Research on the Health of LGBTI Populations (R01 Clinical Trial Optional)

Research on the Health of LGBTI Populations (R01 Clinical Trial Optional) is sponsored by National Institute of Mental Health (NIMH). Funds research projects focusing on the health of LGBTI populations, including mental health aspects.

Expired PA-12-111: Research on the Health of LGBTI Populations [R01] This notice has expired. Check the NIH Guide for active opportunities and notices. Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Kennedy Shriver National Institute of Child Health and Human National Cancer Institute ( NCI ) National Institute on Aging ( NIA ) National Institute on Alcohol Abuse and Alcoholism ( NIAAA ) National Institute of Allergy and Infectious Diseases ( NIAID ) National Institute of Arthritis and Musculoskeletal and Skin Diseases ( NIAMS ) National Institute on Deafness and Other Communication Disorders ( NIDCD ) National Institute on Drug Abuse ( NIDA ) National Institute of Mental Health ( NIMH ) National Institute on Minority Health and Health Disparities ( NIMHD ) Office of Behavioral and Social Sciences Research ( OBSSR ) Office of Research on Women’s Health ( ORWH ) Funding Opportunity Title Research on the Health of LGBTI Populations [R01] R01 Research Project Grant May 18, 2015 - This PA has been reissued as PA-15-261 .

June 3, 2014 - Notice NOT-14-074 supersedes instructions in Section III. 3 regarding applications that are essentially the same. May 30, 2013 ( NOT-OD-13-074 ) - NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after September 25, 2013.

Forms-C applications are required for due dates on or after September 25, 2013. Funding Opportunity Announcement (FOA) Number PA-12-112 , R03 Small Grant Program PA-12-113 , R21 Exploratory/Developmental Grant Additional Information on Eligibility . Catalog of Federal Domestic Assistance (CFDA) Number(s) 93.

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242 ; 93. 307 The National Institutes of Health (NIH) is committed to supporting research that will increase scientific understanding of the health status of various population groups and improve the effectiveness of health interventions and services for individuals within those groups.

High priority is placed on research on populations that appear to have distinctive health risk profiles but have received insufficient attention from investigators. This Funding Opportunity Announcement (FOA) highlights a particular community: lesbian, gay, bisexual, transgender, intersex, and related populations (designated here as LGBTI populations).

Basic, social, behavioral, clinical, and services research relevant to the missions of the sponsoring Institutes and Centers may be proposed. Open Date (Earliest Submission Date) Letter of Intent Due Date dates apply, by 5:00 PM local time of applicant organization. AIDS Application Due Date(s) dates apply by 5:00 PM local time of applicant organization.

Required Application Instructions It is critical that applicants follow the instructions in 424 (R&R) Application Guide , except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts ). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced.

Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV . When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information Part 2. Full Text of the Announcement Section I.

Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV.

Application and Submission Section V. Application Review Information Section VI. Award Administration Information Section VII.

Agency Contacts Section VIII. Other Information I. Funding Opportunity Description The National Institutes of Health (NIH) is committed to supporting research that will increase scientific understanding of the health status of various population groups and improve the effectiveness of health interventions and services for individuals within those groups.

High priority is placed on research on populations that appear to have distinctive health risk profiles but have received insufficient attention from investigators. This Funding Opportunity Announcement (FOA) highlights a particular community: lesbian, gay, bisexual, transgender, intersex, and related populations (designated here as LGBTI populations).

Basic, social, behavioral, clinical, and services research relevant to the missions of the sponsoring Institutes and This FOA focuses on the health of lesbian, gay, bisexual, transgender, intersex, and related populations. The Institute of Medicine (IOM) report issued in March 2011 ( http://www. iom.

edu/Reports/2011/The-Health-of-Lesbian-Gay-Bisexual-and-Transgender-People. aspx ) stated, in reference to LGBTI health, that the existing body of evidence is sparse, and that substantial research is needed.

Potential applicants are urged to read the report, as a number of specific issues are raised and LGBTI populations may be characterized as encompassing several broad, partially overlapping, groups, which are defined in the March 2011 IOM report as follows: One group includes individuals whose sexual orientation as typically conceptualized in terms of sexual attraction, behavior, and/or sexual orientation identity is not exclusively heterosexual.

This group includes people who label themselves (or are labeled) as gay, lesbian, or bisexual, as well as people who do not adopt such labels but nevertheless experience same-sex attraction or engage in same-sex sexual behaviors.

A second group includes individuals whose gender identity differs from the sex originally assigned to them at birth; whose gender expression varies significantly from what is traditionally associated with or typical for that group; and/or who vary from or reject traditional cultural conceptualizations of gender in terms of male-female dichotomy.

This group includes people who label themselves (or are labeled) as transgendered, transsexual, cross-dressers, transvestites, and/or two-spirit. A third group includes individuals who are born with external and/or internal genitalia that vary from typical male or female genitalia, or a chromosomal pattern that varies from XX (female) or XY (male). This group includes people who label themselves (or are labeled) as intersex.

Following recent usage, the term LGBTI [Lesbian, Gay, Bisexual, Transgender and Intersex] is adopted here as a general designation for these diverse populations as well as for individuals within these populations. However, applicants may adopt other classification frameworks and terminologies as appropriate for their proposed research; for example, men who have sex with men (MSM), or homosexual.

Recent data from national health surveys and targeted studies suggest that prevalence rates for some health conditions are higher among LGBTI populations than for the general population. There is evidence that LGBTI individuals delay health care treatment because they fear stigmatization or because their experiences have led them to believe that many health care providers lack knowledge and experience working with LGBTI individuals.

There is also evidence that LGBTI individuals receive health care services that are not as appropriate and effective as those provided to non-LGBTI individuals. This FOA calls for research that will enrich scientific understanding of how sexual orientation and gender identity influence health, perceptions and expectations about health, health behaviors, and barriers and access to health-related services.

This FOA also calls for research on how the household and family structures and processes of LGBTI individuals influence the health, development, and well-being of children born and/or raised in these households and families. This knowledge will also guide new directions for studies of the health of both LGBTI and non-LGBTI populations.

This FOA calls for research that describes the biological, clinical, behavioral, and social processes that affect the health and development among LGBTI populations and among their families, and that leads to the development of effective supportive, preventive and treatment interventions and health service delivery methods that will enhance the health and development of these populations.

Research conducted in response to this FOA must focus on clearly defined health outcomes, rather than on general measures of well-being or adjustment.

This FOA encourages researchers to investigate new research questions related to the health and development of LGBTI individuals and their families and to develop and/or apply innovative methodologies to improve understanding of mechanisms affecting the health and development of these populations. Three types of research on preventive and treatment interventions and health service delivery methods are included within this FOA.

Formative research that will design and pilot test new interventions. Formative research is necessary because evidence-based preventive and treatment interventions for LGBTI individuals, particularly for adolescents and young adults, are scarce. Large-scale implementation and evaluation of preventive and/or treatment interventions that are evidence based.

Adaptations of current interventions that are based by strong rationales, including, at a minimum, pilot data. Research should be designed so that the applicability of its findings beyond the health of the particular sample investigated can be readily assessed.

Applicants should provide a precise description of the target population and of the sampling methods to be employed, paying attention not only to sexual identity, sexual orientation, and gender characteristics, but to such variables as age, generational cohort, race/ethnicity, culture, geography, socioeconomic status, and physical and psychological qualities.

Given the diversity of LGBTI populations, and their unknown distribution in the general population, it is expected that most projects will focus on one or a few Proposed research may draw from the full range of approaches within biological, clinical, behavioral, and social sciences, including both quantitative and qualitative approaches.

Applicants are encouraged to build on and/or incorporate approaches and findings from research on other types of health disparities and from research on influences of sex and gender in biological and behavioral functioning. Proposed research projects must consider the potential risks to and vulnerability of research participants and must ensure their confidentiality and protection.

The ethical and legal implications of the proposed research on LGBTI populations must be considered. While the primary domain of interest is LGBTI populations within the United States, research with non-U.S. populations is acceptable if the applicant can demonstrate the proposed work will contribute to scientific understanding of U.S. LGBTI populations.

Examples of research areas include but are not limited to: and Epidemiological Methods Epidemiological studies to characterize LGBTI populations across the lifespan, by age, race/ethnicity, sexual orientation and gender identity, education, occupation, social networks, family structures, and urban/rural or Research on the nature and diversity of health-related roles perceptions, attitudes, and expectations that influence sexual orientation and gender identity in LGBTI populations and in other populations.

Studies to improve measures and methodologies related to LGBTI populations, including studies that address various logistical and ethical challenges in obtaining representative samples of hidden or difficult to reach Studies that develop new tools for assessing and evaluating how social and peer influences impact LGBTI health, including new information technologies that may influence such health behaviors.

Studies of how social structures, including the internet, built environments and legal and cultural expectations may influence the health including emotional health and resilience, of LGBTI populations.

Of particular interest are studies that address LGBTI individuals who may have unique experiences overcoming discrimination or social marginalization associated with being in other minority groups such as ethnic/racial minority groups, Studies of LBGTI-health relevant issues in elderly and aging populations such as (but not limited to) end of life and long-term care planning and the role of biological and chosen families in social support and Characteristics and Human Development Studies of health-relevant demographic and socioeconomic characteristics of LGBTI populations.

Studies of the interactions and influences of sexual orientation and gender-related characteristics with affective, cognitive, personality and identity processes including identity processes related to race and ethnicity that affect health and health risk behaviors among LGBTI populations.

Studies of the determinants and consequences of the timing of individuals' recognition of and disclosure to others of their sexual or gender identity on their health and health risk behaviors.

Research on the determinants and health consequences of the timing of individuals' recognition of and disclosure to others of their sexual Research on how the health and health outcomes of LGBTI individuals are affected by their interpersonal relationships, social networks, religious affiliations, and by family relationships, structure, and processes. Family includes both family of origin and family of choice.

Studies of protective and resiliency factors and of coping processes within LGBTI populations, including how these factors and processes influence health, partner selection, partner concurrency, family structures, sexual practices, and cross-generational family relationships. Research on how health-related outcomes are affected by changing social perceptions and attitudes toward LGBTI populations.

Research on the role of networks on the health, health-related behavior, and use of health care among LGBTI populations. Research on how gender identity and sexual orientation affect health, health behaviors, and health care use across the life course and how health-related outcomes differ across LGBTI groups.

(See Background section for Studies of suicidality and stress-related illnesses in LGBTI populations, including prevalence, risk and protective factors, and preventive Studies of the mechanisms by which experiences of stigmatization, discrimination, and violence affect health in LGBTI populations.

Such studies may include examination of bullying and harassment of youth in schools and Studies of social network dynamics and how they may foster behavioral risks or, conversely, resiliency and protective norms that help buffer the cumulative effects of discrimination, abuse, or stigma.

Studies of current and emerging patterns of drug and alcohol use and substance use-related risk behaviors and outcomes, including HIV/AIDS and other infectious diseases in LGBTI communities (including such topics as contexts of substance use, social diffusion of particular forms of substance use, and related risk behaviors and distribution networks).

Studies of the interactions of measured health differences associated with sexual orientation and gender-related characteristics with other forms of health disparities (associated with, for example, race/ethnicity, the prevalence and incidence of HIV/AIDS and other infectious as well as noninfectious diseases, socioeconomic status, geography, etc.).

Research with transgender people, including transsexual people who intend to seek, have sought, or have received hormonal or surgical interventions and the health effects of such interventions.

Studies of the acoustic factors that contribute to perception of femininity and masculinity and of other non-voice factors (such as articulation, prosody and body language) that interact to create the perception of femininity or masculinity and the effects on the health of individuals. Studies of the health and developmental effects of early gender assignment in cases of infants born with ambiguous genitalia.

Developmental and longitudinal studies on the health of gender-related and other biological and behavioral characteristics of intersex people, including follow-up studies of persons who have received hormonal or Studies of the development and evaluation of approaches to psychosocial assessment and counseling for intersex people and their families.

Studies of competency and training needs among clinicians, employers, and other service providers who work with LGBTI people. Research to develop and evaluate training and knowledge dissemination programs for clinicians and health service providers on LGBTI-related topics.

Intervention and Services Research Studies to evaluate the stability, fluidity, and other temporal attributes of social norms and networks and how such attributes affect perceptions, attitudes, and behaviors among LGBTI individuals and the resulting effects on Conversely, studies that utilize findings on the social norms and networks of LGBTI populations to develop novel designs and approaches for targeted disease prevention interventions among LGBTI populations.

Comparative effectiveness of treatment approaches to change voice to match individuals' chosen gender.

Research that develops and evaluates new preventive, treatment, counseling and rehabilitative interventions for substance abuse and co-occurring health and mental health disorders that are sensitive to the needs and characteristics of LGBTI people (i.e., culturally competent), including network-based interventions that build on the diffusion capacities of social support networks among LGBTI individuals.

Studies of the beliefs, expectations, norms, and attitudes of LGBTI populations regarding substance abuse and mental health services, including how such beliefs, expectations, norms, and attitudes affect service utilization and effectiveness.

Studies that use venues frequented by LGBTI networks as sites for developing, implementing, and evaluating new interventions to promote health and behavioral risk reduction, and to provide linkages to health services and Application Types Allowed Glossary and the SF 424 (R&R) Application Guide provide details on Funds Available and Anticipated Number of Awards The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious Application budgets are not limited, but need to reflect actual needs of the proposed project.

Scope of the proposed project should determine the project period. The maximum period is 5 years. Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III.

Eligibility Information Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education: Hispanic-serving Institutions Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving Institutions Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Nonprofits without 501(c)(3) IRS Status (Other than Institutions For-Profit Organizations (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Eligible Agencies of the Federal Government U.S. Territory or Possession Independent School Districts Public Housing Authorities/Indian Housing Authorities Native American Tribal Organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement , are allowed. Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award.

Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following Contractor Registration (CCR) must maintain an active registration, to be renewed at least annually All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 4-6 weeks prior to the application due date.

Eligible Individuals (Program Director(s)/Principal Investigator(s)) Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support.

Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) This FOA does not require cost sharing as defined in the NIH Grants Policy Statement .

Additional Information on Eligibility Applicant organizations may submit more than one application, provided that each application is scientifically distinct. NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed.

Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide. IV. Application and Submission Information 1.

Requesting an Application Package Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants. gov .

Form of Application Submission It is critical that applicants follow the instructions in (R&R) Application Guide , except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced.

Applications that are out of compliance with these instructions may be delayed or not accepted for For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Required and Optional Components The forms package associated with this FOA includes all applicable components, mandatory and optional.

Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional All page limitations described in the SF424 Application Page Limits must be followed.

PHS 398 Research Plan Component All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies; GWAS) as provided in the SF424 Do not use the Appendix to circumvent page limits.

Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide Foreign (non-US) institutions must follow policies described Grants Policy Statement , and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide. 3. Submission Dates and Times Part I.

Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission. Organizations must submit applications via Grants.

gov , the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons , NIH’s electronic system for grants are responsible for viewing their application in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide. 4. Intergovernmental Review (E.

O. 12372) This initiative is not subject to intergovernmental All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement . Pre-award costs are allowable only as described in the NIH Grants Policy Statement .

6. Other Submission Requirements and Applications must be submitted electronically following the instructions described in the SF 424 (R&R) Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(R&R) Application Package . Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the Central Contractor Registration (CCR). Additional information may be found in the SF424 (R&R) Application Guide. tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

Requests of $500,000 or more for direct costs in any year Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact NIH program staff at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF 424 (R&R) Application Guide.

Post Submission Materials Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115 . V. Application Review Information Only the review criteria described below will be considered in the review process.

As part of the NIH mission , all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)?

If the project is collaborative or multi-PD(s)/PI(s), do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions?

Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project?

Are potential problems, alternative strategies, and benchmarks for success presented?

If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed?

Will the project benefit from unique features of the scientific environment, subject populations, or collaborative Additional Review Criteria As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.

Protections for Human Subjects For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to Subjects Protection and Inclusion Guidelines .

Inclusion of Women, Minorities, and Children When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines .

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia.

For additional information on review of the Vertebrate Animals section, please for Review of the Vertebrate Animal Section . Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the For Renewals, the committee will consider the progress made in the last funding period. For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project.

If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

Additional Review Considerations As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact/priority score.

Applications from Foreign Organizations Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the