National Institutes of Health (NIH)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Funding Opportunity Title
Epidemiology and Prevention in Alcohol Research (R03)
R03 Small Research Grant Award
Reissue of PA-07-450
Funding Opportunity Announcement (FOA) Number
Catalog of Federal Domestics Assistance (CFDA) Number(s)
The National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institutes of Health (NIH), encourages the submission of investigator-initiated research grant applications to support research investigating the epidemiology of alcohol use, alcohol-related harms, and alcohol use disorders and the prevention of underage drinking, alcohol-related harms, and alcohol use disorders.
October 28, 2010
Open Date (Earliest Submission Date)
January 16, 2011
Letter of Intent Due Date
Application Due Date(s)
Standard dates apply, by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)
Standard dates apply.
Scientific Merit Review
Standard dates apply.
Advisory Council Review
Standard dates apply.
Earliest Start Date(s)
Standard dates apply.
January 8, 2014
Due Dates for E.O. 12372
Required Application Instructions
It is critical that applicants follow the instructions in the SF 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 Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information
Alcohol consumption ranks among the leading risk factors for death and poor health in the United States. Analyses of external, modifiable factors that contribute to death have placed alcohol consumption as the third leading such cause for 2000, after (1) tobacco use, and (2) poor diet and physical inactivity. In 2007, 23,199 deaths in the United States had an alcohol-induced condition as their underlying cause of death, and 45,393 deaths had an alcohol-induced condition as either the underlying cause or a contributing cause of death. The role of alcohol in illness is often inferred from data on health care utilization. A report on alcohol-related hospital discharges based on data from the National Hospital Discharge survey finds that 463,000 hospital discharge episodes in 2007 for persons 15 and older had a principal alcohol-related diagnosis and approximately 1.7 million discharges had an alcohol-related diagnosis of any kind. These overall estimates are surely conservative because they omit a wide range of conditions known to be partially caused by alcohol consumption, including various cancers, cardiac conditions, stroke, gastro-intestinal conditions, and various unintentional and intentional injuries. To fully account for the burden of alcohol-related diseases, some studies attempted to estimate alcohol-attributable fractions for these medical conditions. Taking into account the alcohol-attributable fractions, the CDC's Alcohol-Related Disease Impact (ARDI) system estimates that, on average, about 80,000 deaths each year during 2001-2005 were due to the harmful effect of alcohol consumption. These premature deaths represent about 2.36 million years of potential life lost (YPPLLs).
Epidemiologic research expands knowledge about alcohol use and its associated problems in many ways. It establishes the incidence and prevalence of alcohol use, patterns of drinking (especially high risk drinking), health problems attributable to drinking, and alcohol use disorders. It establishes rates of various problematic consequences of alcohol use such as driving under the influence of alcohol, violent behavior, homicide, suicide, and the spread of infectious diseases such as TB and HIV. Epidemiological studies reveal how these prevalences are distributed among population subgroups potentially elucidating health disparities. They also can indicate the developmental pathways of these phenomena over the life course. Assessment of the causal linkages between alcohol use and health outcomes can reveal both harmful and beneficial effects of alcohol consumption.
Epidemiologic research also identifies risk and protective factors for heavy drinking and alcohol use disorders. The best studies combine risk and protective factors at the individual, familial, small group, and environmental levels. In regard to the environmental level, many interesting contributions have recently been made through spatial modeling studies.
Also important are the relationships between alcohol use disorders, other addictive behaviors, and mental health disorders. Finally, genetic studies are making progress in understanding the interaction between environmental and genetic contributions toward the development of alcohol use disorders.
NIAAA is interested in advancing knowledge in all of the above areas of epidemiologic research.
The key potential benefit of research findings on the rates, developmental patterns, and risk and protective factors of alcohol use and alcohol-related problems is that they will provide a scientific basis for the development of more effective prevention strategies. Indeed an often-neglected task in translational research is making the link between findings of etiological processes and the development and testing of prevention strategies that play on those processes.
Much attention has been given recently to the prevention of underage drinking and on the transition from early drinking to high risk drinking to the development of alcohol use disorders. Many of the prevention initiatives developed in this regard have focused on school-based or college-based strategies for encouraging prevention. Less often examined are interventions that can be implemented in military or workplace settings.
Alcohol consumption during pregnancy has a broad spectrum of deleterious effects on the developing fetus. Effort is needed to develop interventions to prevent fetal alcohol exposure, improve the tools available for diagnosing fetal alcohol spectrum disorders (FASD) more accurately, and broadening our understanding of the mechanisms involved in FASD pathogenesis.
Most commonly, prevention interventions target individually-based mechanisms of change, such as alcohol expectancies or perceived norms about others' drinking. Some studies widen this to include parents, peers, and spouses as agents of change. At wider levels, other programs focus on media messages, alcohol availability, and the complex web of legal and regulatory policy that surrounds the sale and consumption of alcoholic beverages. Especially promising are multi-level strategies that combine both individual and environmental approaches. Also of considerable interest are community-wide strategies that focus a package of several different prevention activities on the same community, hoping to achieve a synergistic effect.
Another promising avenue is to craft prevention strategies effective in specific contexts, such as strategies to engage injury patients seen in emergency rooms, persons screened as high risk drinkers in primary care visits, or pregnant women identified in the course of obstetric or gynecological care. A continuing unresolved need in prevention is to show that preventive strategies known to be effective in the overall population also are appropriate and effective among minority populations. Finally in view of the continuing AIDS epidemic, it is critical to understand the contribution of alcohol use to HIV-related risk taking and to develop strategies that increase early identification of HIV infection and reduce HIV transmission among risk-drinking, alcohol abusing, and alcohol dependent individuals.
In any of these areas, prevention research needs to be concerned with a full range of implementation issues, from demonstrating efficacy in well-controlled trials, to effective delivery under real-world conditions, to the dissemination and translation of effective research into routine practice, and to the demonstration of cost effectiveness and cost offset that can aid in the wider adoption of known-effective strategies. Though most studies focus on establishing the efficacy or effectiveness of one or another intervention strategy, it also is necessary for research to establish better knowledge of the underlying mechanisms of action that promote effectiveness. This task often begins with a careful analysis of the mediators and moderators of successful intervention.
NIAAA wishes to encourage research advances in any of the above areas of prevention science.
Areas of investigation under this Funding Opportunity Announcement (FOA) could include, but are not limited to studies that:
Improve knowledge about the etiology and patterns of comorbidity between alcohol use disorders, other addictive behaviors, and mental health disorders.
Explore factors that influence transitions in drinking patterns across the lifespan, including individual, social context, and environmental factors.
Advance the epidemiology of underage drinking and examine the factors that contribute to early initiation of alcohol use and risk for alcohol use disorders.
Develop innovative statistical methodologies to analyze data sets from cross-sectional and longitudinal studies of alcohol use and develop efficient software tools for implementing these methodologies.
Increase understanding of the role that alcohol plays in the development of chronic diseases and in the management of their treatment.
Improve estimation of alcohol-attributable fractions of morbidity and mortality and the measurement of the burden of alcohol-related illness and mortality.
Improve the targeting of prevention efforts by identifying individuals at highest risk for alcohol use disorders based on family history, genetic association, or biomarker identification.
Replicate and generalize evidence-based environmental strategies developed in successful community trials and undertake studies to develop new community prevention strategies.
Undertake studies of alcohol policies to determine their effects on levels of alcohol-related harms.
Improve understanding of the role of alcohol prices on alcohol consumption and how these effects vary across population groups.
Determine the efficacy and effectiveness of brief interventions among youth to prevent or delay the initiation of alcohol use or to reduce the risk of developing alcohol use disorders and other alcohol-related problems.
Evaluate the effectiveness of brief interventions delivered in a wide variety of contexts, such as emergency rooms, primary care visits, employee assistance programs, and criminal justice settings.
Evaluate strategies to address the problem of college drinking.
Evaluate strategies to reduce alcohol related problems among military personnel and their families.
Develop strategies appropriate for the needs and alcohol-related problems experienced by the elderly.
Develop and test prevention interventions that are based on etiologic findings about the development of alcohol use disorders.
Investigate risk and protective factors for alcohol-related violence and develop and test interventions to prevent alcohol-related violence.
Assess the effectiveness of policies, interventions, and sentencing options designed to reduce drinking driving.
Assess the effectiveness of programs to reduce drinking during pregnancy and the risk of fetal alcohol spectrum disorders (FASD).
Encourage culturally and developmentally appropriate screening, assessment, and intervention, including brief interventions.
Develop and test models using systems science approaches, such as agent-based system dynamics, network, or dynamic micro simulation models, to advance understanding of health-related behaviors and outcomes.
Develop and evaluate effective behavioral, social, and environmental interventions to prevent HIV transmission and acquisition by reducing alcohol-related risk taking.
The common characteristic of the small grants provision of limited funding for a short period of time. Examples of the types of projects that ICs support with the R03 include the following:
Pilot or feasibility studies
Secondary analysis of existing data
Small, self-contained research projects
Development of research methodology
Development of new research technology.
Application Types Allowed
The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.
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 applications.
A project period of up to two years and a budget for direct costs of up to two $25,000 modules, or $50,000 per year, may be requested (i.e., a maximum of $100,000 over two years in four modules of $25,000 each), Commensurate Facilities and Administrative (F&A) costs are allowed.
Award Project Period
Scope of the proposed project should determine the project period. The maximum period is 2 years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
Higher Education Institutions:
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For profit Organizations
Foreign (non-U.S.) components of U.S. Organizations 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
All Program Directors/Principal Investigators (PD/PIs) 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 four (4) weeks prior to the application due date.
Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Project Director/Principal
Investigator (PD/PI) 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 PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
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.
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.
It is critical that applicants follow the instructions in the SF424 (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 review.
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 application submission. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
Resource Sharing Plan
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 (R&R) Application Guide.
Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide, with the following modifications:
No publications or other printed material, with the exception of pre-printed questionnaires or surveys, may be included in the Appendix.
Foreign (non-US) organizations must follow policies described in the NIH Grants Policy Statement, and procedures for foreign organizations described throughout the SF424 (R&R) Application Guide.
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 administration.
Applicants 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.
This initiative is not subject to intergovernmental review.
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.
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 process, visit Applying Electronically.
All PD/PIs 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.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review by components of participating organizations, NIH. Applications that are incomplete will not be reviewed.
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115
The R03 small grant supports discrete, well-defined projects that realistically can be completed in two years and that require limited levels of funding. Because the research project usually is limited, an R03 grant application may not contain extensive detail or discussion. Accordingly, reviewers should evaluate the conceptual framework and general approach to the problem. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or from investigator-generated data. Preliminary data are not required, particularly in applications proposing pilot or feasibility studies.
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/PIs, 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/PI, 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 arrangements?
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 the Human 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 refer to the Worksheet 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 project.
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.
Select Agent Research
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).
Budget and Period of Support
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review (assignments will be shown in the eRA Commons), in accordance with NIH peer review policy and procedures, using the stated review criteria.
As part of the scientific peer review, all applications will:
Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA . Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board
The following will be considered in making funding decisions:
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH Grants
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be
subject to the DUNS, CCR Registration, and Transparency Act requirements as
noted on the Award
Conditions and Information for NIH Grants website.
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NGA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.
Cooperative Agreement Terms and Conditions of Award
When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.FSRS.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
eRA Commons Help Desk(Questions regarding eRA Commons
registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
Marcia Scott, Ph.D.
National Institute on Alcohol Abuse and Alcoholism(NIAAA)
Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).
Judy Fox, GMO
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.
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