83 FR 13491 - Fiscal Year 2018 Generic Drug Regulatory Science Initiatives; Public Workshop; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 61 (March 29, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 61 (March 29, 2018)
| Page Range | 13491-13493 | |
| FR Document | 2018-06260 |
[Federal Register Volume 83, Number 61 (Thursday, March 29, 2018)] [Notices] [Pages 13491-13493] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-06260] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-6644] Fiscal Year 2018 Generic Drug Regulatory Science Initiatives; Public Workshop; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop; request for comments. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled ``FY 2018 Generic Drug Regulatory Science Initiatives.'' The purpose of the public workshop is to provide an overview of the status of regulatory science initiatives for generic drugs and an opportunity for public input on these initiatives. FDA is seeking this input from a variety of stakeholders--industry, academia, patient advocates, professional societies, and other interested parties--as it fulfills its commitment under the Generic Drug User Fee Amendments of 2017 (GDUFA II) to develop an annual list of regulatory science initiatives specific to generic drugs. FDA will take the information it obtains from the public workshop into account in developing its fiscal year (FY) 2019 regulatory science initiatives. DATES: The public workshop will be held on May 24, 2018 from 8:30 a.m. to 4:30 p.m. Submit either electronic or written comments on this public workshop by June 25, 2018. See the SUPPLEMENTARY INFORMATION section for registration date and information. ADDRESSES: The public workshop will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503, sections B and C), Silver Spring, MD 20993-0002. Entrance for the public workshop participants (non-FDA employees) is through Bldg. 1, where routine security check procedures will be performed. For parking and security information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm. You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before June 25, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of June 25, 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. 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 [[Page 13492]] 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-6644 for ``FY 2018 Generic Drug Regulatory Science Initiatives; Public Workshop; 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.'' 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: Stephanie Choi, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 4736, Silver Spring, MD 20993, 240-402- 7960, [email protected]; or Robert Lionberger, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 4722, Silver Spring, MD 20993, 240-402- 7957, [email protected]. SUPPLEMENTARY INFORMATION: I. Background In July 2012, Congress passed the Generic Drug User Fee Amendments of 2012 (GDUFA I) (Pub. L. 112-144). GDUFA I was designed to enhance public access to safe, high-quality generic drugs and to modernize the generic drug program. To support this goal, FDA agreed in the GDUFA I commitment letter to work with industry and interested stakeholders on identifying regulatory science initiatives specific to generic drugs for each fiscal year covered by GDUFA I. In August 2017, GDUFA I was reauthorized until September 2022 through GDUFA II (Pub. L. 115-52). In the GDUFA II commitment letter,\1\ FDA agreed to conduct annual public workshops ``to solicit input from industry and stakeholders for inclusion in an annual list of GDUFA II [r]egulatory [s]cience initiatives.'' The public workshop scheduled for May 24, 2018, seeks to fulfill this agreement. --------------------------------------------------------------------------- \1\ The GDUFA II commitment letter is available at https://www.fda.gov/downloads/ForIndustry/UserFees/GenericDrugUserFees/UCM525234.pdf. --------------------------------------------------------------------------- II. Topics for Discussion at the Public Workshop The purpose of the public workshop is to obtain input from industry and other interested stakeholders on the identification of generic drug regulatory science initiatives for FY 2019. FDA is particularly interested in receiving input regarding the following three topics: 1. FY 2018 regulatory science initiatives,\2\ including specific products or actions that FDA should consider as it implements those initiatives, --------------------------------------------------------------------------- \2\ The FY 2018 regulatory science initiatives are available at https://www.fda.gov/downloads/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/GenericDrugs/UCM582777.pdf. --------------------------------------------------------------------------- 2. newly approved new drug applications that may pose scientific challenges to the future development of generic products referencing those applications, and 3. regulatory science initiatives that FDA should begin to consider in FY 2019. FDA will consider all comments made at this workshop or received through the docket (see ADDRESSES) as it develops its FY 2019 regulatory science initiatives. Information concerning the regulatory science initiatives for generic drugs can be found at https://www.fda.gov/gdufaregscience. III. Participating in the Public Workshop Registration: To register for the public workshop, please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone to [email protected]. Please also indicate in the email whether attendance will be by webcast or in person. Registration is free and based on space availability, with priority given to early registrants. Persons interested in attending this public workshop must register online by April 24, 2018, midnight Eastern Time. Early registration is recommended because seating is limited; therefore, FDA may limit the number of participants from each organization. Registrants will receive confirmation when they have been accepted. If you need special accommodations due to a disability, please contact Stephanie Choi (see FOR FURTHER INFORMATION CONTACT) no later than April 24, 2018. Requests for Oral Presentations: During online registration you may indicate if you wish to present during a public comment session or participate in a specific session, and which topic(s) you wish to address. We will do our best to accommodate requests to make public comments (and requests to participate in the focused sessions). Individuals and organizations with common interests are urged to consolidate or coordinate their [[Page 13493]] presentations, and request time for a joint presentation, or submit requests for designated representatives to participate in the focused sessions. Following the close of registration, we will determine the amount of time allotted to each presenter and the approximate time each oral presentation is to begin, and will select and notify participants by May 8, 2018. All requests to make oral presentations must be received by the close of registration on April 24, 2018, midnight Eastern Time. If selected for presentation, any presentation materials must be emailed to [email protected] no later than May 17, 2018, midnight Eastern Time. No commercial or promotional material will be permitted to be presented or distributed at the public workshop. Streaming Webcast of the Public Workshop: This public workshop will also be webcast. Please register online by April 24, 2018, midnight Eastern Time to attend the workshop remotely. Please note that remote attendees will not be able to speak or make presentations during the public comment period or during any other session of the workshop. To join the workshop via the webcast, please go to https://collaboration.fda.gov/gdufa2018/. If you have never attended a Connect Pro event before, test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program, visit https://www.adobe.com/go/connectpro_overview. FDA has verified the website addresses in this document, as of the date this document publishes in the Federal Register, but websites are subject to change over time. Transcripts: Please be advised that as soon as a transcript of the public workshop is available, it will be accessible at https://www.regulations.gov or at https://www.fda.gov/gdufaregscience. It may be viewed at the Dockets Management Staff (see ADDRESSES). A link to the transcript will also be available on the internet at https://www.fda.gov/gdufaregscience. Dated: March 21, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-06260 Filed 3-28-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 61 / Thursday, March 29, 2018 / Notices 13491
Advisory Committee Information Line, conduct a lottery to determine the fulfills its commitment under the
1–800–741–8138 (301–443–0572 in the speakers for the scheduled open public Generic Drug User Fee Amendments of
Washington, DC area). A notice in the hearing session. The contact person will 2017 (GDUFA II) to develop an annual
Federal Register about last minute notify interested persons regarding their list of regulatory science initiatives
modifications that impact a previously request to speak by May 1, 2018. specific to generic drugs. FDA will take
announced advisory committee meeting Persons attending FDA’s advisory the information it obtains from the
cannot always be published quickly committee meetings are advised that public workshop into account in
enough to provide timely notice. FDA is not responsible for providing developing its fiscal year (FY) 2019
Therefore, you should always check the access to electrical outlets. regulatory science initiatives.
FDA’s website at https://www.fda.gov/ For press inquiries, please contact the DATES: The public workshop will be
AdvisoryCommittees/default.htm and Office of Media Affairs at fdaoma@ held on May 24, 2018 from 8:30 a.m. to
scroll down to the appropriate advisory fda.hhs.gov or 301–796–4540. 4:30 p.m. Submit either electronic or
committee meeting link, or call the FDA welcomes the attendance of the written comments on this public
advisory committee information line to public at its advisory committee workshop by June 25, 2018. See the
learn about possible modifications meetings and will make every effort to SUPPLEMENTARY INFORMATION section for
before coming to the meeting. accommodate persons with disabilities. registration date and information.
SUPPLEMENTARY INFORMATION: If you require accommodations due to a ADDRESSES: The public workshop will
Agenda: The committees will be disability, please contact Moon Hee V. be held at the FDA White Oak Campus,
asked to discuss new drug application Choi (see FOR FURTHER INFORMATION 10903 New Hampshire Ave., Bldg. 31
(NDA) 209588, for buprenorphine CONTACT) at least 7 days in advance of Conference Center, the Great Room (Rm.
sublingual spray, submitted by INSYS the meeting. 1503, sections B and C), Silver Spring,
Development Company, Inc., for the FDA is committed to the orderly MD 20993–0002. Entrance for the public
treatment of moderate-to-severe acute conduct of its advisory committee workshop participants (non-FDA
pain where the use of an opioid meetings. Please visit our website at employees) is through Bldg. 1, where
analgesic is appropriate. The https://www.fda.gov/Advisory routine security check procedures will
committees will also be asked to discuss Committees/AboutAdvisoryCommittees/ be performed. For parking and security
whether this product should be ucm111462.htm for procedures on information, please refer to https://
approved. public conduct during advisory www.fda.gov/AboutFDA/
FDA intends to make background committee meetings. WorkingatFDA/BuildingsandFacilities/
material available to the public no later Notice of this meeting is given under WhiteOakCampusInformation/
than 2 business days before the meeting. the Federal Advisory Committee Act (5 ucm241740.htm.
If FDA is unable to post the background U.S.C. app. 2). You may submit comments as
material on its website prior to the Dated: March 21, 2018. follows. Please note that late, untimely
meeting, the background material will Leslie Kux, filed comments will not be considered.
be made publicly available at the Associate Commissioner for Policy. Electronic comments must be submitted
location of the advisory committee [FR Doc. 2018–06307 Filed 3–28–18; 8:45 am] on or before June 25, 2018. The https://
meeting, and the background material www.regulations.gov electronic filing
BILLING CODE 4164–01–P
will be posted on FDA’s website after system will accept comments until
the meeting. Background material is midnight Eastern Time at the end of
available at https://www.fda.gov/ DEPARTMENT OF HEALTH AND June 25, 2018. Comments received by
AdvisoryCommittees/Calendar/ HUMAN SERVICES mail/hand delivery/courier (for written/
default.htm. Scroll down to the paper submissions) will be considered
appropriate advisory committee meeting Food and Drug Administration timely if they are postmarked or the
link. delivery service acceptance receipt is on
Procedure: Interested persons may [Docket No. FDA–2017–N–6644]
or before that date.
present data, information, or views,
Fiscal Year 2018 Generic Drug Electronic Submissions
orally or in writing, on issues pending
Regulatory Science Initiatives; Public
before the committees. Written Submit electronic comments in the
Workshop; Request for Comments
submissions may be made to the contact following way:
person on or before May 8, 2018. Oral AGENCY: Food and Drug Administration, • Federal eRulemaking Portal:
presentations from the public will be HHS. https://www.regulations.gov. Follow the
scheduled between approximately 1 ACTION: Notice of public workshop; instructions for submitting comments.
p.m. and 2 p.m. Those individuals request for comments. Comments submitted electronically,
interested in making formal oral including attachments, to https://
presentations should notify the contact SUMMARY: The Food and Drug www.regulations.gov will be posted to
person and submit a brief statement of Administration (FDA, the Agency, or the docket unchanged. Because your
the general nature of the evidence or we) is announcing the following public comment will be made public, you are
arguments they wish to present, the workshop entitled ‘‘FY 2018 Generic solely responsible for ensuring that your
names and addresses of proposed Drug Regulatory Science Initiatives.’’ comment does not include any
participants, and an indication of the The purpose of the public workshop is confidential information that you or a
approximate time requested to make to provide an overview of the status of third party may not wish to be posted,
sradovich on DSK3GMQ082PROD with NOTICES
their presentation on or before April 30, regulatory science initiatives for generic such as medical information, your or
2018. Time allotted for each drugs and an opportunity for public anyone else’s Social Security number, or
presentation may be limited. If the input on these initiatives. FDA is confidential business information, such
number of registrants requesting to seeking this input from a variety of as a manufacturing process. Please note
speak is greater than can be reasonably stakeholders—industry, academia, that if you include your name, contact
accommodated during the scheduled patient advocates, professional societies, information, or other information that
open public hearing session, FDA may and other interested parties—as it identifies you in the body of your
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![13492 Federal Register / Vol. 83, No. 61 / Thursday, March 29, 2018 / Notices
comments, that information will be more information about FDA’s posting FDA is particularly interested in
posted on https://www.regulations.gov. of comments to public dockets, see 80 receiving input regarding the following
• If you want to submit a comment FR 56469, September 18, 2015, or access three topics:
with confidential information that you the information at: https://www.gpo.gov/ 1. FY 2018 regulatory science
do not wish to be made available to the fdsys/pkg/FR-2015-09-18/pdf/2015- initiatives,2 including specific products
public, submit the comment as a 23389.pdf. or actions that FDA should consider as
written/paper submission and in the Docket: For access to the docket to it implements those initiatives,
manner detailed (see ‘‘Written/Paper read background documents or the 2. newly approved new drug
Submissions’’ and ‘‘Instructions’’). electronic and written/paper comments applications that may pose scientific
Written/Paper Submissions received, go to https:// challenges to the future development of
www.regulations.gov and insert the generic products referencing those
Submit written/paper submissions as docket number, found in brackets in the applications, and
follows: heading of this document, into the 3. regulatory science initiatives that
• Mail/Hand delivery/Courier (for ‘‘Search’’ box and follow the prompts FDA should begin to consider in FY
written/paper submissions): Dockets and/or go to the Dockets Management 2019.
Management Staff (HFA–305), Food and Staff, 5630 Fishers Lane, Rm. 1061, FDA will consider all comments made
Drug Administration, 5630 Fishers Rockville, MD 20852. at this workshop or received through the
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments FOR FURTHER INFORMATION CONTACT: docket (see ADDRESSES) as it develops its
submitted to the Dockets Management Stephanie Choi, Center for Drug FY 2019 regulatory science initiatives.
Staff, FDA will post your comment, as Evaluation and Research, Food and Information concerning the regulatory
well as any attachments, except for Drug Administration, 10903 New science initiatives for generic drugs can
information submitted, marked and Hampshire Ave., Bldg. 75, Rm. 4736, be found at https://www.fda.gov/
identified, as confidential, if submitted Silver Spring, MD 20993, 240–402– gdufaregscience.
as detailed in ‘‘Instructions.’’ 7960, Stephanie.Choi@fda.hhs.gov; or
III. Participating in the Public
Instructions: All submissions received Robert Lionberger, Center for Drug
Workshop
must include the Docket No. FDA– Evaluation and Research, Food and
2017–N–6644 for ‘‘FY 2018 Generic Drug Administration, 10903 New Registration: To register for the public
Drug Regulatory Science Initiatives; Hampshire Ave., Bldg. 75, Rm. 4722, workshop, please provide complete
Public Workshop; Request for Silver Spring, MD 20993, 240–402– contact information for each attendee,
Comments.’’ Received comments, those 7957, Robert.Lionberger@fda.hhs.gov. including name, title, affiliation,
filed in a timely manner (see SUPPLEMENTARY INFORMATION: address, email, and telephone to
ADDRESSES), will be placed in the docket
GDUFARegulatoryScience@fda.hhs.gov.
I. Background Please also indicate in the email
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly In July 2012, Congress passed the whether attendance will be by webcast
viewable at https://www.regulations.gov Generic Drug User Fee Amendments of or in person.
or at the Dockets Management Staff 2012 (GDUFA I) (Pub. L. 112–144). Registration is free and based on
between 9 a.m. and 4 p.m., Monday GDUFA I was designed to enhance space availability, with priority given to
through Friday. public access to safe, high-quality early registrants. Persons interested in
• Confidential Submissions—To generic drugs and to modernize the attending this public workshop must
submit a comment with confidential generic drug program. To support this register online by April 24, 2018,
information that you do not wish to be goal, FDA agreed in the GDUFA I midnight Eastern Time. Early
made publicly available, submit your commitment letter to work with registration is recommended because
comments only as a written/paper industry and interested stakeholders on seating is limited; therefore, FDA may
submission. You should submit two identifying regulatory science initiatives limit the number of participants from
copies total. One copy will include the specific to generic drugs for each fiscal each organization. Registrants will
information you claim to be confidential year covered by GDUFA I. receive confirmation when they have
with a heading or cover note that states In August 2017, GDUFA I was been accepted.
‘‘THIS DOCUMENT CONTAINS reauthorized until September 2022 If you need special accommodations
CONFIDENTIAL INFORMATION.’’ The through GDUFA II (Pub. L. 115–52). In due to a disability, please contact
Agency will review this copy, including the GDUFA II commitment letter,1 FDA Stephanie Choi (see FOR FURTHER
the claimed confidential information, in agreed to conduct annual public INFORMATION CONTACT) no later than
its consideration of comments. The workshops ‘‘to solicit input from April 24, 2018.
second copy, which will have the industry and stakeholders for inclusion Requests for Oral Presentations:
claimed confidential information in an annual list of GDUFA II During online registration you may
redacted/blacked out, will be available [r]egulatory [s]cience initiatives.’’ The indicate if you wish to present during a
for public viewing and posted on public workshop scheduled for May 24, public comment session or participate
https://www.regulations.gov. Submit 2018, seeks to fulfill this agreement. in a specific session, and which topic(s)
both copies to the Dockets Management II. Topics for Discussion at the Public you wish to address. We will do our
Staff. If you do not wish your name and Workshop best to accommodate requests to make
contact information to be made publicly public comments (and requests to
The purpose of the public workshop participate in the focused sessions).
available, you can provide this
sradovich on DSK3GMQ082PROD with NOTICES
is to obtain input from industry and Individuals and organizations with
information on the cover sheet and not
other interested stakeholders on the common interests are urged to
in the body of your comments and you
identification of generic drug regulatory consolidate or coordinate their
must identify this information as
science initiatives for FY 2019.
‘‘confidential.’’ Any information marked 2 The FY 2018 regulatory science initiatives are
as ‘‘confidential’’ will not be disclosed 1 The GDUFA II commitment letter is available at available at https://www.fda.gov/downloads/Drugs/
except in accordance with 21 CFR 10.20 https://www.fda.gov/downloads/ForIndustry/ ResourcesForYou/Consumers/BuyingUsing
and other applicable disclosure law. For UserFees/GenericDrugUserFees/UCM525234.pdf. MedicineSafely/GenericDrugs/UCM582777.pdf.
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presentations, and request time for a DEPARTMENT OF HEALTH AND You may submit comments as
joint presentation, or submit requests for HUMAN SERVICES follows:
designated representatives to participate Electronic Submissions
in the focused sessions. Following the Food and Drug Administration
close of registration, we will determine Submit electronic comments in the
[Docket No. FDA–2018–N–1015]
the amount of time allotted to each following way:
Joint Meeting of the Arthritis Advisory • Federal eRulemaking Portal:
presenter and the approximate time
Committee and the Drug Safety and https://www.regulations.gov. Follow the
each oral presentation is to begin, and
Risk Management Advisory instructions for submitting comments.
will select and notify participants by Comments submitted electronically,
May 8, 2018. All requests to make oral Committee; Notice of Meeting;
Establishment of a Public Docket; including attachments, to https://
presentations must be received by the www.regulations.gov will be posted to
close of registration on April 24, 2018, Request for Comments
the docket unchanged. Because your
midnight Eastern Time. If selected for AGENCY: Food and Drug Administration, comment will be made public, you are
presentation, any presentation materials HHS. solely responsible for ensuring that your
must be emailed to ACTION: Notice; establishment of a comment does not include any
GDUFARegulatoryScience@fda.hhs.gov public docket; request for comments. confidential information that you or a
no later than May 17, 2018, midnight third party may not wish to be posted,
Eastern Time. No commercial or SUMMARY: The Food and Drug such as medical information, your or
promotional material will be permitted Administration (FDA) announces a
anyone else’s Social Security number, or
forthcoming public advisory committee
to be presented or distributed at the confidential business information, such
meeting of the Arthritis Advisory
public workshop. as a manufacturing process. Please note
Committee and the Drug Safety and Risk
Streaming Webcast of the Public that if you include your name, contact
Management Advisory Committee. The
Workshop: This public workshop will information, or other information that
general function of the committees is to
identifies you in the body of your
also be webcast. Please register online provide advice and recommendations to
comments, that information will be
by April 24, 2018, midnight Eastern FDA on regulatory issues. The meeting
posted on https://www.regulations.gov.
Time to attend the workshop remotely. will be open to the public. FDA is
• If you want to submit a comment
Please note that remote attendees will establishing a docket for public
with confidential information that you
not be able to speak or make comment on this document.
do not wish to be made available to the
presentations during the public DATES: The meeting will be held on public, submit the comment as a
comment period or during any other April 24 and 25, 2018, from 8 a.m. to 5 written/paper submission and in the
session of the workshop. To join the p.m. manner detailed (see ‘‘Written/Paper
workshop via the webcast, please go to ADDRESSES: FDA White Oak Campus, Submissions’’ and ‘‘Instructions’’).
https://collaboration.fda.gov/ 10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm. Written/Paper Submissions
gdufa2018/.
1503), Silver Spring, MD 20993–0002. Submit written/paper submissions as
If you have never attended a Connect Answers to commonly asked questions follows:
Pro event before, test your connection at including information regarding special • Mail/Hand delivery/Courier (for
https://collaboration.fda.gov/common/ accommodations due to a disability, written/paper submissions): Dockets
help/en/support/meeting_test.htm. To visitor parking, and transportation may Management Staff (HFA–305), Food and
get a quick overview of the Connect Pro be accessed at: https://www.fda.gov/ Drug Administration, 5630 Fishers
program, visit https://www.adobe.com/ AdvisoryCommittees/AboutAdvisory Lane, Rm. 1061, Rockville, MD 20852.
go/connectpro_overview. FDA has Committees/ucm408555.htm. • For written/paper comments
verified the website addresses in this FDA is establishing a docket for submitted to the Dockets Management
document, as of the date this document public comment on this meeting. The Staff, FDA will post your comment, as
publishes in the Federal Register, but docket number is FDA–2018–N–1015. well as any attachments, except for
websites are subject to change over time. The docket will close on April 23, 2018. information submitted, marked and
Transcripts: Please be advised that as Submit either electronic or written identified, as confidential, if submitted
soon as a transcript of the public comments on this public meeting by as detailed in ‘‘Instructions.’’
April 23, 2018. Please note that late, Instructions: All submissions received
workshop is available, it will be
untimely filed comments will not be must include the Docket No. FDA–
accessible at https://
considered. Electronic comments must 2018–N–1015 for ‘‘Joint Meeting of the
www.regulations.gov or at https:// Arthritis Advisory Committee and the
be submitted on or before April 23,
www.fda.gov/gdufaregscience. It may be 2018. The https://www.regulations.gov Drug Safety and Risk Management
viewed at the Dockets Management Staff electronic filing system will accept Advisory Committee; Notice of Meeting;
(see ADDRESSES). A link to the transcript comments until midnight Eastern Time Establishment of a Public Docket;
will also be available on the internet at at the end of April 23, 2018. Comments Request for Comments.’’ Received
https://www.fda.gov/gdufaregscience. received by mail/hand delivery/courier comments, those filed in a timely
Dated: March 21, 2018. (for written/paper submissions) will be manner (see the ADDRESSES section),
Leslie Kux, considered timely if they are will be placed in the docket and, except
sradovich on DSK3GMQ082PROD with NOTICES
postmarked or the delivery service for those submitted as ‘‘Confidential
Associate Commissioner for Policy.
acceptance receipt is on or before that Submissions,’’ publicly viewable at
[FR Doc. 2018–06260 Filed 3–28–18; 8:45 am]
date. https://www.regulations.gov or at the
BILLING CODE 4164–01–P Comments received on or before April Dockets Management Staff between 9
10, 2018, will be provided to the a.m. and 4 p.m., Monday through
committees. Comments received after Friday.
that date will be taken into • Confidential Submissions—To
consideration by FDA. submit a comment with confidential
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Document Created: 2018-03-29 00:25:54
Document Modified: 2018-03-29 00:25:54
| 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 of public workshop; request for comments. | |
| Dates | The public workshop will be held on May 24, 2018 from 8:30 a.m. to 4:30 p.m. Submit either electronic or written comments on this public workshop by June 25, 2018. See the SUPPLEMENTARY INFORMATION section for registration date and information. | |
| Contact | Stephanie Choi, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 4736, Silver Spring, MD 20993, 240-402- 7960, [email protected]; or Robert Lionberger, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 4722, Silver Spring, MD 20993, 240-402- 7957, Rob[email protected] | |
| FR Citation | 83 FR 13491 |
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