Agency Information Collection Activities: Submission for OMB Review; Comment Request, 56243-56244 [2017-25612]
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Federal Register / Vol. 82, No. 227 / Tuesday, November 28, 2017 / Notices
Dated: November 21, 2017.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2017–25621 Filed 11–27–17; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifiers: CMS–R–185, CMS–
437 and CMS–10515]
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 December 28, 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.
ethrower on DSK3G9T082PROD with NOTICES
DATES:
VerDate Sep<11>2014
19:51 Nov 27, 2017
Jkt 244001
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. 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 currently
approved collection; Title of
Information Collection: Granting and
Withdrawal of Deeming Authority to
Private Nonprofit Accreditation
Organizations and CLIA Exemption
Under State Laboratory Programs; Use:
The information required is necessary to
determine whether a private
accreditation organization/State
licensure program standards and
accreditation/licensure process is at
least equal to or more stringent than
those of the Clinical Laboratory
Improvement Amendments of 1988
(CLIA). If an accreditation organization
is approved, the laboratories that it
accredits are ‘‘deemed’’ to meet the
CLIA requirements based on this
accreditation. Similarly, if a State
licensure program is determined to have
requirements that are equal to or more
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56243
stringent than those of CLIA, its
laboratories are considered to be exempt
from CLIA certification and
requirements. The information collected
will be used by HHS to: Determine
comparability/equivalency of the
accreditation organization standards
and policies or State licensure program
standards and policies to those of the
CLIA program; to ensure the continued
comparability/equivalency of the
standards; and to fulfill certain statutory
reporting requirements. Form Number:
CMS–R–185 (OMB control number:
0938–0686); Frequency: Occasionally;
Affected Public: Private Sector—
Business or other for-profits and Notfor-profit institutions; Number of
Respondents: 9; Total Annual
Responses: 9; Total Annual Hours:
5,464. (For policy questions regarding
this collection contact Arlene Lopez at
410–786–6782.)
2. Type of Information Collection
Request: Reinstatement with Change of
a previously approved collection; Title
of Information Collection: Psychiatric
Unit Criteria Work Sheet; Use: Certain
specialty hospitals and hospital
specialty distinct-part units may be
excluded from the Inpatient Medicare
Prospective Payment System (IPPS) and
be paid at a different rate. These
specialty hospitals and distinct-part
units of hospitals include Inpatient
Rehabilitation Facilities (IRFs) units,
Inpatient Rehabilitation Facilities (IRFs)
hospitals and Inpatient Psychiatric
Facilities (IPFs).
CMS regulations at 42 CFR 412.20
through 412.29 describe the criteria
under which these specialty hospitals
and specialty distinct-part hospital units
are excluded from the IPPS. Form CMS–
437 is used by Inpatient Psychiatric
Facilities (IPFs) to attest to meeting the
necessary requirements that make them
exempt for receiving payment from
Medicare under the IPPS. These IPFs
must use CMS–437 to attest that they
meet the requirements for IPPS exempt
status prior to being placed into
excluded status. The IPFs must re-attest
to meeting the exclusion criteria
annually. Form Number: CMS–437
(OMB control number: 0938–0358);
Frequency: Annually; Affected Public:
Private sector—Business or other forprofits; Number of Respondents: 1,616;
Total Annual Responses: 1,616; Total
Annual Hours: 1,212. (For policy
questions regarding this collection
contact Caroline Gallaher at 410–786–
8705.)
3. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Payment
Collections Operations Contingency
E:\FR\FM\28NON1.SGM
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56244
Federal Register / Vol. 82, No. 227 / Tuesday, November 28, 2017 / Notices
Plan; Use: Under sections 1401, 1411,
and 1412 of the Affordable Care Act and
45 CFR part 155 subpart D, an Exchange
makes an advance determination of tax
credit eligibility for individuals who
enroll in QHP coverage through the
Exchange and seek financial assistance.
Using information available at the time
of enrollment, the Exchange determines
whether the individual meets the
income and other requirements for
advance payments and the amount of
the advance payments that can be used
to pay premiums. Advance payments
are made periodically under section
1412 of the Affordable Care Act to the
issuer of the QHP in which the
individual enrolls. Section 1402 of the
Affordable Care Act provides for the
reduction of cost sharing for certain
individuals enrolled in a QHP through
an Exchange, and section 1412 of the
Affordable Care Act provides for the
advance payment of these reductions to
issuers. The statute directs issuers to
reduce cost sharing for essential health
benefits for individuals with household
incomes between 100 and 400 percent
of the Federal poverty level (FPL) who
are enrolled in a silver level QHP
through an individual market Exchange
and are eligible for advance payments of
the premium tax credit. The data
collection will be used by HHS to make
payments or collect charges from issuers
under the following programs: advance
payments of the premium tax credit,
advanced cost-sharing reductions, and
Marketplace user fees. The template will
be used to make payments in January
2014 and for a number of months
thereafter, as may be required based on
HHS’s operational progress. Form
Number: CMS–10515 (OMB control
number: 0938–1217); Frequency:
Monthly; Affected Public: Private sector
(Business or other for-profits and notfor-profit institutions); Number of
Respondents: 575; Total Annual
Responses: 7,475; Total Annual Hours:
51,175. (For policy questions regarding
this collection contact Jaya Ghildiyal at
301–492–5149).
ethrower on DSK3G9T082PROD with NOTICES
Dated: November 21, 2017.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2017–25612 Filed 11–27–17; 8:45 am]
BILLING CODE 4120–01–P
VerDate Sep<11>2014
19:51 Nov 27, 2017
Jkt 244001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2016–E–0533 and FDA–
2016–E–0534]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; RAPIVAB
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for RAPIVAB and is publishing this
notice of that determination as required
by law. FDA has made the
determination because of the
submission of applications to the
Director of the U.S. Patent and
Trademark Office (USPTO), Department
of Commerce, for the extension of a
patent which claims that human drug
product.
SUMMARY:
Anyone with knowledge that any
of the dates as published (in the
SUPPLEMENTARY INFORMATION section) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by January 29, 2018.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
May 29, 2018. See ‘‘Petitions’’ in the
SUPPLEMENTARY INFORMATION section for
more information.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before January 29,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of January 29, 2018.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
DATES:
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
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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,
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 Nos. FDA–
2016–E–0533 and FDA–2016–E–0534
for ’’Determination of Regulatory
Review Period for Purposes of Patent
Extension; RAPIVAB.’’ Received
comments, those filed in a timely
manner (see ADDRESSES), 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
E:\FR\FM\28NON1.SGM
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]]>Agencies
[Federal Register Volume 82, Number 227 (Tuesday, November 28, 2017)]
[Notices]
[Pages 56243-56244]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-25612]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifiers: CMS-R-185, CMS-437 and CMS-10515]
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 December 28, 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. 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 currently
approved collection; Title of Information Collection: Granting and
Withdrawal of Deeming Authority to Private Nonprofit Accreditation
Organizations and CLIA Exemption Under State Laboratory Programs; Use:
The information required is necessary to determine whether a private
accreditation organization/State licensure program standards and
accreditation/licensure process is at least equal to or more stringent
than those of the Clinical Laboratory Improvement Amendments of 1988
(CLIA). If an accreditation organization is approved, the laboratories
that it accredits are ``deemed'' to meet the CLIA requirements based on
this accreditation. Similarly, if a State licensure program is
determined to have requirements that are equal to or more stringent
than those of CLIA, its laboratories are considered to be exempt from
CLIA certification and requirements. The information collected will be
used by HHS to: Determine comparability/equivalency of the
accreditation organization standards and policies or State licensure
program standards and policies to those of the CLIA program; to ensure
the continued comparability/equivalency of the standards; and to
fulfill certain statutory reporting requirements. Form Number: CMS-R-
185 (OMB control number: 0938-0686); Frequency: Occasionally; Affected
Public: Private Sector--Business or other for-profits and Not-for-
profit institutions; Number of Respondents: 9; Total Annual Responses:
9; Total Annual Hours: 5,464. (For policy questions regarding this
collection contact Arlene Lopez at 410-786-6782.)
2. Type of Information Collection Request: Reinstatement with
Change of a previously approved collection; Title of Information
Collection: Psychiatric Unit Criteria Work Sheet; Use: Certain
specialty hospitals and hospital specialty distinct-part units may be
excluded from the Inpatient Medicare Prospective Payment System (IPPS)
and be paid at a different rate. These specialty hospitals and
distinct-part units of hospitals include Inpatient Rehabilitation
Facilities (IRFs) units, Inpatient Rehabilitation Facilities (IRFs)
hospitals and Inpatient Psychiatric Facilities (IPFs).
CMS regulations at 42 CFR 412.20 through 412.29 describe the
criteria under which these specialty hospitals and specialty distinct-
part hospital units are excluded from the IPPS. Form CMS-437 is used by
Inpatient Psychiatric Facilities (IPFs) to attest to meeting the
necessary requirements that make them exempt for receiving payment from
Medicare under the IPPS. These IPFs must use CMS-437 to attest that
they meet the requirements for IPPS exempt status prior to being placed
into excluded status. The IPFs must re-attest to meeting the exclusion
criteria annually. Form Number: CMS-437 (OMB control number: 0938-
0358); Frequency: Annually; Affected Public: Private sector--Business
or other for-profits; Number of Respondents: 1,616; Total Annual
Responses: 1,616; Total Annual Hours: 1,212. (For policy questions
regarding this collection contact Caroline Gallaher at 410-786-8705.)
3. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Payment
Collections Operations Contingency
[[Page 56244]]
Plan; Use: Under sections 1401, 1411, and 1412 of the Affordable Care
Act and 45 CFR part 155 subpart D, an Exchange makes an advance
determination of tax credit eligibility for individuals who enroll in
QHP coverage through the Exchange and seek financial assistance. Using
information available at the time of enrollment, the Exchange
determines whether the individual meets the income and other
requirements for advance payments and the amount of the advance
payments that can be used to pay premiums. Advance payments are made
periodically under section 1412 of the Affordable Care Act to the
issuer of the QHP in which the individual enrolls. Section 1402 of the
Affordable Care Act provides for the reduction of cost sharing for
certain individuals enrolled in a QHP through an Exchange, and section
1412 of the Affordable Care Act provides for the advance payment of
these reductions to issuers. The statute directs issuers to reduce cost
sharing for essential health benefits for individuals with household
incomes between 100 and 400 percent of the Federal poverty level (FPL)
who are enrolled in a silver level QHP through an individual market
Exchange and are eligible for advance payments of the premium tax
credit. The data collection will be used by HHS to make payments or
collect charges from issuers under the following programs: advance
payments of the premium tax credit, advanced cost-sharing reductions,
and Marketplace user fees. The template will be used to make payments
in January 2014 and for a number of months thereafter, as may be
required based on HHS's operational progress. Form Number: CMS-10515
(OMB control number: 0938-1217); Frequency: Monthly; Affected Public:
Private sector (Business or other for-profits and not-for-profit
institutions); Number of Respondents: 575; Total Annual Responses:
7,475; Total Annual Hours: 51,175. (For policy questions regarding this
collection contact Jaya Ghildiyal at 301-492-5149).
Dated: November 21, 2017.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2017-25612 Filed 11-27-17; 8:45 am]
BILLING CODE 4120-01-P
