
Applicants are required to provide measures of effectiveness that
will demonstrate the accomplishment of the various identified
objectives of the cooperative agreement. Measures of effectiveness must
relate to the performance goals stated in the ``Purpose'' section of
this announcement. Measures must be objective and quantitative, and
must measure the intended outcome. These measures of effectiveness must
be submitted with the application and will be an element of evaluation.
The goals of CDC-supported research are to advance the
understanding of biological systems, improve the control and prevention
of disease and injury, 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 will
address and consider each of the following criteria equally 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 review criteria are as follows:
Significance: Does this study address poliovirus immunization
status among preschool-aged children in a population at risk for not
being up to date in vaccinations in an all-IPV era?
Approach: Are the conceptual framework, design, methods, and
analyses adequately developed, well-integrated, and appropriate to the
aims of the project? Is the sampling design non-biased? Are the
recruitment goals realistic yet sufficient to estimate poliovirus
seroprevalence among children at risk for not being adequately
immunized? Will the findings be generalizable to other similar
populations in the United States? Does the applicant acknowledge
potential problem areas and consider alternative tactics?
Investigator: Is the investigator 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)? Does the investigator identify an experienced study-
coordinator/research nurse to recruit participants, obtain sera samples
for a pediatric population and process, store and deliver the
specimens? Previous demonstration of ability to conduct and
successfully complete published peer-reviewed epidemiologic/clinical
studies among a pediatric population on vaccine preventable diseases.
Submission of letters of support. Be able to initiate and conclude the
study in the project period while fulfilling recruitment goals.
Environment: Does the scientific environment/study site(s) 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? Is the recruiting site well
described and appropriate for enrolling the target population? Are
laboratory facilities to process, label, and properly store sera
specimens described?
Additional Review Criteria: In addition to the above criteria, the
following items will be considered in the determination of scientific
merit and priority score: Is there evidence that the study site(s) will
have access to a population of preschool-aged children at risk for not
being up to date with vaccinations?
Protection of Human Subjects from Research Risks: Does the
application adequately address the requirements of Title 45 Part 46 for
the protection of human subjects? The involvement of human subjects and
protections from research risk relating to their participation in the
proposed research will be assessed.
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, if
applicable? 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. The priority
score should not be affected by the evaluation of the budget.
[[Page 24598]]
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 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 announcement
will be evaluated for scientific and technical merit by an appropriate
peer review group or charter study section, a Special Emphasis Panel
(SEP), convened by the OPHR in accordance with the review criteria
listed above. As part of the initial merit review, all applications
will:
Undergo a peer review by a SEP. The SEP will be selected
from the NIH pool of scientists or recommendations from the NIP to
serve as reviewers on SEPs. Applications will be ranked for the
secondary review according to scores submitted by the SEP. Only those
applications deemed to have the highest scientific merit by the review
group, generally the top half of the applications under review, will be
discussed and assigned a priority score.
Receive a written critique.
Receive a second programmatic level review by the Office
of Science, NIP.
Award Criteria: Criteria that will be used to make award decisions
during the programmatic review include:
Scientific merit (as determined by peer review).
Availability of funds.
Programmatic priorities.
V.3. Anticipated Announcement and Award Dates:
August 31, 2005.
VI. Award Administration Information
VI.1. Award Notices
Successful applicants will receive a Notice of Award (NoA) from the
CDC Procurement and Grants Office. The NoA shall be the only binding,
authorizing document between the recipient and CDC. The NoA will be
signed by an authorized Grants Management Officer, and mailed to the
recipient fiscal officer identified in the application.
Unsuccessful applicants will receive notification of the results of
the application review by mail.
VI.2. Administrative and National Policy Requirements
45 CFR part 74 and part 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-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-15 Proof of Non-Profit Status.
AR-22 Research Integrity.
AR-23 States and Faith-Based Organizations.
AR-24 Health Insurance Portability and Accountability Act
Requirements.
AR-25 Release and Sharing of Data.
Additional information on these requirements can be found on the
CDC Web site at the following Internet address: http://www.cdc.gov/od/pgo/funding/ARs.htm
.
VI.3. Reporting
You must provide CDC with an original, plus two hard copies of the
following reports:
1. Interim progress report, (use form PHS 2590, OMB Number 0925-
0001, rev. 9/2004 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 additional elements:
a. Progress Toward Measures of Effectiveness.
b. Additional Information Requested by Program.
2. Financial status report, no more than 90 days after the end of
the budget period.
3. Final financial and performance reports, no more than 90 days
after the end of the project period.
These reports must be mailed to the Grants Management Specialist
listed in the ``Agency Contacts'' section of this announcement.
VII. Agency Contacts
We encourage inquiries concerning this announcement. For general
questions, contact: Technical Information Management Section, CDC
Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341.
Telephone: 770-488-2700.
For scientific/research issues, contact: Susan Chu, PhD, MSPH,
Extramural Program Official, Centers for Disease Control and
Prevention, MS E-05, 1600 Clifton Road, Atlanta, GA 30333. Telephone:
404-639-8727. E-mail: SChu@cdc.gov.
For questions about peer review, contact: Mary Lerchen, DrPH,
Scientific Review Administrator, CDC/Office of Public Health Research,
One West Court Square, Suite 7000, MS D-72. Telephone: 404-371-5277.
Fax: 404-371-5215. E-mail: MLerchen@cdc.gov.
For financial, grants management, or budget assistance, contact:
Ann Cole, Grants Management Specialist, CDC Procurement and Grants
Office, 2920 Brandywine Road, Atlanta, GA 30341. Telephone: 770-488-
2686. E-mail: ZLR5@cdc.gov.
VIII. Other Information
This and other CDC funding opportunity announcements can be found
on the CDC Web site, Internet address: http://www.cdc.gov. Click on
``Funding'' then ``Grants and Cooperative Agreements.''
Dated: May 4, 2005.
William P. Nichols,
Director, Procurement and Grants Office, Centers for Disease Control
and Prevention.
[FR Doc. 05-9274 Filed 5-9-05; 8:45 am]
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