83 FR 13283 - Gastrointestinal Drugs Advisory Committee and the Pediatric 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 60 (March 28, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 60 (March 28, 2018)
| Page Range | 13283-13284 | |
| FR Document | 2018-06168 |
[Federal Register Volume 83, Number 60 (Wednesday, March 28, 2018)] [Notices] [Pages 13283-13284] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-06168] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-1184] Gastrointestinal Drugs Advisory Committee and the Pediatric 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 and the Pediatric 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 May 3, 2018, from 8 a.m. to 4:30 p.m. ADDRESSES: DoubleTree by Hilton Hotel Bethesda--Washington DC, Grand Ballroom, 8120 Wisconsin Ave., Bethesda, MD 20814-3624. The conference center's telephone number is 301-652-2000. 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 DoubleTree by Hilton Hotel Bethesda--Washington DC Conference Center can be accessed at: http://doubletree3.hilton.com/en/hotels/maryland/doubletree-by-hilton-hotel-bethesda-washington-dc-WASBHDT/index.html. FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2018-N-1184. The docket will close on May 2, 2018. Submit either electronic or written comments on this public meeting by May 2, 2018. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before May 2, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of May 2, 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 19, 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-1184 for ``Gastrointestinal Drugs Advisory Committee and the Pediatric Advisory Committee; Notice of Meeting; Establishment of a Public [[Page 13284]] 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 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: 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 committees will discuss new drug application (NDA) 209904 for stannsoporfin injection, for intramuscular use, submitted by InfaCare Pharmaceutical Corporation, proposed for the treatment of neonates greater than or equal to 35 weeks of gestational age with indicators of hemolysis who are at risk of developing severe hyperbilirubinemia. 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. All electronic and written submissions submitted to the Docket (see ADDRESSES) on or before April 19, 2018, will be provided to the committees. Oral presentations from the public will be scheduled between approximately 1:15 p.m. and 2:15 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 April 11, 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 12, 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 special accommodations due to a disability, please contact Jay R. 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: March 22, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-06168 Filed 3-27-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 60 / Wednesday, March 28, 2018 / Notices 13283
We have made no adjustments to the Dated: March 22, 2018. comments until midnight Eastern Time
currently approved burden estimate for Leslie Kux, at the end of May 2, 2018. Comments
the information collection. While we Associate Commissioner for Policy. received by mail/hand delivery/courier
have received comments previously [FR Doc. 2018–06155 Filed 3–27–18; 8:45 am] (for written/paper submissions) will be
suggesting our burden estimate may be BILLING CODE 4164–01–P
considered timely if they are
too low, the comments did not discuss postmarked or the delivery service
the basis for such a conclusion. We acceptance receipt is on or before that
therefore specifically invite individual DEPARTMENT OF HEALTH AND date.
respondent experience with the HUMAN SERVICES Comments received on or before April
information collection and associated 19, 2018, will be provided to the
Food and Drug Administration committee. Comments received after
collection burden.
[Docket No. FDA–2018–N–1184]
that date will be taken into
Based on our experience with the consideration by FDA.
information collection over the past 3 Gastrointestinal Drugs Advisory You may submit comments as
years, we estimate that 55 respondents Committee and the Pediatric Advisory follows:
will submit 1 premarket notification Committee; Notice of Meeting; Electronic Submissions
each. We assume that extracting and Establishment of a Public Docket;
summarizing relevant information from Submit electronic comments in the
Request for Comments
existing files and presenting it in a following way:
format that meets the requirements of AGENCY: Food and Drug Administration, • Federal eRulemaking Portal:
§ 190.6 will take approximately 20 HHS. https://www.regulations.gov. Follow the
ACTION: Notice; establishment of a instructions for submitting comments.
hours of work per notification. We have
public docket; request for comments. Comments submitted electronically,
carefully considered the burden
including attachments, to https://
associated with the premarket
SUMMARY: The Food and Drug www.regulations.gov will be posted to
notification requirement and believe Administration (FDA) announces a the docket unchanged. Because your
that estimates greater than 20 hours are forthcoming public advisory committee comment will be made public, you are
likely to include burden associated with meeting of the Gastrointestinal Drugs solely responsible for ensuring that your
researching and generating safety data Advisory Committee and the Pediatric comment does not include any
for a new dietary ingredient. We believe Advisory Committee. The general confidential information that you or a
that the burden of the premarket function of the committees is to provide third party may not wish to be posted,
notification requirement on industry is advice and recommendations to FDA on such as medical information, your or
minimal and reasonable because we are regulatory issues. The meeting will be anyone else’s Social Security number, or
requesting only safety and identity open to the public. FDA is establishing confidential business information, such
information that the manufacturer or a docket for public comment on this as a manufacturing process. Please note
distributor should already have document. that if you include your name, contact
developed to satisfy itself that a dietary DATES: The meeting will be held on May information, or other information that
supplement containing a new dietary 3, 2018, from 8 a.m. to 4:30 p.m. identifies you in the body of your
ingredient is in compliance with the comments, that information will be
ADDRESSES: DoubleTree by Hilton Hotel
FD&C Act. Under section 413(a)(2) of posted on https://www.regulations.gov.
Bethesda—Washington DC, Grand • If you want to submit a comment
the FD&C Act, a dietary supplement that Ballroom, 8120 Wisconsin Ave.,
contains a new dietary ingredient is with confidential information that you
Bethesda, MD 20814–3624. The do not wish to be made available to the
deemed to be adulterated unless there is conference center’s telephone number is
a history of use or other evidence of public, submit the comment as a
301–652–2000. Answers to commonly written/paper submission and in the
safety establishing that the new dietary asked questions about FDA Advisory
ingredient will reasonably be expected manner detailed (see ‘‘Written/Paper
Committee meetings may be accessed at: Submissions’’ and ‘‘Instructions’’).
to be safe under the conditions of use https://www.fda.gov/
recommended or suggested in the AdvisoryCommittees/AboutAdvisory Written/Paper Submissions
labeling of the dietary supplement. This Committees/ucm408555.htm. Submit written/paper submissions as
requirement is separate from and Information about the DoubleTree by follows:
additional to the requirement to submit Hilton Hotel Bethesda—Washington DC • Mail/Hand delivery/Courier (for
a premarket notification for the new Conference Center can be accessed at: written/paper submissions): Dockets
dietary ingredient. FDA’s regulation on http://doubletree3.hilton.com/en/hotels/ Management Staff (HFA–305), Food and
new dietary ingredient notifications, maryland/doubletree-by-hilton-hotel- Drug Administration, 5630 Fishers
§ 190.6(a), requires the manufacturer or bethesda-washington-dc-WASBHDT/ Lane, Rm. 1061, Rockville, MD 20852.
distributor of the dietary supplement or index.html. • For written/paper comments
of the new dietary ingredient to submit FDA is establishing a docket for submitted to the Dockets Management
to FDA the information that forms the public comment on this meeting. The Staff, FDA will post your comment, as
basis for its conclusion that a dietary docket number is FDA–2018–N–1184. well as any attachments, except for
supplement containing the new dietary The docket will close on May 2, 2018. information submitted, marked and
ingredient will reasonably be expected Submit either electronic or written identified, as confidential, if submitted
daltland on DSKBBV9HB2PROD with NOTICES
to be safe. Thus, § 190.6 only requires comments on this public meeting by as detailed in ‘‘Instructions.’’
May 2, 2018. Please note that late, Instructions: All submissions received
the manufacturer or distributor to
untimely filed comments will not be must include the Docket No. FDA–
extract and summarize information that
considered. Electronic comments must 2018–N–1184 for ‘‘Gastrointestinal
should have already been developed to
be submitted on or before May 2, 2018. Drugs Advisory Committee and the
meet the safety requirement in section The https://www.regulations.gov Pediatric Advisory Committee; Notice of
413(a)(2) of the FD&C Act. electronic filing system will accept Meeting; Establishment of a Public
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![13284 Federal Register / Vol. 83, No. 60 / Wednesday, March 28, 2018 / Notices
Docket; Request for Comments.’’ Federal Register about last minute notify interested persons regarding their
Received comments, those filed in a modifications that impact a previously request to speak by April 12, 2018.
timely manner (see ADDRESSES), will be announced advisory committee meeting Persons attending FDA’s advisory
placed in the docket and, except for cannot always be published quickly committee meetings are advised that
those submitted as ‘‘Confidential enough to provide timely notice. FDA is not responsible for providing
Submissions,’’ publicly viewable at Therefore, you should always check the access to electrical outlets.
https://www.regulations.gov or at the FDA’s website at https://www.fda.gov/ For press inquiries, please contact the
Dockets Management Staff between 9 AdvisoryCommittees/default.htm and Office of Media Affairs at fdaoma@
a.m. and 4 p.m., Monday through scroll down to the appropriate advisory fda.hhs.gov or 301–796–4540.
Friday. committee meeting link, or call the FDA welcomes the attendance of the
• Confidential Submissions—To advisory committee information line to public at its advisory committee
submit a comment with confidential learn about possible modifications meetings and will make every effort to
information that you do not wish to be before coming to the meeting. accommodate persons with disabilities.
made publicly available, submit your SUPPLEMENTARY INFORMATION: If you require special accommodations
comments only as a written/paper Agenda: The committees will discuss due to a disability, please contact Jay R.
submission. You should submit two new drug application (NDA) 209904 for Fajiculay (see FOR FURTHER INFORMATION
copies total. One copy will include the stannsoporfin injection, for CONTACT) at least 7 days in advance of
information you claim to be confidential intramuscular use, submitted by the meeting.
with a heading or cover note that states InfaCare Pharmaceutical Corporation, FDA is committed to the orderly
‘‘THIS DOCUMENT CONTAINS proposed for the treatment of neonates conduct of its advisory committee
CONFIDENTIAL INFORMATION.’’ FDA greater than or equal to 35 weeks of meetings. Please visit our website at
will review this copy, including the gestational age with indicators of https://www.fda.gov/
claimed confidential information, in its hemolysis who are at risk of developing AdvisoryCommittees/
consideration of comments. The second severe hyperbilirubinemia. AboutAdvisoryCommittees/
copy, which will have the claimed FDA intends to make background ucm111462.htm for procedures on
confidential information redacted/ material available to the public no later public conduct during advisory
blacked out, will be available for public than 2 business days before the meeting. committee meetings.
viewing and posted on https:// If FDA is unable to post the background Notice of this meeting is given under
www.regulations.gov. Submit both material on its website prior to the the Federal Advisory Committee Act (5
copies to the Dockets Management Staff. meeting, the background material will U.S.C. app. 2).
If you do not wish your name and be made publicly available at the Dated: March 22, 2018.
contact information to be made publicly location of the advisory committee Leslie Kux,
available, you can provide this meeting, and the background material Associate Commissioner for Policy.
information on the cover sheet and not will be posted on FDA’s website after [FR Doc. 2018–06168 Filed 3–27–18; 8:45 am]
in the body of your comments and you the meeting. Background material is
must identify this information as BILLING CODE 4164–01–P
available at https://www.fda.gov/
‘‘confidential.’’ Any information marked AdvisoryCommittees/Calendar/
as ‘‘confidential’’ will not be disclosed default.htm. Scroll down to the DEPARTMENT OF HEALTH AND
except in accordance with 21 CFR 10.20 appropriate advisory committee meeting HUMAN SERVICES
and other applicable disclosure law. For link.
more information about FDA’s posting Procedure: Interested persons may Food and Drug Administration
of comments to public dockets, see 80 present data, information, or views,
FR 56469, September 18, 2015, or access orally or in writing, on issues pending [Docket No. FDA–2018–N–1129]
the information at: https://www.gpo.gov/ before the committees. All electronic
fdsys/pkg/FR-2015-09-18/pdf/2015- Agency Information Collection
and written submissions submitted to
23389.pdf. Activities; Proposed Collection;
the Docket (see ADDRESSES) on or before
Docket: For access to the docket to Comment Request; National
April 19, 2018, will be provided to the
read background documents or the Agriculture and Food Defense Strategy
committees. Oral presentations from the
electronic and written/paper comments Survey
public will be scheduled between
received, go to https:// approximately 1:15 p.m. and 2:15 p.m. AGENCY: Food and Drug Administration,
www.regulations.gov and insert the Those individuals interested in making HHS.
docket number, found in brackets in the formal oral presentations should notify ACTION: Notice.
heading of this document, into the the contact person and submit a brief
‘‘Search’’ box and follow the prompts statement of the general nature of the SUMMARY: The Food and Drug
and/or go to the Dockets Management evidence or arguments they wish to Administration (FDA or Agency) is
Staff, 5630 Fishers Lane, Rm. 1061, present, the names and addresses of announcing an opportunity for public
Rockville, MD 20852. proposed participants, and an comment on the proposed collection of
FOR FURTHER INFORMATION CONTACT: Jay indication of the approximate time certain information by the Agency.
R. Fajiculay, Center for Drug Evaluation requested to make their presentation on Under the Paperwork Reduction Act of
and Research, Food and Drug or before April 11, 2018. Time allotted 1995 (PRA), Federal Agencies are
Administration, 10903 New Hampshire for each presentation may be limited. If required to publish notice in the
daltland on DSKBBV9HB2PROD with NOTICES
Ave., Bldg. 31, Rm. 2417, Silver Spring, the number of registrants requesting to Federal Register concerning each
MD 20993–0002, 301–796–9001, Fax: speak is greater than can be reasonably proposed collection of information and
301–847–8533, email: GIDAC@ accommodated during the scheduled to allow 60 days for public comment in
fda.hhs.gov, or FDA Advisory open public hearing session, FDA may response to the notice. This notice
Committee Information Line, 1–800– conduct a lottery to determine the solicits comments on the information
741–8138 (301–443–0572 in the speakers for the scheduled open public collection requirements for a voluntary
Washington, DC area). A notice in the hearing session. The contact person will survey for the U.S. Department of
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Document Created: 2018-11-01 08:55:51
Document Modified: 2018-11-01 08:55:51
| 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 May 3, 2018, from 8 a.m. to 4:30 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 13283 |
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