81 FR 31243 - Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 96 (May 18, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 96 (May 18, 2016)
| Page Range | 31243-31243 | |
| FR Document | 2016-11678 |
[Federal Register Volume 81, Number 96 (Wednesday, May 18, 2016)] [Notices] [Page 31243] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-11678] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-0001] Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Endocrinologic and Metabolic Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public. DATES: The meeting will be held on June 28, 2016, from 8 a.m. to 5 p.m. ADDRESSES: Hilton Washington DC/Rockville Hotel & Executive Meeting Center, Plaza Ballroom, 1750 Rockville Pike, Rockville, MD 20852. The hotel's telephone number is 301-468-1100. Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm. 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, FAX: 301-847-8533, EMDAC@fda.hhs.gov, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. SUPPLEMENTARY INFORMATION: Agenda: The committee will discuss supplemental new drug application (sNDA) 204629, empagliflozin (JARDIANCE) tablets, and sNDA 206111, empagliflozin and metformin hydrochloride (SYNJARDY) tablets. Both sNDAs are sponsored by Boehringer Ingelheim Pharmaceuticals, Inc., for the proposed additional indication in adult patients with type 2 diabetes mellitus and high cardiovascular risk to reduce the risk of all-cause mortality by reducing the incidence of cardiovascular death and to reduce the risk of cardiovascular death or hospitalization for heart failure. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting link. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before June 14, 2016. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before June 6, 2016. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by June 7, 2016. Persons attending FDA's advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact LaToya Bonner at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: May 11, 2016. Jill Hartzler Warner, Associate Commissioner for Special Medical Programs. [FR Doc. 2016-11678 Filed 5-17-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 96 / Wednesday, May 18, 2016 / Notices 31243
I hereby affirm and ratify any actions Drug Administration, 10903 New arguments they wish to present, the
taken by the Director of Refugee Hampshire Ave., Bldg. 31, Rm. 2417, names and addresses of proposed
Resettlement and the OTIP Director, or Silver Spring, MD 20993–0002, 301– participants, and an indication of the
his or her subordinates, which involved 796–9001, FAX: 301–847–8533, approximate time requested to make
the exercise of authorities prior to the EMDAC@fda.hhs.gov, or FDA Advisory their presentation on or before June 6,
effective date of these January 27, 2016, Committee Information Line, 1–800– 2016. Time allotted for each
delegations. 741–8138 (301–443–0572 in the presentation may be limited. If the
These authorities shall be exercised Washington, DC area). A notice in the number of registrants requesting to
under the Department’s policy on Federal Register about last minute speak is greater than can be reasonably
regulations and the existing delegation modifications that impact a previously accommodated during the scheduled
of authority to approve and issue announced advisory committee meeting open public hearing session, FDA may
regulations. cannot always be published quickly conduct a lottery to determine the
These delegations shall be exercised enough to provide timely notice. speakers for the scheduled open public
under financial and administrative Therefore, you should always check the hearing session. The contact person will
requirements applicable to these Agency’s Web site at http:// notify interested persons regarding their
Administration for Children and www.fda.gov/AdvisoryCommittees/ request to speak by June 7, 2016.
Families authorities. default.htm and scroll down to the Persons attending FDA’s advisory
The delegations listed were effective appropriate advisory committee meeting committee meetings are advised that the
January 27, 2016. link, or call the advisory committee Agency is not responsible for providing
Dated: May 12, 2016. information line to learn about possible access to electrical outlets.
Mark H. Greenberg, modifications before coming to the FDA welcomes the attendance of the
Acting Assistant Secretary for Children and meeting. public at its advisory committee
Families. meetings and will make every effort to
SUPPLEMENTARY INFORMATION:
[FR Doc. 2016–11731 Filed 5–17–16; 8:45 am] Agenda: The committee will discuss accommodate persons with disabilities.
supplemental new drug application If you require accommodations due to a
BILLING CODE 4184–34–P
(sNDA) 204629, empagliflozin disability, please contact LaToya Bonner
(JARDIANCE) tablets, and sNDA at least 7 days in advance of the
DEPARTMENT OF HEALTH AND 206111, empagliflozin and metformin meeting.
HUMAN SERVICES FDA is committed to the orderly
hydrochloride (SYNJARDY) tablets.
conduct of its advisory committee
Both sNDAs are sponsored by
Food and Drug Administration meetings. Please visit our Web site at
Boehringer Ingelheim Pharmaceuticals,
http://www.fda.gov/
[Docket No. FDA–2016–N–0001] Inc., for the proposed additional
AdvisoryCommittees/
indication in adult patients with type 2
Endocrinologic and Metabolic Drugs AboutAdvisoryCommittees/
diabetes mellitus and high
Advisory Committee; Notice of Meeting ucm111462.htm for procedures on
cardiovascular risk to reduce the risk of
public conduct during advisory
all-cause mortality by reducing the
AGENCY: Food and Drug Administration, committee meetings.
incidence of cardiovascular death and to
HHS. Notice of this meeting is given under
reduce the risk of cardiovascular death
ACTION: Notice. the Federal Advisory Committee Act (5
or hospitalization for heart failure.
U.S.C. app. 2).
SUMMARY: The Food and Drug FDA intends to make background
material available to the public no later Dated: May 11, 2016.
Administration (FDA) announces a
forthcoming public advisory committee than 2 business days before the meeting. Jill Hartzler Warner,
meeting of the Endocrinologic and If FDA is unable to post the background Associate Commissioner for Special Medical
Metabolic Drugs Advisory Committee. material on its Web site prior to the Programs.
The general function of the committee is meeting, the background material will [FR Doc. 2016–11678 Filed 5–17–16; 8:45 am]
to provide advice and recommendations be made publicly available at the BILLING CODE 4164–01–P
to the Agency on FDA’s regulatory location of the advisory committee
issues. The meeting will be open to the meeting, and the background material
public. will be posted on FDA’s Web site after DEPARTMENT OF HEALTH AND
the meeting. Background material is HUMAN SERVICES
DATES: The meeting will be held on June
available at http://www.fda.gov/
28, 2016, from 8 a.m. to 5 p.m. Health Resources and Services
AdvisoryCommittees/Calendar/
ADDRESSES: Hilton Washington DC/ Administration
default.htm. Scroll down to the
Rockville Hotel & Executive Meeting appropriate advisory committee meeting
Center, Plaza Ballroom, 1750 Rockville link. Agency Information Collection
Pike, Rockville, MD 20852. The hotel’s Procedure: Interested persons may Activities: Proposed Collection: Public
telephone number is 301–468–1100. present data, information, or views, Comment Request
Answers to commonly asked questions orally or in writing, on issues pending AGENCY: Health Resources and Services
including information regarding special before the committee. Written Administration, HHS.
accommodations due to a disability, submissions may be made to the contact
visitor parking, and transportation may ACTION: Notice.
person on or before June 14, 2016. Oral
sradovich on DSK3TPTVN1PROD with NOTICES
be accessed at: http://www.fda.gov/ presentations from the public will be SUMMARY: In compliance with the
AdvisoryCommittees/ scheduled between approximately 1 requirement for opportunity for public
AboutAdvisoryCommittees/ p.m. and 2 p.m. Those individuals comment on proposed data collection
ucm408555.htm. interested in making formal oral projects (Section 3506(c)(2)(A) of the
FOR FURTHER INFORMATION CONTACT: presentations should notify the contact Paperwork Reduction Act of 1995), the
LaToya Bonner, Center for Drug person and submit a brief statement of Health Resources and Services
Evaluation and Research, Food and the general nature of the evidence or Administration (HRSA) announces
VerDate Sep<11>2014 17:10 May 17, 2016 Jkt 238001 PO 00000 Frm 00020 Fmt 4703 Sfmt 4703 E:\FR\FM\18MYN1.SGM 18MYN1](https://thefederalregister.org/doc/81_FR_31339/page/1.svg)
Document Created: 2016-05-18 00:06:42
Document Modified: 2016-05-18 00:06:42
| 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. | |
| Dates | The meeting will be held on June 28, 2016, from 8 a.m. to 5 p.m. | |
| 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, FAX: 301-847-8533, [email protected], or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. | |
| FR Citation | 81 FR 31243 |
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