80 FR 51824 - Meeting on American Indian/Alaska Native Lesbian, Gay, Bisexual, and Transgender Health Issues

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Indian Health Service

Federal Register Volume 80, Issue 165 (August 26, 2015)

Page Range		51824-51825
FR Document		2015-21068

The Indian Health Service (IHS) is continuing to seek broad public input as it continues efforts to advance and promote the health needs of the American Indian/Alaska Native (AI/AN) Lesbian, Gay, Bisexual, and Transgender (LGBT) community.

Federal Register, Volume 80 Issue 165 (Wednesday, August 26, 2015)

[Federal Register Volume 80, Number 165 (Wednesday, August 26, 2015)]
[Notices]
[Pages 51824-51825]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-21068]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Indian Health Service


Meeting on American Indian/Alaska Native Lesbian, Gay, Bisexual, 
and Transgender Health Issues

AGENCY: Indian Health Service.

ACTION: Notice of meeting.

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SUMMARY: The Indian Health Service (IHS) is continuing to seek broad 
public input as it continues efforts to advance and promote the health 
needs of the American Indian/Alaska Native (AI/AN) Lesbian, Gay, 
Bisexual, and Transgender (LGBT) community.

DATES: The meeting will be held as shown below:
    1. September 11, 2015 from 12:00 p.m. EST to 2:00 p.m. EST.

ADDRESSES: The meeting location is:

[[Page 51825]]

    1. Hubert H. Humphrey Building, 200 Independence Avenue SW., 
Washington, DC 20201.
    Written statements may be submitted to Lisa Neel, MPH, Program 
Coordinator, Office of Clinical and Preventive Services, Indian Health 
Service, 801 Thompson Avenue, Suite 300, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Lisa Neel, MPH, Program Coordinator, 
Office of Clinical and Preventive Services, Indian Health Service, 801 
Thompson Avenue, Suite 300, Rockville, MD 20852, Telephone 301-443-
4305. (This is not a toll-free number.)

SUPPLEMENTARY INFORMATION: The meeting will be open to the public. To 
facilitate the building security process, those who plan to attend 
should RSVP to Lisa Neel at [email protected] or by telephone at 301-
443-4305 no later than 5:00 p.m. EST on August 31, 2015. (This is not a 
toll-free number.) Public attendance will be limited to the space 
available. Members of the public may make statements during the meeting 
to the extent time permits and file written statements with the Agency 
for its consideration. Written statements should be submitted to the 
address listed above.

    Dated: August 19, 2015.
Robert G. McSwain,
Deputy Director, Indian Health Service.
[FR Doc. 2015-21068 Filed 8-25-15; 8:45 am]
 BILLING CODE 4165-16-P

51824 Federal Register / Vol. 80, No. 165 / Wednesday, August 26, 2015 / Notices

event before, test your connection at resulting in the exposure of various determination of the drug effects and
https://collaboration.fda.gov/common/ proteins on the inner surface of the discuss problems related to
help/en/support/meeting_test.htm. To vessels. These proteins trigger the serial interpretation of results. Also, we will
get a quick overview of the Connect Pro activation of coagulation factors that consider the corresponding analytical
program, visit http://www.adobe.com/ make up the coagulation cascade that performance criteria of DOAC testing
go/connectpro_overview. (FDA has culminates in the formation of the required to provide reliable and
verified the Web site addresses in this insoluble clot. informative test results.
document, but FDA is not responsible Although immediate clot formation is Thus, the Center for Devices and
for any subsequent changes to the Web critical to prevent severe blood loss, Radiological Health plans to provide an
sites after this document publishes in excessive clot formation outside of overview of the scientific, clinical, and
the Federal Register). wound healing obstructs blood flow and regulatory challenges that need to be
Comments: FDA is holding this public poses serious medical consequences. To addressed to ultimately support the
workshop to obtain information on in prevent unwanted coagulation, a development of in vitro testing for
vitro diagnostic testing for direct oral number of anticoagulant drugs have patients on DOAC regimens that would
anticoagulants. In order to permit the been developed. Historically, translate into clinically meaningful
widest possible opportunity to obtain anticoagulation drug therapy was results.
public comment, FDA is soliciting limited to the administration of non-
either electronic or written comments specific anticoagulants, such as heparin II. Topics for Discussion at the Public
on all aspects of the public workshop or vitamin K antagonists, that act by Workshop
topics. The deadline for submitting inhibiting the coagulation cascade at The public workshop seeks to involve
comments related to the public several points. Although effective, these industry and academia in addressing
workshop is November 25, 2015. anticoagulants have numerous analytical performance requirements for
Regardless of attendance at the public drawbacks, such as delayed onset and the diagnostic assessment of DOACs.
workshop, interested persons may offset of action, a narrow therapeutic Furthermore, the workshop aims to
submit either electronic comments window, and interactions with food and focus on the clinical circumstances
regarding this document to http:// drugs that necessitate frequent under which patients receiving these
www.regulations.gov or written monitoring and dose adjustments. agents would require testing, including
comments to the Division of Dockets Several tests have been cleared for but not limited to, the following topic
Management (HFA–305), Food and Drug monitoring of patients undergoing areas:
Administration, 5630 Fishers Lane, Rm. vitamin K antagonist therapy. 1. Overview of the effects of DOACs
1061, Rockville, MD 20852. It is only A new class of DOACs has been on traditional coagulation tests;
necessary to send one set of comments. developed in the last decade to 2. identification of clinical scenarios
Identify comments with the docket overcome limitations of traditional that necessitate DOAC testing;
number found in brackets in the anticoagulants. Thus far, FDA has 3. interpretation of coagulation testing
heading of this document. In addition, approved four DOACs: PRAXADA results for patients on DOACs; and
when responding to specific questions (dabigatran), XARELTO (rivaroxiban), 4. considerations for regulatory
as outlined in section II of this ELIQUIS (apixaban), and SAVAYSA review of devices assessing the effect of
document, please identify the question (edoxaban). DOAC therapy creates a DOACs on coagulation.
you are addressing. Received comments need for coagulation testing, which in Dated: August 20, 2015.
may be seen in the Division of Dockets turn poses new challenges. Leslie Kux,
Management between 9 a.m. and 4 p.m., Currently there are no FDA cleared
devices for the characterization of Associate Commissioner for Policy.
Monday through Friday, and will be
posted to the docket at http:// DOAC effects on coagulation. [FR Doc. 2015–21095 Filed 8–25–15; 8:45 am]
www.regulations.gov. Differences in individual responses to BILLING CODE 4164–01–P
Transcripts: Please be advised that as the drugs require laboratories to develop
soon as a transcript is available, it will unique testing schemes to assess a
be accessible at http:// patient’s coagulation status while on DEPARTMENT OF HEALTH AND
www.regulations.gov. It may be viewed DOAC regimens. Thus, the first aim of HUMAN SERVICES
at the Division of Dockets Management this workshop is to discuss the effect of
Indian Health Service
(see Comments). A transcript will also DOACs on traditional coagulation test
be available in either hardcopy or on methods currently on the market and Meeting on American Indian/Alaska
CD–ROM, after submission of a the impact these effects may have on Native Lesbian, Gay, Bisexual, and
Freedom of Information request. The patient management. Transgender Health Issues
Freedom of Information office address is We will also examine clinical
available on the Agency’s Web site at scenarios that would warrant DOAC AGENCY: Indian Health Service.
http://www.fda.gov. A link to the testing. Instructions for coagulation ACTION: Notice of meeting.
transcripts will also be available monitoring as required for vitamin K
approximately 45 days after the public antagonists are not specified in DOAC’s SUMMARY: The Indian Health Service
workshop on the Internet at http:// instructions for use. However, in certain (IHS) is continuing to seek broad public
www.fda.gov/MedicalDevices/ clinical settings assessment of DOAC- input as it continues efforts to advance
NewsEvents/WorkshopsConferences/ induced anticoagulation may be and promote the health needs of the
default.htm. (Select this public advantageous. The second aim of the American Indian/Alaska Native (AI/AN)
rmajette on DSK7SPTVN1PROD with NOTICES

workshop from the posted events list). workshop will focus on medical Lesbian, Gay, Bisexual, and Transgender
SUPPLEMENTARY INFORMATION: conditions that require coagulation (LGBT) community.
testing of patients taking DOACs. DATES: The meeting will be held as
I. Background There are a limited number of shown below:
Coagulation is the process of forming strategies to assess coagulation in 1. September 11, 2015 from 12:00
a clot to stop bleeding. Blood clotting is patients taking DOACs. We will review p.m. EST to 2:00 p.m. EST.
initiated by injury to a blood vessel options for quantitative and qualitative ADDRESSES: The meeting location is:

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Federal Register / Vol. 80, No. 165 / Wednesday, August 26, 2015 / Notices 51825

1. Hubert H. Humphrey Building, 200 Date: September 22, 2015. provisions set forth in sections
Independence Avenue SW., Time: 11:30 a.m. to 12:30 p.m. 552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
Washington, DC 20201. Agenda: To review and evaluate grant as amended. The grant applications and
Written statements may be submitted applications.
Place: National Institutes of Health,
the discussions could disclose
to Lisa Neel, MPH, Program Neuroscience Center, 6001 Executive confidential trade secrets or commercial
Coordinator, Office of Clinical and Boulevard, Rockville, MD 20852 (Telephone property such as patentable material,
Preventive Services, Indian Health Conference Call). and personal information concerning
Service, 801 Thompson Avenue, Suite Contact Person: Shiguang Yang, DVM, individuals associated with the grant
300, Rockville, MD 20852. Ph.D., Scientific Review Officer, Division of applications, the disclosure of which
FOR FURTHER INFORMATION CONTACT: Lisa Extramural Activities, NIDCD, NIH, 6001 would constitute a clearly unwarranted
Neel, MPH, Program Coordinator, Office Executive Blvd., Room 8349, Bethesda, MD invasion of personal privacy.
20892, 301–496–8683, yangshi@
of Clinical and Preventive Services, nidcd.nih.gov. Name of Committee: Center for Scientific
Indian Health Service, 801 Thompson Review Special Emphasis Panel, Shared Mass
Name of Committee: National Institute on
Avenue, Suite 300, Rockville, MD Deafness and Other Communication Spectrometers.
20852, Telephone 301–443–4305. (This Disorders Special Emphasis Panel— Date: September 17–18, 2015.
is not a toll-free number.) Fellowships—Chemical Senses. Time: 8:00 a.m. to 5:00 p.m.
SUPPLEMENTARY INFORMATION: The Date: October 1, 2015. Agenda: To review and evaluate grant
meeting will be open to the public. To Time: 11:00 a.m. to 1:00 p.m. applications.
Agenda: To review and evaluate grant Place: National Institutes of Health, 6701
facilitate the building security process, Rockledge Drive, Bethesda, MD 20892,
those who plan to attend should RSVP applications.
Place: National Institutes of Health, (Virtual Meeting).
to Lisa Neel at lisa.neel@ihs.gov or by Contact Person: David R Jollie, Ph.D.,
Neuroscience Center, 6001 Executive
telephone at 301–443–4305 no later Boulevard, Rockville, MD 20852 (Telephone Scientific Review Officer, Center for
than 5:00 p.m. EST on August 31, 2015. Conference Call). Scientific Review, National Institutes of
(This is not a toll-free number.) Public Contact Person: Shiguang Yang, DVM, Health, 6701 Rockledge Drive, Room 4150,
attendance will be limited to the space Ph.D., Scientific Review Officer, Division of MSC 7806, Bethesda, MD 20892, (301) 435–
available. Members of the public may Extramural Activities, NIDCD, NIH, 6001 1722, jollieda@csr.nih.gov.
make statements during the meeting to Executive Blvd., Room 8349, Bethesda, MD Name of Committee: Immunology
the extent time permits and file written 20892, 301–496–8683, yangshi@ Integrated Review Group, Transplantation,
nidcd.nih.gov. Tolerance, and Tumor Immunology Study
statements with the Agency for its
Name of Committee: Communication Section.
consideration. Written statements Date: October 1–2, 2015.
should be submitted to the address Disorders Review Committee.
Date: October 15–16, 2015. Time: 8:00 a.m. to 5:00 p.m.
listed above. Agenda: To review and evaluate grant
Time: 8:00 a.m. to 5:00 p.m.
Dated: August 19, 2015. Agenda: To review and evaluate grant applications.
Robert G. McSwain, applications. Place: Washington Plaza Hotel, 10 Thomas
Place: Crowne Plaza Chicago Metro Circle NW., Washington, DC 20005.
Deputy Director, Indian Health Service. Contact Person: Jin Huang, Ph.D.,
Downtown, 733 West Madison, Chicago, IL
[FR Doc. 2015–21068 Filed 8–25–15; 8:45 am] Scientific Review Officer, Center for
60661.
BILLING CODE 4165–16–P Contact Person: Eliane Lazar-Wesley, Scientific Review, National Institutes of
Scientific Review Officer, Division of Health, 6701 Rockledge Drive, Room 4199,
Extramural Activities, National Institute on MSC 7812, Bethesda, MD 20892, 301–435–
DEPARTMENT OF HEALTH AND Deafness and Other Communication 1230, jh377p@nih.gov.
HUMAN SERVICES Disorders/NIH, 6001 Executive Blvd., MSC (Catalogue of Federal Domestic Assistance
9670, Bethesda, MD 20892–8401, 301–496– Program Nos. 93.306, Comparative Medicine;
National Institutes of Health 8683, el6r@nih.gov. 93.333, Clinical Research, 93.306, 93.333,
(Catalogue of Federal Domestic Assistance 93.337, 93.393–93.396, 93.837–93.844,
National Institute on Deafness and Program Nos. 93.173, Biological Research 93.846–93.878, 93.892, 93.893, National
Other Communication Disorders; Related to Deafness and Communicative Institutes of Health, HHS)
Notice of Closed Meetings Disorders, National Institutes of Health, HHS) Dated: August 21, 2015.
Pursuant to section 10(d) of the Dated: August 21, 2015. Carolyn Baum,
Federal Advisory Committee Act, as Melanie J. Gray, Program Analyst, Office of Federal Advisory
amended (5 U.S.C. App.), notice is Program Analyst, Office of Federal Advisory Committee Policy.
hereby given of the following meetings. Committee Policy. [FR Doc. 2015–21152 Filed 8–25–15; 8:45 am]
The meetings will be closed to the [FR Doc. 2015–21142 Filed 8–25–15; 8:45 am] BILLING CODE 4140–01–P
public in accordance with the BILLING CODE 4140–01–P
provisions set forth in sections
552b(c)(4) and 552b(c)(6), title 5 U.S.C., DEPARTMENT OF HEALTH AND
as amended. The grant applications and DEPARTMENT OF HEALTH AND HUMAN SERVICES
the discussions could disclose HUMAN SERVICES
confidential trade secrets or commercial National Institutes of Health
property such as patentable material, National Institutes of Health
National Cancer Institute; Notice of
and personal information concerning Meeting
Center for Scientific Review; Notice of
individuals associated with the grant
rmajette on DSK7SPTVN1PROD with NOTICES

Closed Meetings Pursuant to section 10(a) of the
applications, the disclosure of which
would constitute a clearly unwarranted Pursuant to section 10(d) of the Federal Advisory Committee Act, as
invasion of personal privacy. Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is
Name of Committee: National Institute on amended (5 U.S.C. App.), notice is hereby given of a meeting of the
Deafness and Other Communication hereby given of the following meetings. Frederick National Laboratory Advisory
Disorders Special Emphasis Panel; Clinical The meetings will be closed to the Committee to the National Cancer
Trial Review. public in accordance with the Institute.

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Document Created: 2015-12-15 10:58:44
Document Modified: 2015-12-15 10:58:44

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 as shown below:
Contact		Lisa Neel, MPH, Program Coordinator, Office of Clinical and Preventive Services, Indian Health Service, 801 Thompson Avenue, Suite 300, Rockville, MD 20852, Telephone 301-443- 4305. (This is not a toll-free number.)
FR Citation		80 FR 51824

80 FR 51824 - Meeting on American Indian/Alaska Native Lesbian, Gay, Bisexual, and Transgender Health Issues

DEPARTMENT OF HEALTH AND HUMAN SERVICESIndian Health Service

Federal Register Volume 80, Issue 165 (August 26, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Indian Health Service