Public Awareness on Embryo Adoption and/or Donation, 30410-30419 [E6-8081]

Agencies

• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 71, Number 102 (Friday, May 26, 2006)]
[Notices]
[Pages 30410-30419]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-8081]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Public Awareness on Embryo Adoption and/or Donation

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

ACTION: Notice.

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    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

[[Page 30411]]

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

[[Page 30412]]

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 https://www.dunandbradstreet.com or call 1-866-705-
5711. For more information, see the OPA Web site at: https://
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 (https://
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)

[[Page 30413]]

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

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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

[[Page 30415]]

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

[[Page 30416]]

an application. Information about this system is available on the 
Grants.gov Web site, https://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 (240) 453-8822.
    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 https://www.whitehouse.gov/
omb/grants/grants_circulars.html.

[[Page 30417]]

    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

[[Page 30418]]

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

[[Page 30419]]

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: rfuller@osophs.dhhs.gov; telephone: 240-453-