80 FR 69971 - Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 218 (November 12, 2015)

Page Range		69971-69972
FR Document		2015-28672

Federal Register, Volume 80 Issue 218 (Thursday, November 12, 2015)

[Federal Register Volume 80, Number 218 (Thursday, November 12, 2015)]
[Notices]
[Pages 69971-69972]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-28672]


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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.

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    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 December 14, 2015, from 
8 a.m. to 5 p.m.
    Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 
Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-
0002. 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.
    Contact Person: Stephanie L. Begansky, 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 results of the IMProved 
Reduction of Outcomes: Vytorin Efficacy International Trial (IMPROVE-
IT). IMPROVE-IT was a clinical trial that studied the effect of 
ezetimibe/simvastatin compared with simvastatin on the occurrence of 
cardiovascular events in patients with recent acute coronary syndrome. 
The results from this trial have been submitted to support supplemental 
new drug applications 21445/S-038 and 21687/S-054, ZETIA (ezetimibe) 
and VYTORIN (ezetimibe/simvastatin) tablets, respectively, by MSD 
International GmbH. The proposed indication for ZETIA (in combination 
with a statin) and VYTORIN is to reduce

[[Page 69972]]

the risk of cardiovascular events in patients with coronary heart 
disease.
    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 
November 30, 2015. Oral presentations from the public will be scheduled 
between approximately 12:45 p.m. and 1:45 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 November 19, 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 November 20, 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 
disabilities. If you require accommodations due to a disability, please 
contact Stephanie L. Begansky 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: November 2, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2015-28672 Filed 11-10-15; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 80, No. 218 / Thursday, November 12, 2015 / Notices 69971

SUMMARY: The Administration for proposed collection of information, This notice announces a forthcoming
Community Living (ACL) is announcing including the validity of the meeting of a public advisory committee
an opportunity for public comment on methodology and assumptions used; (3) of the Food and Drug Administration
the proposed collection of certain ways to enhance the quality, utility, and (FDA). The meeting will be open to the
information by the agency. Under the clarity of the information to be public.
Paperwork Reduction Act of 1995 (the collected; and (4) ways to minimize the Name of Committee: Endocrinologic
PRA), Federal agencies are required to burden of the collection of information and Metabolic Drugs Advisory
publish notice in the Federal Register on respondents, including through the Committee.
concerning each proposed collection of use of automated collection techniques General Function of the Committee:
information, including each proposed when appropriate, and other forms of To provide advice and
extension of an existing collection of information technology. recommendations to the Agency on
information, and to allow 60 days for The Administration for Community FDA’s regulatory issues.
public comment in response to the Living (ACL) plans to continue an Date and Time: The meeting will be
notice. This notice solicits comments on existing approved collection of held on December 14, 2015, from 8 a.m.
the information collection requirements information for semi-annual and final to 5 p.m.
relating to the continuation of an reports pursuant to the requirements of Location: FDA White Oak Campus,
existing collection for Performance its discretionary grant programs. 10903 New Hampshire Ave., Bldg. 31
Progress Reports previously approved Through its discretionary grant Conference Center, the Great Room (Rm.
for discretionary grants funded by the 1503), Silver Spring, MD 20993–0002.
programs, ACL supports projects for the
U.S. Administration for Community Answers to commonly asked questions
purpose of developing and testing new
Living (ACL). including information regarding special
knowledge and program innovations
DATES: Submit written or electronic
accommodations due to a disability,
with the potential for contributing to the
comments on the collection of visitor parking, and transportation may
independence, well-being, and health of
information by January 11, 2016. be accessed at: http://www.fda.gov/
older adults, people with disabilities
AdvisoryCommittees/
ADDRESSES: Submit electronic across the lifespan, and their families
AboutAdvisoryCommittees/
comments on the collection of and caregivers. Deliverables required by
ucm408555.htm.
information to: lori.stalbaum@ ACL of all grantees are semi-annual and Contact Person: Stephanie L.
acl.hhs.gov. Submit written comments final reports, as provided for in the Begansky, Center for Drug Evaluation
on the collection of information to Lori Department of Health and Human and Research, Food and Drug
Stalbaum, Administration on Services regulations, 45 CFR part 74, Administration, 10903 New Hampshire
Community Living, Washington, DC Section 74.51. These grantee Ave., Bldg. 31, Rm. 2417, Silver Spring,
20201 or by fax to Lori Stalbaum at 202– performance reporting requirements can MD 20993–0002, (301) 796–9001, FAX:
357–3469. be found on AoA’s Web site at http:// (301) 847–8533, EMDAC@fda.hhs.gov,
FOR FURTHER INFORMATION CONTACT: Lori www.acl.gov/Funding_Opportunities/ or FDA Advisory Committee
Stalbaum at 202–357–3452 or Grantee_Info/Reporting.aspx. ACL Information Line, 1–800–741–8138
lori.stalbaum@acl.hhs.gov. estimates the burden of this collection (301–443–0572 in the Washington, DC
SUPPLEMENTARY INFORMATION: Under the of information as follows: Frequency: area). A notice in the Federal Register
PRA (44 U.S.C. 3501–3520), Federal Semi-annually with the Final report about last minute modifications that
agencies must obtain approval from the taking the place of the semi-annual impact a previously announced
Office of Management and Budget report at the end of the final year of the advisory committee meeting cannot
(OMB) for each collection of grant. Respondents: States, public always be published quickly enough to
information they conduct or sponsor. agencies, private nonprofit agencies, provide timely notice. Therefore, you
‘‘Collection of information’’ is defined institutions of higher education, and should always check the Agency’s Web
in 44 U.S.C. 3502(3) and 5 CFR organizations including tribal site at http://www.fda.gov/
1320.3(c) and includes agency request organizations. Estimated Number of AdvisoryCommittees/default.htm and
or requirements that members of the Responses: 600. Total Estimated Burden scroll down to the appropriate advisory
public submit reports, keep records, or Hours: 12,000. committee meeting link, or call the
provide information to a third party. Dated: November 5, 2015. advisory committee information line to
Section 3506(c)(2)(A) of the PRA (44 Kathy Greenlee, learn about possible modifications
U.S.C. 3506(c)(2)(A)) requires Federal Administrator and Assistant Secretary for before coming to the meeting.
agencies to provide a 60-day notice in Aging. Agenda: The committee will discuss
the Federal Register concerning each [FR Doc. 2015–28744 Filed 11–10–15; 8:45 am] the results of the IMProved Reduction of
proposed collection of information, BILLING CODE 4154–01–P
Outcomes: Vytorin Efficacy
including each proposed extension of an International Trial (IMPROVE–IT).
existing collection of information, IMPROVE–IT was a clinical trial that
before submitting the collection to OMB DEPARTMENT OF HEALTH AND studied the effect of ezetimibe/
for approval. To comply with this HUMAN SERVICES simvastatin compared with simvastatin
requirement, ACL is publishing notice on the occurrence of cardiovascular
of the proposed collection of Food and Drug Administration events in patients with recent acute
information set forth in this document. coronary syndrome. The results from
mstockstill on DSK4VPTVN1PROD with NOTICES

With respect to the following collection [Docket No. FDA–2015–N–0001] this trial have been submitted to support
of information, ACL invites comments supplemental new drug applications
on: (1) Whether the proposed collection Endocrinologic and Metabolic Drugs 21445/S–038 and 21687/S–054, ZETIA
of information is necessary for the Advisory Committee; Notice of Meeting (ezetimibe) and VYTORIN (ezetimibe/
proper performance of ACL’s functions, AGENCY: Food and Drug Administration, simvastatin) tablets, respectively, by
including whether the information will HHS. MSD International GmbH. The proposed
have practical utility; (2) the accuracy of indication for ZETIA (in combination
ACTION: Notice.
ACL’s estimate of the burden of the with a statin) and VYTORIN is to reduce

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Document Created: 2015-12-14 14:53:43
Document Modified: 2015-12-14 14:53:43

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 69971

80 FR 69971 - Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 218 (November 12, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration