Submission for OMB Review; Comment Request, 55853-55854 [2015-23353]
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55853
Federal Register / Vol. 80, No. 180 / Thursday, September 17, 2015 / Notices
• DHR is located in Hidalgo County,
which has a percentage increase in
population that is at least 150 percent of
the percentage increase in Texas’
population during the most recent 5year period for which data was available
as of the date that DHR submitted its
request;
• DHR has an annual percentage of
total inpatient admissions under
Medicaid that is equal to or greater than
the average percentage with respect to
such admissions for all hospitals located
in Hidalgo County during the most
recent 12-month period for which data
are available as of the date that DHR
submitted its request;
• DHR certified and provided
satisfactory documentation that it does
not discriminate against beneficiaries of
Federal health care programs and does
not permit physicians practicing at the
hospital to discriminate against such
beneficiaries;
• DHR is located in Texas, which has
an average bed capacity that is less than
the national average bed capacity during
the most recent fiscal year for which
HCRIS, as of the date that the hospital
submitted its request, contained data
from a sufficient number of hospitals to
determine Texas’ average bed capacity
and the national average bed capacity;
and
• DHR has an average bed occupancy
rate that is greater than the average bed
occupancy rate in Texas during the most
recent fiscal year for which HCRIS, as of
the date that DHR submitted its request,
contained data from a sufficient number
of hospitals to determine its average bed
occupancy rate and Texas’ average bed
occupancy rate.
In determining that DHR satisfied the
Medicaid inpatient admissions, bed
capacity and bed occupancy criteria, we
deemed the HCRIS and Texas State
Medicaid Agency data used by DHR to
satisfy the standards set forth in the
regulations published on November 10,
2014, for those criteria.
Our approval grants DHR’s request to
add a total of 551 operating rooms,
procedure rooms, and beds for which
DHR is licensed. Pursuant to
§ 411.362(c)(6), the expansion may
occur only in facilities on the hospital’s
main campus and may not result in the
number of operating rooms, procedure
rooms, and beds for which the hospital
is licensed to exceed 200 percent of the
hospital’s baseline number of operating
rooms, procedure rooms, and beds. DHR
certified that its baseline number of
operating rooms, procedure rooms, and
beds for which it was licensed as of
March 23, 2010, was 551. Accordingly,
we find that granting the additional 551
operating rooms, procedure rooms, and
beds will not exceed the limitation on
a permitted expansion.
IV. Collection of Information
Requirements
This document does not impose
information collection requirements,
that is, reporting, recordkeeping or
third-party disclosure requirements.
Consequently, there is no need for
review by the Office of Management and
Budget under the authority of the
Paperwork Reduction Act of 1995 (44
U.S.C. 3501 et seq.).
Dated: September 4, 2015.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare
& Medicaid Services.
[FR Doc. 2015–23363 Filed 9–16–15; 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: Goal-Oriented Adult Learning in
Self-Sufficiency Study
OMB No.: New Collection
Description: The Administration for
Children and Families (ACF) is
proposing a data collection activity as
part of the Goal-Oriented Adult
Learning in Self-Sufficiency (GOALS)
study. The purpose of the GOALS
project is to address the nexus between
the growing knowledge base in the
psychological sciences and longstanding approaches to self-sufficiency
programs targeted to adults and young
adults. The project will explore the
programmatic implications of existing
research on psychological processes
associated with goal-directed behaviors,
including socio-emotional regulation
and cognitive skills, executive
functioning, and related areas. The
project will synthesize current research
on these topics; address how insights
gained from research can be used to
promote economic advancement among
low-income populations, identify
promising strategies, or strengthen
underlying skills in these areas; and
inform measurement of changes and
developments in skill acquisition.
The proposed information collection
activity consists of exploratory calls
with program directors and
administrators, semi-structured
interviews with key program staff and
community partner organization staff,
and focus group discussions with
program participants. ACF seeks to gain
an in-depth, systematic understanding
of program administration and
implementation, service delivery and
operation, outputs and outcomes, and
identify promising practices and other
areas for further study.
Respondents: Key program directors
and administrators, program staff and
community partner organization staff,
and program participants at selected
program sites.
ANNUAL BURDEN ESTIMATES
Total number
of respondents
Instrument
tkelley on DSK3SPTVN1PROD with NOTICES
Exploratory telephone call semi-structured interview—program directors and administrators ...................................
Site visit semi-structured interview—program staff and
community partner organization staff ...............................
Site visit group discussion—program participants ...............
Estimated Total Annual Burden
Hours: 178.
Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
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17:30 Sep 16, 2015
Jkt 235001
Annual
number of
respondents
Frm 00028
Average
burden hours
per response
Total burden
hours
24
12
1
1
12
180
84
90
42
1
1
1.25
1.25
113
53
Children and Families, Office of
Planning, Research and Evaluation, 370
L’Enfant Promenade SW., Washington,
DC 20447, Attn: OPRE Reports
Clearance Officer. All requests should
PO 00000
Number of
responses per
respondent
Fmt 4703
Sfmt 4703
be identified by the title of the
information collection. Email address:
OPREinfocollection@acf.hhs.gov.
OMB Comment: OMB is required to
make a decision concerning the
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55854
Federal Register / Vol. 80, No. 180 / Thursday, September 17, 2015 / Notices
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,
ACF Reports Clearance Officer.
[FR Doc. 2015–23353 Filed 9–16–15; 8:45 am]
BILLING CODE 4184–07–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–3287]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Medical Device
User Fee Small Business Qualification
and Certification
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
Form FDA 3602 and Form FDA 3602A,
which will allow domestic and foreign
applicants to certify that they qualify as
a small business and pay certain
medical device user fees at reduced
rates.
DATES: Submit either electronic or
written comments on the collection of
information by November 16, 2015.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. All
tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:30 Sep 16, 2015
Jkt 235001
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Medical Device User Fee Small
Business Qualification and
Certification—OMB Control Number
0910–0508—Extension
Section 101 of the Medical Device
User Fee and Modernization Act
(MDUFMA) (Pub. L. 107–250) amends
the Federal Food, Drug, and Cosmetic
Act, to provide for user fees for certain
medical device applications. FDA
published a Federal Register notice on
August 3, 2015 (80 FR 46033),
announcing fees for fiscal year (FY)
2016. To avoid harming small
PO 00000
Frm 00029
Fmt 4703
Sfmt 4703
businesses, MDUFMA provides for
reduced or waived fees for applicants
who qualify as a small business. This
means there are two levels of fees; a
standard fee and a reduced or waived
small business fee. You can qualify for
a small business fee discount under
MDUFMA if you reported gross receipts
or sales of no more than $100 million
on your Federal income tax return for
the most recent tax year. If you have any
affiliates, partners, or parent firms, you
must add their gross receipts or sales to
yours, and the total must be no more
than $100 million. If your gross receipts
or sales are no more than $30 million,
including all of your affiliates, partners,
and parent firms, you will also qualify
for a waiver of the fee for your first
(ever) premarket application (product
development protocol, biologics
licensing application, or premarket
report). An applicant must pay the full
standard fee unless it provides evidence
demonstrating to FDA that it meets the
small business criteria (Form FDA 3602,
‘‘FY 2016 MDUFMA Small Business
Qualification Certification—For a
Business Headquartered in the United
States’’). The evidence required by
MDUFMA is a copy of the most recent
Federal income tax return of the
applicant, and any affiliate, partner, or
parent firm. FDA will review these
materials and decide whether an
applicant is a small business within the
meaning of MDUFMA.
The 2007 Amendments provide an
alternative way for a foreign business to
qualify as a small business eligible to
pay a significantly lower fee when a
medical device user fee must be paid
(Form FDA 3602A, ‘‘FY 2016 MDUFMA
Foreign Small Business Qualification
Certification—For a Business
Headquartered Outside the United
States’’). Before passage of the 2007
Amendments, the only way a business
could qualify as a small business was to
submit a Federal (U.S.) income tax
return showing its gross receipts or sales
that did not exceed a statutory
threshold, currently, $100 million. If a
business could not provide a Federal
income tax return, it did not qualify as
a small business and had to pay the
standard (full) fee. Because many
foreign businesses have not, and cannot,
file a Federal (U.S.) income tax return,
this requirement has effectively
prevented those businesses from
qualifying for the small business fee
rates. Thus, foreign governments,
including the European Union, have
objected. In lieu of a Federal income tax
return, the 2007 Amendments will
allow a foreign business to qualify as a
small business by submitting a
E:\FR\FM\17SEN1.SGM
17SEN1
]]>Agencies
[Federal Register Volume 80, Number 180 (Thursday, September 17, 2015)]
[Notices]
[Pages 55853-55854]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-23353]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for OMB Review; Comment Request
Title: Goal-Oriented Adult Learning in Self-Sufficiency Study
OMB No.: New Collection
Description: The Administration for Children and Families (ACF) is
proposing a data collection activity as part of the Goal-Oriented Adult
Learning in Self-Sufficiency (GOALS) study. The purpose of the GOALS
project is to address the nexus between the growing knowledge base in
the psychological sciences and long-standing approaches to self-
sufficiency programs targeted to adults and young adults. The project
will explore the programmatic implications of existing research on
psychological processes associated with goal-directed behaviors,
including socio-emotional regulation and cognitive skills, executive
functioning, and related areas. The project will synthesize current
research on these topics; address how insights gained from research can
be used to promote economic advancement among low-income populations,
identify promising strategies, or strengthen underlying skills in these
areas; and inform measurement of changes and developments in skill
acquisition.
The proposed information collection activity consists of
exploratory calls with program directors and administrators, semi-
structured interviews with key program staff and community partner
organization staff, and focus group discussions with program
participants. ACF seeks to gain an in-depth, systematic understanding
of program administration and implementation, service delivery and
operation, outputs and outcomes, and identify promising practices and
other areas for further study.
Respondents: Key program directors and administrators, program
staff and community partner organization staff, and program
participants at selected program sites.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Total number Annual number responses per hours per Total burden
of respondents of respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
Exploratory telephone call semi- 24 12 1 1 12
structured interview--program
directors and administrators...
Site visit semi-structured 180 90 1 1.25 113
interview--program staff and
community partner organization
staff..........................
Site visit group discussion-- 84 42 1 1.25 53
program participants...........
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 178.
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, 370 L'Enfant Promenade
SW., Washington, DC 20447, Attn: OPRE Reports Clearance Officer. All
requests should be identified by the title of the information
collection. Email address: OPREinfocollection@acf.hhs.gov.
OMB Comment: OMB is required to make a decision concerning the
[[Page 55854]]
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,
ACF Reports Clearance Officer.
[FR Doc. 2015-23353 Filed 9-16-15; 8:45 am]
BILLING CODE 4184-07-P
