82 FR 46081 - Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management 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 82, Issue 190 (October 3, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 190 (October 3, 2017)
| Page Range | 46081-46083 | |
| FR Document | 2017-21170 |
[Federal Register Volume 82, Number 190 (Tuesday, October 3, 2017)] [Notices] [Pages 46081-46083] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-21170] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-4977] Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management 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 or Agency) announces a forthcoming public [[Page 46082]] advisory committee meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The general function of the committees is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document. DATES: The public meeting will be held on October 31, 2017, 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, 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-4977. The docket will close on October 27, 2017. Submit either electronic or written comments on this public meeting by October 27, 2017. Late, untimely filed comments will not be considered. Electronic comments must be submitted on or before October 27, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of October 27, 2017. 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 17, 2017, will be provided to the committees. Comments received after that date will be taken into consideration by the Agency. 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-4977 for ``Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management 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 office 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.'' The Agency 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.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: Kalyani Bhatt, 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 Agency's Web site 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 committees will discuss new drug application (NDA) 209819, buprenorphine subcutaneous injection, submitted by Indivior Pharmaceuticals, Inc., for treatment of opioid dependence. 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 meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is available at https://www.fda.gov/ [[Page 46083]] 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 committees. All electronic and written submissions submitted to the Docket (see ADDRESSES) on or before October 17, 2017, will be provided to the committees. 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 6, 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 October 10, 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 special accommodations due to a disability, please contact Kalyani Bhatt 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 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 27, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-21170 Filed 10-2-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 190 / Tuesday, October 3, 2017 / Notices 46081
Application No. Drug Applicant
ANDA 074801 ......................... Ketorolac Tromethamine Injection USP, 15 mg/mL and 30 Do.
mg/mL.
ANDA 075385 ......................... Buspirone HCl Tablets USP, 5 mg, 10 mg, and 15 mg ..... Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA,
Inc.
ANDA 075453 ......................... Doxazosin Tablets USP, EQ 1 mg base, EQ 2 mg base, Do.
EQ 4 mg base, and EQ 8 mg base.
ANDA 076883 ......................... Sotalol HCl Tablets USP, 80 mg, 120 mg, and 160 mg .... Teva Pharmaceuticals USA, Inc.
ANDA 077052 ......................... Citalopram Hydrobromide Tablets, EQ 10 mg base, EQ Sun Pharmaceutical Industries, Inc.
20 mg base, and EQ 40 mg base.
ANDA 077937 ......................... Meloxicam Tablets, 7.5 mg and 15 mg .............................. Do.
ANDA 078081 ......................... Amlodipine Besylate Tablets, EQ 2.5 mg base, EQ 5 mg Do.
base, and EQ 10 mg base.
ANDA 078158 ......................... Fosphenytoin Sodium Injection USP, EQ 50 mg Phe- Hospira, Inc.
nytoin Soudium/mL.
ANDA 078483 ......................... Zolpidem Tartrate Extended-Release Tablets USP, 6.25 Synthon Pharmaceuticals, Inc., 1007 Slater Rd., Suite 150, Durham, NC
mg and 12.5 mg. 27703.
ANDA 080136 ......................... Isoniazid Tablets, 100 mg ................................................... Sun Pharmaceutical Industries, Inc.
ANDA 080209 ......................... Prednisone Tablets USP, 5 mg .......................................... Contract Pharmacal Corp., c/o SciRegs International Inc., 6333
Summercrest Dr., Columbia, MD 21045.
ANDA 080224 ......................... Sorbitol; Mannitol Irrigation Solution, 2.7 g/100 mL; 540 Hospira, Inc.
mg/100 mL.
ANDA 083345 ......................... Potassium Chloride for Injection Concentrate USP, 1 Do.
milliequivalent (mEQ)/mL, 1.5 mEQ/mL, and 2 mEQ/mL.
ANDA 083808 ......................... Quinidine Sulfate Tablets USP, 200 mg ............................. Contract Pharmacal Corp., c/o SciRegs International Inc.
ANDA 084623 ......................... Chlordiazepoxide HCl Capsules USP, 10 mg .................... Upsher-Smith Laboratories, Inc., 6701 Evenstad Dr., Maple Grove, MN
55369.
ANDA 084644 ......................... Chlordiazepoxide HCl Capsules USP, 5 mg ...................... Do.
ANDA 084710 ......................... Ogen (estropipate) Vaginal Cream USP, 1.5 mg/g ............ Pfizer Inc.
ANDA 085061 ......................... Folic Acid Tablets USP, 1 mg ............................................ Contract Pharmacal Corp., c/o SciRegs International Inc.
ANDA 085933 ......................... Phentermine HCl Tablets USP ........................................... Lemmon Co., 650 Cathill Rd., Sellersville, PA 18960.
ANDA 086494 ......................... Chlordiazepoxide HCl Capsules, 25 mg ............................. Teva Pharmaceuticals USA, Inc.
ANDA 086821 ......................... Hydroxyzine HCl Injection USP, 50 mg/mL ........................ Hospira, Inc.
ANDA 087416 ......................... Hydroxyzine HCl Injection USP, 25 mg/mL, Carpuject ...... Do.
ANDA 087546 ......................... Hydroxyzine HCl Injection USP, 50 mg/mL, Carpuject ...... Do.
ANDA 087862 ......................... Hydroxyzine HCl Tablets USP, 100 mg ............................. Sun Pharmaceutical Industries, Inc.
ANDA 088147 ......................... Aminophylline in Sodium Chloride 0.45% Injection, 100 Hospira, Inc.
mg/100 mL and 200 mg/100 mL.
ANDA 088367 ......................... Lidocaine HCl Injection USP, 10% ..................................... Do.
ANDA 088542 ......................... Lidocaine HCl Injection USP, 4% ....................................... Do.
ANDA 089162 ......................... Cyclopentolate HCl Ophthalmic Solution, 1% .................... Alcon Pharmaceuticals, Ltd., 6201 South Freeway TC–45, Fort Worth,
TX 76134.
ANDA 089347 ......................... Diatrizoate Meglumine and Diatrizoate Sodium Injection Bracco Diagnostics Inc., 259 Prospect Plains Rd., Bldg. H, Monroe
USP, 66%; 10%. Township, NJ 08831.
ANDA 089393 ......................... Glycopyrrolate Injection USP, 0.2 mg/mL .......................... Hospira, Inc.
ANDA 089488 ......................... Diphenhydramine HCl Capsules, 25 mg ............................ Sun Pharmaceutical Industries, Inc.
ANDA 089521 ......................... Phenytoin Sodium Injection USP, 50 mg/mL, Ampule ....... Hospira, Inc.
ANDA 089537 ......................... Procainamide HCl Injection USP, 500 mg/mL, Carpuject .. Do.
ANDA 089744 ......................... Phenytoin Sodium Injection USP, 50 mg/mL, Carpuject .... Do.
ANDA 089915 ......................... Leucovorin Calcium for Injection, EQ 100 mg base/vial .... Pharmachemie B.V., c/o SICOR Pharmaceuticals, Inc., 19 Hughes,
Irvine, CA 92618.
NDA 202258 ........................... Victrelis (boceprevir) Capsules, 200 mg ............................. Merck Sharp & Dohme Corp., Subsidiary of Merck & Company, Inc., 1
Merck Dr., P.O. Box 100, Whitehouse Station, NJ 08889.
NDA 203093 ........................... Vitekta (elvitegravir) Tablets, 85 mg and 150 mg .............. Gilead Sciences, Inc., 333 Lakeside Dr., Foster City, CA 94404.
Therefore, approval of the Dated: September 27, 2017. DEPARTMENT OF HEALTH AND
applications listed in the table, and all Anna K. Abram, HUMAN SERVICES
amendments and supplements thereto, Deputy Commissioner for Policy, Planning,
is hereby withdrawn, effective Legislation, and Analysis. Food and Drug Administration
November 2, 2017. Introduction or [FR Doc. 2017–21177 Filed 10–2–17; 8:45 am] [Docket No. FDA–2017–N–4977]
delivery for introduction into interstate BILLING CODE 4164–01–P
commerce of products without Joint Meeting of the
approved new drug applications Psychopharmacologic Drugs Advisory
violates section 301(a) and (d) of the Committee and the Drug Safety and
Federal Food, Drug, and Cosmetic Act Risk Management Advisory
(21 U.S.C. 331(a) and (d)). Drug Committee; Notice of Meeting;
products that are listed in the table that Establishment of a Public Docket;
are in inventory on the date that this Request for Comments
asabaliauskas on DSKBBXCHB2PROD with NOTICES
notice becomes effective (see DATES) AGENCY: Food and Drug Administration,
may continue to be dispensed until the HHS.
inventories have been depleted or the ACTION: Notice; establishment of a
drug products have reached their public docket; request for comments.
expiration dates or otherwise become
violative, whichever occurs first. SUMMARY: The Food and Drug
Administration (FDA or Agency)
announces a forthcoming public
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![Federal Register / Vol. 82, No. 190 / Tuesday, October 3, 2017 / Notices 46083
AdvisoryCommittees/Calendar/ DEPARTMENT OF HEALTH AND Written/Paper Submissions
default.htm. Scroll down to the HUMAN SERVICES Submit written/paper submissions as
appropriate advisory committee meeting follows:
link. Food and Drug Administration • Mail/Hand delivery/Courier (for
Procedure: Interested persons may written/paper submissions): Dockets
present data, information, or views, [Docket No. FDA–2013–N–0502] Management Staff (HFA–305), Food and
orally or in writing, on issues pending Drug Administration, 5630 Fishers
Range of Risk Evaluation and Lane, Rm. 1061, Rockville, MD 20852.
before the committees. All electronic Mitigation Strategies Platform
and written submissions submitted to • For written/paper comments
Standards Initiative: Needs submitted to the Dockets Management
the Docket (see ADDRESSES) on or before Assessment; Request for Comments
October 17, 2017, will be provided to Staff, FDA will post your comment, as
the committees. Oral presentations from AGENCY: Food and Drug Administration, well as any attachments, except for
HHS. information submitted, marked and
the public will be scheduled between
identified, as confidential, if submitted
approximately 1 p.m. and 2 p.m. Those ACTION: Notice; request for comments. as detailed in ‘‘Instructions.’’
individuals interested in making formal Instructions: All submissions received
oral presentations should notify the SUMMARY: The Food and Drug must include the Docket No. FDA–
contact person and submit a brief Administration (FDA or the Agency) is 2013–N–0502 for ‘‘REMS Platform
statement of the general nature of the seeking public input on the design of Standards Initiative: Needs Assessment;
evidence or arguments they wish to the REMS Platform Standards Initiative, Request for Comments.’’ Received
present, the names and addresses of as well as methods and best practices comments will be placed in the docket
proposed participants, and an for its construction. To facilitate this, and, except for those submitted as
indication of the approximate time FDA is making available the ‘‘REMS ‘‘Confidential Submissions,’’ publicly
requested to make their presentation on Platform Standards Initiative: Needs viewable at https://www.regulations.gov
or before October 6, 2017. Time allotted Assessment’’ (needs assessment), which or at the Dockets Management Staff
for each presentation may be limited. If summarizes a range of risk evaluation between 9 a.m. and 4 p.m., Monday
the number of registrants requesting to and mitigation strategies (REMS) through Friday.
speak is greater than can be reasonably activities that could be standardized and • Confidential Submissions—To
accommodated during the scheduled integrated into the health care system submit a comment with confidential
through the use of electronic data information that you do not wish to be
open public hearing session, FDA may
standards. made publicly available, submit your
conduct a lottery to determine the
speakers for the scheduled open public DATES: The comment period will be comments only as a written/paper
hearing session. The contact person will open indefinitely. submission. You should submit two
notify interested persons regarding their copies total. One copy will include the
ADDRESSES: You may submit comments information you claim to be confidential
request to speak by October 10, 2017. as follows: with a heading or cover note that states
Persons attending FDA’s advisory Electronic Submissions ‘‘THIS DOCUMENT CONTAINS
committee meetings are advised that the CONFIDENTIAL INFORMATION.’’ The
Agency is not responsible for providing Submit electronic comments in the Agency will review this copy, including
access to electrical outlets. following way: the claimed confidential information, in
FDA welcomes the attendance of the • Federal eRulemaking Portal: its consideration of comments. The
public at its advisory committee https://www.regulations.gov. Follow the second copy, which will have the
meetings and will make every effort to instructions for submitting comments. claimed confidential information
accommodate persons with disabilities. Comments submitted electronically, redacted/blacked out, will be available
including attachments, to https:// for public viewing and posted on
If you require special accommodations
www.regulations.gov will be posted to https://www.regulations.gov. Submit
due to a disability, please contact
the docket unchanged. Because your both copies to the Dockets Management
Kalyani Bhatt at least 7 days in advance comment will be made public, you are
of the meeting. Staff. If you do not wish your name and
solely responsible for ensuring that your contact information to be made publicly
FDA is committed to the orderly comment does not include any available, you can provide this
conduct of its advisory committee confidential information that you or a information on the cover sheet and not
meetings. Please visit our Web site at third party may not wish to be posted, in the body of your comments and you
https://www.fda.gov/Advisory such as medical information, your or must identify this information as
Committees/AboutAdvisoryCommittees/ anyone else’s Social Security number, or ‘‘confidential.’’ Any information marked
ucm111462.htm for procedures on confidential business information, such as ‘‘confidential’’ will not be disclosed
public conduct during advisory as a manufacturing process. Please note except in accordance with 21 CFR 10.20
committee meetings. that if you include your name, contact and other applicable disclosure law. For
information, or other information that more information about FDA’s posting
Notice of this meeting is given under
identifies you in the body of your of comments to public dockets, see 80
the Federal Advisory Committee Act (5 comments, that information will be
asabaliauskas on DSKBBXCHB2PROD with NOTICES
U.S.C. app. 2). FR 56469, September 18, 2015, or access
posted on https://www.regulations.gov. the information at: https://www.gpo.gov/
Dated: September 27, 2017. • If you want to submit a comment fdsys/pkg/FR-2015-09-18/pdf/2015-
Anna K. Abram, with confidential information that you 23389.pdf.
Deputy Commissioner for Policy, Planning, do not wish to be made available to the Docket: For access to the docket to
Legislation, and Analysis. public, submit the comment as a read background documents or the
[FR Doc. 2017–21170 Filed 10–2–17; 8:45 am] written/paper submission and in the electronic and written/paper comments
BILLING CODE 4164–01–P
manner detailed (see ‘‘Written/Paper received, go to https://
Submissions’’ and ‘‘Instructions’’). www.regulations.gov and insert the
VerDate Sep<11>2014 16:49 Oct 02, 2017 Jkt 244001 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 E:\FR\FM\03OCN1.SGM 03OCN1](https://thefederalregister.org/doc/82_FR_46271/page/3.svg)
Document Created: 2017-10-03 01:01:43
Document Modified: 2017-10-03 01:01:43
| 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 public meeting will be held on October 31, 2017, from 8 a.m. to 5 p.m. | |
| Contact | Kalyani Bhatt, 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 Agency's Web site 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 | 82 FR 46081 |
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