Reducing the Risk of Preventable Adverse Drug Events Associated With Hypoglycemia in the Older Population; Public Workshop, 18912-18913 [2017-08178]

Download as PDF jstallworth on DSK7TPTVN1PROD with NOTICES 18912 Federal Register / Vol. 82, No. 77 / Monday, April 24, 2017 / Notices meeting, and the background material will be posted on FDA’s Web site after the meeting. Background material is available at https://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 2, 2017. Oral presentations from the public will be scheduled between approximately 4 p.m. and 5 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 April 24, 2017. 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 April 25, 2017. 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 Rakesh Raghuwanshi 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 https://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 18, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017–08177 Filed 4–21–17; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 13:48 Apr 21, 2017 Jkt 241001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2017–N–0001] Reducing the Risk of Preventable Adverse Drug Events Associated With Hypoglycemia in the Older Population; 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), Professional Affairs and Stakeholder Engagement Staff (PASES), is announcing a 1-day public workshop entitled ‘‘Reducing the Risk of Preventable Adverse Drug Events Associated with Hypoglycemia in the Older Population.’’ The purpose of this workshop is to discuss the importance of individualized glycemic control targets for older patients with diabetes; to reduce the risk of serious hypoglycemia; identify and discuss medication safety efforts, both those that are part of the Safe Use Initiative and those external to FDA, that are of direct relevance and importance to older patients living with the disease; discuss future areas of research which could be explored to reduce the risk of serious hypoglycemia in older diabetic patients; and disseminate the results of this discussion to inform patients, patient advocates, and health care practitioners. DATES: The public workshop will be held on September 12, 2017, from 9 a.m. to 4 p.m. ADDRESSES: The public workshop will be held at FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), 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. SUMMARY: FOR FURTHER INFORMATION CONTACT: Scott Winiecki, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993–0002, 240–402–8824, email: CDERSafeUseInitiative@fda.hhs.gov. SUPPLEMENTARY INFORMATION: PO 00000 Frm 00024 Fmt 4703 Sfmt 4703 I. Background FDA CDER, PASES, is announcing a 1-day public workshop entitled ‘‘Reducing the Risk of Preventable Adverse Drug Events associated with Hypoglycemia in the Older Population.’’ The purpose of this workshop is to: (1) Discuss the importance of individualized glycemic control targets for older patients with diabetes, in order to reduce the risk of serious hypoglycemia; (2) identify and discuss medication safety efforts, both those that are part of the Safe Use Initiative and those external to FDA, that are of direct relevance and importance to older patients living with the disease; (3) discuss future areas of research which could be explored to reduce the risk of serious hypoglycemia in older diabetic patients; and (4) disseminate the results of this discussion to inform patients, patient advocates, and health care practitioners. II. Topics for Discussion at the Public Workshop The symposium will feature presentations on the scope of hypoglycemia-related adverse drug events in the older population, the risks and benefits of various degrees of glycemic control, factors affecting patient centered care, research into effective diabetes management, and the concept and translation of individualized glycemic targets to minimize adverse events in practice settings. Presenters will represent multidisciplinary backgrounds from government, academia, patient safety groups, health care industry, and clinicians. There will be opportunities for collaboration between speakers and attendees as well as question and answer sessions. III. Participating in the Public Workshop Registration: To register for the public workshop, please visit the following Web site: https://wcms.fda.gov/FDAgov/ Drugs/NewsEvents/ ucm538666.htm?SSContributor=true. Please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone. Registration is free and based on space availability, with priority given to early registrants. Persons interested in attending this public workshop must register by August 29, 2017, midnight Eastern Time. Early registration is recommended because seating is limited; therefore, FDA may limit the number of participants from each organization. If time and space permit, E:\FR\FM\24APN1.SGM 24APN1 Federal Register / Vol. 82, No. 77 / Monday, April 24, 2017 / Notices onsite registration on the day of the public workshop will be provided beginning at 7:30 a.m. For those without Internet access, please contact Scott Winiecki, (see FOR FURTHER INFORMATION CONTACT) to register. If you need special accommodations due to a disability, please contact Scott Winiecki no later than September 1, 2017. Transcripts: A transcript of the public workshop will be accessible at https:// www.regulations.gov approximately 30 days after the workshop. It may also be viewed at the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Dated: April 18, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017–08178 Filed 4–21–17; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–N–0179] Training Program for Regulatory Project Managers; Information Available to Industry AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research (CDER) is announcing the continuation of the Regulatory Project Management Site Tours and Regulatory Interaction Program (the Site Tours Program). The purpose of this document is to invite pharmaceutical companies interested in participating in this program to contact CDER. DATES: Pharmaceutical companies may send proposed agendas to the Agency by June 23, 2017. FOR FURTHER INFORMATION CONTACT: Dan Brum, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 5480, Silver Spring, MD 20993–0002, 301–796–0578, dan.brum@fda.hhs.gov. SUPPLEMENTARY INFORMATION: jstallworth on DSK7TPTVN1PROD with NOTICES SUMMARY: I. Background An important part of CDER’s commitment to make safe and effective drugs available to all Americans is optimizing the efficiency and quality of VerDate Sep<11>2014 13:48 Apr 21, 2017 Jkt 241001 the drug review process. To support this primary goal, CDER has initiated various training and development programs to promote high performance in its regulatory project management staff. CDER seeks to significantly enhance review efficiency and review quality by providing the staff with a better understanding of the pharmaceutical industry and its operations. To this end, CDER is continuing its training program to give regulatory project managers the opportunity to tour pharmaceutical facilities. The goals are to provide the following: (1) Firsthand exposure to industry’s drug development processes and (2) a venue for sharing information about project management procedures (but not drug-specific information) with industry representatives. II. The Site Tours Program In this program, over a 2- to 3-day period, small groups (five or less) of regulatory project managers, including a senior level regulatory project manager, can observe operations of pharmaceutical manufacturing and/or packaging facilities, pathology/ toxicology laboratories, and regulatory affairs operations. Neither this tour nor any part of the program is intended as a mechanism to inspect, assess, judge, or perform a regulatory function, but is meant rather to improve mutual understanding and to provide an avenue for open dialogue. During the Site Tours Program, regulatory project managers will also participate in daily workshops with their industry counterparts, focusing on selective regulatory issues important to both CDER staff and industry. The primary objective of the daily workshops is to learn about the team approach to drug development, including drug discovery, preclinical evaluation, tracking mechanisms, and regulatory submission operations. The overall benefit to regulatory project managers will be exposure to project management, team techniques, and processes employed by the pharmaceutical industry. By participating in this program, the regulatory project manager will grow professionally by gaining a better understanding of industry processes and procedures. III. Site Selection All travel expenses associated with the Site Tours Program will be the responsibility of CDER; therefore, selection will be based on the availability of funds and resources for each fiscal year. Selection will also be based on firms having a favorable facility status as determined by FDA’s PO 00000 Frm 00025 Fmt 4703 Sfmt 4703 18913 Office of Regulatory Affairs District Offices in the firms’ respective regions. Firms that want to learn more about this training opportunity or that are interested in offering a site tour should respond by sending a proposed agenda by email directly to Dan Brum (see DATES and FOR FURTHER INFORMATION CONTACT). Dated: April 17, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017–08183 Filed 4–21–17; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2007–D–0369] Product-Specific Guidance for Naloxone Hydrochloride; New Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a new draft guidance for industry on generic naloxone hydrochloride nasal spray entitled ‘‘Draft Guidance on Naloxone Hydrochloride.’’ The new draft guidance, when finalized, will provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for naloxone hydrochloride nasal spray. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final versions of the guidance, submit either electronic or written comments on the draft guidances by June 23, 2017. ADDRESSES: You may submit comments as follows: SUMMARY: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your E:\FR\FM\24APN1.SGM 24APN1

Agencies

[Federal Register Volume 82, Number 77 (Monday, April 24, 2017)]
[Notices]
[Pages 18912-18913]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-08178]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-0001]


Reducing the Risk of Preventable Adverse Drug Events Associated 
With Hypoglycemia in the Older Population; 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), Professional Affairs and Stakeholder 
Engagement Staff (PASES), is announcing a 1-day public workshop 
entitled ``Reducing the Risk of Preventable Adverse Drug Events 
Associated with Hypoglycemia in the Older Population.'' The purpose of 
this workshop is to discuss the importance of individualized glycemic 
control targets for older patients with diabetes; to reduce the risk of 
serious hypoglycemia; identify and discuss medication safety efforts, 
both those that are part of the Safe Use Initiative and those external 
to FDA, that are of direct relevance and importance to older patients 
living with the disease; discuss future areas of research which could 
be explored to reduce the risk of serious hypoglycemia in older 
diabetic patients; and disseminate the results of this discussion to 
inform patients, patient advocates, and health care practitioners.

DATES: The public workshop will be held on September 12, 2017, from 9 
a.m. to 4 p.m.

ADDRESSES: The public workshop will be held at FDA White Oak Campus, 
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room 
(Rm. 1503), 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: Scott Winiecki, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993-0002, 240-402-8824, email: 
CDERSafeUseInitiative@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA CDER, PASES, is announcing a 1-day public workshop entitled 
``Reducing the Risk of Preventable Adverse Drug Events associated with 
Hypoglycemia in the Older Population.'' The purpose of this workshop is 
to: (1) Discuss the importance of individualized glycemic control 
targets for older patients with diabetes, in order to reduce the risk 
of serious hypoglycemia; (2) identify and discuss medication safety 
efforts, both those that are part of the Safe Use Initiative and those 
external to FDA, that are of direct relevance and importance to older 
patients living with the disease; (3) discuss future areas of research 
which could be explored to reduce the risk of serious hypoglycemia in 
older diabetic patients; and (4) disseminate the results of this 
discussion to inform patients, patient advocates, and health care 
practitioners.

II. Topics for Discussion at the Public Workshop

    The symposium will feature presentations on the scope of 
hypoglycemia-related adverse drug events in the older population, the 
risks and benefits of various degrees of glycemic control, factors 
affecting patient centered care, research into effective diabetes 
management, and the concept and translation of individualized glycemic 
targets to minimize adverse events in practice settings. Presenters 
will represent multidisciplinary backgrounds from government, academia, 
patient safety groups, health care industry, and clinicians. There will 
be opportunities for collaboration between speakers and attendees as 
well as question and answer sessions.

III. Participating in the Public Workshop

    Registration: To register for the public workshop, please visit the 
following Web site: https://wcms.fda.gov/FDAgov/Drugs/NewsEvents/ucm538666.htm?SSContributor=true. Please provide complete contact 
information for each attendee, including name, title, affiliation, 
address, email, and telephone.
    Registration is free and based on space availability, with priority 
given to early registrants. Persons interested in attending this public 
workshop must register by August 29, 2017, midnight Eastern Time. Early 
registration is recommended because seating is limited; therefore, FDA 
may limit the number of participants from each organization. If time 
and space permit,

[[Page 18913]]

onsite registration on the day of the public workshop will be provided 
beginning at 7:30 a.m.
    For those without Internet access, please contact Scott Winiecki, 
(see FOR FURTHER INFORMATION CONTACT) to register. If you need special 
accommodations due to a disability, please contact Scott Winiecki no 
later than September 1, 2017.
    Transcripts: A transcript of the public workshop will be accessible 
at https://www.regulations.gov approximately 30 days after the 
workshop. It may also be viewed at the Division of Dockets Management 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852.

    Dated: April 18, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-08178 Filed 4-21-17; 8:45 am]
 BILLING CODE 4164-01-P
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