Poliovirus Antibody Seroprevalence Among Inner City Preschool Children, Post-OPV Era, 24594-24598 [05-9274]

Agencies

• Centers for Disease Control and Prevention
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 70, Number 89 (Tuesday, May 10, 2005)]
[Notices]
[Pages 24594-24598]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-9274]


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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: 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

    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 https://www.dunandbradstreet.com 
or call 1-866-705-5711. For more information, see the CDC Web site at: 
https://www.cdc.gov/od/pgo/funding/pubcommt1.htm.
    This announcement uses the modular budgeting as well as non-modular 
budgeting formats. See: https://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: 
https://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: 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 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: https://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: https://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]
BILLING CODE 4163-18-P