Proposed Data Collection Submitted for Public Comment and Recommendations, 53313-53315 [2021-20843]

Download as PDF lotter on DSK11XQN23PROD with NOTICES1 Federal Register / Vol. 86, No. 184 / Monday, September 27, 2021 / Notices for Surveillance, Epidemiology and Laboratory Services, Office of Public Health Scientific Services, Centers for Disease Control and Prevention, 1600 Clifton Road NE, Mailstop V24–3, Atlanta, Georgia 30329–4018, Telephone: (404) 498–2741; or via email at CLIAC@cdc.gov. FOR FURTHER INFORMATION CONTACT: Heather Stang, MS, Deputy Chief, Quality and Safety Systems Branch, Division of Laboratory Systems, Center for Surveillance, Epidemiology and Laboratory Services, Office of Public Health Scientific Services, Centers for Disease Control and Prevention, 1600 Clifton Road NE, Mailstop V24–3, Atlanta, Georgia 30329–4018, Telephone: (404) 498–2769; HStang@ cdc.gov. SUPPLEMENTARY INFORMATION: The Committee includes three ex officio members (or designees), including the Director, CDC; the Administrator, Centers for Medicare & Medicaid Services (CMS); and the Commissioner, Food and Drug Administration (FDA). A nonvoting representative from the Advanced Medical Technology Association (AdvaMed) serves as the industry liaison. The Designated Federal Official (DFO) or their designee and the Executive Secretary are present at all meetings to ensure meetings are within applicable statutory, regulatory, and HHS General Administration manual directives. Nominations are being sought for individuals who have the expertise and qualifications necessary to contribute to the accomplishments of the committee’s objectives. Nominees will be selected based on expertise in the fields of microbiology (including bacteriology, mycobacteriology, mycology, parasitology, and virology), immunology (including histocompatibility), chemistry, hematology, pathology (including histopathology and cytology), or genetic testing (including cytogenetics); from representatives in the fields of medical technology, bioinformatics, public health, and clinical practice; and from consumer representatives. Federal employees will not be considered for membership. Members may be invited to serve for up to four-year terms. Selection of members is based on candidates’ qualifications to contribute to the accomplishment of CLIAC objectives (https://www.cdc.gov/cliac/). The U.S. Department of Health and Human Services policy stipulates that committee membership be balanced in terms of points of view represented, and the committee’s function. Appointments shall be made without discrimination VerDate Sep<11>2014 18:08 Sep 24, 2021 Jkt 253001 on the basis of age, race, ethnicity, gender, sexual orientation, gender identity, HIV status, disability, and cultural, religious, or socioeconomic status. Nominees must be U.S. citizens, and cannot be full-time employees of the U.S. Government. Current participation on federal workgroups or prior experience serving on a federal advisory committee does not disqualify a candidate; however, HHS policy is to avoid excessive individual service on advisory committees and multiple committee memberships. Committee members are Special Government Employees (SGEs), requiring the filing of financial disclosure reports at the beginning and annually during their terms. CDC reviews potential candidates for CLIAC membership each year and provides a slate of nominees for consideration to the Secretary of HHS for final selection. HHS notifies selected candidates of their appointment near the start of the term in July, or as soon as the HHS selection process is completed. Note that the need for different expertise varies from year to year and a candidate who is not selected in one year may be reconsidered in a subsequent year. Candidates should submit the following items: D Current curriculum vitae, including complete contact information (telephone numbers, mailing address, email address). D At least one letter of recommendation from person(s) not employed by the U.S. Department of Health and Human Services. (Candidates may submit letter(s) from current HHS employees if they wish, but at least one letter must be submitted by a person not employed by an HHS agency (e.g., CDC, NIH, FDA, etc.). Nominations may be submitted by the candidate, or by the person/organization recommending the candidate. 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. 2021–20925 Filed 9–24–21; 8:45 am] BILLING CODE 4163–18–P PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 53313 DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day–21–21IE; Docket No. CDC–2021– 0103] 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 Understanding Health System Approaches to Chronic Pain Management. The proposed study is designed to evaluate the effects of evidence-based guidelines related to chronic pain management and opioid prescribing. SUMMARY: CDC must receive written comments on or before November 26, 2021. DATES: You may submit comments, identified by Docket No. CDC–2021– 0103 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 H21–8, 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. ADDRESSES: Please note: Submit all comments through the Federal eRulemaking portal (regulations.gov) or by U.S. mail to the address listed above. 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 FOR FURTHER INFORMATION CONTACT: E:\FR\FM\27SEN1.SGM 27SEN1 53314 Federal Register / Vol. 86, No. 184 / Monday, September 27, 2021 / Notices H21–8, 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 Understanding Health System Approaches to Chronic Pain Management—New—National Center for Injury Prevention and Control Opioids for Chronic Pain’’) through the ‘‘Generic Clearance for the Collection of Routine Customer Feedback’’ (OMB Control No. 0920–1050). This brief eligibility assessment consisting of surveys was sent to approximately 250 health systems to understand the landscape of health systems and the types of guidelines or policies implemented, and what strategies were used to do so. Of 250 health systems contacted, 46 responded and were considered for the following preliminary phase—the evaluability assessment. The purpose of this data collection effort is to: (1) Obtain an enhanced understanding of facilitators and barriers to guideline-concordant management of chronic pain and opioid prescribing (including access to MOUD) at the health system level, in order to improve patient outcomes while maximizing patient safety and to facilitate uptake by clinicians and health systems, (2) describe unintended benefits and consequences to guideline/ policy implementation, and (3) identify racial and ethnic disparities in guideline/policy implementation. This mixed-methods, pre-post evaluation of health systems’ implementation of chronic pain management and opioid prescribing policies/guidelines, and the resultant outcomes requires both primary data collection (such as surveys, key informant interviews, focus groups, etc.), and secondary data collection (such as administrative, EHR, pharmacy dispensing, prescribing data, etc.) efforts to adequately answer the research questions. While secondary data (QI measures) from health system EHRs will provide longitudinal pre-post measures, primary data is needed to understand the characteristics and mechanisms of practice and patient change that can be attributed to the policies and guidelines. The total burden is estimated to be 577 hours annually. There are no direct costs to respondents other than their time to participate in the study. (NCIPC), Centers for Disease Control and Prevention (CDC). Background and Brief Description CDC requests OMB approval for three years for this new data collection. This study will evaluate the effects of evidence-based guidelines related to chronic pain management and opioid prescribing, including access to medications for opioid use disorder (MOUD) for patients and clinicians in primary care settings among a diverse sample of health systems. Since 1999, nearly 841,000 people have died from drug overdose in the United States. Over 70% of drug overdose deaths in 2019 involved an opioid. From 1999 to 2019, nearly 247,000 people died in the United States from overdoses involving prescription opioids, with rates of deaths involving prescription opioids more than quadrupling from 1999 to 2019. In response, a range of clinical practice guidelines, policies, and regulations have been released in recent years to address the opioid overdose epidemic, with the goals of supporting safer opioid prescribing, improving diagnosis and treatment of OUD, and reducing overdose deaths in the United States. To design this evaluation, we previously conducted and completed a ‘‘Feasibility Assessment of Health Systems’’ via surveys to determine the range of policies and guidelines being implemented by health systems, followed by an ‘‘evaluability assessment’’ by means of interviews with leaders of nine health systems. For the purposes of this evaluation, ‘‘Chronic pain management policies/ guidelines’’ refers to policies/guidelines that may include prescribing of opioid medications, nonpharmacologic therapies, and/or non-opioid medications for chronic pain, as well as OUD assessment and treatment. In early 2020, CDC requested OMB approval for a Feasibility Assessment of Health Systems (‘‘Feedback on the use of the CDC Guideline for Prescribing lotter on DSK11XQN23PROD with NOTICES1 ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Number of responses per respondent Average burden per response (in hours) Total burden (in hours) Type of respondent Form name Patient ............................................... Treatment facility staff (Including primary care clinicians, health system leaders, and other system staff and representatives). Patient Survey .................................. Primary Care Clinician Survey ......... Invitation/Follow up Email ................ 667 1,313 1,980 1 1 2 10/60 10/60 3/60 111 219 198 Health System Leaders Group Interview Guide. Case Study Interview Guide ............ 17 1 1 17 30 1 30/60 15 VerDate Sep<11>2014 18:08 Sep 24, 2021 Jkt 253001 PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 E:\FR\FM\27SEN1.SGM 27SEN1 53315 Federal Register / Vol. 86, No. 184 / Monday, September 27, 2021 / Notices ESTIMATED ANNUALIZED BURDEN HOURS—Continued Type of respondent Member Checking (Validation) Sessions Interview Guide. Total ........................................... ........................................................... Jeffrey M. Zirger, Lead, Information Collection Review Office, Office of Scientific Integrity, Office of Science, Centers for Disease Control and Prevention. [FR Doc. 2021–20843 Filed 9–24–21; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention 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 existing information collection project titled the CDC Worksite Health Scorecard. The collection is an organizational assessment and planning tool designed to help employers identify gaps in their health promotion programs and prioritize high-impact strategies for health promotion at their worksites. DATES: CDC must receive written comments on or before November 26, 2021. SUMMARY: You may submit comments, identified by Docket No. CDC–2021– 0099 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 lotter on DSK11XQN23PROD with NOTICES1 VerDate Sep<11>2014 18:08 Sep 24, 2021 Jkt 253001 1 17 ........................ ........................ ........................ 577 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 H21–8, Atlanta, Georgia 30329; phone: 404–639–7570; 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; SUPPLEMENTARY INFORMATION: Frm 00054 Fmt 4703 Total burden (in hours) 1 Clifton Road NE, MS H21–8, 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. PO 00000 Average burden per response (in hours) 17 FOR FURTHER INFORMATION CONTACT: [60Day–21–1014; Docket No. CDC–2021– 0099] ADDRESSES: Number of responses per respondent Number of respondents Form name Sfmt 4703 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 CDC Worksite Health ScoreCard (CDC ScoreCard) (OMB Control No. 0920– 1014, Exp. 3/31/2022)—Extension— National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC). Background and Brief Description In the United States, chronic diseases such as heart disease, obesity, and diabetes are among the leading causes of death and disability. Although chronic diseases are among the most common and costly health problems, they are also among the most preventable. Adopting healthy behaviors—such as eating nutritious foods, being physically active, and avoiding tobacco use—can prevent the devastating effects and reduce the rates of these diseases. Employers are recognizing the role they can play in creating healthy work environments and providing employees with opportunities to make healthy lifestyle choices. To support these efforts, the Centers for Disease Control and Prevention (CDC) developed an online organizational assessment tool called the CDC Worksite Health Scorecard. The CDC Worksite Health Scorecard is a tool designed to help employers assess whether they have implemented evidence-based health promotion interventions or strategies in their worksites to prevent heart disease, stroke, and related conditions such as hypertension, diabetes, and obesity. The assessment contains 151 core yes/no questions with an additional 20 optional demographic questions divided into 19 E:\FR\FM\27SEN1.SGM 27SEN1

Agencies

[Federal Register Volume 86, Number 184 (Monday, September 27, 2021)]
[Notices]
[Pages 53313-53315]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-20843]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-21-21IE; Docket No. CDC-2021-0103]


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 Understanding Health System 
Approaches to Chronic Pain Management. The proposed study is designed 
to evaluate the effects of evidence-based guidelines related to chronic 
pain management and opioid prescribing.

DATES: CDC must receive written comments on or before November 26, 
2021.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2021-
0103 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 H21-8, 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

[[Page 53314]]

H21-8, 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

    Understanding Health System Approaches to Chronic Pain Management--
New--National Center for Injury Prevention and Control (NCIPC), Centers 
for Disease Control and Prevention (CDC).

Background and Brief Description

    CDC requests OMB approval for three years for this new data 
collection. This study will evaluate the effects of evidence-based 
guidelines related to chronic pain management and opioid prescribing, 
including access to medications for opioid use disorder (MOUD) for 
patients and clinicians in primary care settings among a diverse sample 
of health systems.
    Since 1999, nearly 841,000 people have died from drug overdose in 
the United States. Over 70% of drug overdose deaths in 2019 involved an 
opioid. From 1999 to 2019, nearly 247,000 people died in the United 
States from overdoses involving prescription opioids, with rates of 
deaths involving prescription opioids more than quadrupling from 1999 
to 2019. In response, a range of clinical practice guidelines, 
policies, and regulations have been released in recent years to address 
the opioid overdose epidemic, with the goals of supporting safer opioid 
prescribing, improving diagnosis and treatment of OUD, and reducing 
overdose deaths in the United States.
    To design this evaluation, we previously conducted and completed a 
``Feasibility Assessment of Health Systems'' via surveys to determine 
the range of policies and guidelines being implemented by health 
systems, followed by an ``evaluability assessment'' by means of 
interviews with leaders of nine health systems. For the purposes of 
this evaluation, ``Chronic pain management policies/guidelines'' refers 
to policies/guidelines that may include prescribing of opioid 
medications, nonpharmacologic therapies, and/or non-opioid medications 
for chronic pain, as well as OUD assessment and treatment.
    In early 2020, CDC requested OMB approval for a Feasibility 
Assessment of Health Systems (``Feedback on the use of the CDC 
Guideline for Prescribing Opioids for Chronic Pain'') through the 
``Generic Clearance for the Collection of Routine Customer Feedback'' 
(OMB Control No. 0920-1050). This brief eligibility assessment 
consisting of surveys was sent to approximately 250 health systems to 
understand the landscape of health systems and the types of guidelines 
or policies implemented, and what strategies were used to do so. Of 250 
health systems contacted, 46 responded and were considered for the 
following preliminary phase--the evaluability assessment.
    The purpose of this data collection effort is to: (1) Obtain an 
enhanced understanding of facilitators and barriers to guideline-
concordant management of chronic pain and opioid prescribing (including 
access to MOUD) at the health system level, in order to improve patient 
outcomes while maximizing patient safety and to facilitate uptake by 
clinicians and health systems, (2) describe unintended benefits and 
consequences to guideline/policy implementation, and (3) identify 
racial and ethnic disparities in guideline/policy implementation.
    This mixed-methods, pre-post evaluation of health systems' 
implementation of chronic pain management and opioid prescribing 
policies/guidelines, and the resultant outcomes requires both primary 
data collection (such as surveys, key informant interviews, focus 
groups, etc.), and secondary data collection (such as administrative, 
EHR, pharmacy dispensing, prescribing data, etc.) efforts to adequately 
answer the research questions. While secondary data (QI measures) from 
health system EHRs will provide longitudinal pre-post measures, primary 
data is needed to understand the characteristics and mechanisms of 
practice and patient change that can be attributed to the policies and 
guidelines.
    The total burden is estimated to be 577 hours annually. There are 
no direct costs to respondents other than their time to participate in 
the study.

                                        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)      (in hours)
----------------------------------------------------------------------------------------------------------------
Patient.......................  Patient Survey..             667               1           10/60             111
Treatment facility staff        Primary Care               1,313               1           10/60             219
 (Including primary care         Clinician                 1,980               2            3/60             198
 clinicians, health system       Survey.
 leaders, and other system      Invitation/
 staff and representatives).     Follow up Email.
                                Health System                 17               1               1              17
                                 Leaders Group
                                 Interview Guide.
                                Case Study                    30               1           30/60              15
                                 Interview Guide.

[[Page 53315]]

 
                                Member Checking               17               1               1              17
                                 (Validation)
                                 Sessions
                                 Interview Guide.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............             577
----------------------------------------------------------------------------------------------------------------


Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2021-20843 Filed 9-24-21; 8:45 am]
BILLING CODE 4163-18-P