80 FR 44130 - Agency Forms Undergoing Paperwork Reduction Act Review

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

Federal Register Volume 80, Issue 142 (July 24, 2015)

Page Range		44130-44131
FR Document		2015-18094
Federal Register, Volume 80 Issue 142 (Friday, July 24, 2015)
[Federal Register Volume 80, Number 142 (Friday, July 24, 2015)]
[Notices]
[Pages 44130-44131]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-18094]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-15-0576]


Agency Forms Undergoing Paperwork Reduction Act Review

    The Centers for Disease Control and Prevention (CDC) has submitted 
the following information collection request to the Office of 
Management and Budget (OMB) for review and approval in accordance with 
the Paperwork Reduction Act of 1995. The notice for the proposed 
information collection is published to obtain comments from the public 
and affected agencies.
    Written comments and suggestions from the public and affected 
agencies concerning the proposed collection of information are 
encouraged. Your comments should address any of the following: (a) 
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; (b) Evaluate the 
accuracy of the agencies estimate of the burden of the proposed 
collection of information, including the validity of the methodology 
and assumptions used; (c) Enhance the quality, utility, and clarity of 
the information to be collected; (d) 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 submission of responses; and 
(e) Assess information collection costs.
    To request additional information on the proposed project or to 
obtain a copy of the information collection plan and instruments, call 
(404) 639-7570 or send an email to [email protected]. Written comments and/or 
suggestions regarding the items contained in this notice should be 
directed to the Attention: CDC Desk Officer, Office of Management and 
Budget, Washington, DC 20503 or by fax to (202) 395-5806. Written 
comments should be received within 30 days of this notice.

Proposed Project

    Possession, Use, and Transfer of Select Agents and Toxins (OMB 
Control No. 0920-0576, Expiration Date 11/30/2015)--Revision--Office of 
Public Health Preparedness and Response, Centers for Disease Control 
and Prevention (CDC).

[[Page 44131]]

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 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 for the next three years. 
Information will be collected via fax, email and hard copy mail from 
respondents.
    The revisions to the data collection are primarily changes to the 
forms to clarify instructions, correct editorial errors from previous 
submission, and reformat the structure of the forms based on the day-
to-day processing of these forms. Changes were made to the following 
forms: Report of Identification of a Select Agent or Toxin, Request for 
Exemption, Application for Registration, Request to Transfer Select 
Agents and Toxins, and Administrative Review.
    There is no cost to respondents other than their time. The total 
estimated annualized burden hours are 8,527.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                     Number of    Average burden
          Regulation sections                   Form name            Number of     responses per   per response
                                                                    respondents     respondent      (in hours)
----------------------------------------------------------------------------------------------------------------
73.3 & 73.4...........................  Request for Exclusions..               3               1               1
73.5 & 6..............................  Report of Identification             303               3               1
                                         of a Select Agent or
                                         Toxin.
73.5 & 73.6...........................  Request for Exemption...               1               1               1
73.7..................................  Application for                        5               1               5
                                         Registration.
73.7..................................  Amendment to a                       277               7               1
                                         Certificate of
                                         Registration.
73.9..................................  Documentation of self-               277               1               1
                                         inspection.
73.10.................................  Request for Expedited                  1               1           30/60
                                         Review.
73.11.................................  Security Plan...........             277               1               5
73.12.................................  Biosafety Plan..........             277               1               5
73.13.................................  Request Regarding a                   20               2               1
                                         Restricted Experiment.
73.14.................................  Incident Response Plan..             277               1               5
73.15.................................  Training................             277               1               1
73.16.................................  Request to Transfer                  156               2               1
                                         Select Agents and
                                         Toxins.
73.17.................................  Records.................             277               1           30/60
73.19.................................  Notification of                      215               2               1
                                         Potential Theft, Loss,
                                         or Release.
73.20.................................  Administrative Review...               5               4               1
----------------------------------------------------------------------------------------------------------------


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. 2015-18094 Filed 7-23-15; 8:45 am]
 BILLING CODE 4163-18-P
44130 Federal Register / Vol. 80, No. 142 / Friday, July 24, 2015 / Notices

death information that can be used to voluntarily participate in the web-based and its usual CDR process, enter new
guide program and policy decisions at NCRPCD Case Reporting System. This SDY variables specific to SDY deaths.
the state and local levels. Case Reporting System provides a The data will be entered into the
Child Death Review (CDR) standardized way to compile infant and NCRPCD Case Reporting System,
child death information, already version 4.0. The SDY variables are
Child Death Review (CDR) programs accessed and reviewed by state and available to all users of the Case
function in every state, and the program local teams. Local and state teams own Reporting System, grantees and non-
is often mandated by the state. Case their data and identifiable data (if grantees alike. In addition, unfunded
reviews occur at the local and state entered at all) is not available to anyone local and state CDR teams may wish to
level, depending on the state. States use but the state that owns the data. The conduct specialized advanced clinical
their data to inform prevention NCRPCD Case Report (Version 4.0), reviews and are not prohibited from
strategies and to evaluate the success of available to all CDR programs that use doing so. The SDY Registry aims to
state programs in reducing infant and the Case Reporting System, will include improve data completeness and
child deaths as well as producing new SDY variables. The CDC is asking timeliness of the data entered by
annual reports. SDY Registry grantees to enter new SDY providing technical assistance to
The National Center for the Review
variables into this pre-existing system grantees only.
and Prevention of Child Death
(NCRPCD) provides support and and to use an advanced review to For the purposes of this ICR, a
technical assistance to CDR programs. provide a more in-depth review of a ‘‘respondent’’ is a SDY Registry grantee
This program is funded by the Health sub-set of cases. funded by CDC. As a grantee for CDC’s
Resources and Services Administration Information Collection Request (ICR) cooperative agreement, the respondent
(HRSA). The NCRPCD support covers a agrees to compile a specifically defined
broad array of process-oriented CDR The activities relevant to this set of SDY information about a defined
issues such as forming multi- Information Collection Request (ICR) are set of deaths of children through the
disciplinary teams, moving from state to that SDY Registry (i.e., grantee) CDR state’s CDR program. CDC estimates that
local reviews and strengthening programs will convene an advanced 900 cases will be reported over a three-
partnerships with the local forensic clinical review team of physicians with year period. There are no costs to
community. In addition, the NCRPCD specialties relevant to SDY, and will, respondents other than their time. The
provides support to CDR programs who through the advanced clinical review total annualized burden hours are 2,250.

ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number
Number of burden per
Type of respondent Form name responses per
respondents response
respondent (in hours)

State health personnel .................................... SDY Module ................................................... 9 300 30/60
Pediatric cardiologists ..................................... SDY Module ................................................... 9 300 5/60
Epileptologists ................................................. SDY Module ................................................... 9 300 5/60
Neurologists .................................................... SDY Module ................................................... 9 300 5/60
Forensic pathologists ...................................... SDY Module ................................................... 9 300 5/60

Leroy A. Richardson, the proposed information collection is other forms of information technology,
Chief, Information Collection Review Office, published to obtain comments from the e.g., permitting electronic submission of
Office of Scientific Integrity, Office of the public and affected agencies. responses; and (e) Assess information
Associate Director for Science, Office of the Written comments and suggestions collection costs.
Director, Centers for Disease Control and from the public and affected agencies To request additional information on
Prevention.
concerning the proposed collection of the proposed project or to obtain a copy
[FR Doc. 2015–18146 Filed 7–23–15; 8:45 am] information are encouraged. Your of the information collection plan and
BILLING CODE 4163–18–P comments should address any of the instruments, call (404) 639–7570 or
following: (a) Evaluate whether the send an email to omb@cdc.gov. Written
proposed collection of information is comments and/or suggestions regarding
DEPARTMENT OF HEALTH AND necessary for the proper performance of the items contained in this notice
HUMAN SERVICES
the functions of the agency, including should be directed to the Attention:
Centers for Disease Control and whether the information will have CDC Desk Officer, Office of Management
Prevention practical utility; (b) Evaluate the and Budget, Washington, DC 20503 or
accuracy of the agencies estimate of the by fax to (202) 395–5806. Written
[30Day–15–0576] burden of the proposed collection of comments should be received within 30
information, including the validity of days of this notice.
Agency Forms Undergoing Paperwork
the methodology and assumptions used;
asabaliauskas on DSK5VPTVN1PROD with NOTICES

Reduction Act Review Proposed Project
(c) Enhance the quality, utility, and
The Centers for Disease Control and clarity of the information to be Possession, Use, and Transfer of
Prevention (CDC) has submitted the collected; (d) Minimize the burden of Select Agents and Toxins (OMB Control
following information collection request the collection of information on those No. 0920–0576, Expiration Date 11/30/
to the Office of Management and Budget who are to respond, including through 2015)—Revision—Office of Public
(OMB) for review and approval in the use of appropriate automated, Health Preparedness and Response,
accordance with the Paperwork electronic, mechanical, or other Centers for Disease Control and
Reduction Act of 1995. The notice for technological collection techniques or Prevention (CDC).

VerDate Sep<11>2014 19:59 Jul 23, 2015 Jkt 235001 PO 00000 Frm 00112 Fmt 4703 Sfmt 4703 E:\FR\FM\24JYN1.SGM 24JYN1
Document Created: 2018-02-23 09:24:45
Document Modified: 2018-02-23 09:24:45
Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
FR Citation		80 FR 44130
80 FR 44130 - Agency Forms Undergoing Paperwork Reduction Act Review

DEPARTMENT OF HEALTH AND HUMAN SERVICESCenters for Disease Control and Prevention

Federal Register Volume 80, Issue 142 (July 24, 2015)

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