82_FR_18988 82 FR 18911 - Science Board to the Food and Drug Administration Advisory Committee; Notice of Meeting

82 FR 18911 - Science Board to the Food and Drug Administration Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

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

Page Range18911-18912
FR Document2017-08177

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Science Board to the FDA. The general function of the committee is to provide advice to the Commissioner of Food and Drugs and other appropriate officials on specific, complex scientific and technical issues important to FDA and its mission, including emerging issues within the scientific community. Additionally, the Science Board provides advice to the Agency on keeping pace with technical and scientific developments including in regulatory science, input into the Agency's research agenda and on upgrading its scientific and research facilities and training opportunities. It will also provide, where requested, expert review of Agency sponsored intramural and extramural scientific research programs. This meeting is open to the public.

Federal Register, Volume 82 Issue 77 (Monday, April 24, 2017) 
[Federal Register Volume 82, Number 77 (Monday, April 24, 2017)]
[Notices]
[Pages 18911-18912]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-08177]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Science Board to the Food and Drug Administration Advisory 
Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming 
public advisory committee meeting of the Science Board to the FDA. The 
general function of the committee is to provide advice to the 
Commissioner of Food and Drugs and other appropriate officials on 
specific, complex scientific and technical issues important to FDA and 
its mission, including emerging issues within the scientific community. 
Additionally, the Science Board provides advice to the Agency on 
keeping pace with technical and scientific developments including in 
regulatory science, input into the Agency's research agenda and on 
upgrading its scientific and research facilities and training 
opportunities. It will also provide, where requested, expert review of 
Agency sponsored intramural and extramural scientific research 
programs. This meeting is open to the public.

DATES: The meeting will be held on May 9, 2017, from 2 p.m. to 5 p.m.

ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave, Bldg. 31, Rm. 
1404, Silver Spring, MD 20993. This meeting will take place via audio 
Webcast. To access the link for the audio Webcast check the Agency's 
Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and 
scroll down to the appropriate advisory committee meeting link. Answers 
to commonly asked questions including information regarding special 
accommodations due to a disability, visitor parking, and transportation 
may be accessed at: http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    For those unable to access the audio Webcast, a conference room 
with a speakerphone will be reserved at the meeting location provided 
at the top of the ADDRESSES section. Seating is limited and is 
available on a first come, first served basis.

FOR FURTHER INFORMATION CONTACT: Rakesh Raghuwanshi, Office of the 
Chief Scientist, Office of the Commissioner, Food and Drug 
Administration, 10903 New Hampshire Ave, Bldg. 1, Rm. 3309, Silver 
Spring MD 20993, 301-796-4769, [email protected], or FDA 
Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in 
the Washington, DC area). A notice in the Federal Register about last 
minute modifications that impact a previously announced advisory 
committee meeting cannot always be published quickly enough to provide 
timely notice. Therefore, you should always check the Agency's Web site 
at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to 
the appropriate advisory committee meeting link, or call the advisory 
committee information line to learn about possible modifications before 
coming to the meeting.

SUPPLEMENTARY INFORMATION: 
    Agenda: The Science Board will provide recommendations on the 
Agency's Innovation Funds work plan as prescribed in section 1002 of 
the 21st Century Cures Act (Pub. L. 114-255).
    FDA intends to make background material available to the public no 
later than 2 business days before the meeting. If FDA is unable to post 
the background material on its Web site prior to the meeting, the 
background material will be made publicly available at the location of 
the advisory committee

[[Page 18912]]

meeting, and the background material will be posted on FDA's Web site 
after the meeting. Background material is available at http://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 http://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

Federal Register / Vol. 82, No. 77 / Monday, April 24, 2017 / Notices 18911 Advisory Committee Information Line, Persons attending FDA’s advisory research programs. This meeting is open 1–800–741–8138 (301–443–0572 in the committee meetings are advised that the to the public. Washington, DC area). A notice in the Agency is not responsible for providing DATES: The meeting will be held on May Federal Register about last minute access to electrical outlets. 9, 2017, from 2 p.m. to 5 p.m. modifications that impact a previously FDA welcomes the attendance of the ADDRESSES: FDA White Oak Campus, announced advisory committee meeting public at its advisory committee 10903 New Hampshire Ave, Bldg. 31, cannot always be published quickly meetings and will make every effort to Rm. 1404, Silver Spring, MD 20993. enough to provide timely notice. accommodate persons with disabilities. This meeting will take place via audio Therefore, you should always check the If you require accommodations due to a Webcast. To access the link for the Agency’s Web site at http:// disability, please contact CAPT Serina audio Webcast check the Agency’s Web www.fda.gov/AdvisoryCommittees/ Hunter-Thomas at least 7 days in site at http://www.fda.gov/ default.htm and scroll down to the advance of the meeting. AdvisoryCommittees/default.htm and appropriate advisory committee meeting FDA is committed to the orderly scroll down to the appropriate advisory link, or call the advisory committee conduct of its advisory committee committee meeting link. Answers to information line to learn about possible meetings. Please visit our Web site at: commonly asked questions including modifications before coming to the http://www.fda.gov/ information regarding special meeting. AdvisoryCommittees/ accommodations due to a disability, SUPPLEMENTARY INFORMATION: AboutAdvisoryCommittees/ visitor parking, and transportation may Agenda: On May 17, 2017, the ucm111462.htm for procedures on be accessed at: http://www.fda.gov/ VRBPAC will meet in an open session public conduct during advisory AdvisoryCommittees/ to discuss considerations for evaluation committee meetings. AboutAdvisoryCommittees/ of Respiratory Syncytial Virus vaccine Notice of this meeting is given under ucm408555.htm. candidates in seronegative infants. FDA the Federal Advisory Committee Act (5 For those unable to access the audio intends to make background material U.S.C. app. 2). Webcast, a conference room with a available to the public no later than 2 Dated: April 18, 2017. speakerphone will be reserved at the business days before the meeting. If meeting location provided at the top of Anna K. Abram, FDA is unable to post the background the ADDRESSES section. Seating is Deputy Commissioner for Policy, Planning, material on its Web site prior to the limited and is available on a first come, Legislation, and Analysis. meeting, the background material will first served basis. [FR Doc. 2017–08176 Filed 4–21–17; 8:45 am] be made publicly available at the FOR FURTHER INFORMATION CONTACT: BILLING CODE 4164–01–P location of the advisory committee Rakesh Raghuwanshi, Office of the meeting, and the background material Chief Scientist, Office of the will be posted on FDA’s Web site after DEPARTMENT OF HEALTH AND Commissioner, Food and Drug the meeting. Background material is HUMAN SERVICES Administration, 10903 New Hampshire available at http://www.fda.gov/ Ave, Bldg. 1, Rm. 3309, Silver Spring AdvisoryCommittees/Calendar/ Food and Drug Administration MD 20993, 301–796–4769, default.htm. Scroll down to the rakesh.raghuwanshi@fda.hhs.gov, or appropriate advisory committee meeting [Docket No. FDA–2017–N–0001] FDA Advisory Committee Information link. Line, 1–800–741–8138 (301–443–0572 Science Board to the Food and Drug in the Washington, DC area). A notice in Procedure: Interested persons may Administration Advisory Committee; the Federal Register about last minute present data, information, or views, Notice of Meeting modifications that impact a previously orally or in writing, on issues pending before the committee. Written AGENCY: Food and Drug Administration, announced advisory committee meeting submissions may be made to the contact HHS. cannot always be published quickly person on or before May 10, 2017. Oral ACTION: Notice. enough to provide timely notice. presentations from the public will be Therefore, you should always check the scheduled between approximately 1:15 SUMMARY: The Food and Drug Agency’s Web site at http:// p.m. and 2:15 p.m. Those individuals Administration (FDA) announces a www.fda.gov/AdvisoryCommittees/ interested in making formal oral forthcoming public advisory committee default.htm and scroll down to the presentations should notify the contact meeting of the Science Board to the appropriate advisory committee meeting person and submit a brief statement of FDA. The general function of the link, or call the advisory committee the general nature of the evidence or committee is to provide advice to the information line to learn about possible arguments they wish to present, the Commissioner of Food and Drugs and modifications before coming to the names and addresses of proposed other appropriate officials on specific, meeting. participants, and an indication of the complex scientific and technical issues SUPPLEMENTARY INFORMATION: approximate time requested to make important to FDA and its mission, Agenda: The Science Board will their presentation on or before May 2, including emerging issues within the provide recommendations on the 2017. Time allotted for each scientific community. Additionally, the Agency’s Innovation Funds work plan presentation may be limited. If the Science Board provides advice to the as prescribed in section 1002 of the 21st number of registrants requesting to Agency on keeping pace with technical Century Cures Act (Pub. L. 114–255). speak is greater than can be reasonably and scientific developments including FDA intends to make background jstallworth on DSK7TPTVN1PROD with NOTICES accommodated during the scheduled in regulatory science, input into the material available to the public no later open public hearing session, FDA may Agency’s research agenda and on than 2 business days before the meeting. conduct a lottery to determine the upgrading its scientific and research If FDA is unable to post the background speakers for the scheduled open public facilities and training opportunities. It material on its Web site prior to the hearing session. The contact person will will also provide, where requested, meeting, the background material will notify interested persons regarding their expert review of Agency sponsored be made publicly available at the request to speak by May 3, 2017. intramural and extramural scientific location of the advisory committee VerDate Sep<11>2014 13:48 Apr 21, 2017 Jkt 241001 PO 00000 Frm 00023 Fmt 4703 Sfmt 4703 E:\FR\FM\24APN1.SGM 24APN1

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


Document Created: 2017-04-22 00:11:13
Document Modified: 2017-04-22 00:11:13
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.
DatesThe meeting will be held on May 9, 2017, from 2 p.m. to 5 p.m.
ContactRakesh Raghuwanshi, Office of the Chief Scientist, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave, Bldg. 1, Rm. 3309, Silver Spring MD 20993, 301-796-4769, [email protected], or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting.
FR Citation82 FR 18911 
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR