60 Day FRN

Federal Register / Vol. 83, No. 188 / Thursday, September 27, 2018 / Notices
product under the FD&C Act and (2)
that the conduct which served as the
basis for the conviction undermines the
process for the regulation of drugs. FDA
has considered the applicable factors
listed in section 306(c)(3) of the FD&C
Act and determined that a debarment of
5 years is appropriate.
As a result of the foregoing findings,
Patel is debarred for 5 years from
providing services in any capacity to a
person with an approved or pending
drug product application under sections
505, 512, or 802 of the FD&C Act (21
U.S.C. 355, 360b, or 382), or under
section 351 of the Public Health Service
Act (42 U.S.C. 262), effective September
27, 2018 (see 21 U.S.C. 335a(c)(1)(B) and
(c)(2)(A)(iii) and 21 U.S.C. 321(dd)).
Any person with an approved or
pending drug product application, who
knowingly uses the services of Patel, in
any capacity during his period of
debarment, will be subject to civil
money penalties (section 307(a)(6) of the
FD&C Act (21 U.S.C. 335b(a)(6))). If
Patel, during his period of debarment,
provides services in any capacity to a
person with an approved or pending
drug product application, he will be
subject to civil money penalties (section
307(a)(7) of the FD&C Act). In addition,
FDA will not accept or review any
abbreviated new drug applications
submitted by or with the assistance of
Patel during his period of debarment
(section 306(c)(1)(B) of the FD&C Act).
Dated: September 21, 2018.
George M. Warren,
Director, Office of Scientific Integrity.
[FR Doc. 2018–20977 Filed 9–26–18; 8:45 am]
BILLING CODE 4164–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
[OMB NO. 0917–0028]

Request for Public Comment: 60-Day
Proposed Information Collection:
Addendum to Declaration for Federal
Employment, Child Care and Indian
Child Care Worker Positions
Indian Health Service, HHS.
Notice and request for
comments. Request for extension of
approval.

AGENCY:

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ACTION:

In compliance with the
Paperwork Reduction Act of 1995,
which requires 60 days for public
comment on proposed information
collection projects, the Indian Health
Service (IHS) invites the general public
to take this opportunity to comment on

SUMMARY:

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17:20 Sep 26, 2018

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the information collection titled,
‘‘Addendum to Declaration for Federal
Employment, Child Care and Indian
Child Care Worker Positions,’’ Office of
Management and Budget (OMB) Control
Number 0917–0028.
DATES: November 26, 2018. Your
comments regarding this information
collection are best assured of having full
effect if received within 60 days of the
date of this publication.
ADDRESSES: Send your written
comments, requests for more
information on the proposed collection,
or requests to obtain a copy of the data
collection instrument and instructions
to Evonne Bennett-Barnes by one of the
following methods:
• Mail: Evonne Bennett-Barnes,
Information Collection Clearance
Officer, 5600 Fishers Lane, Mail stop:
09E21B, Rockville, MD 20857.
• Email: Evonne.Bennett-Barnes@
ihs.gov.
• Phone: 301–443–4750.
SUPPLEMENTARY INFORMATION: This
previously approved information
collection project was last published in
the Federal Register (80 FR 53812) on
September 8, 2015, and allowed 30 days
for public comment. No public
comment was received in response to
the notice. This notice announces our
intent to submit this collection, which
expires November 30, 2018, to OMB for
approval of an extension, and to solicit
comments on specific aspects for the
proposed information collection.
A copy of the supporting statement is
available at www.regulations.gov (see
Docket ID IHS_FRDOC_0001).
Proposed Collection: Title:
Addendum to Declaration for Federal
Employment, Child Care and Indian
Child Care Worker Positions (OMB No.
0917–0028). Type of Information
Collection Request: Extension, without
revision, of currently approved
information collection, 0917–0028,
Addendum to Declaration for Federal
Employment, Child Care and Indian
Child Care Worker Positions. There are
no program changes or adjustments in
burden hours. Form(s): Addendum to
Declaration for Federal Employment,
Child Care and Indian Child Care
Worker Positions. Need and Use of
Information Collection: This is a request
for approval of the collection of
information as required by section 408
of the Indian Child Protection and
Family Violence Prevention Act, Public
Law (Pub. L.) 101–630, 104 Stat. 4544,
and 25 United States Code (U.S.C.)
§§ 3201–3210.
The IHS is required to compile a list
of all authorized positions within the

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IHS where the duties and
responsibilities involve regular contact
with, or control over, Indian children;
and to conduct an investigation of the
character of each individual who is
employed, or is being considered for
employment, in a position having
regular contact with, or control over,
Indian children. 25 U.S.C. 3207(a)(1)
and (2). Title 25 U.S.C. 3207(a)(3)
requires regulations prescribing the
minimum standards of character for
individuals appointed to positions
involving regular contact with, or
control over, Indian children, and
section 3207(b) provides that such
standards shall ensure that no such
individuals have been found guilty of,
or entered a plea of nolo contendere or
guilty to any felonious offense, or any
two or more misdemeanor offenses,
under Federal, State, or Tribal law
involving crimes of violence; sexual
assault, molestation, exploitation,
contact or prostitution; crimes against
persons; or offenses committed against
children.
In addition, 34 U.S.C. 20351 (formerly
codified at 42 U.S.C. 13041, which was
transferred to 34 U.S.C. 20351) requires
each agency of the Federal Government,
and every facility operated by the
Federal Government (or operated under
contract with the Federal Government),
that hires (or contracts for hire)
individuals involved with the provision
of child care services to children under
the age of 18 to assure that all existing
and newly hired employees undergo a
criminal history background check. The
background investigation is to be
initiated through the personnel program
of the applicable Federal agency. This
section requires employment
applications for individuals who are
seeking work for an agency of the
Federal Government, or for a facility or
program operated by (or through
contract with) the Federal Government,
in positions involved with the provision
of child care services to children under
the age of 18, to contain a question
asking whether the individual has ever
been arrested for or charged with a
crime involving a child, and if so,
requiring a description of the
disposition of the arrest or charge.
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, Average
burden hour per response, and Total
annual burden hour(s).

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Federal Register / Vol. 83, No. 188 / Thursday, September 27, 2018 / Notices
ESTIMATED ANNUAL BURDEN HOURS
Number of
respondents

Data collection instrument(s)

Average
burden per
response
(in hours)

Total
annual burden
responses
(in hours)

Addendum to Declaration for Federal Employment (OMB 0917–0028) .........

3000

1

12/60

600

Total ..........................................................................................................

3000

........................

........................

600

There are no Capital Costs, Operating
Costs, and/or Maintenance Costs to
report.
Requests for Comments: Your written
comments and/or suggestions are
invited on one or more of the following
points:
(a) Whether the information collection
activity is necessary to carry out an
agency function;
(b) whether the agency processes the
information collected in a useful and
timely fashion;
(c) the accuracy of the public burden
estimate (the estimated amount of time
needed for individual respondents to
provide the requested information);
(d) whether the methodology and
assumptions used to determine the
estimates are logical;
(e) ways to enhance the quality,
utility, and clarity of the information
being collected; and
(f) ways to minimize the public
burden through the use of automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology.
Dated: September 20, 2018.
RADM Michael D. Weahkee,
Assistant Surgeon General, USPHS, Acting
Director, Indian Health Service.

National Institutes of Health
National Institute on Minority Health
and Health Disparities; 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 materials,
and personal information concerning

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Dated: September 20, 2018.
David D. Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2018–20984 Filed 9–26–18; 8:45 am]
BILLING CODE 4140–01–P

Center for Scientific Review; Notice of
Closed Meetings

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

17:20 Sep 26, 2018

Name of Committee: National Institute on
Minority Health and Health Disparities
Special Emphasis Panel; NIMHD Mentored K
Awards.
Date: October 30, 2018.
Time: 12:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Gateway Building, 7201 Wisconsin
Ave, Suite 533, Bethesda, MD 20814 (Virtual
Meeting).
Contact Person: Maryline Laude-Sharp,
Ph.D., Scientific Review Officer, National
Institute on Minority Health and Health
Disparities, National Institutes of Health,
7201 Wisconsin Ave., Bethesda, MD 20814,
(301) 451–9536, [email protected].

National Institutes of Health

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VerDate Sep<11>2014

individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

[FR Doc. 2018–20989 Filed 9–26–18; 8:45 am]

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Number of
responses per
respondent

Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings 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; Molecular
and Cellular Endocrinology Study Section.
Date: October 11, 2018.
Time: 11:00 a.m. to 12:00 p.m.

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Agenda: To review and evaluate grant
applications.
Place: Lorien Hotel & Spa, 1600 King
Street, Alexandria, VA 22314.
Contact Person: Elaine Sierra-Rivera, Ph.D.,
Scientific Review Officer, EMNR IRG, Center
for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6182,
MSC 7892, Bethesda, MD 20892, 301 435–
2514, [email protected].
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Cellular
Aspects of Diabetes and Obesity.
Date: October 16, 2018.
Time: 11:00 a.m. to 12:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: St. Gregory Hotel, 2033 M Street
NW, Washington, DC 20036.
Contact Person: Elaine Sierra-Rivera, Ph.D.,
Scientific Review Officer, EMNR IRG, Center
for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6182,
MSC 7892, Bethesda, MD 20892, 301 435–
2514, [email protected].
Name of Committee: Healthcare Delivery
and Methodologies Integrated Review Group;
Health Disparities and Equity Promotion
Study Section.
Date: October 17–18, 2018.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Lorien Hotel & Spa, 1600 King
Street, Alexandria, VA 22314.
Contact Person: Jessica Bellinger, Ph.D.,
Scientific Review Administrator, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3158,
Bethesda, MD 20892, 301–827–4446,
[email protected].
Name of Committee: Oncology 2—
Translational Clinical Integrated Review
Group; Cancer Immunopathology and
Immunotherapy Study Section.
Date: October 18–19, 2018.
Time: 8:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: InterContinental Chicago Hotel, 505
North Michigan Avenue, Chicago, IL 60611.
Contact Person: Denise R. Shaw, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6158,
MSC 7804, Bethesda, MD 20892, 301–435–
0198, [email protected].
Name of Committee: Musculoskeletal, Oral
and Skin Sciences Integrated Review Group;
Musculoskeletal Rehabilitation Sciences
Study Section.
Date: October 18–19, 2018.
Time: 8:00 a.m. to 6:00 p.m.

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