Program Announcement Technical Assistance Conference Call

Male Family Planning Research Cooperative Agreements

July, 16 2008

1:00 PM EDT

Welcome

Introduction

Purpose and format of call

General TA – will not answer questions specific to individual applications

Introduction of speakers

Materials for Call

What participants should have in front of them:

Program Announcement
Application kit, including
- OASH-1, including forms

Funding Opportunity

This announcement seeks applications for Title X Male Family Planning Research Cooperative Agreements

5 Study Sites will be funded

and

1 Coordinating Site will be funded

What we will cover

Brief overview of Title X
Funding Opportunity
Role of Program and Grants Management
Application and Submission Process

US Department of Health & Human Services

Secretary - Mike Leavitt

Assistant Secretary - Joxel Garcia, M.D., M.B.A.

Office of the Assistant Secretary for Health (OASH) Programs

* Office of Minority Health * Office of HIV/AIDS Policy

* Office of Population Affairs * Office of Research Integrity

* Office on Women's Health * National Vaccine Program

* Office of Regional Health Administrators

* President's Council on Physical Fitness

* Office of the Surgeon General

* Office of Military Liaison and Veterans Affairs

* Office of Disease Prevention and Health Promotion

Organizational Structure

Office of Family Planning

Is within

Office of Population Affairs

Deputy Assistant Secretary for Population Affairs: Vacant

within

Office of the Assistant Secretary for Health

within

U.S. Department of Health and Human Services

Office of Family Planning (within OPA):

Central Office – Rockville, MD (Washington DC area)

Policy Office – Provides guidance and determines policy for all OFP program
Oversees projects with national scope, such as Family Planning Male Training Center, National Training Center and Male and other Research Projects and Cooperative Agreements with a national scope.
Director: Susan Moskosky

Program Overview:
Introduction to Title X of PHS Act

Mission – to aid individuals to freely determine the number and spacing of their children

Title X of the PHS Act authorizes discretionary grants

Sections – focus on Services
- 1001 Services – ALL Other Sections Support Services
- 1003 Training
- 1004 Research
- 1005 Informational and Educational Materials
- 1008 Prohibition of Abortion

A Decentralized Program:
Ten Regional Offices

In major cities, serving multi-state areas

Oversee Title X service grantees and general training grantees

The project officers for the Family Planning Services grantees and the General Training grantees are in the PHS Regional Offices

Ten Public Health Service Regions

*Image of OFP Regional Offices*

Federal Roles

OFP: Programmatic

OASH/OGM: Administrative/Business/Budgetary (funds)

Title X Service Grantee Profile

88 total nationwide

State, territorial, tribal, county, or local health agencies, universities, and faith-based and community-based not for profit agencies

Approximately 4,500 clinics in the service provider network – at least one clinic in ~75% of the counties in the US
Provide FP and related preventive health care to almost 5 million men and women annually
- Just under 6% are males

Overview of Required Title X Services

Voluntary
Confidential
Priority low income
Any individual desiring services – male and female, regardless of ability to pay
Must be under the direction of a physician with training or experience in FP

PHS Act Section 1004 Family Planning Research Grants

AUTHORIZED UNDER SECTION 1004 [300a-2] (a)

The Secretary is authorized to make grants to public or nonprofit private entities and to enter into contracts with public or private entities and individuals for projects for research in the biomedical, contraceptive development, behavioral and program implementation fields related to family planning and population.

Purpose of Title X Research

To promote and encourage projects which focus on increasing knowledge, understanding and techniques related to family planning, reproductive health and other related fields of public health.

Family Planning Research: Outcomes

Increase access to family planning services
Assess more effective methods and systems for the delivery of educational and clinical services
Influence constructive, positive and equitable health behaviors
Convert evidence-based findings into practice

Family Planning Male Research

Male Research Projects
- Round 1: 1997 – 2002
- Round 2: 2003 – 2008
Service Delivery Improvement Projects
- Male focus

I. Funding Opportunity Description

Male Family Planning Research Cooperative Agreement
- To test a comprehensive service delivery model and evaluate its effectiveness and replicability in Title X clinics.
  - 5 Study Sties – clinical locations where the model will be tested
  - 1 Coordinating Center – Responsible for the research protocol, provision of training and technical assistance to the study sites and the overall evaluation

I. Funding Opportunity Description

Male Family Planning Research Cooperative Agreement
- A cooperative agreement is a type of financial award in which "substantial involvement" between the awarding agency and the recipient(s) during the performance period.
  - This award will include OPA/OFP collaboration in the management of the award including the planning and development of the comprehensive service delivery model, and other related elements of the research initiative.

I. Funding Opportunity Description

Service Delivery Model - Components
- Restructuring the Clinical Environment
  - Physical modifications, administrative procedures, schedules, etc.
- Training of Staff
  - Clinical providers – the male exam and other related screening procedures
  - All staff – cultural competency, male-specific needs and related interactive strategies
- Targeted community outreach & clinic promotion
  - Outreach/education strategies, recruitment efforts, via community linkages, partners, friends and family members

II. Award Information

5 Awards for Participating Study Sites
1 Award for Coordinating Center
Due date: 25 July 2008
- 5 PM Eastern time if submitted in hardcopy to the OASH Office of Grants Management/Grant Application Center
- 11:00 PM Eastern Time if submitted electronically via GrantSolutions.gov or Grants.gov

II. Award Information

Study Sites –
- Year 1: $225,000
- Years 2 – 5: $250,000 maximum
Coordinating Center –
- Year 1: $375,000
- Years 2 – 5: $300,000 maximum

*Funding for years beyond year 1 are contingent upon the availability of funds, satisfactory progress on the project and adequate stewardship of Federal resources.

Up to 5 years total

III. Eligibility Information

Any Public or Private Nonprofit agency located in a State or Territory

Faith-based agencies eligible
Must demonstrate the capacity to carry-out the requirements of the project

Eligibility Information – items of note

Study Sties-
- Programs incorporating all 3 components as a deliberate model will not be considered as a study site
- If selected, organizations will be required to make any necessary modifications to existing serves

Eligibility Information – items of note

Coordinating Center Sties
- Applicants should be experienced in the implementation of the comprehensive service delivery model to be tested
- Applicants should have expertise in health services training and research, including data collection, bio-statistical analyses and the management of multiple research sites

III. Application and Submission

If a hard copy of application kit is desired, may be obtained by contacting OASH Office of Grants Management 240-453-8822 (Fax 240-453-8823
The GrantSolutions.gov Help Desk is available Monday - Friday, 10 AM - 6 PM Eastern Time. For assistance: 1-800-618-0223 or (301) 231-6005, or email help@grantsolutions.gov
Proof of Nonprofit Status required with application submission – Program Announcement describes what is acceptable proof
DUNS number required with application—info on how to acquire is in the application kit and www.grants.gov

Application Process

Application kit has all the information needed to prepare application
The Program Announcement provides the information that is required related to the Title X Male Family Planning Research Cooperative Agreement
Follow it carefully!!! The Grant Announcement takes precedence if these is conflicting information in other guidance documents

Application Process

OASH-1 has all the application forms—face page, budget pages, assurances, certifications, etc.
Instructions for filling each form are included
Be complete! Do not leave blanks on forms – indicate n/a where not applicable to the applicant
Certifications/Assurances must be included
Person who signs application must have the legal authorization to act for the agency

Application Process

Provides useful guidance and explanation of each part of application
Describes Program and Business (budget, grants) requirements

Application Process

Complete form SF 424 (Face Page)
Complete budget form SF 424A (Budget Sheet)
Submit a Budget Narrative (budget must be consistent with the applicable Cost Principles)
Sign SF 424 (by authorized signatory)
Sign Title X Assurances (by authorized signatory)

Application and Submission Info

Content and form
- Pay close attention!
- If there is a discrepancy of information, the program announcement takes precedence
- 30 double-spaced page limit for Project Narrative
  - Note fonts and other style requirements
  - Does not include budget, budget justification, required forms, assurances, and certifications
  - Only first 30 pages of the Narrative will be reviewed
  - Limit Appendices to only what is necessary – do not send brochures or bound materials – they will be discarded unread
- Include 1 page abstract – not included in 30 page limit

Application Content – General

Demonstrate understanding of the content of the funding announcement, citing examples of experience as necessary
Demonstrate experience in design, development, implementation and evaluation of family planning service delivery and research as applicable
Provide examples of coordination, management and other methods of collaboration, especially if relevant to the element of the funding announcement
Evidence of relevant administrative, management, and outside funding experience if relevant
Application should be responsive to the announcement!

Application Content

Applications must clearly describe administrative, management, and professional capability of applicant organization in relation to providing the required training and technical assistance project, implementation of the service delivery model

Application Content

Applications must clearly describe the profile of the proposed community to be served/represented, the need exhibited by the community, organization's experience re: providing FP/RH services, capacity to participate in proposed research activity, and ability to collect data related to the research activity.

Project Narrative

Along with the budget, this is the "heart" of the application
Provides information related to the need for the project
Describes organizational capacity
Provides specific information related to how the applicant will develop and implement the project
Includes project work plan with Goals and Objectives (S.M.A.R.T.)
BE CLEAR, COMPLETE and CONCISE

Application Process

Budget Narrative

Provide details of budget
Breakdown each line item and provide an explanation of the costs
Personnel should include salary per person and percent of time each person will spend on grant
Fringe benefits should include percent used and what is included in cost.

A Note about Characteristics

Pay attention to grant application Guidance and Grant Announcement--analyze what is asked for– respond appropriately

Common Questions

Due Date: 25 July 2008
- 5:00 pm – hard copy submission
- 11:00 pm – electronic submission
Page Limit – 30 Pages, double spaced
- This limit is exclusive of appendices, budgets, budget narratives, required forms and other items listed in Section IV, part 2 of the application.
Institutional Review Board (IRB)
- All applicants must comply with the HHS Protection of Human Subjects regulations (45 CFR part 46)

Grants Management

Eleanor Walker

Grants Management Specialist

OASH Office of Grants Management

OASH Office of Grants Management (OGM)

Role: Administrative/Business/Budgetary (funds)

Office in Rockville, Maryland

Provides grants management for all Office of the Assistant Secretary for Health (OASH) Program Offices

Follows the Grants Administration Manual, Grants Policy Directives, and Grants Policy statements—

most rules apply to all Federal grants. Some are agency specific

http://www.hhs.gov/grantsnet/

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

Director: Karen Campbell, Grants Management Officer

OGM's Role

As determined by the DHHS, OGM's role is:

Official signatory for obligating federal grant funds
Official signatory for all grant business
Management and prior approval requests
Monitor all business/financial transactions on grants for compliance to Federal Regulations (including interpretation of Federal Regulations)

OGM's Role

OGM plays a vital role throughout the life of the grant:

Financial Status Report (FSR) Reconciliation
Approval of Key Personnel Changes
Carryover Requests/Budgetary Requests
Technical Assistance
Audit Resolution
And more…

Budget

SF 424A includes budget pages
Follow directions in filling out forms
Be complete; identify all sources of project funds
Applicants should project costs for future years of funding on 424A, Section E

Budget

Must be consistent with the requirements of the Program Announcement
Uniform Administrative Requirements for Grants and Agreements (cost principles in the OMB Circular appropriate to the applicant's organization)
Budgeted costs must derive from proposed activities

OMB Circulars

OMB Circulars which define cost principles that all Federal Grants must adhere to – How to run the business portion of a grant
Circulars show what is allowable and any restrictions on use of funds
OASH Office of Grants Management is responsible for oversight of all financial and business related grant issues

Budget Narrative/Justification

Provide details of budget. Separately identify budget for general training and technical assistance
Breakdown each line item and provide an explanation of the costs
Personnel should include salary per person and percent of time/salary of each person charged to this grant
Fringe benefits should include percent and what is included in cost

Budget Tips

Budget should be commensurate with project activities
Use the correct OMB Cost Principle- http://www.whitehouse.gov/omb/circulars/index.html
Pay attention to allowable costs
Provide adequate justification- market surveys, prior accounting records, cost per unit
Budget Narrative includes line by line breakdown for Federal and Non-Federal shares

Cost Sharing

Applicants should identify financial resources from other sources; should clearly identify sources and amount contributed on both SF424A and in the budget justification
Program Income is generated from registration fees or other means generated as a result of the grant supported activities. It must be reinvested to further the objectives of the project

Financial Infrastructure

Organizational Charts
IRS Tax Exemption Certification
Indirect Cost—must negotiate rate with DHHS' DCA (Division of Cost Allocation): cannot exceed 8 percent
Signed Face Page (SF 424)
Signed Assurances

Budget Review

Budget is reviewed in comparison with project goals and activities
Are there adequate funds for successful implementation?
Is there over-budgeting?- Do not exceed the available amount of funds, including indirect costs
Operating budget should be complete (Federal, Non-Federal, Private, Total funds)

Funding Process

Notice of Grant Award (NGA) notifies successful applicant of selection
Includes any Conditions on the award—Requirements that must be met as a condition of receiving the grant funds
Applicants who were not successful will be notified by the Program Office

Funding Process

OGM is the Official contact for grantees

All official communication related to the grant award is between OGM and successful applicant
Grantees also communicate on a regular basis with the program project officer who oversees programmatic aspects of the grant
OGM maintains the official grant file –the program office maintains working files for each grant

Grants Management Issues-
Post Award

Budget Development and Allowable Expenditure Items
Budget Forecast
Indirect Costs
Notice of Grant Award (NGA) Issuance/Terms and Conditions
Reporting Requirements
Organizational Financial Status Review (FSR)
Grant Closeout

Budget

Final project plan and budget will be negotiated after funding – Amount of award will not change, but allocation to various activities might be modified from what was proposed

Flexibility in schedule and resource planning is expected – will enable successful applicant to respond to emerging needs, lessons learned, and annual Title X priorities
All activities and budget will be approved by OFP project officer prior to implementation

Funding

Project Period – no more than 5 years
- Dependent on adequate progress of the project and availability of funds
- Will submit a non-competing continuation application for years 2 – 3 of the project period
Budget period – funds provided to carryout project activities for one year
- Annual continuing application – progress report, work plan, budget, budget justification

Other Administrative Requirements

Reporting
FSR
Other

Review Process

Criteria listed in Grant Announcement – this is specified in the Title X training regulations
Applications reviewed by Panel of Independent Reviewers
Technical reviews by Federal Program (Title X) and Grants Management staff

Review Process

Objective Review Committee (ORC) – Formal process, confidential
- Objective reviewers – technical experts in applicable field(s)
- (OGM) available for questions and to ensure integrity of process
- Review by OFP for programmatic compliance and OGM for administrative/business compliance
Input from Federal reviews and ORC, as well as likelihood of achieving benefits expected, considered when making award decision

Summary and TIPS

Grant Announcement is the primary guide to programmatic requirements; provides information related to statute, regulations, and OMB circulars which define cost principles
Follow what the Grant Announcement says

Summary and TIPS

The application kit has useful information that will help you develop a complete application

OASH-1 has all forms required along with instructions for completion

Summary and TIPS

Be clear, complete, and concise in project description
Don't make the reviewer search for required information – the easier an application is to review compared to the program announcement, the better the score
Clearly identify all sections of the application – indicate which components you are addressing

Summary and TIPS

The project narrative must include all required information – do not use the appendices to expand the page limit
Make Goals and Objectives Specific Measurable Achievable Realistic Time-framed (S.M.A.R.T.)
Activities should relate to goals and objectives
Budget should relate to goals, objectives, and activities

Summary and TIPS

The program work plan and budget should provide a complete picture of what and how the applicant will address the purpose and expectations of the Grant Announcement.
Clear justification, background research and supporting information should be concise, relevant and persuasive

Summary and TIPS

Budget should be adequate and reasonable to carry out the project work plan and administrative responsibilities of the project
It should make sense

Summary and TIPS

Do not request more Title X funding than is available
Available funding includes indirect costs

Summary and TIPS

Staffing, including position descriptions, should be appropriate and reasonable for the goals, objectives, and activities of the project
Be complete in providing description of what staff will do, expertise required, and percentage time on the project

Summary and TIPS

Review the Application Review Criteria
- Significance
- Feasibility and Likelihood of Producing Meaningful Results
- Competency of Staff and Adequacy of Facilities, Resource and Budget
- Scientific Merit

Summary and TIPS

Use of a systematic approach to planning, implementing, monitoring, and evaluation will assist in maintaining focus and will provide feedback on progress of project
Don't wait until last minute to begin application submission
Electronic submission is encouraged
If you have a question, ASK.

Submission Dates and Times

Multiple submission mechanisms: http://www.grants.gov or www.grantsolutions.gov or

mailing hard-copy
- Address—see Announcement
Electronic submission encouraged.
Pay close attention to due date and deadlines