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Note: list common names for animal species, e. The training or instruction available to scientists, animal technicians, and other personnel involved in animal care, treatment, or use is as follows:. Describe training or instruction on research or testing methods that minimize the number of animals required to obtain valid results and limit animal pain and distress.

Describe training or orientation provided to the IACUC members, including background materials and resources. Any departures from the Guide will be identified specifically and reasons for each departure will be stated. Reports will distinguish significant deficiencies from minor deficiencies. Where program or facility deficiencies are noted, reports will contain a reasonable and specific plan and schedule for correcting each deficiency.

This Institution will maintain for at least 3 years:. A copy of this Assurance and any modifications made to it, as approved by the PHS. Minutes of IACUC meetings, including records of attendance, activities of the committee, and committee deliberations. Records of applications, proposals, and proposed significant changes in the care and use of animals and whether IACUC approval was granted or withheld. Records of semiannual IACUC reports and recommendations including minority views as forwarded to the Institutional Official, [ Insert name or title of the Institutional Official signing the Assurance ].

Records of accrediting body determinations. This Institution will maintain records that relate directly to applications, proposals, and proposed changes in ongoing activities reviewed and approved by the IACUC for the duration of the activity and for an additional 3 years after completion of the activity.

All records shall be accessible for inspection and copying by authorized OLAW or other PHS representatives at reasonable times and in a reasonable manner. The Institutional reporting period is the calendar year January 1 December The annual report will include:. Any change in the accreditation status of the Institution e. Any change in the description of the Institution's program for animal care and use as described in this Assurance. Notification of the dates that the IACUC conducted its semiannual evaluations of the Institution's program and facilities including satellite facilities and submitted the evaluations to the Institutional Official, [ Insert name or title of the Institutional Official signing the Assurance ].

Any serious or continuing noncompliance with the PHS Policy. Any serious deviations from the provisions of the Guide. Reports filed under VI. Authorized Institutional Official.

Name of Institution:. Address: street, city, state, country, postal code. Acting officially in an authorized capacity on behalf of this Institution and with an understanding of the Institution s responsibilities under this Assurance, I assure the humane care and use of animals as specified above. National Institutes of Health. Assurance Number:. Effective Date:. Expiration Date:. Sufficient information to determine that all appointees are appropriately qualified must be provided and the identity of each member must be readily ascertainable by the institution and available to authorized OLAW or other PHS representatives upon request.

This member is expected to represent general community interests in the proper care and use of animals and should not be a laboratory animal user. A consulting veterinarian may not be considered nonaffiliated. Non-voting members and alternate members must be so identified. If there are other individuals within the Institution who may be contacted regarding this Assurance, please provide information below. Contact 1. Contact 2. Gross Square Feet [ include service areas ].

Species Housed [ use common names, e. Approximate Average Daily Inventory. However, the name and location must be provided to OLAW upon request. The Domestic Assurance should not be used by: Foreign institutions Institutions that currently do not have their own animal care and use programs Institutions that are proposing animal activity to be conducted solely at a collaborating institution If one of these bullets describes your institution or if you don t know whether your institution is required to submit an Assurance, contact us at olawdoa mail.

How to use the sample document We have provided this sample document to help you develop an acceptable Domestic Assurance. One or two page attachments can be used to provide the following: Organizational structure of the animal care and use program IACUC membership roster Facility and species inventory Most recent semiannual report of program and facilities.

How to submit Fax your completed Assurance to or e-mail to olawdoa mail. Applicability of Assurance This Assurance applies whenever this Institution conducts the following activities: all research, research training, experimentation, biological testing, and related activities involving live vertebrate animals supported by the PHS.

The following are branches and components over which this Institution has legal authority, included are those that operate under a different name: [ List every branch and major component covered by the Assurance.

Express Service - a carrier that provides delivery services by a specified date and time. Freight - property or any package that exceeds the shipping standards for small packages, that is moving via a carrier, usually in large quantities or volumes.

Government Bill of Lading - the Government version of the bill of lading contract. The Federal Property Management Regulations require that Government agencies use this form because its use automatically incorporates various negotiated Government wide discounts special tariffs with carriers.

Pathogens are defined as microorganisms or recombinant microorganisms that are known or reasonably expected to cause infectious disease in humans or animals when exposure to them occurs. UN , infectious substances affecting humans UN , infectious substances affecting animals Category B — infectious substances that are infectious, but do not meet the criteria for Category A.

Messenger Service - local courier services. Office Move - local or on-site movement of Government property between Government locations. Requester - the Individual who requires shipping services. Shipper - the office or individual responsible for arranging transportation services, preparation of transportation contract documents, and processing of property for shipment. Shipping Supervisor — the supervisory transportation specialist at each NIH location. Ship To - the designated location for delivery of a shipment.

Transportation Officer - the individual responsible for the overall operation of the Shipping Activities at an agency. Government agencies use this form because its use automatically incorporates various negotiated Government wide discounts special tariffs with carriers. Requester — the Institute or Center IC customer individual requiring shipping services who is responsible for completing the NIH Form , "Request for Shipment" with the required signatures.

Administrative Officer — responsible for ensuring the correct common accounting number CAN for the shipping customer is cited on the NIH for funding purposes. Shipping Authority. Report of shipping activity will be provided as required by the Director, DLS. Personal Property Requirements Government property. Request for Shipment. Requesters will complete a NIH form for each package. Packages cannot be accepted without a completed NIH or other supporting documents that may be required for the shipment.

Package Receiving Times. Packages requiring same-day delivery at destination must be received at FFS no later than a. Walk-in packages received before p. To request package pick-up call FFS at FFS must be contacted before p.

Packages received for shipping after the shipping times as stated above will be processed for outbound shipment on the next business day. For shipments of non-hazardous material weighing more than 75 pounds, the Requester should call a local BPA courier to arrange for pick-up service. Requesters must label all packages with both return and destination addresses. Complete addresses including name, building and room number, street address, zip code and phone number facilitates accurate and swift deliveries.

Post Office PO Box numbers are not acceptable. Shipments with Special Requirements. Biological Materials: Materials known or presumed to contain a viable microorganism or its toxin that causes or may cause human disease are subject to additional packaging and shipping requirements. When shipping by air, requesters must assure that packaging is tested and marked according to the United Nations performance standards.

Specific to this FOA: Does the project describe an adequate plan for the conduct of an open and competitive solicitation for subcontractor s who will analyze the samples for immune markers? 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 score, but will not give separate scores for these items.

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 Guidelines for the Review of Human Subjects. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research. The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: 1 description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; 2 justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; 3 interventions to minimize discomfort, distress, pain and injury; and 4 justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals.

Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

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 score. 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.

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 NIDDK, in accordance with NIH peer review policy and procedures , using the stated review criteria.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. The following will be considered in making funding decisions:. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date. A formal notification in the form of a Notice of Award NoA will be provided to the applicant organization for successful applications.

Awardees must comply with any funding restrictions described in Section IV. 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.

This includes any recent legislation and policy applicable to awards that is highlighted on this website. Recipients of federal financial assistance FFA from HHS must administer their programs in compliance with federal civil rights law.

This includes ensuring your programs are accessible to persons with limited English proficiency. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations.

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.

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U. The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism rather than an "acquisition" mechanism , in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities.

Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

Developing the research design and study protocol, including definition of objectives and approaches, sample size and power calculations, and establishing procedures for participant recruitment and follow-up, data collection, quality control, interim data and safety monitoring, final data analysis and interpretation, and publication of results. Establishing a Steering Committee to implement, coordinate and manage the project s. Awardee s will name investigators to serve as members on a Steering Committee and other subcommittees, as appropriate, meeting periodically.

Awardees will be required to accept and implement the common protocol s and procedures approved by the Steering Committee.

Designating Protocol Chairs. The Protocol Chairperson shall function as the scientific coordinator for the protocol and shall assume responsibility for obtaining approval to implement the protocol from the Steering Committee and for developing and monitoring the protocol. Significant modifications to approved protocols must be approved by the Steering Committee. Implementing collection of data specified by the study protocol. Establishing procedures for data quality and completeness.

For research involving multiple sites, a plan for analysis of pooled data will be developed by the Steering Committee. Submitting interim progress reports, when requested or agreed upon by both parties, to the NIDDK Program Official including as a minimum, summary data on protocol performance.

Such reports are in addition to the required annual noncompeting continuation progress report. Reporting of the study findings. Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

The awardee must also be adherent to Study Publication and Presentation Policy. Study investigators are encouraged to publish and to release publicly and disseminate results and other products of the study, in accordance with study protocols and steering committee policies on publications.

Maintaining confidentiality of information: The awardee s will maintain the confidentiality of the information developed by the investigators i. The law requires mandatory registration and results reporting for certain clinical trials of drugs, biologics, and devices. NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:.

Serve as the contact point for all facets of the scientific interaction with the awardee s. For multi-center studies, participate in the Steering Committee that oversees study conduct. Serve as a resource to study investigators with respect to other ongoing NIDDK activities that may be relevant to the study to facilitate compatibility with the NIDDK missions and avoid unnecessary duplication of effort.

Have substantial involvement assisting in the design and coordination of research activities for awardees as elaborated below:. Assisting by providing advice in the management and technical performance of the investigations, coordinating required regulatory clearances for investigational agents used in the study, which are held by NIDDK.

The NIDDK Project Scientist or Project Coordinator may coordinate activities among awardees by assisting in the design, development, and coordination of a common research or clinical protocol and statistical evaluations of data; in the preparation of questionnaires and other data recording forms; and in the publication of results.

Reviewing procedures for assessing data quality and study performance monitoring. In general, to warrant co-authorship, NIDDK staff must have contributed to the following areas: a design of the concepts or experiments being tested; b performance of significant portions of the activity; c participation in analysis and interpretation of study results and d preparation and authorship of pertinent manuscripts. The NIDDK retains, as an option, periodic review of progress by researchers not involved with the study.

Review and approve protocols prior to implementation to insure they are within the scope of peer review, for safety considerations, as required by Federal regulations. The NIDDK Program Official will monitor protocol progress, and may request that a protocol study be closed to accrual for reasons including: a accrual rate insufficient to complete study in a timely fashion; b accrual goals met early; c poor protocol performance; d patient safety and regulatory concerns; e study results that are already conclusive; f low likelihood of showing a benefit of the intervention futility ; and g emergence of new information that diminishes the scientific importance of the study question.

A Steering Committee organized by the study investigator s will be the main governing body of the study. The Steering Committee has primary responsibility to design research activities, establish priorities, develop common protocols and manuals, questionnaires and other data recording forms, establish and maintain quality control among awardees, review progress, monitor patient accrual, coordinate and standardize data management, and cooperate on the publication of results.

Major scientific decisions regarding the core data will be determined by the Steering Committee. The final structure of the Steering Committee and voting procedures will be established at the first meeting. The frequency of Steering Committee meetings will be dictated by a vote of the members of the Steering Committee.

The Chairperson provides leadership to the Committee by conducting the Steering Committee meetings, representing the study group to the External Oversight Committee established by the NIDDK and by interacting closely with the awardees during protocol development and implementation.

A dispute resolution panel will be composed of three members --one selected by the awardee or the Steering Committee, with the NIDDK member not voting , a second member selected by NIDDK, and the third member elected by the two prior selected members. The reporting period for multi-year funded award progress report is the calendar year preceding the anniversary date of the award. A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 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 FY or later.