82 FR 19734 - 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 | 19734-19735 | |
| FR Document | 2017-08738 |
[Federal Register Volume 82, Number 81 (Friday, April 28, 2017)] [Notices] [Pages 19734-19735] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-08738] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifiers: CMS-10151, CMS-10199, CMS-R-13, CMS-10279] 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 Federal Register 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: Reinstatement with change of a previously approved collection; Title of Information Collection: Data Collection for Medicare Beneficiaries Receiving Implantable Cardioverter-Defibrillators for Primary Prevention of Sudden Cardiac Death; Use: We provide coverage for implantable cardioverter-defibrillators (ICDs) for secondary prevention of sudden cardiac death based on extensive evidence showing that use of ICDs among patients with a certain set of physiologic conditions are effective. Accordingly, we consider coverage for ICDs reasonable and necessary under Section 1862(a)(1)(A) of the Social Security Act. However, evidence for use of ICDs for primary prevention of sudden cardiac death is less compelling for certain patients. To encourage responsible and appropriate use of ICDs, we issued a ``Decision Memo for Implantable Defibrillators'' on January 27, 2005, indicating that ICDs will be covered for primary prevention of sudden cardiac death if the beneficiary is enrolled in either an FDA-approved category B IDE clinical trial (42 CFR 405.201), a trial under the CMS Clinical Trial Policy (NCD Manual Sec. 310.1) or a qualifying prospective data collection system (either a practical clinical trial or prospective systematic data collection, which is sometimes referred to as a registry). Form Number: CMS-10151 (OMB control number: 0938- 0967); Frequency: Occasionally; Affected Public: Business or other for- profits, Not-for-profit institutions; Number of Respondents: 1,600; Total Annual Responses: 80,000; Total Annual Hours: 20,000. (For policy questions regarding this collection contact JoAnna Baldwin at 410-786- 7205.) 2. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Data Collection for Medicare Facilities Performing Carotid Artery Stenting with Embolic Protection in Patients at High Risk for Carotid Endarterectomy; Use: We provide coverage for carotid artery stenting (CAS) with embolic protection for patients at high risk for carotid endarterectomy and who also have symptomatic carotid artery stenosis between 50 percent and 70 percent or have asymptomatic carotid artery stenosis [gteqt]80 percent in accordance with the Category B IDE clinical trials regulation (42 CFR 405.201), a trial under the CMS Clinical Trial Policy (NCD Manual Sec. 310.1, or in accordance with the National Coverage Determination on CAS post approval studies (Medicare NCD Manual 20.7). Accordingly, we consider coverage for CAS reasonable and necessary (section 1862(A)(1)(a) of the Social Security Act). However, evidence for use of CAS with embolic protection for patients with high risk for carotid endarterectomy and who also have symptomatic carotid artery stenosis [gteqt]70 percent who are not enrolled in a study or trial is less compelling. To encourage responsible and appropriate use of CAS with embolic protection, we issued a Decision Memo for Carotid Artery Stenting on March 17, 2005, indicating that CAS with embolic protection for symptomatic carotid artery stenosis [gteqt]70 percent will be covered only if performed in facilities that have been determined to be competent in [[Page 19735]] performing the evaluation, procedure and follow-up necessary to ensure optimal patient outcomes. In accordance with this criteria, we consider coverage for CAS reasonable and necessary (section 1862(A)(1)(a) of the Social Security Act). Form Number: CMS-10199 (OMB control number: 0938- 1011); Frequency: Yearly; Affected Public: Business or other for-profit and Not-for-profit institutions; Number of Respondents: 1,370; Total Annual Responses: 4,110; Total Annual Hours: 28,998. (For policy questions regarding this collection contact Sarah Fulton at 410-786- 2749.) 3. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Conditions of Coverage for Organ Procurement Organizations and Supporting Regulations; Use: Section 1138(b) of the Social Security Act, as added by section 9318 of the Omnibus Budget Reconciliation Act of 1986 (Pub. L. 99-509), sets forth the statutory qualifications and requirements that organ procurement organizations (OPOs) must meet in order for the costs of their services in procuring organs for transplant centers to be reimbursable under the Medicare and Medicaid programs. An OPO must be certified and designated by the Secretary as an OPO and must meet performance-related standards prescribed by the Secretary. The corresponding regulations are found at 42 CFR part 486 (Conditions for Coverage of Specialized Services Furnished by Suppliers) under subpart G (Requirements for Certification and Designation and Conditions for Coverage: Organ Procurement Organizations). Since each OPO has a monopoly on organ procurement within its designated service area (DSA), we must hold OPOs to high standards. Collection of this information is necessary for us to assess the effectiveness of each OPO and determine whether it should continue to be certified as an OPO and designated for a particular donation service area by the Secretary or replaced by an OPO that can more effectively procure organs within that DSA. Form Number: CMS-R-13 (OMB control number: 0938-0688); Frequency: Occasionally; Affected Public: Not-for- profit institutions; Number of Respondents: 58; Total Annual Responses: 58; Total Annual Hours: 13,546. (For policy questions regarding this collection contact Diane Corning at 410-786-8486.) 4. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Ambulatory Surgical Center Conditions for Coverage; Use: The Ambulatory Surgical Center (ASC) Conditions for Coverage (CfCs) focus on a patient- centered, outcome-oriented, and transparent processes that promote quality patient care. The CfCs are designed to ensure that each facility has properly trained staff to provide the appropriate type and level of care for that facility and provide a safe physical environment for patients. The CfCs are used by Federal or state surveyors as a basis for determining whether an ASC qualifies for approval or re- approval under Medicare. We, along with the healthcare industry, believe that the availability to the facility of the type of records and general content of records, which this regulation specifies, is standard medical practice and is necessary in order to ensure the well- being and safety of patients and professional treatment accountability. Form Number: CMS-10279 (OMB control number: 0938-1071); Frequency: Annual; Affected Public: Business or other for-profit and Not-for- profit institutions; Number of Respondents: 5,500; Total Annual Responses: 5,500; Total Annual Hours: 209,000. (For policy questions regarding this collection contact Jacqueline Leach at 410-786-4282.) Dated: April 26, 2017. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2017-08738 Filed 4-27-17; 8:45 am] BILLING CODE 4120-01-P
![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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![Federal Register / Vol. 82, No. 81 / Friday, April 28, 2017 / Notices 19735
performing the evaluation, procedure Information Collection: Ambulatory FDA to continue to approve ANDAs that
and follow-up necessary to ensure Surgical Center Conditions for Coverage; refer to the products as long as they
optimal patient outcomes. In accordance Use: The Ambulatory Surgical Center meet relevant legal and regulatory
with this criteria, we consider coverage (ASC) Conditions for Coverage (CfCs) requirements. Through this notice, FDA
for CAS reasonable and necessary focus on a patient-centered, outcome- is hoping to stimulate the economy and
(section 1862(A)(1)(a) of the Social oriented, and transparent processes that increase the regulatory certainty with
Security Act). Form Number: CMS– promote quality patient care. The CfCs respect to generic versions of these drug
10199 (OMB control number: 0938– are designed to ensure that each facility products by confirming that generic
1011); Frequency: Yearly; Affected has properly trained staff to provide the versions of the subject drug products
Public: Business or other for-profit and appropriate type and level of care for may continue to be marketed.
Not-for-profit institutions; Number of that facility and provide a safe physical FOR FURTHER INFORMATION CONTACT:
Respondents: 1,370; Total Annual environment for patients. The CfCs are Stacy Kane, Center for Drug Evaluation
Responses: 4,110; Total Annual Hours: used by Federal or state surveyors as a and Research, Food and Drug
28,998. (For policy questions regarding basis for determining whether an ASC Administration, 10903 New Hampshire
this collection contact Sarah Fulton at qualifies for approval or re-approval Ave., Bldg. 51, Rm. 6236, Silver Spring,
410–786–2749.) under Medicare. We, along with the MD 20993–0002, 301–796–8363,
3. Type of Information Collection healthcare industry, believe that the Stacy.Kane@fda.hhs.gov.
Request: Extension of a currently availability to the facility of the type of
SUPPLEMENTARY INFORMATION: In 1984,
approved collection; Title of records and general content of records,
Information Collection: Conditions of Congress enacted the Drug Price
which this regulation specifies, is
Coverage for Organ Procurement Competition and Patent Term
standard medical practice and is
Organizations and Supporting Restoration Act of 1984 (Pub. L. 98–417)
necessary in order to ensure the well-
Regulations; Use: Section 1138(b) of the (the 1984 amendments), which
being and safety of patients and
Social Security Act, as added by section authorized the approval of duplicate
professional treatment accountability.
9318 of the Omnibus Budget versions of drug products approved
Form Number: CMS–10279 (OMB
Reconciliation Act of 1986 (Pub. L. 99– control number: 0938–1071); Frequency: under an ANDA procedure. ANDA
509), sets forth the statutory Annual; Affected Public: Business or applicants must, with certain
qualifications and requirements that other for-profit and Not-for-profit exceptions, show that the drug for
organ procurement organizations institutions; Number of Respondents: which they are seeking approval
(OPOs) must meet in order for the costs 5,500; Total Annual Responses: 5,500; contains the same active ingredient in
of their services in procuring organs for Total Annual Hours: 209,000. (For the same strength and dosage form as
transplant centers to be reimbursable policy questions regarding this the ‘‘listed drug,’’ which is a version of
under the Medicare and Medicaid collection contact Jacqueline Leach at the drug that was previously approved.
programs. An OPO must be certified and 410–786–4282.) ANDA applicants do not have to repeat
designated by the Secretary as an OPO the extensive clinical testing otherwise
Dated: April 26, 2017. necessary to gain approval of a new
and must meet performance-related
William N. Parham, III, drug application (NDA).
standards prescribed by the Secretary.
Director, Paperwork Reduction Staff, Office The 1984 amendments include what
The corresponding regulations are
of Strategic Operations and Regulatory is now section 505(j)(7) of the Federal
found at 42 CFR part 486 (Conditions Affairs.
for Coverage of Specialized Services Food, Drug, and Cosmetic Act (21 U.S.C.
[FR Doc. 2017–08738 Filed 4–27–17; 8:45 am] 355(j)(7)), which requires FDA to
Furnished by Suppliers) under subpart
G (Requirements for Certification and BILLING CODE 4120–01–P publish a list of all approved drugs.
Designation and Conditions for FDA publishes this list as part of the
Coverage: Organ Procurement ‘‘Approved Drug Products With
DEPARTMENT OF HEALTH AND Therapeutic Equivalence Evaluations,’’
Organizations). HUMAN SERVICES
Since each OPO has a monopoly on which is generally known as the
organ procurement within its designated ‘‘Orange Book.’’ Under FDA regulations,
Food and Drug Administration
service area (DSA), we must hold OPOs a drug is removed from the list if the
to high standards. Collection of this [Docket No. FDA–2017–N–1551] Agency withdraws or suspends
information is necessary for us to assess approval of the drug’s NDA or ANDA
the effectiveness of each OPO and Determination That DEMEROL for reasons of safety or effectiveness, or
determine whether it should continue to (Meperidine Hydrochloride) Injectable if FDA determines that the listed drug
be certified as an OPO and designated and Other Drug Products Were Not was withdrawn from sale for reasons of
for a particular donation service area by Withdrawn From Sale for Reasons of safety or effectiveness (21 CFR 314.162).
the Secretary or replaced by an OPO Safety or Effectiveness Under § 314.161(a) (21 CFR
that can more effectively procure organs AGENCY: Food and Drug Administration, 314.161(a)), the Agency must determine
within that DSA. Form Number: CMS– HHS. whether a listed drug was withdrawn
R–13 (OMB control number: 0938– ACTION: Notice. from sale for reasons of safety or
0688); Frequency: Occasionally; effectiveness: (1) Before an ANDA that
Affected Public: Not-for-profit SUMMARY: The Food and Drug refers to that listed drug may be
institutions; Number of Respondents: Administration (FDA or Agency) has approved, (2) whenever a listed drug is
asabaliauskas on DSK3SPTVN1PROD with NOTICES
58; Total Annual Responses: 58; Total determined that the drug products listed voluntarily withdrawn from sale and
Annual Hours: 13,546. (For policy in this document were not withdrawn ANDAs that refer to the listed drug have
questions regarding this collection from sale for reasons of safety or been approved, and (3) when a person
contact Diane Corning at 410–786– effectiveness. This determination means petitions for such a determination under
8486.) that FDA will not begin procedures to 21 CFR 10.25(a) and 10.30. Section
4. Type of Information Collection withdraw approval of abbreviated new 314.161(d) provides that if FDA
Request: Extension of a currently drug applications (ANDAs) that refer to determines that a listed drug was
approved collection; Title of these drug products, and it will allow withdrawn from sale for safety or
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Document Created: 2017-04-28 03:03:05
Document Modified: 2017-04-28 03:03:05
| 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 19734 |
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