Developing Methods and Strategies To Increase Use of Immunization Registries by Private Providers, 24812-24818 [05-9371]
Download as PDF
24812
Federal Register / Vol. 70, No. 90 / Wednesday, May 11, 2005 / Notices
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.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
VII. Agency Contacts
Background
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. Email: spo2@cdc.gov.
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 timeintensive 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
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
VerDate jul<14>2003
16:48 May 10, 2005
Jkt 205001
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.
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
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¢. 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 longterm 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
E:\FR\FM\11MYN1.SGM
11MYN1
Federal Register / Vol. 70, No. 90 / Wednesday, May 11, 2005 / Notices
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 communitybased 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
VerDate jul<14>2003
16:48 May 10, 2005
Jkt 205001
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
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
24813
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
E:\FR\FM\11MYN1.SGM
11MYN1
24814
Federal Register / Vol. 70, No. 90 / Wednesday, May 11, 2005 / Notices
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 12month 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
VerDate jul<14>2003
16:48 May 10, 2005
Jkt 205001
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 nonresponsive 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.
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
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:
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
E:\FR\FM\11MYN1.SGM
11MYN1
Federal Register / Vol. 70, No. 90 / Wednesday, May 11, 2005 / Notices
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 nonmodular 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.
VerDate jul<14>2003
16:48 May 10, 2005
Jkt 205001
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
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
24815
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
E:\FR\FM\11MYN1.SGM
11MYN1
24816
Federal Register / Vol. 70, No. 90 / Wednesday, May 11, 2005 / Notices
approximately the same size and sociodemographic 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, wellintegrated, 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
VerDate jul<14>2003
16:48 May 10, 2005
Jkt 205001
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.
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
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?
E:\FR\FM\11MYN1.SGM
11MYN1
Federal Register / Vol. 70, No. 90 / Wednesday, May 11, 2005 / Notices
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
VerDate jul<14>2003
16:48 May 10, 2005
Jkt 205001
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.
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
24817
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-tablesearch.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.
E:\FR\FM\11MYN1.SGM
11MYN1
24818
Federal Register / Vol. 70, No. 90 / Wednesday, May 11, 2005 / Notices
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. Email: 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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0045]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Electronic
Records; Electronic Signatures
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by June 10,
2005.
ADDRESSES: OMB is still experiencing
significant delays in the regular mail,
including first class and express mail,
and messenger deliveries are not being
accepted. To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: Fumie Yokota, Desk Officer
for FDA, FAX: 202–395–6974.
FOR FURTHER INFORMATION CONTACT:
Karen Nelson, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–1482.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Electronic Records; Electronic
Signatures—(21 CFR Part 11) (OMB
Control Number 0910–0303)—Extension
FDA regulations in part 11 (21 CFR
part 11) provide criteria for acceptance
of electronic records; electronic
signatures, and handwritten signatures
executed to electronic records as
equivalent to paper records. Under these
regulations, records and reports may be
submitted to FDA electronically
provided the agency has stated our
ability to accept the records
electronically in an agency-established
public docket and that the other
requirements of part 11 are met.
The recordkeeping provisions in part
11 (§§ 11.10, 11.30, 11.50, and 11.300)
require standard operating procedures
(SOPs) to assure appropriate use of, and
precautions for, systems using
electronic records and signatures: (1)
Section 11.10 specifies procedures and
controls for persons who use closed
systems to create, modify, maintain, or
transmit electronic records; (2) section
11.30 specifies procedures and controls
for persons who use open systems to
create, modify, maintain, or transmit
electronic records; (3) section 11.50
specifies procedures and controls for
persons who use electronic signatures;
and (4) section 11.300 specifies controls
to ensure the security and integrity of
electronic signatures based upon use of
identification codes in combination
with passwords. The reporting
provisions (§ 11.100) require persons to
certify in writing to FDA that they will
regard electronic signatures used in
their systems as the legally binding
equivalent of traditional handwritten
signatures.
The burden created by the
information collection provision of this
regulation is a one-time burden
associated with the creation of SOPs,
validation, and certification. The agency
anticipates the use of electronic media
will substantially reduce the paperwork
burden associated with maintaining
FDA required records.
The respondents are businesses and
other for-profit organizations, State or
local governments, Federal agencies,
and nonprofit institutions.
In the Federal Register of February 7,
2005 (70 FR 6447), FDA published a 60day notice requesting public comment
on the information collection
provisions. No comments were received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
21 CFR Section
11.100
1There
Annual Frequency
per Response
4,500
1
Total Annual
Responses
Hours per
Response
4,500
1
are no capital costs or operating and maintenance costs associated with this collection of information.
VerDate jul<14>2003
16:48 May 10, 2005
Jkt 205001
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
E:\FR\FM\11MYN1.SGM
Total Hours
11MYN1
4,500
Agencies
[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]
-----------------------------------------------------------------------
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