Agency Information Collection Activities: Proposed Collection: Public Comment Request, 31243-31244 [2016-11657]
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Federal Register / Vol. 81, No. 96 / Wednesday, May 18, 2016 / Notices
I hereby affirm and ratify any actions
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his or her subordinates, which involved
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The delegations listed were effective
January 27, 2016.
Dated: May 12, 2016.
Mark H. Greenberg,
Acting Assistant Secretary for Children and
Families.
SUPPLEMENTARY INFORMATION:
[FR Doc. 2016–11731 Filed 5–17–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0001]
Endocrinologic and Metabolic Drugs
Advisory Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
meeting of the Endocrinologic and
Metabolic Drugs Advisory Committee.
The general function of the committee is
to provide advice and recommendations
to the Agency on FDA’s regulatory
issues. The meeting will be open to the
public.
DATES: The meeting will be held on June
28, 2016, from 8 a.m. to 5 p.m.
ADDRESSES: Hilton Washington DC/
Rockville Hotel & Executive Meeting
Center, Plaza Ballroom, 1750 Rockville
Pike, Rockville, MD 20852. The hotel’s
telephone number is 301–468–1100.
Answers to commonly asked questions
including information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm408555.htm.
FOR FURTHER INFORMATION CONTACT:
LaToya Bonner, Center for Drug
Evaluation and Research, Food and
sradovich on DSK3TPTVN1PROD with NOTICES
SUMMARY:
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Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417,
Silver Spring, MD 20993–0002, 301–
796–9001, FAX: 301–847–8533,
EMDAC@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area). A notice in the
Federal Register about last minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
Agency’s Web site at https://
www.fda.gov/AdvisoryCommittees/
default.htm and scroll down to the
appropriate advisory committee meeting
link, or call the advisory committee
information line to learn about possible
modifications before coming to the
meeting.
Agenda: The committee will discuss
supplemental new drug application
(sNDA) 204629, empagliflozin
(JARDIANCE) tablets, and sNDA
206111, empagliflozin and metformin
hydrochloride (SYNJARDY) tablets.
Both sNDAs are sponsored by
Boehringer Ingelheim Pharmaceuticals,
Inc., for the proposed additional
indication in adult patients with type 2
diabetes mellitus and high
cardiovascular risk to reduce the risk of
all-cause mortality by reducing the
incidence of cardiovascular death and to
reduce the risk of cardiovascular death
or hospitalization for heart failure.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before June 14, 2016. Oral
presentations from the public will be
scheduled between approximately 1
p.m. and 2 p.m. Those individuals
interested in making formal oral
presentations should notify the contact
person and submit a brief statement of
the general nature of the evidence or
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31243
arguments they wish to present, the
names and addresses of proposed
participants, and an indication of the
approximate time requested to make
their presentation on or before June 6,
2016. Time allotted for each
presentation may be limited. If the
number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by June 7, 2016.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with disabilities.
If you require accommodations due to a
disability, please contact LaToya Bonner
at least 7 days in advance of the
meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: May 11, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical
Programs.
[FR Doc. 2016–11678 Filed 5–17–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects (Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995), the
Health Resources and Services
Administration (HRSA) announces
SUMMARY:
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Federal Register / Vol. 81, No. 96 / Wednesday, May 18, 2016 / Notices
plans to submit an Information
Collection Request (ICR), described
below, to the Office of Management and
Budget (OMB). Prior to submitting the
ICR to OMB, HRSA seeks comments
from the public regarding the burden
estimate, below, or any other aspect of
the ICR.
DATES: Comments on this ICR should be
received no later than July 18, 2016.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 14A39, 5600 Fishers
Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call the HRSA Information Collection
Clearance Officer at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference.
Information Collection Request Title:
The Teaching Health Center Graduate
Medical Education (THCGME) Program
Eligible Resident/Fellow FTE Chart
OMB 0915–0367—REVISION
Abstract: The Teaching Health Center
Graduate Medical Education (THCGME)
Program, Section 340H of the Public
Health Service (PHS) Act, was
established by Section 5508 of Public
Law 111–148. Public Law 114–10, the
Medicare Access and CHIP
Reauthorization Act of 2015 (MACRA)
provided continued funding for the
THCGME Program. The THCGME
Program awards payment for both direct
and indirect expenses to support
training for primary care residents in
community-based ambulatory patient
care settings. The THCGME Program
Eligible Resident/Fellow FTE Chart,
published in the THCGME Funding
Opportunity Announcements (FOAs), is
a means for determining the number of
eligible resident/fellow full-time
equivalents (FTEs) in an applicant’s
primary care residency program. The
current THCGME Program Eligible
Resident/Fellow FTE Chart received
OMB clearance on September 16, 2013.
HRSA is revising the chart to provide
clearer projections over a longer period
of time.
Need and Proposed Use of the
Information: The THCGME Program
Eligible Resident/Fellow FTE Chart
requires applicants to provide data
related to the size and/or growth of the
residency program over previous
academic years, the number of residents
enrolled in the program during the
baseline academic year, and a projection
of the program’s proposed expansion
over the next 5 academic years. It is
imperative that applicants complete this
chart and provide evidence of a planned
expansion, as per the statute, THCGME
funding may only be used to support an
expanded number of residents in a
residency program or to establish a new
residency training program. Utilization
of a chart to gather this important
information has decreased the number
of errors in the eligibility review process
resulting in a more accurate review and
funding process. In the proposed
Number of
respondents
Form name
Number of
responses per
respondent
revisions, the content of the information
collected has not changed; however, the
order in which the information is
presented on the chart has been
modified to provide clearer projections
over a longer period of time. This
extended time frame would allow
programs the flexibility to project the
variations that occur during the natural
expansion and scaling up of residency
programs. This would better equip
HRSA to make more accurate future
funding projections.
Likely Respondents: Teaching Health
Centers applying for THCGME funding
through a THCGME FOA, which may
include new applicants and existing
awardees.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install and utilize
technology and systems for the purpose
of collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and, to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this Information
Collection Request are summarized in
the table below.
Total Estimated Annualized Burden
Hours:
Average
burden per
response
(in hours)
Total
responses
Total burden
hours
90
1
90
0.5
45
Total ..............................................................................
sradovich on DSK3TPTVN1PROD with NOTICES
Teaching Health Center GME Program Eligible Resident/
Fellow FTE Chart .............................................................
90
........................
90
........................
45
HRSA specifically requests comments
on (1) the necessity and utility of the
proposed information collection for the
proper performance of the agency’s
functions, (2) the accuracy of the
estimated burden, (3) ways to enhance
the quality, utility, and clarity of the
information to be collected, and (4) the
use of automated collection techniques
or other forms of information
technology to minimize the information
collection burden.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Jason E. Bennett,
Director, Division of the Executive Secretariat.
Health Resources and Services
Administration
[FR Doc. 2016–11657 Filed 5–17–16; 8:45 am]
BILLING CODE 4165–15–P
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
In compliance with the
requirement for opportunity for public
SUMMARY:
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[Federal Register Volume 81, Number 96 (Wednesday, May 18, 2016)]
[Notices]
[Pages 31243-31244]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-11657]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Public Comment Request
AGENCY: Health Resources and Services Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement for opportunity for public
comment on proposed data collection projects (Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995), the Health Resources and Services
Administration (HRSA) announces
[[Page 31244]]
plans to submit an Information Collection Request (ICR), described
below, to the Office of Management and Budget (OMB). Prior to
submitting the ICR to OMB, HRSA seeks comments from the public
regarding the burden estimate, below, or any other aspect of the ICR.
DATES: Comments on this ICR should be received no later than July 18,
2016.
ADDRESSES: Submit your comments to paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance Officer, Room 14A39, 5600 Fishers
Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the data collection plans and
draft instruments, email paperwork@hrsa.gov or call the HRSA
Information Collection Clearance Officer at (301) 443-1984.
SUPPLEMENTARY INFORMATION: When submitting comments or requesting
information, please include the information request collection title
for reference.
Information Collection Request Title: The Teaching Health Center
Graduate Medical Education (THCGME) Program Eligible Resident/Fellow
FTE Chart OMB 0915-0367--REVISION
Abstract: The Teaching Health Center Graduate Medical Education
(THCGME) Program, Section 340H of the Public Health Service (PHS) Act,
was established by Section 5508 of Public Law 111-148. Public Law 114-
10, the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA)
provided continued funding for the THCGME Program. The THCGME Program
awards payment for both direct and indirect expenses to support
training for primary care residents in community-based ambulatory
patient care settings. The THCGME Program Eligible Resident/Fellow FTE
Chart, published in the THCGME Funding Opportunity Announcements
(FOAs), is a means for determining the number of eligible resident/
fellow full-time equivalents (FTEs) in an applicant's primary care
residency program. The current THCGME Program Eligible Resident/Fellow
FTE Chart received OMB clearance on September 16, 2013. HRSA is
revising the chart to provide clearer projections over a longer period
of time.
Need and Proposed Use of the Information: The THCGME Program
Eligible Resident/Fellow FTE Chart requires applicants to provide data
related to the size and/or growth of the residency program over
previous academic years, the number of residents enrolled in the
program during the baseline academic year, and a projection of the
program's proposed expansion over the next 5 academic years. It is
imperative that applicants complete this chart and provide evidence of
a planned expansion, as per the statute, THCGME funding may only be
used to support an expanded number of residents in a residency program
or to establish a new residency training program. Utilization of a
chart to gather this important information has decreased the number of
errors in the eligibility review process resulting in a more accurate
review and funding process. In the proposed revisions, the content of
the information collected has not changed; however, the order in which
the information is presented on the chart has been modified to provide
clearer projections over a longer period of time. This extended time
frame would allow programs the flexibility to project the variations
that occur during the natural expansion and scaling up of residency
programs. This would better equip HRSA to make more accurate future
funding projections.
Likely Respondents: Teaching Health Centers applying for THCGME
funding through a THCGME FOA, which may include new applicants and
existing awardees.
Burden Statement: Burden in this context means the time expended by
persons to generate, maintain, retain, disclose or provide the
information requested. This includes the time needed to review
instructions; to develop, acquire, install and utilize technology and
systems for the purpose of collecting, validating and verifying
information, processing and maintaining information, and disclosing and
providing information; to train personnel and to be able to respond to
a collection of information; to search data sources; to complete and
review the collection of information; and, to transmit or otherwise
disclose the information. The total annual burden hours estimated for
this Information Collection Request are summarized in the table below.
Total Estimated Annualized Burden Hours:
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of Total burden per Total burden
Form name respondents responses per responses response (in hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
Teaching Health Center GME 90 1 90 0.5 45
Program Eligible Resident/
Fellow FTE Chart...............
-------------------------------------------------------------------------------
Total....................... 90 .............. 90 .............. 45
----------------------------------------------------------------------------------------------------------------
HRSA specifically requests comments on (1) the necessity and
utility of the proposed information collection for the proper
performance of the agency's functions, (2) the accuracy of the
estimated burden, (3) ways to enhance the quality, utility, and clarity
of the information to be collected, and (4) the use of automated
collection techniques or other forms of information technology to
minimize the information collection burden.
Jason E. Bennett,
Director, Division of the Executive Secretariat.
[FR Doc. 2016-11657 Filed 5-17-16; 8:45 am]
BILLING CODE 4165-15-P
