[Federal Register Volume 80, Number 64 (Friday, April 3, 2015)]
[Notices]
[Pages 18242-18244]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-07606]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60 Day-15-0576; Docket No. CDC-2015-0013]


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 efforts 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 information collection entitled Possession, Use, and 
Transfer of Select Agents and Toxins (OMB Control No. 0920-0576). CDC 
is requesting Office of Management and Budget (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 Form to Report Potential Theft, Loss, Release, or 
Occupational Exposure (APHIS/CDC Form 3); (4) Report of Identification 
of Select Agent or Toxin from Clinical/Diagnostic Specimen, Proficiency 
Testing, or Seizure by Federal Law Enforcement (APHIS/CDC Form 4); and 
(5) Request for Exemption of Select Agents and Toxins for an 
Investigational Product (APHIS/CDC Form 5).

DATES: Written comments must be received on or before June 2, 2015.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2015-
0013 by any of the following methods:
     Federal eRulemaking Portal: Regulation.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 comment 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 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 means 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 and to be able to respond to a collection of 
information, to search data sources, to 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 (OMB 
Control No. 0920-0576, Expiration--11/30/2015)--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). 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

[[Page 18243]]

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 agent 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 Form to Report 
Potential Theft, Loss, Release, or Occupational Exposure (APHIS/CDC 
Form 3); (4) Report of Identification of Select Agent or Toxin from 
Clinical/Diagnostic Specimen, Proficiency Testing, or Seizure by 
Federal Law Enforcement (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 data obtained from the FSAP database and is estimated 
as 8,528 hours. Information will be collected via fax, email and hard 
copy mail from respondents. Upon OMB approval, CDC will begin use of 
the revised forms in November 2015 through November 2018. There is no 
cost to the respondents.

                                        Estimated Annualized Burden Hours
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                                                                     Number of    Average burden
          Section                 Form name          Number of     responses per   per response    Total burden
                                                    respondents     respondent      (in hours)         hours
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73.3 & 73.4...............  Request for                        3               1               1               3
                             Exclusions.
73.5 & 6..................  Report of                        303               3               1             909
                             Identification of a
                             Select Agent or
                             Toxin.
73.5 & 73.6...............  Request of Exemption               1               1               1               1
73.7......................  Application for                    5               1               5              25
                             Registration.
73.7......................  Amendment to a                   277               7               1           1,939
                             Certificate of
                             Registration.
73.9......................  Documentation of                 277               1               1             277
                             self-inspection.
73.10.....................  Request for                        1               1           30/60               1
                             Expedited Review.
73.11.....................  Security Plan.......             277               1               5           1,385
73.12.....................  Biosafety Plan......             277               1               5           1,385
73.13.....................  Request Regarding a               20               2               1              40
                             Restricted
                             Experiment.
73.14.....................  Incident Response                277               1               5           1,385
                             Plan.
73.15.....................  Training............             277               1               1             277
73.16.....................  Request to Transfer              156               2               1             312
                             Select Agents and
                             Toxins.
73.17.....................  Records.............             277               1           30/60             139
73.19.....................  Notification of                  215               2               1             430
                             Theft, Loss, or
                             Release.
73.20.....................  Administrative                     5               4               1              20
                             Review.
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    Total.................  ....................  ..............  ..............  ..............           8,528
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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. 2015-07606 Filed 4-2-15; 8:45 am]
 BILLING CODE 4163-18-P