81 FR 31643 - Diabetes Outcome Measures Beyond Hemoglobin A1c: CDER Public Workshop

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 97 (May 19, 2016)

Page Range		31643-31643
FR Document		2016-11846

The Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER), is sponsoring a public workshop entitled ``Diabetes Outcome Measures Beyond Hemoglobin A1c (HbA1c).'' The purpose of this public workshop is to have a forum for dialogue with the public, patients, patient advocacy groups and industry to gain greater appreciation on the extent to which the current regulatory paradigm for antidiabetic drug therapies addresses the needs of patients with diabetes and to identify additional outcomes, beyond HbA1c, that are of direct relevance and importance to patients living with the disease.

Federal Register, Volume 81 Issue 97 (Thursday, May 19, 2016)

[Federal Register Volume 81, Number 97 (Thursday, May 19, 2016)]
[Notices]
[Page 31643]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-11846]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Diabetes Outcome Measures Beyond Hemoglobin A1c: CDER Public 
Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration's (FDA) Center for Drug 
Evaluation and Research (CDER), is sponsoring a public workshop 
entitled ``Diabetes Outcome Measures Beyond Hemoglobin A1c (HbA1c).'' 
The purpose of this public workshop is to have a forum for dialogue 
with the public, patients, patient advocacy groups and industry to gain 
greater appreciation on the extent to which the current regulatory 
paradigm for antidiabetic drug therapies addresses the needs of 
patients with diabetes and to identify additional outcomes, beyond 
HbA1c, that are of direct relevance and importance to patients living 
with the disease.

DATES: The public workshop will be held on August 29, 2016, from 9 a.m. 
to 5 p.m.

ADDRESSES: The public workshop will be held at FDA's White Oak campus, 
10903 New Hampshire Ave., Building 31 (The Great Room B, and C), Silver 
Spring, MD 20993. Entrance for the public workshop participants (non-
FDA employees) is through Building 1 where routine security check 
procedures will be performed. For parking and security information, 
please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.

FOR FURTHER INFORMATION CONTACT: Francis Kalush, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993-0002, [email protected].

SUPPLEMENTARY INFORMATION: FDA is announcing a public workshop entitled 
``Diabetes Outcome Measures Beyond Hemoglobin A1c.'' This public 
workshop is intended to gain greater appreciation on the extent to 
which the current regulatory paradigm for drugs to treat diabetes 
addresses the needs of patients with diabetes, to identify what the 
most urgent unmet patient needs are and to identify measures beyond 
HbA1c that would reliably capture outcomes important to the health or 
quality of life of patients living with diabetes. The ultimate purpose 
of identifying and qualifying these outcomes for regulatory purposes 
would be to continue to support the development of novel therapies that 
directly address the needs of patients living with the disease. There 
will be an opportunity for questions and answers following each 
presentation.
    Registration: There is no registration fee to attend the public 
workshop. Early registration is recommended because seating is limited, 
and registration will be on a first-come, first-served basis. There 
will be no onsite registration. Persons interested in attending this 
workshop must register online at http://www.fda.gov/Drugs/NewsEvents/ucm499281.htm by July 29, 2016. For those without Internet access, 
please contact Francis Kalush (see FOR FURTHER INFORMATION CONTACT) to 
register.
    If you need special accommodations due to a disability, please 
contact Francis Kalush (see FOR FURTHER INFORMATION CONTACT) at least 7 
days in advance.
    Transcripts: A transcript of the workshop will be available for 
review at the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and 
on the Internet at http://www.regulations.gov approximately 30 days 
after the workshop. Transcripts will also be available in either hard 
copy or on CD-ROM, after submission of a Freedom of Information 
request. The Freedom of Information office address is available on the 
Agency's Web site at http://www.fda.gov.

    Dated: May 13, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-11846 Filed 5-18-16; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 97 / Thursday, May 19, 2016 / Notices 31643

when, because of unforeseen groups and industry to gain greater If you need special accommodations
circumstances, a quorum is or will be appreciation on the extent to which the due to a disability, please contact
lacking. Because of the size of the current regulatory paradigm for Francis Kalush (see FOR FURTHER
Committee and the variety in the types antidiabetic drug therapies addresses INFORMATION CONTACT) at least 7 days in
of issues that it will consider, FDA may, the needs of patients with diabetes and advance.
in connection with a particular to identify additional outcomes, beyond Transcripts: A transcript of the
committee meeting, specify a quorum HbA1c, that are of direct relevance and workshop will be available for review at
that is less than a majority of the current importance to patients living with the the Division of Dockets Management
voting members. The Agency’s disease. (HFA–305), Food and Drug
regulations (21 CFR 14.22(d)) authorize DATES: The public workshop will be Administration, 5630 Fishers Lane, Rm.
a committee charter to specify quorum held on August 29, 2016, from 9 a.m. to 1061, Rockville, MD 20852, and on the
requirements. 5 p.m. Internet at http://www.regulations.gov
If functioning as a medical device approximately 30 days after the
ADDRESSES: The public workshop will
panel, a non-voting representative of workshop. Transcripts will also be
be held at FDA’s White Oak campus,
consumer interests and a non-voting available in either hard copy or on CD–
10903 New Hampshire Ave., Building
representative of industry interests will ROM, after submission of a Freedom of
31 (The Great Room B, and C), Silver
be included in addition to the voting Information request. The Freedom of
Spring, MD 20993. Entrance for the
members. Information office address is available
Further information regarding the public workshop participants (non-FDA
employees) is through Building 1 where on the Agency’s Web site at http://
most recent charter and other www.fda.gov.
information can be found at http:// routine security check procedures will
www.fda.gov/AdvisoryCommittees/ be performed. For parking and security Dated: May 13, 2016.
CommitteesMeetingMaterials/ information, please refer to http://www. Leslie Kux,
BloodVaccinesandOtherBiologics/ fda.gov/AboutFDA/WorkingatFDA/ Associate Commissioner for Policy.
BloodProductsAdvisoryCommittee/ BuildingsandFacilities/WhiteOak [FR Doc. 2016–11846 Filed 5–18–16; 8:45 am]
CampusInformation/ucm241740.htm.
ucm121602.htm or by contacting the BILLING CODE 4164–01–P
Designated Federal Officer (see FOR FOR FURTHER INFORMATION CONTACT:
FURTHER INFORMATION CONTACT). In light Francis Kalush, Center for Drug
of the fact that no change has been made Evaluation and Research, Food and DEPARTMENT OF HEALTH AND
to the committee name or description of Drug Administration, 10903 New HUMAN SERVICES
duties, no amendment will be made to Hampshire Ave., Silver Spring, MD
21 CFR 14.100. 20993–0002, DIABHbA1c-CDER@ Food and Drug Administration
This document is issued under the fda.hhs.gov.
Federal Advisory Committee Act (5 SUPPLEMENTARY INFORMATION: FDA is [Docket No. FDA–2016–N–0001]
U.S.C. app.). For general information announcing a public workshop entitled
related to FDA advisory committees, ‘‘Diabetes Outcome Measures Beyond Advisory Committee; Peripheral and
please visit us at http://www.fda.gov/ Hemoglobin A1c.’’ This public Central Nervous System Drugs
AdvisoryCommittees/default.htm. workshop is intended to gain greater Advisory Committee, Renewal
Dated: May 13, 2016. appreciation on the extent to which the AGENCY: Food and Drug Administration,
Jill Hartzler Warner,
current regulatory paradigm for drugs to HHS.
treat diabetes addresses the needs of
Associate Commissioner for Special Medical ACTION:Notice; renewal of advisory
Programs.
patients with diabetes, to identify what
the most urgent unmet patient needs are committee.
[FR Doc. 2016–11774 Filed 5–18–16; 8:45 am]
and to identify measures beyond HbA1c SUMMARY: The Food and Drug
BILLING CODE 4164–01–P
that would reliably capture outcomes Administration (FDA) is announcing the
important to the health or quality of life renewal of the Peripheral and Central
of patients living with diabetes. The Nervous System Drugs Advisory
DEPARTMENT OF HEALTH AND
ultimate purpose of identifying and Committee by the Commissioner of
HUMAN SERVICES
qualifying these outcomes for regulatory Food and Drugs (the Commissioner).
Food and Drug Administration purposes would be to continue to The Commissioner has determined that
support the development of novel it is in the public interest to renew the
[Docket No. FDA–2016–N–0001] therapies that directly address the needs Peripheral and Central Nervous System
of patients living with the disease. Drugs Advisory Committee for an
Diabetes Outcome Measures Beyond
There will be an opportunity for additional 2 years beyond the charter
Hemoglobin A1c: CDER Public
questions and answers following each expiration date. The new charter will be
Workshop
presentation. in effect until June 4, 2018.
AGENCY: Food and Drug Administration, Registration: There is no registration
fee to attend the public workshop. Early DATES: Authority for the Peripheral and
HHS.
registration is recommended because Central Nervous System Drugs Advisory
ACTION: Notice of public workshop. Committee will expire on June 4, 2016,
seating is limited, and registration will
SUMMARY: The Food and Drug be on a first-come, first-served basis. unless the Commissioner formally
Administration’s (FDA) Center for Drug There will be no onsite registration. determines that renewal is in the public
mstockstill on DSK3G9T082PROD with NOTICES

Evaluation and Research (CDER), is Persons interested in attending this interest.
sponsoring a public workshop entitled workshop must register online at http:// FOR FURTHER INFORMATION CONTACT:
‘‘Diabetes Outcome Measures Beyond www.fda.gov/Drugs/NewsEvents/ Moon Hee V. Choi, Center for Drug
Hemoglobin A1c (HbA1c).’’ The ucm499281.htm by July 29, 2016. For Evaluation and Research, Food and
purpose of this public workshop is to those without Internet access, please Drug Administration, 10903 New
have a forum for dialogue with the contact Francis Kalush (see FOR FURTHER Hampshire Ave., Bldg. 31, Rm. 2417,
public, patients, patient advocacy INFORMATION CONTACT) to register. Silver Spring, MD 20993–0002, 301–

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Document Created: 2018-02-07 15:01:27
Document Modified: 2018-02-07 15:01:27

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 public workshop.
Dates		The public workshop will be held on August 29, 2016, from 9 a.m. to 5 p.m.
Contact		Francis Kalush, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, DIABHbA1c- [email protected]
FR Citation		81 FR 31643

81 FR 31643 - Diabetes Outcome Measures Beyond Hemoglobin A1c: CDER Public Workshop

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 97 (May 19, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration