82 FR 3333 - Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the 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 82, Issue 7 (January 11, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 7 (January 11, 2017)
| Page Range | 3333-3335 | |
| FR Document | 2017-00463 |
[Federal Register Volume 82, Number 7 (Wednesday, January 11, 2017)] [Notices] [Pages 3333-3335] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-00463] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-0067] Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments AGENCY: Food and Drug Administration, HHS. [[Page 3334]] 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 Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee. The general function of the committees is to provide advice and recommendations to the Agency on FDA's regulatory issues. At least one portion of the meeting will be closed to the public. FDA is establishing a docket for public comment on this document. DATES: The meeting will be held on March 13, 2017, from 8 a.m. to 5 p.m. and March 14, 2017, from 8 a.m. to 5 p.m. ADDRESSES: College Park Marriott Hotel and Conference Center, Potomac Ballroom, 3501 University Blvd. East, Hyattsville, MD 20783. The conference center's telephone number is 301-985-7300. Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm. 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): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, 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-0067 for ``Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee; Notice of Meeting; Request for Comments.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Division of Dockets Management 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 Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm. 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 Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Stephanie L. Begansky, 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 http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. SUPPLEMENTARY INFORMATION: Agenda: The committees will be asked to discuss safety issues for new drug application (NDA) 201655, OPANA ER (oxymorphone hydrochloride) Extended-release Tablets, by Endo Pharmaceuticals Inc., with the indication of management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The product is an approved extended-release (ER) formulation intended to have abuse-deterrent properties based on its physicochemical properties, however, this information is not currently reflected in product labeling. The committees will be asked to discuss pre- and post- marketing data about the abuse of OPANA ER, and the overall risk- benefit of this product. The committees will also discuss abuse of generic oxymorphone ER and oxymorphone immediate-release (IR) products. 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 [[Page 3335]] 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 http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting link. Procedure: On March 13, 2017, from 9:15 a.m. to 5 p.m., and on March 14, 2017, from 8 a.m. to 5 p.m., the meeting is open to the public. 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 the Addresses section) on or before February 27, 2017, will be provided to the committees. Oral presentations from the public will be scheduled between approximately 8:30 a.m. and 10:30 a.m. on March 14, 2017. 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 February 16, 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 February 17, 2017. Closed Committee Deliberations: On March 13, 2017, from 8 a.m. to 9:15 a.m., the meeting will be closed to permit discussion and review of trade secret and/or confidential commercial information (5 U.S.C. 552b(c)(4)). During this session, the committees will discuss the premarketing drug development program of an extended-release opioid product. Persons attending FDA's advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets. FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2017-N-0067. The docket will close on March 10, 2017. Comments received on or before February 27, 2017, will be provided to the committee. Comments received after that date will be taken into consideration by the Agency. 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 Stephanie L. Begansky at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: January 6, 2017. Janice M. Soreth, Associate Commissioner for Special Medical Programs. [FR Doc. 2017-00463 Filed 1-10-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 7 / Wednesday, January 11, 2017 / Notices 3333
applicable disclosure law. For more contain acetaminophen. These skin have added labeling information about
information about FDA’s posting of reactions can occur with the first-time products that contain both
comments to public dockets, see 80 FR use of acetaminophen or even if acetaminophen and aspirin.
56469, September 18, 2015, or access acetaminophen has been used in the This guidance is being issued
the information at: http://www.fda.gov/ past without any problems. FDA consistent with FDA’s good guidance
regulatoryinformation/dockets/ advised health care professionals to be practices regulation (21 CFR 10.115).
default.htm. aware of this rare risk and consider The guidance represents the current
Docket: For access to the docket to acetaminophen, along with other drugs thinking of FDA on the recommended
read background documents or the already known to have such an warning for OTC acetaminophen-
electronic and written/paper comments association, when assessing patients containing drug products and labeling
received, go to http:// with potentially drug-induced skin statements regarding serious skin
www.regulations.gov and insert the reactions. FDA also advised that anyone reactions. It does not establish any
docket number, found in brackets in the who develops a skin rash or reaction rights for any person and is not binding
heading of this document, into the while using acetaminophen or any other on FDA or the public. You can use an
‘‘Search’’ box and follow the prompts pain reliever/fever reducer should stop alternative approach if it satisfies the
and/or go to the Division of Dockets taking the drug and seek medical requirements of the applicable statutes
Management, 5630 Fishers Lane, Rm. attention right away. Furthermore, the and regulations.
1061, Rockville, MD 20852. announcement advised that anyone who
Submit written requests for single has experienced a serious skin reaction II. Paperwork Reduction Act of 1995
copies of this guidance to the Division when taking acetaminophen in the past Under the guidance, manufacturers
of Drug Information, Center for Drug should not take the drug again and may add to their drug product labeling
Evaluation and Research, Food and should contact their health care a warning statement supplied by FDA
Drug Administration, 10001 New professional to discuss alternative pain that pertains to acetaminophen to
Hampshire Ave., Hillandale Building, relievers/fever reducers. address the risk of serious skin
4th Floor, Silver Spring, MD 20993– In response to FDA’s letters to reactions. Inclusion of the warning
0002. Send one self-addressed adhesive manufacturers holding new drug statement on the labels for these drug
label to assist that office in processing applications and abbreviated new drug products would be exempt from review
your requests. See the SUPPLEMENTARY applications, most manufacturers of
by the Office of Management and
INFORMATION section for electronic acetaminophen-containing prescription
Budget under the Paperwork Reduction
access to the guidance document. and OTC drug products marketed under
Act of 1995 (44 U.S.C. 3501–3520)
FOR FURTHER INFORMATION CONTACT: an approved application now include a
because the public disclosure of
Emily Baker, Office of Unapproved warning statement on their product
information originally supplied by the
Drugs and Labeling Compliance, Center labels to address the risk of serious skin
Federal government to the recipient for
for Drug Evaluation and Research, Food reactions. FDA recommends that
the purpose of disclosure to the public
and Drug Administration, 10903 New manufacturers of all acetaminophen-
is not included within the definition of
Hampshire Ave., Silver Spring, MD containing OTC drug products (both
‘‘collection of information’’ (see 5 CFR
20993–0002, 301–796–7524, single- and combination-ingredient
acetaminophen products) marketed 1320.3(c)(2)).
Emily.Baker@fda.hhs.gov.
under the Tentative Final Monograph III. Electronic Access
SUPPLEMENTARY INFORMATION:
(TFM) for Internal Analgesic,
Antipyretic, and Antirheumatic Drug Persons with access to the Internet
I. Background
Products include in labeling the may obtain the document at either
FDA is announcing the availability of http://www.fda.gov/Drugs/Guidance
a guidance for industry entitled language recommended in this guidance
to warn consumers that acetaminophen ComplianceRegulatoryInformation/
‘‘Recommended Warning for Over-the- Guidances/default.htm or http://
Counter Acetaminophen-Containing may cause severe skin reactions. At this
time, FDA does not intend to take action www.regulations.gov.
Drug Products and Labeling Statements
against the marketing of single- and Dated: January 5, 2017.
Regarding Serious Skin Reactions.’’
combination-ingredient, Leslie Kux,
Acetaminophen, included in many
acetaminophen-containing, OTC drug Associate Commissioner for Policy.
prescription and OTC products, is a
products bearing the recommended [FR Doc. 2017–00375 Filed 1–10–17; 8:45 am]
common active ingredient indicated to
allergy warning that are otherwise
treat pain and reduce fever. On August BILLING CODE 4164–01–P
marketed in compliance with the TFM
1, 2013, FDA issued a Drug Safety
and applicable regulations.
Communication (DSC) informing the In the Federal Registerof November
public that use of acetaminophen has DEPARTMENT OF HEALTH AND
28, 2014 (79 FR 70879), FDA published HUMAN SERVICES
been associated with a risk of rare but a draft guidance entitled
serious skin reactions.1 These skin ‘‘Recommended Warning for Over-the- Food and Drug Administration
reactions, including Stevens-Johnson Counter Acetaminophen-Containing
Syndrome, toxic epidermal necrolysis, Drug Products and Labeling Statements
and acute generalized exanthematous [Docket No. FDA–2017–N–0067]
Regarding Serious Skin Reactions.’’ See:
pustulosis, can be fatal. http://www.fda.gov/downloads/drugs/
The DSC explained that reddening of Joint Meeting of the Drug Safety and
sradovich on DSK3GMQ082PROD with NOTICES
guidancecompliance Risk Management Advisory Committee
the skin, rash, blisters, and detachment regulatoryinformation/guidances/
of the upper surface of the skin can and the Anesthetic and Analgesic Drug
ucm424898.pdf. The November 2014 Products Advisory Committee; Notice
occur with the use of drug products that draft guidance gave interested persons of Meeting; Establishment of a Public
1 FDA Drug Safety Communication: FDA warns of
an opportunity to submit comments Docket; Request for Comments
rare but serious skin reactions with the pain
through January 27, 2015. We have
reliever/fever reducer acetaminophen. http:// made changes to the guidance in AGENCY: Food and Drug Administration,
www.fda.gov/Drugs/DrugSafety/ucm363041.htm. response to comments received and HHS.
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![Federal Register / Vol. 82, No. 7 / Wednesday, January 11, 2017 / Notices 3335
location of the advisory committee meetings and will make every effort to on the draft guidance by March 13,
meeting, and the background material accommodate persons with disabilities. 2017.
will be posted on FDA’s Web site after If you require accommodations due to a ADDRESSES: You may submit comments
the meeting. Background material is disability, please contact Stephanie L. as follows:
available at http://www.fda.gov/ Begansky at least 7 days in advance of
AdvisoryCommittees/Calendar/ the meeting. Electronic Submissions
default.htm. Scroll down to the FDA is committed to the orderly Submit electronic comments in the
appropriate advisory committee meeting conduct of its advisory committee following way:
link. meetings. Please visit our Web site at • Federal eRulemaking Portal: http://
Procedure: On March 13, 2017, from http://www.fda.gov/ www.regulations.gov. Follow the
9:15 a.m. to 5 p.m., and on March 14, AdvisoryCommittees/ instructions for submitting comments.
2017, from 8 a.m. to 5 p.m., the meeting AboutAdvisoryCommittees/ Comments submitted electronically,
is open to the public. Interested persons ucm111462.htm for procedures on including attachments, to http://
may present data, information, or views, public conduct during advisory www.regulations.gov will be posted to
orally or in writing, on issues pending committee meetings. the docket unchanged. Because your
before the committees. All electronic Notice of this meeting is given under comment will be made public, you are
and written submissions submitted to the Federal Advisory Committee Act (5 solely responsible for ensuring that your
the Docket (see the ADDRESSES section) U.S.C. app. 2). comment does not include any
on or before February 27, 2017, will be confidential information that you or a
Dated: January 6, 2017.
provided to the committees. Oral third party may not wish to be posted,
presentations from the public will be Janice M. Soreth,
such as medical information, your or
scheduled between approximately 8:30 Associate Commissioner for Special Medical anyone else’s Social Security number, or
a.m. and 10:30 a.m. on March 14, 2017. Programs.
confidential business information, such
Those individuals interested in making [FR Doc. 2017–00463 Filed 1–10–17; 8:45 am]
as a manufacturing process. Please note
formal oral presentations should notify BILLING CODE 4164–01–P that if you include your name, contact
the contact person and submit a brief information, or other information that
statement of the general nature of the identifies you in the body of your
evidence or arguments they wish to DEPARTMENT OF HEALTH AND comments, that information will be
present, the names and addresses of HUMAN SERVICES posted on http://www.regulations.gov.
proposed participants, and an • If you want to submit a comment
indication of the approximate time Food and Drug Administration
with confidential information that you
requested to make their presentation on do not wish to be made available to the
or before February 16, 2017. Time [Docket No. FDA–2012–D–0529] public submit the comment as a written/
allotted for each presentation may be paper submission and in the manner
limited. If the number of registrants Recommended Statement for Over-the- detailed (see ‘‘Written/Paper
requesting to speak is greater than can Counter Aspirin-Containing Drug Submissions’’ and ‘‘Instructions’’).
be reasonably accommodated during the Products Labeled With Cardiovascular
scheduled open public hearing session, Related Imagery; Draft Guidance for Written/Paper Submissions
FDA may conduct a lottery to determine Industry; Availability Submit written/paper submissions as
the speakers for the scheduled open AGENCY: Food and Drug Administration, follows:
public hearing session. The contact HHS. • Mail/Hand delivery/Courier (for
person will notify interested persons written/paper submissions): Division of
regarding their request to speak by ACTION: Notice of availability. Dockets Management (HFA–305), Food
February 17, 2017. SUMMARY: The Food and Drug and Drug Administration, 5630 Fishers
Closed Committee Deliberations: On Administration (FDA) is announcing the Lane, Rm. 1061, Rockville, MD 20852.
March 13, 2017, from 8 a.m. to 9:15 availability of a draft guidance for • For written/paper comments
a.m., the meeting will be closed to industry entitled ‘‘Recommended submitted to the Division of Dockets
permit discussion and review of trade Statement for Over-the-Counter Aspirin- Management, FDA will post your
secret and/or confidential commercial Containing Drug Products Labeled With comment, as well as any attachments,
information (5 U.S.C. 552b(c)(4)). Cardiovascular Related Imagery.’’ The except for information submitted,
During this session, the committees will guidance is intended to promote the safe marked and identified, as confidential,
discuss the premarketing drug use of nonprescription (also referred to if submitted as detailed in
development program of an extended- as over-the-counter or OTC) aspirin drug ‘‘Instructions.’’
release opioid product. Instructions: All submissions received
products by encouraging drug
Persons attending FDA’s advisory must include the Docket No. FDA–
manufacturers, packagers, and labelers
committee meetings are advised that the 2012–D–0529 for ‘‘Recommended
marketing aspirin drug products with
Agency is not responsible for providing Statement for Over-the-Counter Aspirin-
cardiovascular related imagery to
access to electrical outlets. Containing Drug Products Labeled With
include a statement that reminds
FDA is establishing a docket for Cardiovascular Related Imagery;
consumers to talk to their health care
public comment on this meeting. The Guidance for Industry.’’ Received
provider before using aspirin for their
docket number is FDA–2017–N–0067. comments will be placed in the docket
heart.
sradovich on DSK3GMQ082PROD with NOTICES
The docket will close on March 10, and, except for those submitted as
2017. Comments received on or before DATES: Although you can comment on ‘‘Confidential Submissions,’’ publicly
February 27, 2017, will be provided to any guidance at any time (see 21 CFR viewable at http://www.regulations.gov
the committee. Comments received after 10.115(a)(5)), to ensure that the Agency or at the Division of Dockets
that date will be taken into considers your comments on this draft Management between 9 a.m. and 4 p.m.,
consideration by the Agency. guidance before it begins work on the Monday through Friday.
FDA welcomes the attendance of the final version of the guidance, submit • Confidential Submissions—To
public at its advisory committee either electronic or written comments submit a comment with confidential
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Document Created: 2018-02-01 14:59:30
Document Modified: 2018-02-01 14:59:30
| 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 March 13, 2017, from 8 a.m. to 5 p.m. and March 14, 2017, from 8 a.m. to 5 p.m. | |
| Contact | Stephanie L. Begansky, 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 http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. | |
| FR Citation | 82 FR 3333 |
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