Immunology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments, 52111-52113 [2019-21248]

Download as PDF Federal Register / Vol. 84, No. 190 / Tuesday, October 1, 2019 / Notices Jeffrey M. Zirger, Lead, Information Collection Review Office, Office of Scientific Integrity, Office of Science, Centers for Disease Control and Prevention. [FR Doc. 2019–21167 Filed 9–30–19; 8:45 am] BILLING CODE 4163–19–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2019–N–3767] Immunology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments AGENCY: Food and Drug Administration, HHS. Electronic Submissions Notice; establishment of a public docket; request for comments. jbell on DSK3GLQ082PROD with NOTICES ACTION: SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Immunology Devices Panel of the Medical Devices Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on scientific 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 and 14, 2019, from 8 a.m. to 6 p.m. ADDRESSES: Doubletree by Hilton DC North/Gaithersburg, Grand Ballroom, 620 Perry Pkwy., Gaithersburg, MD 20877. The hotel’s telephone number is 301–977–8900. The hotel’s website is at: https://doubletree3.hilton.com/en/ hotels/maryland/doubletree-by-hiltonwashington-dc-north-gaithersburgGAIGWDT/. Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: https://www.fda.gov/ AdvisoryCommittees/AboutAdvisory Committees/ucm408555.htm. FDA is establishing a docket for public comments on this meeting. The docket number is FDA–2019–N–3767. The docket will close on December 16, 2019. Submit either electronic or written comments on this public meeting to the docket by December 16, VerDate Sep<11>2014 20:09 Sep 30, 2019 Jkt 250001 2019. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before December 16, 2019. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of December 16, 2019. Comments received by mail/hand delivery/courier (for written/paper submission) 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 28, 2019, will be provided to the Committee. Comments received after that date will be taken into consideration by FDA. You may submit comments as follows: 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 Submission’’ 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. PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 52111 • 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–3767 for ‘‘Immunology Devices Panel of the Medical Devices 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 to 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 this 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/201523389.pdf. E:\FR\FM\01OCN1.SGM 01OCN1 jbell on DSK3GLQ082PROD with NOTICES 52112 Federal Register / Vol. 84, No. 190 / Tuesday, October 1, 2019 / Notices 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: Aden Asefa, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G642, Silver Spring, MD 20993–0002, 301–796–0400, FDA.MetalImplants@fda.hhs.gov; 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: On November 13 and 14, 2019, the committee will discuss the topic of immunological responses to metal-containing products regulated as medical devices. The discussion will focus on metal-containing implants as well as dental amalgam. Implants are medical devices that are placed into a surgically or naturally formed opening of the human body and are intended to remain there after the procedure for an extended period of time (typically, greater than 30 days). For decades, metal-containing implants have been used in a large number of medical specialties including cardiology, orthopedics, dentistry, gastroenterology, and neurology or neurosurgery. Recent postmarket issues with some metal-onmetal orthopedic implants and gynecological metal-containing implants have raised questions about the potential for some patients to develop unexpected or heightened biological responses to the implant. These may include local (peri-implant) adverse events and potentially systemic manifestations, which may impact a patient’s quality of life and necessitate medical or surgical intervention. While not considered an implant, dental amalgam is included in this discussion VerDate Sep<11>2014 20:09 Sep 30, 2019 Jkt 250001 because of its potential for patient and user exposure to mercury compounds and some purported similarities in the adverse biological responses and clinical manifestations elicited by some dental amalgams to that of traditional metal implants. FDA is convening this committee to promote an open public discussion of, and seek expert opinion on, currently available scientific and clinical data pertaining to the biological responses to metal implants and dental amalgam and the potential associated clinical sequelae. The committee will be asked to discuss and provide recommendations regarding: • The extent immunological responses to certain metals may cause or contribute to device-related local and systemic adverse effects as well as the potential underlying mechanism(s) involved and corresponding clinical manifestations. • Patient characteristics, metal types, and/or anatomical considerations that may put an individual at higher risk for a heightened immunological response to a metal-containing implant, and methods that may assist in their identification. • Mitigations that may reduce the risk for unintended immunological responses, including changes to device composition and design. • The evidentiary gaps in biomedical research and clinical/diagnostic management associated with immunological responses to metal implants. • The adequacy, conclusions, and evidence gaps identified by a systemic literature review aimed to assess the recent epidemiologic and clinical evidence on adverse health effects reported in relation to occupational or non-occupational exposure to dental amalgam. 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. FDA plans to provide a live webcast of the November 13 and 14, 2019, meeting of the Immunology Devices PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 Panel. While the Center for Devices and Radiological Health is working to make webcasts available to the public, there may be instances where the webcast transmission is not successful; staff will work to reestablish the transmission as soon as possible. The link for the webcast is available at: https:// collaboration.fda.gov. Further information regarding the webcast, including the web address for the webcast, will be made available at least 2 days in advance of the meeting at the following website: November 13, 2019: https:// fda.yorkcast.com/webcast/Play/ 390aea8fa1db4d42ba5 9e514b24e8f301d. November 14, 2019: https:// fda.yorkcast.com/webcast/Play/ d4174e54b00e4f7ab8ffb3ec8c99d3f51d. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. All written and electronic submissions made to the docket on or before October 28, 2019, will be provided to the panel. Oral presentations from the public will be scheduled on November 13, 2019, between approximately 2:15 p.m. and 3:15 p.m., and on November 14, 2019, between approximately 8:15 a.m. and 9:15 a.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 16, 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 17, 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 E:\FR\FM\01OCN1.SGM 01OCN1 52113 Federal Register / Vol. 84, No. 190 / Tuesday, October 1, 2019 / Notices disability, please contact AnnMarie Williams, at AnnMarie.Williams@fda.hhs.gov or 301–796–5966 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/AboutAdvisory Committees/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: September 25, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–21248 Filed 9–30–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2019–N–4329] Determination That KENALOG (Triamcinolone Acetonide) Ointment, 0.025% and 0.1%, and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The 1984 amendments include what is now section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the ‘‘Approved Drug Products With Therapeutic Equivalence Evaluations,’’ which is generally known as the ‘‘Orange Book.’’ Under FDA regulations, a drug is removed from the list if the Agency withdraws or suspends approval of the drug’s NDA or ANDA for reasons of safety or effectiveness, or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162). Under § 314.161(a) (21 CFR 314.161(a)), the Agency must determine whether a listed drug was withdrawn from sale for reasons of safety or effectiveness: (1) Before an ANDA that refers to that listed drug may be approved, (2) whenever a listed drug is voluntarily withdrawn from sale and ANDAs that refer to the listed drug have been approved, and (3) when a person petitions for such a determination under 21 CFR 10.25(a) and 10.30. Section 314.161(d) provides that if FDA determines that a listed drug was withdrawn from sale for safety or effectiveness reasons, the Agency will initiate proceedings that could result in the withdrawal of approval of the ANDAs that refer to the listed drug. FDA has become aware that the drug products listed in the table are no longer being marketed. Application No. Drug name Active ingredient(s) Strength(s) Dosage form/route NDA 011600 .......... KENALOG ...................... Triamcinolone Acetonide .. 0.025%; 0.1% .................... Ointment; Topical .............. NDA 012827 .......... NDA 018029 .......... ROBINUL ........................ ROBINUL FORTE .......... RITALIN–SR ................... 1 milligram (mg) ................ 2 mg .................................. 20 mg ................................ NDA 018164 .......... ANAPROX ...................... Glycopyrrolate ................... Glycopyrrolate ................... Methylphenidate Hydrochloride. Naproxen Sodium ............. Tablet; Oral ....................... Tablet; Oral. Extended-Release Tablet; Oral. Tablet; Oral ....................... NDA 018405 .......... AYGESTIN ..................... Norethindrone Acetate ...... NDA 018452 .......... SEPTRA ......................... NDA 018703 .......... ZANTAC 150 .................. ZANTAC 300 .................. TUSSIONEX PENNKINETIC. Sulfamethoxazole; Trimethoprim. Ranitidine Hydrochloride ... Ranitidine Hydrochloride ... Chlorpheniramine Polistirex; Hydrocodone Polistirex. Equivalent to (EQ) 250 mg Base. 5 mg .................................. ADENOCARD ................. REMERON ..................... MAVIK ............................ MAXALT ......................... Betaxolol Hydrochloride .... Ciprofloxacin Hydrochloride. Adenosine ......................... Mirtazapine ........................ Trandolapril ....................... Rizatriptan Benzoate ......... 16 mg/milliliter (mL); 80 mg/mL. EQ 150 mg Base .............. EQ 300 mg Base .............. EQ 8 mg Chlorpheniramine Maleate/5 mL; EQ 10 mg Hydrocodone Bitartrate/5 mL. 10 mg; 20 mg .................... EQ 100 mg Base; EQ 750 mg Base. 3 mg/mL ............................ 45 mg ................................ 1 mg; 2 mg; 4 mg ............. EQ 5 mg Base .................. NDA 020865 .......... MAXALT–MLT ................ Rizatriptan Benzoate ......... EQ 5 mg Base .................. NDA 020945 .......... NDA 021131 .......... NORVIR .......................... ZYVOX ........................... Ritonavir ............................ Linezolid ............................ 100 mg .............................. 400 mg/200 mL (2 mg/mL) NDA 019111 .......... jbell on DSK3GLQ082PROD with NOTICES SUMMARY: The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements. FOR FURTHER INFORMATION CONTACT: Stacy Kane, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6236, Silver Spring, MD 20993–0002, 301–796–8363, Stacy.Kane@fda.hhs.gov. SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98–417) (the 1984 amendments), which authorized the approval of duplicate versions of drug products approved under an ANDA procedure. ANDA applicants must, with certain exceptions, show that the drug for which they are seeking approval contains the same active ingredient in the same strength and dosage form as the ‘‘listed drug,’’ which is a version of the drug that was previously approved. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA). NDA 019507 .......... NDA 019537 .......... KERLONE ...................... CIPRO ............................ NDA NDA NDA NDA .......... .......... .......... .......... 019937 020415 020528 020864 VerDate Sep<11>2014 18:10 Sep 30, 2019 Jkt 250001 PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 Tablet; Oral ....................... Injectable; Injection ........... Tablet; Oral ....................... Tablet; Oral. Extended-Release Suspension; Oral. Tablets; Oral ..................... Tablet; Oral ....................... Injectable; Injection ........... Tablet; Oral ....................... Tablet; Oral ....................... Tablet; Oral ....................... Orally Disintegrating Tablet; Oral. Capsule; Oral .................... Injectable; Injection ........... E:\FR\FM\01OCN1.SGM 01OCN1 Applicant Mylan Pharmaceuticals, Inc. Casper Pharma LLC. Novartis Pharmaceuticals, Corp. ATNAHS Pharma U.S., Ltd. Teva Branded Pharmaceutical Products R&D, Inc. Monarch Pharmaceuticals, Inc. GlaxoSmithKline. UCB, Inc. Sanofi-Aventis U.S. LLC. Bayer Healthcare Pharmaceuticals, Inc. Astellas Pharma U.S., Inc. Organon USA, Inc. AbbVie, Inc. Merck Sharp & Dohme Corp. Do. AbbVie, Inc. Pharmacia & Upjohn Co.

Agencies

[Federal Register Volume 84, Number 190 (Tuesday, October 1, 2019)]
[Notices]
[Pages 52111-52113]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-21248]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-3767]


Immunology Devices Panel of the Medical Devices 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 Immunology Devices Panel of 
the Medical Devices Advisory Committee. The general function of the 
committee is to provide advice and recommendations to FDA on scientific 
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 and 14, 2019, from 8 
a.m. to 6 p.m.

ADDRESSES: Doubletree by Hilton DC North/Gaithersburg, Grand Ballroom, 
620 Perry Pkwy., Gaithersburg, MD 20877. The hotel's telephone number 
is 301-977-8900. The hotel's website is at: https://doubletree3.hilton.com/en/hotels/maryland/doubletree-by-hilton-washington-dc-north-gaithersburg-GAIGWDT/. Answers to 
commonly asked questions including information regarding special 
accommodations due to a disability, visitor parking, and transportation 
may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    FDA is establishing a docket for public comments on this meeting. 
The docket number is FDA-2019-N-3767. The docket will close on December 
16, 2019. Submit either electronic or written comments on this public 
meeting to the docket by December 16, 2019. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before December 16, 2019. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of December 16, 2019. Comments 
received by mail/hand delivery/courier (for written/paper submission) 
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 28, 2019, will be provided 
to the Committee. Comments received after that date will be taken into 
consideration by FDA. 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 Submission'' 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-3767 for ``Immunology Devices Panel of the Medical Devices 
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 to 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 this 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.

[[Page 52112]]

    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: Aden Asefa, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. G642, Silver Spring, MD 20993-0002, 301-796-0400, 
[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: On November 13 and 14, 2019, the committee will discuss the 
topic of immunological responses to metal-containing products regulated 
as medical devices. The discussion will focus on metal-containing 
implants as well as dental amalgam. Implants are medical devices that 
are placed into a surgically or naturally formed opening of the human 
body and are intended to remain there after the procedure for an 
extended period of time (typically, greater than 30 days). For decades, 
metal-containing implants have been used in a large number of medical 
specialties including cardiology, orthopedics, dentistry, 
gastroenterology, and neurology or neurosurgery. Recent postmarket 
issues with some metal-on-metal orthopedic implants and gynecological 
metal-containing implants have raised questions about the potential for 
some patients to develop unexpected or heightened biological responses 
to the implant. These may include local (peri-implant) adverse events 
and potentially systemic manifestations, which may impact a patient's 
quality of life and necessitate medical or surgical intervention. While 
not considered an implant, dental amalgam is included in this 
discussion because of its potential for patient and user exposure to 
mercury compounds and some purported similarities in the adverse 
biological responses and clinical manifestations elicited by some 
dental amalgams to that of traditional metal implants.
    FDA is convening this committee to promote an open public 
discussion of, and seek expert opinion on, currently available 
scientific and clinical data pertaining to the biological responses to 
metal implants and dental amalgam and the potential associated clinical 
sequelae. The committee will be asked to discuss and provide 
recommendations regarding:
     The extent immunological responses to certain metals may 
cause or contribute to device-related local and systemic adverse 
effects as well as the potential underlying mechanism(s) involved and 
corresponding clinical manifestations.
     Patient characteristics, metal types, and/or anatomical 
considerations that may put an individual at higher risk for a 
heightened immunological response to a metal-containing implant, and 
methods that may assist in their identification.
     Mitigations that may reduce the risk for unintended 
immunological responses, including changes to device composition and 
design.
     The evidentiary gaps in biomedical research and clinical/
diagnostic management associated with immunological responses to metal 
implants.
     The adequacy, conclusions, and evidence gaps identified by 
a systemic literature review aimed to assess the recent epidemiologic 
and clinical evidence on adverse health effects reported in relation to 
occupational or non-occupational exposure to dental amalgam.
    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.
    FDA plans to provide a live webcast of the November 13 and 14, 
2019, meeting of the Immunology Devices Panel. While the Center for 
Devices and Radiological Health is working to make webcasts available 
to the public, there may be instances where the webcast transmission is 
not successful; staff will work to reestablish the transmission as soon 
as possible. The link for the webcast is available at: https://collaboration.fda.gov. Further information regarding the webcast, 
including the web address for the webcast, will be made available at 
least 2 days in advance of the meeting at the following website:
    November 13, 2019: https://fda.yorkcast.com/webcast/Play/390aea8fa1db4d42ba59e514b24e8f301d.
    November 14, 2019: https://fda.yorkcast.com/webcast/Play/d4174e54b00e4f7ab8ffb3ec8c99d3f51d.
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the committee. 
All written and electronic submissions made to the docket on or before 
October 28, 2019, will be provided to the panel. Oral presentations 
from the public will be scheduled on November 13, 2019, between 
approximately 2:15 p.m. and 3:15 p.m., and on November 14, 2019, 
between approximately 8:15 a.m. and 9:15 a.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 16, 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 17, 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

[[Page 52113]]

disability, please contact AnnMarie Williams, at 
[email protected] or 301-796-5966 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: September 25, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-21248 Filed 9-30-19; 8:45 am]
 BILLING CODE 4164-01-P

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