Agency Information Collection Activities: Proposed Collection; Comment Request, 3899-3900 [2013-00860]
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Federal Register / Vol. 78, No. 12 / Thursday, January 17, 2013 / Notices
continue its use of the BPT for the
collection of information for CY2014
through CY2016. Form Number: CMS–
10142 (OCN: 0938–0944); Frequency:
Yearly; Affected Public: Private Sector—
Business or other for-profits and not-forprofit institutions; Number of
Respondents: 555; Total Annual
Responses: 4,995; Total Annual Hours:
149,850. (For policy questions regarding
this collection contact Diane Spitalnic at
410–786–5745. For all other issues call
410–786–1326.)
2. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Plan Benefit
Package (PBP) and Formulary
Submission for Medicare Advantage
(MA) Plans and Prescription Drug Plans
(PDP); Use: Under the Medicare
Modernization Act (MMA), Medicare
Advantage (MA) and Prescription Drug
Plan (PDP) organizations are required to
submit plan benefit packages for all
Medicare beneficiaries residing in their
service area. The plan benefit package
submission consists of the Plan Benefit
Package (PBP) software, formulary file,
and supporting documentation, as
necessary. MA and PDP organizations
use the PBP software to describe their
organization’s plan benefit packages,
including information on premiums,
cost sharing, authorization rules, and
supplemental benefits. They also
generate a formulary to describe their
list of drugs, including information on
prior authorization, step therapy,
tiering, and quantity limits.
Additionally, CMS uses the PBP and
formulary data to review and approve
the plan benefit packages proposed by
each MA and PDP organization.
After receiving OMB clearance in
spring 2000, CMS implemented the PBP
as part of the Contract Year (CY) 2001
Adjusted Community Rate Proposal
(ACRP) process. In addition,
information collected via the PBP and
formulary has been used to support the
marketing material review process, the
National Medicare Education Program,
and other program oversight and
development activities. For instance, the
PBP software automatically generates
the standardized sentences for the
Summary of Benefits (SB) by using the
plan benefit package data entered into
the PBP software by the organization’s
user. These standardized sentences are
used by the MA organizations in their
SB marketing materials and by CMS to
generate plan benefits data for display
in the Medicare & You handbook and on
the www.medicare.gov Web site.
CMS is requesting to continue its use
of the PBP software and formulary
submission for the collection of benefits
VerDate Mar<15>2010
14:19 Jan 16, 2013
Jkt 229001
and related information for CY 2014
through CY 2016. CMS estimates that
578 MA organizations and 63 PDP
organizations will be required to submit
the plan benefit package information in
CY 2014. Based on operational changes
and policy clarifications to the Medicare
program and continued input and
feedback by the industry, CMS has
made the necessary changes to the plan
benefit package submission. Form
Number: CMS–R–262 (OCN: 0938–
0763); Frequency: Yearly; Affected
Public: Private Sector—Business or
other for-profits and not-for-profit
institutions; Number of Respondents:
641; Total Annual Responses: 6,169;
Total Annual Hours: 56,708. (For policy
questions regarding this collection
contact Kristy Holtje at 410–786–2209.
For all other issues call 410–786–1326.)
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS Web Site
address at https://www.cms.gov/
Regulations-and-Guidance/Legislation/
PaperworkReductionActof1995/PRAListing.html, or Email your request,
including your address, phone number,
OMB number, and CMS document
identifier, to Paperwork@cms.hhs.gov,
or call the Reports Clearance Office on
(410) 786–1326.
To be assured consideration,
comments and recommendations for the
proposed information collections must
be received by the OMB desk officer at
the address below, no later than 5 p.m.
on February 19, 2013. OMB, Office of
Information and Regulatory Affairs,
Attention: CMS Desk Officer, Fax
Number: (202) 395–6974, Email:
OIRA_submission@omb.eop.gov.
Dated: January 11, 2013.
Martique Jones,
Deputy Director, Regulations Development
Group, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2013–00858 Filed 1–16–13; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10437]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Centers for Medicare &
Medicaid Services, HHS.
In compliance with the requirement
of section 3506(c)(2)(A) of the
AGENCY:
PO 00000
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Fmt 4703
Sfmt 4703
3899
Paperwork Reduction Act of 1995, the
Centers for Medicare & Medicaid
Services (CMS) is publishing the
following summary of proposed
collections for public comment.
Interested persons are invited to send
comments regarding this 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.
1. Type of Information Collection
Request: New collection; Title of
Information Collection: Generic Social
Marketing & Consumer Testing
Research; Use: The purpose of this
submission is to request an Information
Collection Request (ICR) generic
clearance for a program of consumer
research aimed at a broad audience of
those affected by CMS programs
including Medicare, Medicaid,
Children’s Health Insurance Program
(CHIP), and health insurance exchanges.
This program extends strategic efforts to
reach and tailor communications to
beneficiaries, caregivers, providers,
stakeholders, and any other audiences
that would support the Agency in
improving the functioning of the health
care system, improve patient care and
outcomes, and reduce costs without
sacrificing quality of care. With the
clearance, CMS will create a fast track,
streamlined, proactive process for
collection of data and utilizing the
feedback on service delivery for
continuous improvement of
communication activities aimed at
diverse CMS audiences.
The generic clearance will allow rapid
response to inform CMS initiatives
using a mixture of qualitative and
quantitative consumer research
strategies (including formative research
studies and methodological tests) to
improve communication with key CMS
audiences. As new information
resources and persuasive technologies
are developed, they can be tested and
evaluated for beneficiary response to the
materials and delivery channels. Results
will inform communication
development and information
architecture as well as allow for
continuous quality improvement. The
overall goal is to maximize the extent to
which consumers have access to useful
sources of CMS program information in
E:\FR\FM\17JAN1.SGM
17JAN1
pmangrum on DSK3VPTVN1PROD with
3900
Federal Register / Vol. 78, No. 12 / Thursday, January 17, 2013 / Notices
a form that can help them make the
most of their benefits and options
The activities under this clearance
involve social marketing and consumer
research using samples of self-selected
customers, as well as convenience
samples, and quota samples, with
respondents selected either to cover a
broad range of customers or to include
specific characteristics related to certain
products or services. All collection of
information under this clearance will
utilize a subset of items drawn from a
core collection of customizable items
referred to as the Social Marketing and
Consumer Testing Item Bank. This item
bank is designed to establish a set of
pre-approved generic question that can
be drawn upon to allow for the rapid
turn-around consumer testing required
for CMS to communicate more
effectively with its audiences. The
questions in the item bank are divided
into two major categories. One set
focuses on characteristics of individuals
and is intended primarily for participant
screening and for use in structured
quantitative on-line or telephone
surveys. The other set is less structured
and is designed for use in qualitative
one-on-one and small group discussions
or collecting information related to
subjective impressions of test materials.
A Study Initiation Request Form
detailing each specific study
(description, methodology, estimated
burden) conducted under this clearance
will be submitted before any testing is
initialed. Results will be compiled and
disseminated so that future
communication can be informed by the
testing results. We will use the findings
to create the greatest possible public
benefit. Form Number: CMS–10437
(OCN: 0938–New); Frequency: Yearly;
Affected Public: Individuals. Number of
Respondents: 41,592. Number of
Responses: 28,800. Total Annual Hours:
21,488. (For policy questions regarding
this collection contact Chris Koepke at
410–786–5877. For all other issues call
410–786–1326.)
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS’ Web Site
address at https://www.cms.hhs.gov/
PaperworkReductionActof1995, or
Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov, or call the
Reports Clearance Office on (410) 786–
1326.
In commenting on the proposed
information collections please reference
the document identifier or OMB control
number. To be assured consideration,
comments and recommendations must
VerDate Mar<15>2010
14:19 Jan 16, 2013
Jkt 229001
be submitted in one of the following
ways by March 18, 2013:
1. Electronically. You may submit
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) 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.
Dated: January 11, 2013.
Martique Jones,
Deputy Director, Regulations Development
Group, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2013–00860 Filed 1–16–13; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0007]
Generic Drug User Fee—Active
Pharmaceutical Ingredient and
Finished Dosage Form Facility Fee
Rates for Fiscal Year 2013
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
rate for the generic drug active
pharmaceutical ingredient (API) and
finished dosage form (FDF) facilities
user fees for fiscal year (FY) 2013. The
Federal Food, Drug, and Cosmetic Act
(the FD&C Act), as amended by the
Generic Drug User Fee Amendments of
2012 (GDUFA), enacted the Food and
Drug Administration Safety and
Innovation Act, as further amended by
the FDA User Fee Corrections Act of
2012, authorizes FDA to assess and
collect user fees for certain applications
and supplements associated with
human generic drug products, on
applications in the backlog as of October
1, 2012, on finished dosage form (FDF)
and active pharmaceutical ingredient
(API) facilities, and on Type II API drug
master files (DMF) to be made available
for reference. GDUFA directs FDA to
establish each year the generic drug user
fee rates for the upcoming year. In the
first year of GDUFA (FY 2013), some
rates will be published in separate
SUMMARY:
PO 00000
Frm 00023
Fmt 4703
Sfmt 4703
Federal Register notices because of the
timing specified in the statute. Each
year thereafter the GDUFA fee rates will
be published 60 days before the start of
the fiscal year. This document
establishes the FY 2013 rate for API and
FDF facility fees. These fees are due on
March 4, 2013.
FOR FURTHER INFORMATION CONTACT:
David Miller, Office of Financial
Management (HFA–100), Food and Drug
Administration, 1350 Piccard Dr., PI50,
Rm. 210J, Rockville, MD 20850, 301–
796–7103.
SUPPLEMENTARY INFORMATION:
I. Background
Sections 744A and 744B of the FD&C
Act, as added by GDUFA (21 U.S.C.
379j–41 and 379j–42), establish user
fees associated with human generic drug
products. Fees are assessed on: (1)
Certain applications in the backlog as of
October 1, 2012; (2) certain types of
applications and supplements
associated with human generic drug
products; (3) certain facilities where
human generic drug APIs and FDFs are
produced; and (4) certain Type II API
DMFs associated with human generic
drug products. This notice focuses on
the API and FDF facility fees.
II. Fee Revenue Amount for FY 2013
The total fee revenue amount for FY
2013 is $299,000,000, as set in the
statute. GDUFA directs FDA to use the
yearly revenue amount as a starting
point to set the fees. GDUFA states that
the backlog fee will make up
$50,000,000 of the total revenue
collected for FY 2013. Therefore, the
rest of the fees will make up a
percentage of the remaining
$249,000,000 of the total fee revenue.
For more information about GDUFA,
please refer to the FDA Web site
(https://www.fda.gov/gdufa). The API
and FDF facility fee calculations for FY
2013 are described in this document.
III. Foreign Differential
Under GDUFA, the fee for a facility
located outside the United States and its
territories and possessions shall be not
less than $15,000 and not more than
$30,000 higher than the amount of the
fee for a facility located in the United
States and its territories and
possessions, as determined by the
Secretary. The basis for this differential
is the extra cost incurred by conducting
an inspection outside the United States
and its territories and possessions. For
FY 2013 FDA has determined that the
differential for foreign facilities will be
$15,000. The differential may be
adjusted in future years.
E:\FR\FM\17JAN1.SGM
17JAN1
]]>Agencies
[Federal Register Volume 78, Number 12 (Thursday, January 17, 2013)]
[Notices]
[Pages 3899-3900]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-00860]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-10437]
Agency Information Collection Activities: Proposed Collection;
Comment Request
AGENCY: Centers for Medicare & Medicaid Services, HHS.
In compliance with the requirement of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the Centers for Medicare & Medicaid
Services (CMS) is publishing the following summary of proposed
collections for public comment. Interested persons are invited to send
comments regarding this 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.
1. Type of Information Collection Request: New collection; Title of
Information Collection: Generic Social Marketing & Consumer Testing
Research; Use: The purpose of this submission is to request an
Information Collection Request (ICR) generic clearance for a program of
consumer research aimed at a broad audience of those affected by CMS
programs including Medicare, Medicaid, Children's Health Insurance
Program (CHIP), and health insurance exchanges. This program extends
strategic efforts to reach and tailor communications to beneficiaries,
caregivers, providers, stakeholders, and any other audiences that would
support the Agency in improving the functioning of the health care
system, improve patient care and outcomes, and reduce costs without
sacrificing quality of care. With the clearance, CMS will create a fast
track, streamlined, proactive process for collection of data and
utilizing the feedback on service delivery for continuous improvement
of communication activities aimed at diverse CMS audiences.
The generic clearance will allow rapid response to inform CMS
initiatives using a mixture of qualitative and quantitative consumer
research strategies (including formative research studies and
methodological tests) to improve communication with key CMS audiences.
As new information resources and persuasive technologies are developed,
they can be tested and evaluated for beneficiary response to the
materials and delivery channels. Results will inform communication
development and information architecture as well as allow for
continuous quality improvement. The overall goal is to maximize the
extent to which consumers have access to useful sources of CMS program
information in
[[Page 3900]]
a form that can help them make the most of their benefits and options
The activities under this clearance involve social marketing and
consumer research using samples of self-selected customers, as well as
convenience samples, and quota samples, with respondents selected
either to cover a broad range of customers or to include specific
characteristics related to certain products or services. All collection
of information under this clearance will utilize a subset of items
drawn from a core collection of customizable items referred to as the
Social Marketing and Consumer Testing Item Bank. This item bank is
designed to establish a set of pre-approved generic question that can
be drawn upon to allow for the rapid turn-around consumer testing
required for CMS to communicate more effectively with its audiences.
The questions in the item bank are divided into two major categories.
One set focuses on characteristics of individuals and is intended
primarily for participant screening and for use in structured
quantitative on-line or telephone surveys. The other set is less
structured and is designed for use in qualitative one-on-one and small
group discussions or collecting information related to subjective
impressions of test materials. A Study Initiation Request Form
detailing each specific study (description, methodology, estimated
burden) conducted under this clearance will be submitted before any
testing is initialed. Results will be compiled and disseminated so that
future communication can be informed by the testing results. We will
use the findings to create the greatest possible public benefit. Form
Number: CMS-10437 (OCN: 0938-New); Frequency: Yearly; Affected Public:
Individuals. Number of Respondents: 41,592. Number of Responses:
28,800. Total Annual Hours: 21,488. (For policy questions regarding
this collection contact Chris Koepke at 410-786-5877. For all other
issues call 410-786-1326.)
To obtain copies of the supporting statement and any related forms
for the proposed paperwork collections referenced above, access CMS'
Web Site address at https://www.cms.hhs.gov/PaperworkReductionActof1995,
or Email your request, including your address, phone number, OMB
number, and CMS document identifier, to Paperwork@cms.hhs.gov, or call
the Reports Clearance Office on (410) 786-1326.
In commenting on the proposed information collections please
reference the document identifier or OMB control number. To be assured
consideration, comments and recommendations must be submitted in one of
the following ways by March 18, 2013:
1. Electronically. You may submit 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) 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.
Dated: January 11, 2013.
Martique Jones,
Deputy Director, Regulations Development Group, Office of Strategic
Operations and Regulatory Affairs.
[FR Doc. 2013-00860 Filed 1-16-13; 8:45 am]
BILLING CODE 4120-01-P
