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Poliovirus Antibody Seroprevalence Among Inner City Preschool Children, Post-OPV Era

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Start Preamble

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

Start Authority

Authority: Section 317(k)(1) of the Public Health Service Act, 42 U.S.C. 247b(k)(1).

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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 Start Printed Page 24595the 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-Start Printed Page 24596responsive 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 Start Printed Page 24597prospective 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. Start Printed 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.”

Start Signature

Dated: May 4, 2005.

William P. Nichols,

Director, Procurement and Grants Office, Centers for Disease Control and Prevention.

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[FR Doc. 05-9274 Filed 5-9-05; 8:45 am]

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