83 FR 11759 - Arthritis 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 52 (March 16, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 52 (March 16, 2018)
| Page Range | 11759-11761 | |
| FR Document | 2018-05386 |
[Federal Register Volume 83, Number 52 (Friday, March 16, 2018)] [Notices] [Pages 11759-11761] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-05386] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-0976] Arthritis 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. 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 April 23, 2018, from 8 a.m. to 5 p.m. ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Building 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-2018-N-0976. The docket will close on April 20, 2018. Submit either electronic or written comments on this public meeting by April 20, 2018. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before April 20, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of April 20, 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 April 9, 2018, will be provided to the committee. Comments received after that date will be taken into consideration by FDA. [[Page 11760]] 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-2018-N-0976 for ``Arthritis 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: [email protected], or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the FDA's website at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. SUPPLEMENTARY INFORMATION: Agenda: The committee will discuss new drug application (NDA) 207924, for baricitinib tablets, submitted by Eli Lilly and Company, for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. The discussion will include the following: Efficacy, safety, including the risk of thromboembolic adverse events, dose selection, and overall risk benefit considerations. 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. All electronic and written submissions submitted to the Docket (see ADDRESSES) on or before April 9, 2018, will be provided to the committee. 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 March 30, 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 April 2, 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 [[Page 11761]] accommodate persons with disabilities. If you require accommodations due to a disability, please contact Yinghua Wang (see FOR FURTHER INFORMATION 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: March 13, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-05386 Filed 3-15-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 52 / Friday, March 16, 2018 / Notices 11759
amendment requires that user facilities section 519 of the FD&C Act. The The proposed extension to Forms
such as hospitals, nursing homes, MDUFMA amendment (section 303) FDA 3500, 3500A, and 3500B will only
ambulatory surgical facilities, and required FDA to revise the MedWatch have changes in the form instructions to
outpatient treatment facilities report forms to facilitate the reporting of provide clarity of reporting. The
deaths related to medical devices to information relating to reprocessed proposed changes are regulatory driven,
FDA and to the manufacturer, if known. single-use devices, including the name improving the Centers’ work, and
Serious illnesses and injuries are to be of the reprocessor and whether the improving report processing. The
reported to the manufacturer or to FDA device has been reused. Agency welcomes comments about
if the manufacturer is not known. These translation of Form FDA 3500B
statutory requirements regarding II. Proposed Modification to Existing
Forms FDA 3500, 3500A, and 3500B (consumer) into Spanish and other
mandatory reporting have been codified languages.
by FDA under 21 CFR part 803 (part General changes—The proposed
803). Part 803 mandates the use of Form modifications to Forms FDA 3500 and Formatting modifications are being
FDA 3500A for reporting to FDA on 3500A reflect changes that will bring the proposed to several fields to enhance
medical devices. The Medical Device form into conformance, since the the quality, utility, and clarity of the
User Fee and Modernization Act of 2002 previous authorization in 2015, with information.
(MDUFMA) (Pub. L. 107–250), signed current regulations, rules, and FDA estimates the burden of this
into law October 26, 2002, amended guidances. collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
Number of Total annual Average burden
FDA Center/FDA Form/21 CFR section responses per Total hours
respondents responses per response
respondent
Center for Biologics Evaluation and Research/Center for
Drug Evaluation and Research:
Form 3500 ................................................................. 14,727 1 14,727 0.66 (40 min) .... 9,720
Form 3500A (§§ 310.305, 314.80, 314.98, 600.80, 599 98 58,702 1.21 .................. 71,029
1271.350).
Form 3500A (§§ 310.305 outsourcing facilities) ........ 50 2 100 1.21 .................. 121
Center for Devices and Radiological Health:
Form 3500 ................................................................. 5,233 1 5,233 0.66 (40 min) .... 3,454
Form 3500A (803) ..................................................... 2,277 296 673,992 1.21 .................. 815,530
Center for Food Safety and Applied Nutrition:
Form 3500 ................................................................. 1,793 1 1,793 0.66 (40 min) .... 1,183
Form 3500A ............................................................... 1,659 1 1,659 1.21 .................. 2,007
Center for Tobacco Products:
Form 3500 ................................................................. 39 1 39 0.66 (40 min) .... 26
All Centers:
Form 3500B ............................................................... 13,750 1 13,750 0.46 (28 min) .... 6,325
Total .................................................................... ........................ ........................ ........................ ........................... 909,395
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
The burden estimates have not SUMMARY: The Food and Drug FDA is establishing a docket for
changed from the current approval. Administration (FDA) announces a public comment on this meeting. The
Dated: March 12, 2018. forthcoming public advisory committee docket number is FDA–2018–N–0976.
Leslie Kux,
meeting of the Arthritis Advisory The docket will close on April 20, 2018.
Committee. The general function of the Submit either electronic or written
Associate Commissioner for Policy.
committee is to provide advice and comments on this public meeting by
[FR Doc. 2018–05337 Filed 3–15–18; 8:45 am] April 20, 2018. Please note that late,
recommendations to FDA on regulatory
BILLING CODE 4164–01–P issues. The meeting will be open to the untimely filed comments will not be
public. FDA is establishing a docket for considered. Electronic comments must
public comment on this document. be submitted on or before April 20,
DEPARTMENT OF HEALTH AND 2018. The https://www.regulations.gov
HUMAN SERVICES DATES: The meeting will be held on
electronic filing system will accept
April 23, 2018, from 8 a.m. to 5 p.m.
Food and Drug Administration comments until midnight Eastern Time
ADDRESSES: FDA White Oak Campus, at the end of April 20, 2018. Comments
10903 New Hampshire Ave., Building received by mail/hand delivery/courier
[Docket No. FDA–2018–N–0976] 31 Conference Center, the Great Room (for written/paper submissions) will be
(Rm. 1503), Silver Spring, MD 20993– considered timely if they are
Arthritis Advisory Committee; Notice 0002. Answers to commonly asked postmarked or the delivery service
daltland on DSKBBV9HB2PROD with NOTICES
of Meeting; Establishment of a Public questions including information acceptance receipt is on or before that
Docket; Request for Comments regarding special accommodations due date.
AGENCY: Food and Drug Administration, to a disability, visitor parking, and Comments received on or before April
HHS. transportation may be accessed at: 9, 2018, will be provided to the
https://www.fda.gov/ committee. Comments received after
ACTION: Notice, establishment of a
AdvisoryCommittees/AboutAdvisory that date will be taken into
public docket; request for comments.
Committees/ucm408555.htm. consideration by FDA.
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![Federal Register / Vol. 83, No. 52 / Friday, March 16, 2018 / Notices 11761
accommodate persons with disabilities. I. Background public workshop beginning at 7:30 a.m.
If you require accommodations due to a FDA has made education of the drug The cost of registration is as follows:
disability, please contact Yinghua Wang and device manufacturing community a
(see FOR FURTHER INFORMATION CONTACT) Cost of
high priority to help ensure the quality Category
at least 7 days in advance of the registration
of FDA-regulated drugs and devices.
meeting. The workshop helps to achieve AFDO Members .................... $550
FDA is committed to the orderly objectives set forth in section 406 of the AFDO Non-Members ............ 650
conduct of its advisory committee Food and Drug Administration Additional Fee for Registra-
meetings. Please visit our website at Modernization Act of 1997 (21 U.S.C. tion Postmarked After May
https://www.fda.gov/ 393), which includes working closely 1, 2018 .............................. 100
AdvisoryCommittees/AboutAdvisory with stakeholders and maximizing the
Committees/ucm111462.htm for To register online, please visit http://
availability and clarity of information to www.afdo.org/conference (FDA has
procedures on public conduct during stakeholders and the public. The
advisory committee meetings. verified the website address, but is not
workshop also is consistent with the responsible for subsequent changes to
Notice of this meeting is given under Small Business Regulatory Enforcement
the Federal Advisory Committee Act (5 the website after this document
Fairness Act of 1996 (Pub. L. 104–121), publishes in the Federal Register.) For
U.S.C. app. 2). as outreach activities by government alternative registration, please complete
Dated: March 13, 2018. agencies to small businesses. and submit an AFDO Conference
Leslie Kux, Registration Form, available at http://
II. Topics for Discussion at the Public
Associate Commissioner for Policy. burlington.afdo.org/registration.html,
Workshop
[FR Doc. 2018–05386 Filed 3–15–18; 8:45 am] along with a check or money order
The public workshop helps fulfill the
BILLING CODE 4164–01–P payable to AFDO. Please mail your
Department of Health and Human
completed registration form and
Services and FDA’s mission to protect
payment to: AFDO, 155 West Market St.,
DEPARTMENT OF HEALTH AND the public health. The workshop will
3rd Floor, York, PA 17401. The registrar
HUMAN SERVICES provide FDA-regulated drug and device
will also accept payment through Visa,
entities with information on a number
MasterCard, and American Express
Food and Drug Administration of topics concerning FDA requirements
credit cards. For more information on
related to the production and marketing
[Docket No. FDA–2018–N–0757] the public workshop, or for questions
of drugs and/or devices. The public
about registration, please contact AFDO
Pathways to Global Unity; Public workshop’s agenda is available at http://
at 717–757–2888, afdo@afdo.org, or
Workshop www.afdo.org/conference. Topics for
http://www.afdo.org/conference.
discussion include the following: If you need special accommodations
AGENCY: Food and Drug Administration, • FDA Associate Commissioner for due to a disability, please contact
HHS. Regulatory Affairs Update Krystal Reed (see FOR FURTHER
ACTION: Notice of public workshop. • Health Canada: Single Audit Program INFORMATION CONTACT) at least 21 days in
• Enforcement Trends in Drug, Devices, advance of the workshop.
SUMMARY: The Food and Drug and Compounding Pharmacy
Administration (FDA), in collaboration Dated: March 13, 2018.
Inspections
with the Association of Food and Drug • FDA Compliance Questions Panel Leslie Kux,
Officials (AFDO), is announcing the • International Compliance—Industry Associate Commissioner for Policy.
following public workshop entitled Perspective [FR Doc. 2018–05389 Filed 3–15–18; 8:45 am]
‘‘Pathways to Global Unity.’’ This 21⁄2- • Puerto Rico Emergency Response BILLING CODE 4164–01–P
day public workshop is intended to Update
provide information about FDA drug • Artificial Intelligence
and device regulation to the regulated • Supply Chain Control DEPARTMENT OF HEALTH AND
industries. • Dermal Abyss: Tattoos as Medical HUMAN SERVICES
DATES: The public workshop will be Condition Monitors
• Design Controls for Combination Advisory Council on Alzheimer’s
held on June 11–12, 2018, from 8 a.m.
Products Research, Care, and Services; Meeting
to 5:30 p.m., and on June 13, 2018, from
8 a.m. to 12 p.m. • Benefit Risk—Using Benefit Risk in AGENCY: Assistant Secretary for
ADDRESSES: The public workshop will Making Post-Market Decisions Planning and Evaluation, HHS.
be held at the Doubletree by Hilton III. Participating in the Public ACTION: Notice of meeting.
Hotel Burlington Vermont, 870 Workshop SUMMARY: This notice announces the
Williston Rd., Burlington, VT 05403,
Registration: You are encouraged to public meeting of the Advisory Council
802–865–6626. For directions to the
register by May 1, 2018. Registration on Alzheimer’s Research, Care, and
hotel and information on lodging, visit
fees cover the cost of facilities, Services (Advisory Council). The
http://burlington.afdo.org/hotel.html.
materials, and breaks. Seats are limited; Advisory Council on Alzheimer’s
Attendees are responsible for their own
therefore, please submit your Research, Care, and Services provides
accommodations.
registration as soon as possible. Course advice on how to prevent or reduce the
daltland on DSKBBV9HB2PROD with NOTICES
FOR FURTHER INFORMATION CONTACT: burden of Alzheimer’s disease and
space will be filled in order of receipt
Krystal Reed, Association of Food and of registration. Those accepted into the related dementias on people with the
Drug Officials, 155 West Market St., 3rd course will receive confirmation. disease and their caregivers. During the
Floor, York, PA 17401, 717–757–2888, Registration will close after the course is April meeting, the Clinical Care
Fax: 717–650–3650, email: kreed@ filled. Registration at the site is not Subcommittee will be taking charge of
afdo.org. guaranteed but may be possible on a the theme, focusing on advancing
SUPPLEMENTARY INFORMATION: space-available basis on the day of the consensus on dementia care elements to
VerDate Sep<11>2014 21:54 Mar 15, 2018 Jkt 244001 PO 00000 Frm 00093 Fmt 4703 Sfmt 4703 E:\FR\FM\16MRN1.SGM 16MRN1](https://thefederalregister.org/doc/83_FR_11811/page/3.svg)
Document Created: 2018-03-16 01:12:11
Document Modified: 2018-03-16 01:12:11
| 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 April 23, 2018, 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 11759 |
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