Proposed Information Collection Activity; Comment Request, 78160-78161 [2016-26806]
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78160
Federal Register / Vol. 81, No. 215 / Monday, November 7, 2016 / Notices
approved information collections. The
forms CMS–855A, CMS–855B, and
CMS–855I are approved under OMB
control number 0938–0685; the CMS–
855S is approved under OMB control
number 0938–1056.
IV. Regulatory Impact Statement
A. Background
We have examined the impact of this
notice as required by Executive Order
12866 on Regulatory Planning and
Review (September 30, 1993), Executive
Order 13563 on Improving Regulation
and Regulatory Review (January 18,
2011), the Regulatory Flexibility Act
(RFA) (September 19, 1980, Pub. L. 96–
354), section 1102(b) of the Social
Security Act, section 202 of the
Unfunded Mandates Reform Act of 1995
(March 22, 1995; Pub. L. 104–4),
Executive Order 13132 on Federalism
(August 4, 1999), and the Congressional
Review Act (5 U.S.C. 804(2)).
Executive Orders 12866 and 13563
direct agencies to assess all costs and
benefits of available regulatory
alternatives and, if regulation is
necessary, to select regulatory
approaches that maximize net benefits,
including potential economic,
environmental, public health and safety
effects, distributive impacts, and equity.
A regulatory impact analysis (RIA) must
be prepared for major rules with
economically significant effects ($100
million or more in any 1 year). As
explained in this section of the notice,
we estimate that the total cost of the
increase in the application fee will not
exceed $100 million. Therefore, this
notice does not reach the $100 million
economic threshold and is not
considered a major notice.
B. Costs
The costs associated with this notice
involve the increase in the application
fee amount that certain providers and
suppliers must pay in CY 2017.
sradovich on DSK3GMQ082PROD with NOTICES
1. Estimates of Number of Affected
Institutional Providers in December 3,
2015 Fee Notice
In the December 3, 2015 application
fee notice, we estimated that based on
CMS statistics—
• 10,000 newly enrolling Medicare
institutional providers would be subject
to and pay an application fee in CY
2016.
• 45,000 revalidating Medicare
institutional providers would be subject
to and pay an application fee in CY
2016.
• 9,000 newly enrolling Medicaid and
CHIP providers would be subject to and
pay an application fee in CY 2016.
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16:02 Nov 04, 2016
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• 21,000 revalidating Medicaid and
CHIP providers would be subject to and
pay an application fee in CY 2016.
2. CY 2017 Estimates
a. Medicare
Based on CMS data, we estimate that
in CY 2017 approximately—
• 10,000 newly enrolling institutional
providers will be subject to and pay an
application fee; and
• 43,792 revalidating institutional
providers will be subject to and pay an
application fee.
Using a figure of 53,792 (10,000 newly
enrolling + 43,792 revalidating)
institutional providers, we estimate an
increase in the cost of the Medicare
application fee requirement in CY 2017
of $322,752 (or 53,792 × $6 (or $560
minus $554)) from our CY 2016
projections and as previously described.
b. Medicaid and CHIP
Based on CMS and state statistics, we
estimate that approximately 30,000
(9,000 newly enrolling + 21,000
revalidating) Medicaid and CHIP
institutional providers will be subject to
an application fee in CY 2017. Using
this figure, we project an increase in the
cost of the Medicaid and CHIP
application fee requirement in CY 2017
of $180,000 (or 30,000 × $6 (or $560
minus $554)) from our CY 2016
projections and as previously described.
c. Total
Based on the foregoing, we estimate
the total increase in the cost of the
application fee requirement for
Medicare, Medicaid, and CHIP
providers and suppliers in CY 2017 to
be $502,752 ($180,000 + $322,752) from
our CY 2016 projections.
The RFA requires agencies to analyze
options for regulatory relief of small
businesses. For purposes of the RFA,
small entities include small businesses,
nonprofit organizations, and small
governmental jurisdictions. Most
hospitals and most other providers and
suppliers are small entities, either by
nonprofit status or by having revenues
of less than $7.5 million to $38.5
million in any 1 year. Individuals and
states are not included in the definition
of a small entity. As we stated in the
RIA for the February 2, 2011 final rule
with comment period (76 FR 5952), we
do not believe that the application fee
will have a significant impact on small
entities.
In addition, section 1102(b) of the Act
requires us to prepare a regulatory
impact analysis if a rule may have a
significant impact on the operations of
a substantial number of small rural
hospitals. This analysis must conform to
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Frm 00054
Fmt 4703
Sfmt 4703
the provisions of section 604 of the
RFA. For purposes of section 1102(b) of
the Act, we define a small rural hospital
as a hospital that is located outside of
a Metropolitan Statistical Area for
Medicare payment regulations and has
fewer than 100 beds. We are not
preparing an analysis for section 1102(b)
of the Act because we have determined,
and the Secretary certifies, that this
notice would not have a significant
impact on the operations of a substantial
number of small rural hospitals.
Section 202 of the Unfunded
Mandates Reform Act of 1995 (UMRA)
also requires that agencies assess
anticipated costs and benefits before
issuing any rule whose mandates
require spending in any 1 year of $100
million in 1995 dollars, updated
annually for inflation. In 2016, that
threshold is approximately $146
million. The Agency has determined
that there will be minimal impact from
the costs of this notice, as the threshold
is not met under the UMRA.
Executive Order 13132 establishes
certain requirements that an agency
must meet when it promulgates a
proposed rule (and subsequent final
rule) that imposes substantial direct
requirement costs on state and local
governments, preempts state law, or
otherwise has federalism implications.
Since this notice does not impose
substantial direct costs on state or local
governments, the requirements of
Executive Order 13132 are not
applicable.
In accordance with the provisions of
Executive Order 12866, this notice was
reviewed by the Office of Management
and Budget.
Dated: September 22, 2016.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare
& Medicaid Services.
[FR Doc. 2016–26828 Filed 11–4–16; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
[OMB No.: 0970–0445]
Proposed Information Collection
Activity; Comment Request
Title: Implementation Grants to
Develop a Model Intervention for
Youth/Young Adults with Child Welfare
Involvement at Risk of Homelessness:
Phase II.
Description: The Administration for
Children and Familes (ACF) at the U.S.
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78161
Federal Register / Vol. 81, No. 215 / Monday, November 7, 2016 / Notices
Department of Health and Human
Services (HHS) intends to collect data
for an evaluation of the initiative,
Implementation Grants to Develop a
Model Intervention for Youth/Young
Adults with Child Welfare Involvement
at Risk of Homelessness: Phase II. This
builds on the previously approved
‘‘Planning Grants to Develop a Model
Intervention for Youth/Young Adults
with Child Welfare Involvement at Risk
of Homelessness’’ (Phase I). Phase II is
an initiative, funded by the Children’s
Bureau (CB) within ACF, that will
support implementation grants for
interventions designed to intervene with
youth who have experienced time in
foster care and are most likely to have
a challenging transition into adulthood,
including homelessness and unstable
housing experiences. CB awarded six
implementation grants (Phase II) in
September 2015. During the
implementation phase, organizations
will conduct a range of activities to finetune their comprehensive service
model, determine whether their model
is being implemented as intended, and
develop plans to evaluate the model
under a potential future funding
opportunity (Phase III). During Phase II,
ACF will engage a contractor to:
Conduct a cross-site process evaluation.
Data collected for the process evaluation
will be used to assess grantees’
organizational capacity to implement
and evaluate the model interventions
and to monitor each grantee’s progress
toward achieving the goals of the
implementation period.
Data for the process evaluation will be
collected through: Interviews during site
visits.
Respondents: Grantee agency
directors and staff; partner agency
directors and staff. Partner agencies may
vary by site, but are expected to include
child welfare, mental health, and youth
housing/homelessness agencies.
ANNUAL BURDEN ESTIMATES
Total/annual
number of
respondents
Instrument
Number of
responses per
respondent
Average
burden hours
per response
Total/annual
burden hours
6
60
1
1
1
1.5
6
90
Estimated Total Annual Burden Hours .....................................................
sradovich on DSK3GMQ082PROD with NOTICES
Call to coordinate site visit ..............................................................................
Grantee Site Visit-Semi-Structured Interview Topic Guide .............................
........................
........................
........................
96
In compliance with the requirements
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Planning, Research,
and Evaluation, 330 C Street SW.,
Washington, DC 20201, Attn: OPRE
Reports Clearance Officer. Email
address: OPREinfocollection@
acf.hhs.gov. All requests should be
identified by the title of the information
collection.
The Department specifically requests
comments on (a) whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
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16:02 Nov 04, 2016
Jkt 241001
comments and suggestions submitted
within 60 days of this publication.
Mary Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2016–26806 Filed 11–4–16; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–3586]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Focus Groups
About Drug Products as Used by the
Food and Drug Administration
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the information collection resulting
SUMMARY:
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Fmt 4703
Sfmt 4703
from focus groups about drug products
as used by FDA.
DATES: Submit either electronic or
written comments on the collection of
information by January 6, 2017.
ADDRESSES: You may submit comments
as follows:
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’’).
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]]>Agencies
[Federal Register Volume 81, Number 215 (Monday, November 7, 2016)]
[Notices]
[Pages 78160-78161]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-26806]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
[OMB No.: 0970-0445]
Proposed Information Collection Activity; Comment Request
Title: Implementation Grants to Develop a Model Intervention for
Youth/Young Adults with Child Welfare Involvement at Risk of
Homelessness: Phase II.
Description: The Administration for Children and Familes (ACF) at
the U.S.
[[Page 78161]]
Department of Health and Human Services (HHS) intends to collect data
for an evaluation of the initiative, Implementation Grants to Develop a
Model Intervention for Youth/Young Adults with Child Welfare
Involvement at Risk of Homelessness: Phase II. This builds on the
previously approved ``Planning Grants to Develop a Model Intervention
for Youth/Young Adults with Child Welfare Involvement at Risk of
Homelessness'' (Phase I). Phase II is an initiative, funded by the
Children's Bureau (CB) within ACF, that will support implementation
grants for interventions designed to intervene with youth who have
experienced time in foster care and are most likely to have a
challenging transition into adulthood, including homelessness and
unstable housing experiences. CB awarded six implementation grants
(Phase II) in September 2015. During the implementation phase,
organizations will conduct a range of activities to fine-tune their
comprehensive service model, determine whether their model is being
implemented as intended, and develop plans to evaluate the model under
a potential future funding opportunity (Phase III). During Phase II,
ACF will engage a contractor to: Conduct a cross-site process
evaluation. Data collected for the process evaluation will be used to
assess grantees' organizational capacity to implement and evaluate the
model interventions and to monitor each grantee's progress toward
achieving the goals of the implementation period.
Data for the process evaluation will be collected through:
Interviews during site visits.
Respondents: Grantee agency directors and staff; partner agency
directors and staff. Partner agencies may vary by site, but are
expected to include child welfare, mental health, and youth housing/
homelessness agencies.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Total/annual Number of Average
Instrument number of responses per burden hours Total/annual
respondents respondent per response burden hours
----------------------------------------------------------------------------------------------------------------
Call to coordinate site visit................... 6 1 1 6
Grantee Site Visit-Semi-Structured Interview 60 1 1.5 90
Topic Guide....................................
---------------------------------------------------------------
Estimated Total Annual Burden Hours......... .............. .............. .............. 96
----------------------------------------------------------------------------------------------------------------
In compliance with the requirements of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the Administration for Children and
Families is soliciting public comment on the specific aspects of the
information collection described above. Copies of the proposed
collection of information can be obtained and comments may be forwarded
by writing to the Administration for Children and Families, Office of
Planning, Research, and Evaluation, 330 C Street SW., Washington, DC
20201, Attn: OPRE Reports Clearance Officer. Email address:
OPREinfocollection@acf.hhs.gov. All requests should be identified by
the title of the information collection.
The Department specifically requests comments on (a) whether the
proposed collection of information is necessary for the proper
performance of the functions of the agency, including whether the
information shall have practical utility; (b) the accuracy of the
agency's estimate of the burden of the proposed collection of
information; (c) the quality, utility, and clarity of the information
to be collected; and (d) ways to minimize the burden of the collection
of information on respondents, including through the use of automated
collection techniques or other forms of information technology.
Consideration will be given to comments and suggestions submitted
within 60 days of this publication.
Mary Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2016-26806 Filed 11-4-16; 8:45 am]
BILLING CODE 4184-01-P
