Effectiveness of a Hospital-Based Program for Vaccination of Birth Mothers and Household Contacts With Inactivated Influenza Vaccine, 25079-25084 [05-9457]

Agencies

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

[Federal Register Volume 70, Number 91 (Thursday, May 12, 2005)]
[Notices]
[Pages 25079-25084]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-9457]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Effectiveness of a Hospital-Based Program for Vaccination of 
Birth Mothers and Household Contacts With Inactivated Influenza Vaccine

    Announcement Type: New.
    Funding Opportunity Number: RFA IP05-095.
    Catalog of Federal Domestic Assistance Number: 93.185.
    Letter of Intent Deadline: June 13, 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

    Influenza is a common respiratory infection among young children 
with a prevalence of 20 percent seasonally

[[Page 25080]]

(Neuzil KM, Shy Y et al. ``Burden of interpandemic influenza in 
children younger than five years: a 25-year prospective survey''. 
``Journal of Infectious Diseases 2002''; 185:147-52). Children under 23 
months of age, especially those with underlying respiratory or cardiac 
conditions or those who are immunocompromised (Neuzil KM, Wright PF et 
al. ``Journal of Pediatrics'' 2000; 137(6):856-64.), are at increased 
risk for complications. In October of 2003, the Advisory Committee on 
Immunization Practices (ACIP) recommended that all children aged six to 
23 months should be immunized with inactivated influenza vaccine 
beginning with the 2004-2005 influenza season. For those children 
immunized, this will mean protection from this potentially serious 
disease. However, children from birth though five months of age are 
still vulnerable, since this age group is not recommended for 
vaccination. Vaccination of household contacts, especially the mother, 
is the best strategy for protecting these children.
    Purpose: The purpose of the program is to fund research that will 
promote the implementation of the ACIP's recommendation to vaccinate 
household contacts of persons in groups at high risk of influenza 
related complications with inactivated influenza vaccine. This project 
is specifically targeted to vaccinate post-partum mothers and other 
household contacts in order to protect newborn children who are at 
increased risk of influenza-related hospitalizations and deaths if 
infected with this disease. This is a two year project with year one 
for planning and development and the second year for implementation and 
evaluation activities.
    This program addresses the ``Healthy People 2010'' focus area(s) of 
immunization and infectious disease.
    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 Objectives

     Evaluate the effectiveness of a hospital-based program for 
vaccinating birth mothers in the immediate post-partum period with 
inactivated influenza vaccine during influenza season.
     Identify appropriate strategies to assist NIP in 
implementing programs to improve vaccination rates of birth mothers 
with inactivated influenza vaccine in hospital settings.
     Develop strategies to vaccinate other household contacts 
as soon as possible after the birth of the newborn.

Activities

    Awardee activities for this program are as follows:
    1. Select two birthing hospitals with at least 1,500 deliveries per 
year. Randomly assign one to serve as the intervention hospital and the 
other as the control. The hospitals should be similar in terms of 
demographics of the population served and number of deliveries per 
year.
    2. Implement a strategy for ensuring administration of inactivated 
influenza vaccine to all birth mothers before hospital discharge. This 
may include strategies such as standing orders for vaccination, 
provider reminders though flagging charts, etc.
    3. Select a sample size large enough to have 80 percent power to 
determine if the vaccination rate for the birth mothers is higher in 
the intervention group than in the control group at an alpha 
significance level of 0.05. Since the unit of the randomization is the 
hospital, between-cluster variation may exist and analytic strategies 
to account for this should be included in the study design.
    4. Implement strategies to vaccinate other household contacts of 
the newborn. This may occur at the birthing hospital or at alternate 
sites but vaccination should occur as soon as possible after the birth.
    5. Develop a study design that will include input from hospital 
administrative and nursing staff as well as obstetricians who admit 
patients to the study hospitals to optimize success of the project.
    6. Collect information on demographic data of the participants to 
be analyzed as predictors for immunization.
    7. Document areas where difficulties/barriers arose and how they 
were resolved. This will include implementation activities at the 
facility level as well as a descriptive summary of vaccine acceptance 
or non-acceptance by study participants.
    8. Obtain rates of uptake of vaccine by study participants by a 
review of medical records and/or other verification methods.
    9. Collaboratively disseminate research findings in peer reviewed 
publications and presentations at national professional meetings.
    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:
    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 and conduct of the research project and as coauthors of 
all scientific publications that result from the project.
    3. Provide technical assistance on the selection and evaluation of 
data collection and data collection instruments.
    4. 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.
    5. Contribute subject matter expertise in the areas of 
epidemiologic methods and statistical analysis, and survey research 
consultation.
    6. Participate in the analysis and dissemination of information, 
data and findings from the project, facilitating dissemination of 
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.

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: 1.
    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.

[[Page 25081]]

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 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 Grants Info. Telephone (301) 435-0714, e-mail: 
GrantsInfo@nih.gov.
    Your research plan should address activities to be conducted over 
the entire project period.
    Preference will be given to applicants with a demonstrated 
relationship with two birthing hospitals with at least 1,500 deliveries 
per year as evidenced by letters of support and/or previous 
demonstrated successful collaboration. Place this documentation behind 
the first page of your application form.
    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 13, 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 p.m. Eastern Time on the 
deadline date. If you submit your LOI and

[[Page 25082]]

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 IP05-095, 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 
appropriate?
    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 two birthing hospitals with at least 
1,500 deliveries per year as evidenced by letters of support and/or 
previous demonstrated successful collaboration.
    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

[[Page 25083]]

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.
    Preference will be given to applicants with a demonstrated 
relationship with two birthing hospitals with at least 1,500 deliveries 
per year as evidenced by letters of support and/or previous 
demonstrated successful collaboration. Place this documentation behind 
the first page of your application form.
    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 National Institutes of Health (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.

V.3. Anticipated Announcement and Award Dates

    Anticipated 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.
    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: 
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.''


[[Page 25084]]


    Dated: May 6, 2005.
William P. Nichols,
Director, Procurement and Grants Office, Centers for Disease Control.
[FR Doc. 05-9457 Filed 5-11-05; 8:45 am]
BILLING CODE 4163-18-P