DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

Enhanced HIV/AIDS Surveillance for Perinatal Prevention

 

Announcement Type: New – Type 1

Funding Opportunity Number: CDC-PS09-903

Catalog of Federal Domestic Assistance Number: 93.944

Key Dates:

Application Deadline:  September 26, 2008 

 

Executive Summary:

Enhanced HIV perinatal surveillance activities include two main activities in addition to those activities that are considered core pediatric HIV surveillance. Participating areas are expected to match birth registries to HIV/AIDS registries in order to improve ascertainment of HIV infection for infants born to HIV-infected women, and to collect supplemental information on both mothers and infants from a variety of medical records, including prenatal care charts, labor and delivery charts, infant birth charts, and pediatric charts.

 

I.  Funding Opportunity Description

Authority:

This program is authorized under Sections 301 and 318B of the Public Health Service Act, [42 U.S.C. Sections 241 and 247c-2], as amended.

 

Background:

In February 1994, the Pediatric AIDS Clinical Trial Group Protocol 076 demonstrated that zidovudine (ZDV) could reduce the risk of mother-to-child HIV transmission from 25% to 8%. As a result, a United States Public Health Service (USPHS) task force issued recommendations in August 1994 for the use of ZDV to reduce perinatal HIV transmission. In July 1995, the USPHS published recommendations for HIV counseling and voluntary testing for all pregnant women, which include advice to health care professionals on educating women about the importance of knowing their HIV status and the steps to preventing mother-to-child transmission. Revised recommendations for HIV screening for pregnant women, which further emphasized HIV testing as a routine part of prenatal care, including rapid testing during labor and delivery, were published in 2001.

 

One of the goals of CDC's initiative of Advancing HIV Prevention is to further decrease perinatal HIV transmission. Strategies for accomplishing this goal include: (a) working with prevention partners to disseminate recommendations and support implementation; (b) providing training for providers and health departments in conducting prenatal testing; (c) promoting universal prenatal HIV screening according to the opt-out approach (e.g. HIV testing is part of the routine battery of prenatal tests unless a woman declines); and (d) promoting routine rapid testing during labor and delivery for women whose HIV status is still unknown. These and other strategies will be necessary to further reduce perinatal HIV transmission in the United States. Progress towards this goal may be measured through surveillance efforts of HIV-exposed infants. With the emphasis on the importance of preventing perinatal HIV transmission, the CDC implemented activities targeted at further reducing perinatal transmission of HIV in high prevalence areas. The Enhanced Perinatal Surveillance (EPS) Project was created as an extension of routine HIV/AIDS surveillance activities. Enhanced perinatal surveillance constitutes additional case ascertainment methods, linking of mother-infant pairs and review of supplemental medical records.

 

Purpose:

The purpose of the program is to provide funds to target and follow the progress toward maximal reduction of perinatal HIV transmission. This program addresses the Healthy People 2010 focus area(s) of “Advancing HIV Prevention: to further decrease perinatal HIV transmission.

 

Measurable outcomes of the program will be in alignment with the following performance goal for the National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP): to decrease the number of perinatally acquired AIDS cases, and to further decrease perinatal HIV transmission.

 

Specifically, funding support is needed to allow state and local health departments to evaluate: (1) the impact of implementation of efforts to maximally reduce perinatal HIV transmission; (2) prevention failures for perinatal HIV transmission; (3) the efficacy of zidovudine (ZDV) and other antiretroviral medications in preventing perinatal HIV transmission; (4) potential adverse outcomes of perinatal and postnatal antiretroviral therapy; and (5) the Public Health Service recommendations for opportunistic infection prophylaxis by:

1.   Conducting medical record reviews of mother-infant pairs and longitudinal follow-up of all HIV exposed children to ascertain: (a) knowledge of maternal HIV infection status before birth; (b) infant’s HIV diagnosis; (c) infant’s AIDS diagnosis; (d) infant’s vital status; (e) the use of maternal and neonatal zidovudine (ZDV) and other antiretroviral medications; and (f) efficacy of these medications in preventing HIV transmission.

2.   Conducting medical record reviews to evaluate recommendations for opportunistic infection prophylaxis and initiation of HIV testing and treatment in children.

3.   Assessing potential adverse outcomes of exposure to antiretroviral medications among infected and uninfected children in the short term (e.g., birth defects, ascertained through record reviews and registry matches) and in the long term (e.g., by matching to tumor registries).

4.   Matching HIV/AIDS registries to birth registries to ensure complete ascertainment of mother-infant pairs.

5.   Collaborating with CDC to track progress toward the maximal reduction of perinatal HIV transmission.

 

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/regs/hrpp/researchDefinition.htm

 

Activities:

Awardee activities for this program are as follows:

Implement and continue surveillance for perinatal HIV exposure and pediatric HIV infection by performing the following activities:

a.   Conduct medical record review of mother-infant pairs and longitudinal follow-up of all HIV exposed children to ascertain knowledge of maternal HIV infection status before birth, infant’s HIV diagnosis; infant’s AIDS diagnosis; infant’s vital status; the use of maternal and neonatal zidovudine (ZDV) and other antiretroviral medications, and efficacy of these medications in preventing HIV transmission.

b.   Conduct medical record review to evaluate recommendations for opportunistic infection prophylaxis and initiation of HIV evaluation and treatment in children.

c.   Assess potential adverse outcomes of antiretroviral exposure among infected and uninfected children in the short term (e.g., birth defects, ascertained through record reviews and registry matches) and in the long term (e.g., by matching to tumor registries).

d.   Match HIV/AIDS registries to birth registries to ensure complete ascertainment of mother-infant pairs.

e.   Conduct activities to improve the quality, efficiency, and productivity of the EPS program. All awardees should perform focused analyses or develop activities that explore methods to improve data quality and reporting efficiency and maximize the performance of the system. For example, awardees should conduct activities to improve provider exposure reporting on the Perinatal Case Report Form (PCRF). This includes educating providers on their reporting responsibilities, establishing on-going communication with all reporting sites and providing them feedback, conducting routine visits to reporting sources, and establishing awareness of and support for perinatal surveillance activities. In particular, special efforts shall be made to inform providers of their importance in promptly notifying the health department of perinatal exposure cases in accordance with their state reporting laws.

f.    Applicants should routinely evaluate their perinatal surveillance program and perinatal exposure reporting according to completeness and timeliness standards provided by CDC that have been developed as part of the Technical Guidance for HIV/AIDS Surveillance Programs Volume I: Policies and Procedures document (available at: http://team.cdc.gov; contact the HIV Incidence and Case Surveillance Branch at 404-639-2050 for access information) and according to the EPS outcome standards to be specified by CDC.  At least once a year, all recipients shall re-abstract demographic, risk, laboratory, and clinical data from a representative sample of records to assess the quality and validity of information collected. Evaluation plans should include routine analysis of EPS data to discover possible sources of under-reporting and delays in reporting, monitor data quality, and assess completeness of reporting by methods developed by CDC or by comparing surveillance registries with alternate databases that are not routinely used for case finding (e.g., Medicaid databases, tumor registries, etc). Grantees should send regular updates on their evaluation activities according to the evaluation standards developed by the CDC.   The recipient should analyze and disseminate enhanced HIV/AIDS surveillance data and promote their use for prevention and health services planning and evaluation.  At least annually, all awardees should disseminate reports of aggregate EPS data to key prevention and health services stakeholders and partners. These activities should include:  providing EPS data and ongoing epidemiologic assistance to community planning groups to monitor the impact of implementation of efforts to maximally reduce perinatal HIV transmission; disseminating EPS data through publications and presentations; participating in planning and implementation meetings; conducting EPS analyses to monitor trends, assess need for health-care resources, and project the future impact of the disease; and providing feedback to exposure reporting sources on ways in which EPS data have been used to promote public health.

  1. EPS grantees should report monthly data in the CDC specified format, timeline, and in a secure manner using CDC case reporting forms and software.  Applicants must ensure that the security and confidentiality procedures of the program are consistent with the requirements delineated in the United States Department of Health and Human Services Technical Guidance for HIV/AIDS Surveillance Programs, Volume III: Security and Confidentiality Guidelines (available at: http://www.cdc.gov/hiv/topics/surveillance/resources/guidelines/guidance/index.htm.)An Overall Responsible Party (ORP) must be designated, and a signed statement provided, to certify compliance with the security and confidentiality requirements. The ORP accepts overall responsibility for implementing and enforcing the security standards and may be liable for breaches of confidentiality. The ORP should be a high-ranking public official (e.g., division director or department chief) who has the authority to make decisions about surveillance operations that may affect programs outside the HIV/AIDS surveillance unit.

The certification statement designating the ORP should include the following:

•     A statement acknowledging that all program requirements included in the Technical Guidance for HIV/AIDS Surveillance Programs, Volume III: Security and Confidentiality Guidelines have been implemented unless otherwise justified.

•     A statement that the program requirements apply to all local/state/territorial staff and contractors funded through CDC to perform HIV/AIDS surveillance activities.

•     A statement that the program requirements apply at all sites where the HIV/AIDS Reporting System or other HIV/AIDS surveillance database is maintained.

•     Name and address of organization

•     Phone number

•     Name of the designated ORP

•     Title of ORP

•     Signature of ORP

•     Date

This information should be included with the application and clearly referenced in the table of contents. This certification statement should be submitted annually and any changes in this designation should be communicated in writing to the respective program consultant. HIV/AIDS surveillance funds may be restricted unless the ORP designation has been submitted and is on file for FY 2008 and subsequent budget periods in the HIV Incidence and Case Surveillance Branch, CDC.

h.   All awardees are required to attend CDC-sponsored conferences and workshops consistent with recipient activities in accordance with their cooperative agreement.

 

 In a cooperative agreement, CDC staff members are substantially involved in the program activities, above and beyond routine grant monitoring. 

CDC Activities for this program are as follows:

a.   Provide training in surveillance methodology and program planning and management.

b.   Develop, refine, and disseminate HIV/AIDS surveillance program information that describes effective methods to carry out program activities and monitor progress.

c.   Provide criteria for the surveillance definition of nationally reported HIV infection/disease, and case report forms, and provide assistance in establishing and maintaining a computerized data management system.

d.   Participate in the analysis and dissemination of information and data gathered from program activities and facilitate the transfer and utilization of information and technology among all states and communities.

e.   Provide standardized protocols, data collection forms, and computer software.

f.    Assist in the evaluation of the overall effectiveness of program operations, including the impact of enhanced perinatal surveillance data on the development of public policy and on targeting and evaluating HIV Prevention Community Planning activities.

g.   Disseminate national perinatal surveillance data for public health purposes through routine reports, articles, and presentations.

h.   Maintain a secure and confidential national HIV/AIDS surveillance database.

i.   Provide technical assistance in the area of information technology to assure that reporting areas using electronic transfer of EPS surveillance data:  (1) adhere to appropriate confidentiality and security procedures; and (2) execute the necessary data management and analytic procedures to assure data integrity and accuracy.  Provide guidance to grantees in obtaining equipment that possesses the necessary technologic capabilities to process and transfer data using either CDC provided software or according to standards developed by CDC for reporting to the national system.

j.    Provide timely feedback to states on their data quality and annually evaluate state data according to the pediatric technical guidance and the perinatal data outcome standards to be determined by CDC.

k.   In an effort to promote surveillance integration, CDC may provide technical assistance to grantees to expand future surveillance activities to include collection and reporting of co-infection data with HIV [i.e. sexually transmitted diseases (STD), viral hepatitis (Hep), and tuberculosis (TB)] for maximization of Public Health impact. 

 

II. Award Information

Type of Award: Cooperative Agreement. 

CDC’s involvement in this program is listed in section I. Section above.

Award Mechanism: U62                    

Fiscal Year Funds:  2009

Approximate Current Fiscal Year Funding: $2,073,452

Approximate Total Project Period Funding:  $6,220,356 (This amount is an estimate, and is subject to availability of funds.) Includes both direct and indirect costs

Approximate Number of Awards: 15

Approximate Average Award: $ 90,000 (This amount is for the first 12-month budget period, and includes both direct and indirect costs.) 

Floor of Individual Award Range: $55,000  

Ceiling of Individual Award Range:  $172,000   (This ceiling is for the first 12-month budget period.)  Total costs 

Anticipated Award Date: January 1, 2009

Budget Period Length: 12 Months

Project Period Length: 3.0 Years

Throughout the project period, CDC’s commitment to continuation of awards will be conditioned on the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports), and the determination that continued funding is in the best interest of the Federal government.

 

III. Eligibility Information

III.1. Eligible Applicants

Eligible applicants that can apply for this funding opportunity are listed below:

Chicago; Connecticut, Delaware; Georgia; Houston; Los Angeles; Louisiana; Maryland; New Jersey; New York; New York City; Philadelphia; Puerto Rico; South Carolina; and Texas, or their bona fide agents.  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 applying as a bona fide agent of a state or local government, a letter from the state or local government as documentation of the status is required.  Attach with “Other Attachment Forms” when submitting via www.grants.gov.   

 

This is a complex surveillance activity that focuses on assessing the impact of prevention programs on perinatal HIV transmission outcomes. The complexity of this program relates to identification of eligible participants (HIV-positive pregnant women), coordination with delivery centers and perinatal HIV treatment facilities, and ability to use resulting data to evaluate perinatal prevention programs. These activities require a substantial amount of time and resources to establish and coordinate at the state and local level.  Perinatal prevention programs funded by CDC were designed to reduce perinatal HIV transmission in the United States, and the enhanced perinatal surveillance program (EPS) provides the data by which areas conducting perinatal prevention evaluate the effectiveness of their efforts. 

 

Funds were previously available under Program Announcement PS06-607 to areas with a sufficient number of events (HIV exposed infants) to provide reasonably precise assessments of the effectiveness of perinatal prevention efforts.  Sufficient number of events was defined as a jurisdiction having either:  (1) at least 150 cases of perinatally acquired AIDS by the end of 2001; or (2) the Survey of Childbearing Women Seroprevalence rate in 1994 of greater than or equal to 2.0/1000.  Twenty areas were originally eligible for Program Announcement PS06-607, with 75% or 15 areas subsequently being funded.

 

Continuation of data collection by the funded EPS areas will allow CDC to conduct trend analyses, offer the same quality of technical guidance to funded areas, and to continue successes in evaluating perinatal prevention outcomes.  In addition, the activities to collect EPS outcome measures require substantial resources and commitment on the part of the affected surveillance program.  The funds that are being awarded under this announcement would not be sufficient for projects not previously funded due to the level of resources and established infrastructure required to implement this complex surveillance activity. Continued funding for those already funded for EPS will allow areas to consistently collect data on perinatal measures using data collection systems established during the previous funding cycle, to make improvements in measuring and evaluating EPS data quality, and to continue established relationships with delivery centers and perinatal HIV treatment.  Therefore, CDC limited the eligible applicants  to the 15 areas that have received categorical funding from CDC for Enhanced Perinatal Surveillance for Program Announcement PS-06-607.

 

III.2. Cost Sharing or Matching

 Matching funds are not required for this program.

 

III.3. Other

CDC will accept and review applications with budgets greater than the ceiling of the award range. 

 

Special Requirements:

If the application is incomplete or non-responsive to the special requirements listed in this section, it will not be entered into the review process.  The applicant will be notified if the application did not meet submission requirements.

 

IV. Application and Submission Information

IV.1. Address to Request Application Package

To apply for this funding opportunity use the application forms package posted in Grants.gov.

 

Electronic Submission:

CDC strongly encourages the applicant to submit the application electronically by utilizing the forms and instructions posted for this announcement on www.Grants.gov, the official Federal agency wide E-grant Web site.  Only applicants who apply on-line are permitted to forego paper copy submission of all application forms.

 

Registering the applicant organization through www.Grants.gov is the first step in submitting applications online. Registration information is located in the “Get Registered” screen of www.Grants.gov.  While application submission through www.Grants.gov is optional, CDC strongly encourages applicants to use this online tool.

 

Please visit www.Grants.gov at least 30 days prior to filing an application to become familiar with the registration and submission processes. Under “Get Registered,” the one-time registration process will take three to five days to complete; however, as part of the Grants.gov registration process, registering the organization with the Central Contractor Registry (CCR) annually could take an additional one to two days to complete.  CDC  suggests submitting electronic applications prior to the closing date so if difficulties are encountered, a hard copy of the application can be submitted prior to the deadline.

 

Paper Submission:

Application forms and instructions are available on the CDC Web site, at the following Internet address: http://www.cdc.gov/od/pgo/funding/grants/app_and_forms.shtm.

 

If access to the Internet is not available, or if there is difficulty accessing the forms on-line, contact the CDC Procurement and Grants Office Technical Information Management Section (PGO-TIMS) staff at 770-488-2700 and the application forms can be mailed.

 

IV.2. Content and Form of Submission

Prospective applicants are asked to submit a letter of intent that includes the following information:

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

 

Application:

A Project Abstract must be submitted with the application forms.  All electronic project abstracts must be uploaded in a PDF file format when submitting via Grants.gov.  The abstract must be submitted in the following format, if submitting a paper application:

The Project Abstract must contain a summary of the proposed activity suitable for dissemination to the public.  It should be a self-contained description of the project and should contain a statement of objectives and methods to be employed.  It should be informative to other persons working in the same or related fields and insofar as possible understandable to a technically literate lay reader.  This Abstract must not include any proprietary/confidential information. 

 

A project narrative must be submitted with the application forms.  All electronic narratives must be uploaded in a PDF file format when submitting via Grants.gov.  The narrative must be submitted in the following format, if submitting a paper application:

The narrative should address activities to be conducted over the entire project period and must include the following items in the order listed:

·        Program Plan

·        Objectives

·        Methods

·        Evaluation

·        Proposed Data Uses

·        Staffing

·        Budget (Budget is not counted against narrative page limit)

·        Attachments

 

1.   Describe the current ability of surveillance activities to collect information on all HIV mother- infant pairs.  Applicants that will not implement surveillance for HIV-exposed infants by January 1, 2009 must submit evidence that the activity they propose will be approved by an Institutional Review Board (IRB), as required by CDC.

2.   Describe the methods that will be used in identifying and linking data on HIV mother- infant pairs; conducting systematic chart reviews to complete abstraction forms and HIV/AIDS case report forms; conducting longitudinal follow-up of HIV exposed infants to ascertain infection status and initiation of HIV related treatment and care; and assessing short- and/or long-term outcomes in HIV exposed infants.

3.   Describe the methods that will be used in evaluating the Enhanced Perinatal Surveillance activities, to include a description of the timeliness and completeness of data collection and submission of data to CDC.

4.   Describe how the data from Enhanced Perinatal Surveillance will be coordinated with and used to improve perinatal prevention activities.

5.   Describe the number and qualifications of personnel who will be involved in Enhanced Perinatal Surveillance activities.

6.   Budget

Provide a summary of the budget by the cost categories (such as “salaries and wages, fringes, & travels, etc.) in Standard Form 424A. Justify the funding amounts requested to support the proposed program activities for the first 12 month budget period (January 1, 2009 – December 31, 2009) as follows:

 

·        A detailed budget justification for each cost

category should show a detailed computation of each line item amount as well as stating the reasons for why the items are necessary for performing activities to accomplish the proposed program objectives.

 

·        In the salaries and wages category justification, designate the key employee position(s) by denoting  an  asterisk (*) sign to each applicable employee job title and state that “* Represents a key employee position.” in the end of salaries and wages justification. The key employee designation in IPR is subject to the CDC’s concurrence.

 

·        In the travel category justification, segregate the costs of local travel and out of town or state travels.

 

·        In the contractual or consultant categories, provide the following information:

(1) Name(s) of contractor(s) or consultant(s);

(2) Method of Selection (competitive or sole source, less than full and open competition must be justified);

(3) Period of performance;

(4) Description of activities;

(5) Method of Accountability; and

(6) Itemized budget with narrative justification.

 

·        Provide a copy of an updated indirect cost rate agreement or certificate of cost allocation plans approved by Federal Government, whichever applicable.

 

The proposed budget is subject to negotiation and a final approval by CDC.

 

Additional information may be included in the application appendices.  The appendices will not be counted toward the narrative page limit.  This additional information includes:

 

·        Curriculum Vitaes;

·        Resumes;

·        Organizational Charts;

·        Letters of Support.

 

Additional information submitted via Grants.gov should be uploaded in a PDF file format, and should be named:

  • Attachments should be labeled as follow:  State abbreviation, Part number, Document name and extension name (e.g. GA. Part1.OrgChart.doc) when uploaded into Grants.gov.
  • No more than 10 electronic attachments should be uploaded per application. 

 

The agency or organization is required to have a Dun and Bradstreet Data Universal Numbering System (DUNS) number to apply for a grant or cooperative agreement from the Federal government.  The DUNS number is a nine-digit identification number, which uniquely identifies business entities.  Obtaining a DUNS number is easy and there is no charge.  To obtain a DUNS number, access http://www.dunandbradstreet.com or call

1-866-705-5711. 

 

For more information, see the CDC Web site at: http://www.cdc.gov/od/pgo/funding/grantmain.htm.   

If the application form does not have a DUNS number field, please write the DUNS number at the top of the first page of the application, and/or include the DUNS number in the application cover letter.

 

Additional requirements that may require submittal of additional documentation with the application are listed in section “VI.2.  Administrative and National Policy Requirements.”   

 

IV.3. Submission Dates and Times

Application Deadline Date:  September 26, 2008   

Explanation of Deadlines:  Applications must be received in the CDC Procurement and Grants Office by 5:00 p.m. Eastern Time on the deadline date. 

 

Applications must be submitted electronically at www.Grants.gov.  Applications completed on-line through Grants.gov are considered formally submitted when the applicant organization’s Authorizing Organization Representative (AOR) electronically submits the application to www.Grants.gov.  Electronic applications will be considered as having met the deadline if the application has been successfully submitted electronically by the applicant organization’s AOR to Grants.gov on or before the deadline date and time.

 

When submission of the application is done electronically through Grants.gov (http://www.grants.gov), the application will be electronically time/date stamped and a tracking number will be assigned, which will serve as receipt of submission.  The AOR will receive an e-mail notice of receipt when HHS/CDC receives the application.

 

This announcement is the definitive guide on application content, submission address, and deadline.  It supersedes information provided in the application instructions.  If the application submission does not meet the deadline above, it will not be eligible for review.  The application face page will be returned by HHS/CDC with a written explanation of the reason for non-acceptance.  The applicant will be notified the application did not meet the submission requirements.    

 

IV.4. Intergovernmental Review of Applications

The application is subject to Intergovernmental Review of Federal Programs, as governed by Executive Order (EO) 12372.  This order sets up a system for state and local governmental review of proposed federal assistance applications.  Contact the state single point of contact (SPOC) as early as possible to alert the SPOC to prospective applications and to receive instructions on the State’s process.  Visit the following Web address to get the current SPOC list:

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

 

IV.5. Funding Restrictions

Restrictions, which must be taken into account while writing the budget, are as follows:

  • Recipients may not use funds for research.
  • Recipients may not use funds for clinical care.
  • Recipients may only expend funds for reasonable program purposes, including personnel, travel, supplies, and services, such as contractual.
  • Awardees may not generally use HHS/CDC/ATSDR funding for the purchase of furniture or equipment.  Any such proposed spending must be identified in the budget.
  • The direct and primary recipient in a cooperative agreement program must perform a substantial role in carrying out project objectives and not merely serve as a conduit for an award to another party or provider who is ineligible.
  •  Reimbursement of pre-award costs is not allowed.
  • Funds are awarded for a specifically defined purpose described in this announcement and may not be used for any other purpose or program.

 

Data collection initiated under this cooperative agreement has been approved by the Office of Management and Budget under OMB Number 0920-0573, “Adult and Pediatric HIV/AIDS Confidential Case Reports for National HIV/AIDS Surveillance,” expiration date 02/28/2010.  Any change to the existing data collection will be subject to review and approval by the Office of Management and Budget (OMB) under the Paperwork Reduction Act.

 

If requesting indirect costs in the budget, a copy of the indirect cost rate agreement is required.  If the indirect cost rate is a provisional rate, the agreement should be less than 12 months of age.  The indirect cost rate agreement should be uploaded as a PDF file with “Other Attachment Forms” when submitting via Grants.gov. 

The recommended guidance for completing a detailed justified budget can be found on the CDC Web site, at the following Internet address:

http://www.cdc.gov/od/pgo/funding/budgetguide.htm.

 

 

IV.6. Other Submission Requirements

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

 

Application Submission Address:

Electronic Submission:

CDC strongly encourages applicants to submit applications electronically at www.Grants.gov.  The application package can be downloaded from www.Grants.gov.  Applicants are able to complete it off-line, and then upload and submit the application via the Grants.gov Web site.  E-mail submissions will not be accepted.  If the applicant has technical difficulties in Grants.gov, customer service can be reached by E-mail at support@grants.gov or by phone at 1-800-518-4726 (1-800-518-GRANTS).  The Customer Support Center is open from 7:00a.m. to 9:00p.m. Eastern Time, Monday through Friday. 

 

CDC recommends that submittal of the application to Grants.gov should be prior to the closing date to resolve any unanticipated difficulties prior to the deadline.  Applicants may also submit a back-up paper submission of the application.  Any such paper submission must be received in accordance with the requirements for timely submission detailed in Section IV.3. of the grant announcement. The paper submission must be clearly marked:  “BACK-UP FOR ELECTRONIC SUBMISSION.”  The paper submission must conform to all requirements for non-electronic submissions.  If both electronic and back-up paper submissions are received by the deadline, the electronic version will be considered the official submission.

 

The applicant must submit all application attachments using a PDF file format when submitting via Grants.gov.  Directions for creating PDF files can be found on the Grants.gov Web site.  Use of file formats other than PDF may result in the file being unreadable by staff.

 

V. Application Review Information

V.1. Criteria

Applicants are required to provide measures of effectiveness that will demonstrate the accomplishment of the various identified objectives of the cooperative agreement.  Measures of effectiveness must relate to the performance goals stated in the “Purpose” section of this announcement.  Measures must be objective and quantitative and must measure the intended outcome.  The measures of effectiveness must be submitted with the application and will be an element of evaluation.

 

The application will be evaluated against the following criteria:

 

1.   Methods:  The extent to which the applicant demonstrates technical capability to conduct the project using the appropriate data collection and analytic methods. Specific methods for accomplishing the following technical activities should be described:

a.   Identifying and linking data on related infected mothers and HIV exposed children.

b.   Conducting systematic chart reviews to complete abstraction forms and HIV/AIDS case report forms.

c.   Conducting longitudinal follow-up of HIV-exposed infants to ascertain infection status and initiation of HIV related treatment and care.

d.   Past ability to conduct the project including a description of the timeliness and completeness of data collection and submission to CDC on mother-infant pairs.

e.   Applicants that will not implement surveillance for HIV-exposed infants by January 1, 2009, must submit evidence that the activity proposed will be approved by an IRB, as required by CDC. 

f.    Applicants should describe the plan to improve the quality, efficiency, and productivity of the EPS program. This includes focused analyses or developing activities that explore methods to improve data quality and reporting efficiency and maximize the performance of the system.

2.   Program Plan:  The extent to which the applicant provides a clear and feasible plan for enhancing surveillance activities for children and women by expanding core perinatal surveillance by collecting data:

a.   On all children born to HIV-infected women, including (1) zidovudine (ZDV) and other antiretroviral therapy used during pregnancy, at labor or delivery, and for the neonate; opportunistic infection prophylaxis; (2) initiation of HIV testing and care; (3) HIV infection status; and (4) short as well as long-term outcomes in antiretroviral exposed and unexposed children.

b.   On HIV-infected women who deliver a live infant, including: (1) counseling and therapy they received during pregnancy; (2) date of their HIV diagnosis; (3) dates of initiation of prenatal care; (4) dates of initiation of zidovudine (ZDV) and other antiretroviral therapy; (5) pregnancy outcomes; (6) stage of HIV disease; and (7) HIV risk behaviors.                       

3.   Objectives (15 points):  The extent to which the objectives are specific (with time frames), realistic, and address the required recipient activities as specified in section “I. Funding Opportunities Description.”   

4.   Evaluation :  The extent to which the applicant provides an evaluation plan that is appropriate for measuring progress toward program area and national EPS objectives. The plan should include a specified time-line and methods for identifying promoters and barriers to program success. This must include a description of the timeliness of the system and the completeness of the ascertainment of mother-infant pairs. Provide documentation that the applicant will collaborate with CDC to conduct evaluations during the period of this cooperative agreement according to protocols developed by CDC.

5.   Proposed Data Uses:  Applicants should describe their plans to analyze and disseminate enhanced HIV/AIDS surveillance data and promote their uses for prevention and health services planning and evaluation. The applicant should describe the extent to which data have, or will assist in HIV prevention and care activities, so that these data are used for formulating public health strategies and targeting resources. In areas that received categorical CDC funding for perinatal prevention activities, the extent to which the applicant describes how the data from this system will be coordinated with and be used to improve these activities.

6.   Staffing:  The extend to which the applicant describes the ability to carry out the purposes of the program:  (a) proposed staffing; (b) organizational structure; (c) staff experience and background; (d) identified training needs or plan; and (e) job descriptions and curricula vitae for both proposed and current staff.

7.   Budget (Reviewed, but not scored):  The extent to which the budget is reasonable, clearly justified, and consistent with the intended use of funds. All budget categories should be itemized.

 

V.2. Review and Selection Process

Applications will be reviewed for completeness by the Procurement and Grants Office (PGO) staff and for responsiveness jointly by the National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP) and PGO.  Incomplete applications and applications that are non-responsive to the eligibility criteria will not advance through the review process.  Applicants will be notified the application did not meet submission requirements.

 

A programmatic review will be done to evaluate complete and responsive applications according to the criteria listed in the “V.1.  Criteria” section above.  

 

Funding will be determined by a level of commitment and resources needed by a program to conduct Enhanced Perinatal Surveillance activities subject to the availability of funds. The funding Range will be from $55,000 to $172, 000.

 

V.3. Anticipated Announcement Award Date

The anticipated announcement award date is January 1, 2009.

 

VI. Award Administration Information

VI.1. Award Notices

Successful applicants will receive a Notice of Award (NoA) from the CDC Procurement and Grants Office.  The NoA shall be the only binding, authorizing document between the recipient and CDC.  The NoA will be signed by an authorized Grants Management Officer and emailed to the program director, and a hard copy mailed to the recipient fiscal officer identified in the application.

 

Unsuccessful applicants will receive notification of the results of the application review by mail.

 

VI.2. Administrative and National Policy Requirements

Successful applicants must comply with the administrative requirements outlined in 45 CFR Part 74 and Part 92, as appropriate.  The following additional requirements apply to this project:

  • AR-4               HIV/AIDS Confidentiality Provisions
  • AR-5               HIV Program Review Panel Requirements
  • AR-7               Executive Order 12372
  • AR-9               Paperwork Reduction Act Requirements
  • AR-10                         Smoke-Free Workplace Requirements
  • AR-11                         Healthy People 2010
  • AR-12                         Lobbying Restrictions

Additional information on the requirements can be found on the CDC Web site at the following Internet address: http://www.cdc.gov/od/pgo/funding/Addtl_Reqmnts.htm.

 

CDC Assurances and Certifications can be found on the CDC Web site at the following Internet address: http://www.cdc.gov/od/pgo/funding/grants/foamain.shtm.

 

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.

 

An additional Certifications form from the PHS5161-1 application needs to be included in the Grants.gov electronic submission only.  Applicants should refer to

http://www.cdc.gov/od/pgo/funding/PHS5161-1-Certificates.pdf.  Once the applicant has filled out the form, it should be attached to the Grants.gov submission as an Other Attachments Form.

 

VI.3. Reporting Requirements

The applicant must provide CDC with an annual interim progress report via www.grants.gov:

1.      The interim progress report is due 90 days before the end of the budget period   The progress report will serve as the non-competing continuation application, and must contain the following elements:

a.       Standard Form (“SF”) 424S Form.

b.      SF-424A Budget Information-Non-Construction Programs.

c.       Budget Narrative.

d.      Indirect Cost Rate Agreement.

e.       Project Narrative.

 

The applicant must provide CDC with an original, plus two hard copies of the following reports:

1.      Annual Progress Report; due on 90 days after end of the budget period. The Annual Progress Report will serve as your non-competing Continuation application and annual progress, and must contain the following elements:        

a.       Current Budget Period Activities and Objectives.

b.      Current Budget Period Financial Progress.

c.       New Budget Period Program Proposed Activity Objectives.

d.      Requested amount for the continuation award, to be submitted in accordance with the projected level of funding for the budget periods. 

e.       Detailed line item budget and justification for the amount requested.

f.        Modifications/adjustments concerning changes to support proposed subcontracts, if any.

g.       A description of any programmatic and staffing changes.

h.       Please submit a listing of current staff and an organizational chart in support of this CDC program.

2.   Final performance report is due 90 days after the end of the project period.  The  report must include the following for each program, function, or activity involved:

a.   A description of the program accomplishments and a comparison of actual accomplishments with the objectives established in the work plan for the funding period.

b.   Other pertinent information that includes, but is not limited to, analysis and explanation of unexpected delays or high costs of performance.

c.   A listing of presentations and publications produced by, supported by, or related to program activities.

3.   Financial status report, no more than 90 days after the end of the budget period.

4.   Final financial report for the entire project period, no more than 90 days after the end of the project period.

These reports must be submitted to the attention of the Grants Management Specialist listed in the “VII. Agency Contacts” section of this announcement.

 

VII. Agency Contacts

CDC encourages inquiries concerning this announcement.

For general questions, contact:

            Technical Information Management Section

Department of Health and Human Services

            CDC Procurement and Grants Office

            2920 Brandywine Road, Mail Stop E-14

            Atlanta, GA 30341

            Telephone: 770-488-2700

 

For program technical assistance, contact:

            Valerie Richmond-Reese, Project Officer

Department of Health and Human Services

Centers for Disease Control and Prevention

             1600 Clifton Road, NE, Mail Stop E-47

            Atlanta, GA 30333

            Telephone: 404-639-8996

            E-mail:VRichmond-Reese@cdc.gov

 

For financial, grants management, or budget assistance, contact:

Carolyn Thomas, Grants Management Specialist

Department of Health and Human Services

            CDC Procurement and Grants Office

            2920 Brandywine Road, Mail Stop E-15

Atlanta, GA 30341

            Telephone: 404-639-8054

            E-mail: ckt4@cdc.gov

 

CDC Telecommunications for the hearing impaired or disabled is available at:

TTY 770-488-2783.

                

 

VIII. Other Information

Other CDC funding opportunity announcements can be found on the CDC Web site,

 

Applicants may access the application process and other awarding documents using the Electronic Research Administration System (eRA Commons).  A one-time registration is required for interested institutions/organizations at http://era.nih.gov/ElectronicReceipt/preparing.htm.

Program Directors/Principal Investigators (PD/PIs) should work with their institutions/organizations to make sure they are registered in the eRA Commons.

1.      Organizational/Institutional Registration in the eRA Commons

2.  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 check with their business official to determine whether their organization/institution is already registered in the eRA Commons.  CDC strongly encourages applicants to register to utilize these helpful on-line tools when applying for funding opportunities.


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