Enhancing Utilization of Childhood Immunization Client Recall Practices by Private Providers, 24807-24812 [05-9372]

Agencies

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

[Federal Register Volume 70, Number 90 (Wednesday, May 11, 2005)]
[Notices]
[Pages 24807-24812]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-9372]



[[Page 24807]]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Enhancing Utilization of Childhood Immunization Client Recall 
Practices by Private Providers

    Announcement Type: New.
    Funding Opportunity Number: RFA IP05-088.
    Catalog of Federal Domestic Assistance Number: 93.185.
    Letter of Intent Deadline: June 10, 2005.
    Application Deadline: June 27, 2005.

I. Funding Opportunity Description

    Authority: Section 311 [42 U.S.C. 243] and 317 (k)(1) [42 U.S.C. 
247b (k)(1)] of the Public Health Service Act, as amended.

Background

    Client recall interventions have been strongly recommended by the 
Task Force of Community Preventive Services as a strategy to increase 
vaccination coverage among infants and young children who have missed 
one or more of vaccinations (``Am J Prev Med 2000''; 18 (1S), 97-140). 
The Task Force has recommended this practice in a range of settings and 
populations and a range of scales (from individual practice settings to 
entire communities), either in isolation or as part of a multifaceted 
program. In addition, studies have been implemented in a range of 
settings, including academic clinical practice, public health settings, 
managed care, private practice, and community-wide settings.
    However, immunization recall interventions have not been widely 
adopted by private practitioners. Nationally, fewer than 20 percent of 
private providers use a recall system (``Pediatrics 2003''; 112:1076-
1082). Several barriers include lack of time and funding and the 
inability to identify children at specific ages. A strong predictor of 
current use of recall messages is having a key person (champion) to 
lead the recall effort. Anecdotal evidence suggests that practitioners 
might have difficulty identifying all age cohorts, but would be more 
willing to identify a cohort of children of a specified age. Data from 
the National Immunization Survey suggests that, by seven months, 46 
percent of infants have fallen behind the recommended schedule, and by 
16 months of age, 31 percent remain behind. These two milestones, 
increasing 7 and 16 months immunization rates, may represent critical 
times when recall interventions could be productive.

Purpose

    The purpose of the program is to increase the use of immunization 
recall office procedures among private practitioners who immunize 
children in a given community. Community is defined as a group of 
practitioners located within a geographic boundary. This program 
addresses the ``Healthy People 2010'' focus area of Immunization and 
Infectious Diseases, specifically the ``Healthy People 2010'' Objective 
14-22, which calls for achieving and maintaining effective vaccination 
coverage levels for universally recommended vaccines among young 
children, using a target goal of 90 percent up-to-date (UTD) 
immunization by 2010 for children 19-35 months old.
    Measurable outcomes of the program will be in alignment with the 
performance goal for the Center for Disease Control and Prevention's 
(CDC) National Immunization Program (NIP) to reduce the number of 
indigenous vaccine-preventable diseases.
    Research Objectives:
     Identify factors that facilitate or impede the use of a 
recall mechanism among private practitioners in a defined community;
     Develop a community-based program to overcome such 
barriers and enhance recall practices throughout the entire geographic 
community; and
     Test how effectively the program results in adoption of 
recall mechanisms by local private providers.

Activities

    Definition: Community-based intervention is defined here as an 
intervention program provided to all primary care physicians 
(principally, pediatricians and family practice physicians) in the 
community. For example, a general education program provided to all 
such physicians in a community concerning the value of using a client 
recall program in their practice would qualify. On the other hand, a 
study involving pre-selection and enrollment of only certain local 
physicians, followed by an intervention provided only to them, even if 
designed to provide them with skills or materials suitable to achieve 
the outcome desired, would not qualify.
    Awardee activities for this program are as follows:
    1. Identify two geographic communities in which relatively few 
primary care providers (suggested range, 10-30 percent of practices) 
use client recall procedures to notify and schedule children in their 
practice to return for an immunization office visit. One community will 
serve as the intervention community, the other as the control. The 
control community should be demographically similar to the intervention 
community, but will not be exposed to the intervention. The control and 
intervention communities must be evaluated at the same time intervals 
and in the same manner during the study.
    2. In both communities, determine the knowledge, attitudes, and 
practices of local private providers and their staff concerning the use 
of client recall procedures in their office practices.
    3. Develop or use existing relationships with university faculty, 
state and/or local health department personnel, and an immunization 
coalition to conduct this study. The participation of each of these 
three groups should be active and substantial. University faculty 
should be qualified and interested in conducting program evaluation 
research.
    4. Develop (or use an existing) coalition (or alternatively, a 
partnership, task force, or advisory board) to periodically monitor and 
provide timely feedback on all programmatic activities. If such a 
coalition does not presently exist, the applicant must describe how 
either a broad-based coalition or advisory board will be developed 
during the first six months. Members should include physicians and 
nurses who treat children, health educators, and pharmacists; officials 
from government health departments and social services; administrative 
representatives from health care organizations, licensed child care 
centers, health maintenance organizations, insurers, and hospitals; and 
interested parents, business, and community leaders.
    5. Within the intervention community, identify practice-based or 
physician-based barriers and facilitators to the establishment and/or 
on-going use of client recall procedures.
    6. Use this information to create, develop, and administer a 
community-based intervention program, as defined above, that is 
designed to overcome identified barriers or optimize the use of 
facilitators to the adoption of client recall procedures. Such methods 
may include the use of education, non-cash incentives, and other, 
preferably novel methods. Program elements should be readily applicable 
to many types of practices, or alternatively, have the capacity to be 
easily tailored to each type of practice. The program may involve, for 
example, academic detailing, equipment purchase, train-the-trainer, 
management and training by

[[Page 24808]]

the state or local health department or local immunization coalition, 
incentives by a local professional organization, or other methods. 
Multifaceted incentive programs are generally preferred over those with 
only one feature.
    7. Recall programs must, at a minimum, target under immunized 
children at two discrete ages, seven months and 16 months old. Special 
attention should be paid to children known to have lived at more than 
one address by their first birthday. At least six cycles should be 
conducted at each age; that is, each practice should conduct monthly 
recalls for seven-month-olds and 16 month-olds at least six times 
during the two-year grant period. Patient recall may be conducted using 
either mail, e-mail, or telephone methods, which may involve personal 
calls or auto-dialer techniques.
    8. Justification should be shown to demonstrate that any motivators 
or (non-cash) reward system is low-cost and cost-efficient.
    9. Assess the feasibility of providing the proposed intervention 
program to the entire community before its full institution.
    10. Provide the program throughout the intervention community over 
two years.
    11. Measure the actual cost of the intervention program from the 
provider's perspective.
    12. Measure the degree to which the intervention is associated with 
adoption of recall procedures among all private practices in the 
intervention community, and compare this with any secular trends in 
adoption of recall procedures in the control community. Within those 
practices that conduct any client recall procedures, collect and report 
key process measures of these functions. For example, measure the 
number of telephone contacts made, proportion of mailed recall notices 
returned undeliverable, how many months the office used the recall 
process, changes in daily functions believed locally to support the 
continued use of recall, etc. The benchmark of success for this project 
will be the adoption and on-going use (at 24 months) of recall 
procedures by 20 percent more practices in the intervention above the 
corresponding measure in the control community by the end of the two-
year period. Alternatively, for relatively populous geographic areas, 
adoption of recall procedures by at least 10 more practices in the 
intervention vs. the control community during this period will denote 
success.
    13. At the end of the project period, document changes in 
vaccination coverage, using 4:3:1:3:3:1 Up to Date (UTD) coverage rates 
as the standard. (For varicella, history of disease should be taken 
into account.) Additionally, measure changes in provider's knowledge, 
attitudes, and practices concerning infant and child immunization that 
have resulted from the program. All such results should be compared 
with corresponding findings in the control community.
    14. 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:
    1. Provide CDC investigator(s) to monitor the cooperative agreement 
as project officer(s).
    2. 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.
    3. Provide technical assistance on site selection, data collection 
instruments, analysis, and evaluation methods.
    4. 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.
    5. Contribute subject matter expertise in the areas of 
epidemiologic and survey methods and statistical analysis.
    6. Participate in the analysis and dissemination of information, 
data and findings from the project to facilitate dissemination of 
results.
    7. Serve as liaisons between the recipients of the project award 
and other administrative units within the CDC.
    8. 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: UO1.
    Fiscal Year Funds: 2005.
    Approximate Total Funding: $300,000. (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: $300,000. (Includes direct and indirect 
costs. This amount is for the first 12-month budget period.)
    Floor of Award Range: None.
    Ceiling of Award Range: $300,000. (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: Two (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.
     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.

[[Page 24809]]

III.2. Cost Sharing or Matching

    Matching funds are not required for this program.

III.3. Other

    If you request a funding amount greater than the ceiling of the 
award range, your application will be considered non-responsive, and 
will not be entered into the review process. You will be notified that 
your application did not meet the submission requirements.
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.
     Document in the Appendix that eligibility satisfies the 
criteria of Section III.1.
     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 or institution 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: 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: Three.
     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 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 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 10, 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 27, 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 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 24810]]

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:
     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--RFA IP05-088, 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. The benchmark of success for 
this project will be the adoption of recall procedures by 20 percent 
more practices in the intervention vs. the control community by the end 
of the two-year period. Alternatively, for relatively populous 
geographic areas, adoption of recall procedures by at least 10 
practices during this period will denote success. Other 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 in this 
community? 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?
    The applicant must address the needs of a community containing at 
least 50 private provider offices of pediatricians, family 
practitioners, or doctors of osteopathy where childhood immunizations 
are given. A separate community of similar size and demographic 
composition should be used as a control group. In each, recall 
procedures should be currently in practice in relatively few such 
offices, preferably 10-30 percent. The application should document in 
the research plan the approximate number of provider offices and the 
proportion with recall procedures in place. The cohort of office 
practices should include relatively large (more than 10 immunizing 
physicians) as well as small practices with one or two immunizing 
physicians). If the target audience represents multiple private 
practices, such practices may not have a single, central administrative 
authority. No more than half the practices involved should be located 
in a central county area; the other practices should then be located in 
one or more outlying counties of the core based statistical area (see 
https://www.census.gov/population/www/estimates/aboutmetro.html for 
definition of terms). Practices where no broad scale or comprehensive 
recall program has existed during the past 12 months are less likely to 
be subjected to confounding by other factors, and are therefore 
preferred.
    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?
    If the proposed intervention involves direct communication with 
office practice staff, the applicant must include in the Appendix 
letters of support indicating agreement concerning their access to a 
variety of types of provider offices, or alternatively, note their 
experience in conducting on-site interventions in practitioner's 
offices and discuss ways they intend to overcome such barriers. The 
applicant should specify their progress to date in identifying both the 
intervention and control group of physicians/practices. The control 
group should be one not exposed to the program, yet evaluated at the 
same time intervals as the intervention group to control for secular 
changes in office practice procedures.
    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?
    Novel methods that induce system changes by providing non-cash 
incentives or removing disincentives should be considered.
    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)?
    The applicant must develop or use existing relationships with each 
of three groups--university faculty, state and/or local health 
department personnel, and an immunization coalition--to conduct this 
study. University faculty should have experience in conducting program 
evaluation research. The participation of each of these three groups 
should be active and substantial, and their agreement to participate 
documented in letters of support in the Appendix. The applicant should 
develop (or use an existing) coalition, partnership, task force, or 
advisory board to provide

[[Page 24811]]

timely feedback on all programmatic activities. If such a coalition 
does not presently exist, the applicant must describe how either a 
broad-based coalition or advisory board will be developed during the 
first six months. This coalition should consist of physicians and 
nurses who treat children, health educators, and pharmacists; officials 
from government health department and other key health and social 
services; administrative representatives from health care 
organizations, licensed child care centers, health maintenance 
organizations, insurers, and hospitals; and interested parents, 
business, and community leaders.
    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:
    1. Degree to which the basis of selecting the intervention and 
control communities is described in the application.
    2. Degree of support for the project expressed by immunization 
providers and key stakeholders in the intervention community.
    3. Degree to which the intended program intervention is described, 
and any preliminary or pilot information that suggests the degree to 
which it might be effective in this community.
    4. Ability of applicant to recruit immunization provider private 
practices for this or other similar interventions.
    5. Degree to which activities are specific, measurable, and 
appropriately time-framed.
    6. Extent to which applicant documents plan to sustain use of 
recall procedures in the community following the termination of this 
project.
    7. To what extent is each component of the Special Requirements 
(see Section III.3) met?
    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 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 convened by the OPHR in 
accordance with the review criteria listed above. As part of the 
initial merit review, all applications may:
     Undergo a process in which only those applications deemed 
to have the highest scientific merit 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 Special Emphasis Panel (SEP). 
The SEP will be selected from the NIH pool of scientists or 
recommendations from the National Immunization Program 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.

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-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-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,

[[Page 24812]]

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, 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: MLerchencdc.gov.
    For financial, grants management, or budget assistance, contact: 
Sharron Orum, Grants Management Specialist, CDC Procurement and Grants 
Office, 2920 Brandywine Road, Atlanta, GA 30341. Telephone: (770) 488-
2716. E-mail: spo2@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 5, 2005.
William P. Nichols,
Director, Procurement and Grants Office, Centers for Disease Control 
and Prevention.
[FR Doc. 05-9372 Filed 5-10-05; 8:45 am]
BILLING CODE 4163-18-P