Meeting of the Advisory Committee on Minority Health, 11046-11047 [2017-03247]
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Federal Register / Vol. 82, No. 32 / Friday, February 17, 2017 / Notices
mstockstill on DSK3G9T082PROD with NOTICES
At no time did Ms. Delong or anyone
else employed by PGL register their
MMS manufacturing facilities with FDA
as required under section 510 of the
FD&C Act (21 U.S.C. 360). In addition,
bottled MMS that PGL shipped to
consumers did not bear labeling that
bore the full place of business of the
manufacturer.
On or about November 1, 2010,
November 12, 2010, November 16, 2010,
and June 30, 2011, Ms. Delong or
another person involved with PGL,
delivered for introduction into interstate
commerce a number of packages
containing bottled MMS. These
packages contained MMS that Ms.
Delong knew was primarily intended as
a treatment for disease.
As a result of these convictions, FDA
sent Ms. Delong by certified mail on
October 12, 2016, a notice proposing to
debar her for 12 years from providing
services in any capacity to a person that
has an approved or pending drug
product application. The proposal was
based on a finding under section
306(b)(2)(B)(i)(I) of the FD&C Act, that
Ms. Delong was convicted of
misdemeanors under Federal law for
conduct relating to the regulation of
drug products under the FD&C Act, and
that the type of conduct that served as
the basis for the conviction undermines
the process for the regulation of drugs.
The proposal offered Ms. Delong an
opportunity to request a hearing,
providing her 30 days from the date of
receipt of the letter in which to file the
request, and advised her that failure to
request a hearing constituted a waiver of
the opportunity for a hearing and of any
contentions concerning this action. Ms.
Delong received the proposal on
October 20, 2016. Ms. Delong did not
request a hearing within the timeframe
prescribed by regulation and has,
therefore, waived her opportunity for a
hearing and has waived any contentions
concerning her debarment (21 CFR part
12).
II. Findings and Order
Therefore, the Director, Office of
Enforcement and Import Operations,
Office of Regulatory Affairs, under
section 306(b)(2)(B)(i)(I) of the FD&C
Act, under authority delegated to the
Director (Staff Manual Guide 1410.35),
finds that Karis Copper Delong has been
convicted of four misdemeanor counts
under federal law for conduct relating to
the regulation of drug products under
the FD&C Act, and that the type of
conduct that served as the basis for the
conviction undermines the process for
the regulation of drugs.
Based on consideration of the factors
under section 306(c)(3) of the FD&C Act,
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FDA finds that each offense be accorded
a debarment period of 3 years. Under
section 306(c)(2)(A) of the FD&C Act, in
the case of a person debarred for
multiple offenses, FDA shall determine
whether the periods of debarment shall
run concurrently or consecutively. FDA
has concluded that the 3-year period of
debarment for each of the four offenses
of conviction need to be served
consecutively, resulting in a total
debarment period of 12 years.
As a result of the foregoing finding,
Karis Copper Delong is debarred for a
period of 12 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 (see DATES) (see sections
306(c)(1)(B), (c)(3), and 201(dd) of the
FD&C Act (21 U.S.C. 335a(c)(1)(B),
(c)(3), and 321(dd))). Any person with
an approved or pending drug product
application who knowingly employs or
retains as a consultant or contractor, or
otherwise uses the services of Karis
Copper Delong, in any capacity during
Ms. Delong’s 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 Ms. Delong provides
services in any capacity to a person with
an approved or pending drug product
application during her period of
debarment she 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 Karis Copper Delong
during her period of debarment (section
306(c)(1)(B) of the FD&C Act).
Any application by Ms. Delong for
termination of debarment under section
306(d)(4) of the FD&C Act should be
identified with Docket No. FDA–2016–
N–1677 and sent to the Division of
Dockets Management (see ADDRESSES).
All such submissions are to be filed in
four copies. The public availability of
information in these submissions is
governed by 21 CFR 10.20(j).
Publicly available submissions will be
placed in the docket, and will be
viewable at https://www.regulations.gov
or at the Division of Dockets
Management (see ADDRESSES) between 9
a.m. and 4 p.m., Monday through
Friday.
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Dated: February 13, 2017.
Armando Zamora,
Deputy Director, Office of Enforcement and
Import Operations, Office of Regulatory
Affairs.
[FR Doc. 2017–03172 Filed 2–16–17; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the Advisory Committee on
Minority Health
Department of Health and
Human Services, Office of the Secretary,
Office of Minority Health.
ACTION: Notice of meeting.
AGENCY:
As stipulated by the Federal
Advisory Committee Act, the
Department of Health and Human
Services (DHHS) is hereby giving notice
that the Advisory Committee on
Minority Health (ACMH) will hold a
meeting. This meeting will be open to
the public. Preregistration is required
for both public attendance and
comment. Any individual who wishes
to attend the meetings and/or
participate in the public comment
session should email OMH–ACMH@
hhs.gov.
SUMMARY:
The meeting will be held on
Thursday, March 23, 2017, from 9:00
a.m. to 5:00 p.m. and Friday, March 24,
2017, from 9:00 a.m. to 1:00 p.m.
ADDRESSES: The meeting will be held at
the 5600 Fishers Lane Building, Room
05N76, 5600 Fishers Lane, Rockville,
Maryland 20857.
FOR FURTHER INFORMATION CONTACT: Dr.
Minh Wendt, Designated Federal
Officer, ACMH; Tower Building, 1101
Wootton Parkway, Suite 600, Rockville,
Maryland 20852. Phone: 240–453–8222,
Fax: 240–453–8223; OMH–ACMH@
hhs.gov.
DATES:
In
accordance with Public Law 105–392,
the ACMH was established to provide
advice to the Deputy Assistant Secretary
for Minority Health in improving the
health of each racial and ethnic
minority group and on the development
of goals and specific program activities
of the Office of Minority Health.
Topics to be discussed during this
meeting will include strategies to
improve the health of racial and ethnic
minority populations through the
development of health policies and
programs that will help eliminate health
disparities, as well as other related
issues.
Public attendance at this meeting is
limited to space available. Individuals
SUPPLEMENTARY INFORMATION:
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Federal Register / Vol. 82, No. 32 / Friday, February 17, 2017 / Notices
who plan to attend and need special
assistance, such as sign language
interpretation or other reasonable
accommodations, should notify the
designated contact person at least
fourteen (14) business days prior to the
meeting. Members of the public will
have an opportunity to provide
comments at the meeting. Public
comments will be limited to three
minutes per speaker. Individuals who
would like to submit written statements
should mail or fax their comments to
the Office of Minority Health at least
seven (7) business days prior to the
meeting. Any members of the public
who wish to have printed material
distributed to ACMH committee
members should submit their materials
to the Designated Federal Officer,
ACMH, Tower Building, 1101 Wootton
Parkway, Suite 600, Rockville,
Maryland 20852, prior to close of
business on Thursday, March 16, 2017.
Dated: February 14, 2017.
Minh Wendt,
Designated Federal Officer, ACMH, Office of
Minority Health, U.S. Department of Health
and Human Services.
[FR Doc. 2017–03247 Filed 2–16–17; 8:45 am]
BILLING CODE 4150–29–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the Presidential Advisory
Council on HIV/AIDS
Department of Health and
Human Services, Office of the Secretary,
Office of the Assistant Secretary for
Health.
ACTION: Notice.
AGENCY:
As stipulated by the Federal
Advisory Committee Act, the U.S.
Department of Health and Human
Services is hereby giving notice that the
Presidential Advisory Council on HIV/
AIDS (PACHA or the Council) will be
holding a meeting to continue
discussions and possibly develop
recommendations regarding People
Living with HIV/AIDS. The meeting will
be open to the public.
DATES: The Council meeting is
scheduled to be held on March 13, 2017,
from 9:00 a.m. to approximately 5:00
p.m. (ET) and March 14, 2017, from 9:00
a.m. to approximately 12:00 p.m. (ET).
The meeting will be open to the public.
ADDRESSES: 330 Independence Avenue
SW., Washington, DC 20201 in the
Snow Room (Conference Room 5051).
FOR FURTHER INFORMATION CONTACT: Ms.
Caroline Talev, Public Health Analyst,
Presidential Advisory Council on HIV/
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SUMMARY:
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AIDS, 330 C Street SW., Room L106B,
Washington, DC 20024; (202) 795–7622
or Caroline.Talev@hhs.gov. More
detailed information about PACHA can
be obtained by accessing the Council’s
page on the AIDS.gov Web site at
www.aids.gov/pacha.
SUPPLEMENTARY INFORMATION: PACHA
was established by Executive Order
12963, dated June 14, 1995, as amended
by Executive Order 13009, dated June
14, 1996. In a memorandum, dated July
13, 2010, and under Executive Order
13703, dated July 30, 2015, the
President gave certain authorities to the
PACHA for implementation of the
National HIV/AIDS Strategy for the
United States (Strategy). PACHA is
currently operating under the authority
given in Executive Order 13708, dated
September 30, 2015.
PACHA provides advice, information,
and recommendations to the Secretary
regarding programs, policies, and
research to promote effective treatment,
prevention, and cure of HIV disease and
AIDS, including considering common
co-morbidities of those infected with
HIV as needed, to promote effective HIV
prevention and treatment and quality
services to persons living with HIV
disease and AIDS.
Substantial progress has been made in
addressing the domestic HIV epidemic
since the Strategy was released in July
2010. Under Executive Order 13703, the
National HIV/AIDS Strategy for the
United States: Updated to 2020
(Updated Strategy) was released.
PACHA shall contribute to the federal
effort to improve HIV prevention and
care.
The functions of the Council are
solely advisory in nature.
The Council consists of not more than
25 members. Council members are
selected from prominent community
leaders with particular expertise in, or
knowledge of, matters concerning HIV
and AIDS, public health, global health,
philanthropy, marketing or business, as
well as other national leaders held in
high esteem from other sectors of
society. Council members are appointed
by the Secretary or designee, in
consultation with the White House
Office on National AIDS Policy. The
agenda for the upcoming meeting will
be posted on the AIDS.gov Web site at
www.aids.gov/pacha.
Public attendance at the meeting is
limited to space available. Individuals
who plan to attend and need special
assistance, such as sign language
interpretation or other reasonable
accommodations, should notify Caroline
Talev at Caroline.Talev@hhs.gov. Due to
space constraints, pre-registration for
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11047
public attendance is advisable and can
be accomplished by contacting Caroline
Talev at Caroline.Talev@hhs.gov by
close of business on Monday, March 6,
2017. Members of the public will have
the opportunity to provide comments
during the meeting. Comments will be
limited to two minutes per speaker. Any
individual who wishes to participate in
the public comment session must
register with Caroline Talev at
Caroline.Talev@hhs.gov by close of
business on Monday, March 6, 2017;
registration for public comment will not
be accepted by telephone. Individuals
are encouraged to provide a written
statement of any public comment(s) for
accurate minute taking purposes. Public
comment will be limited to two minutes
per speaker. Any members of the public
who wish to have printed material
distributed to PACHA members at the
meeting are asked to submit, at a
minimum, 1 copy of the material(s) to
Caroline Talev, no later than close of
business on Monday, March 6, 2017.
Dated: February 9, 2017.
B. Kaye Hayes,
Executive Director, Presidential Advisory
Council on HIV/AIDS.
[FR Doc. 2017–03245 Filed 2–16–17; 8:45 am]
BILLING CODE 4150–43–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Center for Advancing
Translational Sciences; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), 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: National Center for
Advancing Translational Sciences Special
Emphasis Panel Review of RFA–TR–16–021:
Coordination Center for the CTSA Program
(U24).
Date: March 14, 2017.
Time: 11:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
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Agencies
[Federal Register Volume 82, Number 32 (Friday, February 17, 2017)]
[Notices]
[Pages 11046-11047]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-03247]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Meeting of the Advisory Committee on Minority Health
AGENCY: Department of Health and Human Services, Office of the
Secretary, Office of Minority Health.
ACTION: Notice of meeting.
-----------------------------------------------------------------------
SUMMARY: As stipulated by the Federal Advisory Committee Act, the
Department of Health and Human Services (DHHS) is hereby giving notice
that the Advisory Committee on Minority Health (ACMH) will hold a
meeting. This meeting will be open to the public. Preregistration is
required for both public attendance and comment. Any individual who
wishes to attend the meetings and/or participate in the public comment
session should email OMH-ACMH@hhs.gov.
DATES: The meeting will be held on Thursday, March 23, 2017, from 9:00
a.m. to 5:00 p.m. and Friday, March 24, 2017, from 9:00 a.m. to 1:00
p.m.
ADDRESSES: The meeting will be held at the 5600 Fishers Lane Building,
Room 05N76, 5600 Fishers Lane, Rockville, Maryland 20857.
FOR FURTHER INFORMATION CONTACT: Dr. Minh Wendt, Designated Federal
Officer, ACMH; Tower Building, 1101 Wootton Parkway, Suite 600,
Rockville, Maryland 20852. Phone: 240-453-8222, Fax: 240-453-8223; OMH-ACMH@hhs.gov.
SUPPLEMENTARY INFORMATION: In accordance with Public Law 105-392, the
ACMH was established to provide advice to the Deputy Assistant
Secretary for Minority Health in improving the health of each racial
and ethnic minority group and on the development of goals and specific
program activities of the Office of Minority Health.
Topics to be discussed during this meeting will include strategies
to improve the health of racial and ethnic minority populations through
the development of health policies and programs that will help
eliminate health disparities, as well as other related issues.
Public attendance at this meeting is limited to space available.
Individuals
[[Page 11047]]
who plan to attend and need special assistance, such as sign language
interpretation or other reasonable accommodations, should notify the
designated contact person at least fourteen (14) business days prior to
the meeting. Members of the public will have an opportunity to provide
comments at the meeting. Public comments will be limited to three
minutes per speaker. Individuals who would like to submit written
statements should mail or fax their comments to the Office of Minority
Health at least seven (7) business days prior to the meeting. Any
members of the public who wish to have printed material distributed to
ACMH committee members should submit their materials to the Designated
Federal Officer, ACMH, Tower Building, 1101 Wootton Parkway, Suite 600,
Rockville, Maryland 20852, prior to close of business on Thursday,
March 16, 2017.
Dated: February 14, 2017.
Minh Wendt,
Designated Federal Officer, ACMH, Office of Minority Health, U.S.
Department of Health and Human Services.
[FR Doc. 2017-03247 Filed 2-16-17; 8:45 am]
BILLING CODE 4150-29-P