82 FR 19733 - Agency Information Collection Activities: Submission for OMB Review; Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services Federal Register Volume 82, Issue 81 (April 28, 2017)
Centers for Medicare & Medicaid Services
Federal Register Volume 82, Issue 81 (April 28, 2017)
| Page Range | 19733-19734 | |
| FR Document | 2017-08663 |
[Federal Register Volume 82, Number 81 (Friday, April 28, 2017)] [Notices] [Pages 19733-19734] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-08663] [[Page 19733]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifiers: CMS-304/CMS-304a, CMS-368/CMS-R-144, and CMS-R- 308] Agency Information Collection Activities: Submission for OMB Review; Comment Request AGENCY: Centers for Medicare & Medicaid Services, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: 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 a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate 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. DATES: Comments on the collection(s) of information must be received by the OMB desk officer by May 30, 2017. ADDRESSES: When commenting on the proposed information collections, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be received by the OMB desk officer via one of the following transmissions: OMB, Office of Information and Regulatory Affairs, Attention: CMS Desk Officer, Fax Number: (202) 395-5806 OR, Email: [email protected]. To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following: 1. Access CMS' Web site address at Web site address at https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html. 2. Email your request, including your address, phone number, OMB number, and CMS document identifier, to [email protected]. 3. Call the Reports Clearance Office at (410) 786-1326. FOR FURTHER INFORMATION CONTACT: William Parham at (410) 786-4669. 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. 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 (44 U.S.C. 3506(c)(2)(A)) requires federal agencies to publish a 30-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. Comments submitted in response to the 60-day FR Notice have been addressed in Appendix A of the ICR. To comply with this requirement, CMS is publishing this notice that summarizes the following proposed collection(s) of information for public comment: 1. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Reconciliation of State Invoice and Prior Quarter Adjustment Statement; Use: Form CMS-304 (Reconciliation of State Invoice) is used by manufacturers to respond to the state's rebate invoice for current quarter utilization. Form CMS-304a (Prior Quarter Adjustment Statement) is required only in those instances where a change to the original rebate data submittal is necessary. Form Number: CMS-304 and -304a (OMB control number: 0938- 0676); Frequency: Quarterly; Affected Public: Business or other for- profits; Number of Respondents: 1,037; Total Annual Responses: 4,148; Total Annual Hours: 187,880. (For policy questions regarding this collection contact Andrea Wellington at 410-786-3490.) 2. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Medicaid Drug Rebate Program Forms; Use: We develop the rebate amount per drug unit from information supplied by the drug manufacturers and distributes these data to the states. States then must report quarterly to the drug manufacturers and report to us the total number of units of each dosage form/strength of their covered outpatient drugs reimbursed during a quarter and the rebate amount to be refunded. This report is due within 60 days of the end of each calendar quarter. The information in the report is based on claims paid by the state Medicaid agency during a calendar quarter. Form CMS-R-144 (Quarterly Report Data) is required from states quarterly to report utilization for any drugs paid for during that quarter. Form CMS-368 (Administrative Data) is required only in those instances where a change to the original data submittal is necessary. Form Number: CMS-368 and -R-144 (OMB control number: 0938-0582); Frequency: Quarterly; Affected Public: State, Local, or Tribal Governments; Number of Respondents: 56; Total Annual Responses: 224; Total Annual Hours: 12,101. (For policy questions regarding this collection contact Andrea Wellington at 410-786-3490.) 3. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: State Children's Health Insurance Program and Supporting Regulations; Use: States must submit title XXI plans and amendments for approval by the Secretary. We use the plan and its subsequent amendments to determine if the state has met the requirements of title XXI. Information provided in the state plan, state plan amendments, and from the other information we are collecting will be used by advocacy groups, beneficiaries, applicants, other governmental agencies, providers groups, research organizations, health care corporations, health care consultants. States will use the information collected to assess state plan performance, health outcomes and an evaluation of the amount of substitution of private coverage that occurs as a result of the subsidies and the effect of the subsidies on access to coverage. Form Number: CMS-R-308 (OMB control number: 0938-0841); Frequency: Yearly, Once, and Occasionally; Affected Public: State, Local, or Tribal Governments; Number of Respondents: 56; Total Annual Responses: 28,294,596; Total Annual Hours: 1,473,885. (For policy questions regarding this collection contact Amy Lutzky at 410-786-0721). [[Page 19734]] Dated: April 25, 2017. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2017-08663 Filed 4-27-17; 8:45 am] BILLING CODE 4120-01-P
![Federal Register / Vol. 82, No. 81 / Friday, April 28, 2017 / Notices 19733
DEPARTMENT OF HEALTH AND PaperworkReductionActof1995/PRA- information supplied by the drug
HUMAN SERVICES Listing.html. manufacturers and distributes these data
2. Email your request, including your to the states. States then must report
Centers for Medicare & Medicaid address, phone number, OMB number, quarterly to the drug manufacturers and
Services and CMS document identifier, to report to us the total number of units of
[Document Identifiers: CMS–304/CMS–304a,
Paperwork@cms.hhs.gov. each dosage form/strength of their
CMS–368/CMS–R–144, and CMS–R–308] 3. Call the Reports Clearance Office at covered outpatient drugs reimbursed
(410) 786–1326. during a quarter and the rebate amount
Agency Information Collection FOR FURTHER INFORMATION CONTACT: to be refunded. This report is due
Activities: Submission for OMB William Parham at (410) 786–4669. within 60 days of the end of each
Review; Comment Request SUPPLEMENTARY INFORMATION: Under the calendar quarter. The information in the
AGENCY: Centers for Medicare & Paperwork Reduction Act of 1995 (PRA) report is based on claims paid by the
Medicaid Services, HHS. (44 U.S.C. 3501–3520), federal agencies state Medicaid agency during a calendar
must obtain approval from the Office of quarter. Form CMS–R–144 (Quarterly
ACTION: Notice.
Management and Budget (OMB) for each Report Data) is required from states
SUMMARY: The Centers for Medicare & collection of information they conduct quarterly to report utilization for any
Medicaid Services (CMS) is announcing or sponsor. The term ‘‘collection of drugs paid for during that quarter. Form
an opportunity for the public to information’’ is defined in 44 U.S.C. CMS–368 (Administrative Data) is
comment on CMS’ intention to collect 3502(3) and 5 CFR 1320.3(c) and required only in those instances where
information from the public. Under the includes agency requests or a change to the original data submittal
Paperwork Reduction Act of 1995 requirements that members of the public is necessary. Form Number: CMS–368
(PRA), federal agencies are required to submit reports, keep records, or provide and –R–144 (OMB control number:
publish notice in the Federal Register information to a third party. Section 0938–0582); Frequency: Quarterly;
concerning each proposed collection of 3506(c)(2)(A) of the PRA (44 U.S.C. Affected Public: State, Local, or Tribal
information, including each proposed 3506(c)(2)(A)) requires federal agencies Governments; Number of Respondents:
extension or reinstatement of an existing to publish a 30-day notice in the
56; Total Annual Responses: 224; Total
collection of information, and to allow Federal Register concerning each
Annual Hours: 12,101. (For policy
a second opportunity for public proposed collection of information,
questions regarding this collection
comment on the notice. Interested including each proposed extension or
reinstatement of an existing collection contact Andrea Wellington at 410–786–
persons are invited to send comments 3490.)
regarding the burden estimate or any of information, before submitting the
other aspect of this collection of collection to OMB for approval. 3. Type of Information Collection
information, including the necessity and Comments submitted in response to the Request: Extension of a currently
utility of the proposed information 60-day FR Notice have been addressed approved collection; Title of
collection for the proper performance of in Appendix A of the ICR. To comply Information Collection: State Children’s
the agency’s functions, the accuracy of with this requirement, CMS is Health Insurance Program and
the estimated burden, ways to enhance publishing this notice that summarizes Supporting Regulations; Use: States
the quality, utility, and clarity of the the following proposed collection(s) of must submit title XXI plans and
information to be collected; and the use information for public comment: amendments for approval by the
of automated collection techniques or 1. Type of Information Collection Secretary. We use the plan and its
other forms of information technology to Request: Extension of a currently subsequent amendments to determine if
minimize the information collection approved collection; Title of the state has met the requirements of
burden. Information Collection: Reconciliation title XXI. Information provided in the
of State Invoice and Prior Quarter state plan, state plan amendments, and
DATES: Comments on the collection(s) of Adjustment Statement; Use: Form CMS–
information must be received by the from the other information we are
304 (Reconciliation of State Invoice) is collecting will be used by advocacy
OMB desk officer by May 30, 2017. used by manufacturers to respond to the groups, beneficiaries, applicants, other
ADDRESSES: When commenting on the state’s rebate invoice for current quarter governmental agencies, providers
proposed information collections, utilization. Form CMS–304a (Prior groups, research organizations, health
please reference the document identifier Quarter Adjustment Statement) is
care corporations, health care
or OMB control number. To be assured required only in those instances where
consultants. States will use the
consideration, comments and a change to the original rebate data
recommendations must be received by information collected to assess state
submittal is necessary. Form Number:
the OMB desk officer via one of the CMS–304 and –304a (OMB control plan performance, health outcomes and
following transmissions: OMB, Office of number: 0938–0676); Frequency: an evaluation of the amount of
Information and Regulatory Affairs, Quarterly; Affected Public: Business or substitution of private coverage that
Attention: CMS Desk Officer, Fax other for-profits; Number of occurs as a result of the subsidies and
Number: (202) 395–5806 OR, Email: Respondents: 1,037; Total Annual the effect of the subsidies on access to
OIRA_submission@omb.eop.gov. Responses: 4,148; Total Annual Hours: coverage. Form Number: CMS–R–308
To obtain copies of a supporting 187,880. (For policy questions regarding (OMB control number: 0938–0841);
asabaliauskas on DSK3SPTVN1PROD with NOTICES
statement and any related forms for the this collection contact Andrea Frequency: Yearly, Once, and
proposed collection(s) summarized in Wellington at 410–786–3490.) Occasionally; Affected Public: State,
this notice, you may make your request 2. Type of Information Collection Local, or Tribal Governments; Number
using one of following: Request: Extension of a currently of Respondents: 56; Total Annual
1. Access CMS’ Web site address at approved collection; Title of Responses: 28,294,596; Total Annual
Web site address at https:// Information Collection: Medicaid Drug Hours: 1,473,885. (For policy questions
www.cms.gov/Regulations-and- Rebate Program Forms; Use: We develop regarding this collection contact Amy
Guidance/Legislation/ the rebate amount per drug unit from Lutzky at 410–786–0721).
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![19734 Federal Register / Vol. 82, No. 81 / Friday, April 28, 2017 / Notices
Dated: April 25, 2017. To obtain copies of a supporting prevention of sudden cardiac death is
William N. Parham, III, statement and any related forms for the less compelling for certain patients.
Director, Paperwork Reduction Staff, Office proposed collection(s) summarized in To encourage responsible and
of Strategic Operations and Regulatory this notice, you may make your request appropriate use of ICDs, we issued a
Affairs. using one of following: ‘‘Decision Memo for Implantable
[FR Doc. 2017–08663 Filed 4–27–17; 8:45 am] 1. Access CMS’ Web site address at Defibrillators’’ on January 27, 2005,
BILLING CODE 4120–01–P Web site address at https:// indicating that ICDs will be covered for
www.cms.gov/Regulations-and- primary prevention of sudden cardiac
Guidance/Legislation/ death if the beneficiary is enrolled in
DEPARTMENT OF HEALTH AND PaperworkReductionActof1995/PRA- either an FDA-approved category B IDE
HUMAN SERVICES Listing.html clinical trial (42 CFR 405.201), a trial
2. Email your request, including your under the CMS Clinical Trial Policy
Centers for Medicare & Medicaid address, phone number, OMB number, (NCD Manual § 310.1) or a qualifying
Services and CMS document identifier, to prospective data collection system
Paperwork@cms.hhs.gov. (either a practical clinical trial or
[Document Identifiers: CMS–10151, CMS–
3. Call the Reports Clearance Office at prospective systematic data collection,
10199, CMS–R–13, CMS–10279]
(410) 786–1326. which is sometimes referred to as a
Agency Information Collection FOR FURTHER INFORMATION CONTACT: registry). Form Number: CMS–10151
Activities: Submission for OMB William Parham at (410) 786–4669. (OMB control number: 0938–0967);
Review; Comment Request Frequency: Occasionally; Affected
SUPPLEMENTARY INFORMATION: Under the
Public: Business or other for-profits,
AGENCY: Centers for Medicare & Paperwork Reduction Act of 1995 (PRA)
Not-for-profit institutions; Number of
Medicaid Services, HHS. (44 U.S.C. 3501–3520), federal agencies
Respondents: 1,600; Total Annual
must obtain approval from the Office of
ACTION: Notice. Responses: 80,000; Total Annual Hours:
Management and Budget (OMB) for each
20,000. (For policy questions regarding
SUMMARY: The Centers for Medicare & collection of information they conduct this collection contact JoAnna Baldwin
Medicaid Services (CMS) is announcing or sponsor. The term ‘‘collection of at 410–786–7205.)
an opportunity for the public to information’’ is defined in 44 U.S.C. 2. Type of Information Collection
comment on CMS’ intention to collect 3502(3) and 5 CFR 1320.3(c) and Request: Revision of a currently
information from the public. Under the includes agency requests or approved collection; Title of
Paperwork Reduction Act of 1995 requirements that members of the public Information Collection: Data Collection
(PRA), federal agencies are required to submit reports, keep records, or provide for Medicare Facilities Performing
publish notice in the Federal Register information to a third party. Section Carotid Artery Stenting with Embolic
concerning each proposed collection of 3506(c)(2)(A) of the PRA (44 U.S.C. Protection in Patients at High Risk for
information, including each proposed 3506(c)(2)(A)) requires federal agencies Carotid Endarterectomy; Use: We
extension or reinstatement of an existing to publish a 30-day notice in the provide coverage for carotid artery
collection of information, and to allow Federal Register concerning each stenting (CAS) with embolic protection
a second opportunity for public proposed collection of information, for patients at high risk for carotid
comment on the notice. Interested including each proposed extension or endarterectomy and who also have
persons are invited to send comments reinstatement of an existing collection symptomatic carotid artery stenosis
regarding the burden estimate or any of information, before submitting the between 50 percent and 70 percent or
other aspect of this collection of collection to OMB for approval. have asymptomatic carotid artery
information, including the necessity and Comments submitted in response to the stenosis ≥80 percent in accordance with
utility of the proposed information 60-day Federal Register Notice have the Category B IDE clinical trials
collection for the proper performance of been addressed in Appendix A of the regulation (42 CFR 405.201), a trial
the agency’s functions, the accuracy of ICR. To comply with this requirement, under the CMS Clinical Trial Policy
the estimated burden, ways to enhance CMS is publishing this notice that (NCD Manual § 310.1, or in accordance
the quality, utility, and clarity of the summarizes the following proposed with the National Coverage
information to be collected; and the use collection(s) of information for public Determination on CAS post approval
of automated collection techniques or comment: studies (Medicare NCD Manual 20.7).
other forms of information technology to 1. Type of Information Collection Accordingly, we consider coverage for
minimize the information collection Request: Reinstatement with change of a CAS reasonable and necessary (section
burden. previously approved collection; Title of 1862(A)(1)(a) of the Social Security Act).
Information Collection: Data Collection However, evidence for use of CAS with
DATES: Comments on the collection(s) of for Medicare Beneficiaries Receiving embolic protection for patients with
information must be received by the Implantable Cardioverter-Defibrillators high risk for carotid endarterectomy and
OMB desk officer by May 30, 2017. for Primary Prevention of Sudden who also have symptomatic carotid
ADDRESSES: When commenting on the Cardiac Death; Use: We provide artery stenosis ≥70 percent who are not
proposed information collections, coverage for implantable cardioverter- enrolled in a study or trial is less
please reference the document identifier defibrillators (ICDs) for secondary compelling. To encourage responsible
or OMB control number. To be assured prevention of sudden cardiac death and appropriate use of CAS with
asabaliauskas on DSK3SPTVN1PROD with NOTICES
consideration, comments and based on extensive evidence showing embolic protection, we issued a
recommendations must be received by that use of ICDs among patients with a Decision Memo for Carotid Artery
the OMB desk officer via one of the certain set of physiologic conditions are Stenting on March 17, 2005, indicating
following transmissions: OMB, Office of effective. Accordingly, we consider that CAS with embolic protection for
Information and Regulatory Affairs, coverage for ICDs reasonable and symptomatic carotid artery stenosis ≥70
Attention: CMS Desk Officer, Fax necessary under Section 1862(a)(1)(A) of percent will be covered only if
Number: (202) 395–5806 OR, Email: the Social Security Act. However, performed in facilities that have been
OIRA_submission@omb.eop.gov. evidence for use of ICDs for primary determined to be competent in
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Document Created: 2017-04-28 03:02:17
Document Modified: 2017-04-28 03:02:17
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Comments on the collection(s) of information must be received by the OMB desk officer by May 30, 2017. | |
| Contact | William Parham at (410) 786-4669. | |
| FR Citation | 82 FR 19733 |
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