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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) 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 (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.
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" below.)
2) Applicants must complete a verification step in the Electronic Research Administration (eRA 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.
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
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 and 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.
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:
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 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
2) Organizational/Institutional Registration in the eRA Commons Prepare to Apply, http://era.nih.gov/ElectronicReceipt/preparing.htm
3) Project Director/Principal Investigator (PD/PI) Registration in the eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.
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 and the eRA 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
Applicants must download the SF424 (R&R) application forms and SF424 (R&R) Application Guide for this FOA through 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
For further assistance, contact PGO TIMS: Telephone 770-488-2700, Email: email@example.com
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 or 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."
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 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
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:
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 and follow steps 1-4. If submittal of the application is done electronically through 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
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 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.
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.
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.
· 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.
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 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
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
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.
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.
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:
4. General Questions Contacts:
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.
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. 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, 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
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.
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
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:
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 and Freedom of Information Act (FOIA) http://www.cdc.gov/od/foia/index.htm.
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.
CDC Home Page: http://www.cdc.gov
CDC Funding Web Page: http://www.cdc.gov/od/pgo/funding/FOAs.htm
CDC Forms Web Page:http://www.cdc.gov/od/pgo/funding/grants/app_and_forms.shtm


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|2. The Universe / Travel & Transport / Transport
2. The Universe / The Earth / North America / Greenland
2. The Universe / Travel & Transport / Travel
Kulusuk International Airport, Greenland
Believe it or not, you might know where this airport is. When flying across the Atlantic and the fuel gauge looks a bit thirsty and the pilot realises that the plane will not make it and he's forced to refuel, the best point to land is the Kulusuk International Airport in Greenland.
Important Flight Data
The Airport
Kulusuk International Airport is one of the biggest in the world. Almost any aircraft can land on its 500 metre-long runway made of sand and volcanic ashes. The only problem is that planes have to stop before running into the Arctic sea right behind the runway.
The airport service is very friendly and comfortable. You can park your plane anywhere you want. If you pay extra, somebody will fuel up your plane for you, so you don't have to hold the pipe on your own and as a highlight they even have a roofed terminal building, where you can sit and buy some souvenirs.
Staying Longer in Kulusuk
Of course you can stay in a hotel, well the hotel at Kulusuk, and visit the fast growing big city where almost 300 people live. They even have hot water, sometimes.
In this exotic town you can even go shopping, take a boat ride to the drifting ice mountains, go fishing or get shot while seeing if it's true that the residents share their wives with passing guests.
If you want to take a virtual flight over Kulusuk then get FS5 material here.
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Psychoanalytic literary criticism refers to literary criticism or literary theory which, in method, concept, or form, is influenced by the tradition of psychoanalysis begun by Sigmund Freud.
Psychoanalytic reading has been practiced since the early development of psychoanalysis itself, and has developed into a heterogeneous interpretive tradition. As Patricia Waugh writes, 'Psychoanalytic literary criticism does not constitute a unified field....However, all variants endorse, at least to a certain degree, the idea that literature...is fundamentally entwined with the psyche'.[1]
|This section needs additional citations for verification. Please help improve this article by adding citations to reliable sources. Unsourced material may be challenged and removed. (May 2011)
The object of psychoanalytic literary criticism, at its very simplest, can be the psychoanalysis of the author or of a particularly interesting character in a given work. In this directly therapeutic form, the criticism is very similar to psychoanalysis itself, closely following the analytic interpretive process discussed in Freud's The Interpretation of Dreams and other works. Critics may view the fictional characters as a psychological case study, attempting to identify such Freudian concepts as Oedipus complex, penis envy, Freudian slips, Id, ego and superego and so on, and demonstrate how they influenced the thoughts and behaviors of fictional characters.
However, more complex variations of psychoanalytic criticism are possible. The concepts of psychoanalysis can be deployed with reference to the narrative or poetic structure itself, without requiring access to the authorial psyche (an interpretation motivated by French psychoanalyst Jacques Lacan's remark that "the unconscious is structured like a language"). Or the founding texts of psychoanalysis may themselves be treated as literature, and re-read for the light cast by their formal qualities on their theoretical content (Freud's texts frequently resemble detective stories, or the archaeological narratives of which he was so fond).
Like all forms of literary criticism, psychoanalytic criticism can yield useful clues to the sometime baffling symbols, actions, and settings in a literary work; however, like all forms of literary criticism, it has its limits. For one thing, some critics rely on psychocriticism as a "one size fits all" approach, when other literary scholars argue that no one approach can adequately illuminate or interpret a complex work of art. As Guerin, et al. put it in A Handbook of Critical Approaches to Literature,[2]
The danger is that the serious student may become theory-ridden, forgetting that Freud's is not the only approach to literary criticism. To see a great work of fiction or a great poem primarily as a psychological case study is often to miss its wider significance and perhaps even the essential aesthetic experience it should provide.
Freud wrote several important essays on literature, which he used to explore the psyche of authors and characters, to explain narrative mysteries, and to develop new concepts in psychoanalysis (for instance, Delusion and Dream in Jensen's Gradiva and his influential readings of the Oedipus myth and Shakespeare's Hamlet in The Interpretation of Dreams). The criticism has been made, however, that in his and his early followers' studies 'what calls for elucidation are not the artistic and literary works themselves, but rather the psychopathology and biography of the artist, writer or fictional characters'.[3] Thus 'many psychoanalysts among Freud's earliest adherents did not resist the temptation to psychoanalyze poets and painters (sometimes to Freud's chagrin'.[4] Later analysts would conclude that 'clearly one cannot psychoanalyse a writer from his text; one can only appropriate him'.[5]
Early psychoanalytic literary criticism would often treat the text as if it were a kind of dream. This means that the text represses its real (or latent) content behind obvious (manifest) content. The process of changing from latent to manifest content is known as the dream work, and involves operations of concentration and displacement. The critic analyzes the language and symbolism of a text to reverse the process of the dream work and arrive at the underlying latent thoughts. The danger is that 'such criticism tends to be reductive, explaining away the ambiguities of works of literature by reference to established psychoanalytic doctrine; and very little of this work retains much influence today'.[6]
Later readers, such as Carl Jung and another of Freud's disciples, Karen Horney, broke with Freud, and their work, especially Jung's, led to other rich branches of psychoanalytic criticism: Horney's to feminist approaches including womb envy, and Jung's to the study of archetypes and the collective unconscious. Jung's work in particular was influential as, combined with the work of anthropologists such as Claude Lévi-Strauss and Joseph Campbell, it led to the entire fields of mythocriticism and archetype analysis.
Northrop Frye considered that 'the literary critic finds Freud most suggestive for the theory of comedy, and Jung for the theory of romance'.[7]
Waugh writes, 'The development of psychoanalytic approaches to literature proceeds from the shift of emphasis from "content" to the fabric of artistic and literary works'.[8] Thus for example Hayden White has explored how 'Freud's descriptions tally with nineteenth-century theories of tropes, which his work somehow reinvents'.[9]
Especially influential here has been the work of Jacques Lacan, an avid reader of literature who used literary examples as illustrations of important concepts in his work (for instance, Lacan argued with Jacques Derrida over the interpretation of Edgar Allan Poe's "The Purloined Letter").
'Lacan's theories have encouraged a criticism which focuses not on the author but on the linguistic processes of the text'.[10] Within this Lacanian emphasis, 'Freud's theories become a place from which to raise questions of interpretation, rhetoric, style, and figuration'.[11]
However, Lacanian scholars have noted that Lacan himself was not interested in literary criticism per se, but in how literature might illustrate a psychoanalytic method or concept.[12]
According to Ousby, 'Among modern critical uses of psychoanalysis is the development of "ego psychology" in the work of Norman Holland, who concentrates on the relations between reader and text'[13] - as with reader response criticism. Rollin writes that 'Holland's experiments in reader response theory suggest that we all read literature selectively, unconsciously projecting our own fantasies into it'.[14]
Thus in crime fiction, for example, 'Rycroft sees the criminal as personifying the reader's unavowed hostility to the parent'.[15]
In 1963, Charles Mauron[16] conceived a structured method to interpret literary works via psychoanalysis. The study implied four different phases:
On Mauron's concept, the author cannot be reduced to a ratiocinating self: his own more or less traumatic biographical past, the cultural archetypes that have suffused his "soul" ironically contrast with the conscious self, The chiasmic relation between the two tales may be seen as a sane and safe acting out. A basically unconscious sexual impulse is symbolically fulfilled in a positive and socially gratifying way, a process known as Sublimation.
'The American critic Harold Bloom has adopted the Freudian notion of the Oedipus Complex to his study of relationships of influence between poets...and his work has also inspired a feminist variant in the work of Sandra Gilbert and Susan Gubar'.[17]
In similar vein, Shoshana Felman has asked with respect to what she calls "the guilt of poetry" the question: 'Could literary history be in any way considered as a repetitive unconscious transference of the guilt of poetry?'.[18]
In Small World: An Academic Romance, one of David Lodge's satires of academia, the naive hero Persse follows Angelica to a forum where she discourses on Romance: '"Roland Barthes has taught us the close connection between narrative and sexuality, between the pleasures of the body and the 'pleasure of the text'....Romance is a multiple orgasm." Persse listened to this stream of filth flowing from between Angelica's exquisite lips and pearly teeth with growing astonishment and burning cheeks, but no one else in the audience seemed to find anything remarkable or disturbing about her presentation'.[19]
In A.S. Byatt's novel Possession, the heroine/feminist scholar, while recognising that '"we live in the truth of what Freud discovered"', concedes that '"the whole of our scholarship - the whole of our thought - we question everything except the centrality of sexuality"'.[20]
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Elite Archery
Elite Archery is one of the newer bow and archery accessory manufacturers in the industry having been first established in 2005. The company has had a very busy time of it in the years since it began production with ownership changing in 2007 and then it was sold to Elite Outdoors in 2009.
The bows from Elite Archery are among some of the smoothest available. The company has made use of advanced technology with the Revolution dual track binary cam system providing plenty of speed and accuracy. The bows such as the Pulse, Pure and Tour feature the patent pending two track EFX, ESX and Tour cam systems.
The Elite Archery company has provided an interesting guarantee for the owners of its compound bows. If something should happen to your bow while you are out on the hunt, a string breaks or the bow is damaged by being dry fired, as an example, Elite Archery will send a replacement bow as a loaner that will arrive the next day so you can finish your hunt. The bow will be supplied with the requested draw weight and draw length as well as a rest, sight and peep installed. Not a bad offer from a new player in the industry. The thing is they promise to get the bow to you no matter how remote the location.
Take a look at the various Elite compound bows that are available for sale. They provide another great option to choose from when looking for your next high quality power bow.
Elite Archery Compound Bows For Sale
Elite Archery Energy 32 Compound bow 29 70 RH NEW CAMO APX
Time Remaining: 14h 33m
Elite Archery Energy 32 Compound bow 28 60 RH NEW CAMO APX
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Elite Energy 32 Compound Bow
Time Remaining: 4d 6h 4m
Elite Synergy Compound Bow 28 70lb
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Elite Synergy Compound Bow 29 60lb
Time Remaining: 5d 8h 7m
2015 Elite Synergy Compound Bow 28 60 lb Black
Time Remaining: 5d 8h 14m
The range of bows that are available on the market today include the four newly released 2011 compound bows to go with the existing bows from the 2010 range. The range has been designed to provide hunters with a choice of speed over accuracy or accuracy over speed with the hunter thrown in as the short frame killer. For the target shooters the highly accurate Tour provides you with all the accuracy assistance you can get.
Elite Archery Compound Bows - Information and Sales
|Elite Answer
|The Elite Answer compound bow is a new bow for the 2012 season and it has been designed after taking in the suggestions and wishes of hunters who have used Elite compound bows in the past. In effect this bow is the "answer" to all of those desires and requests.
|Elite Hunter
|The Elite Hunter compound bow has been designed specifically to cater for the hunter. No matter whether the preference is for treestands, ground blinds or stalking the Hunter is the bow that is recommended by Elite.
|Elite Pure
|The Elite Pure compound bow has been designed to provide the shooter with an accurate compound bow that relies on the stability that is provided. It is a shooting machine that going to make it possible to use in the field or on the range with equal confidence.
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|The Elite Pulse compound bow is the flagship bow of the 2011 season and it is a bow that sits lightly in the hand with an immediately comfortable feel. The draw cycle is smooth and it feels stable when brought to full draw and with a deep valley and high let off it is going to appeal to a lot of people.
|Elite Z28
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|The Elite Tour compound bow is a target bow that is often mentioned when the question of what the best target compound bow on the market is. Those who have used this bow remark on the smoothness of the draw and the accuracy with which it shoots
|Elite XLR


text:
Tags ebm, industrial
Genres industrial, electronic, ebm, darkwave, dark electro (beta)
(flag as incorrect)
April 13, 2012
Listen and figure it out yourself. Also, more to be added soon. Lost some of my music library.
Obelisk by Pzychosys
A mix of the music I've been into lately.
gazelle twin, grimes, electronic, dark ambient, synthpop
Flesh Harvest by Pzychosys
A louder, harsher mix.
aggrotech, harsh ebm, dark electro
Freeze In Silence by Pzychosys
Not really a themed mix of any kind.
synthpop, assemblage 23, project pitchfork, the birthday massacre, ebm
Hallows Eve by Pzychosys
A Halloween mix of a variety of different artists such as Grendel, The Misfits, Horrorpops, and Marilyn Manson.
halloween, misfits, grendel, zombies


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Luxe Tokyo
by Josh Rubin
on 01 April 2005
Luxe City Guide, Tokyo edition. Made from a durable paper stock and folded in to just the right size to fit in a jacket pocket, the Luxe guide will certainly be there with me whenever I find that mysterious sponsor who's going to pay my way. The Luxe guide, as the name suggests, features all top notch shopping, dining and lifestyle info you need. And it's written with a snarky British tone that provides some entertainment along with the valuable information.
Luxe's Asian Grand Tour Box Set
by Ami Kealoha
Luxe's new handmade red box packed full of 12 of their mini-guides to Asia makes the massive continent seem almost manageable. As we've noted here before, their concise descriptions, spunky tone, and conveniently pocketable size, are user...
This Week in Refinery29
by Josh Rubin
This week at Refinery29, while everyone is busy returning to their hometowns for Thanksgiving, Refinery has traveled to Paris to bring you the first installment in a new series titled 'Postcard from Paris'. Taking on the City of Light one...
A highly curated membership-based site offering specialized city guides and insider travel tips
by Josh Rubin
While most online travel sites cater to the occasional trip goer looking to save money, Valet sets its sights on a more discerning clientele of creative professionals with a highly filtered list of hotels in select destinations worldwide. By specifically...
City Guides Spotlight: Nashville
The "Silicon Valley of the music business" offers creative food and experiences to match its shiny vinyl records
by CH Editors
Sponsored content: Dubbed "the Silicon Valley of the music industry" by The Atlantic, Tennessee's capital is where artists from Elvis Presley to the Kings of Leon—and even Bob Dylan—have recorded albums. The residents of Nashville made music history...
City Guides Spotlight: Chicago
A dose of art, music, fresh cuisine and more in America's "Second City"
by CH Editors
Sponsored content: It's time to dismiss the "Second City" nomenclature, as Chicago takes the backseat to nobody. As a haven of early modern architecture in the US, with towering historic structures lining the Loop over looking the Chicago River...
Miami Shopping Guide: Art Basel Edition
Where to stock and flaunt your art party wardrobe for the fairs
by CH Editors
Sponsored content: Next week Art Basel and its plethora of satellite fairs will hit Miami, bringing the international art community together for the industry's most important stateside event of the year. Amidst all the new talent on display are...
Gogo City Guides
Insider tips for where to go on either side of the Channel
by Karen Day
Anyone landing in London Town this week for all of the Frieze festivities will want to pick up or download a copy of the latest Gogo city guide—an essential travel companion for those who like to stay in the know and off the beaten path. Originally...
Le Book NYC 2010
Robert Mapplethorpe photographs grace this year's cover of creative reference Le Book
by Karen Day
Adding to Le Book's already impressive roster of artistic superstars, this year the New York edition of the influential publication tapped the work of late photographer Robert Mapplethorpe to "dress" their covers. For a resource widely serving as the...
Celux Salon
by Josh Rubin
The next tidbit from Theme's second issue is a story about Celux Salon in Tokyo's Aoyama shopping district. It's a members only boutique created by LVMH and featuring highly exclusive items from the big luxury brands as well as lesser...
Phaidon's NYC Pop-Up Store
by Ami Kealoha
Opening next month, Phaidon's first stand-alone store will debut in NYC's Soho neighborhood and stay open through January 2010. With their full range of titles on art and culture, as well as their Wallpaper* City Guides and cookbooks, award...
Amsterdam: Made By Hand
A guide to Amsterdam's hidden ateliers and boutiques
by Karen Day
In her search for the ornate and unique, Australian photographer and stylist Pia Jane Bijkerk traverses the three cities she calls home—Paris, Amsterdam and Sydney—to find winsome boutiques and ateliers peddling handmade goods well off...
City Guides Spotlight: Boston
Our favorite spots in one of America's most historical cities
by CH Editors
Sponsored content: Title Town, Bean Town—whatever your preferred moniker for New England's capital city, Boston has plenty to offer both permanent residents and its ever-present tourist population. One of the country's oldest cities, tradition meets...
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