Expired forms available on this website can be used because the revision application package is currently under review by Office of Management & Budget.

An entity will complete APHIS/CDC Form 1 to apply to possess, use, or transfer select agents and toxins (as described in 7 CFR 331, 9 CFR 121, and 42 CFR 73). Information requested in this form includes: facility information, a list of select agents and/or toxins to be possessed, used, or transferred by the entity, a list of individuals who will have access, or potential access, to select agents and toxins, and information about the work to be performed. For details on how to submit your application and additional information about registering with the Federal Select Agent Program, see Form 1 FAQs. For assistance, contact lrsat@cdc.gov or AgSAS@aphis.usda.gov.

The APHIS/CDC Form 1 is also used to amend an approved registration. To amend an approved certificate of registration, an entity must submit a letter to the Federal Select Agent Program requesting the changes to be made to its registration and updated sections of the APHIS/CDC Form 1 pertinent to the changes requested. Guidance/instructions are provided with the form.

APHIS/CDC Form 1

(expiration date 12/31/2018)

For assistance in the completion of APHIS/CDC Form 1, refer to the Instructions for the Completion of APHIS/CDC Form 1 below. This document provides detailed information and directions to applicants and registered entities on how to complete each section of APHIS/CDC Form 1 and on the submission of registration amendments.

The section of the form or attachment to be completed must be downloaded and saved before information is added. Ensure that you have Adobe Acrobat 11 before downloading the form. The APHIS/CDC Form 1 HELP (Functionality) below describes features of the fillable PDF form and Excel spreadsheets and provides technical help. Contact your file manager or lrsat@cdc.gov or AgSAS@aphis.usda.gov for further assistance.

All fillable form sections and attachments were validated using the following computer operating system/web browser/software combinations:

• Windows XP / Internet Explorer 8
• Windows 7 / Internet Explorer 8 / Internet Explorer 9
• Adobe Reader XI (11)

Instructions for the Completion of APHIS/CDC Form 1

APHIS/CDC Form 1 HELP (Functionality)

APHIS/CDC Form 1 Sections and Attachments

Section 1A and B - Entity Information and Certification of Responsibility
Section 1C - Entity Abstract
Section 2 - RO Certification of Personnel and Facility Activities
Section 3 - Select Agents and Toxins
Section 4A - Laboratorians and Animal Care Staff
Section 4B - Support Staff
Section 4C - Unescorted Visitors
Section 5 (A, B, C)
Section 5A - Entity-Wide Security Assessment and Incident Response
Section 5B - Entity-Wide Biosafety/Biocontainment
Section 5C - Entity Requirements for Federal Select Agent Program Inspectors
Section 6A - Building and Suite/Room Specific Security
Section 6B - Suite/Room Physical Information
Section 7 (A, B, C)
Section 7A - Principal Investigator (PI) Information and Select Agent and Toxin Locations
Section 7B - Strain or Serotype Designation Information
Section 7C - Description of Work
Attachment A - Work with Toxins
Attachment B - Work with Regulated Nucleic Acids, Genetic Modification of Select Agents or Toxins, Recombinant/Synthetic Nucleic Acids or Recombinant/Synthetic Organisms
Attachment C - Work with Animals
Attachment D - Work with Plants
Attachment E - Work with Arthropods
Attachment F - BSL3Ag Laboratories
Attachment G - BSL4/ABSL4 Laboratories