[Federal Register: May 11, 2005 (Volume 70, Number 90)]
[Notices]
[Page 24812-24818]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11my05-58]
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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: 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
[[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 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 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: 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 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 http://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: 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-24 Health Insurance Portability and Accountability Act
Requirements.
AR-25 Release and Sharing of Data.
Additional information on these requirements can be found on the
CDC Web site at the following Internet address: http://www.cdc.gov/od/pgo/funding/ARs.htm
.
VI.3. Reporting
You must provide CDC with an original, plus two hard copies of the
following reports:
1. Interim progress report, (use form PHS 2590, OMB Number 0925-
0001, rev. 9/2004 as posted on the CDC Web site) no less than 90 days
before the end of the budget period. The progress report will serve as
your non-competing continuation application, and must contain the
following additional elements:
a. Progress Toward Measures of Effectiveness.
b. Additional Information Requested by Program.
2. Financial status report, no more than 90 days after the end of
the budget period.
3. Final financial and performance reports, no more than 90 days
after the end of the project period.
These reports must be mailed to the Grants Management Specialist
listed in the ``Agency Contacts'' section of this announcement.
VII. Agency Contacts
We encourage inquiries concerning this announcement.
For general questions, contact: Technical Information Management
Section, CDC Procurement and Grants Office, 2920 Brandywine Road,
Atlanta, GA 30341. Telephone: 770-488-2700.
[[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: http://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