81_FR_60529 81 FR 60359 - Advisory Committee; Endocrinologic and Metabolic Drugs Advisory Committee, Renewal

81 FR 60359 - Advisory Committee; Endocrinologic and Metabolic Drugs Advisory Committee, Renewal

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 170 (September 1, 2016)

Page Range60359-60360
FR Document2016-21040

The Food and Drug Administration (FDA) is announcing the renewal of the Endocrinologic and Metabolic Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Endocrinologic and Metabolic Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until August 27, 2018.

Federal Register, Volume 81 Issue 170 (Thursday, September 1, 2016) 
[Federal Register Volume 81, Number 170 (Thursday, September 1, 2016)]
[Notices]
[Pages 60359-60360]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-21040]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]


Advisory Committee; Endocrinologic and Metabolic Drugs Advisory 
Committee, Renewal

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; renewal of advisory committee.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
renewal of the Endocrinologic and Metabolic Drugs Advisory Committee by 
the Commissioner of Food and Drugs (the Commissioner). The Commissioner 
has determined that it is in the public interest to renew the 
Endocrinologic and Metabolic Drugs Advisory Committee for an additional 
2 years beyond the charter expiration date. The new charter will be in 
effect until August 27, 2018.

DATES: Authority for the Endocrinologic and Metabolic Drugs Advisory 
Committee will expire on August 27, 2016, unless the Commissioner 
formally determines that renewal is in the public interest.

FOR FURTHER INFORMATION CONTACT: LaToya Bonner, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-
796-9001, [email protected].

SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3.65 and approval by 
the Department of Health and Human Services pursuant to 45 CFR part 11 
and by the General Services Administration, FDA is announcing the 
renewal of the Endocrinologic and Metabolic Drugs Advisory Committee. 
The committee is a discretionary Federal advisory committee established 
to provide advice to the Commissioner. The Endocrinologic and Metabolic 
Drugs Advisory Committee advises the Commissioner or designee in 
discharging responsibilities as they relate to helping to ensure safe 
and effective drugs for human use and, as required, any other product 
for which FDA has regulatory responsibility.
    The Committee reviews and evaluates data concerning the safety and 
effectiveness of marketed and investigational human drug products for 
use in the treatment of endocrine and metabolic disorders, and makes 
appropriate recommendations to the Commissioner of Food and Drugs.

[[Page 60360]]

    The Committee shall consist of a core of 11 voting members 
including the Chair. Members and the Chair are selected by the 
Commissioner or designee from among authorities knowledgeable in the 
fields of endocrinology, metabolism, epidemiology or statistics, and 
related specialties. Members will be invited to serve for overlapping 
terms of up to 4 years. Almost all non-Federal members of this 
committee serve as Special Government Employees. The core of voting 
members may include one technically qualified member, selected by the 
Commissioner or designee, who is identified with consumer interests and 
is recommended by either a consortium of consumer-oriented 
organizations or other interested persons. In addition to the voting 
members, the Committee may include one non-voting member who is 
identified with industry interests.
    Further information regarding the most recent charter and other 
information can be found at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/ucm100261.htm or by 
contacting the Designated Federal Officer (see FOR FURTHER INFORMATION 
CONTACT). In light of the fact that no change has been made to the 
committee name or description of duties, no amendment will be made to 
21 CFR 14.100.
    This document is issued under the Federal Advisory Committee Act (5 
U.S.C. app.). For general information related to FDA advisory 
committees, please visit us at http://www.fda.gov/AdvisoryCommittees/default.htm.

    Dated: August 26, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-21040 Filed 8-31-16; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 170 / Thursday, September 1, 2016 / Notices 60359 enough to provide timely notice. brief statement of the general nature of DEPARTMENT OF HEALTH AND Therefore, you should always check the the evidence or arguments they wish to HUMAN SERVICES Agency’s Web site at http:// present, the names and addresses of www.fda.gov/AdvisoryCommittees/ proposed participants, and an Food and Drug Administration default.htm and scroll down to the indication of the approximate time [Docket No. FDA–2016–N–0001] appropriate advisory committee meeting requested to make their presentation on link, or call the advisory committee or before September 21, 2016. Time Advisory Committee; Endocrinologic information line to learn about possible allotted for each presentation may be and Metabolic Drugs Advisory modifications before coming to the limited. If the number of registrants Committee, Renewal meeting. requesting to speak is greater than can AGENCY: Food and Drug Administration, SUPPLEMENTARY INFORMATION: be reasonably accommodated during the HHS. Agenda: On October 5, 2016, during scheduled open public hearing session, session I, the topic to be addressed will ACTION:Notice; renewal of advisory FDA may conduct a lottery to determine committee. be reclassification of quantitative the speakers for the scheduled open Cytomegalovirus (CMV) viral load public hearing session. The contact SUMMARY: The Food and Drug devices from class III (Premarket person will notify interested persons Administration (FDA) is announcing the approval) to class II (510(k)). A nucleic regarding their request to speak by renewal of the Endocrinologic and acid-based in vitro diagnostic device for September 22, 2016. Metabolic Drugs Advisory Committee by the quantitation of CMV viral load, the Commissioner of Food and Drugs within the context of transplant patient Persons attending FDA’s advisory committee meetings are advised that the (the Commissioner). The Commissioner management, is a post-amendment has determined that it is in the public device classified into class III under Agency is not responsible for providing interest to renew the Endocrinologic section 513(f)(1) of the Federal Food, access to electrical outlets. and Metabolic Drugs Advisory Drug, and Cosmetic Act (21 U.S.C. FDA is establishing a docket for Committee for an additional 2 years 360c(f)(1)). To date, the following public comment on this document. The beyond the charter expiration date. The product code has been established for docket number is FDA–2016–N–1660. new charter will be in effect until CMV viral load devices: PAB The docket will close on November 9, August 27, 2018. (Cytomegalovirus (CMV) DNA 2016. Comments received on or before DATES: Authority for the Endocrinologic Quantitative Assay). During session II, September 21, 2016, will be provided to and Metabolic Drugs Advisory the topics to be addressed include the committee. Comments received after Committee will expire on August 27, appropriate initial classification for that date will be taken into 2016, unless the Commissioner formally qualitative or quantitative viral load consideration by the Agency. determines that renewal is in the public devices for Epstein-Barr virus (EBV), BK For press inquiries, please contact the interest. virus (BK), JC virus (JCV), Human Herpesvirus 6 (HHV6), and Adenovirus Office of Media Affairs at fdaoma@ FOR FURTHER INFORMATION CONTACT: infections. FDA is seeking expert fda.hhs.gov or 301–796–4540. LaToya Bonner, Center for Drug recommendations to assess the potential Evaluation and Research, Food and FDA welcomes the attendance of the risks and benefits of these devices when Drug Administration, 10903 New public at its advisory committee used in patients following solid-organ or Hampshire Ave., Bldg. 31, Rm. 2417, meetings and will make every effort to stem cell transplantation. Silver Spring, MD 20993–0002, 301– accommodate persons with disabilities. 796–9001, EMDAC@fda.hhs.gov. FDA intends to make background If you require accommodations due to a material available to the public no later SUPPLEMENTARY INFORMATION: Pursuant disability, please contact Artair Mallett than 2 business days before the meeting. to 41 CFR 102–3.65 and approval by the at Artair.Mallett@fda.hhs.gov or 301– If FDA is unable to post the background Department of Health and Human 796–9638, at least 7 days in advance of Services pursuant to 45 CFR part 11 and material on its Web site prior to the meeting, the background material will the meeting. by the General Services Administration, be made publicly available at the FDA is committed to the orderly FDA is announcing the renewal of the location of the advisory committee conduct of its advisory committee Endocrinologic and Metabolic Drugs meeting, and the background material meetings. Please visit our Web site at Advisory Committee. The committee is will be posted on FDA’s Web site after http://www.fda.gov/ a discretionary Federal advisory the meeting. Background material is AdvisoryCommittees/ committee established to provide advice available at http://www.fda.gov/ AboutAdvisoryCommittees/ to the Commissioner. The AdvisoryCommittees/Calendar/ ucm111462.htm for procedures on Endocrinologic and Metabolic Drugs default.htm. Scroll down to the public conduct during advisory Advisory Committee advises the appropriate advisory committee meeting committee meetings. Commissioner or designee in link. discharging responsibilities as they Procedure: Interested persons may Notice of this meeting is given under relate to helping to ensure safe and present data, information, or views, the Federal Advisory Committee Act (5 effective drugs for human use and, as orally or in writing, on issues pending U.S.C. app. 2). required, any other product for which before the committee. Written FDA has regulatory responsibility. asabaliauskas on DSK3SPTVN1PROD with NOTICES Dated: August 26, 2016. submissions may be made to the contact Leslie Kux, The Committee reviews and evaluates person on or before September 29, 2016. Associate Commissioner for Policy. data concerning the safety and Oral presentations from the public will effectiveness of marketed and [FR Doc. 2016–21045 Filed 8–31–16; 8:45 am] be scheduled on October 5, 2016, investigational human drug products for BILLING CODE 4164–01–P between approximately 1 p.m. and 2 use in the treatment of endocrine and p.m. Those individuals interested in metabolic disorders, and makes making formal oral presentations should appropriate recommendations to the notify the contact person and submit a Commissioner of Food and Drugs. VerDate Sep<11>2014 17:14 Aug 31, 2016 Jkt 238001 PO 00000 Frm 00022 Fmt 4703 Sfmt 4703 E:\FR\FM\01SEN1.SGM 01SEN1

60360 Federal Register / Vol. 81, No. 170 / Thursday, September 1, 2016 / Notices The Committee shall consist of a core Approximate Review Date: November diseases, e.g., diabetes, worsened. ‘‘All of 11 voting members including the 2–4, 2016. Indian’’ rates contain marked variation Chair. Members and the Chair are Earliest Anticipated Start Date: among the ‘‘IHS Areas’’ or regions selected by the Commissioner or November 15, 2016. (Regional Differences in Indian Health designee from among authorities Proof of Non-Profit Status Due Date: 2002–2003); variation by Tribe exists knowledgeable in the fields of October 30, 2016. within Areas as well. The Trends and endocrinology, metabolism, Regional Differences reference can be I. Funding Opportunity Description epidemiology or statistics, and related found on the IHS Web site at http:// specialties. Members will be invited to Statutory Authority www.ihs.gov/dps/publications/. The serve for overlapping terms of up to 4 The Indian Health Service (IHS) daunting task confronting Tribes, years. Almost all non-Federal members Office of Public Health Support (OPHS), research scientists, and health programs of this committee serve as Special Division of Planning, Evaluation and is to reduce the disparities among and Government Employees. The core of Research (DPER), is accepting within areas and Tribes. Factors known voting members may include one to contribute to health status and applications for one new cooperative technically qualified member, selected disparities are complex, and include agreement for the National Native by the Commissioner or designee, who underlying biology, physiology, and Health Research Training Initiative. is identified with consumer interests epigenetics, as well as ethnicity, culture, This initiative will help build capacity and is recommended by either a socioeconomic status, gender/sex, age, and disseminate new and best practices consortium of consumer-oriented geographical access to care, and levels for American Indian and Alaska Native organizations or other interested of insurance. (AI/AN) health research and promote Additional factors known to persons. In addition to the voting Tribally-driven research activity members, the Committee may include contribute to health status and through a variety of educational and disparities include: one non-voting member who is training opportunities. Focus will be on identified with industry interests. 1. Family, home, and work the promotion of health research and environments; Further information regarding the related opportunities for AI/AN most recent charter and other 2. general or culturally specific health students, highlighting promising practices; information can be found at http:// practices and practice-based approaches www.fda.gov/AdvisoryCommittees/ 3. social support systems; to improving the health of AI/AN 4. lack of access to culturally- CommitteesMeetingMaterials/Drugs/ people, and culture-based approaches to appropriate health care; and EndocrinologicandMetabolicDrugs reducing health disparities between AI/ 5. attitudes and beliefs about health. AdvisoryCommittee/ucm100261.htm or AN people and the U.S. population. Health disparities of AI/ANs may also by contacting the Designated Federal Other areas will focus on resilience and reflect a lack of in depth research Officer (see FOR FURTHER INFORMATION protective factors and their role in AI/ relevant to improving their health CONTACT). In light of the fact that no status. Many AI/ANs also distrust AN health outcomes, innovative and change has been made to the committee culturally-based approaches to research for historical reasons. One name or description of duties, no improving the health of AI/AN youth, approach that combats this distrust is to amendment will be made to 21 CFR and dissemination of study findings in ensure that Tribes are managing 14.100. AI/AN health science research to partners in training and research that This document is issued under the involves them, as for example in investigators and providers working in Federal Advisory Committee Act (5 community-based participatory research or with Tribal communities as well as U.S.C. app.). For general information (CBPR) (i.e., a collaborative research Tribal leaders and health officials. related to FDA advisory committees, process between researchers and Activities will include the planning, please visit us at http://www.fda.gov/ community representatives). This coordination, and hosting of research AdvisoryCommittees/default.htm. approach is especially helpful to design meetings and conferences, webinars, Dated: August 26, 2016. hosting of a Web site/Web page for both training relevant to researchers Leslie Kux, dissemination of AI/AN health science from Tribal communities and research Associate Commissioner for Policy. research information, and other relevant to health needs of the [FR Doc. 2016–21040 Filed 8–31–16; 8:45 am] activities to be determined. This IHS communities. Another approach is BILLING CODE 4164–01–P activity is authorized under the Snyder increasing the number of AI/AN Act, codified at 25 U.S.C. 13; the scientists and growing the intellectual Transfer Act, codified at 42 U.S.C. 2001; community of researchers working with DEPARTMENT OF HEALTH AND the Consolidated Appropriations Act, AIAN health research issues. HUMAN SERVICES 2012, Public Law 112–74 and the DPER has the responsibility of Continuing Appropriations Resolution, promoting health research to help Indian Health Service 2013, Public Law 112–175. This improve the health status of AI/ANs. program is described in the Catalog of The development of AI/AN scientists Office of Public Health Support; Federal Domestic Assistance under and scientist-practitioners and Division of Planning, Evaluation & 93.933. enhancing the ability of Tribes to Research; National Native Health participate in and initiate their own Research Training Initiative Background research projects is a key part of asabaliauskas on DSK3SPTVN1PROD with NOTICES Announcement Type: New. The AI/AN populations have long improving quality and delivery of health Funding Announcement Number: experienced poorer health status services. Scientific meetings, HHS–2017–IHS–DPER–001. compared to other Americans. Although conferences, and other training Catalog of Federal Domestic major gains in reducing health opportunities will support AI/AN Assistance Number: 93.933. disparities were made during the last faculty and student development and Key Dates: half of the twentieth century, most gains promote participatory collaboration Application Deadline Date: October stopped by the mid-1980s (Trends in between Tribes and the academic 30, 2016. Indian Health 1998–99) and a few community. Such meetings and other VerDate Sep<11>2014 17:14 Aug 31, 2016 Jkt 238001 PO 00000 Frm 00023 Fmt 4703 Sfmt 4703 E:\FR\FM\01SEN1.SGM 01SEN1


Document Created: 2018-02-09 11:57:12
Document Modified: 2018-02-09 11:57:12
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice; renewal of advisory committee.
DatesAuthority for the Endocrinologic and Metabolic Drugs Advisory Committee will expire on August 27, 2016, unless the Commissioner formally determines that renewal is in the public interest.
ContactLaToya Bonner, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301- 796-9001, [email protected]
FR Citation81 FR 60359 
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