Agency Information Collection Activities: Proposed Collection; Comment Request, 81828-81829 [2015-32880]
Download as PDF
81828
Federal Register / Vol. 80, No. 251 / Thursday, December 31, 2015 / Notices
++ Taxpayer Identification Number
(TIN).
++ National Provider Identifier (NPI).
++ Provider type.
++ Practice site address.
++ Patient insurance.
++ Patient age.
++ Patient sex.
++ Patient race and ethnicity.
++ Patient problem list data.
How useful are the ‘‘filtering’’ criteria
to end users of systems for the purpose
of safety and quality improvement? To
quality improvement staff and
organizations?
• Are there additional filters/data
would be helpful to stratify CQM-Filters
(45 CFR 170.315(c)(4)) data by?
• What, if anything additional,
regarding this testing/certification
should be published via the Certified
Health IT Product List?
III. Collection of Information
Requirements
This document does not impose
information collection requirements,
that is, reporting, recordkeeping or
third-party disclosure requirements.
Consequently, there is no need for
review by the Office of Management and
Budget under the authority of the
Paperwork Reduction Act of 1995 (44
U.S.C. 3501 et seq.).
IV. Response to Comments
Because of the large number of public
comments we normally receive on
Federal Register documents, we are not
able to acknowledge or respond to them
individually. We will consider all
comments we receive by the date and
time specified in the DATES section of
this preamble, and, when we proceed
with a subsequent document, we will
respond to the comments in the
preamble to that document.
Dated: December 3, 2015.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare
& Medicaid Services.
[FR Doc. 2015–32931 Filed 12–30–15; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
tkelley on DSK3SPTVN1PROD with NOTICES
[Document Identifier: CMS–R–284]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Centers for Medicare &
Medicaid Services.
ACTION: Notice.
AGENCY:
VerDate Sep<11>2014
16:49 Dec 30, 2015
Jkt 238001
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 (the
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
60 days for public comment on the
proposed action. Interested persons are
invited to send comments regarding our
burden estimates 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.
SUMMARY:
Comments must be received by
February 29, 2016.
ADDRESSES: When commenting, please
reference the document identifier or
OMB control number. To be assured
consideration, comments and
recommendations must be submitted in
any one of the following ways:
1. Electronically. You may send your
comments electronically to https://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) that are accepting
comments.
2. By regular mail. You may mail
written comments to the following
address:
DATES:
CMS, Office of Strategic Operations and
Regulatory Affairs, Division of
Regulations Development, Attention:
Document Identifier/OMB Control
Number __ Room C4–26–05, 7500
Security Boulevard, Baltimore,
Maryland 21244–1850.
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.
PO 00000
Frm 00024
Fmt 4703
Sfmt 4703
3. Call the Reports Clearance Office at
(410) 786–1326.
FOR FURTHER INFORMATION CONTACT:
Reports Clearance Office at (410) 786–
1326.
SUPPLEMENTARY INFORMATION:
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–R–284 Medicaid Statistical
Information System (MSIS) and
Transformed—Medicaid Statistical
Information System (T–MSIS)
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.
1. Type of Information Collection
Request: Revision of a currently
approved collection. Title of
Information Collection: Medicaid
Statistical Information System (MSIS)
and Transformed—Medicaid Statistical
Information System (T–MSIS); Use: The
data reported in MSIS/T–MSIS are used
by federal, state, and local officials, as
well as by private researchers and
corporations to monitor past and
projected future trends in the Medicaid
program. These data provide the only
national level information available on
enrollees, beneficiaries, and
expenditures. They also provide the
only national level information
available on Medicaid utilization. This
information is the basis for analyses and
for cost savings estimates for the
Department’s cost sharing legislative
initiatives to Congress. The collected
data are also crucial to our actuarial
forecasts. Form Number: CMS–R–284
(OMB control number: 0938–0345);
Frequency: Quarterly and monthly;
E:\FR\FM\31DEN1.SGM
31DEN1
Federal Register / Vol. 80, No. 251 / Thursday, December 31, 2015 / Notices
Affected Public: State, Local, or Tribal
Governments; Number of Respondents:
51; Total Annual Responses: 804; Total
Annual Hours: 8,040. (For policy
questions regarding this collection
contact Camiel Rowe at 410–786–0069.)
Dated: December 24, 2015.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2015–32880 Filed 12–30–15; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–D–4803]
Public Notification of Emerging
Postmarket Medical Device Signals
(‘‘Emerging Signals’’); Draft Guidance
for Industry and Food and Drug
Administration Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of the draft
guidance entitled ‘‘Public Notification
of Emerging Postmarket Medical Device
Signals (‘Emerging Signals’).’’ This
guidance describes the Agency’s policy
for notifying the public about medical
device ‘‘emerging signals.’’ Historically,
FDA has communicated important
medical device postmarket information
after having completed an analysis of
available data and, in most cases, after
having reached a decision about
relevant recommendations for the
device user community and about
whether further regulatory action is
warranted. However, in addition to
these types of public communications,
we believe there also is a need to notify
the public about emerging signals that
the Agency is monitoring or analyzing,
even when the information has not been
fully analyzed, validated, or confirmed,
and for which the Agency does not yet
have specific recommendations. This
draft guidance is not final nor is it in
effect at this time.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment of this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by February 29,
2016.
tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
16:49 Dec 30, 2015
Jkt 238001
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
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 No. FDA–
2015–D–4803 for ‘‘Public Notification of
Emerging Postmarket Medical Device
Signals (‘Emerging Signals’).’’ 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 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
PO 00000
Frm 00025
Fmt 4703
Sfmt 4703
81829
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.
An electronic copy of the draft
guidance document is available for
download from the Internet. See the
SUPPLEMENTARY INFORMATION section for
information on electronic access to the
guidance. Submit written requests for a
single hard copy of the draft guidance
document entitled ‘‘Public Notification
of Emerging Postmarket Medical Device
Signals (‘Emerging Signals’)’’ to the
Office of the Center Director, Guidance
and Policy Development, Center for
Devices and Radiological Health, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5431,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
request.
FOR FURTHER INFORMATION CONTACT:
Rebecca Nipper, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1540, Silver Spring,
MD 20993–0002, 301–796–6527.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\31DEN1.SGM
31DEN1
Agencies
[Federal Register Volume 80, Number 251 (Thursday, December 31, 2015)]
[Notices]
[Pages 81828-81829]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-32880]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-R-284]
Agency Information Collection Activities: Proposed Collection;
Comment Request
AGENCY: Centers for Medicare & Medicaid Services.
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 (the 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 60 days for public
comment on the proposed action. Interested persons are invited to send
comments regarding our burden estimates 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 must be received by February 29, 2016.
ADDRESSES: When commenting, please reference the document identifier or
OMB control number. To be assured consideration, comments and
recommendations must be submitted in any one of the following ways:
1. Electronically. You may send your comments electronically to
https://www.regulations.gov. Follow the instructions for ``Comment or
Submission'' or ``More Search Options'' to find the information
collection document(s) that are accepting comments.
2. By regular mail. You may mail written comments to the following
address:
CMS, Office of Strategic Operations and Regulatory Affairs, Division of
Regulations Development, Attention: Document Identifier/OMB Control
Number __ Room C4-26-05, 7500 Security Boulevard, Baltimore, Maryland
21244-1850.
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:
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-R-284 Medicaid Statistical Information System (MSIS) and
Transformed--Medicaid Statistical Information System (T-MSIS)
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.
1. Type of Information Collection Request: Revision of a currently
approved collection. Title of Information Collection: Medicaid
Statistical Information System (MSIS) and Transformed--Medicaid
Statistical Information System (T-MSIS); Use: The data reported in
MSIS/T-MSIS are used by federal, state, and local officials, as well as
by private researchers and corporations to monitor past and projected
future trends in the Medicaid program. These data provide the only
national level information available on enrollees, beneficiaries, and
expenditures. They also provide the only national level information
available on Medicaid utilization. This information is the basis for
analyses and for cost savings estimates for the Department's cost
sharing legislative initiatives to Congress. The collected data are
also crucial to our actuarial forecasts. Form Number: CMS-R-284 (OMB
control number: 0938-0345); Frequency: Quarterly and monthly;
[[Page 81829]]
Affected Public: State, Local, or Tribal Governments; Number of
Respondents: 51; Total Annual Responses: 804; Total Annual Hours:
8,040. (For policy questions regarding this collection contact Camiel
Rowe at 410-786-0069.)
Dated: December 24, 2015.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2015-32880 Filed 12-30-15; 8:45 am]
BILLING CODE 4120-01-P