Skip to Content


Agency Forms Undergoing Paperwork Reduction Act Review

Document Details

Information about this document as published in the Federal Register.

Document Statistics
Document page views are updated periodically throughout the day and are cumulative counts for this document. Counts are subject to sampling, reprocessing and revision (up or down) throughout the day.
Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Start Preamble

In accordance with the Paperwork Reduction Act of 1995, the Centers for Disease Control and Prevention (CDC) has submitted the information collection request titled Possession, Use, and Transfer of Select Agents and Toxins to the Office of Management and Budget (OMB) for review and approval. CDC previously published a “Proposed Data Collection Submitted for Public Comment and Recommendations” notice on April 3, 2020 to obtain comments from the public and affected agencies. CDC received one comment related to the previous notice. This notice serves to allow an additional 30 days for public and affected agency comments.

CDC will accept all comments for this proposed information collection project. The Office of Management and Budget is particularly interested in comments that:

(a) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

(b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

(c) Enhance the quality, utility, and clarity of the information to be collected;

(d) Minimize the burden of the collection of information on those who are to respond, including, through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses; and

(e) Assess information collection costs.

To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639-7570. Comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to​public/​do/​PRAMain Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function. Direct written comments and/or suggestions regarding the items contained in this notice to the Attention: CDC Desk Officer, Office of Management and Budget, 725 17th Street NW, Washington, DC 20503 or by fax to (202) 395-5806. Provide written comments within 30 days of notice publication.

Proposed Project

Possession, Use, and Transfer of Select Agents and Toxins (OMB Control No. 0920-0576, Exp. 10/31/2020)—Revision—Center for Preparedness and Response (CPR), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

Subtitle A of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, (42 U.S.C. 262a), requires the United States Department of Health and Human Services (HHS) to regulate the possession, use, and transfer of biological agents or toxins that have the potential to pose a severe threat to public health and safety (select agents and toxins). Subtitle B of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (which may be cited as the Agricultural Bioterrorism Protection Act of 2002), (7 U.S.C. 8401), requires the United States Department of Agriculture (USDA) to regulate the possession, use, and Start Printed Page 43845transfer of biological agents or toxins that have the potential to pose a severe threat to animal or plant health, or animal or plant products (select agents and toxins). Accordingly, HHS and USDA have promulgated regulations requiring individuals or entities that possess, use, or transfer select agents and toxins to register with the CDC or the Animal and Plant Health Inspection Service (APHIS). See 42 CFR part 73, 7 CFR part 331, and 9 CFR part 121 (the select agent regulations). The Federal Select Agent Program (FSAP) is the collaboration of the CDC, Division of Select Agents and Toxins (DSAT) and the APHIS Agriculture Select Agent Services (AgSAS) to administer the select agent regulations in a manner to minimize the administrative burden on persons subject to the select agent regulations. The FSAP administers the select agents regulations in close coordination with the Federal Bureau of Investigation's Criminal Justice Information Services (CJIS). Accordingly, CDC and APHIS have adopted an identical system to collect information for the possession, use, and transfer of select agents and toxins.

CDC is requesting OMB approval to continue to collect information under the select agent regulations through the use of five forms: (1) Application for Registration for Possession. Use, and Transfer of Select Agents and Toxins (APHIS/CDC Form 1); (2) Request to Transfer Select Agents or Toxins (APHIS/CDC Form 2); (3) Incident Notification and Reporting (Theft, Loss, or Release) (APHIS/CDC Form 3); (4) Reporting the Identification of a Select Agent or Toxin (APHIS/CDC Form (4); and (5) Request for Exemption of Select Agents and Toxins for an Investigational Product (APHIS/CDC Form 5).

An entity may amend its registration (42 CFR 73.7(h)(1)) if any changes occur to the information previously submitted to CDC. When applying for an amendment to a certificate of registration, an entity would complete the relevant portion of the application package (APHIS/CDC Form 1).

Besides the forms listed above, there is no standard form for the following information:

1. An individual or entity may request an exclusion from the requirements of the select agent regulations of an attenuated strain of a select agent or a select toxin modified to be less potent or toxic. (42 CFR 73.3(e) and 73.4(e)).

2. Annual inspections that are conducted by the entity must be documented. (42 CFR 73.9(a)(6)).

3. An individual's security risk assessment may be expedited upon written request by a Responsible Official and a showing of good cause. (42 CFR 73.10(f)).

4. An individual or entity may request approval to perform a “restricted experiment” (42 CFR 73.13).

5. An individual or entity must develop and implement a written security plan, biosafety plan, and incident response plan (42 CFR 73.11(a), 42 CFR 73.12(a), and 42 CFR 73.14(a)).

6. The Responsible Official at the entity must ensure a record of the training for each individual with access to select agents and toxins and each escorted individual is maintained (42 CFR 73.15(d)).

7. An individual or entity may appeal a denial, revocation, or suspension of registration. (42 CFR 73.20(a)).

8. An individual may appeal a denial, limitation, or revocation of access approval. (42 CFR 73.20(b)).

The total estimated annualized burden for all data collection was calculated using the 2018 Annual Report of the Federal Select Agent Program available at​annualreport2018.html or FSAP IT system and is estimated as 4467 hours. Information will be collected through FSAP IT system, fax, email and hard copy mail from respondents. Upon OMB approval, CDC will begin use of the revised forms in October 2020 through October 2023. There is no cost to the respondents.

Estimated Annualized Burden Hours

SectionForm nameNumber of respondentsNumber of responses per respondentAverage burden per response (in hours)
Sections 3 & 4Request for Exclusions111
Sections 5 & 6Report of Identification of a Select Agent or Toxin1,18111
Sections 5 & 6Request of Exemption111
Section 7Application for Registration315
Section 7Amendment to a Certificate of Registration25351
Section 9Documentation of self-inspection25311
Section 10Request for Expedited Review110.5
Section 11Security Plan25311
Section 12Biosafety Plan25311
Section 13Request Regarding a Restricted Experiment112
Section 14Incident Response Plan25311
Section 15Training25311
Section 16Request to Transfer Select Agents and Toxins25311.5
Section 17Records25310.5
Section 19Notification of Theft, Loss, or Release20111
Section 20Administrative Review2811
Start Signature

Jeffrey M. Zirger,

Lead, Information Collection Review Office, Office of Scientific Integrity, Office of Science, Centers for Disease Control and Prevention.

End Signature End Preamble

[FR Doc. 2020-15655 Filed 7-17-20; 8:45 am]