UNITED STATES DEPARTMENT OF AGRICULTURE OMB Approval 0524-0039

> COOPERATIVE STATE RESEARCH, EDUCATION, AND EXTENSION SERVICE Expires
> 03/31/2005

######### ASSURANCE STATEMENT(S) -- FOR RESEARCH PROJECTS

  --------------------------------- -- -----------------------------------
  STATEMENT OF POLICY -                Representative (AOR) that
  Institutions receiving CSREES        appropriate committees in each
  funding for research are             institution have carried out the
  responsible for protecting human     initial reviews of protocol and
  subjects, providing humane           will conduct continuing reviews of
  treatment of animals, and            supported projects. CSREES also
  monitoring use of recombinant        requires AOR certification by
  DNA. To provide for the adequate     citing a timely date that an
  discharge of this responsibility,    appropriate committee issued an
  CSREES policy requires an            approval or exemption.
  assurance by the institution's       
  Authorized Organizational            

  --------------------------------- -- -----------------------------------

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+---------------------------------+----------------+------------------+
| NOTE: Check appropriate         |                |                  |
| statements, supplying           |                |                  |
| additional information when     |                |                  |
| necessary.                      |                |                  |
+---------------------------------+----------------+------------------+
| 1\. INSTITUTION                 | 2\. CSREES     |                  |
|                                 | PROJECT NUMBER |                  |
|                                 | OR             |                  |
|                                 |                |                  |
|                                 | AWARD NUMBER   |                  |
|                                 | (if known)     |                  |
+---------------------------------+----------------+------------------+
|                                 | 3\. PROJECT    |                  |
|                                 | DIRECTOR(S)    |                  |
+---------------------------------+----------------+------------------+
| 4\. TITLE OF PROJECT            |                |                  |
+---------------------------------+----------------+------------------+
| A. 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      |                |                  |
| Institutes of Health (NIH),     |                |                  |
| DHHS [Guidelines for Research   |                |                  |
| Involving Recombinant DNA       |                |                  |
| Molecules]{.underline}, as      |                |                  |
| revised.                        |                |                  |
+---------------------------------+----------------+------------------+
| B. CARE AND USE OF ANIMALS      |                |                  |
|                                 |                |                  |
| Project does not involve        |                |                  |
| vertebrate animals.             |                |                  |
|                                 |                |                  |
| > Project involves 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  |                |                  |
| USC, 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]{.underline},          |                |                  |
| Federation of Animal Science    |                |                  |
| Societies, 1999.                |                |                  |
+---------------------------------+----------------+------------------+
| C. PROTECTION OF HUMAN SUBJECTS |                |                  |
|                                 |                |                  |
| Project does not involve human  |                |                  |
| subjects.                       |                |                  |
|                                 |                |                  |
| > Project involves human        |                |                  |
| > subjects and                  |                |                  |
| >                               |                |                  |
| > Was approved by the           |                |                  |
| > Institutional Review Board    |                |                  |
| > (IRB) on (Date). Performing   |                |                  |
| > Institution holds a           |                |                  |
| > Federalwide assurance         |                |                  |
| >                               |                |                  |
| > number ; if not, a Single     |                |                  |
| > Project Assurance is          |                |                  |
| > required.                     |                |                  |
| >                               |                |                  |
| > 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            |                |                  |
| > CSREES-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,    |                |                  |
| 1991, as amended, and USDA      |                |                  |
| regulations set forth in 7 CFR  |                |                  |
| 1c, 1992. All nonexempt         |                |                  |
| research involving human        |                |                  |
| subjects must be approved and   |                |                  |
| under continuing review by an   |                |                  |
| IRB. If the performing          |                |                  |
| organization submits a Single   |                |                  |
| Project Assurance, supplemental |                |                  |
| information describing          |                |                  |
| procedures to protect subjects  |                |                  |
| from risks is required.         |                |                  |
+---------------------------------+----------------+------------------+
| SIGNATURE OF AUTHORIZED         | TITLE          | DATE             |
| ORGANIZATIONAL REPRESENTATIVE   |                |                  |
+---------------------------------+----------------+------------------+

According to the Paperwork Reduction Act of 1995, an agency may not
conduct or sponsor, and a person is not required to respond to a
collection of information unless it displays a valid OMB control number.
The valid OMB control number for this information collection is
0524‑0039. The time required to complete this information collection is
estimated to average .50 hour per response, including the time for
reviewing instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing the collection
of information.

**CSREES-2008 (12/02/00)**