88 FR 156 pgs. 55457-55459 - Proposed Data Collection Submitted for Public Comment and Recommendations
Type: NOTICEVolume: 88Number: 156Pages: 55457 - 55459
Pages: 55457, 55458, 55459Docket number: [60Day-23-0576; Docket No. CDC-2023-0061]
FR document: [FR Doc. 2023-17483 Filed 8-14-23; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Centers for Disease Control and Prevention
Official PDF Version: PDF Version
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-23-0576; Docket No. CDC-2023-0061]
Proposed Data Collection Submitted for Public Comment and Recommendations
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. This data collection allows CDC to continue to collect information and ensure compliance under the Select Agent regulations.
DATES:
CDC must receive written comments on or before October 16, 2023.
ADDRESSES:
You may submit comments, identified by Docket No. CDC-2023-0061 by either of the following methods:
• Federal eRulemaking Portal: www.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 H21-8, Atlanta, Georgia 30329.
Instructions: All submissions received must include the agency name and Docket Number. CDC will post, without change, all relevant comments to www.regulations.gov.
Please note: Submit all comments through the Federal eRulemaking portal ( www.regulations.gov ) or by U.S. mail to the address listed above.
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 H21-8, Atlanta, Georgia 30329; Telephone: 404-639-7570; Email: omb@cdc.gov.
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 collection 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;
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; and
5. Assess information collection costs.
Proposed Project
Possession, Use, and Transfer of Select Agents and Toxins (42 CFR 73) (OMB Control No. 0920-0576, Exp. 1/31/2024)-Extension-Office of Readiness and Response (ORR), Centers for Disease Control and Prevention (CDC).
Background and Brief Description
[top] 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
CDC is requesting OMB approval to continue to collect information under the select agent regulations through the use of five forms:
• Application for Registration for Possession. Use, and Transfer of Select Agents and Toxins (APHIS/CDC Form 1) with an addendum form: Form 1 Sec 6A-Amendment to a Certificate of Registration.
• Request to Transfer Select Agents or Toxins (APHIS/CDC Form 2).
• Incident Notification and Reporting (Theft, Loss, or Release) (APHIS/CDC Form 3).
• Reporting the Identification of a Select Agent or Toxin (APHIS/CDC Form 4).
• Request for Exemption of Select Agents and Toxins for an Investigational Product (APHIS/CDC Form 5).
In addition to the forms listed above, the following forms will also be used:
• Request for Exclusions-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)).
• Documentation of self-inspection-Annual inspections that are conducted by the entity must be documented. (42 CFR 73.9(a)(6)).
• Request for Expedited Review-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)).
• Request Regarding a Restricted Experiment-An individual or entity may request approval to perform a "restricted experiment" (42 CFR 73.13).
• Security Plan-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)).
• Training-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)).
• Administrative Review-An individual or entity may appeal a denial, revocation, or suspension of registration. (42 CFR 73.20(a)).
• Biosafety Plan-An individual or entity required to register under this part must develop and implement a written biosafety plan that is commensurate with the risk of the select agent or toxin, given its intended use. The biosafety plan must contain sufficient information and documentation to describe the biosafety and containment procedures for the select agent or toxin, including any animals (including arthropods) or plants intentionally or accidentally exposed to or infected with a select agent (42 CFR 73.12(a)).
• Incident Response Plan-An individual or entity required to register under this part must develop and implement a written incident response plan based upon a site specific risk assessment. The incident response plan must be coordinated with any entity-wide plans, kept in the workplace, and available to employees for review (42 CFR 73.14 (a)).
• Records-An individual or entity required to register under this part must maintain complete records relating to the activities covered by the select agent regulations (42 CFR 73.17 (a)).
The total estimated annualized burden for all data collection was calculated using the 2021 Annual Report of the Federal Select Agent Program available at https://www.selectagents.gov/resources/publications/annualreport/2021.htm or FSAP IT system and is estimated as 3,539 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 January 2024 through January 2027. There is no cost to the respondents.
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| Section | Form name | Number of respondents | Number of responses per respondent | Average burden per response (in hours) | Total burden hours |
|---|---|---|---|---|---|
| Sections 3 & 4 | Request for Exclusions | 1 | 1 | 1 | 1 |
| Sections 5 & 6 | Form 4-Report of Identification of a Select Agent or Toxin | 917 | 1 | 1 | 917 |
| Sections 5 & 6 | Form 5-Request of Exemption | 1 | 1 | 1 | 1 |
| Section 7 | Form 1-Application for Registration | 5 | 1 | 5 | 25 |
| Section 7 | Form 1 Sec 6A-Amendment to a Certificate of Registration | 144 | 5 | 1 | 720 |
| Section 9 | Documentation of self-inspection | 233 | 1 | 1 | 233 |
| Section 10 | Request for Expedited Review | 1 | 1 | 30/60 | 1 |
| Section 11 | Security Plan | 233 | 1 | 1 | 233 |
| Section 12 | Biosafety Plan | 233 | 1 | 1 | 233 |
| Section 13 | Request Regarding a Restricted Experiment | 3 | 1 | 2 | 6 |
| Section 14 | Incident Response Plan | 233 | 1 | 1 | 233 |
| Section 15 | Training | 233 | 1 | 1 | 233 |
| Section 16 | Form 2-Request to Transfer Select Agents and Toxins | 229 | 1 | 1.5 | 380 |
| Section 17 | Records | 233 | 1 | 30/60 | 117 |
| Section 19 | Form 3-Notification of Theft, Loss, or Release | 185 | 1 | 1 | 185 |
| Section 20 | Administrative Review | 22 | 1 | 1 | 22 |
| Total | 3539 |
Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Public Health Ethics and Regulations, Office of Science, Centers for Disease Control and Prevention.
[FR Doc. 2023-17483 Filed 8-14-23; 8:45 am]
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