Proposed Data Collection Submitted for Public Comment and Recommendations, 49374-49375 [2020-17710]

Download as PDF 49374 Federal Register / Vol. 85, No. 157 / Thursday, August 13, 2020 / Notices requested for this information collection total 185, which is a decrease of 737 hours. ESTIMATED ANNUALIZED BURDEN HOURS Form name/CFR reference Nonhuman Primate Importer .. CDC 75.10A Application for Registration as an Importer of Nonhuman Primates (New Importer). CDC 75.10A Application for Registration as an Importer of Nonhuman Primates (Re-Registration). 71.53(g1)(iii) and (h) Documentation and Standard Operating Procedures (no form) (New Importer). 71.53(g)(1)(iii) and (h) Documentation and Standard Operating Procedures (no form) (Registered Importer). Recordkeeping and reporting requirements for importing NHPs: Notification of shipment arrival 71.53(k), (n) (no form). Statements regarding the health of the nonhuman primates during travel and CDC quarantine (42 CFR 71.53(m) (no form). Statements, including necropsy reports, about the nonhuman primates upon their release from CDC quarantine. (42 CFR 71.53(m) (no form). Quarantine release 71.53(l) (no form) ................................... 71.53(v) Form: Filovirus Diagnostic Specimen Submission Form for Non-human Primate Materials. Nonhuman Primate Importer .. Nonhuman Primate Importer .. Nonhuman Primate Importer .. Nonhuman Primate Importer .. Nonhuman Primate Importer .. Nonhuman Primate Importer .. Nonhuman Primate Importer .. Nonhuman Primate Importer .. Jeffrey M. Zirger, Lead, Information Collection Review Office, Office of Scientific Integrity, Office of Science, Centers for Disease Control and Prevention. [FR Doc. 2020–17709 Filed 8–12–20; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day–20–1054; Docket No. CDC–2020– 0090] Proposed Data Collection Submitted for Public Comment and Recommendations Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Notice with comment period. AGENCY: 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 information collection entitled ‘‘Drug Overdose Response Investigation (DORI) Data Collections.’’ CDC will use the SUMMARY: VerDate Sep<11>2014 17:16 Aug 12, 2020 Jkt 250001 information collected to respond to urgent requests from state and local health authorities to provide epidemiological information that allows for the selection of interventions to curb local epidemics of drug overdose. DATES: Written comments must be received on or before October 13, 2020. ADDRESSES: You may submit comments, identified by Docket No. CDC–2020– 0090 by any of the following methods: • Federal eRulemaking Portal: Regulations.gov. Follow the instructions for submitting comments. • Mail: Jeffrey M. Zirger, 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. CDC will post, without change, all relevant comments to Regulations.gov. Please note: Submit all comments 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 Jeffrey M. Zirger, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS– D74, Atlanta, Georgia 30329; phone: 404–639–7570; Email: omb@cdc.gov. PO 00000 Frm 00016 Fmt 4703 Sfmt 4703 Number of responses per respondent Number of respondents Type of respondent Average burden per response (in hours) 1 1 10/60 12 1 10/60 1 1 10 12 1 30/60 25 6 15/60 25 6 15/60 25 3 15/60 25 10 6 10 15/60 20/60 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 the OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below. The OMB is particularly interested in comments that will help: 1. 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; 2. Evaluate the accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; 3. Enhance the quality, utility, and clarity of the information to be collected; and 4. Minimize the burden of the collection of information on those who are to respond, including through the SUPPLEMENTARY INFORMATION: E:\FR\FM\13AUN1.SGM 13AUN1 49375 Federal Register / Vol. 85, No. 157 / Thursday, August 13, 2020 / Notices use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submissions of responses. 5. Assess information collection costs. Proposed Project Drug Overdose Response Investigation (DORI) Data Collections (OMB Control No. 0920–1054, Exp. 03/31/2018)— Revision—National Center for Injury Prevention and Control (NCIPC), Centers for Disease Control and Prevention (CDC). Background and Brief Description In 2015, CDC received OMB approval (OMB Control No. 0920–1054) for a new Generic clearance for a three-year period to collect information to respond to urgent requests from state and local health authorities to provide epidemiological information that allows for the selection of interventions to curb local epidemics of drug overdose. CDC seeks OMB approval for a Revision of this generic clearance for a three-year period. Drug Overdose Response Investigation (DORI) are to be conducted in response to urgent requests from state and local health authorities. Of particular interest is response to increasing trends in, or changing characteristics of, overdose from prescription drugs (with a special interest in opioid analgesics such as oxycodone or methadone; benzodiazepines such as alprazolam) and/or illicit drugs (e.g., heroin). CDC’s National Center for Injury Prevention and Control (NCIPC) is frequently called upon to conduct DORIs at the request of state or local health authorities seeking support to respond to urgent public health problems resulting from drug use, misuse, addiction, and overdose. Such requests are typically, but not always, made through the Epi-Aid mechanism. In most investigations, CDC’s epidemiological response entails rapid and flexible collection of data that evolves during the investigation period. A Generic clearance is requested to ensure that timely information is collected during a DORI, which allows NCIPC to maintain critical mission function by working with state and local health authorities to protect the public’s health. During an unanticipated rise in nonfatal or fatal drug overdose where the substances responsible for the health event need to be identified, drivers and risk factors are undetermined, and/or subgroups at risk need to be identified, immediate action by CDC is necessary to minimize or prevent public harm. CDC must have the ability to rapidly deploy data collection tools to understand the scope of the problem and determine appropriate action. Procedures for each investigation, including specific data collection plans, depend on the time and resources available, number of persons involved, and other circumstances unique to the urgent conditions at hand. Data are collected by epidemiologists, psychologists, medical professionals, subject matter experts, and biostatisticians. Data collected during a DORI are used to understand sudden increases in drug use and misuse associated with fatal and nonfatal overdoses, understand the drivers and risk factors associated with those trends, and identify the groups most affected. This allows CDC to effectively advise states on actions that could be taken to control the local epidemic. During a DORI, data are collected once, with the rare need for follow-up. The estimated annual burden hours are 1,500, there are no costs to respondents other than their time. ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Type of respondent Form name Drug Overdose Response Investigation Participants. DORI Data Collection Instruments ... Jeffrey M. Zirger, Lead, Information Collection Review Office, Office of Scientific Integrity, Office of Science, Centers for Disease Control and Prevention. [FR Doc. 2020–17710 Filed 8–12–20; 8:45 am] BILLING CODE 4163–19–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS–10390] Agency Information Collection Activities: Proposed Collection; Comment Request Centers for Medicare & Medicaid Services, HHS. ACTION: Notice. AGENCY: The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to SUMMARY: VerDate Sep<11>2014 17:16 Aug 12, 2020 Jkt 250001 3,000 comment on CMS’ intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the 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 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency’s functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden. PO 00000 Frm 00017 Fmt 4703 Sfmt 4703 Number of responses per respondent 1 Average burden per response (in hours) 30/60 Total burden hours 1,500 Comments must be received by October 13, 2020. ADDRESSES: When commenting, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be submitted in any one of the following ways: 1. Electronically. You may send your comments electronically to https:// www.regulations.gov. Follow the instructions for ‘‘Comment or Submission’’ or ‘‘More Search Options’’ to find the information collection document(s) that are accepting comments. 2. By regular mail. You may mail written comments to the following address: CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development, Attention: Document Identifier/OMB Control Number ll, Room C4–26–05, 7500 Security Boulevard, Baltimore, Maryland 21244–1850. DATES: E:\FR\FM\13AUN1.SGM 13AUN1

Agencies

[Federal Register Volume 85, Number 157 (Thursday, August 13, 2020)]
[Notices]
[Pages 49374-49375]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-17710]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-20-1054; Docket No. CDC-2020-0090]


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 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 
information collection entitled ``Drug Overdose Response Investigation 
(DORI) Data Collections.'' CDC will use the information collected to 
respond to urgent requests from state and local health authorities to 
provide epidemiological information that allows for the selection of 
interventions to curb local epidemics of drug overdose.

DATES: Written comments must be received on or before October 13, 2020.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2020-
0090 by any of the following methods:
     Federal eRulemaking Portal: Regulations.gov. Follow the 
instructions for submitting comments.
     Mail: Jeffrey M. Zirger, 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. CDC will post, without change, all relevant comments 
to Regulations.gov.
    Please note: Submit all comments 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 Jeffrey M. Zirger, 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 the OMB for approval. To 
comply with this requirement, we are publishing this notice of a 
proposed data collection as described below.
    The OMB is particularly interested in comments that will help:
    1. 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;
    2. Evaluate the accuracy of the agency's estimate of the burden of 
the proposed collection of information, including the validity of the 
methodology and assumptions used;
    3. Enhance the quality, utility, and clarity of the information to 
be collected; and
    4. Minimize the burden of the collection of information on those 
who are to respond, including through the

[[Page 49375]]

use of appropriate automated, electronic, mechanical, or other 
technological collection techniques or other forms of information 
technology, e.g., permitting electronic submissions of responses.
    5. Assess information collection costs.

Proposed Project

    Drug Overdose Response Investigation (DORI) Data Collections (OMB 
Control No. 0920-1054, Exp. 03/31/2018)--Revision--National Center for 
Injury Prevention and Control (NCIPC), Centers for Disease Control and 
Prevention (CDC).

Background and Brief Description

    In 2015, CDC received OMB approval (OMB Control No. 0920-1054) for 
a new Generic clearance for a three-year period to collect information 
to respond to urgent requests from state and local health authorities 
to provide epidemiological information that allows for the selection of 
interventions to curb local epidemics of drug overdose. CDC seeks OMB 
approval for a Revision of this generic clearance for a three-year 
period.
    Drug Overdose Response Investigation (DORI) are to be conducted in 
response to urgent requests from state and local health authorities. Of 
particular interest is response to increasing trends in, or changing 
characteristics of, overdose from prescription drugs (with a special 
interest in opioid analgesics such as oxycodone or methadone; 
benzodiazepines such as alprazolam) and/or illicit drugs (e.g., 
heroin). CDC's National Center for Injury Prevention and Control 
(NCIPC) is frequently called upon to conduct DORIs at the request of 
state or local health authorities seeking support to respond to urgent 
public health problems resulting from drug use, misuse, addiction, and 
overdose. Such requests are typically, but not always, made through the 
Epi-Aid mechanism. In most investigations, CDC's epidemiological 
response entails rapid and flexible collection of data that evolves 
during the investigation period.
    A Generic clearance is requested to ensure that timely information 
is collected during a DORI, which allows NCIPC to maintain critical 
mission function by working with state and local health authorities to 
protect the public's health. During an unanticipated rise in nonfatal 
or fatal drug overdose where the substances responsible for the health 
event need to be identified, drivers and risk factors are undetermined, 
and/or subgroups at risk need to be identified, immediate action by CDC 
is necessary to minimize or prevent public harm. CDC must have the 
ability to rapidly deploy data collection tools to understand the scope 
of the problem and determine appropriate action. Procedures for each 
investigation, including specific data collection plans, depend on the 
time and resources available, number of persons involved, and other 
circumstances unique to the urgent conditions at hand. Data are 
collected by epidemiologists, psychologists, medical professionals, 
subject matter experts, and biostatisticians.
    Data collected during a DORI are used to understand sudden 
increases in drug use and misuse associated with fatal and nonfatal 
overdoses, understand the drivers and risk factors associated with 
those trends, and identify the groups most affected. This allows CDC to 
effectively advise states on actions that could be taken to control the 
local epidemic. During a DORI, data are collected once, with the rare 
need for follow-up. The estimated annual burden hours are 1,500, there 
are no costs to respondents other than their time.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                                     Number of       Number of      burden per     Total  burden
      Type of respondent            Form name       respondents    responses per   response  (in       hours
                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
Drug Overdose Response          DORI Data                  3,000               1           30/60           1,500
 Investigation Participants.     Collection
                                 Instruments.
----------------------------------------------------------------------------------------------------------------


Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2020-17710 Filed 8-12-20; 8:45 am]
BILLING CODE 4163-19-P


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