82 FR 11046 - Meeting of the Advisory Committee on Minority Health
DEPARTMENT OF HEALTH AND HUMAN SERVICES Federal Register Volume 82, Issue 32 (February 17, 2017)
Federal Register Volume 82, Issue 32 (February 17, 2017)
| Page Range | 11046-11047 | |
| FR Document | 2017-03247 |
[Federal Register Volume 82, Number 32 (Friday, February 17, 2017)] [Notices] [Pages 11046-11047] From the Federal Register Online [www.thefederalregister.org] [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 [email protected]. 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; [email protected]. 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
![11046 Federal Register / Vol. 82, No. 32 / Friday, February 17, 2017 / Notices
At no time did Ms. Delong or anyone FDA finds that each offense be accorded Dated: February 13, 2017.
else employed by PGL register their a debarment period of 3 years. Under Armando Zamora,
MMS manufacturing facilities with FDA section 306(c)(2)(A) of the FD&C Act, in Deputy Director, Office of Enforcement and
as required under section 510 of the the case of a person debarred for Import Operations, Office of Regulatory
FD&C Act (21 U.S.C. 360). In addition, multiple offenses, FDA shall determine Affairs.
bottled MMS that PGL shipped to whether the periods of debarment shall [FR Doc. 2017–03172 Filed 2–16–17; 8:45 am]
consumers did not bear labeling that run concurrently or consecutively. FDA BILLING CODE 4164–01–P
bore the full place of business of the has concluded that the 3-year period of
manufacturer. debarment for each of the four offenses
On or about November 1, 2010, DEPARTMENT OF HEALTH AND
of conviction need to be served
November 12, 2010, November 16, 2010, HUMAN SERVICES
and June 30, 2011, Ms. Delong or consecutively, resulting in a total
another person involved with PGL, debarment period of 12 years. Meeting of the Advisory Committee on
delivered for introduction into interstate As a result of the foregoing finding, Minority Health
commerce a number of packages Karis Copper Delong is debarred for a
AGENCY: Department of Health and
containing bottled MMS. These period of 12 years from providing
Human Services, Office of the Secretary,
packages contained MMS that Ms. services in any capacity to a person with Office of Minority Health.
Delong knew was primarily intended as an approved or pending drug product
a treatment for disease. ACTION: Notice of meeting.
application under sections 505, 512, or
As a result of these convictions, FDA 802 of the FD&C Act (21 U.S.C. 355, SUMMARY: As stipulated by the Federal
sent Ms. Delong by certified mail on 360b, or 382), or under section 351 of Advisory Committee Act, the
October 12, 2016, a notice proposing to the Public Health Service Act (42 U.S.C. Department of Health and Human
debar her for 12 years from providing
262), effective (see DATES) (see sections Services (DHHS) is hereby giving notice
services in any capacity to a person that
306(c)(1)(B), (c)(3), and 201(dd) of the that the Advisory Committee on
has an approved or pending drug
product application. The proposal was FD&C Act (21 U.S.C. 335a(c)(1)(B), Minority Health (ACMH) will hold a
based on a finding under section (c)(3), and 321(dd))). Any person with meeting. This meeting will be open to
306(b)(2)(B)(i)(I) of the FD&C Act, that an approved or pending drug product the public. Preregistration is required
Ms. Delong was convicted of application who knowingly employs or for both public attendance and
misdemeanors under Federal law for retains as a consultant or contractor, or comment. Any individual who wishes
conduct relating to the regulation of otherwise uses the services of Karis to attend the meetings and/or
drug products under the FD&C Act, and Copper Delong, in any capacity during participate in the public comment
that the type of conduct that served as Ms. Delong’s debarment, will be subject session should email OMH–ACMH@
the basis for the conviction undermines to civil money penalties (section hhs.gov.
the process for the regulation of drugs. 307(a)(6) of the FD&C Act (21 U.S.C. DATES: The meeting will be held on
The proposal offered Ms. Delong an 335b(a)(6))). If Ms. Delong provides Thursday, March 23, 2017, from 9:00
opportunity to request a hearing, services in any capacity to a person with a.m. to 5:00 p.m. and Friday, March 24,
providing her 30 days from the date of an approved or pending drug product 2017, from 9:00 a.m. to 1:00 p.m.
receipt of the letter in which to file the application during her period of ADDRESSES: The meeting will be held at
request, and advised her that failure to debarment she will be subject to civil the 5600 Fishers Lane Building, Room
request a hearing constituted a waiver of money penalties (section 307(a)(7) of the 05N76, 5600 Fishers Lane, Rockville,
the opportunity for a hearing and of any FD&C Act). In addition, FDA will not Maryland 20857.
contentions concerning this action. Ms. accept or review any abbreviated new FOR FURTHER INFORMATION CONTACT: Dr.
Delong received the proposal on drug applications submitted by or with Minh Wendt, Designated Federal
October 20, 2016. Ms. Delong did not Officer, ACMH; Tower Building, 1101
the assistance of Karis Copper Delong
request a hearing within the timeframe Wootton Parkway, Suite 600, Rockville,
during her period of debarment (section
prescribed by regulation and has, Maryland 20852. Phone: 240–453–8222,
therefore, waived her opportunity for a 306(c)(1)(B) of the FD&C Act).
Fax: 240–453–8223; OMH–ACMH@
hearing and has waived any contentions Any application by Ms. Delong for
hhs.gov.
concerning her debarment (21 CFR part termination of debarment under section
12). 306(d)(4) of the FD&C Act should be SUPPLEMENTARY INFORMATION: In
identified with Docket No. FDA–2016– accordance with Public Law 105–392,
II. Findings and Order the ACMH was established to provide
N–1677 and sent to the Division of
Therefore, the Director, Office of Dockets Management (see ADDRESSES). advice to the Deputy Assistant Secretary
Enforcement and Import Operations, All such submissions are to be filed in for Minority Health in improving the
Office of Regulatory Affairs, under four copies. The public availability of health of each racial and ethnic
section 306(b)(2)(B)(i)(I) of the FD&C information in these submissions is minority group and on the development
Act, under authority delegated to the of goals and specific program activities
governed by 21 CFR 10.20(j).
Director (Staff Manual Guide 1410.35), of the Office of Minority Health.
finds that Karis Copper Delong has been Publicly available submissions will be Topics to be discussed during this
convicted of four misdemeanor counts placed in the docket, and will be meeting will include strategies to
under federal law for conduct relating to viewable at https://www.regulations.gov improve the health of racial and ethnic
mstockstill on DSK3G9T082PROD with NOTICES
the regulation of drug products under or at the Division of Dockets minority populations through the
the FD&C Act, and that the type of Management (see ADDRESSES) between 9 development of health policies and
conduct that served as the basis for the a.m. and 4 p.m., Monday through programs that will help eliminate health
conviction undermines the process for Friday. disparities, as well as other related
the regulation of drugs. issues.
Based on consideration of the factors Public attendance at this meeting is
under section 306(c)(3) of the FD&C Act, limited to space available. Individuals
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![Federal Register / Vol. 82, No. 32 / Friday, February 17, 2017 / Notices 11047
who plan to attend and need special AIDS, 330 C Street SW., Room L106B, public attendance is advisable and can
assistance, such as sign language Washington, DC 20024; (202) 795–7622 be accomplished by contacting Caroline
interpretation or other reasonable or Caroline.Talev@hhs.gov. More Talev at Caroline.Talev@hhs.gov by
accommodations, should notify the detailed information about PACHA can close of business on Monday, March 6,
designated contact person at least be obtained by accessing the Council’s 2017. Members of the public will have
fourteen (14) business days prior to the page on the AIDS.gov Web site at the opportunity to provide comments
meeting. Members of the public will www.aids.gov/pacha. during the meeting. Comments will be
have an opportunity to provide SUPPLEMENTARY INFORMATION: PACHA limited to two minutes per speaker. Any
comments at the meeting. Public was established by Executive Order individual who wishes to participate in
comments will be limited to three 12963, dated June 14, 1995, as amended the public comment session must
minutes per speaker. Individuals who by Executive Order 13009, dated June register with Caroline Talev at
would like to submit written statements 14, 1996. In a memorandum, dated July Caroline.Talev@hhs.gov by close of
should mail or fax their comments to 13, 2010, and under Executive Order business on Monday, March 6, 2017;
the Office of Minority Health at least 13703, dated July 30, 2015, the registration for public comment will not
seven (7) business days prior to the President gave certain authorities to the be accepted by telephone. Individuals
meeting. Any members of the public PACHA for implementation of the are encouraged to provide a written
who wish to have printed material National HIV/AIDS Strategy for the statement of any public comment(s) for
distributed to ACMH committee United States (Strategy). PACHA is accurate minute taking purposes. Public
members should submit their materials currently operating under the authority comment will be limited to two minutes
to the Designated Federal Officer, given in Executive Order 13708, dated per speaker. Any members of the public
ACMH, Tower Building, 1101 Wootton September 30, 2015. who wish to have printed material
Parkway, Suite 600, Rockville, PACHA provides advice, information, distributed to PACHA members at the
Maryland 20852, prior to close of and recommendations to the Secretary meeting are asked to submit, at a
business on Thursday, March 16, 2017. regarding programs, policies, and minimum, 1 copy of the material(s) to
Dated: February 14, 2017. research to promote effective treatment, Caroline Talev, no later than close of
Minh Wendt, prevention, and cure of HIV disease and business on Monday, March 6, 2017.
Designated Federal Officer, ACMH, Office of AIDS, including considering common Dated: February 9, 2017.
Minority Health, U.S. Department of Health co-morbidities of those infected with B. Kaye Hayes,
and Human Services. HIV as needed, to promote effective HIV Executive Director, Presidential Advisory
[FR Doc. 2017–03247 Filed 2–16–17; 8:45 am] prevention and treatment and quality Council on HIV/AIDS.
BILLING CODE 4150–29–P
services to persons living with HIV [FR Doc. 2017–03245 Filed 2–16–17; 8:45 am]
disease and AIDS. BILLING CODE 4150–43–P
Substantial progress has been made in
DEPARTMENT OF HEALTH AND addressing the domestic HIV epidemic
HUMAN SERVICES since the Strategy was released in July DEPARTMENT OF HEALTH AND
2010. Under Executive Order 13703, the HUMAN SERVICES
Meeting of the Presidential Advisory National HIV/AIDS Strategy for the
Council on HIV/AIDS United States: Updated to 2020 National Institutes of Health
(Updated Strategy) was released.
AGENCY: Department of Health and National Center for Advancing
PACHA shall contribute to the federal
Human Services, Office of the Secretary, Translational Sciences; Notice of
effort to improve HIV prevention and
Office of the Assistant Secretary for Closed Meeting
care.
Health.
The functions of the Council are
ACTION: Notice. Pursuant to section 10(d) of the
solely advisory in nature.
Federal Advisory Committee Act, as
SUMMARY: As stipulated by the Federal The Council consists of not more than
amended (5 U.S.C. App.), notice is
Advisory Committee Act, the U.S. 25 members. Council members are
hereby given of the following meeting.
Department of Health and Human selected from prominent community
The meeting will be closed to the
Services is hereby giving notice that the leaders with particular expertise in, or
public in accordance with the
Presidential Advisory Council on HIV/ knowledge of, matters concerning HIV
provisions set forth in sections
AIDS (PACHA or the Council) will be and AIDS, public health, global health,
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
holding a meeting to continue philanthropy, marketing or business, as
as amended. The grant applications and
discussions and possibly develop well as other national leaders held in
the discussions could disclose
recommendations regarding People high esteem from other sectors of
confidential trade secrets or commercial
Living with HIV/AIDS. The meeting will society. Council members are appointed
property such as patentable material,
be open to the public. by the Secretary or designee, in
and personal information concerning
consultation with the White House
DATES: The Council meeting is individuals associated with the grant
Office on National AIDS Policy. The
scheduled to be held on March 13, 2017, applications, the disclosure of which
agenda for the upcoming meeting will
from 9:00 a.m. to approximately 5:00 would constitute a clearly unwarranted
be posted on the AIDS.gov Web site at
p.m. (ET) and March 14, 2017, from 9:00 invasion of personal privacy.
www.aids.gov/pacha.
a.m. to approximately 12:00 p.m. (ET). Public attendance at the meeting is Name of Committee: National Center for
mstockstill on DSK3G9T082PROD with NOTICES
The meeting will be open to the public. limited to space available. Individuals Advancing Translational Sciences Special
ADDRESSES: 330 Independence Avenue who plan to attend and need special Emphasis Panel Review of RFA–TR–16–021:
SW., Washington, DC 20201 in the Coordination Center for the CTSA Program
assistance, such as sign language (U24).
Snow Room (Conference Room 5051). interpretation or other reasonable Date: March 14, 2017.
FOR FURTHER INFORMATION CONTACT: Ms. accommodations, should notify Caroline Time: 11:00 a.m. to 5:00 p.m.
Caroline Talev, Public Health Analyst, Talev at Caroline.Talev@hhs.gov. Due to Agenda: To review and evaluate grant
Presidential Advisory Council on HIV/ space constraints, pre-registration for applications.
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Document Created: 2017-02-17 00:29:05
Document Modified: 2017-02-17 00:29:05
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of meeting. | |
| 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. | |
| 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- [email protected] | |
| FR Citation | 82 FR 11046 |
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