Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments, 53446-53448 [2019-21834]

Download as PDF 53446 Federal Register / Vol. 84, No. 194 / Monday, October 7, 2019 / Notices Administration for Children and Families Submission for OMB Review; Trafficking Victim Assistance Program Data Collection (OMB #0970–0467) Office on Trafficking in Persons; Administration for Children and Families; HHS. ACTION: Request for public comment. AGENCY: The Office on Trafficking in Persons (OTIP), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is requesting to reinstate a previously approved information collection with revisions to information collected on clients enrolled in the Trafficking Victim Assistance Grant Program. DATES: Comments due within 30 days of publication. OMB is required to make a decision concerning the collection of information between 30 and 60 days after publication of this document in the Federal Register. Therefore, a comment is best assured of having its full effect if OMB receives it within 30 days of publication. SUMMARY: Written comments and recommendations for the proposed information collection should be sent directly to the following: Office of Management and Budget, Paperwork Reduction Project, Email: OIRA_ SUBMISSION@OMB.EOP.GOV, Attn: Desk Officer for the Administration for Children and Families. Copies of the proposed collection may be obtained by emailing infocollection@ acf.hhs.gov. Alternatively, copies can also be obtained by writing to the Administration for Children and Families, Office of Planning, Research, and Evaluation, 330 C Street SW, Washington, DC 20201, Attn: OPRE Reports Clearance Officer. All requests, emailed or written, should be identified by the title of the information collection. SUPPLEMENTARY INFORMATION: Description: OTIP awards cooperative agreements for grantees to provide case management services to foreign national victims of a severe form of trafficking in persons who have received or are actively pursuing HHS Certification or Eligibility and their qualified family members (e.g., minor dependent children of victims or family members with derivative T visas), as authorized in the Trafficking Victims Protection Act of 2000 (22 U.S.C. 7105(b)(1)(B)). ADDRESSES: DEPARTMENT OF HEALTH AND HUMAN SERVICES Grantees provide services to qualified persons through a national network of subrecipient organizations. OTIP proposes to collect information to measure grant project performance, provide technical assistance to grantees, assess program outcomes, improve program evaluation, respond to congressional inquiries and mandated reports, and inform policy and program development that is responsive to the needs of victims. The information collection captures information on participant demographics (e.g., age, sex, and country of origin), types of trafficking experienced (sex, labor, or both), types of client enrollment, types of services and benefits provided along with aggregate information on the amount of money spent on each type of service provided, the types of entities providing medical services, the amount of money provided to those entities, the amount of money expended on each type of client enrollment, types of partnerships developed through the grant with subrecipients, and the types of training and technical assistance provided to subrecipient organizations or other partners. Respondents: Trafficking Victim Assistance Program Grantees. ANNUAL BURDEN ESTIMATES Total number of respondents Instrument Client Characteristics and Enrollment Form ........................ Client Service Use and Delivery Form ................................ Client Case Closure Form ................................................... Barriers to Service Delivery and Monitoring Form .............. TVAP Spending Form .......................................................... Partnership Development Enrollment Form ........................ Partnership Development Exit form ..................................... Training Form ....................................................................... Technical Assistance Form .................................................. Estimated Total Annual Burden Hours: 2,005. Authority: 22 U.S.C. 7105. Annual number of respondents 3,300 3,300 3,300 261 261 1 1 1 1 1,100 1,100 1,100 261 261 1 1 1 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Mary B. Jones, ACF/OPRE Certifying Officer. [Docket No. FDA–2019–N–4284] [FR Doc. 2019–21759 Filed 10–4–19; 8:45 am] Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments BILLING CODE 4184–47–P AGENCY: Food and Drug Administration, HHS. Notice; establishment of a public docket; request for comments. ACTION: The Food and Drug Administration (FDA) announces a forthcoming public advisory committee SUMMARY: VerDate Sep<11>2014 18:29 Oct 04, 2019 Jkt 250001 PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 Number of responses per respondent 1 1 1 15 3 261 261 12 12 Average burden hours per response 1 .25 .167 .167 .75 .25 .083 .5 .5 Annual burden hours 1,100 275 183.7 217.935 195.75 21.75 7.221 2 2 meeting of the Endocrinologic and Metabolic Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document. DATES: The meeting will be held on November 13, 2019, from 8 a.m. to 5 p.m. ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993–0002. Answers to commonly asked questions including information regarding special accommodations due to a disability, E:\FR\FM\07OCN1.SGM 07OCN1 Federal Register / Vol. 84, No. 194 / Monday, October 7, 2019 / Notices visitor parking, and transportation may be accessed at: https://www.fda.gov/ AdvisoryCommittees/ AboutAdvisoryCommittees/ ucm408555.htm. FDA is establishing a docket for public comment on this meeting. The docket number is FDA–2019–N–4284. The docket will close on November 12, 2019. Submit either electronic or written comments on this public meeting by November 12, 2019. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before November 12, 2019. The https:// www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of November 12, 2019. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Comments received on or before October 29, 2019, will be provided to the committee. Comments received after that date will be taken into consideration by FDA. In the event that the meeting is cancelled, FDA will continue to evaluate any relevant applications or information, and consider any comments submitted to the docket, as appropriate. You may submit comments as follows: 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 comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the VerDate Sep<11>2014 18:29 Oct 04, 2019 Jkt 250001 manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). 53447 Docket: For access to the docket to read background documents or the electronic and written/paper comments Written/Paper Submissions received, go to https:// Submit written/paper submissions as www.regulations.gov and insert the follows: docket number, found in brackets in the • Mail/Hand delivery/Courier (for heading of this document, into the written/paper submissions): Dockets ‘‘Search’’ box and follow the prompts Management Staff (HFA–305), Food and and/or go to the Dockets Management Drug Administration, 5630 Fishers Staff, 5630 Fishers Lane, Rm. 1061, Lane, Rm. 1061, Rockville, MD 20852. Rockville, MD 20852. • For written/paper comments FOR FURTHER INFORMATION CONTACT: submitted to the Dockets Management LaToya Bonner, Center for Drug Staff, FDA will post your comment, as Evaluation and Research, Food and well as any attachments, except for Drug Administration, 10903 New information submitted, marked and Hampshire Ave., Bldg. 31, Rm. 2417, identified, as confidential, if submitted Silver Spring, MD 20993–0002, 301– as detailed in ‘‘Instructions.’’ Instructions: All submissions received 796–9001, Fax: 301–847–8533, email: EMDAC@fda.hhs.gov, or FDA Advisory must include the Docket No. FDA– Committee Information Line, 1–800– 2019–N–4284 for ‘‘Endocrinologic and 741–8138 (301–443–0572 in the Metabolic Drugs Advisory Committee; Washington, DC area). A notice in the Notice of Meeting; Establishment of a Federal Register about last minute Public Docket; Request for Comments.’’ modifications that impact a previously Received comments, those filed in a announced advisory committee meeting timely manner (see ADDRESSES), will be cannot always be published quickly placed in the docket and, except for enough to provide timely notice. those submitted as ‘‘Confidential Therefore, you should always check the Submissions,’’ publicly viewable at FDA’s website at https://www.fda.gov/ https://www.regulations.gov or at the AdvisoryCommittees/default.htm and Dockets Management Staff between 9 scroll down to the appropriate advisory a.m. and 4 p.m., Monday through committee meeting link, or call the Friday. advisory committee information line to • Confidential Submissions—To learn about possible modifications submit a comment with confidential before coming to the meeting. information that you do not wish to be made publicly available, submit your SUPPLEMENTARY INFORMATION: comments only as a written/paper Agenda: The committee will discuss submission. You should submit two supplemental new drug application copies total. One copy will include the (sNDA) 204629/S–020 for empagliflozin information you claim to be confidential oral tablet, sponsored by Boehringer with a heading or cover note that states Ingelheim Pharmaceuticals, Inc., for the ‘‘THIS DOCUMENT CONTAINS following proposed indication: As an CONFIDENTIAL INFORMATION.’’ FDA adjunct to insulin therapy to improve will review this copy, including the glycemic control in adults with type 1 claimed confidential information, in its diabetes mellitus. consideration of comments. The second FDA intends to make background copy, which will have the claimed material available to the public no later confidential information redacted/ than 2 business days before the meeting. blacked out, will be available for public If FDA is unable to post the background viewing and posted on https:// material on its website prior to the www.regulations.gov. Submit both meeting, the background material will copies to the Dockets Management Staff. be made publicly available at the If you do not wish your name and location of the advisory committee contact information be made publicly meeting, and the background material available, you can provide this will be posted on FDA’s website after information on the cover sheet and not the meeting. Background material is in the body of your comments and you available at https://www.fda.gov/ must identify the information as AdvisoryCommittees/Calendar/ ‘‘confidential.’’ Any information marked default.htm. Scroll down to the as ‘‘confidential’’ will not be disclosed appropriate advisory committee meeting except in accordance with 21 CFR 10.20 link. and other applicable disclosure law. For Procedure: Interested persons may more information about FDA’s posting present data, information, or views, of comments to public dockets, see 80 orally or in writing, on issues pending FR 56469, September 18, 2015, or access before the committee. All electronic and the information at: https://www.gpo.gov/ written submissions submitted to the fdsys/pkg/FR-2015-09-18/pdf/2015Docket (see ADDRESSES) on or before 23389.pdf. October 29, 2019, will be provided to PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 E:\FR\FM\07OCN1.SGM 07OCN1 53448 Federal Register / Vol. 84, No. 194 / Monday, October 7, 2019 / Notices the committee. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 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 October 21, 2019. 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 October 22, 2019. Persons attending FDA’s advisory committee meetings are advised that FDA is not responsible for providing access to electrical outlets. For press inquiries, please contact the Office of Media Affairs at fdaoma@ fda.hhs.gov or 301–796–4540. 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 LaToya Bonner (see FOR FURTHER INFORMATION CONTACT) at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our website 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: October 2, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–21834 Filed 10–4–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Food and Drug Administration [Docket No. FDA–2012–N–0477] [Docket No. FDA–2019–N–3500] Fit for Use Pilot Program Invitation for the Clinical Data Interchange Standards Consortium for Standard for Exchange of Nonclinical Data Implementation Guide: Version 3.1; Correction AGENCY: Food and Drug Administration, HHS. ACTION: The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of Tuesday, August 20, 2019. The document announced a ‘‘Fit for Use Pilot Program Invitation for the Clinical Data Interchange Standards Consortium for Standard for Exchange of Nonclinical Data Implementation Guide: Version 3.1.’’ The document was published with the incorrect contact name, phone number, and email address in the FOR FURTHER INFORMATION CONTACT section. This document corrects those errors. SUMMARY: FOR FURTHER INFORMATION CONTACT: Jesse Anderson, Office of Computational Science, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301– 348–1816, Jesse.Anderson@fda.hhs.gov. In FR Doc. 2019–17877, appearing on page 43139, in the Federal Register of Tuesday, August 20, 2019 (84 FR 43139), the following correction is made: On page 43140, in the first column, in the FOR FURTHER INFORMATION CONTACT section of the document, ‘‘Isaac Chang, Office of Computational Science, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 240–4027501, PRAStaff@ fda.hhs.gov.’’ is corrected to read ‘‘Jesse Anderson, Office of Computational Science, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301– 348–1816, Jesse.Anderson@ fda.hhs.gov.’’ SUPPLEMENTARY INFORMATION: BILLING CODE 4164–01–P Jkt 250001 PO 00000 Frm 00051 Fmt 4703 Food and Drug Administration, HHS. Notice. The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by November 6, 2019. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: 202– 395–7285, or emailed to oira_ submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–0078. Also include the FDA docket number found in brackets in the heading of this document. SUMMARY: [FR Doc. 2019–21784 Filed 10–4–19; 8:45 am] 18:29 Oct 04, 2019 AGENCY: ACTION: Correction. Dated: September 30, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. VerDate Sep<11>2014 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Investigational Device Exemptions Reports and Records Sfmt 4703 FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10a.m.–12p.m., 11601 Landsdown St., North Bethesda, MD 20852, 301–796–8867, PRAStaff@ fda.hhs.gov. In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. SUPPLEMENTARY INFORMATION: Investigational Device Exemptions Reports and Records OMB Control Number 0910–0078— Extension Section 520(g) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360j(g)) establishes the statutory authority to collect information regarding investigational devices and establishes rules under which new medical devices may be tested using human subjects in a clinical setting. The Food and Drug Administration Modernization Act of 1997 (Pub. L. 105– E:\FR\FM\07OCN1.SGM 07OCN1

Agencies

[Federal Register Volume 84, Number 194 (Monday, October 7, 2019)]
[Notices]
[Pages 53446-53448]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-21834]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-4284]


Endocrinologic and Metabolic Drugs Advisory Committee; Notice of 
Meeting; Establishment of a Public Docket; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of a public docket; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming 
public advisory committee meeting of the Endocrinologic and Metabolic 
Drugs Advisory Committee. The general function of the committee is to 
provide advice and recommendations to FDA on regulatory issues. The 
meeting will be open to the public. FDA is establishing a docket for 
public comment on this document.

DATES: The meeting will be held on November 13, 2019, from 8 a.m. to 5 
p.m.

ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 
Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-
0002. Answers to commonly asked questions including information 
regarding special accommodations due to a disability,

[[Page 53447]]

visitor parking, and transportation may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    FDA is establishing a docket for public comment on this meeting. 
The docket number is FDA-2019-N-4284. The docket will close on November 
12, 2019. Submit either electronic or written comments on this public 
meeting by November 12, 2019. Please note that late, untimely filed 
comments will not be considered. Electronic comments must be submitted 
on or before November 12, 2019. The https://www.regulations.gov 
electronic filing system will accept comments until 11:59 p.m. Eastern 
Time at the end of November 12, 2019. Comments received by mail/hand 
delivery/courier (for written/paper submissions) will be considered 
timely if they are postmarked or the delivery service acceptance 
receipt is on or before that date.
    Comments received on or before October 29, 2019, will be provided 
to the committee. Comments received after that date will be taken into 
consideration by FDA. In the event that the meeting is cancelled, FDA 
will continue to evaluate any relevant applications or information, and 
consider any comments submitted to the docket, as appropriate.
    You may submit comments as follows:

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 comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2019-N-4284 for ``Endocrinologic and Metabolic Drugs Advisory 
Committee; Notice of Meeting; Establishment of a Public Docket; Request 
for Comments.'' Received comments, those filed in a timely manner (see 
ADDRESSES), will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' FDA will review 
this copy, including the claimed confidential information, in its 
consideration of comments. The second copy, which will have the claimed 
confidential information redacted/blacked out, will be available for 
public viewing and posted on https://www.regulations.gov. Submit both 
copies to the Dockets Management Staff. If you do not wish your name 
and contact information be made publicly available, you can provide 
this information on the cover sheet and not in the body of your 
comments and you must identify the information as ``confidential.'' Any 
information marked as ``confidential'' will not be disclosed except in 
accordance with 21 CFR 10.20 and other applicable disclosure law. For 
more information about FDA's posting of comments to public dockets, see 
80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: LaToya Bonner, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-
796-9001, Fax: 301-847-8533, email: [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 FDA's website at 
https://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 committee will discuss supplemental new drug 
application (sNDA) 204629/S-020 for empagliflozin oral tablet, 
sponsored by Boehringer Ingelheim Pharmaceuticals, Inc., for the 
following proposed indication: As an adjunct to insulin therapy to 
improve glycemic control in adults with type 1 diabetes mellitus.
    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 website prior to the meeting, the 
background material will be made publicly available at the location of 
the advisory committee meeting, and the background material will be 
posted on FDA's website 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. 
All electronic and written submissions submitted to the Docket (see 
ADDRESSES) on or before October 29, 2019, will be provided to

[[Page 53448]]

the committee. Oral presentations from the public will be scheduled 
between approximately 1 p.m. and 2 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 October 21, 2019. 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 October 22, 2019.
    Persons attending FDA's advisory committee meetings are advised 
that FDA is not responsible for providing access to electrical outlets.
    For press inquiries, please contact the Office of Media Affairs at 
[email protected] or 301-796-4540.
    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 LaToya Bonner (see FOR FURTHER INFORMATION CONTACT) at least 7 
days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our website 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: October 2, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-21834 Filed 10-4-19; 8:45 am]
BILLING CODE 4164-01-P

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