80 FR 81828 - Agency Information Collection Activities: Proposed Collection; Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services Federal Register Volume 80, Issue 251 (December 31, 2015)
Centers for Medicare & Medicaid Services
Federal Register Volume 80, Issue 251 (December 31, 2015)
| Page Range | 81828-81829 | |
| FR Document | 2015-32880 |
[Federal Register Volume 80, Number 251 (Thursday, December 31, 2015)] [Notices] [Pages 81828-81829] From the Federal Register Online [www.thefederalregister.org] [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 http://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 http://www.cms.hhs.gov/PaperworkReductionActof1995. 2. Email your request, including your address, phone number, OMB number, and CMS document identifier, to [email protected]. 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
![81828 Federal Register / Vol. 80, No. 251 / Thursday, December 31, 2015 / Notices
++ Taxpayer Identification Number SUMMARY: The Centers for Medicare & 3. Call the Reports Clearance Office at
(TIN). Medicaid Services (CMS) is announcing (410) 786–1326.
++ National Provider Identifier (NPI). an opportunity for the public to FOR FURTHER INFORMATION CONTACT:
++ Provider type. comment on CMS’ intention to collect Reports Clearance Office at (410) 786–
++ Practice site address. information from the public. Under the 1326.
++ Patient insurance. Paperwork Reduction Act of 1995 (the
++ Patient age. SUPPLEMENTARY INFORMATION:
PRA), federal agencies are required to
++ Patient sex.
++ Patient race and ethnicity. publish notice in the Federal Register Contents
++ Patient problem list data. concerning each proposed collection of This notice sets out a summary of the
How useful are the ‘‘filtering’’ criteria information (including each proposed use and burden associated with the
to end users of systems for the purpose extension or reinstatement of an existing following information collections. More
of safety and quality improvement? To collection of information) and to allow detailed information can be found in
quality improvement staff and 60 days for public comment on the each collection’s supporting statement
organizations? proposed action. Interested persons are and associated materials (see
• Are there additional filters/data invited to send comments regarding our ADDRESSES).
would be helpful to stratify CQM-Filters burden estimates or any other aspect of
(45 CFR 170.315(c)(4)) data by? this collection of information, including CMS–R–284 Medicaid Statistical
• What, if anything additional, any of the following subjects: (1) The Information System (MSIS) and
regarding this testing/certification necessity and utility of the proposed Transformed—Medicaid Statistical
should be published via the Certified information collection for the proper Information System (T–MSIS)
Health IT Product List? performance of the agency’s functions; Under the PRA (44 U.S.C. 3501–
(2) the accuracy of the estimated 3520), federal agencies must obtain
III. Collection of Information burden; (3) ways to enhance the quality,
Requirements approval from the Office of Management
utility, and clarity of the information to and Budget (OMB) for each collection of
This document does not impose be collected; and (4) the use of information they conduct or sponsor.
information collection requirements, automated collection techniques or The term ‘‘collection of information’’ is
that is, reporting, recordkeeping or other forms of information technology to defined in 44 U.S.C. 3502(3) and 5 CFR
third-party disclosure requirements. minimize the information collection 1320.3(c) and includes agency requests
Consequently, there is no need for burden. or requirements that members of the
review by the Office of Management and public submit reports, keep records, or
DATES: Comments must be received by
Budget under the authority of the provide information to a third party.
February 29, 2016.
Paperwork Reduction Act of 1995 (44 Section 3506(c)(2)(A) of the PRA
U.S.C. 3501 et seq.). ADDRESSES: When commenting, please
reference the document identifier or requires federal agencies to publish a
IV. Response to Comments OMB control number. To be assured 60-day notice in the Federal Register
consideration, comments and concerning each proposed collection of
Because of the large number of public
recommendations must be submitted in information, including each proposed
comments we normally receive on
any one of the following ways: extension or reinstatement of an existing
Federal Register documents, we are not
1. Electronically. You may send your collection of information, before
able to acknowledge or respond to them
comments electronically to http:// submitting the collection to OMB for
individually. We will consider all
www.regulations.gov. Follow the approval. To comply with this
comments we receive by the date and
instructions for ‘‘Comment or requirement, CMS is publishing this
time specified in the DATES section of
Submission’’ or ‘‘More Search Options’’ notice.
this preamble, and, when we proceed
to find the information collection 1. Type of Information Collection
with a subsequent document, we will
document(s) that are accepting Request: Revision of a currently
respond to the comments in the
comments. approved collection. Title of
preamble to that document.
2. By regular mail. You may mail Information Collection: Medicaid
Dated: December 3, 2015. Statistical Information System (MSIS)
written comments to the following
Andrew M. Slavitt, and Transformed—Medicaid Statistical
address:
Acting Administrator, Centers for Medicare Information System (T–MSIS); Use: The
& Medicaid Services. CMS, Office of Strategic Operations and data reported in MSIS/T–MSIS are used
[FR Doc. 2015–32931 Filed 12–30–15; 8:45 am] Regulatory Affairs, Division of by federal, state, and local officials, as
BILLING CODE 4120–01–P Regulations Development, Attention: well as by private researchers and
Document Identifier/OMB Control corporations to monitor past and
Number __ Room C4–26–05, 7500 projected future trends in the Medicaid
DEPARTMENT OF HEALTH AND Security Boulevard, Baltimore, program. These data provide the only
HUMAN SERVICES Maryland 21244–1850. national level information available on
To obtain copies of a supporting enrollees, beneficiaries, and
Centers for Medicare & Medicaid statement and any related forms for the expenditures. They also provide the
Services proposed collection(s) summarized in only national level information
[Document Identifier: CMS–R–284] this notice, you may make your request available on Medicaid utilization. This
using one of following: information is the basis for analyses and
tkelley on DSK3SPTVN1PROD with NOTICES
Agency Information Collection 1. Access CMS’ Web site address at for cost savings estimates for the
Activities: Proposed Collection; http://www.cms.hhs.gov/ Department’s cost sharing legislative
Comment Request PaperworkReductionActof1995. initiatives to Congress. The collected
AGENCY: Centers for Medicare & 2. Email your request, including your data are also crucial to our actuarial
Medicaid Services. address, phone number, OMB number, forecasts. Form Number: CMS–R–284
and CMS document identifier, to (OMB control number: 0938–0345);
ACTION: Notice.
Paperwork@cms.hhs.gov. Frequency: Quarterly and monthly;
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![Federal Register / Vol. 80, No. 251 / Thursday, December 31, 2015 / Notices 81829
Affected Public: State, Local, or Tribal ADDRESSES: You may submit comments copies total. One copy will include the
Governments; Number of Respondents: as follows: information you claim to be confidential
51; Total Annual Responses: 804; Total with a heading or cover note that states
Electronic Submissions
Annual Hours: 8,040. (For policy ‘‘THIS DOCUMENT CONTAINS
questions regarding this collection Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The
contact Camiel Rowe at 410–786–0069.) following way: Agency will review this copy, including
• Federal eRulemaking Portal: http:// the claimed confidential information, in
Dated: December 24, 2015.
www.regulations.gov. Follow the its consideration of comments. The
William N. Parham, III, instructions for submitting comments. second copy, which will have the
Director, Paperwork Reduction Staff, Office Comments submitted electronically, claimed confidential information
of Strategic Operations and Regulatory including attachments, to http://
Affairs. redacted/blacked out, will be available
www.regulations.gov will be posted to for public viewing and posted on
[FR Doc. 2015–32880 Filed 12–30–15; 8:45 am] the docket unchanged. Because your http://www.regulations.gov. Submit
BILLING CODE 4120–01–P comment will be made public, you are both copies to the Division of Dockets
solely responsible for ensuring that your Management. If you do not wish your
comment does not include any name and contact information to be
DEPARTMENT OF HEALTH AND confidential information that you or a
HUMAN SERVICES made publicly available, you can
third party may not wish to be posted, provide this information on the cover
Food and Drug Administration such as medical information, your or sheet and not in the body of your
anyone else’s Social Security number, or comments and you must identify this
[Docket No. FDA–2015–D–4803] confidential business information, such information as ‘‘confidential.’’ Any
as a manufacturing process. Please note information marked as ‘‘confidential’’
Public Notification of Emerging that if you include your name, contact will not be disclosed except in
Postmarket Medical Device Signals information, or other information that accordance with 21 CFR 10.20 and other
(‘‘Emerging Signals’’); Draft Guidance identifies you in the body of your applicable disclosure law. For more
for Industry and Food and Drug comments, that information will be information about FDA’s posting of
Administration Staff; Availability posted on http://www.regulations.gov. comments to public dockets, see 80 FR
AGENCY: Food and Drug Administration, • If you want to submit a comment 56469, September 18, 2015, or access
HHS. with confidential information that you the information at: http://www.fda.gov/
do not wish to be made available to the regulatoryinformation/dockets/
ACTION: Notice. public, submit the comment as a default.htm.
SUMMARY: The Food and Drug written/paper submission and in the Docket: For access to the docket to
Administration (FDA or Agency) is manner detailed (see ‘‘Written/Paper read background documents or the
announcing the availability of the draft Submissions’’ and ‘‘Instructions’’). electronic and written/paper comments
guidance entitled ‘‘Public Notification Written/Paper Submissions received, go to http://
of Emerging Postmarket Medical Device www.regulations.gov and insert the
Submit written/paper submissions as docket number, found in brackets in the
Signals (‘Emerging Signals’).’’ This
follows: heading of this document, into the
guidance describes the Agency’s policy • Mail/Hand delivery/Courier (for
for notifying the public about medical ‘‘Search’’ box and follow the prompts
written/paper submissions): Division of and/or go to the Division of Dockets
device ‘‘emerging signals.’’ Historically, Dockets Management (HFA–305), Food
FDA has communicated important Management, 5630 Fishers Lane, Rm.
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after having completed an analysis of An electronic copy of the draft
• For written/paper comments guidance document is available for
available data and, in most cases, after submitted to the Division of Dockets
having reached a decision about download from the Internet. See the
Management, FDA will post your SUPPLEMENTARY INFORMATION section for
relevant recommendations for the comment, as well as any attachments,
device user community and about information on electronic access to the
except for information submitted, guidance. Submit written requests for a
whether further regulatory action is marked and identified, as confidential,
warranted. However, in addition to single hard copy of the draft guidance
if submitted as detailed in document entitled ‘‘Public Notification
these types of public communications, ‘‘Instructions.’’
we believe there also is a need to notify of Emerging Postmarket Medical Device
Instructions: All submissions received
the public about emerging signals that Signals (‘Emerging Signals’)’’ to the
must include the Docket No. FDA–
the Agency is monitoring or analyzing, Office of the Center Director, Guidance
2015–D–4803 for ‘‘Public Notification of
even when the information has not been and Policy Development, Center for
Emerging Postmarket Medical Device
fully analyzed, validated, or confirmed, Devices and Radiological Health, Food
Signals (‘Emerging Signals’).’’ Received
and for which the Agency does not yet and Drug Administration, 10903 New
comments will be placed in the docket
have specific recommendations. This Hampshire Ave., Bldg. 66, Rm. 5431,
and, except for those submitted as
draft guidance is not final nor is it in Silver Spring, MD 20993–0002. Send
‘‘Confidential Submissions,’’ publicly
effect at this time. one self-addressed adhesive label to
viewable at http://www.regulations.gov
DATES: Although you can comment on
assist that office in processing your
or at the Division of Dockets
any guidance at any time (see 21 CFR request.
Management between 9 a.m. and 4 p.m.,
tkelley on DSK3SPTVN1PROD with NOTICES
10.115(g)(5)), to ensure that the Agency Monday through Friday. FOR FURTHER INFORMATION CONTACT:
considers your comment of this draft • Confidential Submissions—To Rebecca Nipper, Center for Devices and
guidance before it begins work on the submit a comment with confidential Radiological Health, Food and Drug
final version of the guidance, submit information that you do not wish to be Administration, 10903 New Hampshire
either electronic or written comments made publicly available, submit your Ave., Bldg. 66, Rm. 1540, Silver Spring,
on the draft guidance by February 29, comments only as a written/paper MD 20993–0002, 301–796–6527.
2016. submission. You should submit two SUPPLEMENTARY INFORMATION:
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Document Created: 2015-12-31 02:15:03
Document Modified: 2015-12-31 02:15:03
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Comments must be received by February 29, 2016. | |
| Contact | Reports Clearance Office at (410) 786- 1326. | |
| FR Citation | 80 FR 81828 |
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