Proposed Data Collection Submitted for Public Comment and Recommendations, 5237-5239 [2024-01550]

Download as PDF 5237 Federal Register / Vol. 89, No. 18 / Friday, January 26, 2024 / Notices Proposed Project Preventive Health and Health Services Block Grant (OMB Control No. 0920– 0106, Exp. 2/29/2024)—Revision— National Center for State, Tribal, Local and Territorial Public Health Infrastructure and Workforce (NCSTLTPHIW), Centers for Disease Control and Prevention (CDC). Background and Brief Description The CDC’s National Center for State, Tribal, Local and Territorial Public Health Infrastructure and Workforce (NCSTLTPHIW) plays a vital role in helping health agencies work to enhance their capacity and improve their performance to strengthen the public health system on all levels. NCSTLTPHIW is CDC’s primary connection to health officials and leaders of State, Tribal, local, and Territorial public health agencies, as well as other government leaders who work with health departments. NCSTLTPHIW administers the Preventive Health and Health Services Block Grant (PHHSBG) for health promotion and disease prevention programs. Sixty-one (61) recipients (50 states, the District of Columbia, two American Indian Tribes, five U.S. territories, and three freely associated states) receive block grant funds to address locally-defined public health needs in innovative ways. The PHHSBG allows awardees to prioritize the use of funds to fill funding gaps in programs that deal with leading causes of death and disability, as well as the ability to respond rapidly to emerging health issues, including outbreaks of foodborne infections and water-borne diseases. As specified in the authorizing legislation for the PHHSBG, CDC collects information from recipients to monitor their objectives and activities. Since 2021, this information has been reported through a web-based electronic system, the Block Grant Information System (BGIS). Each recipient is required to submit a work plan with its selected health outcome objectives, as well as descriptions of the health problems, identified target populations (including portions of those populations disproportionately affected by the health problems), and activities to be addressed in the planned work. In this Revision, CDC requests OMB approval to subdivide the previously approved annual Workplan (12 hours) into two sections: the ‘‘Workplan Start and Advisory Committee Questions Worksheet’’ (two hours) and the ‘‘Workplan Program Questions Worksheet’’ (10 hours). There are no changes to the previously approved questions or the net annualized burden estimate for the Workplan (732 hours). However, questions have been regrouped to improve logical flow, and selected instructions to respondents have been revised for clarity and ease of use. The Annual Progress Report will be continued without changes in total burden hours (671 annualized burden hours), though the burden table is revised to describe how program collects two different sets of questions within the Annual Progress Report (Interim progress questions (seven hours) and Final progress questions (four hours). These revisions to the burden table enable program to better monitor and provide technical assistance to respondents. The Recipient Information Collection will be deleted from the burden table (¥122 annualized burden hours). The BGIS will retain this information, however, the one-time burden of entering the Recipient Information was accounted for in the previous approval period. CDC will continue to use the PHHSBG information collection to identify activities and personnel supported with Block Grant funding, monitor expenditure of funds and recipients’ progress toward their objectives, conduct compliance reviews of Block Grant recipients, and promote the use of evidence-based guidelines and interventions. OMB approval is requested for three years. All information is submitted annually through the electronic BGIS. The total annualized estimated burden is 1,403 hours. There are no costs to respondents other than their time to participate. ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Type of respondents Form name PHHS Block Grant Coordinator ...................... Workplan start and advisory committee questions worksheet. Workplan program questions worksheet ....... Annual Progress Report template (subset of Interim Progress questions). Annual Progress Report template (subset of Final Progress questions). PHHS Block Grant Coordinator ...................... PHHS Block Grant Coordinator ...................... PHHS Block Grant Coordinator ...................... Jeffrey M. Zirger, Lead, Information Collection Review Office, Office of Public Health Ethics and Regulations, Office of Science, Centers for Disease Control and Prevention. DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [FR Doc. 2024–01549 Filed 1–25–24; 8:45 am] [60Day–24–24CB; Docket No. CDC–2024– 0004] lotter on DSK11XQN23PROD with NOTICES1 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). AGENCY: VerDate Sep<11>2014 18:02 Jan 25, 2024 Jkt 262001 PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 ACTION: Number of responses per respondent Average burden per response (in hours) 61 1 2 61 61 1 1 10 7 61 1 4 Notice with comment period. 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 information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Evaluation of an Online Prostate Cancer Decision Aid. This three-arm, randomized controlled SUMMARY: E:\FR\FM\26JAN1.SGM 26JAN1 5238 Federal Register / Vol. 89, No. 18 / Friday, January 26, 2024 / Notices lotter on DSK11XQN23PROD with NOTICES1 trial (RCT) includes eight forms of data collection including surveys and interviews and will evaluate the impact of a virtual human decision aid to help improve the quality of prostate cancer screening and treatment decisions. DATES: CDC must receive written comments on or before March 26, 2024. ADDRESSES: You may submit comments, identified by Docket No. CDC–2024– 0004 by either of the following methods: • Federal eRulemaking Portal: www.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 www.regulations.gov. Please note: Submit all comments through the Federal eRulemaking portal (www.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 H21–8, Atlanta, Georgia 30329; Telephone: 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: VerDate Sep<11>2014 18:02 Jan 25, 2024 Jkt 262001 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 Evaluation of an Online Prostate Cancer Decision Aid—New—National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC). Background and Brief Description The Centers for Disease Control and Prevention (CDC), Division of Cancer Prevention and Control (DCPC) is requesting a new, three-year OMB approval to conduct a three-arm, randomized controlled trial (RCT) to evaluate the impact of a virtual human decision aid to help improve the quality of prostate cancer screening and treatment decisions. Talk to Nathan About Prostate Cancer Screening (hereafter referred to as Nathan) is DCPC’s online, interactive, human simulation decision aid designed to help men learn and make informed decisions about prostate cancer screening. A small, preliminary evaluation of Nathan showed promise in increasing men’s knowledge about prostate cancer and likelihood of engaging in shared decision-making about prostate cancer screening with their health care providers. At this time, a larger, more systematic evaluation can help to understand whether Nathan is effective in areas such as improving knowledge, overcoming health literacy barriers, and resolving decisional PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 conflict, especially among priority populations who are most likely to be affected by prostate cancer and least likely to be screened. Further, as some experts consider the digital divide to be the newest social determinant of health, it is important to explore how, where, and for which populations there may be disparities in accessing and using Nathan. Broadly, the purpose of this information collection is to: (1) assess whether Nathan is more effective at helping men make decisions about prostate cancer screening than an established decision aid or standard educational materials; (2) determine if changes or improvements to Nathan are warranted; and (3) identify ways to incorporate Nathan into primary care. We will select four primary care clinics to participate in this study. The RCT includes a three-group parallel design with one treatment arm and two control arms to test the effectiveness of Nathan for men aged 55–69. We will recruit 900 men aged 55–69 who have an upcoming general health exam at one of the four primary care clinics and randomize them to one of three arms: (1) Nathan (Intervention = 300 men); (2) the Massachusetts Department of Public Health’s (MDPH’s) Patient Decision Aid, Get the Latest Facts about Screening for Prostate Cancer (Control 1 = 300 men); and (3) standard educational materials from the National Cancer Institute (NCI), Prostate Cancer Screening (PDQ®)— Patient Version (Control 2 = 300 men). Eight information collection forms will be implemented to answer our evaluation questions. These include a provider survey; a patient eligibility screener; patient pre-exposure, postexposure, and post-clinic visit surveys; a patient usability survey; patient user experience interviews; and clinic coordinator interviews. Each instrument will be administered once per respondent throughout the course of the study. The provider survey and clinic coordinator interviews will be conducted in English only. All other information collections will be conducted in English or Spanish. The total response burden is estimated to be 1,129 hours. There are no costs to respondents other than their time to participate in data collection activities. E:\FR\FM\26JAN1.SGM 26JAN1 5239 Federal Register / Vol. 89, No. 18 / Friday, January 26, 2024 / Notices ESTIMATED ANNUALIZED BURDEN HOURS Number of responses per respondent Average burden per response (in hours) Total burden (in hours) Form name Primary care providers ...................... Men ages 55–69 ............................... Men ages 55–69 ............................... Men ages 55–69 ............................... Men ages 55–69 ............................... Men ages 55–69 ............................... Men ages 55–69 ............................... Clinic coordinators ............................ Provider survey ................................ Patient eligibility screener ................ Pre-exposure survey ........................ Post-exposure survey ...................... Post-clinic survey ............................. Usability survey ................................ User experience interview ................ Clinic coordinator interview .............. 40 900 900 900 300 30 900 4 1 1 1 1 1 1 1 1 10/60 8/60 20/60 20/60 18/60 20/60 20/60 30/60 7 120 300 300 90 10 300 2 Total ........................................... ........................................................... ........................ ........................ ........................ 1,129 Jeffrey M. Zirger, Lead, Information Collection Review Office, Office of Public Health Ethics and Regulations, Office of Science, Centers for Disease Control and Prevention. [FR Doc. 2024–01550 Filed 1–25–24; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifiers: CMS–10887] Agency Information Collection Activities: Proposed Collection; Comment Request Centers for Medicare & Medicaid Services, Health and Human Services (HHS). ACTION: Notice. AGENCY: The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS’ intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency’s functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden. SUMMARY: lotter on DSK11XQN23PROD with NOTICES1 Number of respondents Type of respondents VerDate Sep<11>2014 18:02 Jan 25, 2024 Jkt 262001 Comments must be received by March 26, 2024. ADDRESSES: When commenting, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be submitted in any one of the following ways: 1. Electronically. You may send your comments electronically to https:// www.regulations.gov. Follow the instructions for ‘‘Comment or Submission’’ or ‘‘More Search Options’’ to find the information collection document(s) that are accepting comments. 2. By regular mail. You may mail written comments to the following address: CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development, Attention: Document Identifier/OMB Control Number: lll, Room C4–26–05, 7500 Security Boulevard, Baltimore, Maryland 21244–1850. To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, please access the CMS PRA website by copying and pasting the following web address into your web browser: https://www.cms.gov/ Regulations-and-Guidance/Legislation/ PaperworkReductionActof1995/PRAListing. DATES: FOR FURTHER INFORMATION CONTACT: William N. Parham at (410) 786–4669. SUPPLEMENTARY INFORMATION: Contents This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection’s supporting statement and associated materials (see ADDRESSES). CMS–10887 The Medicare Advantage and Prescription Drug PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 Programs: Part C and Part D Medicare Advantage Prescription Drug (MARx) System Updates for the Medicare Prescription Payment Plan Program Under the 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. The term ‘‘collection of information’’ is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA requires federal agencies to publish a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice. Information Collection 1. Type of Information Collection Request: New collection (Request for a new OMB control number); Title of Information Collection: The Medicare Advantage and Prescription Drug Programs: Part C and Part D Medicare Advantage Prescription Drug (MARx) System Updates for the Medicare Prescription Payment Plan Program; Use: The IRA amended the Act by adding section 1860D–2(b)(2)(E) which, beginning January 1, 2025, establishes the Medicare Prescription Payment Plan program (hereinafter referred to as the ‘‘program’’). Under this program, MA Organizations offering Part D coverage and Part D sponsors (collectively ‘‘Part D plans’’ or ‘‘Plans’’) are required to offer enrollees the option to pay their Part D cost sharing in monthly amounts spread out over the plan year based on the formulae described in section 1860D–2(b)(2)(E)(iv) of the Act. E:\FR\FM\26JAN1.SGM 26JAN1

Agencies

[Federal Register Volume 89, Number 18 (Friday, January 26, 2024)]
[Notices]
[Pages 5237-5239]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-01550]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-24-24CB; Docket No. CDC-2024-0004]


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 information 
collection, as required by the Paperwork Reduction Act of 1995. This 
notice invites comment on a proposed information collection project 
titled Evaluation of an Online Prostate Cancer Decision Aid. This 
three-arm, randomized controlled

[[Page 5238]]

trial (RCT) includes eight forms of data collection including surveys 
and interviews and will evaluate the impact of a virtual human decision 
aid to help improve the quality of prostate cancer screening and 
treatment decisions.

DATES: CDC must receive written comments on or before March 26, 2024.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2024-
0004 by either of the following methods:
     Federal eRulemaking Portal: www.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 www.regulations.gov.
    Please note: Submit all comments through the Federal eRulemaking 
portal (www.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 H21-8, Atlanta, Georgia 30329; Telephone: 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

    Evaluation of an Online Prostate Cancer Decision Aid--New--National 
Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), 
Centers for Disease Control and Prevention (CDC).

Background and Brief Description

    The Centers for Disease Control and Prevention (CDC), Division of 
Cancer Prevention and Control (DCPC) is requesting a new, three-year 
OMB approval to conduct a three-arm, randomized controlled trial (RCT) 
to evaluate the impact of a virtual human decision aid to help improve 
the quality of prostate cancer screening and treatment decisions.
    Talk to Nathan About Prostate Cancer Screening (hereafter referred 
to as Nathan) is DCPC's online, interactive, human simulation decision 
aid designed to help men learn and make informed decisions about 
prostate cancer screening. A small, preliminary evaluation of Nathan 
showed promise in increasing men's knowledge about prostate cancer and 
likelihood of engaging in shared decision-making about prostate cancer 
screening with their health care providers. At this time, a larger, 
more systematic evaluation can help to understand whether Nathan is 
effective in areas such as improving knowledge, overcoming health 
literacy barriers, and resolving decisional conflict, especially among 
priority populations who are most likely to be affected by prostate 
cancer and least likely to be screened. Further, as some experts 
consider the digital divide to be the newest social determinant of 
health, it is important to explore how, where, and for which 
populations there may be disparities in accessing and using Nathan.
    Broadly, the purpose of this information collection is to: (1) 
assess whether Nathan is more effective at helping men make decisions 
about prostate cancer screening than an established decision aid or 
standard educational materials; (2) determine if changes or 
improvements to Nathan are warranted; and (3) identify ways to 
incorporate Nathan into primary care. We will select four primary care 
clinics to participate in this study. The RCT includes a three-group 
parallel design with one treatment arm and two control arms to test the 
effectiveness of Nathan for men aged 55-69. We will recruit 900 men 
aged 55-69 who have an upcoming general health exam at one of the four 
primary care clinics and randomize them to one of three arms: (1) 
Nathan (Intervention = 300 men); (2) the Massachusetts Department of 
Public Health's (MDPH's) Patient Decision Aid, Get the Latest Facts 
about Screening for Prostate Cancer (Control 1 = 300 men); and (3) 
standard educational materials from the National Cancer Institute 
(NCI), Prostate Cancer Screening (PDQ[supreg])--Patient Version 
(Control 2 = 300 men).
    Eight information collection forms will be implemented to answer 
our evaluation questions. These include a provider survey; a patient 
eligibility screener; patient pre-exposure, post-exposure, and post-
clinic visit surveys; a patient usability survey; patient user 
experience interviews; and clinic coordinator interviews. Each 
instrument will be administered once per respondent throughout the 
course of the study. The provider survey and clinic coordinator 
interviews will be conducted in English only. All other information 
collections will be conducted in English or Spanish. The total response 
burden is estimated to be 1,129 hours. There are no costs to 
respondents other than their time to participate in data collection 
activities.

[[Page 5239]]



                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
      Type of respondents           Form name        Number of     responses per   per response    Total burden
                                                    respondents     respondent      (in hours)      (in hours)
----------------------------------------------------------------------------------------------------------------
Primary care providers........  Provider survey.              40               1           10/60               7
Men ages 55-69................  Patient                      900               1            8/60             120
                                 eligibility
                                 screener.
Men ages 55-69................  Pre-exposure                 900               1           20/60             300
                                 survey.
Men ages 55-69................  Post-exposure                900               1           20/60             300
                                 survey.
Men ages 55-69................  Post-clinic                  300               1           18/60              90
                                 survey.
Men ages 55-69................  Usability survey              30               1           20/60              10
Men ages 55-69................  User experience              900               1           20/60             300
                                 interview.
Clinic coordinators...........  Clinic                         4               1           30/60               2
                                 coordinator
                                 interview.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............           1,129
----------------------------------------------------------------------------------------------------------------


Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Public Health 
Ethics and Regulations, Office of Science, Centers for Disease Control 
and Prevention.
[FR Doc. 2024-01550 Filed 1-25-24; 8:45 am]
BILLING CODE 4163-18-P


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