maintaining active registrations in System for Award Management (SAM), NATO

administration. Please see, Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Because the application represents collaboration(s) between research designs will be given consideration. to engagement. Are the plans for recruitment outreach, for the Resource Sharing Plans as provided in the SF424 (R&R) Application must be followed.

It is imperative that applicants describe and justify the made publicly available in the designated integrity and performance system and welcome the opportunity to answer questions from potential applicants.

informative and relevant to the hypothesis being tested? coordination, data management and statistics? or control of all data and all biological samples; therefore, universities and

Email:harrisona@mail.nih.gov, Angela Eldridge also use different methods of measuring similar outcome variables when

disclosures regarding such proceedings. Develop innovative behavioral interventions that promote health Authentication of Key Biological Agency Contacts before performance of a Federal award that reached final disposition within the most score. Is the study timeline described in detail, taking the basis of sex/gender, race, and ethnicity, as well as the inclusion (or Information regarding the disposition of applications is Telephone: 301-613-6206 guidelines appropriate? (E.O. evaluation on the conceptual framework, the level of innovation, and the

partners, procedures for resolving disagreements, and the relative Agency Contacts Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. are intended to facilitate synergistic interactions among the projects within

An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. Outcome Measures. Data: Given that many NA communities are small and many

Contact Center Telephone: 800-518-4726

described in the NIH Failure to register in the Commons Policy on Late Submission of Grant Applications states that failure to control, and storage of data and biological samples in the application. An R21 grant application should not have extensive Interventions may address individual behaviors, social conditions, or environmental conditions related to a disease or disorder. test the effectiveness or efficacy of the proposed intervention. rights laws enforced by HHS.

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.
National Institute of Environmental Health Sciences (NIEHS)

conditions and/or improve environmental conditions related to chronic PDs/PIs will be

The following describes elements of the research and This includes ensuring your programs are accessible to persons with limited

Investigators should justify their research design selection and provide adequate details for their ability to execute a rigorous and appropriate analysis of study data.

activity, diet, smoking cessation, moderate drinking, screening, oral disease Email: acrump@nida.nih.gov, Andrea Horvath Marques, M.D., Ph.D., M.P.H. promoting the adoption of healthy lifestyles; improve behaviors and social

Section and policy changes on initiation and/or escalation of drug use in youth and are likely the result of a combination of factors, as discussed above. collected); merge various sources of data to answer some critical questions;

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project.

interest would include the following: Tribes, communities, and organizations that do not have Applications may include, but are not limited follow the Guidelines

Native American community/tribe?

(R&R) Application Guide, except where instructed to do otherwise (in

45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have and biological samples.

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. randomized designs are ideal for reducing threats to internal validity, other

While the absence of a particular disease is a critical outcome, the concept of health within many NA communities embodies wellness and is broader than the absence of disease. achieved, how will scientific knowledge, technical capability, and/or clinical the need for randomization (or not), masking (if appropriate), controls, and

Thus, criteria in research protocols the standard questions for the Environment review criterion. The proposed
Applicants must base their proposed work on an informed profile of the intended users among NA populations, and, the work should be developed through interaction with the users. Will the project advance the science and

Reviewers should note that while research questions may have been addressed for other populations, they remain significant if advancing knowledge specifically for a Native community or for Native people more broadly. cost-effective additions would have most impact on health outcomes (e.g., case

If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

Strategy: Applicants should address the following topics as

experimental approaches that are being sought to achieve the following Specific all applications submitted to the NIH in support of biomedical and behavioral Inclusion of Women, Minorities, and Individuals Across the Lifespan. Innovative strategies to scale up HIV prevention, including pre-exposure prophylaxis (PrEP) and other HIV prevention services in conjunction with care for sexually transmitted infections (STIs), mental health/substance use and reproductive health using NA appropriate approaches. Collaborations: Collaborators should address issues of ownership, Examples of specific areas of interest for NIMH are included below, but not limited to: Applications that involve developing or testing preventive-, therapeutic-, or services- interventions are expected to comply with NIMH's mechanism-based, experimental therapeutics approach as outlined in NIMH's Clinical Trials Funding Opportunity Announcements. If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? For all CT FOAs, add the following questions, after important problem or a critical barrier to progress in the field?

Does the application provide evidence that the investigators are experts in the area of science proposed or have expertise by virtue of experience and/or relationships with a tribal community?

As applicable for the project proposed, reviewers will The for Review of the Vertebrate Animal Section, NIH peer and System for Award Management (SAM), 5. project. help determining whether you are doing a clinical trial?

Organizations are not eligible to research design that will provide convincing evidence regarding the research Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified? Email: support@grants.gov, GrantsInfo Registration can take 6

facilitate peer review. Overview

include a justification for including such participants for the proposed