Viral Hepatitis

Viral Hepatitis Home Page

Add this to...
Añadir en...
Favorites
Delicious
Digg
Google Bookmarks

FOA: CDC-RFA-PS12-1209PPHF12

Funding Opportunity Announcement (FOA) CDC-RFA-PS12-1209PPHF12, “PPHF 2012 Viral Hepatitis, Early Identification, and Linkage to Care for Persons with Chronic HBV and HCV Infections

UPDATE EVENT:

On May 18, 2012, the Centers for Disease Control and Prevention (CDC) issued a Funding Opportunity Announcement to support implementation of a viral hepatitis testing initiative to increase early identification of persons with HBV and HCV infections, with a focus on populations that are disproportionately affected by these infections, and to enhance linkage to care, treatment, and preventive services for persons with these infections. CDC will support the provision of services that (1) enhance testing for HBV and HCV infections among persons for whom testing is indicated and (2) ensure that persons living with hepatitis B or hepatitis C are informed, appropriately counseled, and provided with linkage to care, treatment, and preventive services. Enhanced testing efforts should target populations disproportionately affected by chronic hepatitis B and hepatitis C, especially those that are medically underserved. This FOA consists of two (2) categories: Category A - Early Identification and Linkage to Care for Foreign-born Persons with Hepatitis B; and Category B - Testing for HCV Infection and Enhancing Linkage to Medical Care for Persons with Hepatitis C. Approximately $6,500,000 will be awarded using 2012 Prevention Public Health Funds.

Full details of the FOA are posted on www.Grants .gov

Letter of Intent Due Date: June 8, 2012

Application Deadline Date: July 2, 2012, 5:00pm EST

To Access the Announcement & Application Package:

Go to: www.grants.gov
Select: “For Applicants”
Select: “Find Grant Opportunities”
elect: “Basic Search”
Type in the Funding Opportunity Number, formatted as: CDC-RFA-PS12-1209PPHF12

The CDC Division of Viral Hepatitis will be hosting a one-hour webinar for interested/potential applicants to review the FOA. The webinar will also provide the opportunity for applicants to address relevant questions and receive feedback/answers from the Project’s Technical Assistance Team. The webinar will be conducted on May 30, 2012 3:00am – 4:00pm Eastern Daylight Savings Time.

Registration is required for this webinar. To register now, click the link below:
https://cc.readytalk.com/r/doj3wt80pzk5

Frequently Asked Questions

Pre-Award

Is the Letter of Intent (LOI) required?

The LOI is optional. It is also not binding. It does not enter into the review of a subsequent application.

If optional, why ask applicants to provide an LOI?

It will help CDC plan for the review of submitted applications.

Will LOIs be used to encourage agencies to collaborate and submit applications together?

No. This is not the intent of the LOI (see question #2 above).

What information should be included in the LOI?

Descriptive title of proposed project (Category and/or Part applying for)
Name, address, and telephone number of Principal Investigator/Project Director
Name of key personnel
Participating institutions (if any)
Number and title of funding opportunity announcement

Eligibility

What types of agencies/organizations/institutions are eligible for Category A?

Eligible applicants for Category A include any entity(ies) listed as eligible for Category B found in Section III - Eligibility Information (pages 26-27) who are able to serve appropriate populations in the 50 geographic areas/cities listed in the table (pages 24-25).

For Category A, is the target population limited to foreign-born persons from Asia and Africa?

Although the focus of this category is for providing services to person born in highly affected countries in Asia and Africa, services may also be provided to persons born in other countries of high or intermediate HBV prevalence (see MMWR 2008:57[No. RR-8]).

How do you define “community health center (CHC)”?

For the purpose of the FOA, the definition of a community health center is provided by the Health Resource Services Administration (HRSA) on their website, as follows: Health centers are community-based and patient-directed organizations that serve populations with limited access to health care. These include low income populations, the uninsured, those with limited English proficiency, migrant and seasonal farmworkers, individuals and families experiencing homelessness, and those living in public housing. (See full article on community health centers at: http://bphc.hrsa.gov/about/.)

Is a federally qualified CHC eligible to apply for Category A?

Yes.

Is a non-federally qualified CHC eligible to apply for Category A?

Yes.

Are prisons eligible for Category B - Part 3?

Yes. Applicants seeking to provide services in prisons are eligible. While several “settings” were listed as examples in Part 3, eligibility is not limited to applicants providing services in those settings.

Can one applicant be awarded funding for activities in both categories A & B?

Yes. A single applicant can be awarded funding to provide services under any or all of the Categories/Parts of this FOA provided that they meet appropriate eligibility criteria as described.

Is an applicant applying for funding under both Category A and B (or for more than one part of Category B) required to submit separate applications for each Category/Part?

Yes. Separate stand-alone applications are required for each Category and specific Part.

If one institution applies for two parts, would that require two separate applications?

Yes.

General

If I have questions, who do I contact?

See Section VII of the FOA for information about who to contact with questions. All programmatic and technical questions should be directed to Gilberto Ramirez, Project Officer, ghr0@cdc.gov. For questions concerning submission of the application, contact the CDC Procurement and Grants Office at pgotim@cdc.gov or 770-488-2700.

Is there a definition of “linkage to care” in this FOA?

The term “linkage to care” refers to the need for persons with HCV infection or HBV infection to be medically evaluated and to have access to recommended medical care and treatment. Refer to the recipient activities sections for expectations under each Category.

Is there a percentage of funding that should ideally be allocated for testing activities or for “linkage to care” activities?

No. Applicants should provide a budget that is consistent with the purpose, objectives, and proposed program activities for the Categories/Parts of the FOA for which they seek funding.

Will awardees funded under Category B, Part 2b be required to provide technical assistance to all of the CHCs funded through Category B, Part 2a?

No. This is not the purpose of Category B, part 2b.

Are awardees expected to assume responsibility for the medical care of persons who test HBV+ or HCV+ through testing provided under this FOA?

No. Awardees are expected to link persons who are diagnosed as HBV-infected or HCV-infected to further medical evaluation and preventive care as described in the recipient activities sections of the FOA.

What is the purpose of the data collection required for FOA awardees?

Data collected by awardees will be used for project monitoring and evaluation.

May awardees use the data they generate for research?

This announcement is only for non-research activities supported by CDC. If research is proposed, the application will not be reviewed. For the definition of research, please see the CDC Web site at the following internet address: http://www.cdc.gov/od/science/integrity/docs/cdc-policy-distinguishing-public-health-research-nonresearch.pdf [PDF - 14 pages] .

What is the minimum risk factor data that is required to be reported for persons determined to have HCV infection?

The minimum test level risk-related variables to be reported for persons found to have HCV infection include 1) history of injection drug use (yes or no), 2) self-reported HIV status, and 3) birth cohort (whether or not individual was born during 1945-1965).

The FOA indicates that the grant covers hepatitis C testing but that further clinical diagnosis and management is not supported. Is this correct?

Yes. Category B funds from this FOA can only be used for diagnostic testing (anti-HCV and HCV NAT [qualitative or quantitative]). Funding cannot be used for further testing related to treatment decisions or medical management.

If a site is a medical provider and tests someone for hepatitis B or C and the test for that individual is covered by their insurance, can the site count that test as being performed under the program (even if grant funds are not used to pay for the test)?

Yes.

For Category A (hepatitis B), are U.S.-born persons who grew up in other countries with hepatitis B prevalence of >2% eligible to be screened under this FOA? What about foreign-born persons with numerous HBV-infected household contacts who were born in the United States?

Screening and linkage to care programs should be targeted to foreign-born persons from countries of high and intermediate HBV endemicity. However, HBV testing for other persons for whom such testing is recommended by CDC (e.g., household contacts of HBsAg+ persons) is not disallowed under this FOA (refer to MMWR 2008 57 RR 08)

With respect to Category A, what is the requirement for hepatitis B testing and will hepatitis B surface antibody tests be covered with grant funds?

For this FOA, testing for hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (anti-HBc) are required. Testing for anti-HBs (hepatitis B surface antibody) as part of this program may be considered if applicants include costs in their budget and provide justification and rationale.

For Category A applicants, why is anti-HBc testing preferred over anti-HBs?

HBsAg and anti-HBc were chosen because results of these tests clearly distinguish persons with active HBV infection from persons who are immune as a result of past-resolved HBV infection.

Category B states that approximately 1,000 to 4,000 persons are to be tested for HCV through each award.

Is the baseline a minimum of 1,000? The target for the minimum number of persons tested (baseline) is 1,000 persons per award.
Could a grantee propose to test 500 persons (that is, fewer persons)? Yes. Proposals for testing of <1,000 persons are not disallowed.

Category B (pages 8-9) states that awardees are required to document the proportion of HCV RNA+ persons who begin antiviral therapy. Is this requirement applicable to awardees for all Parts of this Category?

No. This requirement applies only to Category B Parts 2a and 2b. Awardees for Category B Parts 1 and Parts 3 are only required to report whether HCV RNA+ clients have a documented initial visit to a medical provider.

For Category B, Part 2a, awardees are expected to report the proportion of persons testing HCV NAT+ who initiate antiviral treatment. Would they also be expected to report on SVR or other patient outcomes beyond initiation of antiviral therapy?

Can funded sites use pooled qualitative HCV RNA assays for diagnosis to keep costs down? Would this practice be considered confirmatory testing?

No. Grantees are expected to use only those tests that have been FDA-approved for use in clinical diagnosis of HCV infection.

Award and Budget Information

What are the possibilities that this cooperative agreement will be extended beyond the current 1-year project period?

PPHF has been funded for 1 year.

Does the award ceiling include institutional overhead costs?

Yes.

Does the total award amount include salary plus fringe?

Yes.

Can applicants include funds in the budget to purchase a computer and/or telemedicine equipment?

Yes. Grantees should identify any supplies and equipment necessary to accomplish the objectives of the project and include these in the budget. They should document why these purchases are necessary, and the budget should be within the allowable funding ceiling for the applicable Part.

Can applicants include client incentives for compliance and follow through (e.g., transportation) to improve rates of screening, testing, and linkage to care?

Incentives are not disallowed. All budget line items should be properly justified and should be consistent with the purpose, objectives, and proposed program activities of the FOA.

Awardees are restricted from using funds to distribute sterile needles or syringes. Is it permissible to cover a portion of the salaries of staff members who engage in syringe exchange provided they are not distributing syringes as part of the FOA activities?

There are no restrictions that apply to the work that staff members may be engaged in outside of the roles that are described in your application. Please refer to the funding restrictions section that begins on P. 37 of the FOA and includes the following: Sec 253. Notwithstanding any other provision of this Act, no funds appropriated in this Act shall be used to carry out any program of distributing sterile needles or syringes for the hypodermic injection of any illegal drug. Also, applicants need to provide a line-item breakdown and justification for all personnel identified in their budget.

If a patient does not have health insurance to cover the costs of hepatitis testing (or confirmatory testing), can these costs be assumed under the grant?

Yes. Hepatitis diagnostic testing is an allowed cost that should be identified in the budget. Please note the Funding Restrictions section of the FOA, which states “Grantees may not use funds to supplant state, local, institution, or organization funds”. Awardees may use tests that are FDA-approved for use in diagnosis of HCV infection.

Should the costs of point-of-care hepatitis C screening tests be included in the budget?

Yes. Under Category B hepatitis C screening test costs may be included in the budget.

Will awardees be able to carry over the funds awarded?

These are 1-year PPHF dollars and must be obligated by the end of the budget/project period. If there are unexpended funds, requests for extensions will be considered on a case-by-case basis.

Can these funds be used for training?

As is the case for purchase of supplies and equipment, applicants who wish to provide training as a project activity should identify associated costs in their budgets and describe how these activities are necessary to accomplish the objectives of the project

Are applicants required to have any certifications and licenses?

No special certifications or licenses are required as a condition for application. Applicants should adhere to applicable state and local certification or licensing requirements.

Application and Submission Information

For Category A, are applicants required to have an agreement with their county or state health department?

CDC encourages applicants to build partnerships that include state and/or local health departments as well as community based organizations and other partners that may be appropriate. If the applicant intends to work with partners to conduct the activities outlined in the FOA, original letters of support or commitment and/or memoranda of agreement should be included in the application (see Section IV Application and Submission Information).

For Section V - Application Review Information (pages 50 and 51), no specific information is provided regarding venues for Category B, Part 3. Why?

The statement at the beginning of Paragraph 2 on page 50 applies to parts 1, 2, and 3. Applicants for Category B, Part 3 funding should identify the type of settings and venues (health-care and community-based) that will be used in conducting the above activities.

Does Attachment I need to be filled out and included as part of the application?

No. The attachment is only a summary of the minimum data variables that applicants will be collecting and reporting using the CDC developed reporting template.

Are letters of support required?

Letters of support or commitment are highly-encouraged (and are part of the evaluation criteria) if the applicant organization intends to work and collaborate with partners to conduct the activities outlined in the FOA. Letters of support provided in the application do not count towards the application page limit.

If a city health department will be submitting four separate applications, does the principal investigator (PI) have to be the same for all four?

No. The PIs can differ.

Will there be multiple awards within some states?

Possibly. Please review the funding preferences in Section V (pages 60 and 61) of the FOA.

Should applicants submit resumes or curricula vitae for the proposed staff?

Resumes and curricula vitae should be included for key personnel and are excellent ways to document the experience of staff who will be responsible for the management and coordination of project activities. These materials will not count towards the page limit.

Data Collection and Reporting

Will a data collection and reporting system be developed?

The Hepatitis Testing and Linkage to Care data collection and reporting system is being developed and will be made available to funded sites soon after grant awards are made.

How often do data reports need to be submitted to CDC?

Data on HBV and HCV testing should be submitted to CDC on a monthly basis. Aggregate programmatic-level data should be submitted on a quarterly basis. In addition, interim progress reports should be submitted (due 20 calendar days after the mid-point of the grant cycle), as well as annual progress reports (due 20 calendar days after the end of the grant period or on or about October 20, 2013).

What type of file will we be expected to submit with the test information? Will data have to be encrypted?

A web-based application will be developed and made available to awardees for data collection. All of the data transfer and all of those pieces will occur within the context of this secure Web-based system.