Agency Information Collection Activities: Submission for OMB Review; Comment Request, 50455-50456 [2019-20856]
Download as PDF
<![CDATA[
jbell on DSK3GLQ082PROD with NOTICES
Federal Register / Vol. 84, No. 186 / Wednesday, September 25, 2019 / Notices
State MMA Phase Down (SPD)
exchange enables CMS to implement the
Medicare Prescription Drug,
Improvement, and Modernization Act,
also called the Medicare Modernization
Act (MMA), which was enacted into law
in 2003. This data exchange allows the
State Medicaid Agency (SMA) to
identify Medicare beneficiaries with
coverage under the Medicaid program.
The SMAs also identify other lowincome Medicare beneficiaries who
have applied for the Part D Low-Income
Subsidy (LIS). As a result of the
identification of these two groups of
beneficiaries, CMS auto-assigns and/or
facilitates enrollment of the appropriate
beneficiaries into Part D plans.
Section 1860 D–14 of the Social
Security Act sets forth requirements for
premium and cost-sharing subsidies for
low-income beneficiaries enrolled in
Medicare Part D. Based on this statute,
42 CFR 423.771, provides guidance
concerning limitations for payments
made by and on behalf of low-income
Medicare beneficiaries who enroll in
Part D plans. 42 CFR 423.771 (b)
establishes requirements for
determining a beneficiary’s eligibility
for full subsidy under the Part D
program. Regulations set forth in
423.780 and 423.782 outline premium
and cost sharing subsidies to which full
subsidy eligible are entitled under the
Part D program. Form Number: CMS–
10344 (OMB control number: 0938–
1127); Frequency: Monthly; Affected
Public: State, Local, or Tribal
Governments; Number of Respondents:
51; Total Annual Responses: 612; Total
Annual Hours: 612. (For policy
questions regarding this collection
contact Roland Horrea at 410–786–
0668.)
3. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Electronic
Funds Transfer Authorization
Agreement; Use: Section 1815(a) of the
Social Security Act provides the
authority for the Secretary of Health and
Human Services to pay providers/
suppliers of Medicare services at such
time or times as the Secretary
determines appropriate (but no less
frequently than monthly). Under
Medicare, CMS, acting for the Secretary,
contracts with Fiscal Intermediaries and
Carriers to pay claims submitted by
providers/suppliers who furnish
services to Medicare beneficiaries.
Under CMS’ payment policy, Medicare
providers/suppliers have the option of
receiving payments electronically. Form
Number: CMS–588 (OMB control
number: 0938–0626); Frequency: On
occasion; Affected Public: Business or
VerDate Sep<11>2014
18:25 Sep 24, 2019
Jkt 247001
other for-profit and Not-for-profit
institutions; Number of Respondents:
100,000; Total Annual Responses:
100,000; Total Annual Hours: 100,000.
For questions regarding this collection
contact Kim McPhillips at 410–786–
5374.
Dated: September 20, 2019.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2019–20858 Filed 9–24–19; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifiers: CMS–10595]
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.
DATES: Comments on the collection(s) of
information must be received by the
OMB desk officer by October 25, 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
SUMMARY:
PO 00000
Frm 00085
Fmt 4703
Sfmt 4703
50455
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/
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: Extension without change of a
currently approved collection; Title of
Information Collection: QHP Issuers
Data Collection for Notices for Plan or
Display Errors Special Enrollment
Periods; Use: The Patient Protection and
Affordable Care Act (Pub. L. 111–148)
and Health Care and Education
Reconciliation Act of 2010 (Pub. L. 111–
152), collectively referred to as the
PPACA, established new competitive
private health insurance markets called
Marketplaces, or Exchanges, which gave
millions of Americans and small
businesses access to qualified health
plans (QHPs), including stand-alone
dental plans (SADPs)— private health
E:\FR\FM\25SEN1.SGM
25SEN1
50456
Federal Register / Vol. 84, No. 186 / Wednesday, September 25, 2019 / Notices
and dental insurance plans that have
been certified as meeting certain
standards.
In the final rule, the Patient Protection
and Affordable Care Act; HHS Notice of
Benefit and Payment Parameters for
2017 (CMS–9937–F), we finalized 45
CFR 156.1256, which requires QHP
issuers, in the case of a material plan or
benefit display error included in 45 CFR
155.420(d)(12), to notify their enrollees
of the error and the enrollees’ eligibility
for a special enrollment period (SEP)
within 30 calendar days after the issuer
is informed by an Federally-facilitated
Exchange (FFE) that the error is
corrected, if directed to do so by the
FFE. This requirement provides
notification to QHP enrollees of errors
that may have impacted their QHP
selection and enrollment and any
associated monthly or annual costs, as
well as the availability of an SEP under
§ 155.420(d)(12) for the enrollee to
select a different QHP, if desired. The
Centers for Medicare and Medicaid
Services (CMS) is renewing this
information collection request (ICR) in
connection with standards regarding
Plan or Display Errors SEPs. The title of
the package has been changed to better
reflect its subject matter. The burden
estimate for the ICR included in this
package reflects the time and effort for
QHP issuers to provide notifications to
enrollees on the ICRs regarding Plan or
Display Errors SEPs. Form Number:
CMS–10595 (OMB control number:
0938–1301); Frequency: Yearly; Affected
Public: Private Sector (business or other
for-profits, not-for-profit institutions);
Number of Respondents: 505; Total
Annual Responses: 3,400; Total Annual
Hours: 1,700. (For questions regarding
this collection contact Deborah Hunter
at 202–309–1098).
Dated: September 20, 2019.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2019–20856 Filed 9–24–19; 8:45 am]
jbell on DSK3GLQ082PROD with NOTICES
BILLING CODE 4120–01–P
VerDate Sep<11>2014
18:25 Sep 24, 2019
Jkt 247001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–D–3614]
Recommendations for Sponsors of
Medically Important Antimicrobial
Drugs Approved for Use in Animals to
Voluntarily Bring Under Veterinary
Oversight All Products That Continue
To Be Available Over-the-Counter;
Draft Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA, we, or Agency) is
announcing the availability of a draft
guidance for industry (GFI) #263
entitled ‘‘Recommendations for
Sponsors of Medically Important
Antimicrobial Drugs Approved for Use
in Animals to Voluntarily Bring Under
Veterinary Oversight All Products That
Continue to be Available Over-theCounter.’’ This draft guidance
document, when finalized, will provide
information to sponsors of medically
important antimicrobial new animal
drug products who are interested in
changing the approved marketing status
of these products from over-the-counter
(OTC) to by veterinary prescription (Rx)
consistent with FDA’s recommendation
that the use of such drugs in animals be
limited to uses that include veterinary
oversight to mitigate development of
antimicrobial resistance. It also will
recommend timeframes for stakeholders
wishing to comply voluntarily with this
guidance.
DATES: Submit either electronic or
written comments on the draft guidance
by December 24, 2019 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
PO 00000
Frm 00086
Fmt 4703
Sfmt 4703
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
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.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2019–D–3614 for ‘‘Recommendations
for Sponsors of Medically Important
Antimicrobial Drugs Approved for Use
in Animals to Voluntarily Bring Under
Veterinary Oversight All Products That
Continue to be Available Over-theCounter.’’ Received comments will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. 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 comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
E:\FR\FM\25SEN1.SGM
25SEN1
]]>Agencies
[Federal Register Volume 84, Number 186 (Wednesday, September 25, 2019)]
[Notices]
[Pages 50455-50456]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-20856]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifiers: CMS-10595]
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 October 25, 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/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: Extension without change
of a currently approved collection; Title of Information Collection:
QHP Issuers Data Collection for Notices for Plan or Display Errors
Special Enrollment Periods; Use: The Patient Protection and Affordable
Care Act (Pub. L. 111-148) and Health Care and Education Reconciliation
Act of 2010 (Pub. L. 111-152), collectively referred to as the PPACA,
established new competitive private health insurance markets called
Marketplaces, or Exchanges, which gave millions of Americans and small
businesses access to qualified health plans (QHPs), including stand-
alone dental plans (SADPs)-- private health
[[Page 50456]]
and dental insurance plans that have been certified as meeting certain
standards.
In the final rule, the Patient Protection and Affordable Care Act;
HHS Notice of Benefit and Payment Parameters for 2017 (CMS-9937-F), we
finalized 45 CFR 156.1256, which requires QHP issuers, in the case of a
material plan or benefit display error included in 45 CFR
155.420(d)(12), to notify their enrollees of the error and the
enrollees' eligibility for a special enrollment period (SEP) within 30
calendar days after the issuer is informed by an Federally-facilitated
Exchange (FFE) that the error is corrected, if directed to do so by the
FFE. This requirement provides notification to QHP enrollees of errors
that may have impacted their QHP selection and enrollment and any
associated monthly or annual costs, as well as the availability of an
SEP under Sec. 155.420(d)(12) for the enrollee to select a different
QHP, if desired. The Centers for Medicare and Medicaid Services (CMS)
is renewing this information collection request (ICR) in connection
with standards regarding Plan or Display Errors SEPs. The title of the
package has been changed to better reflect its subject matter. The
burden estimate for the ICR included in this package reflects the time
and effort for QHP issuers to provide notifications to enrollees on the
ICRs regarding Plan or Display Errors SEPs. Form Number: CMS-10595 (OMB
control number: 0938-1301); Frequency: Yearly; Affected Public: Private
Sector (business or other for-profits, not-for-profit institutions);
Number of Respondents: 505; Total Annual Responses: 3,400; Total Annual
Hours: 1,700. (For questions regarding this collection contact Deborah
Hunter at 202-309-1098).
Dated: September 20, 2019.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2019-20856 Filed 9-24-19; 8:45 am]
BILLING CODE 4120-01-P
