**Part I Overview Information**

**United States Department of Health and Human Services (HHS)**

**Issuing Organization**

Centers for Disease Control and Prevention (NCIRD/CDC) at
http://www.cdc.gov/ncird/

**Participating Organizations**

Centers for Disease Control and Prevention (CDC) at http://www.cdc.gov/

**Components of Participating Organizations**

Coordinating Center for Infectious Diseases (CCID/CDC) at
http://www.cdc.gov/about/organization/ccid.htm

**Title:** Development, Implementation and Evaluation of Strategies to
Increase Vaccination of Adolescents Affiliated with a Medical Home (U01)

The policies, guidelines, terms, and conditions of the HHS Centers for
Disease Control and Prevention (CDC) stated in this announcement might
differ from those used by the HHS National Institutes of Health (NIH).
If written guidance for completing this application is not available on
the CDC website, then CDC will direct applicants elsewhere for that
information.

**Authority:** 42 U.S.C. 247b(k)(1) of the Public Health Service Act, as
amended

**Announcement Type:** New

**Instructions for Submission of Electronic Research Applications:**

**NOTICE:** Applications submitted in response to this Funding
Opportunity Announcement (FOA) for Federal assistance must be submitted
electronically through Grants.gov
([http://www.grants.gov](http://www.grants.gov/)) using the SF424
Research and Related (R&R) forms and the SF424 (R&R) Application Guide. 

This FOA must be read in conjunction with the application package
instructions included with this announcement on [Grants.gov/Apply for
Grants](http://www.grants.gov/Apply) (hereafter referred to as,
Grants.gov/Apply.)

A registration process is necessary before submission, and applicants
are strongly encouraged to start the process at least four weeks prior
to the grant submission date. See [Section IV](#SectionIV).

**Two steps are required for on time submission:**

1\) The application must be successfully received by Grants.gov no later
than 5:00 p.m. Eastern Standard Time on the application submission
receipt date (see "[Key Dates](#KeyDates)" below.)

2\) Applicants must complete a verification step in the Electronic
Research Administration (eRA
[Commons](https://commons.era.nih.gov/commons/)) within two business
days of notification. Note: Since email can be unreliable, it is the
responsibility of the applicant to periodically check on their
application status in the eRA
[Commons](https://commons.era.nih.gov/commons/).

**Funding Opportunity Announcement (FOA) Number:** **RFA-IP-09-006**

**Catalog of Federal Domestic Assistance Number(s):** 93.185

**Key Dates**

Release/Posted Date: January 26, 2009\
Letter of Intent Receipt Date: Not applicable\
Application Submission Receipt Date(s): March 26, 2009\
Peer Review Date(s): May 2009\
Council Review Date(s): June 2009

Earliest Anticipated Start Date(s): September 10, 2009

Additional Information to Be Available Date: Not applicable

Expiration Date: TBD

**Due Date for E.O. 12372**

Due no later than 60 days after the application receipt date.

**Additional Overview Content**

**Funding Opportunity Announcement Glossary**: [FOA Glossary
Terminology](http://www.cdc.gov/od/pgo/funding/glossary.htm)

**Table of Contents**

Part I Overview Information\
\
Part II Full Text of Announcement\
\
Section I. Funding Opportunity Description\
   1. Research Objectives\
\
Section II. Award Information\
   1. Mechanism(s) of Support\
   2. Funds Available\
\
Section III. Eligibility Information\
   1. Eligible Applicants\
       A. Eligible Institutions\
       \
   2.Cost Sharing or Matching\
   3.Other - Special Eligibility Criteria\
\
Section IV. Application and Submission Information\
   1. Request Application Information\
   2. Content and Form of Application Submission\
   3. Submission Dates and Times\
       A. Receipt and Review and Anticipated Start Dates\
           1. Letter of Intent\
       B. Submitting an Application to CDC\
       C. Application Processing\
   4. Intergovernmental Review\
   5. Funding Restrictions\
   6. Other Submission Requirements\
\
Section V. Application Review Information\
   1. Criteria\
   2. Review and Selection Process\
       A. Additional Review Criteria\
       B. Additional Review Considerations\
       C. Sharing Research Data\
       D. Sharing Research Resources

3\. Anticipated Announcement and Award Dates\
\
Section VI. Award Administration Information\
   1. Award Notices\
   2. Administrative and National Policy Requirements\
       A. Cooperative Agreement

            1. Recipient Rights and Responsibilities\
           2. HHS/CDC Responsibilities\
           3. Collaborative Responsibilities

3\. Reporting\
\
Section VII. Agency Contact(s)\
   1. Scientific/Research Contact(s)\
   2. Peer Review Contact(s)\
   3. Financial/ Grants Management Contact(s)

4\. General Questions Contact(s)\
\
Section VIII. Other Information - Required Federal Citations

**Part II - Full Text of Announcement**

**Section I. Funding Opportunity Description**

**1. Research Objectives**

The National Center for Immunization and Respiratory Diseases (NCIRD) of
CDC within HHS is committed to achieving the health promotion and
disease prevention objectives of \"Healthy People 2010\" and to
measuring program performance as stipulated by the Government
Performance and Review Act (GPRA).  This FOA addresses "Healthy People
2010" priority area(s) of Immunization and Infectious Diseases and is in
alignment with HHS/CDC/NCIRD's performance goal(s) to reduce the number
of indigenous vaccine-preventable diseases. For more information, see
[www.health.gov/healthypeople](http://www.health.gov/healthypeople) and
[www.whitehouse.gov/omb/mgmt-gpra/](http://www.whitehouse.gov/omb/mgmt-gpra/).

Nature of the research opportunity:

The purpose of the FOA is to help identify strategies for increasing
vaccination of adolescents affiliated with medical homes.

Pertinent background information that establishes the need for the
research:

Over the last three years, an historically unprecedented number of new
vaccination recommendations for adolescents have been made by CDC's
Advisory Committee on Immunization Practices (ACIP). In 2005, ACIP
recommended that adolescents should routinely receive meningococcal
conjugate vaccine (MCV4) as well as tetanus toxoid, reduced diphtheria
toxoid, and acellular pertussis (Tdap) vaccine. In 2006, ACIP
recommended routine vaccination with three doses of quadrivalent human
papillomavirus (HPV) vaccine for girls aged 11-12 years. In addition,
catch-up HPV vaccination is recommended for females aged 13-26 years who
have not been vaccinated previously or who have not completed the full
vaccine series. In 2008, ACIP recommended annual influenza vaccination
for all persons aged 6 months through 18 years beginning no later than
the 2009-2010 influenza season. In addition to new recommendations, ACIP
continues to recommend that adolescents receive four vaccines (to
prevent Hepatitis B, polio, varicella, measles, mumps, and rubella) if
adolescents have not yet received all doses as recommended. Two
additional vaccines (to prevent pneumococcal disease and Hepatitis A)
are also recommended for adolescents in high risk groups.

The introduction of three new vaccines specifically targeting
adolescents presents unique challenges to vaccinating this population.
Compared with infants and young children, adolescents are less frequent
consumers of preventive health services: 44% of high-school students
reported not having seen a doctor or nurse during the past 12 months for
a preventive care visit. Based on a recent nationally representative
study, an estimated 9% of adolescent medical visits were made for
preventive care, and vaccinations were delivered to adolescents
primarily during preventive visits. In addition, parents of teens have
limited awareness of new adolescent vaccines, and therefore may not
actively seek to have their children vaccinated as recommended.

Interventions effective at increasing vaccination rates have been
reviewed in the Guide to Community Preventive Services; however, because
only one vaccine was routinely recommended for adolescents before 2005,
very few interventions have been tested among adolescents and their
parents. Proven strategies are needed to encourage adolescents to visit
their primary care provider to receive recommended vaccinations and to
reduce immunization opportunities missed by providers at the time of
visits. In addition to identifying effective strategies to increase
adolescent vaccination rates, there is also interest in determining the
extent to which increased delivery of adolescent vaccines in medical
practice settings may have ancillary benefits such as increased delivery
of other recommended clinical preventive services to the adolescent
population.

Scientific knowledge to be achieved:

Knowledge of effective medical practice-based approaches to increase
adolescent vaccination is limited. While a number of interventions have
been found to be effective in increasing vaccination rates among other
groups, few have been tested specifically in adolescent populations.
With recently recommended new vaccines for adolescents, identifying
evidence-based strategies is increasingly important.

RFA Objectives

The applicants must address all of the following four research
objectives in the research plan of the application:

1\. Determine which evidence-based interventions to increase vaccination
are considered by medical practices to be feasible and sustainable for
adolescent vaccination. Based on this information and formative research
with parents of adolescents, identify a strategy to be implemented and
tested. Important note: A strategy must be comprised of 2 or more
interventions, and at least one intervention must be evidence-based.

2\. Determine effectiveness of a selected strategy in increasing
adolescent vaccination rates and assess effect on number and type of
visits.

3\. Determine effect of selected strategy on receipt of other
recommended clinical preventive services in adolescents.

4\. Determine the resources utilized to implement the selected strategy
in the participating practices.

Applicants are expected to provide a research plan that addresses the
following elements:

1\) Description of formative research with physicians and practice
staff, exploring topics including but not limited to: identification of
resources and planning needed to facilitate specific interventions;
exploration of feasibility and sustainability of potential
interventions; identification of potential strategies to promote
commitment of practice staff to increasing adolescent vaccination;
assessment of use of immunization information systems and barriers to
use; and identification of factors expected to impact capacity of
practice staff to administer vaccines.

2\) Description of formative research with parents of adolescents,
focusing on topics including: parental awareness of programs (e.g.,
Vaccines for Children program, Medicaid) that facilitate access to
immunizations in medical homes; the likely impact of providing
information about the programs to parents; and the acceptability to
parents of interventions being considered for implementation as part(s)
of the study strategy. Because of limited study duration, investigators
considering an educational outreach intervention as part of a potential
final strategy are encouraged to consider either using or adapting
existing, field-tested communications tools.

3\) Description of participating practices including type(s) of
practices (e.g., family practice, pediatric, multi-specialty), location
(e.g., urban, rural, medically underserved), specialties of physicians
(may include family practice physicians, pediatricians, internal
medicine -- pediatrics physicians, and adolescent medicine specialists)
and approximate number of adolescents affiliated with practices is
required. Applications may be strengthened by the provision of patient
demographics (e.g., race/ethnicity), if available, for all or any subset
of patients aged 21 years or younger.

4\) Description of study design which is sufficiently robust to
determine effectiveness of selected strategy. Study design should
include division of practices into intervention and control arms
(randomization is optional). Sample size calculations and the
assumptions upon which they are based must be clearly described. Planned
analyses should account for clustering of adolescents within practices.

5\) Description of methods for collecting data with variables including
number and types of vaccinations administered, number and type of visits
(e.g., preventive, problem-based, immunization only), receipt of other
clinical preventive services, and missed opportunities. The description
should identify data source and methods for validating administrative
data or, if applicable, information systems data. Approaches to
collecting information or accounting for vaccinations received outside
of medical homes (e.g., in complementary settings such as schools,
public health clinics) should be described.

6\) Description of the analytic plan for assessing effectiveness in
terms of vaccine uptake, increases in clinical preventive services,
change in number and type of visits, and characterization of adolescents
less likely to respond to the intervention.

7\) Description of methods for evaluating the implementation of the
selected strategy. The evaluation goals should include understanding the
extent to which the selected intervention was implemented and assessing
the degree of fidelity with which the strategy was implemented in
participating medical homes.

8\) Description of a plan for collecting and analyzing data to measure
the costs associated with implementing the selected adolescent
vaccination strategy. If feasible, analysis may compare costs to
benefits (for example, how do changes in billing revenues compare to
costs incurred for implementation of a strategy that included addition
of special vaccination clinics?).

9\) Description of current and foreseeable state vaccination mandates
(including college entry requirements) targeting adolescents affiliated
with the selected medical homes and discussion of how the presence or
absence of mandates might affect study design, implementation, results
interpretation, and generalizability.

Given that the strategy under evaluation will not have been selected as
of the writing of the application, it is understood that some specifics
cannot be provided, but relevant considerations should be addressed.

References:

1- Szilagyi PG, Rand CM, McLaurin J, Tan L, Britto M, Francis A, Dunne
E, Rickert D, for the Working Group on Adolescent Vaccination in the
Medical Home. Delivering adolescent vaccinations in the medical home: A
new era? Pediatrics. 2008;121(S1): S15-S24.

2- Albertin C, Rand CM, Fryer G, Shone L, Schaffer SJ, Szilagyi PG.
Adolescent health care utilization across the U.S.: who may be reached
for immunization? Paper presented at: Pediatric Academic Societies
meeting, San Francisco, CA, April 29, 2006.

3- Rand CM, Shone LP, Albertin C, Auinger P, Klein JD, Szilagyi PG.
National health care visit patterns of adolescents: implications for
delivery of new adolescent vaccines. Arch Pediatr Adolesc Med.
2007;161:252-9.

4- Rand CM, Szilagyi PG, Albertin C, Auinger P. Additional health care
visits needed among adolescents for human papillomavirus vaccine
delivery within the medical home. Pediatrics. 2007;120:461-466.

5- Vaccines. Guide to Community Preventive Services Website. Centers for
Disease Control and Prevention (website page updated 3 July 2008,
accessed 3 July 2008). Available at:
http://www.thecommunityguide.org/vaccine/default.htm

Research and experimental approaches:

Applicants are expected to conduct formative research with varied
medical practices and health care providers experienced in delivering
vaccinations and providing primary care to diverse populations aged 21
years or younger in their community/state. The purpose of the formative
research is to identify, among interventions that have been shown to be
effective in either adolescents or other age groups, those interventions
judged most likely to be feasible and potentially sustainable to
increase vaccination of adolescents. Applicants are also expected to
conduct formative research among parents of adolescents affiliated with
the selected medical homes. Based on this formative work, a strategy
which must include 2 or more interventions will be selected and
implemented by participating practices. While the strategy is required
to include at least one evidence-based component, it may include one or
more innovative components. At minimum, the selected strategy should
target adolescents aged 11-12 years, but may also include older
adolescents as well. The strategy will be evaluated in terms of
effectiveness in increasing vaccination, effect on number and type of
visits by adolescents, and potential changes in receipt of other
recommended preventive services for this age group. It will also be
evaluated in terms of resources utilized to implement the strategy.

This FOA requires applicants to work with physicians and staff in
community, ambulatory medical homes to increase vaccination rates among
adolescents consistent with current ACIP vaccination recommendations.
Ideally, this research will lead to identification of sustainable,
generalizable, effective strategies that may be implemented widely.
Because practices and communities may offer opportunities to respond to
this FOA in creative ways that may maximize the yield of this research,
this FOA is intentionally written to allow some flexibility in research
design and implementation. However, in all aspects of research design,
execution, analysis and dissemination, applicants will be expected to
adhere to sound epidemiologic methods and standards. Applicants are
expected to employ a study design that includes control practices and a
sufficient number of practices with adequate numbers of adolescents, so
that meaningful conclusions about effectiveness of the selected strategy
can be drawn.

Because studies of the effectiveness of reminder/recall interventions
among adolescents are currently being conducted, applicants should not
focus their proposals on this potential intervention. Reminder/recall
may be a component of a selected multi-component strategy for this
solicited research, but must not be the sole evidence-based
intervention.

Applicants will be expected to disseminate research findings through
peer reviewed publications and presentations at national professional
meetings.

Purchase of vaccine with study-related funds is prohibited as part of
this project.

See Section VIII, Other Information - Required Federal Citations, for
policies related to this announcement.\
\
**Section II. Award Information**

**1. Mechanism(s) of Support**

This funding opportunity will use the U01 activity code.

The HHS/CDC U01 is a cooperative agreement assistance instrument. Under
the U01 assistance instrument, the Recipient Organization retains the
primary responsibility and dominant role for planning, directing, and
executing the proposed project, and with HHS/CDC staff is substantially
involved as a partner with the Recipient Organization, as described in
Section VI.2.A., \"Cooperative Agreement".

**2. Funds Available**

The participating Centers, Institutes and Offices (CIO)(s), NCIRD
intends to commit approximately up to \$550,000 dollars in FY2009 to
fund 1-2 applications. The average award amount will be \$275,000 and
will include direct and indirect costs for the first 12 month budget
period. An applicant may request a project period of up to 3 years. An
applicant may request up to \$275,000 for the first 12 month budget
period (FY09). The approximate total project period funded amount is
\$1,650,000 for both direct and indirect costs. The anticipated start
date for new awards is September 10, 2009.

All estimated funding amounts are subject to availability of funds.

If an applicant requests a funding amount greater than the ceiling of
the award range, HHS/CDC will consider the application non-responsive,
and it will not enter into the review process. HHS/CDC will notify the
applicant that the application did not meet the submission requirements.

**Section III. Eligibility Information**

**1. Eligible Applicants**\
\
**1.A. Eligible Institutions**

You may submit an application(s) if your organization has any of the
following characteristics:

-   Public nonprofit organizations

-   Private nonprofit organizations

-   Universities

-   Colleges

-   Research institutions

-   Hospitals

-   Community-based organizations

-   Faith-based organizations

-   Federally recognized or state-recognized American Indian/Alaska
    Native tribal governments

-   American Indian/Alaska Native tribally designated organizations

-   Alaska Native health corporations

-   Urban Indian health organizations

-   Tribal epidemiology centers

-   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. Attach this
> documentation behind the first page of your application form or for
> electronic applications, use a PDF file and attach as "Other
> Documents" and label as appropriate.

**2. Cost Sharing or Matching**

Cost sharing or matching is not required.

The most current HHS Grants Policy Statement is available at:
<http://www.hhs.gov/grantsnet/docs/HHSGPS_107.doc>

**3. Other-Special Eligibility Criteria**

An applicant may submit only one application under this announcement.

Only studies proposed for conduct in the United States are eligible for
consideration.

If your application is incomplete or non-responsive to the special
requirements listed in this section, it will not enter into the review
process.

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.

**Section IV. Application and Submission Information**

To download a SF424 (R&R) Application Package and SF424 (R&R)
Application Instructions for completing the SF424 (R&R) forms for this
FOA, link to [Grants.gov/Apply](http://www.grants.gov/Apply) and follow
the directions provided on that Web site.

A one-time registration is required for institutions/organizations at
the following:

-   Grants.gov Get
    Registered,http://www.grants.gov/applicants/get_registered.jsp

-   eRA Commons Prepare to Apply,
    <http://era.nih.gov/ElectronicReceipt/preparing.htm>

IMPORTANT: both the applicant organization, as well as, the PD/PI must
register in eRA Commons for an application to be accepted
electronically. The Credentials Log-In, referenced in Section IV. 2.
Content and Form of Application Submission, is obtained through Step #3
in the required actions below.

PD/PIs should work with their institutions/organizations to make sure
they are registered in the eRA Commons.

The following three steps are required before an applicant
institution/organization can submit an electronic application, as
follows:

1\) Organizational/Institutional Registration in Grants.gov Get
Registered, http://www.grants.gov/applicants/get_registered.jsp

-   Your organization will need to obtain a [Data Universal Number
    System (DUNS)
    number](https://eupdate.dnb.com/requestoptions/government/ccrreg/)
    and register with the [Central Contractor Registration
    (CCR)](http://www.bpn.gov/ccr/scripts/index.html) as part of the
    Grants.gov registration process.

-   If your organization does not have a Taxpayer Identification Number
    (TIN) or Employer Identification Number (EIN), allow for extra time.
    A valid TIN or EIN is necessary for CCR registration.

-   The CCR also validates the EIN against Internal Revenue Service
    records, a step that will take an additional one to two business
    days.

-   Direct questions regarding Grants.gov registration to:\
    [Grants.gov Customer Support](http://grants.gov/CustomerSupport)\
    Contact Center Phone: 800-518-4726\
    Business Hours: M-F 7:00 a.m. - 9:00 p.m. Eastern Time\
    Email <support@grants.gov>

2\) Organizational/Institutional Registration in the eRA Commons Prepare
to Apply, <http://era.nih.gov/ElectronicReceipt/preparing.htm>

-   To find out if an organization is already eRA Commons-registered,
    see the \"[List of Grantee Organizations Registered in eRA
    Commons."](http://era.nih.gov/userreports/ipf_com_org_list.cfm)

-   Direct questions regarding the eRA Commons registration to:\
    eRA Commons Help Desk\
    Phone: 301-402-7469 or 866-504-9552 (Toll Free)\
    TTY: 301-451-5939\
    Business hours M-F 7:00 a.m. -- 8:00 p.m. Eastern Time\
    Email <commons@od.nih.gov>

3\) Project Director/Principal Investigator (PD/PI) Registration in the
eRA Commons: Refer to the [NIH eRA Commons System (COM) Users
Guide](http://era.nih.gov/Docs/COM_UGV2630.pdf).

-   The individual designated as the PD/PI on the application must also
    be registered in the eRA Commons. It is not necessary for PDs/PIs to
    register with Grants.gov.

-   The PD/PI must hold a PD/PI account in the eRA Commons and must be
    affiliated with the applicant organization. This account cannot have
    any other role attached to it other than the PD/PI.

-   This registration/affiliation must be done by the Authorized
    Organization Representative/Signing Official (AOR/SO) or their
    designee who is already registered in the eRA Commons.

-   Both the PD/PI and AOR/SO need separate accounts in the eRA Commons
    since both hold different roles for authorization and to view the
    application process.

Note that if a PD/PI is also an HHS peer-reviewer with an Individual
DUNS and CCR registration, that particular DUNS number and CCR
registration are for the individual reviewer only. These are different
than any DUNS number and CCR registration used by an applicant
organization. Individual DUNS and CCR registration should be used only
for the purposes of personal reimbursement and should not be used on any
grant applications submitted to the Federal Government.

Several of the steps of the registration process could take four weeks
or more. Therefore, applicants should immediately check with their
business official to determine whether their organization/institution is
already registered in both [Grants.gov](http://www.grants.gov/) and the
eRA [Commons](https://commons.era.nih.gov/commons/). The HHS/CDC
strongly encourages applicants to use the Grants.gov electronic
applications process and have organizations and PD/PIs complete all
necessary registrations.

**1. Request Application Information**\
\
Applicants must download the SF424 (R&R) application forms and SF424
(R&R) Application Guide for this FOA through
[Grants.gov/Apply](http://www.grants.gov/Apply).

Note: Only the forms package directly attached to a specific FOA can be
used. You will not be able to use any other SF424 (R&R) forms (e.g.,
sample forms, forms from another FOA); although some of the
\"Attachment\" files may be useable for more than one FOA.\
\
For further assistance, contact PGO TIMS: Telephone 770-488-2700, Email:
PGOTIM@cdc.gov\
\
HHS/CDC Telecommunications for the hearing impaired: TTY 770-488-2783.

**2. Content and Form of Application Submission**

Prepare all applications using the SF424 (R&R) application forms and in
accordance with the SF424 (R&R) Application Guide ([MS
Word](http://grants2.nih.gov/grants/funding/424/SF424_RR_Guide_General.doc)
or
[PDF](http://grants2.nih.gov/grants/funding/424/SF424_RR_Guide_General.pdf)).

The SF424 (R&R) Application Guide is critical to submitting a complete
and accurate application to HHS/CDC. There are fields within the SF424
(R&R) application components that, although not marked as mandatory, are
required by HHS/CDC (e.g., the "Credential" log-in field of the
"Research & Related Senior/Key Person Profile" component must contain
the PD/PI assigned eRA Commons User ID). Agency-specific instructions
for such fields are clearly identified in the Application Guide. For
additional information, see "Tips and Tools for Navigating Electronic
Submission" on the front page of "[Electronic Submission of Grant
Applications](http://era.nih.gov/ElectronicReceipt/)."

The SF424 (R&R) application is comprised of data arranged in separate
components. Some components are required, others are optional. The forms
package associated with this FOA in
[Grants.gov/Apply](http://www.grants.gov/Apply) will include all
applicable components, mandatory and optional. A completed application
in response to this FOA will include the following components:

**Required Components:**

SF424 (R&R) (Cover component)\
Research & Related Project/Performance Site Locations\
Research & Related Other Project Information\
Research & Related Senior/Key Person\
Research & Related Budget\
\
PHS398 Cover Page Supplement\
PHS398 Research Plan\
PHS398 Checklist

**Optional Components:**\
\
PHS398 Cover Letter File\
Research & Related Sub award Budget Attachment(s) Form

Note: While both budget components are included in the SF424 (R&R) forms
package, the CDC U01 (activity code) uses ONLY the detailed Research &
Related Budget. (Do not use the PHS 398 Modular Budget.)

**3. Submission Dates and Times**

See Section IV.3.A for details

**3. A. Submission, Review and Anticipated Start Dates**\
\
Letter of Intent Receipt Date: Not Applicable

Application Submission Receipt Date(s): March 26, 2009

Peer Review Date (s): May 2009

Council Review Date (s): June 2009

Earliest Anticipated Start Date: September 10, 2009\
\
**3.A.1. Letter of Intent**

A letter of intent is not applicable to this funding opportunity
announcement.

**3.B. Submitting an Application to CDC**

If the instructions in this announcement differ in any way from the 424
R&R instructions, follow the instructions in this announcement.

To submit an application in response to this FOA, applicants should
access this FOA via [Grants.gov/Apply](http://www.grants.gov/Apply) and
follow steps 1-4. If submittal of the application is done electronically
through Grants.gov ([http://www.grants.gov](http://www.grants.gov/)),
the application will be electronically time/date stamped by Grants.gov.
The applicants' Authorized Organization Representative (AOR) will
receive an e-mail notice of receipt from eRA Commons and Grants.gov when
HHS/CDC receives the application.

**3.C. Application Processing**\
\
HHS/CDC must receive applications on or before 5:00 P.M. Eastern
Standard Time on the application submission date(s) described above
(Section IV.3.A.). If HHS/CDC receives an application after that
submission date and time, the application may be delayed in the review
process or not reviewed.

Once an application package has been successfully submitted through
Grants.gov, any errors have been addressed, and the assembled
application has been created in the eRA Commons, the PD/PI and the
Authorized Organization Representative/Signing Official (AOR/SO) have
two business days to view the application image.

-   If everything is acceptable, no further action is necessary. The
    application will automatically move forward for processing by the
    CDC, PGO, Technical Information Management Section, after two
    business days.

-   Prior to the submission deadline, the AOR/SO can "Reject" the
    assembled application and submit a changed/corrected application
    within the two day viewing window. This option should be used if the
    AOR/SO determines that warnings should be addressed. Reminder:
    warnings do not stop further application processing. If an
    application submission results in warnings (but no errors) it will
    automatically move forward after two business days if no action is
    taken. Please remember that some warnings may not be applicable or
    may need to be addressed after application submission.

-   If the two day window falls after the submission deadline, the
    AOR/SO will have the option to "Reject" the application if, due to
    an eRA Commons or Grants.gov system issue, the application does not
    correctly reflect the submitted application package (e.g., some part
    of the application was lost or didn't transfer correctly during the
    submission process). The AOR/SO should first contact the [eRA
    Commons Helpdesk](http://ithelpdesk.nih.gov/eRA/) to confirm the
    system error, document the issue, and determine the best course of
    action. HHS/CDC will not penalize the applicant for an eRA Commons
    or Grants.gov system issue.

-   If the AOR/SO chooses to "Reject" the image after the submission
    deadline for a reason other than an eRA Commons or Grants.gov system
    failure, a changed/corrected application still can be submitted but
    it will be subject to the CDC late policy guidelines and may not be
    accepted. The reason for this delay should be explained in the cover
    letter attachment and must refer only to Commons errors and/or
    technical errors.

-   Both the AOR/SO and PD/PI will receive e-mail notifications when the
    application is rejected or the application automatically moves
    forward in the process after two days.

Upon receipt, applications will be evaluated for completeness and
responsiveness by the Coordinating Center for Infectious Diseases (CCID)
and HHS/CDC Procurement and Grants Office (PGO). HHS/CDC will not review
incomplete and non-responsive applications.

There will be an acknowledgement of receipt of applications from
Grants.gov and the eRA [Commons](https://commons.era.nih.gov/commons/).

**4. Intergovernmental Review**

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>.

**5. Funding Restrictions**

All HHS/CDC awards are subject to the terms and conditions, cost
principles, and other considerations described in the HHS Grants Policy
Statement.

Additional guidance can be found at HHS [Grants Policy
Statement](http://grants.nih.gov/grants/policy/policy.htm).

Restrictions, which applicants must take into account while writing
their budgets, are as follows:

-   Funds relating to the conduct of research which involves human
    subjects will be restricted until the appropriate assurances and
    Institutional Review Board approvals are in place. Awardees may not
    enroll human subjects until they receive a revised Notice of Award
    from the Procurement and Grants Office lifting the human subject's
    restriction.

-   Pre-Award Costs will not be reimbursed.

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-   Purchase of vaccine with study-related funds is prohibited as part
    of this project.

**6. Other Submission Requirements**

Awardees upon acceptance of Notice of Award (NoA), must agree to the
\"Cooperative Agreement Terms and Conditions of Award\" in Section VI.
\"Award Administration Information".

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.
If submitting electronically, use a PDF version of the agreement, attach
it in Grants.gov under "Other Attachments", and title it appropriately.

Applicants' research plan(s) should address activities they will conduct
over the entire project period.

The HHS/CDC requires the PD/PI to fill in his/her eRA Commons User ID in
the "PROFILE -- Project Director/Principal Investigator" section,
"Credential" log-in field of the "Research & Related Senior/Key Person
Profile" component. The applicant organization must include its DUNS
number in its Organization Profile in the eRA Commons. This DUNS number
must match the DUNS number provided at CCR registration with Grants.gov.
For additional information, see Registration FAQs -- Important Tips \--
[Electronic Submission of Grant
Applications](http://era.nih.gov/ElectronicReceipt/preparing.htm#4c).

**Research Plan Component Sections**

While each section of the Research Plan component needs to be uploaded
separately as a PDF attachment, applicants are encouraged to construct
the Research Plan component as a single document, separating sections
into distinct PDF attachments just before uploading the files. This
approach will enable applicants to better monitor formatting
requirements such as page limits. All attachments must be provided to
HHS/CDC in PDF format, filenames must be included with no spaces or
special characters, and a PDF extension must be used. Do not include any
information in a header or footer of the attachments. A header will be
system-generated that references the PD/PI. Page numbers for the footer
will be system-generated in the complete application, with all pages
sequentially numbered; therefore, do not number the pages of your
attachments.  Your research plan must not exceed 25 pages.

The following materials may be included in the Appendix:

Up to five publications, manuscripts (accepted for publication),
abstracts, patents, or other printed materials directly relevant to the
proposed project. Do not include manuscripts submitted for
publication. Applicants should refer to instruction guides and specific
Funding Opportunity Announcements (FOAs) to determine the appropriate
limit on the number of publications that may be submitted for a
particular program. Note that not all grant activity codes allow the
inclusion of publications.

-   Publications in press:  Include only a publication list with a link
    to the publicly available on-line journal article or the NIH Pub Med
    Central (PMC) submission identification number. Do not include the
    entire article.

-   Manuscripts accepted for publication but not yet published: The
    entire article may be submitted electronically as a PDF attachment.

-   Manuscripts published but a publicly available online journal link
    is not available:  The entire article may be submitted
    electronically as a PDF attachment.

-   Surveys, questionnaires, data collection instruments, clinical
    protocols, and informed consent documents.

-   Graphic images of gels, micrographs, etc. provided that the image
    (may be reduced in size) is also included within the (stated) page
    limit of Items 2-5 of the Research Plan component. No images may be
    included in the Appendix that are not also represented within the
    Research Plan.

Please note the following restriction on appendix attachments: The
Research Plan [Appendix attachments]{.underline} are limited to 10
attachments. Appendices are uploaded as attachments in the PHS 398
Research Plan form, in field #18, within the electronic application
package. An applicant will receive an error message if the number of
appendix attachments exceeds 10, which will result in an unsuccessful
submission of the application. You may include more than one
publication, or other allowable appendix material, within one
attachment; however, do not let your attachments exceed 10."

Do not to use the Appendix to circumvent the page limitations of the
Research Plan component. An application that does not observe the
relevant policies and procedures will not be considered in the review
process. Applicants are reminded to review specific FOAs for any
additional program-specific guidance on Appendix material and other
application requirements.

**Plan for Sharing Research Data**.\
The precise content of the data-sharing plan will vary, depending on the
data being collected and how the investigator is planning to share the
data. Applicants should describe briefly the expected schedule for data
sharing, the format of the final dataset, the documentation they will
provide, whether or not any analytic tools also will be provided,
whether or not a data-sharing agreement will be required and, if so, a
brief description of such an agreement (including the criteria for
deciding who can receive the data and whether or not the awardee will
place any conditions on their use), and the mode of data sharing (e.g.,
under their own auspices by mailing a disk or posting data on their
institutional or personal website, through a data archive or enclave).
References to data sharing may also be appropriate in other sections of
the application.

All applicants must include a plan for sharing research data in their
application. The HHS/CDC data sharing policy is available at
<http://www.cdc.gov/od/pgo/funding/ARs.htm> under Additional
Requirements 25 Release and Sharing of Data. All investigators
responding to this funding opportunity should include a description of
how final research data will be shared, or explain why data sharing is
not possible.\
\
The reasonableness of the data sharing plan or the rationale for not
sharing research data will be assessed by the reviewers. However,
reviewers will not factor the proposed data sharing plan into the
determination of scientific merit or the priority score.

**Sharing Research Resources**

HHS policy requires that grant award recipients make unique research
resources readily available for research purposes to qualified
individuals within the scientific community after publication (see the
HHS Grants Policy Statement
<http://www.hhs.gov/grantsnet/docs/HHSGPS_107.doc>.) Investigators
responding to this funding opportunity should include a plan for sharing
research resources addressing how unique research resources will be
shared or explain why sharing is not possible.\
\
The adequacy of the resources sharing plan and any related data sharing
plans will be considered by the HHS/CDC Program staff of the funding
organization when making recommendations about funding applications. The
effectiveness of the resource sharing will be evaluated as part of the
administrative review of each non-competing Grant Progress Report (PHS
2590,<http://grants.nih.gov/grants/funding/2590/2590.htm>). See [Section
VI.3. Reporting](#SectionVI3).

**Section V. Application Review Information**

**1. Criteria**

> Only the review criteria described below will be considered in the
> review process.\
> **\
> **

-   Scientific merit of the proposed project as determined by peer
    review

-   Availability of funds

-   Relevance of program priorities and the priorities of the U.S.
    Department of Health and Human Services

-   Funding decision criteria will include a priority score,
    programmatic importance/value relative to program priorities,
    research portfolio balance, geographic locations ((East, West,
    North, South),and study population consideration (ethnicity, and
    SES).

-   Letters of support from partner performance sites are encouraged.
    Preference may be given to applicants who provide letters of support
    from performance sites over those who do not

-   The applicants that do not address all of the four research
    objectives in the research plan of the application may not be funded
    even if they rank higher than other applications that address all
    required objectives.

**2. Review and Selection Process**\
\
Applications that are complete and responsive to the FOA will be
evaluated for scientific and technical merit by an appropriate peer
review group convened by CCID in accordance with the review criteria
stated below.\
\
As part of the initial merit review, all applications will:

-   Undergo a selection process in which only those applications deemed
    to have the highest scientific merit, generally the top half of
    applications under review, will be discussed and assigned a priority
    score

-   Receive a written critique; and

-   Receive a second level of review by HHS/CDC CCID

-   Applications submitted in response to this FOA will compete for
    available funds with all other eligible applications. The criteria
    listed in Section V.1. will be considered in making funding
    recommendations.

The goals of HHS/CDC-supported research are to advance the understanding
of health promotion and the prevention of disease, injury, and
disability, and enhance preparedness. In the written comments, evaluate
the application to judge the likelihood the proposed research will have
a substantial impact on the pursuit of these goals. Each of these
criteria will be addressed by the reviewers and considered in assigning
the overall score, weighting them and weighted, as appropriate for each
applications.

-   Significance

-   Approach

-   Innovation

-   Investigators

-   Environment

Note that an 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.\
\
Significance: Does this study address an important problem? If the
applicant achieves the aims of the application, how will it advance
scientific knowledge or clinical practice? What will be the effect of
these studies on the concepts, methods, technologies, treatments, or
preventative interventions that drive this field? Has the applicant
described a study design that will lend itself to the identification of
strategies that will be sustainable, generalizable, and effective?\
\
Approach: Are the conceptual or clinical framework, design, methods, and
analyses adequately developed, well integrated, well reasoned, and
appropriate to the aims of the project? Does the applicant acknowledge
potential problem areas and consider alternative tactics? Does the
research plan address all of the required objectives and elements? Are
the proposed study medical practices and adolescent patient populations
diverse? Does the project include plans to measure progress toward
achieving the stated research objectives? Is there an appropriate work
plan and time line included?

Innovation: Is the project original and innovative? For example: Does
the project challenge existing paradigms or clinical practice; address
an innovative hypothesis or critical barrier to progress in the field?
Does the project develop or employ novel concepts, approaches,
methodologies, tools, or technologies for this area? Given that
reminder-recall has been well-studied in other populations and that
reminder-recall studies among adolescents are currently underway, what
features does the proposed research plan include that will advance
health services research?\
\
\
Investigators: Are the investigators 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?
Does the investigative team bring complementary and integrated expertise
to the project (if applicable)? Has the Principal Investigator conducted
health services research or immunization-related research and published
findings in a peer-reviewed journal, as required to be considered as an
applicant? If the Principal Investigator's health services research
experience has not previously focused on immunization, has the Principal
Investigator identified one or more co-investigators who have conducted
immunization-related research and published findings in a peer-reviewed
journal? Does the applicant have experience in office-based research,
i.e., research conducted in outpatient offices and yielding insight into
the experiences between patients and physicians in that setting, and
immunization-related research? Is the application of any qualified
investigator strengthened further by either personal expertise or
inclusion of co-investigators with expertise in health care economics,
program evaluation, and advanced statistical analyses, respectively?

Environment: Does the scientific environment in which the applicant will
do the work contribute to the probability of success? Do the proposed
studies benefit from unique features of the scientific environment, or
subject populations, or employ useful collaborative arrangements? Is
there evidence of institutional support? Is there an appropriate degree
of commitment and cooperation of other interested parties as evidenced
by letters of support detailing the nature and extent of the
involvement? Is there evidence of support from the appropriate local
health department?

**2.A. Additional Review Criteria**\
\
In addition to the above criteria, the following items will be
considered in the determination of scientific merit and the priority
score:

***Protection of Human Subjects from Research Risk: When human subjects
are involved, HHS/CDC will assess the available protections from
research risk that relate to their participation in the proposed
research. \[see the Research Plan, Section 2, item 8 on Human Subjects
in the SF424 (R&R)\]
<http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm>. Additional
HHS/CDC Requirements under AR-1 Human Subjects Requirements are
available on the Internet at the following address:
<http://www.cdc.gov/od/pgo/funding/ARs.htm>.***

***Inclusion of Women and Minorities in Research:***

***Does the application adequately address the HHS/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 (see Section 2,
item 9 Inclusion or Women and Minorities of the Research Plan component
of the SF424 (R&R). .***

Biohazards: If applicants propose the applicant has proposed materials
or procedures that are potentially hazardous to research personnel
and/or the environment, HHS/CDC will determine if the proposed
protection is adequate.\
\
**2.B. Additional Review Considerations**\
\
Budget and Period of Support: The reasonableness of the proposed budget
and the appropriateness of the requested period of support in relation
to the proposed research may be assessed by the reviewers. Is the number
of person months listed for the effort of the PD/PI appropriate for the
work proposed? Is each budget category realistic and justified in terms
of the aims and methods? The evaluation of the budget should not effect
the priority score.\
\
**2.C. Sharing Research Data**

Data Sharing Plan: HHS/CDC will assess the reasonableness of the data
sharing plan. However, reviewers will not factor the proposed data
sharing plan into the determination of scientific merit or the priority
score. The presence of a data sharing plan will be part of the terms and
conditions of the award. The funding organization will be responsible
for monitoring the data sharing policy. Program staff will be
responsible for the administrative review of the plan for sharing
research data.

**2.D. Sharing Research Resources**\
\
HHS policy requires that recipients of grant awards make unique research
resources readily available for research purposes to qualified
individuals within the scientific community after publication. Please
see <http://grants.nih.gov/grants/policy/gps/8postnew.htm#phs>.
Investigators responding to this funding opportunity should include a
plan on sharing research resources.

Program staff will be responsible for the administrative review of the
plan for sharing research resources.

The adequacy of the resources sharing plan will be considered by Program
staff of the funding organization when making recommendations about
funding applications. The effectiveness of the resource sharing will be
evaluated as part of the administrative review of each non-competing
Grant Progress Report (HHS/PHS 2590
<http://grants.nih.gov/grants/funding/2590/2590.htm>). See Section VI.3.
Reporting .\
\
**3. Anticipated Announcement and Award Dates**

Earliest anticipated award date is September 10, 2009.

**Section VI. Award Administration Information**

**1. Award Notices**\
\
After the peer review of the application is completed, the applicant
organization will receive a written critique called a "Summary
Statement." The applicant organization and the PD/PI will be able to
access the Summary Statement via the eRA Commons.

HHS/CDC will contact those applicants under consideration for funding
for additional information.

A formal notification in the form of a Notice of Award (NoA) will be
provided to the applicant organization. The NoA signed by the Grants
Management Officer (GMO) is the authorizing document. HHS/CDC will mail
and/or e-mail this document to the recipient fiscal officer identified
in the application.

Selection of the application for award is not an authorization to begin
performance. Any cost incurred before receipt of the NoA is at the
recipient's risk. These costs may be reimbursed only to the extent
considered allowable pre-award costs. See also Section IV.5. Funding
Restrictions.

**2. Administrative and National Policy Requirements**

The Code of Federal Regulations 45 CFR Part 74 and Part 92 have details
about requirements. 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>. Additional
requirements are available Section VIII. Other Information of this
document or on the HHS/CDC website at the following Internet address:
<http://www.cdc.gov/od/pgo/funding/ARs.htm>. These will be incorporated
into the NoA by reference.

The following terms and conditions will be incorporated into the NoA and
will be provided to the appropriate institutional official and a
courteous copy to the PD/PI at the time of award.

**2.A. Cooperative Agreement**

The following terms of award are in addition to, and not in lieu of,
otherwise applicable Office of Management and Budget (OMB)
administrative guidelines, HHS grant administration regulations at 45
CFR Parts 74 and 92 (Part 92 is applicable when State and local
Governments are eligible to apply), and other HHS/CDC grant
administration policies.\
\
The administrative and funding instrument used for this program will be
the cooperative agreement U01 an \"assistance\" instrument (rather than
an \"acquisition\" instrument), in which substantial HHS/CDC
programmatic involvement with the awardees is anticipated during the
performance of the activities. Under the cooperative agreement, the
HHS/CDC purpose is to support and stimulate the recipients\' activities
by involvement in and otherwise working jointly with the award
recipients in a partnership role; it is not to assume direction, prime
responsibility, or a dominant role in the activities. Consistent with
this concept, the dominant role and prime responsibility resides with
the awardees for the project as a whole, although specific tasks and
activities may be shared among the awardees and the HHS/CDC may share
specific tasks and activities, as defined above.\
\
**2.A.1. Recipient Rights and Responsibilities**

The Recipient will have the primary responsibility for the following:

-   Planning, directing, and executing the proposed project with CDC
    staff being substantially involved as a partner.

-   Documenting areas where difficulties/barriers arose and how they
    were resolved.

-   Refining protocols in order to improve the study based on reviewers'
    comments in the summary statements.

-   Conducting formative research with immunization providers serving
    socioeconomically diverse pediatric populations, and with parents.

-   Based on findings from formative research, conduct a pilot project.

-   Obtaining the appropriate human subjects clearances at local sites,
    and working with CDC project scientists to obtain CDC human subjects
    clearance.

-   Participating in conference calls with project scientists to
    collaborate on the development of the research protocols and
    providing progress updates.

-   Attend an annual meeting at CDC or present findings at the National
    Immunization Conference;

-   Sharing data with CDC scientists.

-   Present and submit the study (or its various components) for
    publication in a peer-reviewed journal, and make presentations at
    national professional meetings.

Recipient Organization will retain custody of and have primary rights to
the information, data and software developed under this award, subject
to U.S. Government rights of access consistent with current HHS/CDC
policies.\
\
**2.A.2. HHS/CDC Responsibilities**

An HHS/CDC Project Scientist will have substantial programmatic
involvement that is above and beyond the normal stewardship role in
awards, as described below:

-   Monitor the cooperative agreement.

-   Assist in the development, implementation and evaluation of the
    research 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. If needed, the CDC IRB will review and
    approve the project protocol or will defer to outside IRB, and may
    do so on at least an annual basis until the research project is
    completed.

-   Provide technical assistance in the areas of epidemiological
    methods, qualitative methods, statistical analysis, and adolescent
    vaccination.

-   Collaborate with the investigators on interpretation of results and
    dissemination and publication of results if CDC contribution merits
    this.

-   Plan an annual meeting between awardee/s and CDC to coordinate
    planned efforts and review progress.

-   Assist in the review and approval of protocols and questionnaires.

    Additionally, an HHS/CDC agency program official or CIO program
    director will be responsible for the normal scientific and
    programmatic stewardship of the award and will be named in the NoA.

    []{#SectionVI3 .anchor}**3. Reporting**\
    \
    Recipient Organization must provide HHS/CDC with an original, plus
    two hard copies of the following reports:

1.  Non-Competing Grant Progress Report, (use form PHS 2590, posted on
    the HHS/CDC website, <http://www.cdc.gov/od/pgo/funding/forms.htm>
    and at <http://grants.nih.gov/grants/funding/2590/2590.htm>, no less
    than 120 days prior to the end of the current budget period. The
    progress report will serve as the non-competing continuation
    application.

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.

Recipient Organization must forward these reports by the U.S. Postal
Service or express delivery to the Grants Management Specialist listed
in the "Agency Contacts" section of this FOA.

Although the financial plans of the HHS/CDC CIO(s) provide support for
this program, awards pursuant to this funding opportunity are contingent
upon 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.

**Section VII. Agency Contacts**

HHS/CDC encourages your inquiries concerning this FOA and welcomes the
opportunity to answer questions from potential applicants. Inquiries can
fall into three areas: scientific/research, peer review, and financial
or grants management issues:\
\
**1. Scientific/Research Contacts:**\
\
Dr. Lourdes Mueller

Extramural Programs

Strategic Science and Program Unit

Coordinating Center for Infectious Diseases

Centers for Disease Control and Prevention

U.S. Department of Health and Human Services

1600 Clifton Road, MS E-60

Atlanta, GA 30333

Telephone: (404) 498-2207

FAX: (404) 498-2626

Email: LMueller@cdc.gov\
\
**2. Peer Review Contacts:**

Dr. Wendy Carr

Extramural Programs

Strategic Science and Program Unit

Coordinating Center for Infectious Diseases

Centers for Disease Control and Prevention

U.S. Department of Health and Human Services

1600 Clifton Road, MS E-60

Atlanta, GA 30333

Telephone: (404) 498-2276

FAX: (404) 498-2626

Email:IBT5@cdc.gov\
\
**3. Financial or Grants Management Contacts:**

Michael Vance\
Procurement and Grants Office\
Center for Disease Control and Prevention

U.S. Department of Health and Human Services\
Colgate Building, 3^rd^ Floor\
2920 Brandywine Road\
Atlanta, GA 30341\
Telephone: (770) 488-2686\
Fax: (770) 488-2044\
Email: mav5@cdc.gov

**4. General Questions Contacts:**\
\
Technical Information Management Section

CDC Procurement and Grants Office

U.S. Department of Health and Human Services

2920 Brandywine Road

Atlanta, GA 30341

Telephone: 770-488-2700

Email: <PGOTIM@cdc.gov>

**Section VIII. Other Information**

**Required Federal Citations**

**Human Subjects Protection**\
Federal regulations (45 CFR Part 46) require that applications and
proposals involving human subjects must be evaluated with reference to
the risks to the subjects, the adequacy of protection against these
risks, the potential benefits of the research to the subjects and
others, and the importance of the knowledge gained or to be gained
(<http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm>).
Additional HHS/CDC Requirements under AR-1 Human Subjects Requirements
can be found on the Internet at the following address:
<http://www.cdc.gov/od/pgo/funding/ARs.htm>.

**Requirements for Inclusion of Women and Racial and Ethnic Minorities
in Research**

It is the policy of the Centers for Disease Control and Prevention (CDC)
and the Agency for Toxic Substances and Disease Registry (ATSDR) to
ensure that individuals of both sexes and the various racial and ethnic
groups will be included in CDC/ATSDR-supported research projects
involving human subjects, whenever feasible and appropriate. Racial and
ethnic groups are those defined in OMB Directive No. 15 and include
American Indian or Alaska Native, Asian, Black or African American,
Hispanic or Latino, Native Hawaiian or Other Pacific Islander.
Applicants shall ensure that women, racial and ethnic minority
populations are appropriately represented in applications for research
involving human subjects. Where clear and compelling rationale exist
that inclusion is inappropriate or not feasible, this situation must be
explained as part of the application. This policy does not apply to
research studies when the investigator cannot control the race,
ethnicity, and/or sex of subjects. Further guidance to this policy is
contained in the Federal Register, Vol. 60, No. 179, pages 47947-47951,
and dated Friday, September 15, 1995.

**INCLUSION OF PERSONS UNDER THE AGE OF 21 IN RESEARCH**\
The policy of CDC is that persons under the age of 21 must be included
in all human subjects research that is conducted or supported by CDC,
unless there are scientific and ethical reasons not to include them.
This policy applies to all CDC-conducted or CDC-supported research
involving human subjects, including research that is otherwise exempt in
accordance with Sections 101(b) and 401(b) of [[45 C.F.R. Part 46, HHS
Policy for the Protection of Human
Subjects]{.underline}](http://www.access.gpo.gov/nara/cfr/waisidx_05/45cfr46_05.html).
Therefore, proposals for research involving human subjects must include
a description of plans for including persons under the age of 21. If
persons under the age of 21 will be excluded from the research, the
application or proposal must present an acceptable justification for the
exclusion.

In an extramural research plan, the investigator should create a section
titled \"Participation of persons under the age of 21.\" This section
should provide either a description of the plans to include persons
under the age of 21 and a rationale for selecting or excluding a
specific age range, or an explanation of the reason(s) for excluding
persons under the age of 21 as participants in the research. When
persons under the age of 21 are included, the plan must also include a
description of the expertise of the investigative team for dealing with
individuals at the ages included, the appropriateness of the available
facilities to accommodate the included age groups, and the inclusion of
a sufficient number of persons under the age of 21 to contribute to a
meaningful analysis relative to the purpose of the study. Scientific
review groups at CDC will assess each application as being acceptable or
unacceptable in regard to the age-appropriate inclusion or exclusion of
persons under the age of 21 in the research project, in addition to
evaluating the plans for conducting the research in accordance with
these provisions.

The inclusion of children (as defined by the applicable law of the
jurisdiction in which the research will be conducted) as subjects in
research must be in compliance with all applicable subparts of [[45
C.F.R. Part
46]{.underline}](http://www.access.gpo.gov/nara/cfr/waisidx_05/45cfr46_05.html),
as well as with other pertinent federal laws and regulations.

The policy of inclusion of persons under the age of 21 in CDC-conducted
or CDC-supported research activities in foreign countries (including
collaborative activities) is the same as that for research conducted in
the United States.

**Executive Order 12372 Review**

Applications are subject to Intergovernmental Review of Federal
Programs, as governed by Executive Order (E.O.) 12372. The order sets up
a system for State and local governmental review of proposed Federal
assistance applications. Applicants should contact their State single
point of contact (SPOC) as early as possible to alert the SPOC to
prospective applications and to receive instructions on the State
process. For proposed projects serving more than one State, the
applicant is advised to contact the SPOC for each State affected.

Click on the following link to get the current SPOC list

<http://www.whitehouse.gov/omb/grants/spoc.html>

Indian tribes must request tribal government review of their
applications.

Specs or tribal governments that have recommendations about an
application submitted to HHS/CDC should send them, in a document bearing
the program announcement number, no more than 60 days after the
application deadline date, to:

> Michael Vance, Grants Management Specialist\
> Procurement and Grants Office\
> Announcement Number IP09-006\
> Centers for Disease Control and Prevention (CDC)\
> 2920 Brandywine Road\
> Atlanta, Georgia 30341-4146

HHS/CDC does not guarantee to accept or justify its non-acceptance of
recommendations that are received more than 60 days after the
application deadline.

**Public Health System Reporting Requirements**

This program is subject to the Public Health System Reporting
Requirements. Under these requirements, all community-based
non-governmental organizations submitting health services applications
must prepare and submit the items identified below to the head of the
appropriate State and/or local health agency(s) in the program area(s)
that may be impacted by the proposed project no later than the
application deadline date of the Federal application. The appropriate
State and/or local health agency is determined by the applicant. The
following information must be provided:

> A. A copy of the face page of the application (SF 424).
>
> B. A summary of the project that should be titled \"Public Health
> System Impact Statement\" (PHSIS), not exceed one page, and include
> the following:

1.  A description of the population to be served.

2.  A summary of the services to be provided.

3.  A description of the coordination plans with the appropriate state
    and/or local health agencies.

If the State and/or local health official should desire a copy of the
entire application, it may be obtained from the State Single Point of
Contact (SPOC) or directly from the applicant.

Smoke-Free Workplace Requirements

HHS/CDC strongly encourages all recipients to provide a smoke-free
workplace and to promote abstinence from all tobacco products. Public
Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain
facilities that receive Federal funds in which education, library, day
care, health care, or early childhood development services are provided
to children.

 

# Healthy People 2010

The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of \"Healthy People 2010,\"
a PHS-led national activity for setting priority areas. This FOA is
related to one or more of the priority areas. Potential applicants may
obtain a copy of \"Healthy People 2010\" at
[www.healthypeople.gov](http://www.health.gov/healthypeople)

### Lobbying Restrictions

Applicants should be aware of restrictions on the use of HHS funds for
lobbying of Federal or State legislative bodies. Under the provisions of
31 U.S.C. Section 1352, recipients (and their sub-tier contractors) are
prohibited from using appropriated Federal funds (other than profits
from a Federal contract) for lobbying congress or any Federal agency in
connection with the award of a particular contract, grant, cooperative
agreement, or loan. This includes grants/cooperative agreements that, in
whole or in part, involve conferences for which Federal funds cannot be
used directly or indirectly to encourage participants to lobby or to
instruct participants on how to lobby.

In addition no part of HHS/CDC appropriated funds, shall be used, other
than for normal and recognized executive-legislative relationships, for
publicity or propaganda purposes, for the preparation, distribution, or
use of any kit, pamphlet, booklet, publication, radio, television, or
video presentation designed to support or defeat legislation pending
before the Congress or any State or local legislature, except in
presentation to the Congress or any State or local legislature itself.
No part of the appropriated funds shall be used to pay the salary or
expenses of any grant or contract recipient, or agent acting for such
recipient, related to any activity designed to influence legislation or
appropriations pending before the Congress or any State or local
legislature.

Any activity designed to influence action in regard to a particular
piece of pending legislation would be considered \"lobbying.\" That is
lobbying for or against pending legislation, as well as indirect or
\"grass roots\" lobbying efforts by award recipients that are directed
at inducing members of the public to contact their elected
representatives at the Federal or State levels to urge support of, or
opposition to, pending legislative proposals is prohibited. As a matter
of policy, HHS/CDC extends the prohibitions to lobbying with respect to
local legislation and local legislative bodies.

The provisions are not intended to prohibit all interaction with the
legislative branch, or to prohibit educational efforts pertaining to
public health. Clearly there are circumstances when it is advisable and
permissible to provide information to the legislative branch in order to
foster implementation of prevention strategies to promote public health.
However, it would not be permissible to influence, directly or
indirectly, a specific piece of pending legislation

It remains permissible to use HHS/CDC funds to engage in activity to
enhance prevention; collect and analyze data; publish and disseminate
results of research and surveillance data; implement prevention
strategies; conduct community outreach services; provide leadership and
training, and foster safe and healthful environments.

Recipients of HHS/CDC grants and cooperative agreements need to be
careful to prevent CDC funds from being used to influence or promote
pending legislation. With respect to conferences, public events,
publications, and \"grassroots\" activities that relate to specific
legislation, recipients of HHS/CDC funds should give close attention to
isolating and separating the appropriate use of HHS/CDC funds from
non-CDC funds. HHS/CDC also cautions recipients of HHS/CDC funds to be
careful not to give the appearance that HHS/CDC funds are being used to
carry out activities in a manner that is prohibited under Federal law.

Accounting System Requirements

The services of a certified public accountant licensed by the State
Board of Accountancy or the equivalent must be retained throughout the
project as a part of the recipient\'s staff or as a consultant to the
recipient\'s accounting personnel. These services may include the
design, implementation, and maintenance of an accounting system that
will record receipts and expenditures of Federal funds in accordance
with accounting principles, Federal regulations, and terms of the
cooperative agreement or grant.

 

**Capability Assessment**

It may be necessary to conduct an on-site evaluation of some applicant
organization\'s financial management capabilities prior to or
immediately following the award of the grant or cooperative agreement.
Independent audit statements from a Certified Public Accountant (CPA)
for the preceding two fiscal years may also be required.

**Proof of Non-profit Status**

Proof of nonprofit status must be submitted by private nonprofit
organizations with the application. Any of the following is acceptable
evidence of nonprofit status: (a) a reference to the applicant
organization\'s listing in the Internal Revenue Service\'s (IRS) most
recent list of tax-exempt organizations described in section 501(c)(3)
of the IRS Code; (b) a copy of a currently valid IRS tax exemption
certificate; (c) a statement from a State taxing body, State Attorney
General, or other appropriate State Official certifying that the
applicant organization has a nonprofit status and that none of the net
earnings accrue to any private shareholders or individuals; (d) a
certified copy of the organization\'s certificate of incorporation or
similar document that clearly establishes nonprofit status; (e) any of
the above proof for a State or national parent organization and a
statement signed by the parent organization that the applicant
organization is a local nonprofit affiliate.

**Security Clearance Requirement**

All individuals who will be performing work under a grant or cooperative
agreement in a HHS/CDC-owned or leased facility (on-site facility) must
receive a favorable security clearance, and meet all security
requirements. This means that all awardees employees, fellows, visiting
researchers, interns, etc., no matter the duration of their stay at
HHS/CDC must undergo a security clearance process.

**Compliance with Executive Order 13279**

Faith-based organization are eligible to receive federal financial
assistance, and their applications are evaluated in the same manner and
using the same criteria as those for non-faith-based organizations in
accordance with Executive Order 13279, Equal Protection of the Laws for
Faith-Based and Community Organizations. All applicants should, however,
be aware of restrictions on the use of direct financial assistance from
the Department of Health and Human Services (DHHS) for inherently
religious activities. Under the provisions of Title 45, Parts 74, 87, 92
and 96, organizations that receive direct financial assistance from DHHS
under any DHHS program may not engage in inherently religious
activities, such as worship, religious instruction, or proselytization
as a part of the programs or services funded with direct financial
assistance from DHHS. If an organization engages in such activities, it
must offer them separately, in time or location, from the programs or
services funded with direct DHHS assistance, and participation must be
voluntary for the beneficiaries of the programs or services funded with
such assistance. A religious organization that participates in the DHHS
funded programs or services will retain its independence from Federal,
State, and local governments, and may continue to carry out its mission,
including the definition, practice, and expression of its religious
beliefs, provided that it does not use direct financial assistance from
DHHS to support inherently religious activities such as those activities
described above. A faith-based organization may, however, use space in
its facilities to provide programs or services funded with financial
assistance from DHHS without removing religious art, icons, scriptures,
or other religious symbols. In addition, a religious organization that
receives financial assistance from DHHS retains its authority over its
internal governance, and it may retain religious terms in its
organization=s name, select its board members on a religious basis, and
include religious references in its organization=s mission statements
and other governing documents in accordance with all program
requirements, statutes, and other applicable requirements governing the
conduct of DHHS funded activities. For further guidance on the use of
DHHS direct financial assistance see Title 45, Code of Federal
Regulations, Part 87, Equal Treatment for Faith-Based Organizations, and
visit the internet site:

<http://www.whitehouse.gov/government/fbci/>

**Health Insurance Portability and Accountability Act Requirements**

Recipients of this grant award should note that pursuant to the
Standards for Privacy of Individually Identifiable Health Information
promulgated under the Health Insurance Portability and Accountability
Act (HIPAA) (45 CFR Parts 160 and 164) covered entities may disclose
protected health information to public health authorities authorized by
law to collect or receive such information for the purpose of preventing
or controlling disease, injury, or disability, including, but not
limited to, the reporting of disease, injury, vital events such as birth
or death, and the conduct of public health surveillance, public health
investigations, and public health interventions. The definition of a
public health authority includes a person or entity acting under a grant
of authority from or contract with such public agency. HHS/CDC considers
this project a public health activity consistent with the Standards for
Privacy of Individually Identifiable Health Information and HHS/CDC will
provide successful recipients a specific grant of public health
authority for the purposes of this project.

**Release and Sharing of Data**

The Data Release Plan is the Grantee\'s assurance that the dissemination
of any and all data collected under the HHS/CDC data sharing agreement
will be released as follows:

a.  In a timely manner.

b.  Completely, and as accurately as possible.

c.  To facilitate the broader community.

d.  Developed in accordance with CDC policy on Releasing and Sharing
    Data.

April 16, 2003, <http://www.cdc.gov/od/foia/policies/sharing.htm>, and
in full compliance with the 1996 Health Insurance Portability and
Accountability Act (HIPPA), (where applicable), The Office of Management
and Budget Circular A110, (2000) revised 2003,
[www.whitehouse.gov/omb/query.html?col=omb&qt=Releasing+and+Sharing+of+Data](http://www.whitehouse.gov/omb/query.html?col=omb&qt=Releasing+and+Sharing+of+Data)
and Freedom of Information Act (FOIA)
[http://www.cdc.gov/od/foia/index.htm](http://www.4.law.cornell.edu/uscode/5/5/552/html).

Applications must include a copy of the applicant\'s Data Release Plan. 
Applicants should provide HHS/CDC with appropriate documentation on the
reliability of the data.  Applications submitted without the required
Plan may be ineligible for award.  Award will be made when reviewing
officials have approved an acceptable Plan.  The successful applicant
and the Program Manager will determine the documentation format. 
HHS/CDC recommends data is released in the form closest to micro data
and one that will preserve confidentiality. 

**Conference Disclaimer and Use of Logos**

{Mandatory for all grants and cooperative agreements.}

**Disclaimer:** Where a conference is funded by a grant or cooperative
agreement, a sub grant or a contract the recipient must include the
following statement on conference materials, including promotional
materials, agenda, and internet sites:

*"Funding for this conference was made possible \[in part\] by \[insert
grant or cooperative agreement award number\] from the Centers for
Disease Control and Prevention(CDC) or the Agency for Toxic Substances
and Disease Registry (ATSDR) . The views expressed in written conference
materials or publications and by speakers and moderators do not
necessarily reflect the official policies of the Department of Health
and Human Services; nor does mention of trade names, commercial
practices, or organizations imply endorsement by the U.S. Government."*

**Logos:** Neither the HHS nor the CDC ("CDC" includes ATSDR) logo may
be displayed if such display would cause confusion as to the source of
the conference or give the false appearance of Government endorsement. A
non-federal entity's unauthorized use of the HHS name or logo is
governed by U.S.C. § 1320b-10, which prohibits the misuse of the HHS
name and emblem in written communication. The appropriate use of the HHS
logo is subject to the review and approval of the Office of the
Assistant Secretary for Public Affairs (OASPA). Moreover, the Office of
the Inspector General has authority to impose civil monetary penalties
for violations (42 C.F.R. Part 1003). Neither the HHS nor the CDC logo
can be used on conference materials under a grant, cooperative
agreement, contract or co-sponsorship agreement without the expressed,
written consent of either the Project Officer or the Grants Management
Officer. It is the responsibility of the grantee (or recipient of funds
under a cooperative agreement) to request consent for the use of the
logo in sufficient detail to assure a complete depiction and disclosure
of all uses of the Government logos, and to assure that in all cases of
the use of Government logos, the written consent of either the Project
Officer or the Grants Management Officer has been received.