Submission for OMB Review; Comment Request, 8500-8501 [2016-03460]
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Federal Register / Vol. 81, No. 33 / Friday, February 19, 2016 / Notices
(OMB Control Number: 0938–0679);
Frequency: Occasionally; Affected
Public: Individuals or Households;
Number of Respondents: 462,000; Total
Annual Responses: 462,000; Total
Annual Hours: 418,563. (For policy
questions regarding this collection
contact Paula Smith at 410–786–4709.)
3. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Rate Increase
Disclosure and Review Reporting
Requirements; Use: Section 1003 of the
Affordable Care Act adds a new section
2794 of the PHS Act which directs the
Secretary of the Department of Health
and Human Services (the Secretary), in
conjunction with the states, to establish
a process for the annual review of
‘‘unreasonable increases in premiums
for health insurance coverage.’’ The
statute provides that health insurance
issuers must submit to the Secretary and
the applicable state justifications for
unreasonable premium increases prior
to the implementation of the increases.
Section 2794 also specifies that
beginning with plan years beginning in
2014, the Secretary, in conjunction with
the states, shall monitor premium
increases of health insurance coverage
offered through an Exchange and
outside of an Exchange.
Section 2794 directs the Secretary to
ensure the public disclosure of
information and justification relating to
unreasonable rate increases. Section
2794 requires that health insurance
issuers submit justification for an
unreasonable rate increase to CMS and
the relevant state prior to its
implementation. Additionally, section
2794 requires that rate increases
effective in 2014 (submitted for review
in 2013) be monitored by the Secretary,
in conjunction with the states. To those
ends, Section 154 of the CFR establishes
various reporting requirements for
health insurance issuers, including a
Preliminary Justification for a proposed
rate increase, a Final Justification for
any rate increase determined by a state
or CMS to be unreasonable, and a
notification requirement for
unreasonable rate increases which the
issuer will not implement.
In order to obtain the information
necessary to monitor premium increases
of health insurance coverage offered
through an Exchange and outside of an
Exchange, 45 CFR 154.215 would
require health insurance issuers to
submit the Unified Rate Review
Template for all single risk pool
coverage products in the individual or
small group (or merged) market,
regardless of whether any plan within a
product is subject to a rate increase.
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17:59 Feb 18, 2016
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That regulation would also require
health insurance issuers to submit an
Actuarial Memorandum (in addition to
the Unified Rate Review Template)
when a plan within a product is subject
to a rate increase. Although the two
required documents are submitted at the
risk pool level, the requirement to
submit is based on increases at the plan
level.
In order to conduct a review to assess
reasonableness when a plan within a
product has a rate increase that is
subject to review, health insurance
issuers would be required to submit a
written description justifying the
increase (in addition to the Unified Rate
Review Template and Actuarial
Memorandum). Although the required
documents are submitted at the risk
pool level, the requirement to submit is
based on increases at the plan level.
Form Number: CMS–10379 (OMB
Control Number: 0938–1141);
Frequency: Yearly; Affected Public:
State and Private sector (Business or
other for-profits and Not-for-profit
institutions); Number of Respondents:
1,081; Total Annual Responses: 1,621;
Total Annual Hours: 17,837. (For policy
questions regarding this collection
contact Lisa Cuozzo at 410–786–1746.)
4. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Medical Loss
Ratio Annual Reports, MLR Notices, and
Recordkeeping Requirements; Use:
Under Section 2718 of the Affordable
Care Act and implementing regulation
at 45 CFR part 158, a health insurance
issuer (issuer) offering group or
individual health insurance coverage
must submit a report to the Secretary
concerning the amount the issuer
spends each year on claims, quality
improvement expenses, non-claims
costs, Federal and State taxes and
licensing and regulatory fees, the
amount of earned premium, and
beginning with the 2014 reporting year,
the amounts related to the transitional
reinsurance, risk adjustment, and risk
corridors. An issuer must provide an
annual rebate if the amount it spends on
certain costs compared to its premium
revenue (excluding Federal and States
taxes and licensing and regulatory fees)
does not meet a certain ratio, referred to
as the medical loss ratio (MLR). Each
issuer is required to submit annually
MLR data, including information about
any rebates it must provide, on a form
prescribed by CMS, for each State in
which the issuer conducts business.
Each issuer is also required to provide
a rebate notice to each policyholder that
is owed a rebate and each subscriber of
policyholders that are owed a rebate for
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any given MLR reporting year.
Additionally, each issuer is required to
maintain for a period of seven years all
documents, records and other evidence
that support the data included in each
issuer’s annual report to the Secretary.
Under Section 1342 of the Patient
Protection and Affordable Care Act and
implementing regulation at 45 CFR part
153, issuers of qualified health plans
(QHPs) must participate in a risk
corridors program. A QHP issuer is
required to pay charges to or receive
payments from CMS based on the ratio
of the issuer’s allowable costs to the
target amount. Each QHP issuer is
required to submit an annual report to
CMS concerning the issuer’s allowable
costs, allowable administrative costs,
and the amount of premium.
The 2015 MLR Reporting Form and
Instructions reflect changes for the 2015
reporting/benefit year and beyond. In
2016, it is expected that issuers will
submit fewer reports and send fewer
notices to policyholders and
subscribers, which will reduce burden
on issuers. On the other hand, it is
expected that issuers will send more
rebate checks in the mail to individual
market policyholders, which will
increase burden for some issuers. It is
estimated that there will be a net
reduction in total burden from 271,600
to 235,148. Form Number: CMS–10418
(OMB Control Number: 0938–1164);
Frequency: Annually; Affected Public:
Private Sector, Business or other forprofits and not-for-profit institutions;
Number of Respondents: 538; Number
of Responses: 2,818; Total Annual
Hours: 235,148. (For policy questions
regarding this collection contact
Christina Whitefield at 301–492–4172.)
Dated: February 16, 2016.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2016–03474 Filed 2–18–16; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: Native Employment Works
(NEW) Program Plan Guidance and
Native Employment Works (NEW)
Program Report.
OMB No.: 0970–0174.
Description: The Native Employment
Works (NEW) program plan is the
E:\FR\FM\19FEN1.SGM
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Federal Register / Vol. 81, No. 33 / Friday, February 19, 2016 / Notices
application for NEW program funding.
As approved by the Department of
Health and Human Services (HHS), it
documents how the grantee will carry
out its NEW program. The NEW
program plan guidance provides
instructions for preparing a NEW
program plan and explains the process
for plan submission every third year.
There are two versions of this plan
guidance: One for tribes that include
their NEW program in a Public Law
102–477 project, and one for tribes that
do not. The primary difference between
the guidance documents is in the
instructions for how to submit the plan.
The NEW program report provides
information on the activities and
accomplishments of grantees’ NEW
programs. The NEW program report and
instructions specify the program data
that NEW grantees report annually.
Respondents: Federally recognized
Indian Tribes and Tribal organizations
that are NEW program grantees.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
1 15
NEW program plan guidance for non-477 Tribes ...........................................
NEW program plan guidance for 477 Tribes ...................................................
NEW program report .......................................................................................
3 44
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Additional Information
Food and Drug Administration
Copies of the proposed collection may
be obtained by writing to the
Administration for Children and
Families, Office of Planning, Research
and Evaluation, 330 C Street SW.,
Washington, DC 20201. Attention
Reports Clearance Officer. All requests
should be identified by the title of the
information collection. Email address:
infocollection@acf.hhs.gov.
[Docket No. FDA–2014–D–0310]
OMB is required to make a decision
concerning the collection of information
between 30 and 60 days after
publication of this document in the
Federal Register. Therefore, a comment
is best assured of having its full effect
if OMB receives it within 30 days of
publication. Written comments and
recommendations for the proposed
information collection should be sent
directly to the following: Office of
Management and Budget, Paperwork
Reduction Project, Email: OIRA_
SUBMISSION@OMB.EOP.GOV, Attn:
Desk Officer for the Administration for
Children and Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2016–03460 Filed 2–18–16; 8:45 am]
asabaliauskas on DSK5VPTVN1PROD with NOTICES
BILLING CODE 4184–01–P
17:59 Feb 18, 2016
Food and Drug Administration,
HHS.
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
entitled ‘‘Immunogenicity-Related
Considerations for Low Molecular
Weight Heparin.’’ This guidance
discusses how applicants for low
molecular weight heparin (LMWH)
products should provide information on
impurities and their potential impact on
immunogenicity.
DATES: Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: You may submit comments
as follows:
SUMMARY:
OMB Comment
VerDate Sep<11>2014
Guidance for Industry on
Immunogenicity-Related
Considerations for Low Molecular
Weight Heparin; Availability
ACTION:
Jkt 238001
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
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1
1
1
2 11
Estimated Total Annual Burden
Hours: 1,414.
AGENCY:
Number of
responses per
respondent
Average
burden hours
per response
29
29
15
Total burden
hours
435
319
660
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–
2014–D–0310 for ‘‘ImmunogenicityRelated Considerations for Low
Molecular Weight Heparin.’’ 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
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]]>Agencies
[Federal Register Volume 81, Number 33 (Friday, February 19, 2016)]
[Notices]
[Pages 8500-8501]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-03460]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for OMB Review; Comment Request
Title: Native Employment Works (NEW) Program Plan Guidance and
Native Employment Works (NEW) Program Report.
OMB No.: 0970-0174.
Description: The Native Employment Works (NEW) program plan is the
[[Page 8501]]
application for NEW program funding. As approved by the Department of
Health and Human Services (HHS), it documents how the grantee will
carry out its NEW program. The NEW program plan guidance provides
instructions for preparing a NEW program plan and explains the process
for plan submission every third year. There are two versions of this
plan guidance: One for tribes that include their NEW program in a
Public Law 102-477 project, and one for tribes that do not. The primary
difference between the guidance documents is in the instructions for
how to submit the plan. The NEW program report provides information on
the activities and accomplishments of grantees' NEW programs. The NEW
program report and instructions specify the program data that NEW
grantees report annually.
Respondents: Federally recognized Indian Tribes and Tribal
organizations that are NEW program grantees.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Number of responses per hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
NEW program plan guidance for non-477 Tribes.... \1\ 15 1 29 435
NEW program plan guidance for 477 Tribes........ \2\ 11 1 29 319
NEW program report.............................. \3\ 44 1 15 660
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 1,414.
Additional Information
Copies of the proposed collection may be obtained by writing to the
Administration for Children and Families, Office of Planning, Research
and Evaluation, 330 C Street SW., Washington, DC 20201. Attention
Reports Clearance Officer. All requests should be identified by the
title of the information collection. Email address:
infocollection@acf.hhs.gov.
OMB Comment
OMB is required to make a decision concerning the collection of
information between 30 and 60 days after publication of this document
in the Federal Register. Therefore, a comment is best assured of having
its full effect if OMB receives it within 30 days of publication.
Written comments and recommendations for the proposed information
collection should be sent directly to the following: Office of
Management and Budget, Paperwork Reduction Project, Email:
OIRA_SUBMISSION@OMB.EOP.GOV, Attn: Desk Officer for the Administration
for Children and Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2016-03460 Filed 2-18-16; 8:45 am]
BILLING CODE 4184-01-P
