Diabetes Outcome Measures Beyond Hemoglobin A1c: CDER Public Workshop, 31643 [2016-11846]

Download as PDF Federal Register / Vol. 81, No. 97 / Thursday, May 19, 2016 / Notices when, because of unforeseen circumstances, a quorum is or will be lacking. Because of the size of the Committee and the variety in the types of issues that it will consider, FDA may, in connection with a particular committee meeting, specify a quorum that is less than a majority of the current voting members. The Agency’s regulations (21 CFR 14.22(d)) authorize a committee charter to specify quorum requirements. If functioning as a medical device panel, a non-voting representative of consumer interests and a non-voting representative of industry interests will be included in addition to the voting members. Further information regarding the most recent charter and other information can be found at https:// www.fda.gov/AdvisoryCommittees/ CommitteesMeetingMaterials/ BloodVaccinesandOtherBiologics/ BloodProductsAdvisoryCommittee/ ucm121602.htm or by contacting the Designated Federal Officer (see FOR FURTHER INFORMATION CONTACT). In light of the fact that no change has been made to the committee name or description of duties, no amendment will be made to 21 CFR 14.100. This document is issued under the Federal Advisory Committee Act (5 U.S.C. app.). For general information related to FDA advisory committees, please visit us at https://www.fda.gov/ AdvisoryCommittees/default.htm. Dated: May 13, 2016. Jill Hartzler Warner, Associate Commissioner for Special Medical Programs. [FR Doc. 2016–11774 Filed 5–18–16; 8:45 am] BILLING CODE 4164–01–P 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. 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 mstockstill on DSK3G9T082PROD with NOTICES SUMMARY: VerDate Sep<11>2014 18:47 May 18, 2016 Jkt 238001 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 https://www. fda.gov/AboutFDA/WorkingatFDA/ BuildingsandFacilities/WhiteOak CampusInformation/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 https:// 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. PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 31643 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 https://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 https:// 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2016–N–0001] Advisory Committee; Peripheral and Central Nervous System Drugs Advisory Committee, Renewal AGENCY: Food and Drug Administration, HHS. Notice; renewal of advisory committee. ACTION: The Food and Drug Administration (FDA) is announcing the renewal of the Peripheral and Central Nervous System Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Peripheral and Central Nervous System Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until June 4, 2018. DATES: Authority for the Peripheral and Central Nervous System Drugs Advisory Committee will expire on June 4, 2016, unless the Commissioner formally determines that renewal is in the public interest. FOR FURTHER INFORMATION CONTACT: Moon Hee V. Choi, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993–0002, 301– SUMMARY: E:\FR\FM\19MYN1.SGM 19MYN1

Agencies

[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]


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

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 https://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 https://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 https://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 https://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

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.