81 FR 8500 - Submission for OMB Review; Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families Federal Register Volume 81, Issue 33 (February 19, 2016)
Administration for Children and Families
Federal Register Volume 81, Issue 33 (February 19, 2016)
| Page Range | 8500-8501 | |
| FR Document | 2016-03460 |
[Federal Register Volume 81, Number 33 (Friday, February 19, 2016)] [Notices] [Pages 8500-8501] From the Federal Register Online [www.thefederalregister.org] [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: [email protected]. 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: [email protected], 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
![8500 Federal Register / Vol. 81, No. 33 / Friday, February 19, 2016 / Notices
(OMB Control Number: 0938–0679); That regulation would also require any given MLR reporting year.
Frequency: Occasionally; Affected health insurance issuers to submit an Additionally, each issuer is required to
Public: Individuals or Households; Actuarial Memorandum (in addition to maintain for a period of seven years all
Number of Respondents: 462,000; Total the Unified Rate Review Template) documents, records and other evidence
Annual Responses: 462,000; Total when a plan within a product is subject that support the data included in each
Annual Hours: 418,563. (For policy to a rate increase. Although the two issuer’s annual report to the Secretary.
questions regarding this collection required documents are submitted at the Under Section 1342 of the Patient
contact Paula Smith at 410–786–4709.) risk pool level, the requirement to Protection and Affordable Care Act and
3. Type of Information Collection submit is based on increases at the plan implementing regulation at 45 CFR part
Request: Revision of a currently level. 153, issuers of qualified health plans
approved collection; Title of In order to conduct a review to assess (QHPs) must participate in a risk
Information Collection: Rate Increase reasonableness when a plan within a corridors program. A QHP issuer is
Disclosure and Review Reporting product has a rate increase that is required to pay charges to or receive
Requirements; Use: Section 1003 of the subject to review, health insurance payments from CMS based on the ratio
Affordable Care Act adds a new section issuers would be required to submit a of the issuer’s allowable costs to the
2794 of the PHS Act which directs the written description justifying the target amount. Each QHP issuer is
Secretary of the Department of Health increase (in addition to the Unified Rate required to submit an annual report to
and Human Services (the Secretary), in Review Template and Actuarial CMS concerning the issuer’s allowable
conjunction with the states, to establish Memorandum). Although the required costs, allowable administrative costs,
a process for the annual review of documents are submitted at the risk and the amount of premium.
‘‘unreasonable increases in premiums pool level, the requirement to submit is The 2015 MLR Reporting Form and
for health insurance coverage.’’ The based on increases at the plan level. Instructions reflect changes for the 2015
statute provides that health insurance Form Number: CMS–10379 (OMB reporting/benefit year and beyond. In
issuers must submit to the Secretary and Control Number: 0938–1141); 2016, it is expected that issuers will
the applicable state justifications for Frequency: Yearly; Affected Public: submit fewer reports and send fewer
unreasonable premium increases prior State and Private sector (Business or notices to policyholders and
to the implementation of the increases. other for-profits and Not-for-profit subscribers, which will reduce burden
Section 2794 also specifies that institutions); Number of Respondents: on issuers. On the other hand, it is
beginning with plan years beginning in 1,081; Total Annual Responses: 1,621; expected that issuers will send more
2014, the Secretary, in conjunction with Total Annual Hours: 17,837. (For policy rebate checks in the mail to individual
the states, shall monitor premium questions regarding this collection market policyholders, which will
increases of health insurance coverage contact Lisa Cuozzo at 410–786–1746.) increase burden for some issuers. It is
offered through an Exchange and 4. Type of Information Collection estimated that there will be a net
outside of an Exchange. Request: Extension of a currently reduction in total burden from 271,600
Section 2794 directs the Secretary to approved collection; Title of to 235,148. Form Number: CMS–10418
ensure the public disclosure of Information Collection: Medical Loss (OMB Control Number: 0938–1164);
information and justification relating to Ratio Annual Reports, MLR Notices, and Frequency: Annually; Affected Public:
unreasonable rate increases. Section Recordkeeping Requirements; Use: Private Sector, Business or other for-
2794 requires that health insurance Under Section 2718 of the Affordable profits and not-for-profit institutions;
issuers submit justification for an Care Act and implementing regulation Number of Respondents: 538; Number
unreasonable rate increase to CMS and at 45 CFR part 158, a health insurance
of Responses: 2,818; Total Annual
the relevant state prior to its issuer (issuer) offering group or
Hours: 235,148. (For policy questions
implementation. Additionally, section individual health insurance coverage
regarding this collection contact
2794 requires that rate increases must submit a report to the Secretary
Christina Whitefield at 301–492–4172.)
effective in 2014 (submitted for review concerning the amount the issuer
in 2013) be monitored by the Secretary, spends each year on claims, quality Dated: February 16, 2016.
in conjunction with the states. To those improvement expenses, non-claims William N. Parham, III,
ends, Section 154 of the CFR establishes costs, Federal and State taxes and Director, Paperwork Reduction Staff, Office
various reporting requirements for licensing and regulatory fees, the of Strategic Operations and Regulatory
health insurance issuers, including a amount of earned premium, and Affairs.
Preliminary Justification for a proposed beginning with the 2014 reporting year, [FR Doc. 2016–03474 Filed 2–18–16; 8:45 am]
rate increase, a Final Justification for the amounts related to the transitional BILLING CODE 4120–01–P
any rate increase determined by a state reinsurance, risk adjustment, and risk
or CMS to be unreasonable, and a corridors. An issuer must provide an
notification requirement for annual rebate if the amount it spends on DEPARTMENT OF HEALTH AND
unreasonable rate increases which the certain costs compared to its premium HUMAN SERVICES
issuer will not implement. revenue (excluding Federal and States
In order to obtain the information taxes and licensing and regulatory fees) Administration for Children and
necessary to monitor premium increases does not meet a certain ratio, referred to Families
of health insurance coverage offered as the medical loss ratio (MLR). Each
through an Exchange and outside of an issuer is required to submit annually Submission for OMB Review;
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Exchange, 45 CFR 154.215 would MLR data, including information about Comment Request
require health insurance issuers to any rebates it must provide, on a form Title: Native Employment Works
submit the Unified Rate Review prescribed by CMS, for each State in (NEW) Program Plan Guidance and
Template for all single risk pool which the issuer conducts business. Native Employment Works (NEW)
coverage products in the individual or Each issuer is also required to provide Program Report.
small group (or merged) market, a rebate notice to each policyholder that OMB No.: 0970–0174.
regardless of whether any plan within a is owed a rebate and each subscriber of Description: The Native Employment
product is subject to a rate increase. policyholders that are owed a rebate for Works (NEW) program plan is the
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![Federal Register / Vol. 81, No. 33 / Friday, February 19, 2016 / Notices 8501
application for NEW program funding. There are two versions of this plan accomplishments of grantees’ NEW
As approved by the Department of guidance: One for tribes that include programs. The NEW program report and
Health and Human Services (HHS), it their NEW program in a Public Law instructions specify the program data
documents how the grantee will carry 102–477 project, and one for tribes that that NEW grantees report annually.
out its NEW program. The NEW do not. The primary difference between Respondents: Federally recognized
program plan guidance provides the guidance documents is in the
Indian Tribes and Tribal organizations
instructions for preparing a NEW instructions for how to submit the plan.
that are NEW program grantees.
program plan and explains the process The NEW program report provides
for plan submission every third year. information on the activities and
ANNUAL BURDEN ESTIMATES
Number of Average
Number of Total burden
Instrument responses per burden hours
respondents hours
respondent per response
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 DEPARTMENT OF HEALTH AND anyone else’s Social Security number, or
Hours: 1,414. HUMAN SERVICES confidential business information, such
as a manufacturing process. Please note
Additional Information Food and Drug Administration that if you include your name, contact
Copies of the proposed collection may information, or other information that
[Docket No. FDA–2014–D–0310]
be obtained by writing to the identifies you in the body of your
Guidance for Industry on comments, that information will be
Administration for Children and
Immunogenicity-Related posted on http://www.regulations.gov.
Families, Office of Planning, Research • If you want to submit a comment
and Evaluation, 330 C Street SW., Considerations for Low Molecular
Weight Heparin; Availability with confidential information that you
Washington, DC 20201. Attention do not wish to be made available to the
Reports Clearance Officer. All requests AGENCY: Food and Drug Administration, public, submit the comment as a
should be identified by the title of the HHS. written/paper submission and in the
information collection. Email address: ACTION: Notice. manner detailed (see ‘‘Written/Paper
infocollection@acf.hhs.gov. Submissions’’ and ‘‘Instructions’’).
SUMMARY: The Food and Drug
OMB Comment Written/Paper Submissions
Administration (FDA) is announcing the
OMB is required to make a decision availability of a guidance for industry Submit written/paper submissions as
entitled ‘‘Immunogenicity-Related follows:
concerning the collection of information
Considerations for Low Molecular • Mail/Hand delivery/Courier (for
between 30 and 60 days after written/paper submissions): Division of
publication of this document in the Weight Heparin.’’ This guidance
discusses how applicants for low Dockets Management (HFA–305), Food
Federal Register. Therefore, a comment and Drug Administration, 5630 Fishers
is best assured of having its full effect molecular weight heparin (LMWH)
products should provide information on Lane, Rm. 1061, Rockville, MD 20852.
if OMB receives it within 30 days of
impurities and their potential impact on • For written/paper comments
publication. Written comments and submitted to the Division of Dockets
immunogenicity.
recommendations for the proposed Management, FDA will post your
DATES: Submit either electronic or comment, as well as any attachments,
information collection should be sent
directly to the following: Office of written comments on Agency guidances except for information submitted,
at any time. marked and identified, as confidential,
Management and Budget, Paperwork
Reduction Project, Email: OIRA_ ADDRESSES: You may submit comments if submitted as detailed in
SUBMISSION@OMB.EOP.GOV, Attn: as follows: ‘‘Instructions.’’
Desk Officer for the Administration for Instructions: All submissions received
Electronic Submissions
Children and Families. must include the Docket No. FDA–
Submit electronic comments in the 2014–D–0310 for ‘‘Immunogenicity-
Robert Sargis, following way: Related Considerations for Low
Reports Clearance Officer. • Federal eRulemaking Portal: http:// Molecular Weight Heparin.’’ Received
[FR Doc. 2016–03460 Filed 2–18–16; 8:45 am]
www.regulations.gov. Follow the comments will be placed in the docket
instructions for submitting comments. and, except for those submitted as
BILLING CODE 4184–01–P
Comments submitted electronically, ‘‘Confidential Submissions,’’ publicly
including attachments, to http:// viewable at http://www.regulations.gov
asabaliauskas on DSK5VPTVN1PROD with NOTICES
www.regulations.gov will be posted to or at the Division of Dockets
the docket unchanged. Because your Management between 9 a.m. and 4 p.m.,
comment will be made public, you are Monday through Friday.
solely responsible for ensuring that your • Confidential Submissions—To
comment does not include any submit a comment with confidential
confidential information that you or a information that you do not wish to be
third party may not wish to be posted, made publicly available, submit your
such as medical information, your or comments only as a written/paper
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Document Created: 2018-02-02 14:31:48
Document Modified: 2018-02-02 14:31:48
| 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 | |
| FR Citation | 81 FR 8500 |
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