Proposed Data Collection Submitted for Public Comment and Recommendations, 32705-32707 [2017-14915]

Download as PDF 32705 Federal Register / Vol. 82, No. 135 / Monday, July 17, 2017 / Notices Background and Brief Description Overdose deaths involving prescription opioids and heroin have reached epidemic levels in the U.S. and continue to rise. To address the prescription drug/opioid overdose crisis, the federal government has recently allocated funding to improve access to treatment for opioid use disorders, reduce opioid related deaths, and strengthen drug misuse prevention efforts. One program resulting from the federal government’s efforts to address the opioid crisis is, the Substance Abuse and Mental Health Services Agency (SAMHSA) Grants to Prevent Prescription Drug/Opioid OverdoseRelated Deaths (PDO/naloxone grant). This collection will be to evaluate the Substance Abuse and Mental Health Services Agency (SAMHSA) Grants to Prevent Prescription Drug/Opioid Overdose-Related Deaths. This evaluation will seek to describe and understand the scope and impact of the program on overdose. To address the prescription drug/opioid overdose The intended use of the resulting data is to increase CDC and SAMHSA understanding of the scope and impact of the program on overdose fatalities and how program effectiveness may vary among different sub-populations and settings, and to increase knowledge of barriers and facilitators to program implementation. Key informant interviews and focus groups with participants in the activities enacted by the twelve state grant recipients will be methodology used. This will include state administrators of the grant and other PDO/Naloxone stakeholders including advisory council members, first responders, social service providers, laypersons including end users and their family and friend. All focus groups and interviews will be analyzed through qualitative content analysis, including utilization of a systematic coding scheme. Total burden in hours for this collection is 381. There are no costs to respondents other than their time. crisis, the federal government has recently allocated funding to improve access to treatment for opioid use disorders, reduce opioid related deaths, and strengthen drug misuse prevention efforts. One program resulting from the federal government’s efforts to address the opioid crisis is, the Substance Abuse and Mental Health Services Agency (SAMHSA) Grants to Prevent Prescription Drug/Opioid OverdoseRelated Deaths (PDO/naloxone grant). Through this program, SAMHSA awarded funding to 12 states. The funding is aimed at reducing the number of prescription drug/opioid overdose-related deaths and adverse events among individuals 18 years of age and older through educating and training first responders and other key community sectors on the prevention of prescription drug/opioid overdoserelated deaths, including the purchase and distribution of naloxone. SAMHSA is funding the grant and CDC is responsible for conducting the grantee evaluation. ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Number of responses per respondent Average burden per response (in hours) Total burden (in hours) Type of respondents Form name PDO/Naloxone Advisory Committee Members and Grantees. PDO/Naloxone Grantees .................. Focus Group Discussion Guide ....... 140 1 1.5 210 Individual Interview Discussion Guide for Grantees. Individual Interview Discussion Guide for Partners. Individual Interview Discussion Guide for Laypersons. Recruitment contact script ............... 36 1 1 36 84 1 1 84 24 1 1 24 284 1 5/60 24 Key Informant Selection Tool ........... 12 1 15/60 3 ........................................................... ........................ ........................ ........................ 381 PDO/Naloxone Stakeholders and Partners. PDO/Naloxone Laypersons .............. All participants (PDO Naloxone grantees, advisory committee, stakeholders and partners, laypersons). PDO/Naloxone Grantees .................. Total ........................................... 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. 2017–14914 Filed 7–14–17; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day–17–1054; Docket No. CDC–2017– 0055] asabaliauskas on DSKBBXCHB2PROD with NOTICES BILLING CODE 4163–18–P 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 SUMMARY: VerDate Sep<11>2014 17:45 Jul 14, 2017 Jkt 241001 PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 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 E:\FR\FM\17JYN1.SGM 17JYN1 asabaliauskas on DSKBBXCHB2PROD with NOTICES 32706 Federal Register / Vol. 82, No. 135 / Monday, July 17, 2017 / Notices for the selection of interventions to curb local epidemics of drug overdose. DATES: Written comments must be received on or before September 15, 2017. ADDRESSES: You may submit comments, identified by Docket No. CDC–2017– 0055 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 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 Leroy A. Richardson, 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. 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 VerDate Sep<11>2014 17:45 Jul 14, 2017 Jkt 241001 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 Drug Overdose Response Investigation (DORI) Data Collections (OMB control number 0920–1054, Expiration 03/31/ 218)—Extension—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 number 0920–1054) for a new OMB generic clearance for a threeyear 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 an extension of this generic plan for another three-year period. Drug Overdose Response Investigation (DORI) are to be conducted in response to urgent requests from state and local health authorities to provide epidemiological information that allows for the selection of interventions to curb PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 local epidemics of drug overdose. 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, abuse, and overdose. Such requests are typically, but not always, made through CDC’s Epi-Aid mechanism; in most investigations, CDC’s epidemiological response entails rapid and flexible collection of data that evolves during the investigation period. 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. There are no costs to respondents other than their time. E:\FR\FM\17JYN1.SGM 17JYN1 32707 Federal Register / Vol. 82, No. 135 / Monday, July 17, 2017 / Notices ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Number of responses per respondent Average burden per response (in hours) Total burden hours Type of respondent Form name Drug Overdose Response Investigation Participants. Drug Overdose Response Investigation Data Collection Instruments. 2,700 1 30/60 1,350 Total ........................................... ........................................................... ........................ ........................ ........................ 1350 [FR Doc. 2017–14915 Filed 7–14–17; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Fees for Sanitation Inspection of Cruise Ships Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: General notice. AGENCY: VSP helps the cruise line industry fulfill its responsibility for developing and implementing comprehensive sanitation programs to minimize the risk for acute gastroenteritis. Every vessel that has a foreign itinerary and carries 13 or more passengers is subject to twice-yearly unannounced inspections and, when necessary, reinspection. DATES: These fees are effective October 1, 2017, through September 30, 2018. FOR FURTHER INFORMATION CONTACT: CDR Aimee Treffiletti, Chief, Vessel Sanitation Program, National Center for Environmental Health, Centers for Disease Control and Prevention, 4770 Buford Highway NE., MS F–59, Atlanta, Georgia 30341–3717; phone: 800–323– 2132, 770–488–7070, or 954–356–6650; email: vsp@cdc.gov. SUPPLEMENTARY INFORMATION: The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) announces fees for vessel sanitation inspections for Fiscal Year (FY) 2018. These inspections are conducted by HHS/ CDC’s Vessel Sanitation Program (VSP). Purpose and Background Total cost of VSP = Total cost of operating the program, such as administration, travel, staffing, sanitation inspections, and outbreak response. Weighted number of annual inspections = Total number of ships and inspections per year accounting for vessel size, number of inspectors needed for vessel size, travel logistics to conduct inspections, and vessel location and arrivals in U.S. jurisdiction per year. Fee asabaliauskas on DSKBBXCHB2PROD with NOTICES SUMMARY: The fee schedule was originally established and published in the Federal Register on July 17, 1987 (52 FR 27060). It was most recently published in the Federal Register on August 19, 2016 (81 FR 55460). The fee schedule for FY 2018 is presented in Appendix A. VerDate Sep<11>2014 17:45 Jul 14, 2017 Jkt 241001 HHS/CDC established the Vessel Sanitation Program (VSP) in the 1970s as a cooperative activity with the cruise ship industry. VSP helps the cruise ship industry prevent and control the introduction, transmission, and spread of gastrointestinal illnesses on cruise The fee schedule (Appendix A) will be effective October 1, 2017, through September 30, 2018. ships. VSP operates under the authority of the Public Health Service Act (Section 361 of the Public Health Service Act; 42 U.S.C. 264, ‘‘Control of Communicable Diseases’’). Regulations found at 42 CFR 71.41 (Foreign Quarantine—Requirements Upon Arrival at U.S. Ports: Sanitary Inspection; General Provisions) state that carriers arriving at U.S. ports from foreign areas are subject to sanitary inspections to determine whether rodent, insect, or other vermin infestations exist, contaminated food or water, or other sanitary conditions requiring measures for the prevention of the introduction, transmission, or spread of communicable diseases are present. The fee schedule for sanitation inspections of passenger cruise ships by VSP was first published in the Federal Register on November 24, 1987 (52 FR 45019). HHS/CDC began collecting fees on March 1, 1988. This notice announces fees that are effective for FY 2018, beginning on October 1, 2017, through September 30, 2018. The following formula will be used to determine the fees: Dated: July 12, 2017. Sandra Cashman, Executive Secretary, Centers for Disease Control and Prevention. Appendix A Applicability The fees will apply to all passenger cruise vessels for which inspections are conducted as part of HHS/CDC’s VSP. Inspections and reinspections involve the same procedures, require the same amount of time, and are therefore charged at the same rates. PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 FEE SCHEDULE FOR EACH VESSEL SIZE Vessel size (GRT 1) Extra Small (<3,000 GRT) .... Small (3,001–15,000 GRT) .. Medium (15,001–30,000 GRT) ................................. Large (30,001–60,000 GRT) Extra Large (60,001–120,000 GRT) ................................. E:\FR\FM\17JYN1.SGM 17JYN1 Inspection fee US$1,495 2,990 5,980 8,970 11,960 EN17JY17.000</GPH> 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.

Agencies

[Federal Register Volume 82, Number 135 (Monday, July 17, 2017)]
[Notices]
[Pages 32705-32707]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-14915]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-17-1054; Docket No. CDC-2017-0055]


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

[[Page 32706]]

for the selection of interventions to curb local epidemics of drug 
overdose.

DATES: Written comments must be received on or before September 15, 
2017.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2017-
0055 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 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 Leroy A. Richardson, 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.

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

    Drug Overdose Response Investigation (DORI) Data Collections (OMB 
control number 0920-1054, Expiration 03/31/218)--Extension--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 number 0920-1054) 
for a new OMB 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 an extension of this generic plan for 
another three-year period.
    Drug Overdose Response Investigation (DORI) are to be conducted in 
response 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. 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, abuse, and 
overdose. Such requests are typically, but not always, made through 
CDC's Epi-Aid mechanism; in most investigations, CDC's epidemiological 
response entails rapid and flexible collection of data that evolves 
during the investigation period.
    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. There are no costs to respondents other than their 
time.

[[Page 32707]]



                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
      Type of respondent            Form name        Number of     responses per   per response    Total burden
                                                    respondents     respondent      (in hours)         hours
----------------------------------------------------------------------------------------------------------------
Drug Overdose Response          Drug Overdose              2,700               1           30/60           1,350
 Investigation Participants.     Response
                                 Investigation
                                 Data Collection
                                 Instruments.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............            1350
----------------------------------------------------------------------------------------------------------------


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. 2017-14915 Filed 7-14-17; 8:45 am]
BILLING CODE 4163-18-P