Emergency Clearance: Public Information Collection Requirements Submitted to the Office of Management and Budget (OMB), 63302-63303 [2011-26344]
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63302
Federal Register / Vol. 76, No. 197 / Wednesday, October 12, 2011 / Notices
Frequency of Response: 1.
Average minutes per response: 15.
Burden hours: 125.
An agency may not conduct or
sponsor, and a person is not required to
respond to, a collection of information
unless it displays a currently valid
Office of Management and Budget
control number.
Keith Tucker,
Paperwork Reduction Act Clearance Officer,
Office of the Secretary.
[FR Doc. 2011–26319 Filed 10–11–11; 8:45 am]
BILLING CODE P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare and Medicaid
Services
[Document Identifier CMS–10379]
Emergency Clearance: Public
Information Collection Requirements
Submitted to the Office of Management
and Budget (OMB)
Center for Medicare and
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 and Medicaid
Services (CMS), Department of Health
and Human Services, 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.
We are, however, requesting an
emergency review of the information
collection referenced below. In
compliance with the requirement of
section 3506(c)(2)(A) of the Paperwork
Reduction Act of 1995, we have
submitted to the Office of Management
and Budget (OMB) the following
requirements for emergency review. We
are requesting an emergency review
because the collection of this
information is needed before the
expiration of the normal time limits
under OMB’s regulations at 5 CFR
jlentini on DSK4TPTVN1PROD with NOTICES
AGENCY:
VerDate Mar<15>2010
17:43 Oct 11, 2011
Jkt 226001
1320.13. This is necessary to ensure
compliance with an initiative of the
Administration. We cannot reasonably
comply with the normal clearance
procedures in that public harm is
reasonably likely to result if normal
clearance procedures are followed as
stated in 5 CFR 1320.13(a)(2)(i). The
approval of this data collection process
is essential to ensuring that consumers
enrolled in individual and small group
association products receive the
consumer protections provided under
Section 1003 of the Affordable Care Act.
In absence of this change, a significant
number of individual and small group
rate increases for the 2012 plan year
would not be subject to the review and
public disclosure requirements of the
rate review program and, instead, would
be subject to rate increases that are
largely unregulated.
1. Type of Information Collection
Request: Revision of a currently
approved; Title of Information
Collection: Rate Increase Disclosure and
Review Reporting Requirements (45
CFR Part 154). Use: Under the Section
1003 of the Affordable Care Act (Section
2794 of the Public Health Service Act),
The Secretary, in conjunction with the
States, is required to establish a process
for the annual review, beginning with
the 2010 plan year, of unreasonable
increases in premiums for health
insurance coverage. Section 2794 directs
the Secretary to ensure the public
disclosure of information of
unreasonable rate increases and
justification for those increases.
On December 23, 2010, CMS
published a proposed rate review
regulation in the Federal Register for
public comment (Rate Increase
Disclosure and Review Rule, 75 FR
81004). CMS revised the proposed rule
based on the public comments and
published the final rate review
regulation in the Federal Register on
May 19, 2011. The final rule defines the
unreasonable rate review process and
issuer reporting and disclosure
requirements (Rate Increase Disclosure
and Review Rule, 76 FR 29964). The
regulation establishes the following
reporting requirements:
• The Preliminary Justification: This
data collection is required of all health
insurance issuers for all rate increases
that exceed the ‘‘subject to review’’’
reporting threshold as defined in the
rule. This information will be posted on
an HHS Web site.
• Rate Review Final Determination:
This data collection requires States with
effective rate review programs and CMS
to report their review findings and
unreasonable rate increase
determinations on all rate increases that
PO 00000
Frm 00025
Fmt 4703
Sfmt 4703
are subject to review. This information
will be posted on an HHS Web site.
• The Final Justification for An
Unreasonable Rate Increase: This data
collection is required of health
insurance issuers that elect to
implement a rate increase that is
determined to be unreasonable based on
State or CMS review. This information
will be posted on the Health Insurance
Issuer’s Web site and on a CMS Web
site.
1. Preliminary Justification
The Preliminary Justification consists
of three parts, Part I: Rate Increase
Summary, Part II: Written Explanation
of the Rate Increase, and Part III: Rate
Filing Documentation. Issuers must
complete Parts I and II for all rate
increases that exceed the reporting
threshold as defined in the rule. As
described in the preamble of the rule,
this information would be collected to
provide consumers with basic
information on all rate increases that are
subject to review under the rate review
program.
Under the rule, ‘‘subject to review’’
rate increases would be reviewed by
either States or CMS, depending on
whether a State has an effective rate
review program. Issuers would only be
required to submit Part III of the
Preliminary Justification when CMS is
conducting the review of a rate increase
that is ‘‘subject to review.’’ Accordingly,
Part III requires health insurance issuers
to provide detailed rate data that would
be used for the purposes of conducting
thorough actuarial reviews and for
making determinations about whether
rate increases are unreasonable.
This Notice contains the following
information about the Preliminary
Justification:
• Preliminary Justification Issuer
Instructions: health insurance issuer
instructions for completing all three
parts of the Preliminary Justification.
• Part I Worksheet: a standardized
Excel worksheet that must be used to
complete Part I of the Preliminary
Justification.
• Sample internet display of the Rate
Review Consumer Disclosure:
Information provided in the Preliminary
Justification would be posted on an
HHS Web site. This sample display
shows how the information contained in
the Part I Worksheet would be displayed
to consumers.
2. Rate Review Final Determination
Under the rule, States and CMS
would have to provide a Rate Review
Final Determination at the close of their
review of all ‘‘subject to review’’ rate
increases. The Rate Review Final
E:\FR\FM\12OCN1.SGM
12OCN1
Federal Register / Vol. 76, No. 197 / Wednesday, October 12, 2011 / Notices
jlentini on DSK4TPTVN1PROD with NOTICES
Determination must provide the State’s
or CMS’ determination on whether a
rate increases is ‘unreasonable’. Section
154.301(a)(3) of the rule provides a list
of actuarial review elements that must
be taken into account as part of the rate
review process. The Final
Determination must provide a brief
statement explaining how the review of
elements set forth in § 154.301(a)(3)
caused the State or CMS to arrive at its
determination that the rate is
unreasonable.
The Rate Review Final Determination
will be entered into a data entry text box
in the Rate Review Data Collection
System. CMS is estimating that this
statement would be approximately a
paragraph in length. There is no specific
form or set of instructions associated
with this reporting requirement, apart
from the reporting requirements
provided in the rule. The information
provided in the Rate Review Final
Determination will be posted as part of
the rate review consumer disclosure
information on an HHS Web site.
3. Final Justification for An
Unreasonable Rate Increase
The rule states that if a health
insurance issuer implements a rate
increase determined by CMS or a State
to be unreasonable, the health insurance
issuer must provide a Final Justification
for an Unreasonable Rate Increase. In
the Final Justification, issuers would
have to provide a short statement about
why they are electing to implement an
unreasonable rate increase. This
statement would be entered into a data
entry text box in the Rate Review Data
Collection System and would not need
to be more than a paragraph or two in
length. There is no form or instructions
associated with this statement apart
from the requirements provided in the
regulation.
The Final Justification Statement will
be posted on an HHS Web site in the
same location as the Preliminary
Justification and Rate Review Final
Determination. Additionally, health
insurance issuers implementing rate
increases that were determined to be
unreasonable, must post all of this
information—the Preliminary
Justification, the Rate Review Final
Determination, and the Final
Justification Statement on their Web
sites for a period of 3 years.
In addition to the aforementioned
requirements, we have revised the
information collection request as a
result of an amendment to the
regulation discussed in the final rule
that published September 6, 2011 (76
FR 54969). The amendment to the rate
review final rule updated the
VerDate Mar<15>2010
17:43 Oct 11, 2011
Jkt 226001
applicability of the rate review
requirements to include products that
would be considered part of the
individual or small group market had
they not been sold through associations,
including those that are consider to be
large group products under State law or
have been otherwise excluded from
State’s existing definitions for
individual and small group products.
This change will result in an increase in
the total number of rate increases that
are subject to the rate review reporting
requirements. The amendment did not
propose any changes to the information
that issuers must submit for each rate
increase. Thus, burden associated with
each rate increase submission remains
unchanged from the final rate review
rule. Form Number: CMS–10379; (OCN:
0938–1141) Frequency: Annually;
Affected Public: Private Sector and
States; Number of Respondents: 452;
Number of Responses: 1,201; Total
Annual Hours: 15,213. (For policy
questions regarding this collection,
contact Sally McCarty at (301) 492–
4489. For all other issues call 410–786–
1326.)
CMS is requesting OMB review and
approval of this collection by October
31, 2011, with a 180-day approval
period. Written comments and
recommendations will be considered
from the public if received by the
individuals designated below by
October 21, 2011.
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/
PaperworkReductionActof1995/PRAL/
list.asp or E-mail 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.
Interested persons are invited to send
comments regarding the burden or any
other aspect of these collections of
information requirements. However, as
noted above, comments on these
information collection and
recordkeeping requirements must be
received via one of the following
methods by October 21, 2011.
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,
PO 00000
Frm 00026
Fmt 4703
Sfmt 4703
63303
Division of Regulations Development,
Attention: Document Identifier/OMB
Control Number, Room C4–26–05, 7500
Security Boulevard, Baltimore,
Maryland 21244–1850.
3. By E-mail to OMB. OMB, Office of
Information and Regulatory Affairs,
Attention: CMS Desk Officer, E-mail:
OIRA_submission@omb.eop.gov.
Dated: October 6, 2011.
Martique Jones,
Director, Regulations Development Group,
Division B, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2011–26344 Filed 10–7–11; 11:15 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–D–0694]
Guidance for Industry on Warnings
and Precautions, Contraindications,
and Boxed Warning Sections of
Labeling for Human Prescription Drug
and Biological Products—Content and
Format; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
entitled ‘‘Warnings and Precautions,
Contraindications, and Boxed Warning
Sections of Labeling for Human
Prescription Drug and Biological
Products—Content and Format.’’ This
guidance is intended to assist applicants
and reviewers in drafting the ‘‘Warnings
and Precautions, Contraindications, and
Boxed Warning’’ sections of labeling for
human prescription drug and biological
products. The recommendations in this
guidance will help ensure that the
labeling is clear, useful, informative,
and to the extent possible, consistent in
content and format.
DATES: Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for
single copies of this guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Silver Spring, MD
20993–0002. Send one self-addressed
adhesive label to assist that office in
processing your requests. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the guidance
document.
SUMMARY:
E:\FR\FM\12OCN1.SGM
12OCN1
Agencies
[Federal Register Volume 76, Number 197 (Wednesday, October 12, 2011)]
[Notices]
[Pages 63302-63303]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-26344]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare and Medicaid Services
[Document Identifier CMS-10379]
Emergency Clearance: Public Information Collection Requirements
Submitted to the Office of Management and Budget (OMB)
AGENCY: Center for Medicare and 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 and Medicaid
Services (CMS), Department of Health and Human Services, 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.
We are, however, requesting an emergency review of the information
collection referenced below. In compliance with the requirement of
section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, we have
submitted to the Office of Management and Budget (OMB) the following
requirements for emergency review. We are requesting an emergency
review because the collection of this information is needed before the
expiration of the normal time limits under OMB's regulations at 5 CFR
1320.13. This is necessary to ensure compliance with an initiative of
the Administration. We cannot reasonably comply with the normal
clearance procedures in that public harm is reasonably likely to result
if normal clearance procedures are followed as stated in 5 CFR
1320.13(a)(2)(i). The approval of this data collection process is
essential to ensuring that consumers enrolled in individual and small
group association products receive the consumer protections provided
under Section 1003 of the Affordable Care Act. In absence of this
change, a significant number of individual and small group rate
increases for the 2012 plan year would not be subject to the review and
public disclosure requirements of the rate review program and, instead,
would be subject to rate increases that are largely unregulated.
1. Type of Information Collection Request: Revision of a currently
approved; Title of Information Collection: Rate Increase Disclosure and
Review Reporting Requirements (45 CFR Part 154). Use: Under the Section
1003 of the Affordable Care Act (Section 2794 of the Public Health
Service Act), The Secretary, in conjunction with the States, is
required to establish a process for the annual review, beginning with
the 2010 plan year, of unreasonable increases in premiums for health
insurance coverage. Section 2794 directs the Secretary to ensure the
public disclosure of information of unreasonable rate increases and
justification for those increases.
On December 23, 2010, CMS published a proposed rate review
regulation in the Federal Register for public comment (Rate Increase
Disclosure and Review Rule, 75 FR 81004). CMS revised the proposed rule
based on the public comments and published the final rate review
regulation in the Federal Register on May 19, 2011. The final rule
defines the unreasonable rate review process and issuer reporting and
disclosure requirements (Rate Increase Disclosure and Review Rule, 76
FR 29964). The regulation establishes the following reporting
requirements:
The Preliminary Justification: This data collection is
required of all health insurance issuers for all rate increases that
exceed the ``subject to review''' reporting threshold as defined in the
rule. This information will be posted on an HHS Web site.
Rate Review Final Determination: This data collection
requires States with effective rate review programs and CMS to report
their review findings and unreasonable rate increase determinations on
all rate increases that are subject to review. This information will be
posted on an HHS Web site.
The Final Justification for An Unreasonable Rate Increase:
This data collection is required of health insurance issuers that elect
to implement a rate increase that is determined to be unreasonable
based on State or CMS review. This information will be posted on the
Health Insurance Issuer's Web site and on a CMS Web site.
1. Preliminary Justification
The Preliminary Justification consists of three parts, Part I: Rate
Increase Summary, Part II: Written Explanation of the Rate Increase,
and Part III: Rate Filing Documentation. Issuers must complete Parts I
and II for all rate increases that exceed the reporting threshold as
defined in the rule. As described in the preamble of the rule, this
information would be collected to provide consumers with basic
information on all rate increases that are subject to review under the
rate review program.
Under the rule, ``subject to review'' rate increases would be
reviewed by either States or CMS, depending on whether a State has an
effective rate review program. Issuers would only be required to submit
Part III of the Preliminary Justification when CMS is conducting the
review of a rate increase that is ``subject to review.'' Accordingly,
Part III requires health insurance issuers to provide detailed rate
data that would be used for the purposes of conducting thorough
actuarial reviews and for making determinations about whether rate
increases are unreasonable.
This Notice contains the following information about the
Preliminary Justification:
Preliminary Justification Issuer Instructions: health
insurance issuer instructions for completing all three parts of the
Preliminary Justification.
Part I Worksheet: a standardized Excel worksheet that must
be used to complete Part I of the Preliminary Justification.
Sample internet display of the Rate Review Consumer
Disclosure: Information provided in the Preliminary Justification would
be posted on an HHS Web site. This sample display shows how the
information contained in the Part I Worksheet would be displayed to
consumers.
2. Rate Review Final Determination
Under the rule, States and CMS would have to provide a Rate Review
Final Determination at the close of their review of all ``subject to
review'' rate increases. The Rate Review Final
[[Page 63303]]
Determination must provide the State's or CMS' determination on whether
a rate increases is `unreasonable'. Section 154.301(a)(3) of the rule
provides a list of actuarial review elements that must be taken into
account as part of the rate review process. The Final Determination
must provide a brief statement explaining how the review of elements
set forth in Sec. 154.301(a)(3) caused the State or CMS to arrive at
its determination that the rate is unreasonable.
The Rate Review Final Determination will be entered into a data
entry text box in the Rate Review Data Collection System. CMS is
estimating that this statement would be approximately a paragraph in
length. There is no specific form or set of instructions associated
with this reporting requirement, apart from the reporting requirements
provided in the rule. The information provided in the Rate Review Final
Determination will be posted as part of the rate review consumer
disclosure information on an HHS Web site.
3. Final Justification for An Unreasonable Rate Increase
The rule states that if a health insurance issuer implements a rate
increase determined by CMS or a State to be unreasonable, the health
insurance issuer must provide a Final Justification for an Unreasonable
Rate Increase. In the Final Justification, issuers would have to
provide a short statement about why they are electing to implement an
unreasonable rate increase. This statement would be entered into a data
entry text box in the Rate Review Data Collection System and would not
need to be more than a paragraph or two in length. There is no form or
instructions associated with this statement apart from the requirements
provided in the regulation.
The Final Justification Statement will be posted on an HHS Web site
in the same location as the Preliminary Justification and Rate Review
Final Determination. Additionally, health insurance issuers
implementing rate increases that were determined to be unreasonable,
must post all of this information--the Preliminary Justification, the
Rate Review Final Determination, and the Final Justification Statement
on their Web sites for a period of 3 years.
In addition to the aforementioned requirements, we have revised the
information collection request as a result of an amendment to the
regulation discussed in the final rule that published September 6, 2011
(76 FR 54969). The amendment to the rate review final rule updated the
applicability of the rate review requirements to include products that
would be considered part of the individual or small group market had
they not been sold through associations, including those that are
consider to be large group products under State law or have been
otherwise excluded from State's existing definitions for individual and
small group products. This change will result in an increase in the
total number of rate increases that are subject to the rate review
reporting requirements. The amendment did not propose any changes to
the information that issuers must submit for each rate increase. Thus,
burden associated with each rate increase submission remains unchanged
from the final rate review rule. Form Number: CMS-10379; (OCN: 0938-
1141) Frequency: Annually; Affected Public: Private Sector and States;
Number of Respondents: 452; Number of Responses: 1,201; Total Annual
Hours: 15,213. (For policy questions regarding this collection, contact
Sally McCarty at (301) 492-4489. For all other issues call 410-786-
1326.)
CMS is requesting OMB review and approval of this collection by
October 31, 2011, with a 180-day approval period. Written comments and
recommendations will be considered from the public if received by the
individuals designated below by October 21, 2011.
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/PaperworkReductionActof1995/PRAL/list.asp or E-mail 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.
Interested persons are invited to send comments regarding the
burden or any other aspect of these collections of information
requirements. However, as noted above, comments on these information
collection and recordkeeping requirements must be received via one of
the following methods by October 21, 2011.
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.
3. By E-mail to OMB. OMB, Office of Information and Regulatory
Affairs, Attention: CMS Desk Officer, E-mail: OIRA_submission@omb.eop.gov.
Dated: October 6, 2011.
Martique Jones,
Director, Regulations Development Group, Division B, Office of
Strategic Operations and Regulatory Affairs.
[FR Doc. 2011-26344 Filed 10-7-11; 11:15 am]
BILLING CODE 4120-01-P