Developing Methods and Strategies To Increase Use of Immunization Registries by Private Providers, 24812-24818 [05-9371]

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 24812-24818]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-9371]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Developing Methods and Strategies To Increase Use of Immunization 
Registries by Private Providers

    Announcement Type: New.
    Funding Opportunity Number: RFA IP05-096.
    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

    Immunization registries are confidential, computerized information 
systems that collect vaccination histories and help ensure correct and 
timely immunizations, especially for children. Even though the United 
States currently enjoys the highest immunization rates and lowest 
disease levels ever, the growing complexity of the childhood 
vaccination schedule, as well as the need to vaccinate a new birth 
cohort of four million infants each year, makes such recordkeeping 
imperative. Inaccurate vaccination histories could lead to unnecessary 
immunization or missed opportunities for immunization. Because about 20 
percent of children see a second provider during the second year of 
life and the paper records from the first provider may not be 
available, there is some risk that toddlers may receive an unnecessary 
vaccination. This waste increases the cost of medical care and results 
in an unnecessary injection for the young child. On the other hand, if 
a provider who sees a child for some but not all immunizations relies 
on the parent's hand-held vaccination records, a missed opportunity for 
immunization may occur if the parent forgets to bring in the child's 
records. The provider may then either (1) remind the parent verbally at 
the time to bring in the record for review at the next visit, or (2) 
attempt to obtain all immunization records from other known 
immunization providers, a time-intensive function. Instead, by 
electronically combining such records, registries can reduce both the 
possibility of extra immunizations as well as missed opportunities, as 
well as enhance other aspects of an immunization program by identifying 
at-risk and high-risk persons.
    Presently 44 states have statewide or regional registries. 
Nationwide, although about 75 percent of public vaccination providers 
use them, only an estimated 31 percent of private providers do so. Only 
seven states have a majority (75 percent) of providers using their 
central registry. Although studies indicate that providers in general 
support registry use, several barriers persist. Many providers are not 
aware of the existence of a registry, despite significant promotion. 
Many are concerned that the registry available to them is not easily 
integrated into their other data systems (e.g., appointments, billing, 
electronic medical records), lacks accuracy compared with hard copy 
records, or does not already contain the immunization history of 
patients sufficient to make real-time decisions in the office. Fees and 
other costs are perceived as a barrier as well. However, published 
research has refuted the basis of many of these perceptions. CDC has 
found that the median cost per child younger than six years is $4.71; 
another recent study estimated the per-shot additional cost at 
56[cent]. Further, where a strong computer record system was put into 
place, registries were found to be 78 percent sensitive, compared with 
only 55 percent sensitivity for parental vaccination cards.
    Given the presently low use of registries in private office 
practices, coupled with the high proportion of children (greater than 
60 percent according to the 2003 National Immunization Survey) who 
receive at least some immunizations by private practitioners, a high 
degree of acceptance and use of registries by private providers is 
critical to its long-term success.

Purpose

    This study is designed to determine methods and strategies to 
overcome obstacles to full, active participation of a state or county-
based immunization registry (``central registry'') by private 
practitioners. The methods and strategies developed and applied will 
seek to change procedures in those private practice offices in which 
county or state based immunization registries are not fully and 
actively used.
    Several definitions apply for the purpose of this Announcement. 
``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

[[Page 24813]]

program provided to all such physicians in a community concerning the 
value of using a registry 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.
    Full, active registry use by a practice, for the purpose of this 
Announcement, is defined as: (a) The existence of a highly functional 
central registry to receive reports from providers; (b) submission of 
new records from practices to the central registry at least twice per 
month; and (c) submission of greater than 50 percent of all new 
immunizations given by a provider since his/her last report.
    This program addresses the ``Healthy People 2010'' focus area of 
Immunization and Infectious Diseases, specifically Objective 14-26 of 
increasing to 95 percent the proportion of children aged greater than 
six years who are enrolled in a fully operational population-based 
immunization registry.
    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 Objective: To develop and test the effectiveness of a 
community-based intervention to increase registry participation in 
private physician offices.
    Activities: Awardee activities for this program are as follows: 
Awardees will develop, pilot-test, implement, and evaluate a strategy 
to convert at least ten private practices (or 20 percent of all 
practices in the intervention community, whichever is less) from non-
use or partial use to full registry use. The individual steps 
(activities) needed to accomplish this are described below.
    1. Identify two geographic separate communities (e.g. Memphis vs. 
Knoxville or Kansas City vs. St Louis) in which relatively few primary 
care providers fully and actively participate in their state or 
regional immunization registry. One 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. Providers from both communities must report to the 
same, single central registry site. The identity of the intervention 
and control communities and the justification for their selection 
should, if possible, be made explicit in the application. If one or 
both communities have not yet been identified, the applicant should 
specify their progress to date in identifying them.
    2. In both communities, determine the knowledge, attitudes, and 
practices of local private providers and their staff concerning the use 
of registries in their office practices.
    3. Within the intervention community, identify practice-based or 
physician-based barriers (and enablers) to the establishment and/or on-
going full active use of registry programs.
    4. Use these data to create, develop, and administer an 
intervention program designed to overcome identified barriers using 
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 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. This award is not intended to be used to 
develop or modify existing software already in use by the central 
registry. Justification should be shown to demonstrate that any 
motivators or (non-cash) reward system is low-cost and cost-efficient.
    5. Assess the feasibility of providing the proposed intervention 
program to the entire intervention community before its full 
institution.
    6. Provide the program throughout the intervention community over 
two years.
    7. Measure the actual cost of the intervention program from the 
provider's perspective.
    8. Measure the degree to which the intervention is associated with 
a change in the proportion of provider offices that become full active 
registry users. A successful outcome is defined as a practice that 
converts from non-use or partial use to full, active use of the 
registry, as defined above. The two-year goal is a 20 percent increase 
above the control community in the number of practices adopting full 
registry use by the 24th month. For relatively populous geographic 
areas, an alternate goal is a conversion of at least 10 practices 
during this period.
    9. Develop an evaluation plan and conduct research that documents 
changes in knowledge and attitudes and any collateral benefits 
resulting from the intervention relative to the control community. In 
addition, document any unexpected or untoward (negative) outcomes that 
result. These data may require before-after survey(s) and measurements 
of provider registry participation in the two communities, among other 
potentially valuable methods.
    10. Collaboratively disseminate research findings in peer-reviewed 
publications and for use in determining national policy.
    11. Develop and institute a plan for sustaining registry use in the 
geographic area once the last funding cycle ends.
    In a cooperative agreement such as this, 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, conduct, and evaluation of the research project and as 
coauthors of scientific publications that result from the project.
    3. Provide technical assistance on site selection, data collection 
instruments, analysis, and evaluation plan and methods.
    4. Assist in the development of research protocols for 
Institutional Review Board (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 epidemiologic methods, 
statistical analysis, and survey methods.
    6. Participate in the analysis and dissemination of project 
findings and facilitate dissemination of these 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.
References
    1. Glanzner JE, Beaty BL, Pearson KA et al. ``Using an immunization 
registry: effect on practice costs and time''. ``Ambulatory Pediatrics 
2004''; 4:34-40
    2. Ortega AN, Andrews SF, Katz SH et al. ``Comparing a computer-
based childhood vaccination registry with

[[Page 24814]]

parental vaccination cards: a population-based study of Delaware 
children''. ``Clinical Pediatrics 1997''; 36:217-21.

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: $200,000. (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: $200,000. (Includes direct and indirect 
costs. This amount is for the first 12-month budget period.)
    Floor of Award Range: None.
    Ceiling of Award Range: $200,000. (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.
     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

    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 fails to meet the 
following criteria, it will be considered non-responsive and will not 
be entered into the review process. You will be notified that your 
application did not meet submission requirements. The applicant must:
     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 it satisfies the eligibility 
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 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, provided they document in the 
Appendix that they represent the provider network for this project. 
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: 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

[[Page 24815]]

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 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 4:00 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 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 Institutional Review 
Board 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 IP05-096, 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 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, especially, 
on the use of registries by other private practitioners?
    Select two geographically-defined communities composed of 25 or 
more pediatrics or family practice groups (each of which may have more 
than one immunization provider) where full active immunization registry 
participation is rare but exists. One will serve as the intervention 
community, the other as the control community. The control community, 
defined as one not subjected to the intervention, should be

[[Page 24816]]

approximately the same size and socio-demographic composition as the 
intervention community. As a guide concerning size, a suitable 
intervention or control community should have more than five percent 
but fewer than 30 percent of its practices actively and fully 
participating prior to the intervention.
    Document the number of practices in the intervention and control 
communities and their degree of registry use, and registry capacity in 
terms of core standards present (see below).
    12 Functional Standards of a Registry:
    (1) Electronically store data on all core data elements approved by 
the National Vaccine Advisory Committee (NVAC);
    (2) Establish a registry record within six weeks of birth for each 
newborn child born in the geographic catchment area;
    (3) Enable access to and retrieval of immunization information in 
the registry at the time of encounter;
    (4) Receive & process immunization information within one month of 
vaccine administration;
    (5) Protect the confidentiality of health care information;
    (6) Ensure security of health care information;
    (7) Exchange immunization records using HL7 standards;
    (8) Automatically determine the routine childhood immunization(s) 
needed, in compliance with current ACIP recommendations, when an 
individual presents for a scheduled immunization;
    (9) Automatically identify individuals due/late for immunization(s) 
to enable the production of reminder/recall notifications;
    (10) Automatically produce immunization coverage reports by 
providers, age groups, and geographic areas;
    (11) Produce official immunization records; and
    (12) Promote accuracy and completeness of registry data.
    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?
    To what extent has the applicant selected suitable and appropriate 
intervention and control communities according to the application 
guidance concerning: (1) The number of practices presently in 
operation; (2) the number of practices currently using a registry to 
any extent; (3) the extent to which a single central registry exists 
for the intervention and control communities; and (4) the extent to 
which that central registry complies with the functional registry 
standards described above.
    To what extent has the applicant fully engaged the assets of an 
immunization or child health coalition, as well as university 
researchers experienced in evaluation science?
    Identify the central registry to be used, and include a letter of 
support from an authorized official of that central registry. Because 
this application seeks to engage private practice offices in the use of 
an existing central registry, that registry should be highly functional 
already. Twelve accepted functional standards of registries listed 
below are metrics of maturity and performance; the registry to which 
the provider submits new data must meet Standards 3, 4, 5, and 6, plus 
any three of the other eight functional standards below. Documentation 
of the degree to which the applicant's registry meets these standards 
should be included in the Appendix of the application. Additional 
information concerning these standards may be found at https://
www.cdc.gov/nip/registry/min-funct-stds2001.htm.
    12 Functional Standards of a Registry:
    (1) Electronically store data on all core data elements approved by 
the National Vaccine Advisory Committee (NVAC);
    (2) Establish a registry record within six weeks of birth for each 
newborn child born in the geographic catchment area;
    (3) Enable access to and retrieval of immunization information in 
the registry at the time of encounter;
    (4) Receive & process immunization information within one month of 
vaccine administration;
    (5) Protect the confidentiality of health care information;
    (6) Ensure security of health care information;
    (7) Exchange immunization records using HL7 standards;
    (8) Automatically determine the routine childhood immunization(s) 
needed, in compliance with current ACIP recommendations, when an 
individual presents for a scheduled immunization;
    (9) Automatically identify individuals due/late for immunization(s) 
to enable the production of reminder/recall notifications;
    (10) Automatically produce immunization coverage reports by 
providers, age groups, and geographic areas;
    (11) Produce official immunization records; and
    (12) Promote accuracy and completeness of registry data.
    The nature of the intended intervention and its evaluation must be 
specified. 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 practitioners' 
offices and discuss ways they intend to overcome such barriers.
    Show evidence via letter(s) of support that they plan to work in 
partnership with the state and/or local immunization registry manager.
    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)?
    The applicant must have active and substantial participation from 
each of three groups: (1) University faculty; (2) state and/or local 
health department personnel; and (3) an immunization coalition. 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 group 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. University faculty should be qualified 
and interested in conducting program evaluation research. Explicit, 
detailed, written commitments should be provided as letters of support 
in the Appendix of the application, and will strengthen the 
application.
    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?

[[Page 24817]]

    Has the supplied evidence indicated project support and full 
engagement by immunization coalitions, university, and public health?
    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. To what extent has the applicant provided detail indicating the 
functioning level of the central registry that indicates its full 
functional capacity according to the guidelines provided above?
    2. As an indication of its degree of functionality, the central 
registry to which the providers submit new data must meet Standards 3, 
4, 5, and 6 described above plus any three of the eight other 
functional standards outlined there.
    3. Has the applicant addressed each of the special requirements 
under Section III.3?
    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, 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 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.
    Preference will be given to applicants with experience working 
collaboratively with CDC or other granting agency, particularly on 
immunization research projects.

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, 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.

[[Page 24818]]

    For scientific/research issues, contact: Susan Chu, PhD, MSPH, 
Extramural Program Official, National Immunization Program, 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: 
Yolanda Ingram-Sledge, Grants Management Specialist, CDC Procurement 
and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341. Telephone: 
770-488-2787. E-mail: Ysledge@cdc.gov.

VIII. Other Information

    This and other CDC funding opportunity announcements can be found 
on the CDC Web site, Internet address: 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. 05-9371 Filed 5-10-05; 8:45 am]
BILLING CODE 4163-18-P