[Federal Register: May 10, 2005 (Volume 70, Number 89)]
[Notices]
[Page 24598-24603]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10my05-91]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Expanding the Utilization of Pro-Active Pharmacist Pneumococcal
Vaccination Programs
Announcement Type: New.
Funding Opportunity Number: RFA IP05-092.
Catalog of Federal Domestic Assistance Number: 93.185.
Letter of Intent Deadline: June 9, 2005.
Application Deadline: June 24, 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
Pneumococcal vaccination rates are less than 50 percent among
persons 18-64 with conditions that are indications for vaccination,
with particularly low
[[Page 24599]]
rates among persons 18-49. In the clinical setting, the challenge of
targeting patients based on medical conditions in contrast to targeting
based on age is thought to contribute to these low vaccination rates.
Pharmacists are in an excellent position to both counsel high-risk
patients about pneumococcal vaccination, as well as to offer them
pneumococcal vaccinations since vaccination by pharmacists is currently
authorized in 43 states. A high proportion of persons that take
prescription medication have frequent contacts with pharmacists.
Pharmacists, in turn, can identify persons with indications for
pneumococcal vaccination. Patients taking medication for chronic
cardiovascular disease (e.g. congestive heart failure,
cardiomyopathies), chronic pulmonary disease (COPD, emphysema), and
chronic liver disease are candidates for pneumococcal vaccinations.
It has been shown that customers respond well to pharmacist
recommendation and it has also been shown that pharmacist vaccination
is effective in increasing vaccination rates among their clients (1-3).
Methods used have included patient reminders (either in the form of a
sticker on a medication or a mailed reminder) or proactive offering of
vaccination when prescriptions are filled.
Citations
1. Grabenstein JD et al. ``Effect of vaccination by community
pharmacists among adult prescription recipients''. ``Medical Care
2001''; 39:340-348.
2. Grabenstein JD. et al. ``Community pharmacists as immunization
advocates: a clinical pharmacoepidemiologic experiment''. ``Internat J
Pharm Pract. 1993''; 2:5-10.
3. Ernst ME et al. ``Implementation of a community pharmacy-based
influenza vaccination program''. ``J Am Pharm Assoc 1997''; 37:570-80.
Purpose
The purpose of this program is to examine the feasibility of
expanding the utilization of pro-active pharmacist influenza
vaccination programs and examine the impact of such programs on
pneumococcal vaccination rates among pharmacy clients.
This program addresses the ``Healthy People 2010'' focus area(s) of
Immunization and Infectious Diseases.
Measurable outcomes of the program will be in alignment with the
performance goal for the Centers for Disease Control and Prevention's
(CDC) National Immunization Program (NIP) to reduce the number of
indigenous vaccine-preventable diseases.
Research Objectives
Identify pharmacies without pro-active pharmacist
vaccination programs.
Establish new pro-active pharmacist vaccination programs.
Determine the adoption rate of pharmacist vaccination and
impact on pneumococcal vaccination rates among pharmacy clients.
Determine resources needed to implement pro-active
pharmacist vaccination programs.
Activities
Awardee activities for this program are as follows:
Define a study universe of pharmacies that will be
targeted for implementation of pro-active offering of vaccine (ways in
which the universe is defined include, but are not limited to, a
pharmacy chain or all pharmacies in a community). This sample should
include pharmacies that serve clients with a range of sociodemographic
characteristics and should include at least 30 pharmacies.
Determine the conditions and respective indicator
medications that will be targeted based on the relative prevalence of
indications for pneumococcal vaccination in customer population in age
group. At least three conditions should be included.
Promote the implementation of pro-active offering of
pneumococcal vaccination, providing technical assistance as needed. To
promote continuity of care, pharmacies should plan to inform primary
care providers when clients have received pneumococcal vaccine by
sending them information for the patient's records (e.g. by mail or
fax).
Although the primary interest is pneumococcal vaccination
in persons 18-64 with high risk conditions, interventions can be
expanded to include persons 65 and older (targeted based on age rather
than indicator medications) and to include influenza vaccination.
Implementation of pneumococcal vaccination outside of the influenza
vaccination season may be optimal given added work-load related to
influenza vaccination activities.
Develop an evaluation protocol that will include
determining baseline pharmacy vaccination practices, determining rate
of adoption (the number of pharmacies approached, the number
interested, the number that implemented), determining the impact of the
intervention among those not previously vaccinated (number/percent of
high-risk clients assessed and vaccinated), determining barriers to
adoption and to effective implementation, and pharmacist and customer
attitudes.
Quantifying resources needed to achieve program
implementation.
Identify key staff available to develop project.
Collaboratively disseminate research findings in peer-
reviewed publications and for use in determining national policy.
In a cooperative agreement, CDC staff is substantially involved in
the program activities, above and beyond routine grant monitoring.
CDC Activities for this program are as follows:
Provide CDC investigator(s) to monitor the cooperative
agreement as project officer(s).
Participate as active project team members in the
development, implementation and conduct of the research project and as
coauthors of all scientific publications that result from the project.
Provide technical assistance on the selection and
evaluation of data collection and data collection instruments.
Assist in the development of research protocols for
Institutional Review Boards (IRB) review. The CDC IRB will review and
approve the project protocol initially and on at least an annual basis
until the research project is completed.
Contribute subject matter expertise in the areas of
epidemiologic methods and statistical analysis, and survey research
consultation.
Participate in the analysis and dissemination of
information, data and findings from the project, facilitating
dissemination of results.
Serve as liaisons between the recipients of the project
award and other administrative units within the CDC.
Facilitate an annual meeting between awardee and CDC to
coordinate planned efforts and review progress.
II. Award Information
Type of Award: Cooperative Agreement.
CDC involvement in this program is listed in the Activities Section
above.
Mechanism of Support: U01.
Fiscal Year Funds: 2005.
Approximate Total Funding: $150,000 (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: $150,000 (Includes direct and indirect
costs. This amount is for the first 12-month budget period.)
Floor of Award Range: None.
[[Page 24600]]
Ceiling of Award Range: $150,000 (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 is incomplete or non-responsive to the
requirements listed in this section, it will not be entered into the
review process. You will be notified that your application did not meet
submission requirements.
Late applications will be considered non-responsive. See
section ``IV.3. Submission Dates and Times'' for more information on
deadlines.
Note: Title 2 of the United States Code Section 1611
states that an organization described in Section 501(c)(4) of the
Internal Revenue Code that engages in lobbying activities is not
eligible to receive Federal funds constituting an award, grant, or
loan.
Individuals Eligible To Become Principal Investigators
Any individual with the skills, knowledge, and resources necessary
to carry out the proposed research is invited to work with their
institution to develop an application for support. Individuals from
underrepresented racial and ethnic groups as well as individuals with
disabilities are always encouraged to apply for CDC programs.
IV. Application and Submission Information
IV.1. Address To Request Application Package
To apply for this funding opportunity, use application form PHS 398
(OMB number 0925-0001 rev. 9/2004). Forms and instructions are
available in an interactive format on the CDC Web site, at the
following Internet address: http://www.cdc.gov/od/pgo/forminfo.htm.
Forms and instructions are also available in an interactive format
on the National Institutes of Health (NIH) Web site at the following
Internet address: http://grants.nih.gov/grants/funding/phs398/phs398.html
.
If you do not have access to the Internet, or if you have
difficulty accessing the forms on-line, you may contact the CDC
Procurement and Grants Office Technical Information Management Section
(PGO-TIM) staff at: 770-488-2700. Application forms can be mailed to
you.
IV.2. Content and Form of Application Submission
Letter of Intent (LOI): Your LOI must be written in the following
format:
Maximum number of pages: 2
Font size: 12-point unreduced
Double Single spaced
Paper size: 8.5 by 11 inches
Page margin size: One inch
Printed only on one side of page
Written in plain language, avoid jargon
Your LOI must contain the following information:
Descriptive title of the proposed research
Name, address, e-mail address, telephone number, and FAX
number of the Principal Investigator
Names of other key personnel
Participating institutions
Number and title of this Announcement
Application: Follow the PHS 398 application instructions for
content and formatting of your application. For further assistance with
the PHS 398 application form, contact PGO-TIM staff at 770-488-2700, or
contact GrantsInfo, Telephone (301)435-0714, e-mail:
GrantsInfo@nih.gov.
Your research plan should address activities to be conducted over
the entire project period.
You are required to have a Dun and Bradstreet Data Universal
Numbering System (DUNS) number to apply for a grant or cooperative
agreement from the Federal government. Your DUNS number must be entered
on line 11 of the face page of the PHS 398 application form. The DUNS
number is a nine-digit identification number, which uniquely identifies
business entities. Obtaining a DUNS number is easy and there is no
charge. To obtain a DUNS number, access http://www.dunandbradstreet.com
or call 1-866-705-5711. For more information, see the CDC Web site at:
http://www.cdc.gov/od/pgo/funding/pubcommt1.htm.
This announcement uses the non-modular budgeting format.
Additional requirements that may require you to submit additional
documentation with your application are listed in section ``VI.2.
Administrative and National Policy Requirements.''
IV.3. Submission Dates and Times
LOI Deadline Date: June 9, 2005.
CDC requests that you send a LOI if you intend to apply for this
program. Although the LOI is not required, not binding, and does not
enter into the review of your subsequent application,
[[Page 24601]]
the LOI will be used to gauge the level of interest in this program,
and to allow CDC to plan the application review.
Application Deadline Date: June 24, 2005.
Explanation of Deadlines: LOIs must be received in the CDC Office
of Public Health Research (OPHR) and applications must be received in
the CDC Procurement and Grants Office by 4 p.m. Eastern Time on the
deadline date. If you submit your LOI or application by the United
States Postal Service or commercial delivery service, you must ensure
that the carrier will be able to guarantee delivery by the closing date
and time. If CDC receives your submission after closing due to: (1)
Carrier error, when the carrier accepted the package with a guarantee
for delivery by the closing date and time, or (2) significant weather
delays or natural disasters, you will be given the opportunity to
submit documentation of the carriers guarantee. If the documentation
verifies a carrier problem, CDC will consider the submission as having
been received by the deadline.
This announcement is the definitive guide on LOI and application
content, submission address, and deadline. It supersedes information
provided in the application instructions. If your application does not
meet the deadline above, it will not be eligible for review, and will
be discarded. You will be 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 IRB approvals are in
place.
Reimbursement of pre-award costs is not allowed.
If you are requesting indirect costs in your budget, you must
include a copy of your indirect cost rate agreement. If your indirect
cost rate is a provisional rate, the agreement should be less than 12
months of age.
IV.6. Other Submission Requirements
LOI Submission Address: Submit your LOI by express mail, delivery
service, fax, or E-mail to: Mary Lerchen, DrPH, Scientific Review
Administrator, CDC/Office of Public Health Research, One West Court
Square, Suite 7000, MS D-72, Telephone: 404-371-5277, Fax: 404-371-
5215, E-mail: MLerchen@cdc.gov.
Application Submission Address: Submit the original and one hard
copy of your application by mail or express delivery service to:
Technical Information Management Section'' RFA IP05-092, 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? If the
aims of the application are achieved, how will scientific knowledge be
advanced? What will be the effect of these studies on the concepts or
methods that drive this field?
Approach: Are the conceptual framework, design, methods, and
analyses adequately developed, well-integrated, and appropriate to the
aims of the project? Does the applicant acknowledge potential problem
areas and consider alternative tactics?
Innovation: Does the project employ novel concepts, approaches or
methods? Are the aims original and innovative? Does the project
challenge existing paradigms or develop new methodologies or
technologies?
Investigator: Is the investigator appropriately trained and well
suited to carry out this work? Is the work proposed appropriate to the
experience level of the principal investigator and other researchers
(if any)?
Environment: Does the scientific environment in which the work will
be done contribute to the probability of success? Do the proposed
experiments take advantage of unique features of the scientific
environment or employ useful collaborative arrangements? Is there
evidence of institutional support? Are letters of support included, if
applicable?
Additional Review Criteria: In addition to the above criteria, the
following items will be considered in the determination of scientific
merit and priority score:
Preference will be given to applicants with a demonstrated
relationship with pharmacies as evidenced by letters of support and/or
previous demonstrated successful collaboration. Place this
[[Page 24602]]
documentation behind the first page of your application form.
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 Special Emphasis Panel (SEP).
The SEP will be selected from the NIH pool of scientists or
recommendations from the NIP to serve as reviewers on SEPs.
Applications will be ranked for the secondary review according to
scores submitted by the SEP. Only those applications deemed to have the
highest scientific merit by the review group, generally the top half of
the applications under review, will be discussed and assigned a
priority score.
Award Criteria: Criteria that will be used to make award decisions
during the programmatic review include:
Scientific merit (as determined by peer review)
Availability of funds
Programmatic priorities
V.3. Anticipated Announcement and Award Dates
Award Date: August 31, 2005.
VI. Award Administration Information
VI.1. Award Notices
Successful applicants will receive a Notice of Award (NoA) from the
CDC Procurement and Grants Office. The NoA shall be the only binding,
authorizing document between the recipient and CDC. The NoA will be
signed by an authorized Grants Management Officer, and mailed to the
recipient fiscal officer identified in the application.
Unsuccessful applicants will receive notification of the results of
the application review by mail from the Scientific Review
Administrator, NIP.
VI.2. Administrative and National Policy Requirements
45 CFR Part 74 and Part 92
For more information on the Code of Federal Regulations, see the
National Archives and Records Administration at the following Internet
address: http://www.access.gpo.gov/nara/cfr/cfr-table-search.html.
The following additional requirements apply to this project:
AR-1 Human Subjects Requirements
AR-2 Requirements for Inclusion of Women and Racial and
Ethnic Minorities in Research
AR-7 Executive Order 12372
AR-8 Public Health System Reporting Requirements
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 elements:
a. Progress Toward Measures of Effectiveness.
b. Additional Information Requested by Program.
2. Financial status report, no more than 90 days after the end of
the budget period.
3. Final financial and performance reports, no more than 90 days
after the end of the project period.
These reports must be mailed to the Grants Management Specialist
listed in the ``Agency Contacts'' section of this announcement.
VII. Agency Contacts
We encourage inquiries concerning this announcement.
For general questions, contact: Technical Information Management
Section, CDC Procurement and Grants Office, 2920 Brandywine Road,
Atlanta, GA 30341, Telephone: 770-488-2700.
For scientific/research issues, contact: Susan Chu, PhD, MSPH,
Extramural Program Official, Centers for Disease Control and
Prevention, National Immunization Program, MS E-05, 1600 Clifton Road
NE., Atlanta, GA 30333, Telephone: (404) 639-8727, E-mail:
SChu@cdc.gov.
For questions about peer review, contact: Mary Lerchen, DrPH,
Scientific Review Administrator, CDC/Office of Public Health Research,
One West Court Square, Suite 7000, MS D-72, Telephone: 404-371-5277,
Fax: 404-371-5215, E-mail: MLerchen@cdc.gov.
For financial, grants management, or budget assistance, contact:
Ann Cole, Grants Management Specialist, CDC Procurement and Grants
Office, 2920 Brandywine Road, MS K-14, Atlanta, GA 30341, Telephone:
770-488-2686, E-mail: ZLR5@cdc.gov.
[[Page 24603]]
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 4, 2005.
William P. Nichols,
Director, Procurement and Grants Office, Centers for Disease Control
and Prevention.
[FR Doc. 05-9273 Filed 5-9-05; 8:45 am]
BILLING CODE 4163-18-P