83 FR 45936 - Gastrointestinal Drugs 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 176 (September 11, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 176 (September 11, 2018)
| Page Range | 45936-45937 | |
| FR Document | 2018-19670 |
[Federal Register Volume 83, Number 176 (Tuesday, September 11, 2018)] [Notices] [Pages 45936-45937] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-19670] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-0055] Gastrointestinal Drugs 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 Gastrointestinal Drugs 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 October 18, 2018, from 8 a.m. to 5 p.m. ADDRESSES: Bethesda Marriott, 5151 Pooks Hill Rd., the Grand Ballroom, Bethesda, MD 20814. The conference center's telephone number is 301- 897-9400. 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. Information about the Bethesda Marriott can be accessed at: https://www.marriott.com/hotels/travel/wasbt-bethesda-marriott/. FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2018-N-0055. The docket will close on October 16, 2018. Submit either electronic or written comments on this public meeting by October 16, 2018. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before October 16, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of October 16, 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 October 9, 2018, will be provided to the committee. 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 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-0055 for ``Gastrointestinal Drugs Advisory Committee; Notice of Meeting; Establishment of a Public [[Page 45937]] 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: Jay R. Fajiculay, 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: GIDAC@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 committee will discuss new drug application (NDA) 210166 for prucalopride tablets for oral administration, submitted by Shire Development, LLC, proposed for the treatment of chronic idiopathic constipation in adults. 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 October 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 October 1, 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 October 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 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 Jay Fajiculay (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: September 4, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-19670 Filed 9-10-18; 8:45 am] BILLING CODE 4164-01-P
![45936 Federal Register / Vol. 83, No. 176 / Tuesday, September 11, 2018 / Notices
FDA intends to make background public conduct during advisory system will accept comments until
material available to the public no later committee meetings. midnight Eastern Time at the end of
than 2 business days before the meeting. Notice of this meeting is given under October 16, 2018. Comments received
If FDA is unable to post the background the Federal Advisory Committee Act (5 by mail/hand delivery/courier (for
material on its website prior to the U.S.C. app. 2). written/paper submissions) will be
meeting, the background material will Dated: September 4, 2018. considered timely if they are
be made publicly available at the Leslie Kux, postmarked or the delivery service
location of the advisory committee acceptance receipt is on or before that
Associate Commissioner for Policy.
meeting, and the background material date.
[FR Doc. 2018–19669 Filed 9–10–18; 8:45 am]
will be posted on FDA’s website after Comments received on or before
the meeting. Background material is BILLING CODE 4164–01–P
October 9, 2018, will be provided to the
available at https://www.fda.gov/ committee. Comments received after
AdvisoryCommittees/Calendar/ that date will be taken into
default.htm. Scroll down to the DEPARTMENT OF HEALTH AND
consideration by FDA.
appropriate advisory committee meeting HUMAN SERVICES You may submit comments as
link. Food and Drug Administration follows:
Procedure: Interested persons may
present data, information, or views, [Docket No. FDA–2018–N–0055] Electronic Submissions
orally or in writing, on issues pending Submit electronic comments in the
before the committees. All electronic Gastrointestinal Drugs Advisory following way:
and written submissions submitted to Committee; Notice of Meeting; • Federal eRulemaking Portal:
the Docket (see the ADDRESSES section) Establishment of a Public Docket; https://www.regulations.gov. Follow the
on or before October 9, 2018, will be Request for Comments instructions for submitting comments.
provided to the committees. Oral AGENCY: Food and Drug Administration, Comments submitted electronically,
presentations from the public will be HHS. including attachments, to https://
scheduled between approximately 1 www.regulations.gov will be posted to
ACTION: Notice; establishment of a
p.m. and 2 p.m. Those individuals the docket unchanged. Because your
public docket; request for comments.
interested in making formal oral comment will be made public, you are
presentations should notify the contact SUMMARY: The Food and Drug solely responsible for ensuring that your
person and submit a brief statement of Administration (FDA) announces a comment does not include any
the general nature of the evidence or forthcoming public advisory committee confidential information that you or a
arguments they wish to present, the meeting of the Gastrointestinal Drugs third party may not wish to be posted,
names and addresses of proposed Advisory Committee. The general such as medical information, your or
participants, and an indication of the function of the committee is to provide anyone else’s Social Security number, or
approximate time requested to make advice and recommendations to FDA on confidential business information, such
their presentation on or before October regulatory issues. The meeting will be as a manufacturing process. Please note
1, 2018. Time allotted for each open to the public. FDA is establishing that if you include your name, contact
presentation may be limited. If the a docket for public comment on this information, or other information that
number of registrants requesting to document. identifies you in the body of your
speak is greater than can be reasonably comments, that information will be
DATES: The meeting will be held on
accommodated during the scheduled posted on https://www.regulations.gov.
open public hearing session, FDA may October 18, 2018, from 8 a.m. to 5 p.m. • If you want to submit a comment
conduct a lottery to determine the ADDRESSES: Bethesda Marriott, 5151 with confidential information that you
speakers for the scheduled open public Pooks Hill Rd., the Grand Ballroom, do not wish to be made available to the
hearing session. The contact person will Bethesda, MD 20814. The conference public, submit the comment as a
notify interested persons regarding their center’s telephone number is 301–897– written/paper submission and in the
request to speak by October 2, 2018. 9400. Answers to commonly asked manner detailed (see ‘‘Written/Paper
Persons attending FDA’s advisory questions including information Submissions’’ and ‘‘Instructions’’).
committee meetings are advised that regarding special accommodations due
FDA is not responsible for providing to a disability, visitor parking, and Written/Paper Submissions
access to electrical outlets. transportation may be accessed at: Submit written/paper submissions as
For press inquiries, please contact the https://www.fda.gov/Advisory follows:
Office of Media Affairs at fdaoma@ Committees/AboutAdvisoryCommittees/ • Mail/Hand delivery/Courier (for
fda.hhs.gov or 301–796–4540. ucm408555.htm. Information about the written/paper submissions): Dockets
FDA welcomes the attendance of the Bethesda Marriott can be accessed at: Management Staff (HFA–305), Food and
public at its advisory committee https://www.marriott.com/hotels/travel/ Drug Administration, 5630 Fishers
meetings and will make every effort to wasbt-bethesda-marriott/. Lane, Rm. 1061, Rockville, MD 20852.
accommodate persons with disabilities. FDA is establishing a docket for • For written/paper comments
If you require accommodations due to a public comment on this meeting. The submitted to the Dockets Management
disability, please contact Jay Fajiculay docket number is FDA–2018–N–0055. Staff, FDA will post your comment, as
(see FOR FURTHER INFORMATION CONTACT) The docket will close on October 16, well as any attachments, except for
at least 7 days in advance of the 2018. Submit either electronic or information submitted, marked and
daltland on DSKBBV9HB2PROD with NOTICES
meeting. written comments on this public identified, as confidential, if submitted
FDA is committed to the orderly meeting by October 16, 2018. Please as detailed in ‘‘Instructions.’’
conduct of its advisory committee note that late, untimely filed comments Instructions: All submissions received
meetings. Please visit our website at will not be considered. Electronic must include the Docket No. FDA–
https://www.fda.gov/Advisory comments must be submitted on or 2018–N–0055 for ‘‘Gastrointestinal
Committees/AboutAdvisoryCommittees/ before October 16, 2018. The https:// Drugs Advisory Committee; Notice of
ucm111462.htm for procedures on www.regulations.gov electronic filing Meeting; Establishment of a Public
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![Federal Register / Vol. 83, No. 176 / Tuesday, September 11, 2018 / Notices 45937
Docket; Request for Comments.’’ Federal Register about last minute FDA is not responsible for providing
Received comments, those filed in a modifications that impact a previously access to electrical outlets.
timely manner (see ADDRESSES), will be announced advisory committee meeting For press inquiries, please contact the
placed in the docket and, except for cannot always be published quickly Office of Media Affairs at fdaoma@
those submitted as ‘‘Confidential enough to provide timely notice. fda.hhs.gov or 301–796–4540.
Submissions,’’ publicly viewable at Therefore, you should always check the FDA welcomes the attendance of the
https://www.regulations.gov or at the FDA’s website at https://www.fda.gov/ public at its advisory committee
Dockets Management Staff between 9 AdvisoryCommittees/default.htm and meetings and will make every effort to
a.m. and 4 p.m., Monday through scroll down to the appropriate advisory accommodate persons with disabilities.
Friday. committee meeting link, or call the If you require accommodations due to a
• Confidential Submissions—To advisory committee information line to disability, please contact Jay Fajiculay
submit a comment with confidential learn about possible modifications (see FOR FURTHER INFORMATION CONTACT)
information that you do not wish to be before coming to the meeting. at least 7 days in advance of the
made publicly available, submit your SUPPLEMENTARY INFORMATION: meeting.
comments only as a written/paper Agenda: The committee will discuss FDA is committed to the orderly
submission. You should submit two new drug application (NDA) 210166 for conduct of its advisory committee
copies total. One copy will include the prucalopride tablets for oral meetings. Please visit our website at
information you claim to be confidential administration, submitted by Shire https://www.fda.gov/Advisory
with a heading or cover note that states Development, LLC, proposed for the Committees/AboutAdvisoryCommittees/
‘‘THIS DOCUMENT CONTAINS treatment of chronic idiopathic ucm111462.htm for procedures on
CONFIDENTIAL INFORMATION.’’ FDA constipation in adults. public conduct during advisory
will review this copy, including the FDA intends to make background committee meetings.
claimed confidential information, in its material available to the public no later Notice of this meeting is given under
consideration of comments. The second than 2 business days before the meeting. the Federal Advisory Committee Act (5
copy, which will have the claimed If FDA is unable to post the background U.S.C. app. 2).
confidential information redacted/ material on its website prior to the
meeting, the background material will Dated: September 4, 2018.
blacked out, will be available for public
be made publicly available at the Leslie Kux,
viewing and posted on https://
www.regulations.gov. Submit both location of the advisory committee Associate Commissioner for Policy.
copies to the Dockets Management Staff. meeting, and the background material [FR Doc. 2018–19670 Filed 9–10–18; 8:45 am]
If you do not wish your name and will be posted on FDA’s website after BILLING CODE 4164–01–P
contact information be made publicly the meeting. Background material is
available, you can provide this available at https://www.fda.gov/
information on the cover sheet and not AdvisoryCommittees/Calendar/ DEPARTMENT OF HEALTH AND
in the body of your comments and you default.htm. Scroll down to the HUMAN SERVICES
must identify the information as appropriate advisory committee meeting
link. Food and Drug Administration
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed Procedure: Interested persons may
present data, information, or views, [Docket No. FDA–2018–N–3031]
except in accordance with 21 CFR 10.20
orally or in writing, on issues pending
and other applicable disclosure law. For
before the committee. All electronic and Agency Information Collection
more information about FDA’s posting
written submissions submitted to the Activities; Proposed Collection;
of comments to public dockets, see 80
Docket (see ADDRESSES) on or before Comment Request; Tobacco Products,
FR 56469, September 18, 2015, or access
October 9, 2018, will be provided to the User Fees, Requirements for the
the information at: https://www.gpo.gov/
committee. Oral presentations from the Submission of Data Needed To
fdsys/pkg/FR-2015-09-18/pdf/2015-
public will be scheduled between Calculate User Fees for Domestic
23389.pdf.
approximately 1 p.m. and 2 p.m. Those Manufacturers and Importers of
Docket: For access to the docket to
individuals interested in making formal Tobacco Products
read background documents or the oral presentations should notify the
electronic and written/paper comments contact person and submit a brief AGENCY: Food and Drug Administration,
received, go to https:// statement of the general nature of the HHS.
www.regulations.gov and insert the evidence or arguments they wish to ACTION: Notice.
docket number, found in brackets in the present, the names and addresses of
heading of this document, into the proposed participants, and an SUMMARY: The Food and Drug
‘‘Search’’ box and follow the prompts indication of the approximate time Administration (FDA or Agency) is
and/or go to the Dockets Management requested to make their presentation on announcing an opportunity for public
Staff, 5630 Fishers Lane, Rm. 1061, or before October 1, 2018. Time allotted comment on the proposed collection of
Rockville, MD 20852. for each presentation may be limited. If certain information by the Agency.
FOR FURTHER INFORMATION CONTACT: Jay the number of registrants requesting to Under the Paperwork Reduction Act of
R. Fajiculay, Center for Drug Evaluation speak is greater than can be reasonably 1995 (PRA), Federal Agencies are
and Research, Food and Drug accommodated during the scheduled required to publish notice in the
Administration, 10903 New Hampshire open public hearing session, FDA may Federal Register concerning each
daltland on DSKBBV9HB2PROD with NOTICES
Ave., Bldg. 31, Rm. 2417, Silver Spring, conduct a lottery to determine the proposed collection of information,
MD 20993–0002, 301–796–9001, Fax: speakers for the scheduled open public including each proposed extension of an
301–847–8533, email: GIDAC@ hearing session. The contact person will existing collection of information, and
fda.hhs.gov, or FDA Advisory notify interested persons regarding their to allow 60 days for public comment in
Committee Information Line, 1–800– request to speak by October 2, 2018. response to the notice. This notice
741–8138 (301–443–0572 in the Persons attending FDA’s advisory solicits comments on the information
Washington, DC area). A notice in the committee meetings are advised that collection for tobacco product user fees.
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Document Created: 2018-09-11 01:03:26
Document Modified: 2018-09-11 01:03:26
| 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 October 18, 2018, from 8 a.m. to 5 p.m. | |
| Contact | Jay R. Fajiculay, 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 45936 |
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