Agency Information Collection Activities: Submission for OMB Review; Comment Request, 72066-72067 [2015-29343]
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72066
Federal Register / Vol. 80, No. 222 / Wednesday, November 18, 2015 / Notices
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN—Continued
Number of
respondents/
POCs
Form name
Total ..........................................................................................................
Total burden
hours
280
454
Average
hourly wage
rate*
NA
Total cost
burden
$18,613
* National Compensation Survey: Occupational wages in the United States May 2014, ‘‘U.S. Department of Labor, Bureau of Labor Statistics.’’
a) and c) Based on the mean hourly wages for Computer Programmer (15–1131). b) Based on the mean hourly wage for Chief Executives (11–
1011). https://www.bls.gov/oes/current/oes_nat.htm#15–0000.
Request for Comments
In accordance with the Paperwork
Reduction Act, comments on AHRQ’s
information collection are requested
with regard to any of the following: (a)
Whether the proposed collection of
information is necessary for the proper
performance of AHRQ health care
research and information dissemination
functions, including whether the
information will have practical utility;
(b) the accuracy of AHRQ’s estimate of
burden (including hours and costs) of
the proposed collection(s) of
information; (c) ways to enhance the
quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information upon the
respondents, including the use of
automated collection techniques or
other forms of information technology.
Comments submitted in response to
this notice will be summarized and
included in the Agency’s subsequent
request for OMB approval of the
proposed information collection. All
comments will become a matter of
public record.
Sharon B. Arnold,
Deputy Director.
[FR Doc. 2015–29440 Filed 11–17–15; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifiers: CMS–10433]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
asabaliauskas on DSK5VPTVN1PROD with NOTICES
ACTION:
Notice.
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
SUMMARY:
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18:50 Nov 17, 2015
Jkt 238001
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 any of the
following subjects: (1) The necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions; (2) the accuracy
of the estimated burden; (3) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(4) 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 18, 2015:
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
https://www.cms.hhs.gov/
PaperworkReductionActof1995.
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:
Reports Clearance Office at (410) 786–
1326.
SUPPLEMENTARY INFORMATION: Under the
Paperwork Reduction Act of 1995 (PRA)
(44 U.S.C. 3501–3520), federal agencies
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Fmt 4703
Sfmt 4703
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 information collection; Title
of Information Collection: Initial Plan
Data Collection to Support Qualified
Health Plan (QHP) Certification and
Other Financial Management and
Exchange Operations; Use: As required
by the CMS–9989–F, Patient Protection
and Affordable Care Act; Establishment
of Exchanges and Qualified Health
Plans; Exchange Standards for
Employers (77 FR 18310) (Exchange
Establishment Rule), published on
March 27, 2012, each Exchange must
assume responsibilities related to the
certification and offering of Qualified
Health Plans (QHPs). To offer insurance
through an Exchange, a health insurance
issuer must have its health plans
certified as QHPs by the Exchange.
A QHP must meet certain minimum
certification standards, such as those
pertaining to essential community
providers, essential health benefits, and
actuarial value. In order to meet those
standards, the Exchange is responsible
for collecting data and validating that
QHPs meet these minimum
requirements as described in the
Exchange rule under 45 CFR parts 155
and 156, based on the Affordable Care
Act, as well as other requirements
determined by the Exchange. In
E:\FR\FM\18NON1.SGM
18NON1
Federal Register / Vol. 80, No. 222 / Wednesday, November 18, 2015 / Notices
addition to data collection for the
certification of QHPs, the reinsurance
and risk adjustment programs outlined
by the Affordable Care Act, detailed in
45 CFR part 153, as established by
CMS–9975–F, Patient Protection and
Affordable Care Act; Standards for
Reinsurance, Risk Corridors, and Risk
Adjustment (77 FR 17220), published in
March 23, 2012, have general
information reporting requirements that
apply to issuers, group health plans,
third party administrators, and plan
offerings outside of the Exchanges.
Subsequent regulations for these
programs including the final HHS
Notice of Benefit and Payment
Parameters for 2014 and the Program
Integrity: Exchange, Premium
Stabilization Programs, and Market
Standards; Amendments to the HHS
Notice of Benefit and Payment
Parameters for 2014 provide further
reporting requirements. Form Number:
CMS–10433 (OMB Control Number
0938–1187); Frequency: Annually;
Affected Public: States and Private
Sector; Number of Respondents: 26,951;
Number of Responses: 26,951; Total
Annual Hours: 235,153. (For questions
regarding this collection contact Leigha
Basini at 301–492–4380.)
Dated: November 12, 2015.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2015–M–1707, FDA–
2015–M–2218, FDA–2015–M–2217, FDA–
2015–M–2497, FDA–2015–M–2219, FDA–
2015–M–2499, FDA–2015–M–2634, FDA–
2015–M–2584, FDA–2015–M–2618, FDA–
2015–M–2739, FDA–2015–M–2740, and
FDA–2015–M–2964]
Medical Devices; Availability of Safety
and Effectiveness Summaries for
Premarket Approval Applications
Food and Drug Administration,
asabaliauskas on DSK5VPTVN1PROD with NOTICES
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is publishing a
list of premarket approval applications
(PMAs) that have been approved. This
list is intended to inform the public of
the availability of safety and
effectiveness summaries of approved
PMAs through the Internet and the
SUMMARY:
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18:50 Nov 17, 2015
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ADDRESSES:
You may submit comments
as follows:
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,
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
[FR Doc. 2015–29343 Filed 11–17–15; 8:45 am]
AGENCY:
Agency’s Division of Dockets
Management.
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, 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–
2015–M–1707, FDA–2015–M–2218,
FDA–2015–M–2217, FDA–2015–M–
2497, FDA–2015–M–2219, FDA–2015–
M–2499, FDA–2015–M–2634, FDA–
2015–M–2584, FDA–2015–M–2618,
FDA–2015–M–2739, FDA–2015–M–
2740, and FDA–2015–M–2964 for
‘‘Medical Devices; Availability of Safety
and Effectiveness Summaries for
Premarket Approval Applications.’’
Received comments will be placed in
the docket and, except for those
submitted as ‘‘Confidential
PO 00000
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72067
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
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 Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.fda.gov/
regulatoryinformation/dockets/
default.htm.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Melissa Torres, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1650, Silver Spring,
MD 20993–0002, 301–796–5576.
SUPPLEMENTARY INFORMATION:
I. Background
In accordance with sections 515(d)(4)
and (e)(2) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C.
360e(d)(4) and (e)(2)), notification of an
order approving, denying, or
withdrawing approval of a PMA will
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]]>Agencies
[Federal Register Volume 80, Number 222 (Wednesday, November 18, 2015)]
[Notices]
[Pages 72066-72067]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-29343]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifiers: CMS-10433]
Agency Information Collection Activities: Submission for OMB
Review; Comment Request
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 any of the following subjects: (1)
The necessity and utility of the proposed information collection for
the proper performance of the agency's functions; (2) the accuracy of
the estimated burden; (3) ways to enhance the quality, utility, and
clarity of the information to be collected; and (4) 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 18, 2015:
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 https://www.cms.hhs.gov/PaperworkReductionActof1995.
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: Reports Clearance Office at (410) 786-
1326.
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 information collection; Title of Information Collection:
Initial Plan Data Collection to Support Qualified Health Plan (QHP)
Certification and Other Financial Management and Exchange Operations;
Use: As required by the CMS-9989-F, Patient Protection and Affordable
Care Act; Establishment of Exchanges and Qualified Health Plans;
Exchange Standards for Employers (77 FR 18310) (Exchange Establishment
Rule), published on March 27, 2012, each Exchange must assume
responsibilities related to the certification and offering of Qualified
Health Plans (QHPs). To offer insurance through an Exchange, a health
insurance issuer must have its health plans certified as QHPs by the
Exchange.
A QHP must meet certain minimum certification standards, such as
those pertaining to essential community providers, essential health
benefits, and actuarial value. In order to meet those standards, the
Exchange is responsible for collecting data and validating that QHPs
meet these minimum requirements as described in the Exchange rule under
45 CFR parts 155 and 156, based on the Affordable Care Act, as well as
other requirements determined by the Exchange. In
[[Page 72067]]
addition to data collection for the certification of QHPs, the
reinsurance and risk adjustment programs outlined by the Affordable
Care Act, detailed in 45 CFR part 153, as established by CMS-9975-F,
Patient Protection and Affordable Care Act; Standards for Reinsurance,
Risk Corridors, and Risk Adjustment (77 FR 17220), published in March
23, 2012, have general information reporting requirements that apply to
issuers, group health plans, third party administrators, and plan
offerings outside of the Exchanges. Subsequent regulations for these
programs including the final HHS Notice of Benefit and Payment
Parameters for 2014 and the Program Integrity: Exchange, Premium
Stabilization Programs, and Market Standards; Amendments to the HHS
Notice of Benefit and Payment Parameters for 2014 provide further
reporting requirements. Form Number: CMS-10433 (OMB Control Number
0938-1187); Frequency: Annually; Affected Public: States and Private
Sector; Number of Respondents: 26,951; Number of Responses: 26,951;
Total Annual Hours: 235,153. (For questions regarding this collection
contact Leigha Basini at 301-492-4380.)
Dated: November 12, 2015.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2015-29343 Filed 11-17-15; 8:45 am]
BILLING CODE 4120-01-P
