[Federal Register Volume 81, Number 251 (Friday, December 30, 2016)]
[Notices]
[Pages 96456-96457]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-31739]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-17-0576; Docket No. CDC-2016-0125]


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.

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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 to take this opportunity to comment on proposed and/or 
continuing information collections, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on a proposed 
revision of the CDC information collection project entitled 
``Possession, Use, and Transfer of Select Agents and Toxins.''

DATES: Written comments must be received on or before February 28, 
2017.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2016-
0125 by any of the following methods:
     Federal eRulemaking Portal: Regulations.gov. Follow the 
instructions for submitting comments.
     Mail: Leroy A. Richardson, 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. All relevant comments received will be posted 
without change to Regulations.gov, including any personal information 
provided. For access to the docket to read background documents or 
comments received, go to Regulations.gov.
    Please note: All public comments should be submitted through the 
Federal eRulemaking portal (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 the Information Collection Review Office, 
Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-
D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: [email protected].

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 OMB for approval. To 
comply with this requirement, we are publishing this notice of a 
proposed data collection as described below.
    Comments are invited on: (a) Whether the proposed collection of 
information is necessary for the proper performance of the functions of 
the agency, including whether the information shall have practical 
utility; (b) the accuracy of the agency's estimate of the burden of the 
proposed collection of information; (c) ways to enhance the quality, 
utility, and clarity of the information to be

[[Page 96457]]

collected; (d) ways to minimize the burden of the collection of 
information on respondents, including through the use of automated 
collection techniques or other forms of information technology; and (e) 
estimates of capital or start-up costs and costs of operation, 
maintenance, and purchase of services to provide information. Burden is 
the total time, effort, or financial resources expended by persons to 
generate, maintain, retain, disclose, or provide information to or for 
a Federal agency. This includes the time needed to review instructions; 
to develop, acquire, install and utilize technology and systems for the 
purpose of collecting, validating and verifying information, processing 
and maintaining information, and disclosing and providing information; 
to train personnel to respond to a collection of information, search 
data sources, and complete and review the collection of information; 
and to transmit or otherwise disclose the information.

Proposed Project

    Possession, Use, and Transfer of Select Agents and Toxins (42 CFR 
73) (OMB Control No. 0920-0576, exp. 12/31/2018)--Revision--Office of 
Public Health Preparedness and Response (OPHPR), 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). The HHS Secretary delegated the responsibility for 
promulgating and implementing select agent regulations found at 42 CFR 
part 73 to CDC Division of Select Agents and Toxins (DSAT). The Animal 
and Plant Health Inspection Service (APHIS)/Agriculture Select Agent 
Services (AgSAS) was delegated responsibility by USDA for select agent 
regulations (7 CFR part 331, and 9 CFR part 121). The Federal Select 
Agent Program (FSAP) is the collaboration of the DSAT and AgSAS to 
administer the select agent regulations in a manner to minimize the 
administrative burden on persons subject to the select agent 
regulations. 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 revise the collected information 
under the select agent regulations through the use of the APHIS/CDC 
Form 3 (Report of Theft, Loss, or Release of Select Agents and Toxins). 
The Report of Theft, Loss, or Release of Select Agent and Toxin form 
(42 CFR 73.19(a),(b)) must be completed by an individual or an entity 
whenever the individual or entity experiences a theft, loss, or release 
of a select agent or toxin.
    CDC is proposing to revise the form to further clarify what needs 
to be reported as a ``release'' and ``loss'' and additional fields to 
assist with categorizing the type of release (e.g., spill within 
secondary containment, occupational exposure, possible breach of 
facility containment, etc.), type of exposure, and the understanding of 
safety and security risk levels relative to human illness. Estimated 
average time to complete this form is one hour.
    The total estimated annualized burden for this collection was 
calculated using data obtained from the FSAP database and is estimated 
as 430 hours. Information will be collected via fax, email and hard 
copy mail from respondents. Upon OMB approval, CDC will continue use of 
the revised form through November 2018. There is no cost to the 
respondents.

                                                            Estimated Annualized Burden Hours
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                                                                                                             Number of    Average burden
              Type of respondents                               Form name                    Number of     responses per   per response    Total burden
                                                                                            respondents     respondent      (in hours)         hours
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73.19 Section..................................  Report of Theft, Loss, or Release of                215               1               2             430
                                                  Select Agents and Toxins.
                                                                                         ---------------------------------------------------------------
    Total......................................  .......................................  ..............  ..............  ..............             430
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Leroy A. Richardson,
Chief, Information Collection Review Office, Office of Scientific 
Integrity, Office of the Associate Director for Science, Office of the 
Director, Centers for Disease Control and Prevention.
[FR Doc. 2016-31739 Filed 12-29-16; 8:45 am]
 BILLING CODE 4163-18-P