81_FR_96707 81 FR 96456 - Proposed Data Collection Submitted for Public Comment and Recommendations

81 FR 96456 - Proposed Data Collection Submitted for Public Comment and Recommendations

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 81, Issue 251 (December 30, 2016)

Page Range96456-96457
FR Document2016-31739

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.''

Federal Register, Volume 81 Issue 251 (Friday, December 30, 2016) 
[Federal Register Volume 81, Number 251 (Friday, December 30, 2016)]
[Notices]
[Pages 96456-96457]
From the Federal Register Online  [www.thefederalregister.org]
[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.

-----------------------------------------------------------------------

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
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                             Number of    Average burden
              Type of respondents                               Form name                    Number of     responses per   per response    Total burden
                                                                                            respondents     respondent      (in hours)         hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
73.19 Section..................................  Report of Theft, Loss, or Release of                215               1               2             430
                                                  Select Agents and Toxins.
                                                                                         ---------------------------------------------------------------
    Total......................................  .......................................  ..............  ..............  ..............             430
--------------------------------------------------------------------------------------------------------------------------------------------------------


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

96456 Federal Register / Vol. 81, No. 251 / Friday, December 30, 2016 / Notices clinic visits for body measurements and Respondents will also be interviewed. Participation in the study is voluntary biological specimen collection (blood, They will be asked about demographic and there is no cost to respondents other urine, and hair). Their blood will be and lifestyle factors, hobbies, health than their time. The estimated tested for polychlorinated biphenyls, conditions that may affect fish annualized burden for the program metals, perfluorinated compounds, consumption and fishing habits, and averaged over the three-year study persistent pesticides, and lipids. Urine types of jobs which can contribute to period is 231 hours among 166 will be tested for polycyclic aromatic chemical exposure. Some dietary respondents. There is no cost to hydrocarbons and creatinine. The hair questions will be asked with a focus on respondents other than their time spent samples (optional) will be saved for a consumption of Great Lakes fish. in the study. later analysis. ESTIMATED ANNUALIZED BURDEN HOURS Average Number of Number of burden per Total burden Type of respondents Form name responses per respondents response (in hours) respondent (in hours) Licensed Anglers ........... Eligibility Screening Survey (paper) .................... 156 1 5/60 13 Eligibility Screening Survey (online) .................... 28 1 5/60 2 Study Questionnaire (paper) ............................... 58 1 30/60 29 Study Questionnaire (online) ............................... 87 1 30/60 44 Clinic Visit Checklist and Body Measurements ... 133 1 35/60 78 Follow-up Survey ................................................. 133 1 5/60 11 Burmese Refugees ........ Eligibility Screening Survey ................................. 42 1 5/60 4 Contact Information Form .................................... 33 1 5/60 3 Study Questionnaire ............................................ 33 1 40/60 22 Clinic Visit Checklist and Body Measurements ... 33 1 35/60 19 Network Size Questions ...................................... 33 1 5/60 3 Follow-up Survey ................................................. 33 1 5/60 3 Total ........................ .............................................................................. ........................ ........................ ........................ 231 Leroy A. Richardson, Act of 1995. This notice invites instruments, contact the Information Chief, Information Collection Review Office, comment on a proposed revision of the Collection Review Office, Centers for Office of Scientific Integrity, Office of the CDC information collection project Disease Control and Prevention, 1600 Associate Director for Science, Office of the entitled ‘‘Possession, Use, and Transfer Clifton Road NE., MS–D74, Atlanta, Director, Centers for Disease Control and of Select Agents and Toxins.’’ Georgia 30329; phone: 404–639–7570; Prevention. Email: omb@cdc.gov. DATES: Written comments must be [FR Doc. 2016–31738 Filed 12–29–16; 8:45 am] received on or before February 28, 2017. SUPPLEMENTARY INFORMATION: Under the BILLING CODE 4163–18–P ADDRESSES: You may submit comments, Paperwork Reduction Act of 1995 (PRA) identified by Docket No. CDC–2016– (44 U.S.C. 3501–3520), Federal agencies DEPARTMENT OF HEALTH AND 0125 by any of the following methods: must obtain approval from the Office of HUMAN SERVICES • Federal eRulemaking Portal: Management and Budget (OMB) for each Regulations.gov. Follow the instructions collection of information they conduct Centers for Disease Control and for submitting comments. or sponsor. In addition, the PRA also Prevention • Mail: Leroy A. Richardson, requires Federal agencies to provide a Information Collection Review Office, 60-day notice in the Federal Register [60Day–17–0576; Docket No. CDC–2016– Centers for Disease Control and concerning each proposed collection of 0125] Prevention, 1600 Clifton Road NE., MS– information, including each new D74, Atlanta, Georgia 30329. proposed collection, each proposed Proposed Data Collection Submitted Instructions: All submissions received extension of existing collection of for Public Comment and must include the agency name and information, and each reinstatement of Recommendations Docket Number. All relevant comments previously approved information AGENCY: Centers for Disease Control and received will be posted without change collection before submitting the Prevention (CDC), Department of Health to Regulations.gov, including any collection to OMB for approval. To and Human Services (HHS). personal information provided. For comply with this requirement, we are ACTION: Notice with comment period. access to the docket to read background publishing this notice of a proposed documents or comments received, go to data collection as described below. SUMMARY: The Centers for Disease Regulations.gov. Comments are invited on: (a) Whether Control and Prevention (CDC), as part of Please note: All public comments the proposed collection of information its continuing effort to reduce public should be submitted through the is necessary for the proper performance srobinson on DSK5SPTVN1PROD with NOTICES burden and maximize the utility of Federal eRulemaking portal of the functions of the agency, including government information, invites the (Regulations.gov) or by U.S. mail to the whether the information shall have general public and other Federal address listed above. practical utility; (b) the accuracy of the agencies to take this opportunity to FOR FURTHER INFORMATION CONTACT: To agency’s estimate of the burden of the comment on proposed and/or request more information on the proposed collection of information; (c) continuing information collections, as proposed project or to obtain a copy of ways to enhance the quality, utility, and required by the Paperwork Reduction the information collection plan and clarity of the information to be VerDate Sep<11>2014 19:18 Dec 29, 2016 Jkt 241001 PO 00000 Frm 00024 Fmt 4703 Sfmt 4703 E:\FR\FM\30DEN1.SGM 30DEN1

Federal Register / Vol. 81, No. 251 / Friday, December 30, 2016 / Notices 96457 collected; (d) ways to minimize the and Response Act of 2002, (42 U.S.C. adopted an identical system to collect burden of the collection of information 262a), requires the United States information for the possession, use, and on respondents, including through the Department of Health and Human transfer of select agents and toxins. use of automated collection techniques Services (HHS) to regulate the CDC is requesting OMB approval to or other forms of information possession, use, and transfer of revise the collected information under technology; and (e) estimates of capital biological agents or toxins that have the the select agent regulations through the or start-up costs and costs of operation, potential to pose a severe threat to use of the APHIS/CDC Form 3 (Report maintenance, and purchase of services public health and safety (select agents of Theft, Loss, or Release of Select to provide information. Burden is the and toxins). Subtitle B of the Public Agents and Toxins). The Report of total time, effort, or financial resources Health Security and Bioterrorism Theft, Loss, or Release of Select Agent expended by persons to generate, Preparedness and Response Act of 2002 and Toxin form (42 CFR 73.19(a),(b)) maintain, retain, disclose, or provide (which may be cited as the Agricultural must be completed by an individual or information to or for a Federal agency. Bioterrorism Protection Act of 2002), (7 an entity whenever the individual or This includes the time needed to review U.S.C. 8401), requires the United States entity experiences a theft, loss, or instructions; to develop, acquire, install Department of Agriculture (USDA) to release of a select agent or toxin. and utilize technology and systems for regulate the possession, use, and transfer of biological agents or toxins CDC is proposing to revise the form to the purpose of collecting, validating and further clarify what needs to be reported verifying information, processing and that have the potential to pose a severe threat to animal or plant health, or as a ‘‘release’’ and ‘‘loss’’ and additional maintaining information, and disclosing fields to assist with categorizing the and providing information; to train animal or plant products (select agents and toxins). The HHS Secretary type of release (e.g., spill within personnel to respond to a collection of secondary containment, occupational information, search data sources, and delegated the responsibility for promulgating and implementing select exposure, possible breach of facility complete and review the collection of containment, etc.), type of exposure, information; and to transmit or agent regulations found at 42 CFR part 73 to CDC Division of Select Agents and and the understanding of safety and otherwise disclose the information. security risk levels relative to human Toxins (DSAT). The Animal and Plant Proposed Project Health Inspection Service (APHIS)/ illness. Estimated average time to Possession, Use, and Transfer of Agriculture Select Agent Services complete this form is one hour. Select Agents and Toxins (42 CFR 73) (AgSAS) was delegated responsibility by The total estimated annualized (OMB Control No. 0920–0576, exp. 12/ USDA for select agent regulations (7 burden for this collection was 31/2018)—Revision—Office of Public CFR part 331, and 9 CFR part 121). The calculated using data obtained from the Health Preparedness and Response Federal Select Agent Program (FSAP) is FSAP database and is estimated as 430 (OPHPR), Centers for Disease Control the collaboration of the DSAT and hours. Information will be collected via and Prevention (CDC). AgSAS to administer the select agent fax, email and hard copy mail from regulations in a manner to minimize the respondents. Upon OMB approval, CDC Background and Brief Description administrative burden on persons will continue use of the revised form Subtitle A of the Public Health subject to the select agent regulations. through November 2018. There is no Security and Bioterrorism Preparedness Accordingly, CDC and APHIS have cost to the respondents. ESTIMATED ANNUALIZED BURDEN HOURS Average Number of Number of burden per Total burden Type of respondents Form name responses per respondents response hours respondent (in hours) 73.19 Section ................. Report of Theft, Loss, or Release of Select 215 1 2 430 Agents and Toxins. Total ........................ .............................................................................. ........................ ........................ ........................ 430 Leroy A. Richardson, DEPARTMENT OF HEALTH AND SUMMARY: The Centers for Disease Chief, Information Collection Review Office, HUMAN SERVICES Control and Prevention (CDC), as part of Office of Scientific Integrity, Office of the its continuing efforts to reduce public Associate Director for Science, Office of the Centers for Disease Control and burden and maximize the utility of Director, Centers for Disease Control and Prevention government information, invites the Prevention. general public and other Federal [FR Doc. 2016–31739 Filed 12–29–16; 8:45 am] [60Day–17–1074; Docket No. CDC–2016– agencies to take this opportunity to BILLING CODE 4163–18–P 0123] comment on proposed and/or continuing information collections, as Proposed Data Collection Submitted required by the Paperwork Reduction for Public Comment and srobinson on DSK5SPTVN1PROD with NOTICES Recommendations Act of 1995. This notice invites comment on the revision of the AGENCY: Centers for Disease Control and information collection entitled Prevention (CDC), Department of Health ‘‘Colorectal Cancer Control Program and Human Services (HHS). (CRCCP) Monitoring Activities.’’ The change to the collection will include a ACTION: Notice with comment period. VerDate Sep<11>2014 19:18 Dec 29, 2016 Jkt 241001 PO 00000 Frm 00025 Fmt 4703 Sfmt 4703 E:\FR\FM\30DEN1.SGM 30DEN1


Document Created: 2016-12-30 05:16:06
Document Modified: 2016-12-30 05:16:06
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice with comment period.
DatesWritten comments must be received on or before February 28, 2017.
ContactTo 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]
FR Citation81 FR 96456 
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