Skip to Content

We invite you to try out our new beta eCFR site at https://ecfr.federalregister.gov. We’ve made big changes to make the eCFR easier to use. Be sure to leave feedback using the 'Help' button on the bottom right of each page!

Notice

Proposed Data Collection Submitted for Public Comment and Recommendations

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 including its time on Public Inspection. 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

AGENCY:

Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).

ACTION:

Notice with comment period.

SUMMARY:

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Possession, Use, and Transfer of Select Agents and Toxins (42 CFR part 73). This information collection intends to support the Public Health Safety and Bioterrorism Preparedness and Response Act of 2002 and ensure select agents or toxins are managed appropriately to prevent any threats to human health or safety. Data will be used to fulfill the requirements promulgated by HHS under this part and also subject to corresponding regulations promulgated by USDA.

DATES:

CDC must receive written comments on or before June 2, 2020.

ADDRESSES:

You may submit comments, identified by Docket No. CDC-20-0034 by any of the following methods:

  • Federal eRulemaking Portal: Regulations.gov. Follow the instructions for submitting comments.
  • Mail: Jeffrey M. Zirger, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road, NE, MS-D74, Atlanta, Georgia 30329.

Instructions: All submissions received must include the agency name and Docket Number. CDC will post, without change, all relevant comments to Regulations.gov.

Please note: Submit all comments through the Federal eRulemaking portal (regulations.gov) or by U.S. mail to the address listed above.

Start Further Info

FOR FURTHER INFORMATION CONTACT:

To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact Jeffrey M. Zirger, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: omb@cdc.gov.

End Further Info End Preamble Start Supplemental Information

SUPPLEMENTARY INFORMATION:

Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each Start Printed Page 18981collection of information they conduct or sponsor. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to the OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below.

The OMB is particularly interested in comments that will help:

1. 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;

2. Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

3. Enhance the quality, utility, and clarity of the information to be collected; and

4. 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 submissions of responses.

5. Assess information collection costs.

Proposed Project

Possession, Use, and Transfer of Select Agents and Toxins (OMB Control No. 0920-0576)—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 transfer 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 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 https://www.selectagents.gov/​annualreport2018.html or FSAP IT system and is estimated as 4465 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)Total burden hours
Sections 3 & 4Request for Exclusions1111
Sections 5 & 6Report of Identification of a Select Agent or Toxin1,181111,181
Sections 5 & 6Request of Exemption1111
Start Printed Page 18982
Section 7Application for Registration31515
Section 7Amendment to a Certificate of Registration253511,265
Section 9Documentation of self-inspection25311253
Section 10Request for Expedited Review110.51
Section 11Security Plan25311253
Section 12Biosafety Plan25311253
Section 13Request Regarding a Restricted Experiment1122
Section 14Incident Response Plan25311253
Section 15Training25311252
Section 16Request to Transfer Select Agents and Toxins25311.5380
Section 17Records25310.5127
Section 19Notification of Theft, Loss, or Release20111201
Section 20Administrative Review281128
Total4465
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 Supplemental Information

[FR Doc. 2020-06948 Filed 4-2-20; 8:45 am]

BILLING CODE 4163-18-P