Submission for OMB Review; Comment Request, 49390-49391 [2018-21226]
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49390
Federal Register / Vol. 83, No. 190 / Monday, October 1, 2018 / Notices
amozie on DSK3GDR082PROD with NOTICES
drive the bidding process. CMS
maintains and updates each BPT file
and releases new versions every April.
The BPT files may be downloaded
from the Health Plan Management
System website (or HPMS), which is a
restricted-access website, so users must
obtain approval from CMS before using
it. From HPMS, the BPT files may be
downloaded as part of the Plan Benefit
Package (or PBP) software, or they may
be downloaded as stand-alone blank
files. These files are made available to
users on the first Monday of April every
year and an HPMS memo is released
announcing the software availability.
Plan sponsors are required to upload the
completed BPTs to HPMS by the first
Monday in June each year.
MAOs and PDPs use the Bid Pricing
Tool (BPT) software to develop their
actuarial pricing bid. The information
provided in the BPT is the basis for the
plan’s enrollee premiums and CMS
payments for each contract year. The
tool collects data such as medical
expense development (from claims data
and/or manual rating), administrative
expenses, profit levels, and projected
plan enrollment information. By statute,
completed BPTs are due to CMS by the
first Monday of June each year. Form
Number: CMS–10142 (OMB control
number: 0938–0944); Frequency: Yearly;
Affected Public: Private Sector, Business
or other for-profits and Not- for-profit
institution; Number of Respondents:
555; Total Annual Responses: 4,995;
Total Annual Hours: 149,850. (For
policy questions regarding this
collection contact Rachel Shevland at
410–786–3026.)
2. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Contract Year
2020 Plan Benefit Package (PBP)
Software and Formulary Submission;
Use: CMS requires that MA and PDP
organizations submit a completed Plan
Benefit Package (PBP) and formulary as
part of the annual bidding process.
During this process, organizations
prepare their proposed plan benefit
packages for the upcoming contract year
and submit them to CMS for review and
approval. 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. This
allows CMS to review the benefit
packages in a consistent way across all
submitted bids during with incredibly
tight timeframes. This data is also used
to populate data on Medicare Plan
Finder, which allows beneficiaries to
access and compare Medicare
Advantage and Prescription Drug plans.
Form Number: CMS–R–262 (OMB
control number 0938–0763); Frequency:
Yearly; Affected Public: Private Sector,
Business or other for-profits and Notfor-profit institution; Number of
Respondents: 570; Total Annual
Responses: 6,760; Total Annual Hours:
65,354.50 (For policy questions
regarding this collection contact Kristy
Holtje at 410–786–2209.)
3. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Medicaid State
Plan Base Plan Pages; Use: State
Medicaid agencies complete the plan
pages while we review the information
to determine if the state has met all of
the requirements of the provisions the
states choose to implement. If the
requirements are met, we will approve
the amendments to the state’s Medicaid
plan giving the state the authority to
implement the flexibilities. For a state to
receive Medicaid Title XIX funding,
there must be an approved Title XIX
state plan. Form Number: CMS–179
(OMB control number 0938–0193);
Frequency: Occasionally; Affected
Public: State, Local, and Tribal
Governments; Number of Respondents:
56; Total Annual Responses: 1,120;
Total Annual Hours: 22,400. (For policy
questions regarding this collection
Number of
respondents
Information collection instrument
Employer Services Profile ................................................................................
Debt Inquiry Insurer Profile ..............................................................................
Portal Registration Screens .............................................................................
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contact Annette Pearson at 410–786–
6958.)
Dated: September 21, 2018.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2018–20995 Filed 9–28–18; 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
Proposed Projects:
Title: Federal Child Support Portal
Registration.
OMB No.: 0970–0370.
Description: The federal Office of
Child Support Enforcement (OCSE),
Division of Federal Systems, maintains
the Child Support Portal (Portal),
through which authorized users may
view, update, or upload information for
child support purposes. To securely
access the Portal as an authorized user,
OCSE creates profiles within the Portal
for employers, insurers, and multistate
financial institutions (MSFIs) using
information provided in the Employer
Service Profile Form and the Debt
Inquiry Insurer Profile Form (see OMB
No: 0970–0196 for the MSFI Profile
Form). State child support agencies
manage and authenticate authorization
for individual users via the state proxy
server; therefore, a profile form is not
required.
The federal Child Support Portal
Registration information collection
activities are authorized by 42 U.S.C.
653(m)(2), which requires the Secretary
to establish and implement safeguards
to restrict access to confidential
information in the Federal Parent
Locator Service to authorized persons,
and to restrict use of such information
to authorized purposes.
Respondents: Employers, Financial
Institutions, Insurers, and Child Support
Agencies.
Annual Burden Estimates:
Number of
responses per
respondent
2,144
22
2,338
E:\FR\FM\01OCN1.SGM
1
1
1
01OCN1
Average
burden
hours per
response
0.08
0.08
0.15
Total
burden
hours
171.52
1.76
350.70
Federal Register / Vol. 83, No. 190 / Monday, October 1, 2018 / Notices
Estimated Total Annual Burden
Hours (Rounded from 523.98): 524.
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.
Emily B. Jabbour,
ACF/OPRE Certifying Officer.
[FR Doc. 2018–21226 Filed 9–28–18; 8:45 am]
BILLING CODE 4184–41–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Community Living
Administration on Intellectual and
Developmental Disabilities, President’s
Committee for People With Intellectual
Disabilities
Administration for Community
Living, HHS.
ACTION: Notice.
AGENCY:
Thursday, November 8, 2018
from 9:00 a.m. to 4:30 p.m.; and Friday,
November 9, 2018 from 9:00 a.m. to 4:30
p.m. These meetings will be open to the
general public.
ADDRESSES: These meetings will be held
at the U.S. Access Board, located at
1331 F Street NW, Suite 800,
Washington, DC 20004. Individuals who
would like to participate via conference
call may do so by dialing toll-free #: 1–
888–949–2790, when prompted enter
pass code: 1989852. Individuals whose
full participation in the meeting will
require special accommodations (e.g.,
sign language interpreting services,
assistive listening devices, materials in
alternative format such as large print or
Braille) should notify Ms. Allison Cruz,
Director, Office of Innovation, via email
at Allison.Cruz@acl.hhs.gov, or via
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DATES:
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telephone at 202–795–7334, no later
than Monday, October 19, 2018. The
PCPID will attempt to accommodate
requests made after this date, but cannot
guarantee the ability to grant requests
received after the deadline. All meeting
sites are barrier free, consistent with the
Americans with Disabilities Act (ADA)
and the Federal Advisory Committee
Act (FACA).
FOR FURTHER INFORMATION CONTACT: Ms.
Allison Cruz, Director, Office of
Innovation, 330 C Street SW, Switzer
Building, Room 1114, Washington, DC
20201. Telephone: 202–795–7334. Fax:
202–795–7334. Email: Allison.Cruz@
acl.hhs.gov
The
PCPID acts in an advisory capacity to
the President and the Secretary of
Health and Human Services on a broad
range of topics relating to programs,
services and support for individuals
with intellectual disabilities. The PCPID
executive order stipulates that the
Committee shall: (1) Provide such
advice concerning intellectual
disabilities as the President or the
Secretary of Health and Human Services
may request; and (2) provide advice to
the President concerning the following
for people with intellectual disabilities:
(A) Expanding employment
opportunities; (B) connecting people to
services; (C) supporting families and
caregivers; (D) strengthening the
networks; and (E) protecting rights and
preventing abuse.
Agenda: The Committee Members
will discuss preparation of the PCPID
2019 Report to the President, including
its content and format, and related data
collection and analysis required to
complete the writing of the Report.
SUPPLEMENTARY INFORMATION:
Dated: September 24, 2018.
Mary Lazare,
Principal Deputy Administrator,
Administration for Community Living.
[FR Doc. 2018–21319 Filed 9–28–18; 8:45 am]
BILLING CODE 4154–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
49391
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled ‘‘Contents
of a Complete Submission for Threshold
Analyses and Human Factors
Submissions to an IND, NDA, BLA, or
ANDA.’’ The draft guidance provides
recommendations to industry and FDA
staff regarding the content and
submission procedures for use-related
risk analyses, human factors validation
study protocols and reports, threshold
analyses, and comparative use human
factors study protocols and reports.
DATES: Submit either electronic or
written comments on the draft guidance
by November 30, 2018 to ensure that the
Agency considers your comments in
this review.
ADDRESSES: You may submit comments
as follows:
SUMMARY:
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
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
Food and Drug Administration
[Docket No. FDA–2018–D–3275]
Contents of a Complete Submission
for Threshold Analyses and Human
Factors Submissions to Drug and
Biologic Applications; Draft Guidance
for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
PO 00000
Notice of availability.
Frm 00039
Fmt 4703
Sfmt 4703
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
E:\FR\FM\01OCN1.SGM
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]]>Agencies
[Federal Register Volume 83, Number 190 (Monday, October 1, 2018)]
[Notices]
[Pages 49390-49391]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-21226]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for OMB Review; Comment Request
Proposed Projects:
Title: Federal Child Support Portal Registration.
OMB No.: 0970-0370.
Description: The federal Office of Child Support Enforcement
(OCSE), Division of Federal Systems, maintains the Child Support Portal
(Portal), through which authorized users may view, update, or upload
information for child support purposes. To securely access the Portal
as an authorized user, OCSE creates profiles within the Portal for
employers, insurers, and multistate financial institutions (MSFIs)
using information provided in the Employer Service Profile Form and the
Debt Inquiry Insurer Profile Form (see OMB No: 0970-0196 for the MSFI
Profile Form). State child support agencies manage and authenticate
authorization for individual users via the state proxy server;
therefore, a profile form is not required.
The federal Child Support Portal Registration information
collection activities are authorized by 42 U.S.C. 653(m)(2), which
requires the Secretary to establish and implement safeguards to
restrict access to confidential information in the Federal Parent
Locator Service to authorized persons, and to restrict use of such
information to authorized purposes.
Respondents: Employers, Financial Institutions, Insurers, and Child
Support Agencies.
Annual Burden Estimates:
----------------------------------------------------------------------------------------------------------------
Number of Average
Information collection instrument Number of responses per burden hours Total burden
respondents respondent per response hours
----------------------------------------------------------------------------------------------------------------
Employer Services Profile....................... 2,144 1 0.08 171.52
Debt Inquiry Insurer Profile.................... 22 1 0.08 1.76
Portal Registration Screens..................... 2,338 1 0.15 350.70
----------------------------------------------------------------------------------------------------------------
[[Page 49391]]
Estimated Total Annual Burden Hours (Rounded from 523.98): 524.
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.
Emily B. Jabbour,
ACF/OPRE Certifying Officer.
[FR Doc. 2018-21226 Filed 9-28-18; 8:45 am]
BILLING CODE 4184-41-P
