Part I Overview Information

United States Department of Health and Human Services (HHS)

Issuing Organization

HHS Centers for Disease Control and Prevention (CDC/NCZVED/DPD/MB), at http://www.cdc.gov/malaria

Participating Organizations

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

Components of Participating Organizations

National Center for Zoonotic, Vector, and Enteric Diseases (NCZVED/CDC), at http://www.cdc.gov/malaria

Title: Monitoring and Evaluation of Malaria Activities in the Greater Mekong Subregion (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: This program is authorized under sections 307, [42 U.S.C. sections 242l], 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 may 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 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-CK-08-003

Catalog of Federal Domestic Assistance Number(s): 93.283 Centers for Disease Control and Prevention – Investigations and Technical Assistance

Key Dates

Release/Posted Date: November 2, 2007
Letter of Intent Receipt Date: Not applicable
Application Submission Receipt Date(s): January 2, 2008
Peer Review Date(s): March 2008
Council Review Date(s): March-April 2008

Earliest Anticipated Start Date(s): June 30, 2008

Additional Information to Be Available Date: Not applicable

Expiration Date: January 3, 2008

Due Date for E.O. 12372

Executive Order 12372 does not apply to this program.

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 Zoonotic, Vector-Borne, and Enteric Diseases 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 RFA addresses “Healthy People 2010” priority area(s) of Access to Quality Health Services and is in alignment with National Center of Zoonotic, Vector-Borne, and Enteric Diseases performance goal(s) to help people around the world live safer, healthier and longer lives through health promotion, health protection, and health diplomacy. For more information, www.healthypeople.gov. and

http://intra-apps.cdc.gov/fmo/

The HHS Centers for Disease Control and Prevention (CDC) announces the availability of Fiscal Year (FY) 2008 funds for an international cooperative agreement program with an eligible international partner organization. The purpose of this cooperative agreement program is to assist with the development of operational research, surveillance, and monitoring and evaluation activities in the Greater Mekong Subregion (GMS) in conjunction with national malaria programs and other partners in the sub-region.

The research plan of the application should address all of the following objectives and associated activities:

(a) Assist national malaria control programs in the conduct of monitoring and evaluation of regional malaria program activities on important human infectious diseases prevalent in the GMS, with an emphasis on malaria (including adapting global Roll Back Malaria indicators and the Malaria Indicators Survey for the Mekong sub-Region)

ACTIVITIES: Participation in the development of a new GMS strategic framework to monitor and evaluate ongoing malaria control programs including the revision of the Kunming Indicators:

http://w3.whothai.org/LinkFiles/Roll_Back_Malaria_MKRBM_Strategy_revised_Feb03.pdf

These activities include:

(1) working with the U.S. Agency for International Development (USAID), the World Health Organization (WHO), HHS/CDC, national programs, and other partners to develop new tools and approaches to enhance the current monitoring and evaluation activities related to the malaria programs in GMS; and

(2) developing methods to increase the sensitivity of surveillance systems to gather epidemiologic data on malaria cases so that systems are sensitive enough to detect epidemics in a timely manner.

(b) Collaborate with HHS/ CDC to provide technical assistance to national and subregional authorities in the development and implementation of a malaria operational research agenda for the region in collaboration with national programs, WHO, USAID, and other partners.

ACTIVITIES: Developing and implementing multifaceted, multidisciplinary operations research protocols, by working closely with the WHO, USAID, national malaria-control programs, the Cambodian/Thai Multi-Drug Resistance (MDR) Task Force, and other partners in the Greater Mekong Sub-region (GMS). Examples of such topics may include but not be limited to the following:

(1) Strengthening the ability of public and private health facilities and linked community intervention efforts to provide the timely and appropriate care and treatment of febrile patients in malaria risk areas. This can include exploring client care-seeking behaviors, and prescriber practices, the ability of the health facility to appropriately diagnosis febrile illnesses, and the availability and quality of the first-line, anti-malarial drugs used by Government and private providers;

(2) Promoting the importance of administering the correct anti-malarial drug and correct dosage by drug-sellers, pharmacists, patients, caretakers and other private-sector agents in the community;

(3) Assisting Mekong malaria partners in providing epidemiologic support in such studies as the monitoring of drug quality;

(4) Monitoring surveillance studies of therapeutic efficacy at key sentinel sites identified by national malaria control programs; and

(5) Developing new strategies to assess the pharmacokinetic properties of artemisinin combination therapy in relation to optimizing dosing.

(c) Further strengthen the institutional capacity of the region’s malaria programs by contributing to the training curriculum of the Asian Collaborative Training Network for Malaria.

ACTIVITIES: Participating in the development of local-language training curricula for operational research, case management, or other appropriately related malaria topics for artemisinin-based combination therapy (ACT) malaria courses in the Asia region.

(d) Assist malaria control programs in incorporating the results of programmatic lessons learned and research findings into operational disease prevention and control programs in the GMS; and to ensure sharing of expertise and research findings with the Ministries of Health and other partners.

ACTIVITIES: Participate in development and supervision of national and subregional strategic plans for malaria control in collaboration with national malaria control programs, Roll Back Malaria, USAID and HHS/ CDC.

(e) Assist national malaria control programs in developing other supportive activities focused on malaria interventions consistent with national and regional initiatives, such as the Roll Back Malaria (RBM) Initiative.

ACTIVITIES: Disseminate results of research and prevention activities through written publications, oral presentations, hosting study tours, or by other means, in both English and the most common local languages.

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) of the National Center for Zoonotic, Vector-Borne, and Enteric Diseases intends to commit approximately $800,000 in direct and indirect costs in FY2008 to fund one application. The average award amount will be $800,000 for direct and indirect costs for the first 12-month budget period. An applicant may request a project period of up to five years. An applicant may request up to $800,000 for the first 12-month budget period. The approximate total project period funded amount is five years for a total project period funding amount of $4,000,000. The anticipated start date for new awards is June 30, 2008.

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

Eligible Applicants

1.A. Eligible Institutions

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

· Public or Nonprofit Foreign Institutions

· Public nonprofit organizations

· Private nonprofit organizations

· Universities

· Colleges

· Research institutions

· Hospitals

· Community-based organizations

· Faith-based organizations

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

· American Indian/Alaska Native tribally designated organizations

· Alaska Native health corporations

· Urban Indian health organizations

· Tribal epidemiology centers

· State and local governments or their Bona Fide Agents (this includes the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, the Commonwealth of the Northern Marianna Islands, American Samoa, Guam, the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau)

· Political subdivisions of States (in consultation with States)

A Bona Fide Agent is an agency/organization identified by the state as eligible to submit an application under the state eligibility in lieu of a state application. If you are applying as a bona fide agent of a state or local government, you must provide a letter from the state or local government as documentation of your status. Attach this documentation behind the first page of your application form or for electronic applications, use a PDF file and attach as “Other Documents” and label as appropriate.

2. Cost Sharing or Matching

Cost sharing or matching is not required.

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

3. Other-Special Eligibility Criteria

HHS/CDC will provide support to an internationally recognized organization with an established record of assisting malaria control programs in the Mekong subregion with monitoring, evaluation and operational research activities. The implementing partner will demonstrate its ability to effectively influence policy, conduct operations research and advocate for best practices in malaria control at the global and national levels. In particular, the recipient will demonstrate the capability to adapt global malaria indicators and the RBM Malaria Indicators Survey for the specific conditions that prevail in the Mekong sub-Region. Applicants can demonstrate these capabilities by providing written reports of previous monitoring and evaluation and operations research activities conducted in partnership with national malaria control programs as well as demonstrating completing previous awards from HHS/ CDC, USAID or other development partners. Applicants must provide a letter of support from at least 2 national malaria control programs in the Mekong subregion.

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:

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

Your organization will need to obtain a Data Universal Number System (DUNS) number and register with the Central Contractor Registration (CCR) as part of the Grants.gov registration process.
If your organization does not have a Taxpayer Identification Number (TIN) or Employer Identification Number (EIN), allow for extra time. A valid TIN or EIN is necessary for CCR registration.
The CCR also validates the EIN against Internal Revenue Service records, a step that will take an additional one to two business days.
Applicants outside the US are required to include a NATO Commercial and Government Entity (NCAGE) number on their CCR registration. See section IV.2. Content and Form of Application Submission, for instructions.
Direct questions regarding Grants.gov registration to:
Grants.gov Customer Support
Contact Center Phone: 800-518-4726
Business Hours: M-F 7:00 a.m. - 9:00 p.m. Eastern Time
Email support@grants.gov

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

To find out if an organization is already eRA Commons-registered, see the "List of Grantee Organizations Registered in eRA Commons.”
Direct questions regarding the eRA Commons registration to:
eRA Commons Help Desk
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Business hours M-F 7:00 a.m. – 8:00 p.m. Eastern Time
Email commons@od.nih.gov

3) Project Director/Principal Investigator (PD/PI) Registration in the eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.

The individual designated as the PD/PI on the application must also be registered in the eRA Commons. It is not necessary for PDs/PIs to register with Grants.gov.
The PD/PI must hold a PD/PI account in the eRA Commons and must be affiliated with the applicant organization. This account cannot have any other role attached to it other than the PD/PI.
This registration/affiliation must be done by the Authorized Organization Representative/Signing Official (AOR/SO) or their designee who is already registered in the eRA Commons.
Both the PD/PI and AOR/SO need separate accounts in the eRA Commons since both hold different roles for authorization and to view the application process.

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

Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered in both Grants.gov 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 Information

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 FOA.

For further assistance, contact PGO TIMS: Telephone 770-488-2700, Email: PGOTIM@cdc.gov

HHS/CDC Telecommunications for the hearing impaired: TTY 770-488-2783.

2. Content and Form of Application Submission

Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide (MS Word 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 component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
Research & Related Budget

PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist

Optional Components:

PHS398 Cover Letter File
Research & Related Sub award Budget Attachment(s) Form

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

Foreign Organizations

Several special provisions apply to applications submitted by foreign organizations:

· Charge back of customs and import fees is not allowed.

· Format: every effort should be made to comply with the format specifications which are based upon a standard US paper size of 8.5" x 11".

· Organizations must comply with Federal/CDC policies on human subjects, animals, and biohazards.

· Organizations must comply with Federal/CDC biosafety and biosecurity regulations. See Section VI. 2. Administrative Requirements http://oerdbdev.od.nih.gov/AGS/Admin/BoilerPlate/ShowDraftRFA.cfm, "Cooperative Agreement Terms and Conditions of Award".

· Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment exiting U.S. resources.

NATO Commercial and Governmental Entity (NCAGE) Code are required for foreign organizations only. See below for instructions:

Registrants located outside of the U.S. are required to include an NATO Commercial and Governmental Entity (NCAGE) Code on their CCR registration, or their registration will be considered incomplete. All countries outside of the U.S. need this number, not just NATO countries.
The Code is a five-character ID number used extensively within the federal government. It is used to support a variety of mechanized systems throughout the government and provides for a standardized method of identifying a given facility at a specific location (from CCR Handbook)
The form and instructions can be found at http://www.dlis.dla.mil/Forms/Form_AC135.asp
Additional instructions for completing the form can be found at http://www.dlis.dla.mil/Forms/form_ac135instr.asp
In Block 2 of the form, select the country where your organization is located from a drop-down list. This list currently includes 30 countries; if your country does not appear on the list, choose ‘other.’
Submit the form via the Internet by clicking the ‘Send Request/Envoyez Demande’ button at the bottom of the form.
Once you click on the “Send Request” button, the form is automatically sent for processing to the country you selected in block 2. If you selected ‘Other’ for country, these requests will be processed by the NATO Maintenance and Supply Agency (NAMSA) in Luxembourg.
If you cannot submit this form by Internet, you can obtain an NCAGE by contacting the National Codification Bureau of the country where your organization is located. For a list of addresses, go to http://www.dlis.dla.mil/nato_poc.asp.

For help from within the U.S., call 1-888-227-2423
For help from outside the U.S., call 1-269-961-7766
Email NCAGE@dlis.dla.mil for any problems in getting an NCAGE code

Prior to registering in CCR, insure that your newly assigned NCAGE is listed on the Business Identification Number Cross- Reference System (BINCS) at www.bpn.gov/bincs. If the assigned NCAGE is not listed in BINCS call 269-961-4623 or send a message to NCAGE@dlis.dla.mil.
Note to U.S. submitters: Organizations with an address containing APO, FPO, or AE do not need an NCAGE assigned by an Allied Nation and should not fill out this form. Instead, register in the Central Contractor Registration (CCR) system at www.ccr.gov and you will receive a U.S. CAGE Code.
CAGE codes for U.S. territories like Guam, Puerto Rico, and the Virgin Islands will be assigned by the U.S by registering in CCR.

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): January 2, 2008
Peer Review Date(s): March 2008

Council Review Date(s): March-April 2008

Earliest Anticipated Start Date(s): June 30, 2008

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 SF424 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.

All requested information must be received in the HHS/CDC Procurement and Grants Office by 5:00 p.m. Eastern Time on the deadline date. If an applicant submits materials by the United States Postal Service or commercial delivery service, you must ensure that the carrier will be able to guarantee delivery by the closing date and time. If HHS/CDC receives your submission after closing because of : (1) carrier error, when the carrier accepted the package with a guarantee for delivery by the closing date and time, or (2) significant weather delays or natural disasters, you have the opportunity to submit documentation of the carrier’s guarantee. If the documentation verifies a carrier problem, HHS/CDC will consider the submission as having been received by the deadline.

This announcement is the definitive guide on Letter Of Intent (LOI) and application content, submission address, and deadline. It supersedes information provided in the application instructions. If your application does not meet the deadline described in Section IV.3.A, it will not be eligible for review, and HHS/CDC will discard it. You will receive notification that you did not meet the submission requirements.

Otherwise, HHS/CDC will not notify you upon receipt of your paper submission. If you have a question about the receipt of your application, first contact your courier. If you still have a question, contact the PGO-TIMS staff at: 770-488-2700. Before calling, please wait two to three days after the submission deadline. This will allow time for HHS/CDC to process and log submissions.

Technical Information Management Section – CK08-003

CDC, Procurements and Grants Office

U.S. Department of Health and Human Services

2920 Brandywine Road

Atlanta, GA 30341

Phone: 770-488-2700 ET

3.C. Application Processing

HHS/CDC must receive applications on or before 5:00 P.M. Eastern 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 complete and non-responsive applications.

There will be an acknowledgement of receipt of applications from Grants.gov and the eRA Commons.

4. Intergovernmental Review

Executive Order 12372 does not apply to this program.

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 will be restricted until the appropriate assurances and Institutional Review Board approvals are in place.

· Specific language for international announcements is posted on the PGO intranet site: http://pgo.cdc.gov/pgo/ViewHome.do

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”.

The institution must possess the requisite scientific and technical expertise, the infrastructure capacity and experience in conducting the described operations research topics, and have collaborative relationships with national malaria control programs in the Mekong Region and internationally to ensure that all aspects of this agreement can be fulfilled. The institution must have expertise in adapting and implementing Roll Back Malaria indicators for monitoring and evaluation http://www.who.org/rbm. Applicants that demonstrate experience assisting national malaria control programs to adapt and implement the RBM Malaria Indicators Survey, particularly in the Mekong sub-Region will be funded over those that may rank higher but do not demonstrate this expertise. Previous relevant experience including that related to RBM must be documented by including written reports, adapted materials, published manuscripts and letters of support in the appendix.

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

The HHS/CDC requires the PD/PI 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. If your research plan exceeds the page limitation, your application may be considered unresponsive and ineligible for review.

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 may 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.

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

· The institution must possess the requisite scientific and technical expertise, the infrastructure capacity and experience in conducting the described operations research topics, and have collaborative relationships with national malaria control programs in the Mekong Region and internationally to ensure that all aspects of this agreement can be fulfilled. The institution must have expertise in adapting and implementing Roll Back Malaria indicators for monitoring and evaluation {www.who.org/rbm}. Applicants that demonstrate experience assisting national malaria control programs to adapt and implement the RBM Malaria Indicators Survey, particularly in the Mekong sub-Region will be funded over those that may rank higher but do not demonstrate this expertise. Previous relevant experience including that related to RBM must be documented by including written reports, adapted materials, published manuscripts and letters of support in the appendix.

· Applications that incorporate the greatest number of the following priorities will be funded over those that rank higher but do not:

1) Applicants that demonstrate internationally recognized expertise by participating in Roll Back Malaria and Global Malaria Program task forces and working groups. Membership and participation can be documented in the individual investigators’ Curriculum Viteas (CVs) and/or letters of support from RBM and/ or GMP.

2) Applicants who have conducted operations research and/or demonstration projects addressing home and community management of malaria through community health workers and/ or private providers and retailers. These experiences can be documented by including written reports, established funding agreements or letters of support in the appendix.

3) Applicants who have participated in the Asian Collaborative Training Network for Malaria steering group or specific training workshops. Participation in ACT Malaria may be demonstrated in individual investigators’ CVs or in a letter of support from the network.

4) Applicants who have provided direct assistance to one or more national malaria programs in adapting and completing the RBM Malaria Indicators Survey. Written materials for training data collectors or written reports of Malaria Indicators Surveys should be provided in the application’s appendix

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 decisions.

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?

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 applicant demonstrate that the approach incorporates best practices as recommended by global and regional malaria control guidelines and recommendations?

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? Does the proposal address the adaptation of RBM indicators and the Malaria Indicators Survey for the specific conditions of the Mekong sub-Region? Has the applicant appended materials from previous work that demonstrate this accomplishment?

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)? Have the investigators demonstated previous experience with operations research and monitoring and evaluation for malaria control programs. Do their CVs or letters of support indicate previous participation in global and subregional networks relevant to this application (RBM, GMP, ACT Malaria)?

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 a letter of support from at least two national malaria control programs and sub-Regional organizations?

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). .

Care and Use of Vertebrate Animals in Research: If applicants plan to use vertebrate animals in the project, HHS/CDC will assess the five items described under Section 2, item 12 Vertebrate Animals of the Research Plan component of the SF424 (R&R). Additional HHS/CDC Requirements under AR-3 Animal Subjects Requirements are available on the Internet at the following address: http://www.cdc.gov/od/pgo/funding/ARs.htm.

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.

3. Anticipated Announcement and Award Dates

Earliest anticipated award date is June 30, 2008.

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:

A. Participate with CDC in protocol development

B. Share data with CDC

C. Co-publish with CDC investigators

D. Participate in meetings and/or phone calls with CDC scientists to jointly develop methods of approach for this study

E. Assist in the development of a research protocol for review by the Institutional Review Boards (IRB) of all cooperating institutions that are participating in the research project

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:

A. Provide technical assistance in support of jointly planned activities;

B. Provide scientific support and assistance for program personnel through short-term and long-term exchanges of experts;

C. Provide program and scientific support and training and participate in the development of study protocols, the implementation and evaluation of studies, epidemiological and laboratory studies, management and analysis of data, writing, and dissemination of information;

D. Provide program and scientific support in the development and support of a long-term agenda for operational research and program implementation;

E. Assist in the development of a research protocol for review by the Institutional Review Boards (IRB) of all cooperating institutions that are participating in the research project. The HHS/CDC IRB will review and approve the protocol initially, and on at least an annual basis, until the research project is completed; and

F. Provide reagents or materials that are not on the prohibited list, as needed.

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:

1. Scientific/Research Contacts:

Dr. Trudy Messmer
Extramural Program

Coordinating Center for Infectious Diseases
Centers for Disease Control and Prevention

U.S. Department of Health and Human Services

1600 Clifton Road, MS C-19

Atlanta, GA 30333

Telephone: (404) 639-2176

TMessmer@cdc.gov

2. Peer Review Contacts:

Dr. Juliana Cyril
Office of Public Health Research

Centers for Disease Control and Prevention
U.S. Department of Health and Human Services
1600 Clifton Road
Atlanta, GA 30333
Telephone: (404) 639-4639
Fax: 404-639-4903
Email: JCyril@cdc.gov

3. Financial or Grants Management Contacts:

Mr. Steward Nichols
Procurement and Grants Office
Center for Disease Control and Prevention

U.S. Department of Health and Human Services
Street Address
Atlanta, GA Zip Code
Telephone: (770) 488-2788
Fax: (770) 488-2688
Email: shn8@cdc.gov

4. General Questions Contacts:

Technical Information Management Section

CDC Procurement and Grants Office

U.S. Department of Health and Human Services

2920 Brandywine Road

Atlanta, GA 30341

Telephone: 770-488-2700

Email: PGOTIM@cdc.gov

Section VIII. Other Information

Required Federal Citations

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

Use of Animals in Research
Recipients of PHS support for activities involving live, vertebrate animals must comply with the PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable. Additional HHS/CDC Requirements under AR-3 Animal Subjects Requirements can be found on at http://www.cdc.gov/od/pgo/funding/ARs.htm.

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

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

INCLUSION OF PERSONS UNDER THE AGE OF 21 IN RESEARCH
The policy of CDC is that persons under the age of 21 must be included in all human subjects research that is conducted or supported by CDC, unless there are scientific and ethical reasons not to include them. This policy applies to all CDC-conducted or CDC-supported research involving human subjects, including research that is otherwise exempt in accordance with Sections 101(b) and 401(b) of 45 C.F.R. Part 46, HHS Policy for the Protection of Human Subjects. 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.

Patient Care

Ensure that all STD or HIV infected patients enrolled in the proposed project will be linked to an appropriate local care system that can address their specific needs, such as medical care, counseling, social services, and therapy.

Paperwork Reduction Act Requirements

Under the Paperwork Reduction Act, projects that involve the collection of information from 10 or more individuals and funded by a grant or a cooperative agreement will be subject to review and approval by the Office of Management and Budget (OMB).

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.

Lobbying Restrictions

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

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

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

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

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

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

Prohibition on Use of HHS/CDC Funds for Certain Gun Control Activities

The Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act specifies that: "None of the funds made available for injury prevention and control at the Centers for Disease Control and Prevention may be used to advocate or promote gun control."

Anti-Lobbying Act requirements prohibit lobbying Congress with appropriated Federal monies. Specifically, this Act prohibits the use of Federal funds for direct or indirect communications intended or designed to influence a member of Congress with regard to specific Federal legislation. This prohibition includes the funding and assistance of public grassroots campaigns intended or designed to influence members of Congress with regard to specific legislation or appropriation by Congress.

In addition to the restrictions in the Anti-Lobbying Act, HHS/CDC interprets the language in the HHS/CDC's Appropriations Act to mean that HHS/CDC's funds may not be spent on political action or other activities designed to affect the passage of specific Federal, State, or local legislation intended to restrict or control the purchase or use of firearms.

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.

Research Integrity

The signature of the institution official on the face page of the application submitted under this Funding Opportunity Announcement is certifying compliance with the Department of Health and Human Services (DHHS) regulations in Title 42 Part 93, Subparts A-E, entitled PUBLIC HEALTH SERVICE POLICIES ON RESEARCH MISCONDUCT.

The regulation places requirements on institutions receiving or applying for funds under the PHS Act that are monitored by the DHHS Office of Research Integrity (ORI) (http://ori.hhs.gov./policies/statutes.shtml).

For example:

Section 93.301 Institutional assurances. (a) General policy. An institution with PHS supported biomedical or behavioral research, research training or activities related to that research or research training must provide PHS with an assurance of compliance with this part, satisfactory to the Secretary. PHS funding components may authorize [Page 28389] funds for biomedical and behavioral research, research training, or activities related to that research or research training only to institutions that have approved assurances and required renewals on file with ORI. (b) Institutional Assurance. The responsible institutional official must assure on behalf of the institution that the institution-- (1) Has written policies and procedures in compliance with this part for inquiring into and investigating allegations of research misconduct; and (2) Complies with its own policies and procedures and the requirements of this part.

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

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