Agency Forms Undergoing Paperwork Reduction Act Review, 44130-44131 [2015-18094]

Download as PDF 44130 Federal Register / Vol. 80, No. 142 / Friday, July 24, 2015 / Notices death information that can be used to guide program and policy decisions at the state and local levels. Child Death Review (CDR) Child Death Review (CDR) programs function in every state, and the program is often mandated by the state. Case reviews occur at the local and state level, depending on the state. States use their data to inform prevention strategies and to evaluate the success of state programs in reducing infant and child deaths as well as producing annual reports. The National Center for the Review and Prevention of Child Death (NCRPCD) provides support and technical assistance to CDR programs. This program is funded by the Health Resources and Services Administration (HRSA). The NCRPCD support covers a broad array of process-oriented CDR issues such as forming multidisciplinary teams, moving from state to local reviews and strengthening partnerships with the local forensic community. In addition, the NCRPCD provides support to CDR programs who voluntarily participate in the web-based NCRPCD Case Reporting System. This Case Reporting System provides a standardized way to compile infant and child death information, already accessed and reviewed by state and local teams. Local and state teams own their data and identifiable data (if entered at all) is not available to anyone but the state that owns the data. The NCRPCD Case Report (Version 4.0), available to all CDR programs that use the Case Reporting System, will include new SDY variables. The CDC is asking SDY Registry grantees to enter new SDY variables into this pre-existing system and to use an advanced review to provide a more in-depth review of a sub-set of cases. Information Collection Request (ICR) The activities relevant to this Information Collection Request (ICR) are that SDY Registry (i.e., grantee) CDR programs will convene an advanced clinical review team of physicians with specialties relevant to SDY, and will, through the advanced clinical review and its usual CDR process, enter new SDY variables specific to SDY deaths. The data will be entered into the NCRPCD Case Reporting System, version 4.0. The SDY variables are available to all users of the Case Reporting System, grantees and nongrantees alike. In addition, unfunded local and state CDR teams may wish to conduct specialized advanced clinical reviews and are not prohibited from doing so. The SDY Registry aims to improve data completeness and timeliness of the data entered by providing technical assistance to grantees only. For the purposes of this ICR, a ‘‘respondent’’ is a SDY Registry grantee funded by CDC. As a grantee for CDC’s cooperative agreement, the respondent agrees to compile a specifically defined set of SDY information about a defined set of deaths of children through the state’s CDR program. CDC estimates that 900 cases will be reported over a threeyear period. There are no costs to respondents other than their time. The total annualized burden hours are 2,250. ESTIMATED ANNUALIZED BURDEN HOURS Type of respondent State health personnel .................................... Pediatric cardiologists ..................................... Epileptologists ................................................. Neurologists .................................................... Forensic pathologists ...................................... 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. 2015–18146 Filed 7–23–15; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention asabaliauskas on DSK5VPTVN1PROD with NOTICES [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 VerDate Sep<11>2014 19:59 Jul 23, 2015 Jkt 235001 SDY SDY SDY SDY SDY Module Module Module Module Module ................................................... ................................................... ................................................... ................................................... ................................................... 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 PO 00000 Frm 00112 Fmt 4703 Sfmt 4703 Number responses per respondent Number of respondents Form name 9 9 9 9 9 300 300 300 300 300 Average burden per response (in hours) 30/60 5/60 5/60 5/60 5/60 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 omb@cdc.gov. 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). E:\FR\FM\24JYN1.SGM 24JYN1 44131 Federal Register / Vol. 80, No. 142 / Friday, July 24, 2015 / Notices 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 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. 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 ESTIMATED ANNUALIZED BURDEN HOURS Form name 73.3 & 73.4 ..................................................... 73.5 & 6 .......................................................... 73.17 ............................................................... 73.19 ............................................................... 73.20 ............................................................... 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. DEPARTMENT OF HEALTH AND HUMAN SERVICES [FR Doc. 2015–18094 Filed 7–23–15; 8:45 am] [Document Identifier: CMS–437A & CMS– 437B and CMS–10488] BILLING CODE 4163–18–P asabaliauskas on DSK5VPTVN1PROD with NOTICES Number of responses per respondent 3 303 1 3 1 1 1 5 277 277 1 277 277 20 277 277 156 1 1 7 1 1 1 1 2 1 1 2 1 5 1 1 30/60 5 5 1 5 1 1 277 215 1 2 30/60 1 5 4 1 Request for Exclusions .................................. Report of Identification of a Select Agent or Toxin. Request for Exemption .................................. Application for Registration ............................ Amendment to a Certificate of Registration ... Documentation of self-inspection ................... Request for Expedited Review ...................... Security Plan .................................................. Biosafety Plan ................................................ Request Regarding a Restricted Experiment Incident Response Plan ................................. Training .......................................................... Request to Transfer Select Agents and Toxins. Records .......................................................... Notification of Potential Theft, Loss, or Release. Administrative Review .................................... 73.5 & 73.6 ..................................................... 73.7 ................................................................. 73.7 ................................................................. 73.9 ................................................................. 73.10 ............................................................... 73.11 ............................................................... 73.12 ............................................................... 73.13 ............................................................... 73.14 ............................................................... 73.15 ............................................................... 73.16 ............................................................... Centers for Medicare & Medicaid Services Agency Information Collection Activities: Submission for OMB Review; Comment Request ACTION: Notice. The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS’ intention to collect SUMMARY: VerDate Sep<11>2014 19:59 Jul 23, 2015 Jkt 235001 PO 00000 Frm 00113 Fmt 4703 Sfmt 4703 Average burden per response (in hours) Number of respondents Regulation sections information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including any of the following subjects: The necessity and utility of the proposed information collection for the proper performance of the agency’s functions; the accuracy of E:\FR\FM\24JYN1.SGM 24JYN1

Agencies

[Federal Register Volume 80, Number 142 (Friday, July 24, 2015)]
[Notices]
[Pages 44130-44131]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 omb@cdc.gov. 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

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.