83 FR 1371 - Anesthetic and Analgesic Drug Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 8 (January 11, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 8 (January 11, 2018)
| Page Range | 1371-1373 | |
| FR Document | 2018-00359 |
[Federal Register Volume 83, Number 8 (Thursday, January 11, 2018)] [Notices] [Pages 1371-1373] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-00359] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-6826] Anesthetic and Analgesic Drug Products 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 Anesthetic and Analgesic Drug Products 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 February 14, 2018, from 1:30 p.m. to 5 p.m., and February 15, 2018, from 8 a.m. to 5 p.m. ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Avenue, 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, 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-2017-N-6826. The docket will close on February 13, 2018. Submit either electronic or written comments on this public meeting by February 13, 2018. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before February 13, 2018. The https://www.regulations.gov electronic filing [[Page 1372]] system will accept comments until midnight Eastern Time at the end of February 13, 2018. 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 January 31, 2018, 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 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-2017-N-6826 for ``Anesthetic and Analgesic Drug Products 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.thefederalregister.org/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: Moon Hee V. Choi, 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 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) 022496/S-009, for EXPAREL (bupivacaine liposomal injectable suspension), submitted by Pacira Pharmaceuticals, Inc., to produce local analgesia and as a nerve block to produce regional analgesia. 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. Written submissions may be made to the contact person on or before January 31, 2018. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. on February 15, 2018. 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 January 23, 2018. 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 [[Page 1373]] regarding their request to speak by January 24, 2018. 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 Moon Hee V. Choi at least 7 days in advance of the meeting (See FOR FURTHER INFORMATION CONTACT). 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: January 4, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-00359 Filed 1-10-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 8 / Thursday, January 11, 2018 / Notices 1371
until the approval phase begins. The 203 days occurred during the approval No. FDA–2013–S–0610. Submit written
approval phase starts with the initial phase. These periods of time were petitions (two copies are required) to the
submission of an application to market derived from the following dates: Dockets Management Staff (HFA–305),
the device and continues until 1. The date an exemption under Food and Drug Administration, 5630
permission to market the device is section 520(g) of the Federal Food, Drug, Fishers Lane, Rm. 1061, Rockville, MD
granted. Although only a portion of a and Cosmetic Act (FD&C Act) (21 U.S.C. 20852.
regulatory review period may count 360j(g)) involving this device became Dated: January 8, 2018.
toward the actual amount of extension effective: February 10, 2014. The
Leslie Kux,
that the Director of USPTO may award applicant claims that the investigational
device exemption (IDE) required under Associate Commissioner for Policy.
(half the testing phase must be
subtracted as well as any time that may section 520(g) of the FD&C Act for [FR Doc. 2018–00355 Filed 1–10–18; 8:45 am]
have occurred before the patent was human tests to begin became effective BILLING CODE 4164–01–P
issued), FDA’s determination of the on April 3, 2014. However, FDA records
length of a regulatory review period for indicate that the IDE was determined
a medical device will include all of the substantially complete for clinical DEPARTMENT OF HEALTH AND
testing phase and approval phase as studies to have begun on February 10, HUMAN SERVICES
specified in 35 U.S.C. 156(g)(3)(B). 2014, which represents the IDE effective
FDA has approved for marketing the date. Food and Drug Administration
medical device MICRA 2. The date an application was [Docket No. FDA–2017–N–6826]
TRANSCATHETER PACING SYSTEM. initially submitted with respect to the
MICRA TRANSCATHETER PACING device under section 515 of the FD&C Anesthetic and Analgesic Drug
SYSTEM is indicated for use in patients Act (21 U.S.C. 360e): September 17, Products Advisory Committee; Notice
who have experienced one or more of 2015. FDA has verified the applicant’s of Meeting; Establishment of a Public
the following conditions: (1) claim that the premarket approval Docket; Request for Comments
Symptomatic paroxysmal or permanent application (PMA) for MICRA
AGENCY: Food and Drug Administration,
high-grade atrioventricular (AV) block TRANSCATHETER PACING SYSTEM
HHS.
in the presence of atrial fibrillation (AF); (PMA P150033) was initially submitted
(2) symptomatic paroxysmal or September 17, 2015. ACTION: Notice, establishment of a
permanent high-grade AV block in the 3. The date the application was public docket; request for comments.
absence of AF, as an alternative to dual approved: April 6, 2016. FDA has SUMMARY: The Food and Drug
chamber pacing, when atrial lead verified the applicant’s claim that PMA Administration (FDA) announces a
placement is considered difficult, high P150033 was approved on April 6, 2016. forthcoming public advisory committee
risk, or not deemed necessary for This determination of the regulatory
meeting of the Anesthetic and Analgesic
effective therapy; (3) symptomatic review period establishes the maximum
Drug Products Advisory Committee. The
bradycardia-tachycardia syndrome or potential length of a patent extension.
general function of the committee is to
sinus node dysfunction (sinus However, the USPTO applies several
provide advice and recommendations to
bradycardia or sinus pauses), as an statutory limitations in its calculations
FDA on regulatory issues. The meeting
alternative to atrial or dual chamber of the actual period for patent extension.
will be open to the public. FDA is
pacing when atrial lead placement is In its applications for patent extension,
establishing a docket for public
considered difficult, high risk, or not this applicant seeks 457 days and 494
comment on this document.
deemed necessary for effective therapy. days of patent term extension.
DATES: The meeting will be held on
Subsequent to this approval, the USPTO III. Petitions
received patent term restoration February 14, 2018, from 1:30 p.m. to 5
applications for MICRA Anyone with knowledge that any of p.m., and February 15, 2018, from 8 a.m.
TRANSCATHETER PACING SYSTEM the dates as published are incorrect may to 5 p.m.
(U.S. Patent Nos. 7,824,805 and submit either electronic or written ADDRESSES: FDA White Oak Campus,
8,129,622) from Medtronic, Inc., and the comments and, under 21 CFR 60.24, ask 10903 New Hampshire Avenue, Bldg. 31
USPTO requested FDA’s assistance in for a redetermination (see DATES). Conference Center, the Great Room (Rm.
determining the patents’ eligibility for Furthermore, as specified in § 60.30 (21 1503), Silver Spring, MD 20993–0002.
patent term restoration. In a letter dated CFR 60.30), any interested person may Answers to commonly asked questions
March 13, 2017, FDA advised the petition FDA for a determination including information regarding special
USPTO that this medical device had regarding whether the applicant for accommodations due to a disability,
undergone a regulatory review period extension acted with due diligence visitor parking, and transportation may
and that the approval of MICRA during the regulatory review period. To be accessed at: https://www.fda.gov/
TRANSCATHETER PACING SYSTEM meet its burden, the petition must AdvisoryCommittees/
represented the first permitted comply with all the requirements of AboutAdvisoryCommittees/
commercial marketing or use of the § 60.30, including but not limited to: ucm408555.htm.
product. Thereafter, the USPTO Must be timely (see DATES), must be FDA is establishing a docket for
requested that FDA determine the filed in accordance with § 10.20, must public comment on this meeting. The
product’s regulatory review period. contain sufficient facts to merit an FDA docket number is FDA–2017–N–6826.
investigation, and must certify that a The docket will close on February 13,
II. Determination of Regulatory Review true and complete copy of the petition 2018. Submit either electronic or
srobinson on DSK9F5VC42PROD with NOTICES
Period has been served upon the patent written comments on this public
FDA has determined that the applicant. (See H. Rept. 857, part 1, 98th meeting by February 13, 2018. Please
applicable regulatory review period for Cong., 2d sess., pp. 41–42, 1984.) note that late, untimely filed comments
MICRA TRANSCATHETER PACING Petitions should be in the format will not be considered. Electronic
SYSTEM is 788 days. Of this time, 585 specified in 21 CFR 10.30. comments must be submitted on or
days occurred during the testing phase Submit petitions electronically to before February 13, 2018. The https://
of the regulatory review period, while https://www.regulations.gov at Docket www.regulations.gov electronic filing
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![Federal Register / Vol. 83, No. 8 / Thursday, January 11, 2018 / Notices 1373
regarding their request to speak by Place: National Institute on Aging, Place: Residence Inn Bethesda Downtown,
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Persons attending FDA’s advisory Wisconsin Avenue, Bethesda, MD 20892. 20814.
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Ph.D., Scientific Review Officer, National Scientific Review Officer, Center for
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For press inquiries, please contact the 2C218, Bethesda, MD 20892, 301–496–9374, MSC 7818, Bethesda, MD 20892, (301) 435–
Office of Media Affairs at fdaoma@ grimaldim2@mail.nih.gov. 2359, shayiqr@csr.nih.gov.
fda.hhs.gov or 301–796–4540. (Catalogue of Federal Domestic Assistance Name of Committee: Healthcare Delivery
FDA welcomes the attendance of the Program Nos. 93.866, Aging Research, and Methodologies Integrated Review Group;
public at its advisory committee National Institutes of Health, HHS) Community-Level Health Promotion Study
meetings and will make every effort to Section.
Dated: January 8, 2018.
accommodate persons with disabilities. Date: February 12–13, 2018.
Melanie J. Pantoja, Time: 8:00 a.m. to 6:00 p.m.
If you require accommodations due to a
Program Analyst, Office of Federal Advisory Agenda: To review and evaluate grant
disability, please contact Moon Hee V. Committee Policy. applications.
Choi at least 7 days in advance of the Place: Hotel Nikko San Francisco, 222
[FR Doc. 2018–00389 Filed 1–10–18; 8:45 am]
meeting (See FOR FURTHER INFORMATION Mason Street, San Francisco, CA 94102.
BILLING CODE 4140–01–P
CONTACT). Contact Person: Ping Wu, Ph.D., Scientific
FDA is committed to the orderly Review Officer, Center for Scientific Review,
conduct of its advisory committee National Institutes of Health, 6701 Rockledge
DEPARTMENT OF HEALTH AND Drive, Room 3166, Bethesda, MD 20892, 301–
meetings. Please visit our website at HUMAN SERVICES
https://www.fda.gov/ 451–8428, wup4@csr.nih.gov.
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AboutAdvisoryCommittees/ and Skin Sciences Integrated Review Group;
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ucm111462.htm for procedures on Center for Scientific Review; Notice of
Section.
public conduct during advisory Closed Meetings Date: February 12–13, 2018.
committee meetings. Time: 8:00 a.m. to 5:30 p.m.
Pursuant to section 10(d) of the
Notice of this meeting is given under Agenda: To review and evaluate grant
Federal Advisory Committee Act, as
the Federal Advisory Committee Act (5 applications.
amended, notice is hereby given of the
U.S.C. app. 2). Place: Virginian Suites, 1500 Arlington
following meetings. Boulevard, Arlington, VA 22209.
Dated: January 4, 2018. The meetings will be closed to the Contact Person: Baljit S Moonga, Ph.D.,
Leslie Kux, public in accordance with the Scientific Review Officer, Center for
Associate Commissioner for Policy. provisions set forth in sections Scientific Review, National Institutes of
[FR Doc. 2018–00359 Filed 1–10–18; 8:45 am] 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Health, 6701 Rockledge Drive, Room 4214,
BILLING CODE 4164–01–P as amended. The grant applications and MSC 7806, Bethesda, MD 20892, 301–435–
the discussions could disclose 1777, moongabs@mail.nih.gov.
confidential trade secrets or commercial Name of Committee: Risk, Prevention and
DEPARTMENT OF HEALTH AND property such as patentable material, Health Behavior Integrated Review Group;
HUMAN SERVICES and personal information concerning Addiction Risks and Mechanisms Study
Section.
individuals associated with the grant
National Institutes of Health Date: February 12–13, 2018.
applications, the disclosure of which Time: 8:00 a.m. to 6:00 p.m.
would constitute a clearly unwarranted Agenda: To review and evaluate grant
National Institute on Aging; Notice of invasion of personal privacy. applications.
Closed Meeting Place: The Dupont Hotel, 1500 New
Name of Committee: Center for Scientific
Pursuant to section 10(d) of the Review Special Emphasis Panel; Hampshire Avenue NW, Washington, DC
Federal Advisory Committee Act, as Undiagnosed Diseases Network Phase II. 20036.
Date: January 30, 2018. Contact Person: Kristen Prentice, Ph.D.,
amended, notice is hereby given of the
Time: 11:00 a.m. to 3:00 p.m. Scientific Review Officer, Center for
following meeting. Scientific Review, National Institutes of
Agenda: To review and evaluate grant
The meeting will be closed to the applications. Health, 6701 Rockledge Drive, Room 3112,
public in accordance with the Place: National Institutes of Health, 6701 MSC 7808, Bethesda, MD 20892, (301) 496–
provisions set forth in sections Rockledge Drive, Bethesda, MD 20892 0726, prenticekj@mail.nih.gov.
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., (Virtual Meeting). Name of Committee: Digestive, Kidney and
as amended. The grant applications and Contact Person: Wallace Ip, Ph.D., Urological Systems Integrated Review Group;
the discussions could disclose Scientific Review Officer, Center for Pathobiology of Kidney Disease Study
confidential trade secrets or commercial Scientific Review, National Institutes of Section.
property such as patentable material, Health, 6701 Rockledge Drive, Room 5128, Date: February 13–14, 2018.
MSC 7840, Bethesda, MD 20892, 301–435– Time: 8:00 a.m. to 6:00 p.m.
and personal information concerning 1191, ipws@mail.nih.gov. Agenda: To review and evaluate grant
individuals associated with the grant
This notice is being published less than 15 applications.
applications, the disclosure of which days prior to the meeting due to the timing Place: Residence Inn Bethesda, 7335
would constitute a clearly unwarranted limitations imposed by the review and Wisconsin Avenue, Bethesda, MD 20814.
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invasion of personal privacy. funding cycle. Contact Person: Atul Sahai, Ph.D.,
Name of Committee: National Institute on Name of Committee: Cell Biology Scientific Review Officer, Center for
Aging Special Emphasis Panel; Revision Integrated Review Group; Development—2 Scientific Review, National Institutes of
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Date: February 6, 2018. Date: February 8–9, 2018. MSC 7818, Bethesda, MD 20892, 301–435–
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Agenda: To review and evaluate grant Agenda: To review and evaluate grant Name of Committee: Cell Biology
applications. applications. Integrated Review Group; Molecular and
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Document Created: 2018-01-11 04:54:22
Document Modified: 2018-01-11 04:54:22
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice, establishment of a public docket; request for comments. | |
| Dates | The meeting will be held on February 14, 2018, from 1:30 p.m. to 5 p.m., and February 15, 2018, from 8 a.m. to 5 p.m. | |
| Contact | Moon Hee V. Choi, 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 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. | |
| FR Citation | 83 FR 1371 |
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