Document ID: FDA-2016-N-0001-0054
Agency: fda
Document Type: Notice
Title: Diabetes Outcome Measures Beyond Hemoglobin A1c: CDER Public
Workshop
Posted Date: 2016-05-19T04:00Z

[Federal Register Volume 81, Number 97 (Thursday, May 19, 2016)]
[Notices]
[Page 31643]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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.

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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, DIABHbA1c-CDER@fda.hhs.gov.

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