Expanding the Utilization of Pro-Active Pharmacist Pneumococcal Vaccination Programs, 24598-24603 [05-9273]

Agencies

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

[Federal Register Volume 70, Number 89 (Tuesday, May 10, 2005)]
[Notices]
[Pages 24598-24603]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-9273]


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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: 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 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 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 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: https://
www.whitehouse.gov/omb/grants/spoc.html.

IV.5. Funding Restrictions

    Restrictions, which must be taken into account while writing your 
budget, are as follows:
     Funds relating to the conduct of research will not be 
released until the appropriate assurances and IRB approvals are in 
place.
     Reimbursement of pre-award costs is not allowed.
    If you are requesting indirect costs in your budget, you must 
include a copy of your indirect cost rate agreement. If your indirect 
cost rate is a provisional rate, the agreement should be less than 12 
months of age.

IV.6. Other Submission Requirements

    LOI Submission Address: Submit your LOI by express mail, delivery 
service, fax, or E-mail to: Mary Lerchen, DrPH, Scientific Review 
Administrator, CDC/Office of Public Health Research, One West Court 
Square, Suite 7000, MS D-72, Telephone: 404-371-5277, Fax: 404-371-
5215, E-mail: MLerchen@cdc.gov.
    Application Submission Address: Submit the original and one hard 
copy of your application by mail or express delivery service to: 
Technical Information Management 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: 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-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: 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 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: https://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