Announcement Type: New.
Funding Opportunity Number: RFA IP05-093.
Catalog of Federal Domestic Assistance Number: 93.185
Letter of Intent Deadline: June 9, 2005.
Application Deadline: June 24, 2005.
I. Funding Opportunity Description
Disparities in pneumococcal vaccination rates between Blacks and Hispanics 65 years of age and older compared with Whites are substantial and persist after taking into account socioeconomic status and access to care (CDC. “Racial/ethnic disparities in influenza and pneumococcal vaccination levels among persons aged greater than or equal to 65 years—United States, 1989-2001.” “Morbidity and Mortality Weekly Report (MMWR) 2003;” 52:958-62). While attitudes towards vaccination may contribute to these differences, they are unlikely the sole cause. Recent (unpublished) studies that have examined acceptance of vaccination when vaccine is offered systematically have shown no marked differences in acceptance by race/Start Printed Page 24591ethnicity and reasons for non-vaccination do not vary markedly by race/ethnicity. Recent research has highlighted the fact that Blacks and Whites are largely seen by different providers, and that these providers are different both in terms of their training and in terms of the resources available to them (Bach PB et al., “Primary care physicians who treat Blacks and Whites.” “New England Journal of Medicine (NEJM) 2004” 351:575-584). Population-level differences in pneumococcal vaccination may thus reflect differences in immunization practices between medical practices where White patients are seen and those where Black and/or Hispanic patients are seen.
The purpose of this program is to fund research that will determine the extent to which practice-level differences in adult immunization practices may contribute to the disparities observed in pneumococcal vaccination at the population level.
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 the performance goal for the Centers for Disease Control and Prevention's (CDC) National Immunization Program (NIP) to reduce the number of indigenous vaccine-preventable diseases.
Determine if the attributes of practices where Black and/or Hispanic patients are seen compared with practices where Whites are seen contribute to the disparities observed in population pneumococcal vaccination rates.
Awardee activities for this program are as follows:
- Identify a methodology for selecting a sample of clinical settings that are representative of where elderly Blacks and elderly Whites receive primary care in a geographically defined area (city or region).
- Using this methodology recruit a sufficient number of settings for the study to ensure that statistically valid comparisons among medical practice subgroups can be made. This should be demonstrated by sample size estimates and power calculations.
- Although the primary objective is to focus on comparing settings where Blacks and Whites are seen, the project may be expanded to also include settings where Hispanics are seen.
- Blacks (and Hispanics, if applicable) should account for at least 20 percent of the population and Whites should also account for a minimum 20 percent of the population in the geographically defined area.
- Because pneumococcal immunization disparities persist across socioeconomic status (SES), it is important that the study be able to control for this potential confounder, i.e.; a range of SES among practices is important.
- Collect information concerning immunization practices, including, but not limited to:
1. Medical practices facilitating vaccinations through standing orders and telephone or mail reminders;
2. Chart organization that may facilitate or hinder identification of persons needing vaccination;
3. General clinic organization (time spent waiting to see the provider or other staff, and time spent with provider);
4. Collection of information on vaccination coverage rates in sampled practices (either from chart review or from administrative data) to try to correlate provider practices with coverage; and
5. The degree to which patients see same provider over time), and physician knowledge and attitudes about vaccination.
- Although the primary interest is pneumococcal vaccination, activities may be expanded to include influenza vaccination.
- Collaboratively disseminate research findings in peer-reviewed publications and for use in determining national policy.
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 investigator(s) to monitor the cooperative agreement as project officer(s).
- Participate as active project team members in the development, implementation and conduct of the research project and as coauthors of all scientific publications that result from the project.
- Provide technical assistance on the selection and evaluation of data collection and data collection instruments.
- Assist in the development of research protocols for Institutional Review Boards (IRB) review. The CDC IRB will review and approve the project protocol initially and on at least an annual basis until the research project is completed.
- Contribute subject matter expertise in the areas of epidemiologic methods and statistical analysis, and survey research consultation.
- Participate in the analysis and dissemination of information, data and findings from the project, facilitating dissemination of results.
- Serve as liaisons between the recipients of the project award and other administrative units within the CDC.
- Facilitate an annual meeting between awardee and CDC to coordinate planned efforts and review progress.
II. Award Information
Type of Award: Cooperative Agreement. CDC involvement in this program is listed in the Activities Section above.
Mechanism of Support: U01.
Fiscal Year Funds: 2005.
Approximate Total Funding: $250,000. (Includes direct and indirect costs. This amount is an estimate, and is subject to availability of funds.)
Approximate Number of Awards: One.
Approximate Average Award: $250,000. (Includes direct and indirect costs. This amount is for the first 12-month budget period.)
Floor of Award Range: None.
Ceiling of Award Range: $250,000. (Includes direct and indirect costs. This ceiling is for the first 12-month budget period.)
Anticipated Award Date: August 31, 2005.
Budget Period Length: 12 months.
Project Period Length: 2 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 are limited to public and private nonprofit organizations and by governments and their agencies, such as: (For profit organizations are not eligible under Section 317(k)(1) [42 U.S.C. 247b(k)(1) of the Public Health Service Act, as amended.)
- Public nonprofit organizations
- Private nonprofit organizations
- Small, minority, women-owned businesses
- Colleges Start Printed Page 24592
- Research institutions
- 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.
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.
Special Requirements: If your application is incomplete or non-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 always encouraged to apply for CDC programs.
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: 2.
- Font size: 12-point unreduced.
- Double 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 GrantsInfo, Telephone (301)435-0714, E-mail: GrantsInfo@nih.gov.
Your research plan should address activities to be conducted over the entire project period.
You are required to have a Dun and Bradstreet Data Universal Numbering System (DUNS) number to apply for a grant or cooperative agreement from the Federal government. Your DUNS number must be entered on line 11 of the face page of the PHS 398 application form. The DUNS number is a nine-digit identification number, which uniquely identifies business entities. Obtaining a DUNS number is easy and there is no charge. To obtain a DUNS number, access http://www.dunandbradstreet.com or call 1-866-705-5711. For more information, see the CDC Web site at: http://www.cdc.gov/od/pgo/funding/pubcommt1.htm.
This announcement uses the non-modular budgeting format.
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 LOI or 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 Start Printed Page 24593notified 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 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 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:
- 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.
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, delivery service, fax, or e-mail 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 IP05-093, 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
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 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: 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)?
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 letters of support included, if appropriate?
Additional Review Criteria: In addition to the above criteria, the following items will be considered in the determination of scientific merit and priority score: None
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? 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.
V.2. Review and Selection Process
Applications will be reviewed for completeness by the Procurement and Grants Office (PGO) and for responsiveness by the OPHR. Incomplete applications and applications that are non-responsive to the eligibility criteria will not advance Start Printed Page 24594through 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 process in which 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, National Immunization Program.
- 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.
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
Award Date: 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 from the Scientific Review Administrator, NIP.
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-7 Executive Order 12372
- AR-10 Smoke-Free Workplace Requirements
- AR-11 Healthy People 2010
- AR-12 Lobbying Restrictions
- 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.
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 website) 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. 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, National Immunization Program, MS E-05, 1600 Clifton Road NE., 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, MS K-14, 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.
[FR Doc. 05-9270 Filed 5-9-05; 8:45 am]
BILLING CODE 4163-18-P