Agency Information Collection Activities: Submission for OMB Review; Comment Request, 40106-40107 [2014-16083]
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tkelley on DSK3SPTVN1PROD with NOTICES
40106
Federal Register / Vol. 79, No. 133 / Friday, July 11, 2014 / Notices
Information Collection
1. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Solicitation for
Applications for Medicare Prescription
Drug Plan 2015 Contracts; Use: The
information will be collected under the
solicitation of proposals from PDP, MA–
PD, Cost Plan, PACE, and EGWP
applicants. We will use the information
to ensure that applicants meet our
requirements and support the
determination of contract awards.
Participation in the Part D program is
voluntary in nature. Only organizations
that are interested in participating in the
program will respond to the solicitation.
The MA–PDs that voluntarily
participate in the Part C program must
submit a Part D application and
successful bid. Form Number: CMS–
10137 (OMB control number: 0938—
0936); Frequency: Yearly; Affected
Public: Private sector—Business or other
for-profits and Not-for-profit
institutions; Number of Respondents:
254; Total Annual Responses: 254; Total
Annual Hours: 2,193. (For policy
questions regarding this collection
contact Arianne Spaccarelli at 410–786–
5715).
2. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Part C—
Medicare Advantage and 1876 Cost Plan
Expansion Application; Use: The
information will be collected under the
solicitation of Part C applications from
MA, EGWP Plan, and Cost Plan
applicants and will be used to ensure
that applicants meet our requirements
and support the determination of
contract awards. Participation in all
programs is voluntary in nature; only
organizations that are interested in
participating in the program will
respond to the solicitation. The MA–
PDs that voluntarily participate in the
Part C program must submit a Part D
application and successful bid. Form
Number: CMS–10237 (OMB control
number: 0938–0935); Frequency: Yearly;
Affected Public: Private sector—
Business or other for-profits and Notfor-profit institutions; Number of
Respondents: 566; Total Annual
Responses: 566; Total Annual Hours:
22,625. (For policy questions regarding
this collection contact Melissa Staud at
410–786–3669).
3. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Generic
Clearance for Medicaid and CHIP State
Plan, Waiver, and Program Submissions;
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Use: State Medicaid and CHIP agencies
are responsible for developing
submissions to CMS, including State
plan amendments and requests for
waivers and program demonstrations.
States use templates when they are
available and submit the forms to
review for consistency with statutory
and regulatory requirements (or in the
case of waivers and demonstrations
whether the proposal is likely to
promote the objectives of the Medicaid
program). If the requirements are met,
we approve the States’ submissions
giving the States the authority to
implement the flexibilities. For a State
to receive Medicaid Title XIX funding,
there must be an approved Title XIX
State plan.
The development of streamlined
submissions forms enhances the
collaboration and partnership between
States and CMS by documenting our
policy for States to use as they are
developing program changes.
Streamlined forms improve efficiency of
administration by creating a common
and user-friendly understanding of the
information we need to quickly process
requests for State plan amendments,
waivers, and demonstration, as well as
ongoing reporting. Form Number: CMS–
10398 (OMB control number: 0938–
1148); Frequency: Collection specific,
but generally the frequency is yearly,
once, and occasionally; Affected Public:
State, Local, or Tribal Governments;
Number of Respondents: 56; Total
Annual Responses: 1,120; Total Annual
Hours: 28,747. (For policy questions
regarding this collection contact
Annette Pearson at 410–786–6858).
4. Type of Information Collection
Request: New collection (Request for a
new OMB control number); Title of
Information Collection: Executive
Summary Form for Research Identifiable
Data; Use: The Centers for Medicare &
Medicaid Services (CMS) is responsible
for administering the Medicare,
Medicaid and State Children’s Health
Insurance Programs. We collect data to
support the Agency’s mission and
operations. These data include
information about Medicare
beneficiaries, Medicare claims,
Medicare providers, and Medicaid
eligibility and claims. We disclose the
identifiable data consistent with the
routine uses identified in the Privacy
Act Systems of Records notices that are
published in the Federal Register and
the limitations on uses and disclosures
that are set out in the HIPAA Privacy
Rule.
All requests for identifiable data are
received and reviewed by the Division
of Privacy Operations & Compliance
(DPOC) in the Office of E-Health
PO 00000
Frm 00049
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Standards and Services. The DPOC staff
and the CMS Privacy Officer review the
requests to determine if there is legal
authorization for disclosure of the data.
If legal authorization exists, the request
is reviewed to ensure that the minimal
data necessary is requested and
approved for the project. Requests for
identifiable data for research purposes
must be submitted to and approved by
the CMS Privacy Board. To assist the
CMS Privacy Board with its review of
research data requests, OIPDA has
developed the Executive Summary (ES)
forms. The ES collects all the
information that the CMS Privacy Board
needs to review and make a
determination on whether the request
meets the requirements for release of
identifiable data for research purposes.
We currently have three versions of the
ES Form and an ES Supplement for
Requestors of the National Death Index
(NDI) Causes of Death Variables. Each
meets the need for a different type of
requestor. Form Number: CMS–10522
(OMB control number: 0938–New);
Frequency: On occasion; Affected
Public: State, Local, or Tribal
Governments; Number of Respondents:
325; Total Annual Responses: 325; Total
Annual Hours: 650. (For policy
questions regarding this collection
contact Kim Elmo at 410–786–0161).
Dated: July 3, 2014.
Martique Jones,
Deputy Director, Regulations Development
Group, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2014–16076 Filed 7–10–14; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifiers: CMS–304/CMS–304a,
CMS–368/CMS–R–144 and CMS–10517]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
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
information, including each proposed
extension or reinstatement of an existing
collection of information, and to allow
SUMMARY:
E:\FR\FM\11JYN1.SGM
11JYN1
tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 133 / Friday, July 11, 2014 / Notices
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 August 11, 2014.
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,
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20:23 Jul 10, 2014
Jkt 232001
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 a currently
approved collection; Title of
Information Collection: Reconciliation
of State Invoice and Prior Quarter
Adjustment Statement; Use: Form CMS–
304 (Reconciliation of State Invoice) is
used by manufacturers to respond to the
state’s rebate invoice for current quarter
utilization. Form CMS–304a (Prior
Quarter Adjustment Statement) is
required only in those instances where
a change to the original rebate data
submittal is necessary. Form Number:
CMS–304 and –304a (OMB control
number: 0938–0676); Frequency:
Quarterly; Affected Public: Private
sector—Business or other for-profits;
Number of Respondents: 1,037; Total
Annual Responses: 4,148; Total Annual
Hours: 187,880. (For policy questions
regarding this collection contact Andrea
Wellington at 410–786–3490.)
2. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Medicaid Drug
Rebate Program Forms; Use: We develop
the rebate amount per drug unit from
information supplied by the drug
manufacturers and distributes these data
to the states. States then must report
quarterly to the drug manufacturers and
report to us the total number of units of
each dosage form/strength of their
covered outpatient drugs reimbursed
during a quarter and the rebate amount
to be refunded. This report is due
within 60 days of the end of each
calendar quarter. The information in the
report is based on claims paid by the
state Medicaid agency during a calendar
quarter. Form CMS–R–144 (Quarterly
Report Data) is required from states
quarterly to report utilization for any
drugs paid for during that quarter. Form
CMS–368 (Administrative Data) is
required only in those instances where
a change to the original data submittal
is necessary. Form Number: CMS–368
and –R–144 (OMB control number:
0938–0582); Frequency: Quarterly;
Affected Public: State, Local, or Tribal
Governments; Number of Respondents:
56; Total Annual Responses: 224; Total
Annual Hours: 12,101. (For policy
questions regarding this collection
contact Andrea Wellington at 410–786–
3490.)
3. Type of Information Collection
Request: New collection (Request for a
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40107
new control number); Title of
Information Collection: The Predictive
Learning Analytics Tracking Outcome
(PLATOTM); Use: The Predictive
Learning Analytics Tracking Outcome
(PLATOTM) is a web-based application
tool that will serve as the centerpiece of
the advanced analytics initiative with
the Centers for Medicare & Medicaid
Services (CMS) and Health Integrity,
LLC, the National Benefit Integrity
Medicare Integrity Contractor (NBI
MEDIC). Developed by Health Integrity,
LLC and licensed for one of its
contracts—the NBI MEDIC—PLATOTM
utilizes a cutting-edge advanced
analytics fraud detection process in
conjunction with a state-of-the-art webbased user interface tool to present
fraud and abuse lead information
visually to Medicare Part D plan
sponsors. Summary data, based on
National Prescription Drug Event Data
and actions from all Part D plan
sponsors, is shared with law
enforcement, CMS, NBI MEDIC, and
Part D plan sponsors to review historic
actions taken against providers who are
enrolled in the Medicare Part D
program, which will assist in detecting
and preventing fraud, waste, and abuse.
Form Number: CMS–10517 (OMB
control number: 0938—New);
Frequency: Monthly; Affected Public:
Private sector—Business or other forprofits and Not-for-profit institutions;
Number of Respondents: 1,550; Total
Annual Responses: 1,550; Total Annual
Hours: 18,600. (For policy questions
regarding this collection contact Delois
Newkirk at 410–786–1247.)
Dated: July 3, 2014.
Martique Jones,
Deputy Director, Regulations Development
Group, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2014–16083 Filed 7–10–14; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–D–0125]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Guidance for
Industry on Establishing That a
Tobacco Product Was Commercially
Marketed in the United States as of
February 15, 2007
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
E:\FR\FM\11JYN1.SGM
Notice.
11JYN1
]]>Agencies
[Federal Register Volume 79, Number 133 (Friday, July 11, 2014)]
[Notices]
[Pages 40106-40107]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-16083]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifiers: CMS-304/CMS-304a, CMS-368/CMS-R-144 and CMS-
10517]
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
[[Page 40107]]
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 August 11, 2014.
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: Extension of a currently
approved collection; Title of Information Collection: Reconciliation of
State Invoice and Prior Quarter Adjustment Statement; Use: Form CMS-304
(Reconciliation of State Invoice) is used by manufacturers to respond
to the state's rebate invoice for current quarter utilization. Form
CMS-304a (Prior Quarter Adjustment Statement) is required only in those
instances where a change to the original rebate data submittal is
necessary. Form Number: CMS-304 and -304a (OMB control number: 0938-
0676); Frequency: Quarterly; Affected Public: Private sector--Business
or other for-profits; Number of Respondents: 1,037; Total Annual
Responses: 4,148; Total Annual Hours: 187,880. (For policy questions
regarding this collection contact Andrea Wellington at 410-786-3490.)
2. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Medicaid Drug
Rebate Program Forms; Use: We develop the rebate amount per drug unit
from information supplied by the drug manufacturers and distributes
these data to the states. States then must report quarterly to the drug
manufacturers and report to us the total number of units of each dosage
form/strength of their covered outpatient drugs reimbursed during a
quarter and the rebate amount to be refunded. This report is due within
60 days of the end of each calendar quarter. The information in the
report is based on claims paid by the state Medicaid agency during a
calendar quarter. Form CMS-R-144 (Quarterly Report Data) is required
from states quarterly to report utilization for any drugs paid for
during that quarter. Form CMS-368 (Administrative Data) is required
only in those instances where a change to the original data submittal
is necessary. Form Number: CMS-368 and -R-144 (OMB control number:
0938-0582); Frequency: Quarterly; Affected Public: State, Local, or
Tribal Governments; Number of Respondents: 56; Total Annual Responses:
224; Total Annual Hours: 12,101. (For policy questions regarding this
collection contact Andrea Wellington at 410-786-3490.)
3. Type of Information Collection Request: New collection (Request
for a new control number); Title of Information Collection: The
Predictive Learning Analytics Tracking Outcome (PLATOTM);
Use: The Predictive Learning Analytics Tracking Outcome (PLATO\TM\) is
a web-based application tool that will serve as the centerpiece of the
advanced analytics initiative with the Centers for Medicare & Medicaid
Services (CMS) and Health Integrity, LLC, the National Benefit
Integrity Medicare Integrity Contractor (NBI MEDIC). Developed by
Health Integrity, LLC and licensed for one of its contracts--the NBI
MEDIC--PLATO\TM\ utilizes a cutting-edge advanced analytics fraud
detection process in conjunction with a state-of-the-art web-based user
interface tool to present fraud and abuse lead information visually to
Medicare Part D plan sponsors. Summary data, based on National
Prescription Drug Event Data and actions from all Part D plan sponsors,
is shared with law enforcement, CMS, NBI MEDIC, and Part D plan
sponsors to review historic actions taken against providers who are
enrolled in the Medicare Part D program, which will assist in detecting
and preventing fraud, waste, and abuse. Form Number: CMS-10517 (OMB
control number: 0938--New); Frequency: Monthly; Affected Public:
Private sector--Business or other for-profits and Not-for-profit
institutions; Number of Respondents: 1,550; Total Annual Responses:
1,550; Total Annual Hours: 18,600. (For policy questions regarding this
collection contact Delois Newkirk at 410-786-1247.)
Dated: July 3, 2014.
Martique Jones,
Deputy Director, Regulations Development Group, Office of Strategic
Operations and Regulatory Affairs.
[FR Doc. 2014-16083 Filed 7-10-14; 8:45 am]
BILLING CODE 4120-01-P
