2.35—Recordkeeping requirements.
(1)
Minutes of IACUC meetings, including records of attendance, activities of the Committee, and Committee deliberations;
(2)
Records of proposed activities involving animals and proposed significant changes in activities involving animals, and whether IACUC approval was given or withheld; and
(3)
Records of semiannual IACUC reports and recommendations (including minority views), prepared in accordance with the requirements of § 2.31(c)(3) of this subpart, and forwarded to the Institutional Official.
(b)
Every research facility shall make, keep, and maintain records or forms which fully and correctly disclose the following information concerning each live dog or cat purchased or otherwise acquired, owned, held, or otherwise in their possession or under their control, transported, euthanized, sold, or otherwise disposed of by the research facility. The records shall include any offspring born of any animal while in the research facility's possession or under its control:
(1)
The name and address of the person from whom a dog or cat was purchased or otherwise acquired, whether or not the person is required to be licensed or registered under the Act;
(2)
The USDA license or registration number of the person if he or she is licensed or registered under the Act;
(3)
The vehicle license number and State, and the driver's license number (or photographic identification card for nondrivers issued by a State) and State of the person, if he or she is not licensed or registered under the Act;
(5)
The official USDA tag number or tattoo assigned to each dog or cat under § 2.38(g) of this subpart;
(8)
If dogs or cats are acquired from any person not licensed or registered under the Act and not a pound or shelter, the research facility must obtain a certification that the animals were born and raised on the person's premises and that the person has sold fewer than 25 dogs and/or cats that year.
(c)
In addition to the information required to be kept and maintained by every research facility concerning each live dog or cat under paragraph (a) of this section, every research facility transporting, selling, or otherwise disposing of any live dog or cat to another person, shall make and maintain records or forms which fully and correctly disclose the following information:
(1)
The name and address of the person to whom a live dog or cat is transported, sold, or otherwise disposed of;
(3)
The method of transportation, including the name of the initial carrier or intermediate handler, or if a privately owned vehicle is used to transport the dog or cat, the name of the owner of the privately owned vehicle.
(d)
(1)
The USDA Interstate and International Certificate of Health Examination for Small Animals (APHIS Form 7001) and Record of Aquisition and Dogs and Cats on Hand (APHIS Form 7005) are forms which may be used by research facilities to keep and maintain the information required by paragraph (b) of this section.
(2)
The USDA Interstate and International Certificate of Health Examination for Small Animals (APHIS Form 7001) and Record of Disposition of Dogs and Cats (APHIS Form 7006) are forms which may be used by research facilities to keep and maintain the information required by paragraph (c) of this section.
(e)
One copy of the record containing the information required by paragraphs (b) and (c) of this section shall accompany each shipment of any live dog or cat sold or otherwise disposed of by a research facility; Provided, however, That, except as provided in § 2.133 of this part, information that indicates the source and date of acquisition of any dog or cat need not appear on the copy of the record accompanying the shipment. One copy of the record containing the information required by paragraphs (b) and (c) of this section shall be retained by the research facility.
(f)
All records and reports shall be maintained for at least three years. Records that relate directly to proposed activities and proposed significant changes in ongoing activities reviewed and approved by the IACUC shall be maintained for the duration of the activity and for an additional three years after completion of the activity. All records shall be available for inspection and copying by authorized APHIS or funding Federal agency representatives at reasonable times. APHIS inspectors will maintain the confidentiality of the information and will not remove the materials from the research facilities' premises unless there has been an alleged violation, they are needed to investigate a possible violation, or for other enforcement purposes. Release of any such materials, including reports, summaries, and photographs that contain trade secrets or commercial or financial information that is privileged or confidential will be governed by applicable sections of the Freedom of Information Act. Whenever the Administrator notifies a research facility in writing that specified records shall be retained pending completion of an investigation or proceeding under the Act, the research facility shall hold those records until their disposition is authorized in writing by the Administrator.
(Approved by the Office of Management and Budget under control number 0579-0254)