Proposed Data Collection Submitted for Public Comment and Recommendations, 17604-17606 [2021-06881]

Download as PDF 17604 Federal Register / Vol. 86, No. 63 / Monday, April 5, 2021 / Notices Rhode Island; Southern Nevada Health District, Nevada; and Tennessee. The total annual time burden requested will be reduced by 766 hours for reasons described below. • Although the annual number of restaurants remains the same (n=400), we have reduced the number of respondents from ten to five food workers per restaurant. Thus, the total number of food workers to be interviewed is reduced from 4,000 to 2,000 per year. • The average time burden for food workers has been reduced from 20 minutes to 17 minutes per response for recruiting, informed consent, and interview. Thus, the total time burden for food workers is reduced from 1,333 to 500 hours per year. • There are no requested changes to the number of managers; however, their time burden has increased by 200 hours per year. We have transferred the respondent type for observation from health department staff in 2018 to the managers in 2021. Managers incur this additional time burden by allowing health department staff to conduct the observation activities in their establishments. This change does not result in any net difference in overall time burden requested but eliminates one respondent type. The total estimated annual burden requested is 1,011 hours. There is no cost to the respondents other than their time. ESTIMATED ANNUALIZED BURDEN HOURS Number of responses per respondent Average burden per response (in hours) Total burden (in hours) Form name Retail managers ................................ Manager Recruiting Script ............... Manager Interview/Assessment ....... Observation ...................................... Worker Recruiting Screener and Informed Consent. Worker Interview/Assessment .......... 889 400 400 2,000 1 1 1 1 3/60 30/60 30/60 2/60 44 200 200 67 2,000 1 15/60 500 ........................................................... ........................ ........................ ........................ 1,011 Retail food workers ........................... Total ........................................... Jeffrey M. Zirger, Lead, Information Collection Review Office, Office of Scientific Integrity, Office of Science, Centers for Disease Control and Prevention. [FR Doc. 2021–06883 Filed 4–2–21; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-2021–21DZ; Docket No. CDC–2021– 0031] 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 effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Harm Reduction Toolkit for NonPrescription Syringe Sales in Community Pharmacies. The aim of the SUMMARY: jbell on DSKJLSW7X2PROD with NOTICES Number of respondents Type of respondents VerDate Sep<11>2014 17:23 Apr 02, 2021 Jkt 253001 project is to create harm reduction products that can help: (1) Facilitate greater access to sterile syringes through pharmacy-based non-prescription syringe sales (NPSS), (2) minimize the burden of NPSS distribution on pharmacists, and (3) improve pharmacy personnel’s understanding of, and skills with, NPSS efforts. DATES: CDC must receive written comments on or before June 4, 2021. ADDRESSES: You may submit comments, identified by Docket No. CDC–2021– 0031 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– PO 00000 Frm 00019 Fmt 4703 Sfmt 4703 D74, Atlanta, Georgia 30329; phone: 404–639–7118; Email: omb@cdc.gov. 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 SUPPLEMENTARY INFORMATION: E:\FR\FM\05APN1.SGM 05APN1 17605 Federal Register / Vol. 86, No. 63 / Monday, April 5, 2021 / Notices 4. 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 submissions of responses. 5. Assess information collection costs. Proposed Project Harm Reduction Toolkit for NonPrescription Syringe Sales in Community Pharmacies—New— National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC). Background and Brief Description Injection drug use, through shared use of injection equipment, increases risk of acquiring blood borne pathogens such as HIV and hepatitis C virus (HCV). While stopping injection drug use is an optimal goal for preventing transmission of bloodborne pathogens among persons who inject drugs (PWID), it is not always achievable. However, use of sterile needles and syringes, for each injection, can significantly reduce risk of acquiring bloodborne pathogens and access to sterile syringes can reduce needle sharing among PWID. Community pharmacies are in a unique position to provide access to sterile syringes through nonprescription syringe sales (NPSS). Pharmacies are in this position partly because they are among the most accessible of healthcare settings. In fact, approximately 90% of urban costumers live within two miles of a pharmacy and 70% of rural costumers are within 15 miles of a pharmacy. Pharmacies also have extended hours of operations access to the online training videos for pharmacists and pharmacy personnel regarding NPSS and the post-test survey will be completed in the week following the one-week training period. An estimated 60 pharmacy personnel will complete the pre-test and post-test surveys. Data from the pre/post-test surveys will be collected entirely online. The purpose of the surveys is to assess pharmacy personnel’s skills and knowledge pertaining to NPSS before and after access to the NPSS online training. Data on pharmacy syringe sales and service referrals (e.g., referrals for HIV testing and substance use treatment) will be collected from each of the 12 participant pharmacies store or log records before and after the oneweek training period. Each participant pharmacy’s manager will conduct a onetime data collection of aggregated syringe sales and service referrals data from the 30-day period before and after the training period. The purpose of these data is to describe syringe sales and service referrals before and after pharmacy personnel’s access to the NPSS online training. Lastly, one project director will determine website usage of the training website and resource locator for PWID. Training website usage data will be paired with the pre-test and post-test surveys and skill scores and analyzed for correlations between usage and knowledge, comfort, and use of NPSS skills. The numbers of syringe customers and service referrals and usage of the resource website for PWID will be described. CDC requests OMB approval for an estimated 73 annual burden hours. There are no costs to respondents other than their time. making them more accessible to patients. While pharmacies represent potential sites for NPSS, education and tools are needed to build pharmacists’ NPSS-related skills and to support pharmacists in the delivery of NPSS and other harm reduction services. The overarching aim of this project is to create harm reduction products that can help: (1) Facilitate greater access to sterile syringes through pharmacy-based NPSS (2) minimize the burden of NPSS distribution on pharmacists, and (3) improve pharmacy personnel’s understanding of, and skills with, NPSS efforts. The project will demonstrate how pharmacy personnel can use a contractor developed harm reduction kit for PWID and online training videos for pharmacy personnel on NPSS, for HIV prevention. CDC requests OMB approval to collect standardized data from an in-field demonstration and evaluation of three contractor developed resources for harm reduction: Harm reduction kit for persons who inject drugs (PWID); online training videos for pharmacists and pharmacy personnel regarding NPSS; and a resource website for PWID. The in-field demonstration and evaluation will take place at 12 project pharmacies over one six-week period. The information collection has three primary components: (1) Online pre-test and post-test surveys (2) number of pharmacy syringe sales and service referrals, and (3) website usage (for the training website and the resource website for PWID). Pharmacy personnel who participate in the in-field demonstration will complete a one-time online pre-test survey and a one-time online post-test survey. The pre-test survey will be completed in the week prior to the participants being given jbell on DSKJLSW7X2PROD with NOTICES ESTIMATED ANNUALIZED BURDEN HOURS Number of responses per respondent Number of respondents Average burden per response (in hours) Total burden hours Type of respondents Form name Pharmacists and pharmacy technicians. Pharmacists and pharmacy technicians. Pharmacy manager ........................... Pre-test survey ................................. 60 1 30/60 30 Post-test survey ............................... 60 1 30/60 30 12 1 60/60 12 Project director .................................. Pharmacy syringe sales and service referrals. Website usage ................................. 1 1 15/60 1 Total ........................................... ........................................................... ........................ ........................ ........................ 73 VerDate Sep<11>2014 17:23 Apr 02, 2021 Jkt 253001 PO 00000 Frm 00020 Fmt 4703 Sfmt 4703 E:\FR\FM\05APN1.SGM 05APN1 17606 Federal Register / Vol. 86, No. 63 / Monday, April 5, 2021 / Notices Jeffrey M. Zirger, Lead, Information Collection Review Office, Office of Scientific Integrity, Office of Science, Centers for Disease Control and Prevention. [FR Doc. 2021–06881 Filed 4–2–21; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [Docket No. CDC–2021–0034] Advisory Committee on Immunization Practices (ACIP) Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Notice of meeting and request for comment. AGENCY: In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC), announces the following meeting of the Advisory Committee on Immunization Practices (ACIP). This meeting is open to the public. Time will be available for public comment. The meeting will be webcast live via the World Wide Web; for more information on ACIP please visit the ACIP website: https://www.cdc.gov/ vaccines/acip/. DATES: The meeting will be held on June 23–24, 2021, from 9:00 a.m. to 5:30 p.m., EDT (times subject to change). Written comments must be received on or before June 24, 2021. ADDRESSES: You may submit comments, identified by Docket No. CDC–2021– 0034 by any of the following methods: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. • Mail: Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS H24–8, Atlanta, Georgia 30329– 4027, Attn: June ACIP Meeting. Instructions: All submissions received must include the Agency name and Docket Number. All relevant comments received in conformance with the https://www.regulations.gov suitability policy will be posted without change to https://www.regulations.gov, including any personal information provided. For access to the docket to read background documents or comments received, go to https://www.regulations.gov. Written public comments submitted 72 hours prior to the ACIP meeting will be provided to ACIP members before the meeting. FOR FURTHER INFORMATION CONTACT: Stephanie Thomas, ACIP Committee jbell on DSKJLSW7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:23 Apr 02, 2021 Jkt 253001 Management Specialist, Centers for Disease Control and Prevention, National Center for Immunization and Respiratory Diseases, 1600 Clifton Road NE, MS–H24–8, Atlanta, Georgia 30329– 4027; Telephone: (404) 639–8367; Email: ACIP@cdc.gov. SUPPLEMENTARY INFORMATION: Purpose: The committee is charged with advising the Director, CDC, on the use of immunizing agents. In addition, under 42 U.S.C. 1396s, the committee is mandated to establish and periodically review and, as appropriate, revise the list of vaccines for administration to vaccine-eligible children through the Vaccines for Children (VFC) program, along with schedules regarding dosing interval, dosage, and contraindications to administration of vaccines. Further, under provisions of the Affordable Care Act, section 2713 of the Public Health Service Act, immunization recommendations of the ACIP that have been approved by the Director of the Centers for Disease Control and Prevention and appear on CDC immunization schedules must be covered by applicable health plans. Matters To Be Considered: The agenda will include discussions on cholera vaccine, dengue vaccine, ebola vaccine, hepatitis vaccines, herpes zoster vaccines, influenza vaccines, orthopoxvirus vaccine, pneumococcal vaccine, rabies vaccine and tickborne encephalitis vaccine. Recommendation votes on dengue vaccine, ebola vaccine, influenza vaccines and rabies vaccine are scheduled. Vaccines for Children (VFC) votes on dengue vaccine and influenza vaccines are scheduled. Agenda items are subject to change as priorities dictate. For more information on the meeting agenda visit https:// www.cdc.gov/vaccines/acip/meetings/ meetings-info.html. Meeting Information: The meeting will be webcast live via the World Wide Web; for more information on ACIP please visit the ACIP website: https:// www.cdc.gov/vaccines/acip/. Public Participation Interested persons or organizations are invited to participate by submitting written views, recommendations, and data. Please note that comments received, including attachments and other supporting materials, are part of the public record and are subject to public disclosure. Comments will be posted on https://www.regulations.gov. Therefore, do not include any information in your comment or supporting materials that you consider confidential or inappropriate for public disclosure. If you include your name, contact information, or other PO 00000 Frm 00021 Fmt 4703 Sfmt 9990 information that identifies you in the body of your comments, that information will be on public display. CDC will review all submissions and may choose to redact, or withhold, submissions containing private or proprietary information such as Social Security numbers, medical information, inappropriate language, or duplicate/ near duplicate examples of a mass-mail campaign. CDC will carefully consider all comments submitted into the docket. Oral Public Comment: This meeting will include time for members of the public to make an oral comment. Oral public comment will occur before any scheduled votes including all votes relevant to the ACIP’s Affordable Care Act and Vaccines for Children Program roles. Priority will be given to individuals who submit a request to make an oral public comment before the meeting according to the procedures below. Procedure for Oral Public Comment: All persons interested in making an oral public comment at the June 23–24, 2021, ACIP meeting must submit a request at https://www.cdc.gov/vaccines/ acip/meetings/ no later than 11:59 p.m., EDT, June 18, 2021, according to the instructions provided. If the number of persons requesting to speak is greater than can be reasonably accommodated during the scheduled time, CDC will conduct a lottery to determine the speakers for the scheduled public comment session. CDC staff will notify individuals regarding their request to speak by email by June 21, 2021. To accommodate the significant interest in participation in the oral public comment session of ACIP meetings, each speaker will be limited to 3 minutes, and each speaker may only speak once per meeting. Written Public Comment: The docket will be opened to receive written comments on June 1, 2021. Written comments must be received on or before June 24, 2021. The Director, Strategic Business Initiatives Unit, Office of the Chief Operating Officer, Centers for Disease Control and Prevention, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry. Kalwant Smagh, Director, Strategic Business Initiatives Unit, Office of the Chief Operating Officer, Centers for Disease Control and Prevention. [FR Doc. 2021–06904 Filed 4–2–21; 8:45 am] BILLING CODE 4163–18–P E:\FR\FM\05APN1.SGM 05APN1

Agencies

[Federal Register Volume 86, Number 63 (Monday, April 5, 2021)]
[Notices]
[Pages 17604-17606]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-06881]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-2021-21DZ; Docket No. CDC-2021-0031]


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 the opportunity to comment on a proposed and/or 
continuing information collection, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on a proposed 
information collection project titled Harm Reduction Toolkit for Non-
Prescription Syringe Sales in Community Pharmacies. The aim of the 
project is to create harm reduction products that can help: (1) 
Facilitate greater access to sterile syringes through pharmacy-based 
non-prescription syringe sales (NPSS), (2) minimize the burden of NPSS 
distribution on pharmacists, and (3) improve pharmacy personnel's 
understanding of, and skills with, NPSS efforts.

DATES: CDC must receive written comments on or before June 4, 2021.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2021-
0031 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: 404-639-7118; 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

[[Page 17605]]

    4. 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 
submissions of responses.
    5. Assess information collection costs.

Proposed Project

    Harm Reduction Toolkit for Non-Prescription Syringe Sales in 
Community Pharmacies--New--National Center for HIV/AIDS, Viral 
Hepatitis, STD and TB Prevention (NCHHSTP), Centers for Disease Control 
and Prevention (CDC).

Background and Brief Description

    Injection drug use, through shared use of injection equipment, 
increases risk of acquiring blood borne pathogens such as HIV and 
hepatitis C virus (HCV). While stopping injection drug use is an 
optimal goal for preventing transmission of bloodborne pathogens among 
persons who inject drugs (PWID), it is not always achievable. However, 
use of sterile needles and syringes, for each injection, can 
significantly reduce risk of acquiring bloodborne pathogens and access 
to sterile syringes can reduce needle sharing among PWID.
    Community pharmacies are in a unique position to provide access to 
sterile syringes through non-prescription syringe sales (NPSS). 
Pharmacies are in this position partly because they are among the most 
accessible of healthcare settings. In fact, approximately 90% of urban 
costumers live within two miles of a pharmacy and 70% of rural 
costumers are within 15 miles of a pharmacy. Pharmacies also have 
extended hours of operations making them more accessible to patients. 
While pharmacies represent potential sites for NPSS, education and 
tools are needed to build pharmacists' NPSS-related skills and to 
support pharmacists in the delivery of NPSS and other harm reduction 
services.
    The overarching aim of this project is to create harm reduction 
products that can help: (1) Facilitate greater access to sterile 
syringes through pharmacy-based NPSS (2) minimize the burden of NPSS 
distribution on pharmacists, and (3) improve pharmacy personnel's 
understanding of, and skills with, NPSS efforts. The project will 
demonstrate how pharmacy personnel can use a contractor developed harm 
reduction kit for PWID and online training videos for pharmacy 
personnel on NPSS, for HIV prevention.
    CDC requests OMB approval to collect standardized data from an in-
field demonstration and evaluation of three contractor developed 
resources for harm reduction: Harm reduction kit for persons who inject 
drugs (PWID); online training videos for pharmacists and pharmacy 
personnel regarding NPSS; and a resource website for PWID. The in-field 
demonstration and evaluation will take place at 12 project pharmacies 
over one six-week period. The information collection has three primary 
components: (1) Online pre-test and post-test surveys (2) number of 
pharmacy syringe sales and service referrals, and (3) website usage 
(for the training website and the resource website for PWID). Pharmacy 
personnel who participate in the in-field demonstration will complete a 
one-time online pre-test survey and a one-time online post-test survey. 
The pre-test survey will be completed in the week prior to the 
participants being given access to the online training videos for 
pharmacists and pharmacy personnel regarding NPSS and the post-test 
survey will be completed in the week following the one-week training 
period. An estimated 60 pharmacy personnel will complete the pre-test 
and post-test surveys. Data from the pre/post-test surveys will be 
collected entirely online. The purpose of the surveys is to assess 
pharmacy personnel's skills and knowledge pertaining to NPSS before and 
after access to the NPSS online training. Data on pharmacy syringe 
sales and service referrals (e.g., referrals for HIV testing and 
substance use treatment) will be collected from each of the 12 
participant pharmacies store or log records before and after the one-
week training period. Each participant pharmacy's manager will conduct 
a one-time data collection of aggregated syringe sales and service 
referrals data from the 30-day period before and after the training 
period. The purpose of these data is to describe syringe sales and 
service referrals before and after pharmacy personnel's access to the 
NPSS online training. Lastly, one project director will determine 
website usage of the training website and resource locator for PWID. 
Training website usage data will be paired with the pre-test and post-
test surveys and skill scores and analyzed for correlations between 
usage and knowledge, comfort, and use of NPSS skills. The numbers of 
syringe customers and service referrals and usage of the resource 
website for PWID will be described.
    CDC requests OMB approval for an estimated 73 annual burden hours. 
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 respondents           Form name       respondents    responses per   response (in        hours
                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
Pharmacists and pharmacy        Pre-test survey.              60               1           30/60              30
 technicians.
Pharmacists and pharmacy        Post-test survey              60               1           30/60              30
 technicians.
Pharmacy manager..............  Pharmacy syringe              12               1           60/60              12
                                 sales and
                                 service
                                 referrals.
Project director..............  Website usage...               1               1           15/60               1
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............              73
----------------------------------------------------------------------------------------------------------------



[[Page 17606]]

Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2021-06881 Filed 4-2-21; 8:45 am]
BILLING CODE 4163-18-P


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