Proposed Data Collection Submitted for Public Comment and Recommendations, 38098-38100 [2021-15228]

Download as PDF 38098 Federal Register / Vol. 86, No. 135 / Monday, July 19, 2021 / Notices lotter on DSK11XQN23PROD with NOTICES1 evolving COVID–19 vaccine development and regulatory processes. The Secretary of Health and Human Services has determined that COVID–19 is a Public Health Emergency. A notice of this ACIP meeting has also been posted on CDC’s ACIP website at: http:// www.cdc.gov/vaccines/acip/index.html. In addition, CDC has sent notice of this ACIP meeting by email to those who subscribe to receive email updates about ACIP. 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 COVID–19 vaccine safety. 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: http:// www.cdc.gov/vaccines/acip/index.html. 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 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 VerDate Sep<11>2014 18:23 Jul 16, 2021 Jkt 253001 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. Written Public Comment: Written comments must be received on or before July 22, 2021. 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 July 22, 2021, ACIP meeting must submit a request at http://www.cdc.gov/vaccines/acip/ meetings/ no later than 11:59 p.m., EDT, July 20, 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 12:00 p.m., EDT, July 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. 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. 2021–15322 Filed 7–14–21; 4:15 pm] BILLING CODE 4163–18–P PO 00000 Frm 00112 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day–21–21GO; Docket No. CDC–2021– 0068] 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 Evaluating the use of EHMRs in health settings to improve organizational implementation and worker adoption during and after the COVID–19 pandemic. NIOSH proposes using surveys and interviews to understand how elastomeric half mask respirators (EHMRs) are being perceived and used by healthcare and first responder settings during the COVID–19 pandemic. DATES: CDC must receive written comments on or before September 17, 2021. SUMMARY: You may submit comments, identified by Docket No. CDC–2021– 0068 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, ADDRESSES: E:\FR\FM\19JYN1.SGM 19JYN1 38099 Federal Register / Vol. 86, No. 135 / Monday, July 19, 2021 / Notices 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 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; 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; and 5. Assess information collection costs. Proposed Project Evaluating the use of EHMRs in health settings to improve organizational implementation and worker adoption during and after the COVID–19 pandemic—New—National that posted in September 2020, titled, ‘‘A National Elastomeric Half Mask Respirator (EHMR) Strategy for Use in Healthcare Settings During an Infectious Disease Outbreak/Pandemic.’’—Vol. 85, No. 178. The announcement requested information regarding the deployment and use of EHMRs in healthcare settings and first responder organizations during the COVID–19 crisis. This proposed study involves conducting surveys and interviews. Individual workers who receive EHMRs from their organization will have the option to voluntarily participate in a pre-/post-survey. Voluntary data collection at the organizational level with members of management will occur using an interview format that follows a semi-structured approach to capture information throughout the duration of NIOSH’s research study. Individual workers (via surveys) and organization management (via interviews) will participate in data collection activities over a period of approximately 4–9 months to assess perceptions, knowledge, attitudes, and experiences using EHMRs as well as best practices for adoption and implementation of EHMRs at their organizations. Individuals who are asked to respond are those who notified NIOSH of their interest of participating in the study. Respondents are expected to include a variety of job types including industrial hygienists, occupational health professionals, infection control professionals, physicians, nurse practitioners, nurses, infection preventionists, fire department chiefs, battalion chiefs, sheriffs, shift supervisors, firefighters, police officers, and paramedics. A multi-site approach is necessary to answer and further validate findings related to the study objectives. By conducting several studies at healthcare and first responder locations, NIOSH researchers can make the case for research progression, which enhances the reliability and validity of any revised guidance. NIOSH requests approval for a total of 42,877 estimated burden hours. There are no costs to respondents other than their time to participate. Institute of Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC). Background and Brief Description CDC/NIOSH is requesting approval of a new data collection for a period of two years under the project titled ‘‘Evaluating the use of EHMRs in health settings to improve organizational implementation and worker adoption during and after the COVID–19 pandemic.’’ The data collection activities were initiated under the Public Health Emergency PRA waiver. NIOSH has the responsibility to conduct research relating to innovative methods, techniques, and approaches dealing with occupational safety and health problems. Additionally, OSHA’s Emergency Temporary Standard (ETS) for COVID–19 in Healthcare released in June 2021 (29 CFR 1910, Subpart U) is facilitating the need for this work. Finally, during the nationwide shortage of filtering facepiece respirators (FFRs), the Food and Drug Administration (FDA) issued an emergency use authorization (EUA), allowing the use of all NIOSH-approved respiratory protective devices in healthcare settings during the pandemic—of which elastomeric half mask respirators (EHMRs) were included (85 FR 17335, March 27, 2020). This EUA was provided for alternative FFR use in healthcare settings to prevent wearer (i.e., worker) exposure to airborne particulates because of the COVID–19 pandemic and the life-threatening illness it can cause (FDA, 2020). Currently, organizations are being confronted with the use of new respiratory protection and questions on how to best support its implementation during the pandemic. To that end, the purpose of this demonstration research study is to assess the integration of EHMRs in various healthcare and first responder settings and subsequently update and enhance EHMR best practices and implementation guidelines to encourage adoption and consequently, reduce PPE supply shortages during the current and future pandemics. This project is supported through a NIOSH Federal Register Notice (FRN) lotter on DSK11XQN23PROD with NOTICES1 ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Type of respondent Form name Organizational manager/POC ....................... Informed Consent ................. Time 1 Interview ................... Time 2 Interview ................... Time 3 Interview ................... VerDate Sep<11>2014 18:23 Jul 16, 2021 Jkt 253001 PO 00000 Frm 00113 Fmt 4703 Sfmt 4703 Number of responses per respondent 150 150 150 150 E:\FR\FM\19JYN1.SGM 3 1 1 1 19JYN1 Average burden per response (in hours) 5/60 45/60 45/60 45/60 Total burden hours 38 113 113 113 38100 Federal Register / Vol. 86, No. 135 / Monday, July 19, 2021 / Notices ESTIMATED ANNUALIZED BURDEN HOURS—Continued Average burden per response (in hours) Total burden hours Form name Individual Healthcare/First Responder ......... Informed Consent ................. Baseline Survey .................... Follow-up Survey .................. 51,000 51,000 51,000 2 1 1 5/60 20/60 20/60 8,500 17,000 17,000 Total ....................................................... ............................................... ........................ ........................ ........................ 42,877 Jeffrey M. Zirger, Lead, Information Collection Review Office, Office of Scientific Integrity, Office of Science, Centers for Disease Control and Prevention. [FR Doc. 2021–15228 Filed 7–16–21; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day–21–1244; Docket No. CDC–2021– 0063] 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 an Extension of a previously approved information collection project titled Assessment of Occupational Injury among Fire Fighters Using a Followback Survey. The purpose of this project is to collect follow-back telephone interview data from injured and exposed firefighters treated in emergency departments (EDs) and produce a descriptive summary of these injuries and exposures. DATES: CDC must receive written comments on or before September 17, 2021. ADDRESSES: You may submit comments, identified by Docket No. CDC–2021– 0063 by any of the following methods: • Federal eRulemaking Portal: Regulations.gov. Follow the instructions for submitting comments. SUMMARY: lotter on DSK11XQN23PROD with NOTICES1 Number of responses per respondent Number of respondents Type of respondent VerDate Sep<11>2014 18:23 Jul 16, 2021 Jkt 253001 • 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. 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, PO 00000 Frm 00114 Fmt 4703 Sfmt 4703 including the validity of the methodology and assumptions used; 3. Enhance the quality, utility, and clarity of the information to be collected; 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; and 5. Assess information collection costs. Proposed Project Assessment of Occupational Injury among Fire Fighters Using a Followback Survey (OMB Control No. 0920– 1244)—Extension—National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC). Background and Brief Description Studies have reported that firefighters have high rates of non-fatal injuries and illnesses as compared to the general worker population. As firefighters perform critical public safety activities and protect the safety and health of the public, it follows that understanding and preventing injuries and exposures among firefighters will have a benefit reaching beyond the workers to the public. As mandated in the Occupational Safety and Health Act of 1970 (Pub. L. 91–596), the mission of NIOSH is to conduct research and investigations on occupational safety and health. Related to this mission, the purpose of this project is to conduct research that will provide a detailed description of nonfatal occupational injuries and exposures incurred by firefighters. This information will offer detailed insight into events that lead to the largest number of nonfatal injuries and exposures among firefighters. The project will use two related data sources. The first source is data abstracted from medical records of firefighters treated in a nationally stratified sample of emergency E:\FR\FM\19JYN1.SGM 19JYN1

Agencies

[Federal Register Volume 86, Number 135 (Monday, July 19, 2021)]
[Notices]
[Pages 38098-38100]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-15228]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-21-21GO; Docket No. CDC-2021-0068]


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 Evaluating the use of EHMRs in 
health settings to improve organizational implementation and worker 
adoption during and after the COVID-19 pandemic. NIOSH proposes using 
surveys and interviews to understand how elastomeric half mask 
respirators (EHMRs) are being perceived and used by healthcare and 
first responder settings during the COVID-19 pandemic.

DATES: CDC must receive written comments on or before September 17, 
2021.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2021-
0068 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,

[[Page 38099]]

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;
    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; and
    5. Assess information collection costs.

Proposed Project

    Evaluating the use of EHMRs in health settings to improve 
organizational implementation and worker adoption during and after the 
COVID-19 pandemic--New--National Institute of Occupational Safety and 
Health (NIOSH), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

    CDC/NIOSH is requesting approval of a new data collection for a 
period of two years under the project titled ``Evaluating the use of 
EHMRs in health settings to improve organizational implementation and 
worker adoption during and after the COVID-19 pandemic.'' The data 
collection activities were initiated under the Public Health Emergency 
PRA waiver. NIOSH has the responsibility to conduct research relating 
to innovative methods, techniques, and approaches dealing with 
occupational safety and health problems. Additionally, OSHA's Emergency 
Temporary Standard (ETS) for COVID-19 in Healthcare released in June 
2021 (29 CFR 1910, Subpart U) is facilitating the need for this work. 
Finally, during the nationwide shortage of filtering facepiece 
respirators (FFRs), the Food and Drug Administration (FDA) issued an 
emergency use authorization (EUA), allowing the use of all NIOSH-
approved respiratory protective devices in healthcare settings during 
the pandemic--of which elastomeric half mask respirators (EHMRs) were 
included (85 FR 17335, March 27, 2020). This EUA was provided for 
alternative FFR use in healthcare settings to prevent wearer (i.e., 
worker) exposure to airborne particulates because of the COVID-19 
pandemic and the life-threatening illness it can cause (FDA, 2020).
    Currently, organizations are being confronted with the use of new 
respiratory protection and questions on how to best support its 
implementation during the pandemic. To that end, the purpose of this 
demonstration research study is to assess the integration of EHMRs in 
various healthcare and first responder settings and subsequently update 
and enhance EHMR best practices and implementation guidelines to 
encourage adoption and consequently, reduce PPE supply shortages during 
the current and future pandemics.
    This project is supported through a NIOSH Federal Register Notice 
(FRN) that posted in September 2020, titled, ``A National Elastomeric 
Half Mask Respirator (EHMR) Strategy for Use in Healthcare Settings 
During an Infectious Disease Outbreak/Pandemic.''--Vol. 85, No. 178. 
The announcement requested information regarding the deployment and use 
of EHMRs in healthcare settings and first responder organizations 
during the COVID-19 crisis.
    This proposed study involves conducting surveys and interviews. 
Individual workers who receive EHMRs from their organization will have 
the option to voluntarily participate in a pre-/post-survey. Voluntary 
data collection at the organizational level with members of management 
will occur using an interview format that follows a semi-structured 
approach to capture information throughout the duration of NIOSH's 
research study. Individual workers (via surveys) and organization 
management (via interviews) will participate in data collection 
activities over a period of approximately 4-9 months to assess 
perceptions, knowledge, attitudes, and experiences using EHMRs as well 
as best practices for adoption and implementation of EHMRs at their 
organizations. Individuals who are asked to respond are those who 
notified NIOSH of their interest of participating in the study. 
Respondents are expected to include a variety of job types including 
industrial hygienists, occupational health professionals, infection 
control professionals, physicians, nurse practitioners, nurses, 
infection preventionists, fire department chiefs, battalion chiefs, 
sheriffs, shift supervisors, firefighters, police officers, and 
paramedics.
    A multi-site approach is necessary to answer and further validate 
findings related to the study objectives. By conducting several studies 
at healthcare and first responder locations, NIOSH researchers can make 
the case for research progression, which enhances the reliability and 
validity of any revised guidance.
    NIOSH requests approval for a total of 42,877 estimated burden 
hours. There are no costs to respondents other than their time to 
participate.

                                        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)
----------------------------------------------------------------------------------------------------------------
Organizational manager/POC....  Informed Consent             150               3            5/60              38
                                Time 1 Interview             150               1           45/60             113
                                Time 2 Interview             150               1           45/60             113
                                Time 3 Interview             150               1           45/60             113

[[Page 38100]]

 
Individual Healthcare/First     Informed Consent          51,000               2            5/60           8,500
 Responder.
                                Baseline Survey.          51,000               1           20/60          17,000
                                Follow-up Survey          51,000               1           20/60          17,000
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............          42,877
----------------------------------------------------------------------------------------------------------------


Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2021-15228 Filed 7-16-21; 8:45 am]
BILLING CODE 4163-18-P