NIFA Application Kit

OMB Number: 0524-0039

Expiration Date: XX/XX/202X

UNITED STATES DEPARTMENT OF AGRICULTURE

NATIONAL INSTITUTE OF FOOD AND AGRICULTURE

Assurance Statement(s)

STATEMENT OF POLICY - Institutions receiving NIFA funding for research. Institution’s Authorized Organizational Representative (AOR) that appropriate are responsible for protecting human subjects, providing humane treatment of committees in each institution have carried out the initial review of protocols animals, and monitoring use of recombinant DNA. To provide for the adequate and will conduct continuing reviews of supported projects. Discharge of this responsibility, NIFA policy requires an assurance.

NOTE: Check appropriate statements, supplying additional information when necessary.

1. INSTITUTION	2. NIFA PROJECT NUMBER OR AWARD NUMBER (if known)
	3. PROJECT DIRECTOR(S)

4. TITLE OF PROJECT

1. BIOSAFETY OF RECOMBINANT DNA

☐Project does not involve recombinant DNA.

☐Project involves recombinant DNA and was either approved ( ) or determined to be exempt ( ) from the NIH Guidelines by an Institutional Biosafety Committee (IBC) on ______________ (Date).

This performing organization agrees to assume primary responsibility for complying with both the intent and procedures of the National Institute of Health (NIH), DHHS Guidelines for Research Involving Recombinant DNA Molecules, as revised. A link to the guidelines can be found at: https://osp.od.nih.gov/wp-content/uploads/NIH_Guidelines.pdf.

2. CARE AND USE OF ANIMALS

☐ Project does not involve use of vertebrate animals.

☐ Project involves use of vertebrate animals and was approved by the Institutional Animal Care and Use Committee (IACUC) on _______________ (Date).

This performing organization agrees to assume primary responsibility for complying with the Animal Welfare Act (7 U.S.C. 2131-2156), Public Law 89-544, 1996, as amended, and the regulations promulgated thereunder by the Secretary of Agriculture in 9 CFR Parts, 1, 2, 3, and 4. In the case of domesticated farm animals housed under farm conditions, the institution shall adhere to the principles stated in the Guide for the Care and Use of Agricultural Animals in Agricultural Research and Teaching, Federation of Animal Science Societies, 1999.

3. PROTECTION OF HUMAN SUBJECTS

☐Project does not involve use of human subjects.

☐Project involves use of human subjects and

☐Was approved by the Institutional Review Board (IRB) on _______________ (Date). Performing Institutional holds a Federal wide assurance number _______________.

☐Is exempt based on exemption number _______________.

☐Specific plans involving human subjects depend upon completion of survey instruments, prior animal studies, or development of material or procedures. No human subjects will be involved in research until approved by the IRB and a revised Form NIFA-2008 is submitted.

This performing organization agrees to assume primary responsibility for complying with the Federal Policy for Protection of Human Subjects as set forth in 45 CFR Part 46, as amended, and USDA regulations set forth in 7 CFR 1c. All nonexempt research involving human subjects must be approved and under continuing review by an IRB.

Public reporting for collection of information is estimated to average XX minutes, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information, unless it displays a current valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to NIFA, OGFM, 2312 East Bannister Road, Mail Stop 10,000, Kansas City, MO 64131, Attention Policy Section. Do not return the completed form to this address. National Institute of Food and Agriculture US Department of Agriculture OMB No. 0524-0039 Form Approved For Use Through XX/XX/XXXX