Agency Information Collection Activities: Submission for OMB Review; Comment Request, 57735-57736 [2019-23506]
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Federal Register / Vol. 84, No. 208 / Monday, October 28, 2019 / Notices
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’ website address at
website address at https://www.cms.gov/
Regulations-and-Guidance/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 N. Parham at (410) 786–4669.
SUPPLEMENTARY INFORMATION:
khammond on DSKJM1Z7X2PROD with NOTICES
Contents
This notice sets out a summary of the
use and burden associated with the
following information collections. More
detailed information can be found in
each collection’s supporting statement
and associated materials (see
ADDRESSES).
CMS–3427 End Stage Renal Disease
Application and Survey and
Certification Report
CMS–484, 846, 854, 847, 848, 849,
10125, and 10126 Durable
Medical Equipment Medicare
Administrative
Under the PRA (44 U.S.C. 3501–
3520), federal agencies must obtain
approval from the Office of Management
and Budget (OMB) for each collection of
information they conduct or sponsor.
The term ‘‘collection of information’’ is
defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA
requires federal agencies to publish a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, before
submitting the collection to OMB for
approval. To comply with this
requirement, CMS is publishing this
notice.
Information Collection
1. Type of Information Collection
Request: Reinstatement with change of a
previously approved collection; Title of
Information Collection: End Stage Renal
Disease Application and Survey and
Certification Report; Use: Part I of this
form is a facility identification and
screening measurement used to initiate
the certification and recertification of
VerDate Sep<11>2014
16:58 Oct 25, 2019
Jkt 250001
ESRD facilities. Part II is completed by
the Medicare/Medicaid State survey
agency to determine facility compliance
with ESRD conditions for coverage.
Form Number: CMS–3427 (OMB control
number: 0938–0360); Frequency: Every
three years; Affected Public: Private
sector (Business or other for-profit and
Not-for profit institutions); Number of
Respondents: 7,493; Total Annual
Responses: 2,473; Total Annual Hours:
824. (For policy questions regarding this
collection contact Jennifer Milby at 410–
786–8828).
2. Type of Information Collection
Request: Extension without change of a
currently approved collection; Title of
Information Collection: Durable Medical
Equipment Medicare Administrative
Contractor Certificate of Medical
Necessity and Supporting
Documentation Requirements; Use: The
certificates of medical necessity (CMNs)
collect information required to help
determine the medical necessity of
certain items. CMS requires CMNs
where there may be a vulnerability to
the Medicare program. Each initial
claim for these items must have an
associated CMN for the beneficiary.
Suppliers (those who bill for the items)
complete the administrative information
(e.g., patient’s name and address, items
ordered, etc.) on each CMN. The 1994
Amendments to the Social Security Act
require that the supplier also provide a
narrative description of the items
ordered and all related accessories, their
charge for each of these items, and the
Medicare fee schedule allowance (where
applicable). The supplier then sends the
CMN to the treating physician or other
clinicians (e.g., physician assistant,
LPN, etc.) who completes questions
pertaining to the beneficiary’s medical
condition and signs the CMN. The
physician or other clinician returns the
CMN to the supplier who has the option
to maintain a copy and then submits the
CMN electronically to CMS, along with
a claim for reimbursement. Form
Numbers: CMS–484, 846, 847, 848, 849,
10125, 10126 (OMB control number:
0938–0679); Frequency: Occasionally;
Affected Public: Individuals or
Households; Number of Respondents:
1,335,658; Total Annual Responses:
1,335,658; Total Annual Hours: 267,132.
(For policy questions regarding this
collection contact Melissa Singer at
410–786–0365.)
Dated: October 23, 2019.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2019–23504 Filed 10–25–19; 8:45 am]
BILLING CODE 4120–01–P
PO 00000
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57735
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier CMS–10400]
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 November 27,
2019.
DATES:
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’ website address at
website address at https://www.cms.gov/
Regulations-and-Guidance/Legislation/
ADDRESSES:
E:\FR\FM\28OCN1.SGM
28OCN1
khammond on DSKJM1Z7X2PROD with NOTICES
57736
Federal Register / Vol. 84, No. 208 / Monday, October 28, 2019 / Notices
PaperworkReductionActof1995/PRAListing.html
1. Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov.
2. 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. 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: Revision of a currently
approved collection; Title of
Information Collection: Establishment of
Exchanges and Qualified Health Plans;
Use: The Patient Protection and
Affordable Care Act (Pub. L. 111–148)
and the Health Care and Education
Reconciliation Act of 2010 (Pub. L.111–
152) (collectively, the Patient Protection
and Affordable Care Act (PPACA)) were
signed into law in 2010. The PPACA
established competitive private health
insurance markets, called Marketplaces
or Exchanges, which give millions of
Americans and small businesses access
to qualified health plans (QHPs),
including stand-alone dental plans
(SADPs)—private health and dental
insurance plans that are certified as
meeting certain standards.
As directed by the rule Establishment
of Exchanges and Qualified Health
Plans; Exchange Standards for
Employers (77 FR 18310) (Exchange
rule), each Exchange assumed
responsibilities related to the
certification and offering of QHPs.
Under 45 CFR 156.280(e)(5)(ii), each
QHP issuer that offers non-excepted
abortion services must submit to the
State Insurance Commissioner a
VerDate Sep<11>2014
16:58 Oct 25, 2019
Jkt 250001
segregation plan describing how the
QHP issuer establishes and maintains
separate payment accounts for any QHP
covering non-excepted abortion
services, and pursuant to
§ 156.280(e)(5)(iii), each QHP issuer
must annually attest to compliance with
PPACA section 1303 and applicable
regulations. This segregation plan is
used to verify that the QHP issuer’s
financial and other systems fully
conform to the segregation requirements
required by the PPACA. Form Number:
CMS–10400 (OMB control number
0938–1156); Frequency: Annually;
Affected Public: Private Sector (business
or other for-profits, not-for-profit
institutions); Number of Respondents:
210; Number of Responses: 210; Total
Annual Hours: 580. For questions
regarding this collection contact
Michele Oshman at 410–786–4396.
Dated: October 23, 2019.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2019–23506 Filed 10–25–19; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–3708]
InvaGen Pharmaceuticals, Inc.;
Proposal To Withdraw Approval of an
Abbreviated New Drug Application for
Trandolapril Tablets; Opportunity for a
Hearing
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration’s (FDA or Agency)
Center for Drug Evaluation and Research
(CDER) is proposing to withdraw
approval of an abbreviated new drug
application (ANDA) for trandolapril
tablets and is announcing an
opportunity for the holder of the ANDA
to request a hearing on this proposal.
The basis for the proposal is that the
holder of the ANDA has repeatedly
failed to submit the required data to
support a finding of bioequivalence for
this ANDA.
DATES: InvaGen Pharmaceuticals, Inc.
may submit a request for a hearing by
November 27, 2019. Submit all data,
information, and analyses upon which
the request for a hearing relies by
December 27, 2019. Submit electronic or
written comments by December 27,
2019.
SUMMARY:
PO 00000
Frm 00049
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Sfmt 4703
The request for a hearing
may be submitted by InvaGen
Pharmaceuticals, Inc. by either of the
following methods:
ADDRESSES:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments to
submit your request for a hearing.
Comments submitted electronically to
https://www.regulations.gov, including
any attachments to the request for a
hearing, will be posted to the docket
unchanged.
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• Because your request for a hearing
will be made public, you are solely
responsible for ensuring that your
request does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. The request
for a hearing must include the Docket
No. FDA–2019–N–3708 for ‘‘InvaGen
Pharmaceuticals, Inc.; Proposal to
Withdraw Approval of an Abbreviated
New Drug Application for Trandolapril
Tablets; Opportunity for a Hearing.’’
The request for a hearing will be placed
in the docket and publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
InvaGen Pharmaceuticals, Inc. may
submit all data and analyses upon
which the request for a hearing relies in
the same manner as the request for a
hearing except as follows:
• Confidential Submissions—To
submit any data and analyses with
confidential information that you do not
wish to be made publicly available,
submit your data and analyses only as
a written/paper submission. You should
submit two copies total of all data and
analyses. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of any decisions on
this matter. The second copy, which
E:\FR\FM\28OCN1.SGM
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]]>Agencies
[Federal Register Volume 84, Number 208 (Monday, October 28, 2019)]
[Notices]
[Pages 57735-57736]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-23506]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier CMS-10400]
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 November 27, 2019.
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' website address at website address at https://
www.cms.gov/Regulations-and-Guidance/Legislation/
[[Page 57736]]
PaperworkReductionActof1995/PRA-Listing.html
1. Email your request, including your address, phone number, OMB
number, and CMS document identifier, to [email protected].
2. 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. 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: Revision of a currently
approved collection; Title of Information Collection: Establishment of
Exchanges and Qualified Health Plans; Use: The Patient Protection and
Affordable Care Act (Pub. L. 111-148) and the Health Care and Education
Reconciliation Act of 2010 (Pub. L.111-152) (collectively, the Patient
Protection and Affordable Care Act (PPACA)) were signed into law in
2010. The PPACA established competitive private health insurance
markets, called Marketplaces or Exchanges, which give millions of
Americans and small businesses access to qualified health plans (QHPs),
including stand-alone dental plans (SADPs)--private health and dental
insurance plans that are certified as meeting certain standards.
As directed by the rule Establishment of Exchanges and Qualified
Health Plans; Exchange Standards for Employers (77 FR 18310) (Exchange
rule), each Exchange assumed responsibilities related to the
certification and offering of QHPs. Under 45 CFR 156.280(e)(5)(ii),
each QHP issuer that offers non-excepted abortion services must submit
to the State Insurance Commissioner a segregation plan describing how
the QHP issuer establishes and maintains separate payment accounts for
any QHP covering non-excepted abortion services, and pursuant to Sec.
156.280(e)(5)(iii), each QHP issuer must annually attest to compliance
with PPACA section 1303 and applicable regulations. This segregation
plan is used to verify that the QHP issuer's financial and other
systems fully conform to the segregation requirements required by the
PPACA. Form Number: CMS-10400 (OMB control number 0938-1156);
Frequency: Annually; Affected Public: Private Sector (business or other
for-profits, not-for-profit institutions); Number of Respondents: 210;
Number of Responses: 210; Total Annual Hours: 580. For questions
regarding this collection contact Michele Oshman at 410-786-4396.
Dated: October 23, 2019.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2019-23506 Filed 10-25-19; 8:45 am]
BILLING CODE 4120-01-P
