83 FR 61651 - Joint Meeting of the Arthritis 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 83, Issue 231 (November 30, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 231 (November 30, 2018)
| Page Range | 61651-61653 | |
| FR Document | 2018-25991 |
[Federal Register Volume 83, Number 231 (Friday, November 30, 2018)] [Notices] [Pages 61651-61653] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-25991] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-4227] Joint Meeting of the Arthritis 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) announces a forthcoming public advisory committee meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The general function of the committees 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 January 11, 2019, from 8 a.m. to 5 p.m. ADDRESSES: College Park Marriott Hotel and Conference Center, General Vessey Ballroom, 3501 University Blvd. East, Hyattsville, MD 20783. The conference center's telephone number is 301-985-7300. Answers to commonly asked questions about FDA Advisory Committee meetings may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm. Information about the College Park Marriott Hotel and Conference Center can be accessed at: https://www.marriott.com/hotels/travel/wasum-college-park-marriott-hotel-and-conference-center/. FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2018-N-4227. The docket will close on January 10, 2019. Submit either electronic or written comments on this public meeting by January 10, 2019. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before January 10, 2019. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of January 10, 2019. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Comments received on or before December 27, 2018, will be provided to the committees. 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 [[Page 61652]] 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-2018-N-4227 for ``Joint Meeting of the Arthritis 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 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: Yinghua S. Wang, 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: AAC@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: The committees will discuss supplemental new drug application (sNDA) 021-856, ULORIC (febuxostat) tablets, sponsored by Takeda Pharmaceuticals, which includes the results from the postmarketing safety trial required by FDA to evaluate the cardiovascular safety of febuxostat, entitled ``Cardiovascular Safety of Febuxostat and Allopurinol in Patients with Gout and Cardiovascular Morbidities (CARES).'' Febuxostat is a xanthine oxidase inhibitor indicated for the chronic management of hyperuricemia in patients with gout. The committees' discussion will include the results from the CARES trial, the benefit risk assessment of febuxostat, and potential regulatory actions. 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 committees. Written submissions may be made to the contact person on or before December 27, 2018. 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 December 18, 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 regarding their request to speak by December 19, 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 fdaoma@fda.hhs.gov or 301-796-4540. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Yinghua S. Wang (see FOR FURTHER INFORMATION [[Page 61653]] CONTACT) at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: November 26, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-25991 Filed 11-29-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 231 / Friday, November 30, 2018 / Notices 61651
Staff, 5630 Fishers Lane, Rm. 1061, evidence or arguments they wish to SUMMARY: The Food and Drug
Rockville, MD 20852. present, the names and addresses of Administration (FDA) announces a
FOR FURTHER INFORMATION CONTACT: proposed participants, and an forthcoming public advisory committee
Kalyani Bhatt, Center for Drug indication of the approximate time meeting of the Arthritis Advisory
Evaluation and Research, Food and requested to make their presentation on Committee and the Drug Safety and Risk
Drug Administration, 10903 New or before December 20, 2018. Time Management Advisory Committee. The
Hampshire Ave., Bldg. 31, Rm. 2417, allotted for each presentation may be general function of the committees is to
Silver Spring, MD 20993–0002, 301– limited. If the number of registrants provide advice and recommendations to
796–9001, Fax: 301–847–8533, email: requesting to speak is greater than can FDA on regulatory issues. The meeting
BRUDAC@fda.hhs.gov, or FDA Advisory be reasonably accommodated during the will be open to the public. FDA is
Committee Information Line, 1–800– scheduled open public hearing session, establishing a docket for public
741–8138 (301–443–0572 in the FDA may conduct a lottery to determine comment on this document.
Washington, DC area). A notice in the the speakers for the scheduled open DATES: The meeting will be held on
Federal Register about last minute public hearing session. The contact January 11, 2019, from 8 a.m. to 5 p.m.
modifications that impact a previously person will notify interested persons ADDRESSES: College Park Marriott Hotel
announced advisory committee meeting regarding their request to speak by and Conference Center, General Vessey
cannot always be published quickly December 21, 2018. Ballroom, 3501 University Blvd. East,
enough to provide timely notice. Persons attending FDA’s advisory Hyattsville, MD 20783. The conference
Therefore, you should always check the committee meetings are advised that center’s telephone number is 301–985–
FDA’s website at https://www.fda.gov/ FDA is not responsible for providing 7300. Answers to commonly asked
AdvisoryCommittees/default.htm and access to electrical outlets. questions about FDA Advisory
scroll down to the appropriate advisory For press inquiries, please contact the
Committee meetings may be accessed at:
committee meeting link, or call the Office of Media Affairs at fdaoma@
https://www.fda.gov/
advisory committee information line to fda.hhs.gov or 301–796–4540.
FDA welcomes the attendance of the AdvisoryCommittees/AboutAdvisory
learn about possible modifications Committees/ucm408555.htm.
before coming to the meeting. public at its advisory committee
meetings and will make every effort to Information about the College Park
SUPPLEMENTARY INFORMATION: Marriott Hotel and Conference Center
accommodate persons with disabilities.
Agenda: The committee will discuss can be accessed at: https://
If you require accommodations due to a
biologics license application 761062, www.marriott.com/hotels/travel/wasum-
disability, please contact Kalyani Bhatt
romosozumab injection, submitted by college-park-marriott-hotel-and-
(see FOR FURTHER INFORMATION CONTACT)
Amgen, for the proposed indication of conference-center/.
at least 7 days in advance of the
treatment of osteoporosis in FDA is establishing a docket for
meeting.
postmenopausal women at high risk for FDA is committed to the orderly public comment on this meeting. The
fracture, defined as a history of conduct of its advisory committee docket number is FDA–2018–N–4227.
osteoporotic fracture, or multiple risk meetings. Please visit our website at The docket will close on January 10,
factors for fracture; or patients who have https://www.fda.gov/ 2019. Submit either electronic or
failed or are intolerant of other available AdvisoryCommittees/AboutAdvi written comments on this public
osteoporosis therapy. soryCommittees/ucm111462.htm for meeting by January 10, 2019. Please
FDA intends to make background procedures on public conduct during note that late, untimely filed comments
material available to the public no later advisory committee meetings. will not be considered. Electronic
than 2 business days before the meeting. Notice of this meeting is given under comments must be submitted on or
If FDA is unable to post the background the Federal Advisory Committee Act (5 before January 10, 2019. The https://
material on its website prior to the U.S.C. app. 2). www.regulations.gov electronic filing
meeting, the background material will system will accept comments until
be made publicly available at the Dated: November 26, 2018.
11:59 p.m. Eastern Time at the end of
location of the advisory committee Leslie Kux, January 10, 2019. Comments received by
meeting, and the background material Associate Commissioner for Policy. mail/hand delivery/courier (for written/
will be posted on FDA’s website after [FR Doc. 2018–26029 Filed 11–29–18; 8:45 am] paper submissions) will be considered
the meeting. Background material is BILLING CODE 4164–01–P timely if they are postmarked or the
available at https://www.fda.gov/ delivery service acceptance receipt is on
AdvisoryCommittees/Calendar/ or before that date.
default.htm. Scroll down to the DEPARTMENT OF HEALTH AND Comments received on or before
appropriate advisory committee meeting HUMAN SERVICES December 27, 2018, will be provided to
link. the committees. Comments received
Procedure: Interested persons may Food and Drug Administration
after that date will be taken into
present data, information, or views, [Docket No. FDA–2018–N–4227] consideration by FDA.
orally or in writing, on issues pending You may submit comments as
before the committee. All electronic and Joint Meeting of the Arthritis Advisory follows:
written submissions submitted to the Committee and the Drug Safety and
Docket (see ADDRESSES) on or before Risk Management Advisory Electronic Submissions
December 31, 2018, will be provided to Committee; Notice of Meeting; Submit electronic comments in the
amozie on DSK3GDR082PROD with NOTICES1
the committee. Oral presentations from Establishment of a Public Docket; following way:
the public will be scheduled between Request for Comments • Federal eRulemaking Portal: https://
approximately 1 p.m. and 2 p.m. Those AGENCY: Food and Drug Administration, www.regulations.gov. Follow the
individuals interested in making formal HHS. instructions for submitting comments.
oral presentations should notify the Comments submitted electronically,
ACTION: Notice; establishment of a
contact person and submit a brief including attachments, to https://
public docket; request for comments.
statement of the general nature of the www.regulations.gov will be posted to
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![Federal Register / Vol. 83, No. 231 / Friday, November 30, 2018 / Notices 61653
CONTACT) at least 7 days in advance of Comments received by mail/hand • Confidential Submissions—To
the meeting. delivery/courier (for written/paper submit a comment with confidential
FDA is committed to the orderly submissions) will be considered timely information that you do not wish to be
conduct of its advisory committee if they are postmarked or the delivery made publicly available, submit your
meetings. Please visit our website at service acceptance receipt is on or comments only as a written/paper
https://www.fda.gov/Advisory before that date. submission. You should submit two
Committees/AboutAdvisoryCommittees/ copies total. One copy will include the
ucm111462.htm for procedures on Electronic Submissions
information you claim to be confidential
public conduct during advisory Submit electronic comments in the with a heading or cover note that states
committee meetings. following way: ‘‘THIS DOCUMENT CONTAINS
Notice of this meeting is given under • Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The
the Federal Advisory Committee Act (5 https://www.regulations.gov. Follow the Agency will review this copy, including
U.S.C. app. 2). instructions for submitting comments. the claimed confidential information, in
Dated: November 26, 2018.
Comments submitted electronically, its consideration of comments. The
including attachments, to https:// second copy, which will have the
Leslie Kux,
www.regulations.gov will be posted to claimed confidential information
Associate Commissioner for Policy. the docket unchanged. Because your redacted/blacked out, will be available
[FR Doc. 2018–25991 Filed 11–29–18; 8:45 am] comment will be made public, you are for public viewing and posted on
BILLING CODE 4164–01–P solely responsible for ensuring that your https://www.regulations.gov. Submit
comment does not include any both copies to the Dockets Management
confidential information that you or a Staff. If you do not wish your name and
DEPARTMENT OF HEALTH AND third party may not wish to be posted,
HUMAN SERVICES contact information to be made publicly
such as medical information, your or available, you can provide this
anyone else’s Social Security number, or information on the cover sheet and not
Food and Drug Administration
confidential business information, such in the body of your comments and you
[Docket No. FDA–2018–N–4131] as a manufacturing process. Please note must identify this information as
that if you include your name, contact ‘‘confidential.’’ Any information marked
Agency Information Collection information, or other information that
Activities; Proposed Collection; as ‘‘confidential’’ will not be disclosed
identifies you in the body of your except in accordance with 21 CFR 10.20
Comment Request; Food and Drug comments, that information will be
Administration Adverse Event Reports; and other applicable disclosure law. For
posted on https://www.regulations.gov. more information about FDA’s posting
Electronic Submissions • If you want to submit a comment of comments to public dockets, see 80
AGENCY: Food and Drug Administration, with confidential information that you FR 56469, September 18, 2015, or access
HHS. do not wish to be made available to the the information at: https://www.gpo.gov/
ACTION: Notice. public, submit the comment as a fdsys/pkg/FR-2015-09-18/pdf/2015-
written/paper submission and in the 23389.pdf.
SUMMARY: The Food and Drug manner detailed (see ‘‘Written/Paper Docket: For access to the docket to
Administration (FDA, Agency, or we) is Submissions’’ and ‘‘Instructions’’). read background documents or the
announcing an opportunity for public Written/Paper Submissions electronic and written/paper comments
comment on the proposed collection of received, go to https://
certain information by the Agency. Submit written/paper submissions as
www.regulations.gov and insert the
Under the Paperwork Reduction Act of follows:
• Mail/Hand Delivery/Courier (for docket number, found in brackets in the
1995 (PRA), Federal Agencies are heading of this document, into the
required to publish notice in the written/paper submissions): Dockets
Management Staff (HFA–305), Food and ‘‘Search’’ box and follow the prompts
Federal Register concerning each and/or go to the Dockets Management
proposed collection of information, Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852. Staff, 5630 Fishers Lane, Rm. 1061,
including each proposed extension of an Rockville, MD 20852.
• For written/paper comments
existing collection of information, and FOR FURTHER INFORMATION CONTACT:
submitted to the Dockets Management
to allow 60 days for public comment in Domini Bean, Office of Operations,
Staff, FDA will post your comment, as
response to the notice. This notice Food and Drug Administration, Three
well as any attachments, except for
solicits comments on the use of the FDA White Flint North, 10A–12M, 11601
information submitted, marked and
Electronic Submission Gateway (ESG) Landsdown St., North Bethesda, MD
identified, as confidential, if submitted
and the Safety Reporting Portal (SRP) to 20852, 301–796–5733, PRAStaff@
as detailed in ‘‘Instructions.’’
collect adverse event reports and other fda.hhs.gov.
Instructions: All submissions received
safety information for FDA-regulated
must include the Docket No. FDA– SUPPLEMENTARY INFORMATION:
products.
2018–N–4131 for ‘‘Agency Information
DATES: Submit either electronic or Collection Activities; Proposed I. Background
written comments on the collection of Collection; Comment Request; FDA Under the PRA (44 U.S.C. 3501–
information by January 29, 2019. Adverse Event Reports; Electronic 3520), Federal Agencies must obtain
ADDRESSES: You may submit comments Submissions.’’ Received comments, approval from the Office of Management
as follows. Please note that late, those filed in a timely manner (see and Budget (OMB) for each collection of
amozie on DSK3GDR082PROD with NOTICES1
untimely filed comments will not be ADDRESSES), will be placed in the docket information they conduct or sponsor.
considered. Electronic comments must and, except for those submitted as ‘‘Collection of information’’ is defined
be submitted on or before January 29, ‘‘Confidential Submissions,’’ publicly in 44 U.S.C. 3502(3) and 5 CFR
2019. The https://www.regulations.gov viewable at https://www.regulations.gov 1320.3(c) and includes Agency requests
electronic filing system will accept or at the Dockets Management Staff or requirements that members of the
comments until 11:59 p.m. Eastern Time between 9 a.m. and 4 p.m., Monday public submit reports, keep records, or
at the end of January 29, 2019. through Friday. provide information to a third party.
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Document Created: 2018-11-30 04:35:20
Document Modified: 2018-11-30 04:35:20
| 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 January 11, 2019, from 8 a.m. to 5 p.m. | |
| Contact | Yinghua S. Wang, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301- 796-9001, Fax: 301-847-8533, email: [email protected], or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the FDA's website at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. | |
| FR Citation | 83 FR 61651 |
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