Proposed Data Collection Submitted for Public Comment and Recommendations, 58915-58917 [2021-23187]

Download as PDF 58915 Federal Register / Vol. 86, No. 203 / Monday, October 25, 2021 / Notices data used for the dose reconstruction. Signing this form does not indicate that the claimant agrees with the outcome of the dose reconstruction. The dose reconstruction results will be supplied to the claimant and to the DOL, the agency that will utilize them as one part of its determination of whether the claimant is eligible for compensation under the Act. Total annualized burden is estimated to be 3900 hours. There is no cost to respondents other than their time. ESTIMATED ANNUALIZED BURDEN HOURS Form name Claimant .......................................................... Claimant .......................................................... Initial Interview ............................................... Conclusion Form OCAS–1 ............................. Jeffrey M. Zirger, Lead, Information Collection Review Office, Office of Scientific Integrity, Office of Science, Centers for Disease Control and Prevention. [FR Doc. 2021–23182 Filed 10–22–21; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day–22–1260; Docket No. CDC–2021– 0114] Proposed Data Collection Submitted for Public Comment and Recommendations Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). AGENCY: ACTION: 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 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 ‘‘Maritime Illness Database and Reporting System (MIDRS).’’ The purpose of this data collection is to provide U.S.-bound passenger vessel operators an electronic reporting system to assist with their legal requirement to notify CDC of the number of passengers and crew members onboard their ship who have reportable acute gastroenteritis (AGE) as defined by federal quarantine regulations. SUMMARY: jspears on DSK121TN23PROD with NOTICES1 Number of respondents Type of respondents CDC must receive written comments on or before December 27, 2021. DATES: VerDate Sep<11>2014 18:00 Oct 22, 2021 Jkt 256001 You may submit comments, identified by Docket No. CDC–2021– 0114 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 H21–8, Atlanta, Georgia 30329; phone: 404–639–7118; 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: ADDRESSES: PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 3600 3600 Number of responses per respondent 1 1 Average burden per response (in hours) 1 5/60 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 Maritime Illness Database and Reporting System (MIDRS) (OMB Control No. 0920–1260, Exp. 04/30/ 2022)—Extension—National Center for Environmental Health (NCEH), Centers for Disease Control and Prevention (CDC). Background and Brief Description The purpose of this Extension Information Collection Request (ICR) is to request a three-year Paperwork Reduction Act (PRA) clearance for CDC’s Maritime Illness Database and Reporting System (MIDRS) surveillance system. Operationally, CDC has divided the responsibilities for enforcing foreign quarantine regulations between the Vessel Sanitation Program (VSP) and the Division of Global Migration and Quarantine (DGMQ). VSP takes the lead on overseeing acute gastroenteritis (AGE) illness surveillance and outbreak investigation activities on passenger ships using MIDRS, while DGMQ monitors all non-AGE illnesses and E:\FR\FM\25OCN1.SGM 25OCN1 58916 Federal Register / Vol. 86, No. 203 / Monday, October 25, 2021 / Notices deaths on passenger vessels as well as all diseases of public health concern on all other conveyances with international itineraries bound for the U.S. under ‘‘Foreign Quarantine Regulations (42 CFR part 71)’’ (OMB Control No. 0920– 0134, Exp. 03/31/2022). The MIDRS data collection system consists of a surveillance system that receives information electronically through a web-based reporting portal; data can also be submitted by phone, email, or fax, and entered into MIDRS by VSP. AGE cases reported to MIDRS are totals for the entire voyage and do not represent the number of active AGE cases at any given port of call or at food/activity histories. Of note, VSP will not receive any information from or about the AGE cases; this information is collected and owned by the cruise line and maintained on the ship as part of the AGE case’s medical record. VSP reviews these records during operational inspections to confirm they are available if needed, and if there is an AGE outbreak or report of unusual AGE illness for a particular voyage. The total annualized time burden requested is 1,537 burden hours. A summary of the estimated annualized burden hours is shown in the table below. There are no costs to respondents other than their time. disembarkation. The AGE log, 72-hour food/activity history and other required documentation are completed and maintained on the ship. Data collected will allow VSP to quickly detect AGE outbreaks, provide epidemiologic and sanitation guidance to stop the outbreak, craft public health recommendations to prevent future outbreaks, and monitor AGE illness trends to identify important changes over time. There are two types of respondents for this data collection: Cruise ship medical staff or other designated personnel who report AGE cases, and AGE cases who provide information for the 72-hour ESTIMATED ANNUALIZED BURDEN HOURS Type of respondent Cruise ship medical staff or other designated personnel. AGE passenger and crew cases. jspears on DSK121TN23PROD with NOTICES1 Total ........................ Number of respondents Form name Number of responses per respondent Total burden (in hours) 71.21(c) Gastrointestinal Illnesses reports 24 and 4 hours before arrival (MIDRS). 250 10 3/60 125 71.21(c) Recordkeeping—Gastrointestinal Illnesses reports 24 and 4 hours before arrival (MIDRS). 71.21(c) AGE Logs .............................................. 71.21(c) Recordkeeping—medical records (AGE Logs). 71.21(c) Interviews with AGE crew case cabin mates and immediate contacts to determine AGE illness status and documentation of interview dates/times. 71.21(c) Recordkeeping—medical records (Interviews with AGE crew case cabin mates and immediate contacts to determine AGE illness status and documentation of interview dates/times). 71.21(c) Documentation of 3-day pre-embarkation AGE illness assessment for all crew members. 71.21(c) Recordkeeping—medical records (Documentation of 3-day pre-embarkation AGE illness assessment for all crew members). 71.21(c) Documentation of date/time of last symptom and clearance to return to work for food and nonfood employees. 71.21(c) Recordkeeping—medical records (Documentation of date/time of last symptom and clearance to return to work for food and nonfood employees). 71.21(c) Recordkeeping—medical records (72 hour food/activity histories). 71.21(c) 72-hour food/activity history .................. 250 1 1/60 4 250 250 10 1 10/60 1/60 417 4 250 3 5/60 63 250 1 1/60 4 250 5 3/60 63 250 1 1/60 4 250 1 3/60 12 250 1 1/60 4 250 1 1/60 4 5,000 1 10/60 833 .............................................................................. ........................ ........................ ........................ 1,537 Jeffrey M. Zirger, Lead, Information Collection Review Office, Office of Scientific Integrity, Office of Science,Centers for Disease Control and Prevention. [FR Doc. 2021–23187 Filed 10–22–21; 8:45 am] BILLING CODE 4163–18–P VerDate Sep<11>2014 Average burden per response (in hours) 18:46 Oct 22, 2021 Jkt 256001 PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 E:\FR\FM\25OCN1.SGM 25OCN1 Federal Register / Vol. 86, No. 203 / Monday, October 25, 2021 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS–6091–N] RIN 0938–ZB70 Medicare, Medicaid, and Children’s Health Insurance Programs; Provider Enrollment Application Fee Amount for Calendar Year 2022 Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Notice. AGENCY: This notice announces a $631.00 calendar year (CY) 2022 application fee for institutional providers that are initially enrolling in the Medicare or Medicaid program or the Children’s Health Insurance Program (CHIP); revalidating their Medicare, Medicaid, or CHIP enrollment; or adding a new Medicare practice location. This fee is required with any enrollment application submitted on or after January 1, 2022 and on or before December 31, 2022. DATES: The application fee announced in this notice is effective on January 1, 2022. FOR FURTHER INFORMATION CONTACT: Frank Whelan, (410) 786–1302. SUPPLEMENTARY INFORMATION: SUMMARY: jspears on DSK121TN23PROD with NOTICES1 I. Background In the February 2, 2011 Federal Register (76 FR 5862), we published a final rule with comment period titled ‘‘Medicare, Medicaid, and Children’s Health Insurance Programs; Additional Screening Requirements, Application Fees, Temporary Enrollment Moratoria, Payment Suspensions and Compliance Plans for Providers and Suppliers.’’ This rule finalized, among other things, provisions related to the submission of application fees as part of the Medicare, Medicaid, and CHIP provider enrollment processes. As provided in section 1866(j)(2)(C)(i) of the Social Security Act (the Act) and in 42 CFR 424.514, ‘‘institutional providers’’ that are initially enrolling in the Medicare or Medicaid programs or CHIP, revalidating their enrollment, or adding a new Medicare practice location are required to submit a fee with their enrollment application. An ‘‘institutional provider’’ for purposes of Medicare is defined at § 424.502 as ‘‘any provider or supplier that submits a VerDate Sep<11>2014 18:46 Oct 22, 2021 Jkt 256001 paper Medicare enrollment application using the CMS–855A, CMS–855B (not including physician and non-physician practitioner organizations), CMS–855S, CMS–20134, or associated internetbased PECOS enrollment application.’’ As we explained in the February 2, 2011 final rule (76 FR 5914), in addition to the providers and suppliers subject to the application fee under Medicare, Medicaid-only and CHIP-only institutional providers would include nursing facilities, intermediate care facilities for persons with intellectual disabilities (ICF/IID), psychiatric residential treatment facilities; they may also include other institutional provider types designated by a state in accordance with their approved state plan. As indicated in § 424.514 and § 455.460, the application fee is not required for either of the following: • A Medicare physician or nonphysician practitioner submitting a CMS–855I. • A prospective or revalidating Medicaid or CHIP provider— ++ Who is an individual physician or non-physician practitioner; or ++ That is enrolled as an institutional provider in Title XVIII of the Act or another state’s Title XIX or XXI plan and has paid the application fee to a Medicare contractor or another state. II. Provisions of the Notice Section 1866(j)(2)(C)(i)(I) of the Act established a $500 application fee for institutional providers in calendar year (CY) 2010. Consistent with section 1866(j)(2)(C)(i)(II) of the Act, § 424.514(d)(2) states that for CY 2011 and subsequent years, the preceding year’s fee will be adjusted by the percentage change in the consumer price index (CPI) for all urban consumers (all items; United States city average, CPI–U) for the 12-month period ending on June 30 of the previous year. Each year since 2011, accordingly, we have published in the Federal Register an announcement of the application fee amount for the forthcoming CY based on the formula noted previously. Most recently, in the November 23, 2020 Federal Register (85 FR 74724), we published a notice announcing a fee amount for the period of January 1, 2021 through December 31, 2021 of $599.00. The $599.00 fee amount for CY 2021 was used to calculate the fee amount for 2022 as specified in § 424.514(d)(2). According to Bureau of Labor Statistics (BLS) data, the CPU–U increase for the period of July 1, 2020 PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 58917 through June 30, 2021 was 5.4 percent. As required by § 424.514(d)(2), the preceding year’s fee of $599 will be adjusted by 5.4 percent. This results in a CY 2022 application fee amount of $631.35 ($599 × 1.054). As we must round this to the nearest whole dollar amount, the resultant application fee amount for CY 2022 is $631.00. III. Collection of Information Requirements This document does not impose information collection requirements, that is, reporting, recordkeeping, or third-party disclosure requirements. Consequently, there is no need for review by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995. However, it does reference previously approved information collections. The Forms CMS–855A, CMS–855B, and CMS–855I are approved under OMB control number 0938–0685; the Form CMS–855S is approved under OMB control number 0938–1056. IV. Regulatory Impact Statement A. Background and Review Requirements We have examined the impact of this notice as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96– 354), section 1102(b) of the Act, section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 1995; Pub. L. 104–4), Executive Order 13132 on Federalism (August 4, 1999), and the Congressional Review Act (5 U.S.C. 804(2)). Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits, including potential economic, environmental, public health and safety effects, distributive impacts, and equity. A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more in any 1 year). As explained in this section of the notice, we estimate that the total cost of the increase in the application fee will not exceed $100 million. Therefore, this notice does not reach the $100 million E:\FR\FM\25OCN1.SGM 25OCN1

Agencies

[Federal Register Volume 86, Number 203 (Monday, October 25, 2021)]
[Notices]
[Pages 58915-58917]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-23187]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-22-1260; Docket No. CDC-2021-0114]


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 ``Maritime Illness Database and 
Reporting System (MIDRS).'' The purpose of this data collection is to 
provide U.S.-bound passenger vessel operators an electronic reporting 
system to assist with their legal requirement to notify CDC of the 
number of passengers and crew members onboard their ship who have 
reportable acute gastroenteritis (AGE) as defined by federal quarantine 
regulations.

DATES: CDC must receive written comments on or before December 27, 
2021.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2021-
0114 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 H21-8, 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;
    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

    Maritime Illness Database and Reporting System (MIDRS) (OMB Control 
No. 0920-1260, Exp. 04/30/2022)--Extension--National Center for 
Environmental Health (NCEH), Centers for Disease Control and Prevention 
(CDC).

Background and Brief Description

    The purpose of this Extension Information Collection Request (ICR) 
is to request a three-year Paperwork Reduction Act (PRA) clearance for 
CDC's Maritime Illness Database and Reporting System (MIDRS) 
surveillance system.
    Operationally, CDC has divided the responsibilities for enforcing 
foreign quarantine regulations between the Vessel Sanitation Program 
(VSP) and the Division of Global Migration and Quarantine (DGMQ). VSP 
takes the lead on overseeing acute gastroenteritis (AGE) illness 
surveillance and outbreak investigation activities on passenger ships 
using MIDRS, while DGMQ monitors all non-AGE illnesses and

[[Page 58916]]

deaths on passenger vessels as well as all diseases of public health 
concern on all other conveyances with international itineraries bound 
for the U.S. under ``Foreign Quarantine Regulations (42 CFR part 71)'' 
(OMB Control No. 0920-0134, Exp. 03/31/2022).
    The MIDRS data collection system consists of a surveillance system 
that receives information electronically through a web-based reporting 
portal; data can also be submitted by phone, email, or fax, and entered 
into MIDRS by VSP. AGE cases reported to MIDRS are totals for the 
entire voyage and do not represent the number of active AGE cases at 
any given port of call or at disembarkation. The AGE log, 72-hour food/
activity history and other required documentation are completed and 
maintained on the ship.
    Data collected will allow VSP to quickly detect AGE outbreaks, 
provide epidemiologic and sanitation guidance to stop the outbreak, 
craft public health recommendations to prevent future outbreaks, and 
monitor AGE illness trends to identify important changes over time.
    There are two types of respondents for this data collection: Cruise 
ship medical staff or other designated personnel who report AGE cases, 
and AGE cases who provide information for the 72-hour food/activity 
histories. Of note, VSP will not receive any information from or about 
the AGE cases; this information is collected and owned by the cruise 
line and maintained on the ship as part of the AGE case's medical 
record. VSP reviews these records during operational inspections to 
confirm they are available if needed, and if there is an AGE outbreak 
or report of unusual AGE illness for a particular voyage.
    The total annualized time burden requested is 1,537 burden hours. A 
summary of the estimated annualized burden hours is shown in the table 
below. There are no costs to respondents other than their time.

                                                            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)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cruise ship medical staff or other designated    71.21(c) Gastrointestinal Illnesses                 250              10            3/60             125
 personnel.                                       reports 24 and 4 hours before arrival
                                                  (MIDRS).
                                                 71.21(c) Recordkeeping--                            250               1            1/60               4
                                                  Gastrointestinal Illnesses reports 24
                                                  and 4 hours before arrival (MIDRS).
                                                 71.21(c) AGE Logs......................             250              10           10/60             417
                                                 71.21(c) Recordkeeping--medical records             250               1            1/60               4
                                                  (AGE Logs).
                                                 71.21(c) Interviews with AGE crew case              250               3            5/60              63
                                                  cabin mates and immediate contacts to
                                                  determine AGE illness status and
                                                  documentation of interview dates/times.
                                                 71.21(c) Recordkeeping--medical records             250               1            1/60               4
                                                  (Interviews with AGE crew case cabin
                                                  mates and immediate contacts to
                                                  determine AGE illness status and
                                                  documentation of interview dates/
                                                  times).
                                                 71.21(c) Documentation of 3-day pre-                250               5            3/60              63
                                                  embarkation AGE illness assessment for
                                                  all crew members.
                                                 71.21(c) Recordkeeping--medical records             250               1            1/60               4
                                                  (Documentation of 3-day pre-
                                                  embarkation AGE illness assessment for
                                                  all crew members).
                                                 71.21(c) Documentation of date/time of              250               1            3/60              12
                                                  last symptom and clearance to return
                                                  to work for food and nonfood employees.
                                                 71.21(c) Recordkeeping--medical records             250               1            1/60               4
                                                  (Documentation of date/time of last
                                                  symptom and clearance to return to
                                                  work for food and nonfood employees).
                                                 71.21(c) Recordkeeping--medical records             250               1            1/60               4
                                                  (72 hour food/activity histories).
AGE passenger and crew cases...................  71.21(c) 72-hour food/activity history.           5,000               1           10/60             833
                                                                                         ---------------------------------------------------------------
    Total......................................  .......................................  ..............  ..............  ..............           1,537
--------------------------------------------------------------------------------------------------------------------------------------------------------


Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science,Centers for Disease Control and 
Prevention.
[FR Doc. 2021-23187 Filed 10-22-21; 8:45 am]
BILLING CODE 4163-18-P