82_FR_18989 82 FR 18912 - Reducing the Risk of Preventable Adverse Drug Events Associated With Hypoglycemia in the Older Population; Public Workshop

82 FR 18912 - Reducing the Risk of Preventable Adverse Drug Events Associated With Hypoglycemia in the Older Population; Public Workshop

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 77 (April 24, 2017)

Page Range18912-18913
FR Document2017-08178

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.

Federal Register, Volume 82 Issue 77 (Monday, April 24, 2017) 
[Federal Register Volume 82, Number 77 (Monday, April 24, 2017)]
[Notices]
[Pages 18912-18913]
From the Federal Register Online  [www.thefederalregister.org]
[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.

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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 http://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: 
[email protected].

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: http://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

18912 Federal Register / Vol. 82, No. 77 / Monday, April 24, 2017 / Notices meeting, and the background material DEPARTMENT OF HEALTH AND I. Background will be posted on FDA’s Web site after HUMAN SERVICES FDA CDER, PASES, is announcing a the meeting. Background material is 1-day public workshop entitled available at http://www.fda.gov/ Food and Drug Administration ‘‘Reducing the Risk of Preventable AdvisoryCommittees/Calendar/ Adverse Drug Events associated with default.htm. Scroll down to the [Docket No. FDA–2017–N–0001] Hypoglycemia in the Older Population.’’ appropriate advisory committee meeting The purpose of this workshop is to: (1) link. Reducing the Risk of Preventable Adverse Drug Events Associated With Discuss the importance of Procedure: Interested persons may individualized glycemic control targets present data, information, or views, Hypoglycemia in the Older Population; Public Workshop for older patients with diabetes, in order orally or in writing, on issues pending to reduce the risk of serious before the committee. Written AGENCY: Food and Drug Administration, hypoglycemia; (2) identify and discuss submissions may be made to the contact HHS. medication safety efforts, both those that person on or before May 2, 2017. Oral ACTION: Notice of public workshop. are part of the Safe Use Initiative and presentations from the public will be those external to FDA, that are of direct scheduled between approximately 4 SUMMARY: The Food and Drug relevance and importance to older p.m. and 5 p.m. Those individuals Administration’s (FDA) Center for Drug patients living with the disease; (3) interested in making formal oral Evaluation and Research (CDER), discuss future areas of research which presentations should notify the contact Professional Affairs and Stakeholder could be explored to reduce the risk of person and submit a brief statement of Engagement Staff (PASES), is serious hypoglycemia in older diabetic the general nature of the evidence or announcing a 1-day public workshop patients; and (4) disseminate the results arguments they wish to present, the entitled ‘‘Reducing the Risk of of this discussion to inform patients, names and addresses of proposed Preventable Adverse Drug Events patient advocates, and health care participants, and an indication of the Associated with Hypoglycemia in the practitioners. approximate time requested to make Older Population.’’ The purpose of this their presentation on or before April 24, workshop is to discuss the importance II. Topics for Discussion at the Public 2017. Time allotted for each of individualized glycemic control Workshop presentation may be limited. If the targets for older patients with diabetes; The symposium will feature number of registrants requesting to to reduce the risk of serious presentations on the scope of speak is greater than can be reasonably hypoglycemia; identify and discuss hypoglycemia-related adverse drug accommodated during the scheduled medication safety efforts, both those that events in the older population, the risks open public hearing session, FDA may are part of the Safe Use Initiative and and benefits of various degrees of conduct a lottery to determine the those external to FDA, that are of direct glycemic control, factors affecting speakers for the scheduled open public relevance and importance to older patient centered care, research into hearing session. The contact person will patients living with the disease; discuss effective diabetes management, and the notify interested persons regarding their future areas of research which could be concept and translation of request to speak by April 25, 2017. explored to reduce the risk of serious individualized glycemic targets to Persons attending FDA’s advisory hypoglycemia in older diabetic patients; minimize adverse events in practice committee meetings are advised that the and disseminate the results of this settings. Presenters will represent Agency is not responsible for providing discussion to inform patients, patient multidisciplinary backgrounds from access to electrical outlets. advocates, and health care practitioners. government, academia, patient safety FDA welcomes the attendance of the DATES: The public workshop will be groups, health care industry, and public at its advisory committee held on September 12, 2017, from 9 a.m. clinicians. There will be opportunities meetings and will make every effort to to 4 p.m. for collaboration between speakers and accommodate persons with disabilities. ADDRESSES: The public workshop will attendees as well as question and If you require accommodations due to a be held at FDA White Oak Campus, answer sessions. disability, please contact Rakesh 10903 New Hampshire Ave., Bldg. 31 III. Participating in the Public Raghuwanshi at least 7 days in advance Conference Center, the Great Room (Rm. Workshop of the meeting. 1503), Silver Spring, MD 20993. FDA is committed to the orderly Entrance for the public workshop Registration: To register for the public conduct of its advisory committee participants (non-FDA employees) is workshop, please visit the following meetings. Please visit our Web site at through Building 1, where routine Web site: http://wcms.fda.gov/FDAgov/ http://www.fda.gov/ security check procedures will be Drugs/NewsEvents/ AdvisoryCommittees/ performed. For parking and security ucm538666.htm?SSContributor=true. AboutAdvisoryCommittees/ information, please refer to http:// Please provide complete contact ucm111462.htm for procedures on www.fda.gov/AboutFDA/ information for each attendee, including public conduct during advisory WorkingatFDA/BuildingsandFacilities/ name, title, affiliation, address, email, committee meetings. WhiteOakCampusInformation/ and telephone. Notice of this meeting is given under ucm241740.htm. Registration is free and based on the Federal Advisory Committee Act (5 space availability, with priority given to FOR FURTHER INFORMATION CONTACT: early registrants. Persons interested in jstallworth on DSK7TPTVN1PROD with NOTICES U.S.C. app. 2). Scott Winiecki, Center for Drug attending this public workshop must Dated: April 18, 2017. Evaluation and Research, Food and register by August 29, 2017, midnight Anna K. Abram, Drug Administration, 10903 New Eastern Time. Early registration is Deputy Commissioner for Policy, Planning, Hampshire Ave., Silver Spring, MD recommended because seating is Legislation, and Analysis. 20993–0002, 240–402–8824, email: limited; therefore, FDA may limit the [FR Doc. 2017–08177 Filed 4–21–17; 8:45 am] CDERSafeUseInitiative@fda.hhs.gov. number of participants from each BILLING CODE 4164–01–P SUPPLEMENTARY INFORMATION: organization. If time and space permit, VerDate Sep<11>2014 13:48 Apr 21, 2017 Jkt 241001 PO 00000 Frm 00024 Fmt 4703 Sfmt 4703 E:\FR\FM\24APN1.SGM 24APN1

Federal Register / Vol. 82, No. 77 / Monday, April 24, 2017 / Notices 18913 onsite registration on the day of the the drug review process. To support this Office of Regulatory Affairs District public workshop will be provided primary goal, CDER has initiated Offices in the firms’ respective regions. beginning at 7:30 a.m. various training and development Firms that want to learn more about this For those without Internet access, programs to promote high performance training opportunity or that are please contact Scott Winiecki, (see FOR in its regulatory project management interested in offering a site tour should FURTHER INFORMATION CONTACT) to staff. CDER seeks to significantly respond by sending a proposed agenda register. If you need special enhance review efficiency and review by email directly to Dan Brum (see accommodations due to a disability, quality by providing the staff with a DATES and FOR FURTHER INFORMATION please contact Scott Winiecki no later better understanding of the CONTACT). than September 1, 2017. pharmaceutical industry and its Dated: April 17, 2017. Transcripts: A transcript of the public operations. To this end, CDER is Anna K. Abram, workshop will be accessible at https:// continuing its training program to give regulatory project managers the Deputy Commissioner for Policy, Planning, www.regulations.gov approximately 30 Legislation, and Analysis. days after the workshop. It may also be opportunity to tour pharmaceutical [FR Doc. 2017–08183 Filed 4–21–17; 8:45 am] viewed at the Division of Dockets facilities. The goals are to provide the following: (1) Firsthand exposure to BILLING CODE 4164–01–P Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. industry’s drug development processes 1061, Rockville, MD 20852. and (2) a venue for sharing information about project management procedures DEPARTMENT OF HEALTH AND Dated: April 18, 2017. HUMAN SERVICES (but not drug-specific information) with Anna K. Abram, industry representatives. Food and Drug Administration Deputy Commissioner for Policy, Planning, Legislation, and Analysis. II. The Site Tours Program [Docket No. FDA–2007–D–0369] [FR Doc. 2017–08178 Filed 4–21–17; 8:45 am] In this program, over a 2- to 3-day BILLING CODE 4164–01–P period, small groups (five or less) of Product-Specific Guidance for regulatory project managers, including a Naloxone Hydrochloride; New Draft senior level regulatory project manager, Guidance for Industry; Availability DEPARTMENT OF HEALTH AND can observe operations of HUMAN SERVICES AGENCY: Food and Drug Administration, pharmaceutical manufacturing and/or HHS. packaging facilities, pathology/ Food and Drug Administration toxicology laboratories, and regulatory ACTION: Notice of availability. [Docket No. FDA–2014–N–0179] affairs operations. Neither this tour nor SUMMARY: The Food and Drug any part of the program is intended as Administration (FDA, the Agency, or Training Program for Regulatory a mechanism to inspect, assess, judge, we) is announcing the availability of a Project Managers; Information or perform a regulatory function, but is new draft guidance for industry on Available to Industry meant rather to improve mutual generic naloxone hydrochloride nasal understanding and to provide an avenue AGENCY: Food and Drug Administration, spray entitled ‘‘Draft Guidance on for open dialogue. During the Site Tours HHS. Naloxone Hydrochloride.’’ The new Program, regulatory project managers ACTION: Notice. draft guidance, when finalized, will will also participate in daily workshops provide product-specific SUMMARY: The Food and Drug with their industry counterparts, recommendations on, among other Administration’s (FDA’s) Center for focusing on selective regulatory issues things, the design of bioequivalence Drug Evaluation and Research (CDER) is important to both CDER staff and (BE) studies to support abbreviated new announcing the continuation of the industry. The primary objective of the drug applications (ANDAs) for naloxone Regulatory Project Management Site daily workshops is to learn about the hydrochloride nasal spray. Tours and Regulatory Interaction team approach to drug development, including drug discovery, preclinical DATES: Although you can comment on Program (the Site Tours Program). The any guidance at any time (see 21 CFR purpose of this document is to invite evaluation, tracking mechanisms, and regulatory submission operations. The 10.115(g)(5)), to ensure that the Agency pharmaceutical companies interested in considers your comment on this draft participating in this program to contact overall benefit to regulatory project managers will be exposure to project guidance before it begins work on the CDER. final versions of the guidance, submit management, team techniques, and DATES: Pharmaceutical companies may either electronic or written comments processes employed by the send proposed agendas to the Agency by pharmaceutical industry. By on the draft guidances by June 23, 2017. June 23, 2017. participating in this program, the ADDRESSES: You may submit comments FOR FURTHER INFORMATION CONTACT: Dan regulatory project manager will grow as follows: Brum, Center for Drug Evaluation and professionally by gaining a better Research, Food and Drug Electronic Submissions understanding of industry processes and Administration, 10903 New Hampshire procedures. Submit electronic comments in the Ave., Bldg. 22, Rm. 5480, Silver Spring, following way: MD 20993–0002, 301–796–0578, III. Site Selection • Federal eRulemaking Portal: dan.brum@fda.hhs.gov. All travel expenses associated with https://www.regulations.gov. Follow the jstallworth on DSK7TPTVN1PROD with NOTICES SUPPLEMENTARY INFORMATION: the Site Tours Program will be the instructions for submitting comments. responsibility of CDER; therefore, Comments submitted electronically, I. Background selection will be based on the including attachments, to https:// An important part of CDER’s availability of funds and resources for www.regulations.gov will be posted to commitment to make safe and effective each fiscal year. Selection will also be the docket unchanged. Because your drugs available to all Americans is based on firms having a favorable comment will be made public, you are optimizing the efficiency and quality of facility status as determined by FDA’s solely responsible for ensuring that your VerDate Sep<11>2014 13:48 Apr 21, 2017 Jkt 241001 PO 00000 Frm 00025 Fmt 4703 Sfmt 4703 E:\FR\FM\24APN1.SGM 24APN1


Document Created: 2017-04-22 00:11:09
Document Modified: 2017-04-22 00:11:09
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of public workshop.
DatesThe public workshop will be held on September 12, 2017, from 9 a.m. to 4 p.m.
ContactScott Winiecki, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 240-402-8824, email: [email protected]
FR Citation82 FR 18912 
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