E6-8081. Public Awareness on Embryo Adoption and/or Donation

AGENCY:

Office of Public Health and Science, Office of the Secretary, DHHS.

ACTION:

Notice.

Announcement Type: This is the initial announcement of a competitive funding opportunity for cooperative agreement projects.

Funding Opportunity Number: OPHS-2006-EA.

CFDA Number: 93.007.

DATES:

Applications are due no later than June 26, 2006. A Letter of Intent (LOI) is requested on or before June 12, 2006.

SUMMARY:

The Office of Public Health and Science (OPHS) announces the availability of Fiscal Year (FY) 2006 funds to support a total of three to four new cooperative agreement grant projects, with the goal of increasing public awareness of embryo donation and/or adoption. Approximately $1,000,000 in funding is available on a competitive basis for cooperative agreements each in the range of $250,000 to $350,000 per year. Projects will be funded in annual increments (budget periods) and for a project period of two years. Funding for all budget periods beyond the first year of the cooperative agreement is contingent upon the availability of funds, satisfactory progress of the project, and adequate stewardship of Federal funds. The OPHS intends to fund at least one project in each of three distinct categories (professional meeting(s); training for professionals to equip them with the skills necessary to provide information and education; and an evidence-based assessment of the emerging field of embryo donation and/or adoption) with the goal of increasing public awareness regarding embryo donation and/or adoption. Entities may apply for more than one category; however, a separate application is required for each category identified in this announcement. Applicants must demonstrate experience with embryo donation and/or adoption programs that conform with professionally recognized standards governing embryo donation and/or adoption and other applicable Federal or State requirements. For the purposes of this announcement, embryo donation and/or adoption is defined as the donation of frozen embryo(s) from one party to a recipient who wishes to bear and raise a child or children.

I. Funding Opportunity Description

The Office of Public Health and Science (OPHS) of the Department of Health and Human Services (DHHS) announces the availability of funds for FY 2006 and requests applications for cooperative agreement projects that will contribute to increasing public awareness of embryo donation and/or adoption.

The OPHS is under the direction of the Assistant Secretary for Health (ASH), who serves as the Senior Advisor on public health and science issues to the Secretary of the Department of Health and Human Services (DHHS). The Office serves as the focal point for leadership and coordination across the Department in public health and science; provides direction to program offices within OPHS; and provides advice and counsel on public health and science issues to the Secretary.

The increasing success of assisted reproductive technologies (ART) has resulted in a situation in which an infertile couple typically creates several embryos through in-vitro fertilization (IVF). During IVF treatments, couples may produce many embryos in an attempt to conceive with several being cryopreserved (frozen) for future use. If a couple conceives without using all of the stored embryos, they may choose to have the remaining unused embryos donated for donation and adoption allowing other infertile couples the experience of pregnancy and birth. Embryo donation and/or adoption is a relatively new process in which individuals who have extra frozen embryos agree to release the embryos for transfer to the uterus of another woman, either known or anonymous to the donor(s) for the purpose of the recipient(s) attempting to bear a child and be that child's parent.

Legislative History

Public Law 109-149, the Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2006, which includes appropriations for DHHS, authorizes the Secretary to conduct a public awareness campaign to educate Americans about the existence of frozen embryos available for donation and/or adoption.

The FY 2006 Senate Committee on Appropriations Report (S. Rep. 109-103) contains the following statement:

The Committee continues to believe that increasing public awareness of embryo donation and adoption remains an important goal. The Committee has provided $2,000,000 for the Department's embryo adoption awareness campaign, which is $1,008,000 more than the comparable fiscal year 2005 funding level and the administration request.

The FY 2006 House Committee on Appropriations Report (H. Rep. 109-143) contains the following statement:

The Committee provides $992,000 for the embryo adoption awareness campaign, which is the same as the Administration request and the comparable fiscal year 2005 level. These funds will be used for a competitive grant program to continue embryo adoption public awareness activities.

The Conference Report (H.R. Conf. Rep. 109-337) accompanying the FY 2006 Appropriations for the Departments of Labor, Health and Human Services and Education and Related Agencies bill did not include a statement addressing embryo adoption and/or donation awareness activities; however, the budget table accompanying the conference report allocated $2 million.

Review of Grant Materials

Grantees shall submit all materials proposed for use in the funded project (including, but not limited to, Web sites, videos, training materials, brochures, fact sheets, press releases, agendas, curricula, reports, journal articles, promotional pieces, advertisements, PSA's, articles, mailings) to the OPHS Project Officer for review and approval prior to use in the funded program. The review shall ensure that materials are consistent with the requirements of this announcement and other applicable grant requirements.

Grant Attribution

The OPHS is interested in making available to the public the results and accomplishments of activities that it funds. Therefore, grantees will be required to place an acknowledgment of OPHS grant support and a disclaimer, as appropriate, on any publication written or published with such support and, if feasible, on any publication reporting the results of or describing a grant-supported activity.

II. Award Information

Funding Instrument Type: Cooperative Agreement.

Anticipated Total Funding: $1,000,000.

Anticipated Number of Awards: A total of 3-4. OPHS anticipates funding one or two projects in each category.

Expected Amounts of Individual Awards: $250,000-350,000.

Floor of Award Range: None.

Ceiling of Award Range: $350,000 for the first 12 month budget period. OPHS will not accept and review applications with budgets greater than the ceiling of the award range.

Project Periods for Awards: 24 months. The projects will be awarded for a project period of 24 months. The initial grant award will be for a 12-month budget period. The award of continuation funding beyond each 12-month budget period will be subject to the availability of funds, satisfactory progress on the part of the grantee, and a determination that continued funding would be in the best interest of the government.

Applications are encouraged from organizations which are currently operating programs that have the capability of expanding and enhancing public awareness of embryo donation and/or adoption, and that have the capability to conduct a rigorous evaluation of the funded project.

A cooperative agreement is a grant award instrument establishing an “assistance” relationship between OPHS and a recipient, in which substantial programmatic involvement with the recipient is anticipated during the performance of the activity. The recipient will have lead responsibilities in all aspects of the project, including any modifications to the project, conduct of the project, and preparation of any publications. The OPHS project officer will collaborate with the recipients, as appropriate, and provide consultation, assistance, and support in planning, implementing, and evaluating all aspects of the proposed project plan. OPHS will have substantial programmatic involvement during conduct of the project, through technical assistance, advice and coordination. Substantial involvement as a partner would include, for example, assisting in planning an agenda, selecting speakers, organizing a symposium, determining the content of a training curricula and related educational materials, determining the topics or data to reviewed as part of an assessment, and determining the acceptability of articles or reports. OPHS will provide assistance in the preparation and review of any reports that may be disseminated as part of a funded project.

III. Eligibility Information

1. Eligible Applicants

Eligible applicants must demonstrate previous experience with embryo donation and/or adoption and be knowledgeable in all elements of the process of embryo donation and/or adoption. Only agencies and organizations, not individuals, are eligible to apply. Eligible applicants include public agencies, non-profit organizations, and for-profit organizations. One agency must be identified as the applicant organization and will have legal responsibility for the project. Additional agencies and organizations can be included as co-participants, subgrantees, subcontractors, or collaborators if they will assist in providing expertise and in helping to meet the needs of the recipients.

Any public or private nonprofit organization or agency is eligible to apply for a cooperative agreement grant. However, only those organizations or agencies which demonstrate the capability of providing the proposed services and meet the requirements of this announcement are considered for awards. Faith-based and community-based organizations that meet the eligibility requirements are encouraged to apply for these embryo donation and/or adoption public awareness cooperative agreement projects. Please note, however, that cooperative agreement funds may not be used for inherently religious activities, such as worship, religious instruction, and proselytization. If an organization engages in such activities, they must be offered separately in time or location from the cooperative agreement program and participation must be voluntary for program beneficiaries. A cooperative agreement program, in providing services and outreach related to program services, cannot discriminate against current or prospective program beneficiaries on the basis of religion, a religious belief, a refusal to hold a religious belief, or a refusal to actively participate in a religious practice.

Applicants should note that section 74.81 of the DHHS grants administration regulations (45 CFR part 74) indicates that, except for awards under certain Asmall business@ programs, no grant funds may be paid as profit to any recipient even if the recipient is a commercial organization. Profit is any amount in excess of allowable direct and indirect costs.

2. Cost Sharing or Matching

None.

3. Other

Applicants are 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 OPA Web site at: http://opa.osophs.dhhs.gov/​duns.html.

IV. Application and Submission Information

1. Address To Request Application Package

Application kits may be requested from, and applications submitted to the Office of Grants Management, Office of Public Health and Science, U.S. Department of Health and Human Services, 1101 Wootton Parkway, Suite 550, Rockville, Maryland 20852, 240-453-8822. Application kits are also available online at: https://egrants.osophs.dhhs.gov or the Grants.gov Web site portal (http://www.grant.gov) or by fax at 240-453-8823.

2. Content and Form of Application Submission

The OPHS requests that you send a Letter of Intent (LOI) if you intend to apply for this program. Although the LOI is not required, not binding, and does not enter into the review of your subsequent application, the LOI will be used to gauge the level of interest in this program, estimate the potential review workload, and allow OPHS to plan the review process. The information will be used to determine the number of expert reviewers needed to evaluate the applications. The narrative should be not more than two double-spaced pages, printed on one side, with one-inch margins, and in 12-point font, unreduced. The LOI should include the following information: “Attention: Embryo Adoption Public Awareness Campaign Letter of Intent for Category #__;” name and address of the applicant institution; name, address and telephone number of the contact person; and specific objectives to be addressed by the proposed project.

Applications must be prepared on the forms supplied (OPHS-1) and in the manner prescribed in the application kits provided by the OPHS. The application must be signed by an individual authorized to act for the applicant agency and to assume responsibility for the obligations imposed by the terms and conditions of the grant award.

To be considered for funding, applicants must submit one signed original of the application and two photocopies in one package, including all forms and attachments. Please label the application envelope: “Attention: Embryo Adoption Public Awareness Campaign Category #__.” The application should be typed and should be no more than 50 double-spaced pages (excluding attachments), printed on one side, with one-inch margins, and in 12-point font, unreduced. All pages, including appendices should be numbered sequentially and stapled, or otherwise secured, in the upper left corner.

Applications must include a one-page abstract of the proposed project. The abstract will be used to provide reviewers with an overview of the application, and will form the basis for the applications summary in grants management documents.

Program Requirements/Application Content

This notice solicits applications for cooperative agreement grant projects in three distinct categories: (1) Professional meeting(s) with the goal of increasing public awareness about embryo donation and/or adoption; (2) Training for professionals who work in ART and/or embryo donation and/or adoption in order to equip them with the skills necessary to provide information and education to the public; and (3) Evidence-based assessment of the emerging field of embryo donation and/or adoption in order to identify the most pressing information gaps for efficient and effective campaigns to increase public awareness of embryo donation and/or adoption.

Category #1—Professional Meeting(s) on Embryo Donation and/or Adoption

The OPHS is interested in supporting a professional meeting (or a series of meetings) that further the goal of increasing public awareness of embryo donation and/or adoption by gaining visibility and fostering collaboration among professionals who are committed to addressing areas of development in the field of embryo donation and/or adoption. For the purpose of this announcement, such a meeting (or meetings) is defined as a gathering, symposium, seminar, conference, workshop or any other organized, formal meeting where people assemble to coordinate, exchange, and disseminate information or explore or clarify the subject of embryo donation and/or adoption. Among the goals of such a professional meeting would be to foster multi-disciplinary and multi-sector interactions that will stimulate development in communications and increase public awareness regarding the practice of embryo donation and/or adoption. A professional meeting is expected to actively foster an environment conducive to collaboration among a variety of professionals in the field.

The types of meeting activities eligible for support include, but are not limited to: (1) A meeting where issues or challenges in the delivery of information on embryo donation and/or adoption are defined and an agenda or strategy for studying them is developed; (2) a meeting where technical, medical, legal, ethical, social, and/or policy issues of major importance in the field are addressed or new ideas are developed; and (3) dissemination conferences where critical information is summarized and communicated broadly to organizations and individuals that have the capability to use the information to develop, deliver or improve public awareness campaigns on embryo donation and/or adoption. OPHS is especially interested in supporting a project that demonstrates strategies which include plans for disseminating conference materials beyond the participants attending the event. Such strategies might include, but are not limited to, submitting articles for publication, posting information on a Web site, and seeking formal opportunities to discuss conference information with others.

Applicants should include a brief summary of the proposed meeting(s), including proposed dates, location, type of participants, goals and specific topics to be covered. The summary should include the objectives, specific program and logistical arrangements for the meeting. Applicants should describe the format and agenda, including the principal topics to be covered, problems to be addressed, and developments or contributions the meeting might stimulate regarding public awareness of embryo donation and/or adoption. Applicants are expected to provide a detailed justification for the meeting, including the professional need, timeliness and usefulness of the meeting to the embryo donation and/or adoption community. The grant application should describe the composition and role of an organizing committee, and provide the names and credentials of proposed key participants in the meeting, including the basis for their selection and documentation of their interest in participating. The applications should also describe the expected size and composition of the audience, as well as the method for selection. The OPHS is also interested in description of plans for publicizing the meeting and publication of proceedings or other methods of disseminating information during or after the meeting(s).

Category #2—Training Regarding Embryo Donation and/or Adoption

The OPHS is interested in supporting training for health, social service and other involved professionals (e.g., physicians, nurses, embryologists, counselors, social workers, clinic staff, etc.) that address the complex legal, medical, psychosocial, ethical and practical issues that confront embryo donors and recipients. OPHS anticipates funding one applicant to establish a training project that focuses on embryo donation and/or adoption information and education services. The successful applicant will provide training that will enhance and support quality services and public awareness of embryo donation and/or adoption in the United States. The purpose of the training program to be funded under this announcement is to ensure that professionals working in the area of embryo donation and/or adoption have the knowledge, skills, and abilities necessary to effectively provide information and education services regarding embryo donation and/or adoption to the public. The successful applicant will use evidence-based information and approaches in all aspects of training and act as a resource on embryo donation and/or adoption to other entities interested in increasing public awareness of embryo donation and/or adoption.

Embryo donation and/or adoption is an emerging field and the practice of embryo donation and/or adoption is complicated by the different attitudes and expectations that professionals, as well as potential donors and recipients, have about this option. Many clinical settings may not be aware of or comfortable with providing information to their patients about embryo donation and/or adoption. Current and future efforts will add significantly to the body of knowledge related to embryo donation and/or adoption, providing evidence-based information that will enable providers to develop effective programs. This emerging body of knowledge should also provide the basis for training content. The applicant must be able to incorporate current, evidence-based information as it becomes available in all phases of training design, delivery, and evaluation. Applicant organizations must demonstrate significant experience in the design, development, implementation, successful completion, and evaluation of training activities. In addition, the successful applicant must demonstrate skill and experience in providing training to diverse groups. The successful applicant will provide evidence of familiarity with embryo donation and/or adoption and the ability to translate evidence-based information into training activities.

The training project is intended to serve a national network for interested professionals, both medical and social service providers, as well as other professionals that may have an interest. Eligible activities include, but are not limited to: (1) Conducting training events that focus on information, education, and clinical services that will enhance and support public awareness of embryo donation and/or adoption; (2) developing strategies to translate evidence-based information on embryo donation and/or adoption into effective educational and clinical practice through training; (3) identifying or developing and disseminating training materials and resources related to embryo donation and/or adoption; (4) supporting appropriate speakers at training events; and (5) building the capacity of professionals to educate and serve individuals who are interested in embryo donation and/or adoption.

The applicant funded under this announcement will be expected to conduct training activities with continuing education content relevant to the medical, legal, psychosocial, ethical and practical issues involved with embryo donation. This continuing education content may be offered to professionals working with populations who may be interested in embryo donation and/or adoption. Training provided is intended to enhance the ability of multiple levels of providers to share information about and assist couples with embryo donation and/or adoption. Training content and design should be adjusted to the skill and practice role of the target audience. Continuing education credits must be available for training activities provided under this announcement. The content and number of offerings should be based on an assessment of the need and offerings should be designed and delivered in a manner appropriate to the content and professional preparation of the participants. Distance learning components may be part of the training offerings.

Category #3—Evidence-Based Assessment of Embryo Donation and/or Adoption Public Awareness

OPHS is interested in supporting a project that will advance our understanding of embryo donation and/or adoption in the United States, and will also improve strategies for communicating information that will ultimately increase public awareness of embryo donation and/or adoption. One of the purposes of such a project is to serve as a resource for the efficient translation of knowledge generated through this and other related projects to the practice efforts in the field of embryo donation and/or adoption. This work will contribute to a longer-term strategy to address the complex issues associated with embryo donation and/or adoption. OPHS is interested in a project that will analyze necessary data and information to assess progress toward the goal of improving public awareness of embryo donation and/or adoption. One of the purposes of this project is to facilitate information exchange among professionals in the field of embryo donation and adoption.

The types of activities eligible for support include, but are not limited to: (1) The development and distribution of periodic publications (e.g., “Updates” or “Issues in Brief”) to highlight findings, collaborations, presentations, publications, and other noteworthy items generated by embryo donation and/or adoption grantees and other entities engaged in efforts to increase public awareness of embryo donation and/or adoption; and/or (2) analyses on key issues in order to increase the availability of data and evidence-based information which will be useful to professionals in improving or increasing public awareness about embryo donation and/or adoption. Applicants should describe the set of information needs in the area of embryo donation and/or adoption public awareness, and propose a coherent program of quantitative and/or qualitative analysis or assessment designed to fill these needs in a practical and creative manner. The principal purpose of this project is not to collect original data; however, if it is relevant and can be demonstrated that appropriate data do not exist elsewhere, some collection of original data is not precluded. Applicants must provide a plan on how information from the project will be disseminated.

Application Narrative

In the narrative section of the application, applicants are advised to describe the strategies and processes that they will use. The applicant should document its capacity to undertake a project in one of the identified categories that is focused on increasing public awareness of embryo donation and/or adoption. Applicants are encouraged to present a description of approaches that may be used, as well as any supplemental materials. Moreover, applicants are advised to demonstrate a familiarity with and understanding of professionally recognized standards or practices (both medical and legal issues) pertaining to embryo donation and/or adoption, as well as supportive services for potential donor or recipient couples. The applicant organization should clearly demonstrate its professional knowledge and experience in embryo donation and/or adoption.

Applicants should include information about their history in working with embryo donation and/or adoption, and the organization's capacity to further the goal of increasing public awareness of embryo donation and/or adoption. As part of the project narrative, applicants are advised to describe the methods they will use to recruit, select, train and evaluate individuals who will implement the project.

Applicants, in the project narrative, are encouraged to present a plan for evaluation of the project. The evaluation plan should be two tiered to address: (1) Process, including the planning, content and quality of the products (e.g., videos, pamphlets, journal articles, presentations, survey instruments, focus groups projects, pilot test reports, conference proceedings, etc.) produced and (2) participant satisfaction and/or project effectiveness, as appropriate. Applicants that do not have the in-house capacity to conduct an evaluation are advised to propose contracting with a third party evaluator to conduct the evaluation.

Applicants should prepare a project description statement in accordance with the following general instructions and use the information provided in this section and the evaluation criteria section to develop the application content. Applications will be evaluated on the criteria listed, so it is important to follow them in describing your program plan. The narrative should contain the following sections in the order presented below:

1. Project Summary/Abstract: Provide a summary of the project description not to exceed one page. Care should be taken to produce an abstract/summary that accurately and concisely reflects the proposed project since the abstract will be used to provide reviewers with an overview of the application, will form the basis for an application summary in official documents, and it may be posted on the OPHS Web site. It should describe the objectives of the project, the approach to be used and the results or benefits expected.

2. Objectives and Need for Assistance: Clearly identify the physical, economic, social, legal, financial, institutional, and/or other problem(s) requiring a solution. The need for assistance must be demonstrated and the principal and subordinate objectives of the project must be clearly stated; supporting documentation, such as letters of support and testimonials from concerned interests other than the applicant, may be included. Any relevant data based on studies should be included or referred to in the endnotes/footnotes. In developing the project description, the applicant may volunteer to provide information on the total range of related projects being conducted or supported (or to be initiated), some of which may be outside the scope of the program announcement.

Describe the specific geographic region that will be served by the organization. This section should include a justification for the selection of the region, based on, for example, geographic size or the number and types of ART centers in the area. There are no geographic restrictions on where the prospective projects may be conducted. The OPHS will accept applications for projects of national, regional, or local scope. The rationale for the project scope must be justified in detail.

3. Approach: Outline a plan of action, which describes the scope and detail of how the proposed work will be accomplished. Account for all functions or activities identified in the application. Cite factors that might accelerate or decelerate the work, and state your reason for taking the proposed approach rather than others. Describe any unusual features of the project such as design or technological innovations, reductions in cost or time, or extraordinary social and community involvement. Provide quantitative monthly or quarterly projections of the accomplishments to be achieved for each function or activity in such terms as the number of program activities to be held, or appropriate measurable outcomes. When accomplishments cannot be quantified by activity or function, list them in chronological order to show the schedule of accomplishments and their target dates.

4. Evaluation: Provide a narrative addressing how the results of the project and the conduct of the project will be evaluated. In addressing the evaluation of results, state how you will determine the extent to which the project has achieved its stated objectives and the extent to which the accomplishment of objectives can be attributed to the project. Discuss the criteria to be used to evaluate results, and explain the methodology that will be used to determine if the needs identified and discussed are being met and if the project results and benefits are being achieved. With respect to the conduct of the project, define the procedures to be employed to determine whether the project is being conducted in a manner consistent with the work plan presented and discuss the impact of the project's various activities on the project's effectiveness.

5. Organizational Profiles: Provide information on the applicant organization and cooperating partners such as organizational charts, financial statements, audit reports or statements from CPAs/Licensed Public Accountants, Employer Identification Numbers, names of bond carriers, contact persons and telephone numbers, and other documentation of professional accreditation, information on compliance with Federal/State/local government standards, documentation of experience in the program area, and other pertinent information.

6. Budget and Budget Justification: Provide a narrative budget justification that describes how the categorical costs are derived. Discuss the necessity, reasonableness, and allocability of the proposed costs. Identify the project director or principal investigator, if known. For each staff person, provide the title, time commitment to the project (in months), time commitment to the project (as a percentage or full-time equivalent), annual salary, grant salary, and wage rates. Do not include the costs of consultants or personnel costs of delegate agencies or of specific project(s) or businesses to be financed by the applicant. Provide a breakdown of the amounts and percentages that comprise fringe benefit costs such as health insurance, FICA, retirement insurance, and taxes, unless treated as part of an approved indirect cost rate. Include information on the costs of project-related travel by employees of the applicant organization (does not include costs of consultant travel). For each trip, show the total number of traveler(s), travel destination, duration of trip, per diem, mileage allowances, if privately owned vehicles will be used, and other transportation costs and subsistence allowances. For each type of equipment requested, provide a description of the equipment, the cost per unit, the number of units, the total cost, and a plan for use on the project, as well as use or disposal of the equipment after the project ends. An applicant organization that uses its own definition for equipment should provide a copy of its policy or section of its policy which includes the equipment definition. Specify general categories of supplies and their costs. Show computations and provide other information, which supports the amount requested. Include information on the costs of all contracts for services and goods except for those, which belong under other categories such as equipment, supplies, construction, etc. Third-party evaluation contracts (if applicable) and contracts with secondary recipient organizations, including delegate agencies and specific project(s) or businesses to be financed by the applicant, should be included under this category. Whenever the applicant intends to delegate part of the project to another agency, the applicant must provide a detailed budget and budget narrative for each delegate agency, by agency title, along with the required supporting information.

3. Submission Dates and Times

Applications must be submitted to the OPHS Office of Grants Management, Office of Public Health and Science, U.S. Department of Health and Human Services, 1101 Wootton Parkway, Suite 550, Rockville, Maryland, 20852. Letters of Intent should also be sent to this address.

Submission Mechanisms

The Office of Public Health and Science (OPHS) provides multiple mechanisms for the submission of applications, as described in the following sections. Applicants will receive notification via mail from the OPHS Office of Grants Management confirming the receipt of applications submitted using any of these mechanisms. Applications submitted to the OPHS Office of Grants Management after the deadlines described below will not be accepted for review. Applications which do not conform to the requirements of the grant announcement will not be accepted for review and will be returned to the applicant.

Applications may only be submitted electronically via the electronic submission mechanisms specified below. Any applications submitted via any other means of electronic communication, including facsimile or electronic mail, will not be accepted for review. While applications are accepted in hard copy, the use of the electronic application submission capabilities provided by the OPHS eGrants system or the Grants.gov Web site Portal is encouraged.

Electronic grant application submissions must be submitted no later than 5 p.m. Eastern Time on the deadline date specified in the DATES section of the announcement using one of the electronic submission mechanisms specified below. All required hardcopy original signatures and mail-in items must be received by the OPHS Office of Grants Management no later than 5 p.m. Eastern Time on the next business day after the deadline date specified in the DATES section of the announcement.

Applications will not be considered valid until all electronic application components, hardcopy original signatures, and mail-in items are received by the OPHS Office of Grants Management according to the deadlines specified above. Application submissions that do not adhere to the due date requirements will be considered late and will be deemed ineligible.

Applicants are encouraged to initiate electronic applications early in the application development process, and to submit early on the due date or before. This will aid in addressing any problems with submissions prior to the application deadline.

Electronic Submissions Via the Grants.gov Web site Portal

The Grants.gov Web site Portal provides organizations with the ability to submit applications for OPHS grant opportunities. Organizations must successfully complete the necessary registration processes in order to submit an application. Information about this system is available on the Grants.gov Web site, http://www.grants.gov.

In addition to electronically submitted materials, applicants may be required to submit hard copy signatures for certain Program related forms, or original materials as required by the announcement. It is imperative that the applicant review both the grant announcement, as well as the application guidance provided within the Grants.gov application package, to determine such requirements. Any required hard copy materials, or documents that require a signature, must be submitted separately via mail to the OPHS Office of Grants Management, and, if required, must contain the original signature of an individual authorized to act for the applicant agency and the obligations imposed by the terms and conditions of the grant award.

Electronic applications submitted via the Grants.gov Web site Portal must contain all completed online forms required by the application kit, the Program Narrative, Budget Narrative and any appendices or exhibits. All required mail-in items must be received by the due date requirements specified above. Mail-In items may only include publications, resumes, or organizational documentation.

Upon completion of a successful electronic application submission via the Grants.gov Web site Portal, the applicant will be provided with a confirmation page from Grants.gov indicating the date and time (Eastern Time) of the electronic application submission, as well as the Grants.gov Receipt Number. It is critical that the applicant print and retain this confirmation for their records, as well as a copy of the entire application package.

All applications submitted via the Grants.gov Web site Portal will be validated by Grants.gov. Any applications deemed “Invalid” by the Grants.gov Web site Portal will not be transferred to the OPHS eGrants system, and OPHS has no responsibility for any application that is not validated and transferred to OPHS from the Grants.gov Web site Portal. Grants.gov will notify the applicant regarding the application validation status. Once the application is successfully validated by the Grants.gov Web site Portal, applicants should immediately mail all required hard copy materials to the OPHS Office of Grants Management to be received by the deadlines specified above. It is critical that the applicant clearly identify the Organization name and Grants.gov Application Receipt Number on all hard copy materials.

Once the application is validated by Grants.gov, it will be electronically transferred to the OPHS eGrants system for processing. Upon receipt of both the electronic application from the Grants.gov Web site Portal, and the required hardcopy mail-in items, applicants will receive notification via mail from the OPHS Office of Grants Management confirming the receipt of the application submitted using the Grants.gov Web site Portal.

Applicants should contact Grants.gov regarding any questions or concerns regarding the electronic application process conducted through the Grants.gov Web site Portal.

Electronic Submissions Via the OPHS eGrants System

The OPHS electronic grants management system, eGrants, provides for applications to be submitted electronically. Information about this system is available on the OPHS eGrants Web site, https://egrants.osophs.dhhs.gov, or may be requested from the OPHS Office of Grants Management at [phone].

When submitting applications via the OPHS eGrants system, applicants are required to submit a hard copy of the application face page (Standard Form 424) with the original signature of an individual authorized to act for the applicant agency and assume the obligations imposed by the terms and conditions of the grant award. If required, applicants will also need to submit a hard copy of the Standard Form LLL and/or certain Program related forms (e.g., Program Certifications) with the original signature of an individual authorized to act for the applicant agency.

Electronic applications submitted via the OPHS eGrants system must contain all completed online forms required by the application kit, the Program Narrative, Budget Narrative and any appendices or exhibits. The applicant may identify specific mail-in items to be sent to the Office of Grants Management separate from the electronic submission; however these mail-in items must be entered on the eGrants Application Checklist at the time of electronic submission, and must be received by the due date requirements specified above. Mail-In items may only include publications, resumes, or organizational documentation.

Upon completion of a successful electronic application submission, the OPHS eGrants system will provide the applicant with a confirmation page indicating the date and time (Eastern Time) of the electronic application submission. This confirmation page will also provide a listing of all items that constitute the final application submission including all electronic application components, required hardcopy original signatures, and mail-in items, as well as the mailing address of the OPHS Office of Grants Management where all required hard copy materials must be submitted.

As items are received by the OPHS Office of Grants Management, the electronic application status will be updated to reflect the receipt of mail-in items. It is recommended that the applicant monitor the status of their application in the OPHS eGrants system to ensure that all signatures and mail-in items are received.

Mailed or Hand-Delivered Hard Copy Applications

Applicants who submit applications in hard copy (via mail or hand-delivered) are required to submit an original and two copies of the application. The original application must be signed by an individual authorized to act for the applicant agency or organization and to assume for the organization the obligations imposed by the terms and conditions of the grant award.

Mailed or hand-delivered applications will be considered as meeting the deadline if they are received by the OPHS Office of Grant Management on or before 5 p.m. Eastern Time on the deadline date specified in the DATES section of the announcement. The application deadline date requirement specified in this announcement supersedes the instructions in the OPHS-1. Applications that do not meet the deadline will be returned to the applicant unread.

4. Intergovernmental Review

This program is not subject to the intergovernmental review requirements of Executive Order 12372, “Intergovernmental Review of Federal Programs,” as implemented by 45 CFR part 100.

5. Funding Restrictions

The allowability, allocability, reasonableness and necessity of direct and indirect costs that may be charged to OPHS grants are outlined in the following documents: OMB Circular A-21 (Institutions of Higher Education); OMB Circular A-87 (State and Local Governments); OMB Circular A-122 (Nonprofit Organizations); and 45 CFR part 74, Appendix E (Hospitals). Copies of the Office of Management and Budget (OMB) Circulars are available on the Internet at http://www.whitehouse.gov/​omb/​grants/​grants_​circulars.html.

Applicants for cooperative agreements are expected to anticipate and justify their funding needs and the activities to be carried out with those funds in preparing the budget and accompanying narrative portions of their applications. If applicants are uncertain whether a particular cost is allowable, they should contact the OPHS Office of Grants Management at 240-453-8822 for further information.

V. Application Review Information

1. Criteria

Each application for a cooperative agreement grant project will be evaluated individually according to the following criteria by a panel of independent reviewers appointed by the OPHS. Before the review panel convenes, each application will be screened for applicant organization eligibility, as well as to make sure the application contains all of the essential elements.

Applicants that meet the requirements of this program announcement will be notified by the Office of Grants Management. A panel of at least three reviewers will use the evaluation criteria listed below to determine the strengths and weaknesses of each application, provide comments and assign numerical scores. Applicants should address each criterion in the project application. The point values (summing up to 100) indicate the maximum numerical weight each criterion will be accorded in the review process.

Criterion 1: Objectives and Need for Assistance (30 Points)

Applicants must demonstrate a clear understanding of the legislative goals and demonstrate how their approach to the project design will contribute to achieve the legislative goals. Applicants must also demonstrate an understanding of the information and skills needed by the designated staff, as well as of the intended audience. Applicants should provide letters of commitment or Memoranda of Understanding from organizations, agencies and consultants that will be partners or collaborators in the proposed project. These documents should describe the role of the agency, organization or consultant and detail specific tasks to be performed. Specific review criteria include:

(1) Extent to which the application reflects an understanding of the legislative goals of the public awareness campaign for embryo donation and/or adoption, and implementation will contribute to achieving the legislative goals;

(2) Extent to which the application clearly describes and documents an understanding of the need for assistance to support and/or enhance existing efforts regarding public awareness of embryo donation and/or adoption;

(3) Extent to which the application reflects a knowledge and understanding of the challenges involved with embryo donation and/or adoption, and in increasing public awareness about embryo donation and/or adoption;

(4) Extent to which the application reflects a knowledge and understanding of the medical and legal framework of embryo donation and/or adoption, and the services and resources in the geographic area in which the proposed project will be conducted;

(5) Extent to which the application explains how the proposed project will contribute to increased knowledge of the problems, issues, and effective strategies and best practices in the field of embryo donation and/or adoption; and

(6) Extent to which the application presents a vision of how the project will advance embryo donation and/or adoption public awareness, and discusses broad contextual factors that will facilitate or impede increasing public awareness of embryo donation and/or adoption.

Criterion 2: Approach (30 Points)

In this section, applicants are expected to define goals and specific, measurable objectives for the project. Goals are an end product of an effective project. Objectives are measurable steps for reaching goals. Applicants are advised to describe a preliminary, yet appropriate and feasible plan of action pertaining to the scope of the proposed project and provide details on how the proposed project will be accomplished. If the project involves partnerships with other agencies and organizations, then the roles of each partner should be clearly specified. Applicants are required to describe how the project will be evaluated to determine the extent to which it has achieved its stated goals and objectives. Applicants are expected to present a project design that includes detailed procedures for documenting project activities that is sufficient to implement the goals and provide for an evaluation. The evaluation design is expected to include process and outcome analyses, if feasible. Applicants are expected to report on their evaluation results in their final report to the OPHS upon completion of the project period. Applicants are required to describe the activities that they will develop pursuant to the project. Applicants should discuss the intended audiences for these activities (e.g., ART centers, adoption organizations, practitioners, professional organizations that work with infertile couples, potential recipients, or donors) and present a dissemination plan specifying the venues for conveying the information. This criterion consists of four broad topics: (A) Project design, (B) implementation, (C) evaluation, and (D) dissemination. Specific review criteria include:

(A) Design of the Project

(1) Extent to which the application reflects a familiarity with and understanding of professionally-recognized standards and/or other relevant Federal or State requirements pertaining to embryo donation and/or adoption.

(2) Extent to which the proposed project goals, objectives and outcomes are clearly specified and measurable, and reflect an understanding of the context in which embryo donation and/or adoption operates; and

(3) Extent to which the application presents an approach that is: (a) Competency based, (b) consistent with the nationally recognized guidelines, and (c) can be evaluated.

(B) Implementation

(1) Extent to which the application clearly describes and provides a justification for the selection of the geographic region that will be served by the project;

(2) Extent to which the application presents an appropriate, feasible and realistic plan for conducting the project;

(3) Extent to which the application presents an appropriate, feasible and realistic plan for recruiting, selecting, and training individuals to conduct the project;

(4) Extent to which the application provides an appropriate, feasible and realistic plan for documenting project activities and results, that can be used to describe and evaluate the project, and participant satisfaction; and

(5) Extent to which the proposed project will establish and coordinate linkages with other appropriate agencies and organizations.

(C) Evaluation

(1) Extent to which the methods of evaluation are feasible, comprehensive and appropriate to the goals, objectives and context of the project;

(2) Extent to which the applicant provides an appropriate, feasible and realistic plan for evaluating the project, including performance feedback and assessment of program progress that can be used as a basis for program adjustments;

(3) Extent to which the methods of evaluation include process and outcome analyses, as appropriate, for assessing the effectiveness of program strategies and the implementation process; and

(4) Extent to which the methods of evaluation include the use of objective performance measures that are clearly related to the intended outcomes of the program and will produce quantitative and qualitative results.

(D) Dissemination

(1) Extent to which the application provides an appropriate, feasible and realistic plan for dissemination of information and related educational materials;

(2) Extent to which the intended audience is clearly identified and defined and is appropriate to the goals of the proposed program;

(3) Extent to which the program's products will be useful to the respective audiences;

(4) Extent to which the applicant presents a realistic schedule for developing these products, and provides a dissemination plan that is appropriate in scope and budget to each of the audiences; and

(5) Extent to which the products to be developed during the program are described clearly and will address the goal of dissemination of information and are designed to support evidence-based improvements of practices in the field.

Criterion 3: Organizational Profile (20 Points)

Applicants need to demonstrate that they have the capacity to implement the proposed program. Capacity includes: (1) Previous experience with similar projects; (2) experience with the target audience; (3) qualifications and experience of the project leadership; (4) experience and commitment of any consultants and subcontractors; and, (5) appropriateness of the organizational structure. This criterion consists of three broad topics: (A) management plan, (B) staff qualifications, and (C) organizational capacity and resources.

Applicants are expected to present a sound and feasible management plan for implementing the proposed program. This section should detail how the program will be structured and managed, how the timeliness of activities will be ensured, how quality control will be maintained, and how costs will be controlled. The role and responsibilities of the lead agency should be clearly defined and, if appropriate, applicants should discuss the management and coordination of activities carried out by any partners, subcontractors and consultants. Applicants should include a list of organizations and consultants who will work with the project, along with a short description of the nature of their contribution or effort. Applicants are also expected to produce a time line that presents a reasonable schedule of target dates, and accomplishments. The time line should include the sequence and timing of the major tasks and subtasks, important milestones, reports, and completion dates. The application should also discuss factors that may affect project implementation or the outcomes and present realistic strategies for the resolution of these difficulties.

Applicants must provide evidence that project staff have the requisite experience, and expertise to carry out the proposed project on time, within budget, and with a high degree of quality. Include information on staff knowledge of the medical and legal issues concerning embryo donation and/or adoption, and experience working in this area. Brief resumes of current and proposed staff, as well as job descriptions, should be included. Resumes must indicate the position that the individual will fill, and each position description must specifically describe the job as it relates to the proposed project.

Applicants must show that they have the organizational capacity and resources to successfully carry out the project on time and to a high standard of quality, including the capacity to resolve a variety of technical and management problems that may occur. If the proposed project involves partnering and/or subcontracting with other agencies/organizations, then the application should include an organizational capability statement for each participating organization documenting the ability of the partners and/or subcontractors to fulfill their assigned roles and functions. Specific review criteria include:

(A) Management Plan

(1) Extent to which the management plan presents a realistic approach to achieving the objectives of the proposed project on time and within budget, including clearly defined responsibilities, time lines and milestones for accomplishing project tasks;

(2) Extent to which the role and responsibilities of the lead agency are clearly defined and the time commitments of the project director and other key project personnel (including consultants) are appropriate and adequate to meet the objectives of the proposed project; and

(3) Extent to which the applicant discusses factors that may affect the development and implementation of the project and presents realistic strategies for the resolution of these difficulties.

(B) Staff Qualifications

(1) Extent to which the proposed project director, key project staff and consultants have the necessary technical skill, knowledge and experience to successfully carry out their responsibilities; and

(2) Extent to which staffing is adequate for the proposed project, including administration, program services, data processing and analysis, evaluation, reporting and implementation of the project.

(C) Organizational Capacity and Resources

(1) Extent to which the applicant and partnering organizations collectively have experience in embryo donation and/or adoption consistent with professionally recognized guidelines;

(2) Extent to which the applicant has experience in developing and implementing similar projects; and

(3) Extent to which the applicant has adequate organizational resources for the proposed project, including administration, program operations, data processing and analysis, and evaluation.

Criterion 4: Budget and Budget Justification (20 Points)

Applicants are expected to present a detailed budget for both the first and second year budget periods. The budget is should present reasonable project costs, appropriately allocated across component areas and sufficient to accomplish the objectives. Consideration shall be given to project delays due to start-up when preparing the budget. Applicants are expected to allocate sufficient funds in the budget to provide for two meetings each year with the Project Officer in Rockville, Maryland, and regular conference calls for programmatic collaboration during the performance of the project. Specific review criteria include:

(1) Extent to which applicant demonstrates that the project costs and budget information submitted for the proposed program are reasonable and justified in terms of the proposed tasks and the anticipated results and benefits; and,

(2) Extent to which the fiscal control and accounting procedures are adequate to ensure prudent use, proper and timely disbursement and an accurate accounting of funds received under this announcement.

Review and Selection Process

Each application submitted to the OPHS Office of Grants Management will be screened to determine whether it was received by the closing date and time.

The results of a competitive review are a primary factor in making funding decisions. In addition, Federal staff will conduct administrative reviews of the applications and, in light of the results of the competitive review, will recommend applications for funding to the ASH. The ASH may also solicit and consider comments from Office of Public Health and Science staff and others within DHHS in making funding decisions. Final grant awards decisions will be made by the ASH. The ASH will fund those projects which will, in his/her judgment, best promote the purposes of this program, within the limits of funds available for such projects.

VI. Award Administration Information

1. Award Notices

The OPHS does not release information about individual applications during the review process. When final decisions have been made, successful applicants will be notified by letter of the outcome of the final funding decisions. The official document notifying an applicant that a project as been approved for funding is the Notice of Grant Award (NGA), signed by the OPHS Grants Management Officer, which sets forth the amount of funds granted, the terms and conditions of the award, the effective date of the grant, the budget period for which initial support will be given, and the total project period for which support is contemplated. The ASH will notify an organization in writing when its application will not be funded. Every effort will be made to notify all unsuccessful applicants as soon as possible after final decisions are made.

2. Administrative and National Policy Requirements

In accepting this award, the grantee stipulates that the award and any activities thereunder are subject to all provisions in 45 CFR parts 74 (non-governmental) and 92 (governmental) currently in effect or implemented during the period of the grant.

The DHHS Appropriations Act requires that when issuing statements, press releases, requests for proposals, bid solicitations, and other documents describing projects or programs funded in whole or in part with Federal money, grantees shall clearly state the percentage and dollar amount of the total costs of the program or project which will be financed with Federal money and the percentage and dollar amount of the total costs of the project or program that will be financed by non-governmental sources.

3. Reporting Requirements

A successful applicant under this notice will submit: (a) Progress reports; (b) annual Financial Status Reports; and (c) a final performance report, including an evaluation report, and Financial Status Report. Reporting formats are established in accordance with provisions of the general regulations which apply under 45 CFR parts 74 and 92. Applicants must submit all required reports in a timely manner, in recommended formats and submit a final report on the project, including any information on evaluation results, at the completion of the project period.

The final performance report should contain an overview of the program from start to finish, including information on: (a) Summary of the project, (b) state of the major goals and objectives of the project, (c) list of significant accomplishments, (d) description of innovative features, (e) statement of significant problems encountered and solutions developed, (f) a complete written disclosure of any invention, curriculum, publication, video, pamphlet conceived or produced as part of the grant funded project, (g) a copy of any products developed in association with the project. The final evaluation report should reflect an assessment of the program. It should describe factors contributing to both program success and problem areas. The report should include a description of the project's objectives, interventions, evaluation model and hypotheses, findings and conclusions. The report should include a summary of the program statistics and findings. It should discuss the implications of project findings as they relate to the project objectives, as well as a set of recommendations based on the findings (where appropriate). The appendices to the evaluation report should include any data collection instruments and relevant references. Copies of any published articles, based on the project or project evaluation findings are also requested.

Agencies receiving $500,000 or more in total Federal funds are required to undergo an annual audit as described in OMB Circular A-133, “Audits of States, Local Governments, and Non-Profit Organizations.”

VII. Agency Contacts

Office of Grants Management Contact: Robin Fuller Department of Health and Human Services, Office of Public Health and Science, OPHS Grants Management Office, 1101 Wootton Parkway, Suite 550, Rockville, Maryland, 20852. E-mail: [e-mail]; telephone: [phone].

Program Office Contact: Evelyn Kappeler, Department of Health and Human Services, Office of Public Health and Science, Office of Population Affairs, 1101 Wootton Parkway, Suite 750, Rockville, Maryland, 20852. E-mail: [e-mail]; telephone: [phone].

Dated: May 19, 2006.

John O. Agwunobi,

Assistant Secretary for Health, Office of Public Health and Science.