Agency Information Collection Activities: Submission for OMB Review; Comment Request, 19734-19735 [2017-08738]
Download as PDF
<![CDATA[
19734
Federal Register / Vol. 82, No. 81 / Friday, April 28, 2017 / Notices
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
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
Centers for Medicare &
Medicaid 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
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.
SUMMARY:
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:
OIRA_submission@omb.eop.gov.
asabaliauskas on DSK3SPTVN1PROD with NOTICES
DATES:
VerDate Sep<11>2014
17:38 Apr 27, 2017
Jkt 241001
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-andGuidance/Legislation/
PaperworkReductionActof1995/PRAListing.html
2. Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov.
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 cardioverterdefibrillators (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
PO 00000
Frm 00083
Fmt 4703
Sfmt 4703
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 § 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 ≥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 § 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 ≥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 ≥70
percent will be covered only if
performed in facilities that have been
determined to be competent in
E:\FR\FM\28APN1.SGM
28APN1
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 82, No. 81 / Friday, April 28, 2017 / Notices
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
VerDate Sep<11>2014
17:38 Apr 27, 2017
Jkt 241001
Information Collection: Ambulatory
Surgical Center Conditions for Coverage;
Use: The Ambulatory Surgical Center
(ASC) Conditions for Coverage (CfCs)
focus on a patient-centered, outcomeoriented, 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 wellbeing 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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–1551]
Determination That DEMEROL
(Meperidine Hydrochloride) Injectable
and Other Drug Products Were Not
Withdrawn From Sale for Reasons of
Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) has
determined that the drug products listed
in this document were not withdrawn
from sale for reasons of safety or
effectiveness. This determination means
that FDA will not begin procedures to
withdraw approval of abbreviated new
drug applications (ANDAs) that refer to
these drug products, and it will allow
SUMMARY:
PO 00000
Frm 00084
Fmt 4703
Sfmt 4703
19735
FDA to continue to approve ANDAs that
refer to the products as long as they
meet relevant legal and regulatory
requirements. Through this notice, FDA
is hoping to stimulate the economy and
increase the regulatory certainty with
respect to generic versions of these drug
products by confirming that generic
versions of the subject drug products
may continue to be marketed.
FOR FURTHER INFORMATION CONTACT:
Stacy Kane, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6236, Silver Spring,
MD 20993–0002, 301–796–8363,
Stacy.Kane@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
(the 1984 amendments), which
authorized the approval of duplicate
versions of drug products approved
under an ANDA procedure. ANDA
applicants must, with certain
exceptions, show that the drug for
which they are seeking approval
contains the same active ingredient in
the same strength and dosage form as
the ‘‘listed drug,’’ which is a version of
the drug that was previously approved.
ANDA applicants do not have to repeat
the extensive clinical testing otherwise
necessary to gain approval of a new
drug application (NDA).
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)), which requires FDA to
publish a list of all approved drugs.
FDA publishes this list as part of the
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
which is generally known as the
‘‘Orange Book.’’ Under FDA regulations,
a drug is removed from the list if the
Agency withdraws or suspends
approval of the drug’s NDA or ANDA
for reasons of safety or effectiveness, or
if FDA determines that the listed drug
was withdrawn from sale for reasons of
safety or effectiveness (21 CFR 314.162).
Under § 314.161(a) (21 CFR
314.161(a)), the Agency must determine
whether a listed drug was withdrawn
from sale for reasons of safety or
effectiveness: (1) Before an ANDA that
refers to that listed drug may be
approved, (2) whenever a listed drug is
voluntarily withdrawn from sale and
ANDAs that refer to the listed drug have
been approved, and (3) when a person
petitions for such a determination under
21 CFR 10.25(a) and 10.30. Section
314.161(d) provides that if FDA
determines that a listed drug was
withdrawn from sale for safety or
E:\FR\FM\28APN1.SGM
28APN1
]]>Agencies
[Federal Register Volume 82, Number 81 (Friday, April 28, 2017)]
[Notices]
[Pages 19734-19735]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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:
OIRA_submission@omb.eop.gov.
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 Paperwork@cms.hhs.gov.
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
