Request for Public Comment: 60 Day Notice for Extension of the Indian Health Service Loan Repayment Program, 55107-55108 [2017-25049]
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Federal Register / Vol. 82, No. 222 / Monday, November 20, 2017 / Notices
Section 510(m)(2) of the FD&C Act
provides that, 1 day after the date of
publication of the list under section
510(m)(1), FDA may exempt a device on
its own initiative or upon petition of an
interested person, if FDA determines
that a 510(k) is not necessary to provide
reasonable assurance of the safety and
effectiveness of the device. This section,
as amended by the 21st Century Cures
Act (Pub. L. 114–255), requires FDA to
publish in the Federal Register a notice
of intent to exempt a device, or of the
petition, and to provide a 60-day
comment period. Within 120 days of
publication of this document, FDA must
publish in the Federal Register its final
determination regarding the exemption
of the device that was the subject of the
notice. If FDA fails to respond to a
petition under this section within 180
days of receiving it, the petition shall be
deemed granted.
II. Criteria for Exemption
There are a number of factors FDA
may consider to determine whether a
510(k) is necessary to provide
reasonable assurance of the safety and
effectiveness of a class II device. These
factors are discussed in the guidance the
Agency issued on February 19, 1998,
entitled ’’Procedures for Class II Device
Exemptions from Premarket
Notification, Guidance for Industry and
CDRH Staff.’’ That guidance is available
through the internet at https://
www.fda.gov/downloads/
MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/UCM080199.pdf
or by sending an email request to CDRHGuidance@fda.hhs.gov to receive a copy
of the document. Please use the
document number 159 to identify the
guidance you are requesting.
nshattuck on DSK9F9SC42PROD with NOTICES
III. Proposed Class II Device
Exemptions
FDA has received the following
petition requesting an exemption from
premarket notification for a class II
device: Paul Hyman, Hyman, Phelps &
McNamara, PC, 700 13th St. NW., Suite
1200, Washington, DC 20005–5929, for
OTC denture repair kits, classified
under 21 CFR 872.3570.
IV. Paperwork Reduction Act of 1995
This notice refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
21 CFR 807, subpart E, regarding
premarket notification submissions,
VerDate Sep<11>2014
15:15 Nov 17, 2017
Jkt 244001
have been approved under OMB control
number 0910–0120.
Dated: November 9, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–25065 Filed 11–17–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
Request for Public Comment: 60 Day
Notice for Extension of the Indian
Health Service Loan Repayment
Program
Indian Health Service, HHS.
Notice and request for
comments. Request for extension of
approval.
AGENCY:
ACTION:
In compliance with the
Paperwork Reduction Act of 1995, the
Indian Health Service (IHS) invites the
general public to take this opportunity
to comment on the information
collection Office of Management and
Budget (OMB) Control Number 0917–
0014, titled, ‘‘IHS Loan Repayment
Program (LRP).’’
This previously approved information
collection project was last published in
the Federal Register (80 FR 23558) on
April 28, 2015, and allowed 60 and 30
days for public comment. No public
comment was received in response to
the notices. This notice announces our
intent to submit this collection, which
expires July 31, 2018, to OMB for
approval of an extension and solicit
comments on specific aspects for the
proposed information collection.
A copy of the draft supporting
statement is available at
www.regulations.gov (see Docket ID
IHS_FRDOC_0001).
DATES: Consideration will be given to all
comments received by January 19, 2018.
ADDRESSES: Submit comments to Jackie
Santiago by one of the following
methods:
• Mail: Jackie Santiago, Chief, Loan
Repayment Program, 5600 Fishers Lane,
Mail Stop: 11E53A, Rockville, MD
20857.
• Phone: 301–443–2486.
• Email: Jackie.Santiago@ihs.gov.
• Fax: 301–443–4815.
Comments submitted in response to
this notice will be made available to the
public by publishing them in the 30 day
Federal Register notice for this
information collection. For this reason,
please do not include information of a
confidential nature, such as sensitive
SUMMARY:
PO 00000
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Fmt 4703
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55107
personal information or proprietary
information. If comments are submitted
via email, the email address will be
automatically captured and included as
part of the comment that is placed in the
public docket and made available on the
Internet. Please note that responses to
this public comment request containing
any routine notice about the
confidentiality of the communication
will be treated as public comments that
may be made available to the public
notwithstanding the inclusion of the
routine notice.
FOR FURTHER INFORMATION CONTACT: To
request additional information, please
contact Evonne Bennett-Barnes,
Information Collection Clearance Officer
at: Evonne.Bennett-Barnes@ihs.gov or
301–443–4750.
SUPPLEMENTARY INFORMATION: The IHS is
submitting the proposed information
collection to OMB for review, as
required by section 3507(a)(1)(D) of the
Paperwork Reduction Act of 1995. This
notice is soliciting comments from
members of the public and affected
agencies as required by 44 U.S.C.
3506(c)(2)(A) concerning the proposed
collection of information to: (1) Evaluate
whether the proposed collection of
information is necessary for the proper
performance of the functions of the
agency, including whether the
information will have practical utility;
(2) Evaluate the accuracy of the agency’s
estimate of the burden of the proposed
collection of information; (3) Enhance
the quality, utility, and clarity of the
information to be collected; and (4)
Minimize the burden of the collection of
information on those who are to
respond; including through the use of
appropriate automated collection
techniques of other forms of information
technology, e.g., permitting electronic
submission of responses.
Title: 0917–0014, ‘‘Indian Health
Service Loan Repayment Program.’’
Type of Information Collection
Request: Three year extension approval
of this information collection.
OMB Control Number: 0917–0014.
Forms: Educational and Professional
Background, Financial Information, and
General Applicant Information (i.e. all
forms are part of the LRP application).
The LRP application is available in an
electronically fillable and fileable
format.
Need and Use of Information
Collection: The IHS LRP identifies
health professionals with pre-existing
financial obligations for education
expenses that meet program criteria and
who are qualified and willing to serve
at, often remote, IHS health care
facilities. Under the program, eligible
E:\FR\FM\20NON1.SGM
20NON1
55108
Federal Register / Vol. 82, No. 222 / Monday, November 20, 2017 / Notices
health professionals sign a contract
through which the IHS agrees to repay
part or all of their indebtedness in
exchange for an initial two-year service
commitment to practice fulltime at an
eligible Indian health program. This
program is necessary to augment the
critically low health professional staff at
IHS health care facilities.
Eligible health professionals wishing
to have their health education loans
repaid may apply to the IHS LRP. A
two-year contract obligation is signed by
both parties, and the individual agrees
to work at an eligible Indian health
program location and provide health
services to American Indian and Alaska
Native individuals.
The information collected via the online application from individuals is
analyzed and a score is given to each
applicant. This score will determine
which applicants will be awarded each
fiscal year. The administrative scoring
system assigns a score to the geographic
location according to vacancy rates for
that fiscal year and also considers
whether the location is in an isolated
area. When an applicant accepts
employment at a location, the applicant
in turn ‘‘picks-up’’ the score of that
location.
Status of the Proposed Information
Collection: Renewal of a current
collection.
Affected Public: Individuals and
households.
Type of Respondents: Individuals.
The table below provides: Types of
data collection instruments, Estimated
number of respondents, Number of
responses per respondent, Annual
number of responses, Average burden
hour per response, and Total annual
burden hour(s).
ESTIMATED BURDEN HOURS
Data collection instrument(s)
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total annual
responses
(in hours)
LRP Application (3 forms in total) ....................................................................
1,726
1
1.5
2,589
There are no Capital Costs, Operating
Costs, and/or Maintenance Costs to
report.
RADM Michael D. Weahkee,
Assistant Surgeon General, U.S. Public Health
Service, Acting Director, Indian Health
Service.
[FR Doc. 2017–25049 Filed 11–17–17; 8:45 am]
BILLING CODE 4165–16–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
nshattuck on DSK9F9SC42PROD with NOTICES
Center for Scientific Review; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel: Member
Conflict: Clinical Neurological Disorders and
Aging.
Date: December 4, 2017.
Time: 10:00 a.m. to 12:00 p.m.
Agenda: To review and evaluate grant
applications.
VerDate Sep<11>2014
15:15 Nov 17, 2017
Jkt 244001
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Samuel C. Edwards, Ph.D.,
Chief, Brain Disorders and Clinical
Neuroscience, Center for Scientific Review,
National Institutes of Health, 6701 Rockledge
Drive, Room 5210, MSC 7846, Bethesda, MD
20892, (301) 435–1246, edwardss@
csr.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: November 13, 2017.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2017–25043 Filed 11–17–17; 8:45 am]
BILLING CODE 4140–01–P
Emergency Care Research to the
National Institute of Neurological
Disorders and Stroke.
Any interested person may file
written comments by sending an email
to reorgcomments@nigms.nih.gov by
December 4, 2017. The statement should
include the individual’s name, and
when applicable, professional
affiliation.
DATES:
The following email address
has been established for comments on
the reorganization: reorgcomments@
nigms.nih.gov.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Stephanie Older, Chief, Office of
Communications and Public Liaison,
NIGMS, reorgcomments@nigms.nih.gov,
301–496–7301.
The
National Institute of General Medical
Sciences (NIGMS) of the National
Institutes of Health (NIH) is seeking
public comment regarding its proposal
to reorganize four of its scientific
divisions into three: (1) Biophysics,
Biomedical Technology and
Computational Biosciences; (2) Genetics
and Molecular, Cellular and
Developmental Biology; and (3)
Pharmacology, Physiology, and
Biological Chemistry. Pursuant to
section 10(a) of the Federal Advisory
Committee Act, as amended (5 U.S.C.
App.), NIGMS will launch public Web
site information at https://nigms.nih.gov
to encourage further public discussion
of the proposal to reorganize. NIGMS
will also provide information via its
blog, https://loop.nigms.nih.gov/.
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of General Medical
Sciences Notice of Organizational
Change
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The National Institute of
General Medical Sciences (NIGMS) of
the National Institutes of Health (NIH) is
seeking public comment regarding its
proposal to reorganize and to rename its
Center for Research Capacity Building to
the Division for Research Capacity
Building, and transfer the Office of
SUMMARY:
PO 00000
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]]>Agencies
[Federal Register Volume 82, Number 222 (Monday, November 20, 2017)]
[Notices]
[Pages 55107-55108]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-25049]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Indian Health Service
Request for Public Comment: 60 Day Notice for Extension of the
Indian Health Service Loan Repayment Program
AGENCY: Indian Health Service, HHS.
ACTION: Notice and request for comments. Request for extension of
approval.
-----------------------------------------------------------------------
SUMMARY: In compliance with the Paperwork Reduction Act of 1995, the
Indian Health Service (IHS) invites the general public to take this
opportunity to comment on the information collection Office of
Management and Budget (OMB) Control Number 0917-0014, titled, ``IHS
Loan Repayment Program (LRP).''
This previously approved information collection project was last
published in the Federal Register (80 FR 23558) on April 28, 2015, and
allowed 60 and 30 days for public comment. No public comment was
received in response to the notices. This notice announces our intent
to submit this collection, which expires July 31, 2018, to OMB for
approval of an extension and solicit comments on specific aspects for
the proposed information collection.
A copy of the draft supporting statement is available at
www.regulations.gov (see Docket ID IHS_FRDOC_0001).
DATES: Consideration will be given to all comments received by January
19, 2018.
ADDRESSES: Submit comments to Jackie Santiago by one of the following
methods:
Mail: Jackie Santiago, Chief, Loan Repayment Program, 5600
Fishers Lane, Mail Stop: 11E53A, Rockville, MD 20857.
Phone: 301-443-2486.
Email: Jackie.Santiago@ihs.gov.
Fax: 301-443-4815.
Comments submitted in response to this notice will be made
available to the public by publishing them in the 30 day Federal
Register notice for this information collection. For this reason,
please do not include information of a confidential nature, such as
sensitive personal information or proprietary information. If comments
are submitted via email, the email address will be automatically
captured and included as part of the comment that is placed in the
public docket and made available on the Internet. Please note that
responses to this public comment request containing any routine notice
about the confidentiality of the communication will be treated as
public comments that may be made available to the public
notwithstanding the inclusion of the routine notice.
FOR FURTHER INFORMATION CONTACT: To request additional information,
please contact Evonne Bennett-Barnes, Information Collection Clearance
Officer at: Evonne.Bennett-Barnes@ihs.gov or 301-443-4750.
SUPPLEMENTARY INFORMATION: The IHS is submitting the proposed
information collection to OMB for review, as required by section
3507(a)(1)(D) of the Paperwork Reduction Act of 1995. This notice is
soliciting comments from members of the public and affected agencies as
required by 44 U.S.C. 3506(c)(2)(A) concerning the proposed collection
of information to: (1) Evaluate whether the proposed collection of
information is necessary for the proper performance of the functions of
the agency, including whether the information will have practical
utility; (2) Evaluate the accuracy of the agency's estimate of the
burden of the proposed collection of information; (3) Enhance the
quality, utility, and clarity of the information to be collected; and
(4) Minimize the burden of the collection of information on those who
are to respond; including through the use of appropriate automated
collection techniques of other forms of information technology, e.g.,
permitting electronic submission of responses.
Title: 0917-0014, ``Indian Health Service Loan Repayment Program.''
Type of Information Collection Request: Three year extension
approval of this information collection.
OMB Control Number: 0917-0014.
Forms: Educational and Professional Background, Financial
Information, and General Applicant Information (i.e. all forms are part
of the LRP application). The LRP application is available in an
electronically fillable and fileable format.
Need and Use of Information Collection: The IHS LRP identifies
health professionals with pre-existing financial obligations for
education expenses that meet program criteria and who are qualified and
willing to serve at, often remote, IHS health care facilities. Under
the program, eligible
[[Page 55108]]
health professionals sign a contract through which the IHS agrees to
repay part or all of their indebtedness in exchange for an initial two-
year service commitment to practice fulltime at an eligible Indian
health program. This program is necessary to augment the critically low
health professional staff at IHS health care facilities.
Eligible health professionals wishing to have their health
education loans repaid may apply to the IHS LRP. A two-year contract
obligation is signed by both parties, and the individual agrees to work
at an eligible Indian health program location and provide health
services to American Indian and Alaska Native individuals.
The information collected via the on-line application from
individuals is analyzed and a score is given to each applicant. This
score will determine which applicants will be awarded each fiscal year.
The administrative scoring system assigns a score to the geographic
location according to vacancy rates for that fiscal year and also
considers whether the location is in an isolated area. When an
applicant accepts employment at a location, the applicant in turn
``picks-up'' the score of that location.
Status of the Proposed Information Collection: Renewal of a current
collection.
Affected Public: Individuals and households.
Type of Respondents: Individuals.
The table below provides: Types of data collection instruments,
Estimated number of respondents, Number of responses per respondent,
Annual number of responses, Average burden hour per response, and Total
annual burden hour(s).
Estimated Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden Total annual
Data collection instrument(s) Number of responses per per response responses (in
respondents respondent (in hours) hours)
----------------------------------------------------------------------------------------------------------------
LRP Application (3 forms in total).......... 1,726 1 1.5 2,589
----------------------------------------------------------------------------------------------------------------
There are no Capital Costs, Operating Costs, and/or Maintenance
Costs to report.
RADM Michael D. Weahkee,
Assistant Surgeon General, U.S. Public Health Service, Acting Director,
Indian Health Service.
[FR Doc. 2017-25049 Filed 11-17-17; 8:45 am]
BILLING CODE 4165-16-P
