80 FR 24256 - Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 83 (April 30, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 83 (April 30, 2015)
| Page Range | 24256-24256 | |
| FR Document | 2015-10023 |
[Federal Register Volume 80, Number 83 (Thursday, April 30, 2015)] [Notices] [Page 24256] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-10023] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-0001] Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Endocrinologic and Metabolic Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations to the Agency on FDA's regulatory issues. Date and Time: The meeting will be held on June 9, 2015, from 8 a.m. to 5 p.m. Location: Hilton Washington DC North/Gaithersburg, Grand Ballroom, 620 Perry Parkway, Gaithersburg, MD 20877. The hotel telephone number is 301-977-8900. Contact Person: Philip Bautista, 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. Agenda: The committee will discuss the safety and efficacy of biologics license application 125559, proposed trade name PRALUENT (established name: Alirocumab) for injection, submitted by Sanofi Aventis, U.S., as an adjunct to diet, for long-term treatment of adult patients with primary hypercholesterolemia (non-familial and heterozygous familial) or mixed dyslipidemia including patients with type 2 diabetes mellitus, to reduce low-density lipoprotein cholesterol, total cholesterol, non-high-density lipoprotein cholesterol, apolipoprotein B, tryglyceride, and lipoprotein A, and to increase high-density lipoprotein cholesterol and apolipoprotein A-1 either in combination with a statin or as monotherapy including in patients who cannot tolerate statins. 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 May 26, 2015. Oral presentations from the public will be scheduled between approximately 1:15 p.m. to 2:15 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 May 15, 2015. 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 May 18, 2015. 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 physical disabilities or special needs. If you require special accommodations due to a disability, please contact Philip Bautista 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: April 24, 2015. Peter Lurie, Associate Commissioner for Public Health Strategy and Analysis. [FR Doc. 2015-10023 Filed 4-29-15; 8:45 am] BILLING CODE 4164-01-P
![24256 Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Notices
establishment of certification programs General Function of the Committee: AdvisoryCommittees/Calendar/
for health information technology (HIT) To provide advice and default.htm. Scroll down to the
(45 CFR part 170, RIN 0991–AB59). The recommendations to the Agency on appropriate advisory committee meeting
functionality of certified EHR FDA’s regulatory issues. link.
technology should facilitate the Date and Time: The meeting will be
held on June 9, 2015, from 8 a.m. to 5 Procedure: Interested persons may
implementation of meaningful use.
p.m. present data, information, or views,
Subsequently, final rules have been
issued by CMS (77 FR 53968) and ONC Location: Hilton Washington DC orally or in writing, on issues pending
(77 FR 72985) to create a Stage 2 of North/Gaithersburg, Grand Ballroom, before the committee. Written
meaningful use criteria and other 620 Perry Parkway, Gaithersburg, MD submissions may be made to the contact
changes to the CMS EHR Incentive 20877. The hotel telephone number is person on or before May 26, 2015. Oral
Programs and the 2014 Edition 301–977–8900. presentations from the public will be
Certification Criteria for EHR Contact Person: Philip Bautista, scheduled between approximately 1:15
technology. Center for Drug Evaluation and p.m. to 2:15 p.m. Those individuals
The information collection Research, Food and Drug interested in making formal oral
requirements contained in this Administration, 10903 New Hampshire presentations should notify the contact
information collection request are Ave., Bldg. 31, Rm. 2417, Silver Spring, person and submit a brief statement of
needed to implement the HITECH Act. MD 20993–0002, 301–796–9001, Fax: the general nature of the evidence or
In order to avoid duplicate payments, 301–847–8533, EMDAC@fda.hhs.gov, or arguments they wish to present, the
all EPs are enumerated through their FDA Advisory Committee Information names and addresses of proposed
National Provider Identifier (NPI), while Line, 1–800–741–8138 (301–443–0572 participants, and an indication of the
all eligible hospitals and CAHs are in the Washington, DC area). A notice in approximate time requested to make
enumerated through their CMS the Federal Register about last minute their presentation on or before May 15,
Certification Number (CCN). State modifications that impact a previously
2015. Time allotted for each
Medicaid agencies and CMS use the announced advisory committee meeting
presentation may be limited. If the
provider’s tax identification number and cannot always be published quickly
enough to provide timely notice. number of registrants requesting to
NPI or CCN combination in order to speak is greater than can be reasonably
make payment, validate payment Therefore, you should always check the
Agency’s Web site at http:// accommodated during the scheduled
eligibility and detect and prevent open public hearing session, FDA may
duplicate payments for EPs, eligible www.fda.gov/AdvisoryCommittees/
default.htm and scroll down to the conduct a lottery to determine the
hospitals and CAHs. Form Number:
appropriate advisory committee meeting speakers for the scheduled open public
CMS–10336 (OMB control number:
link, or call the advisory committee hearing session. The contact person will
0938–1158); Frequency: Occasionally;
information line to learn about possible notify interested persons regarding their
Affected Public: Private sector; Number
modifications before coming to the request to speak by May 18, 2015.
of Respondents: 214,694; Total Annual
Responses: 214,694; Total Annual meeting. Persons attending FDA’s advisory
Hours: 2,034,740. (For policy questions Agenda: The committee will discuss committee meetings are advised that the
regarding this collection contact the safety and efficacy of biologics Agency is not responsible for providing
Elisabeth Myers at 410–786–4751.) license application 125559, proposed access to electrical outlets.
trade name PRALUENT (established
Dated: April 28, 2015. name: Alirocumab) for injection, FDA welcomes the attendance of the
William N. Parham, III, submitted by Sanofi Aventis, U.S., as an public at its advisory committee
Director, Paperwork Reduction Staff, Office adjunct to diet, for long-term treatment meetings and will make every effort to
of Strategic Operations and Regulatory of adult patients with primary accommodate persons with physical
Affairs. hypercholesterolemia (non-familial and disabilities or special needs. If you
[FR Doc. 2015–10197 Filed 4–29–15; 8:45 am] heterozygous familial) or mixed require special accommodations due to
BILLING CODE 4120–01–P dyslipidemia including patients with a disability, please contact Philip
type 2 diabetes mellitus, to reduce low- Bautista at least 7 days in advance of the
density lipoprotein cholesterol, total meeting.
DEPARTMENT OF HEALTH AND cholesterol, non-high-density
HUMAN SERVICES FDA is committed to the orderly
lipoprotein cholesterol, apolipoprotein conduct of its advisory committee
B, tryglyceride, and lipoprotein A, and meetings. Please visit our Web site at
Food and Drug Administration
to increase high-density lipoprotein http://www.fda.gov/
[Docket No. FDA–2015–N–0001] cholesterol and apolipoprotein A–1
AdvisoryCommittees/
either in combination with a statin or as
Endocrinologic and Metabolic Drugs AboutAdvisoryCommittees/
monotherapy including in patients who
Advisory Committee; Notice of Meeting ucm111462.htm for procedures on
cannot tolerate statins.
FDA intends to make background public conduct during advisory
AGENCY: Food and Drug Administration, committee meetings.
HHS. material available to the public no later
than 2 business days before the meeting. Notice of this meeting is given under
ACTION: Notice.
If FDA is unable to post the background the Federal Advisory Committee Act (5
mstockstill on DSK4VPTVN1PROD with NOTICES
This notice announces a forthcoming material on its Web site prior to the U.S.C. app. 2).
meeting of a public advisory committee meeting, the background material will Dated: April 24, 2015.
of the Food and Drug Administration be made publicly available at the
location of the advisory committee Peter Lurie,
(FDA). The meeting will be open to the
public. meeting, and the background material Associate Commissioner for Public Health
Name of Committee: Endocrinologic will be posted on FDA’s Web site after Strategy and Analysis.
and Metabolic Drugs Advisory the meeting. Background material is [FR Doc. 2015–10023 Filed 4–29–15; 8:45 am]
Committee. available at http://www.fda.gov/ BILLING CODE 4164–01–P
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Document Created: 2018-02-21 10:15:17
Document Modified: 2018-02-21 10:15:17
| 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. | |
| FR Citation | 80 FR 24256 |
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