83 FR 7048 - Endocrinologic and Metabolic 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 33 (February 16, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 33 (February 16, 2018)
| Page Range | 7048-7050 | |
| FR Document | 2018-03237 |
[Federal Register Volume 83, Number 33 (Friday, February 16, 2018)] [Notices] [Pages 7048-7050] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-03237] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-0468] Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice; request for comments. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Endocrinologic and Metabolic 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 May 10, 2018, from 8 a.m. to 5 p.m. ADDRESSES: Tommy Douglas Conference Center, the Ballroom, 10000 New Hampshire Ave., Silver Spring, MD 20903. The conference center's telephone number is 240-645-4000. Answers to commonly asked questions about FDA Advisory Committee meetings may be accessed at: https:// www.fda.gov/AdvisoryCommittees/ [[Page 7049]] AboutAdvisoryCommittees/ucm408555.htm. Information about the Tommy Douglas Conference Center can be accessed at: http://www.tommydouglascenter.com. FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2018-N-0468. The docket will close on May 9, 2018. Submit either electronic or written comments on this public meeting by May 9, 2018. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before May 9, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of May 9, 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 26, 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-0468 for ``Endocrinologic and Metabolic Drugs 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: LaToya Bonner, 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 the safety and efficacy of new drug application (NDA) 210645, for volanesoren solution for subcutaneous injection, submitted by Akcea Therapeutics, Inc. The proposed indication is as an adjunct to diet for the treatment of patients with familial chylomicronemia syndrome. 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 26, 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 [[Page 7050]] 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 18, 2018. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by April 19, 2018. Persons attending FDA's advisory committee meetings are advised that FDA is not responsible for providing access to electrical outlets. For press inquiries, please contact the Office of Media Affairs at [email protected] 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 LaToya Bonner (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: February 9, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-03237 Filed 2-15-18; 8:45 am] BILLING CODE 4164-01-P
![7048 Federal Register / Vol. 83, No. 33 / Friday, February 16, 2018 / Notices
• For written/paper comments You may submit comments on any (44 U.S.C. 3501–3520). The collections
submitted to the Dockets Management guidance at any time (see 21 CFR of information in 21 CFR part 312 have
Staff, FDA will post your comment, as 10.115(g)(5)). been approved under OMB control
well as any attachments, except for Submit written requests for single number 0910–0014, the collections of
information submitted, marked and copies of the draft guidance to the information in 21 CFR part 314 have
identified, as confidential, if submitted Division of Drug Information, Center for been approved under OMB control
as detailed in ‘‘Instructions.’’ Drug Evaluation and Research, Food number 0910–0001, and the collections
Instructions: All submissions received and Drug Administration, 10001 New of information referred to in the
must include the Docket No. FDA– Hampshire Ave., Hillandale Building, guidance for industry entitled
2013–N–0035 for ‘‘Amyotrophic Lateral 4th Floor, Silver Spring, MD 20993– ‘‘Establishment and Operation of
Sclerosis: Developing Drugs for 0002. Send one self-addressed adhesive Clinical Trial Data Monitoring
Treatment; Draft Guidance for label to assist that office in processing Committees’’ (available at https://
Industry’’. Received comments will be your requests. See the SUPPLEMENTARY www.fda.gov/downloads/Regulatory
placed in the docket and, except for INFORMATION section for electronic Information/Guidances/ucm127073.pdf)
access to the draft guidance document. have been approved under OMB control
those submitted as ‘‘Confidential
FOR FURTHER INFORMATION CONTACT: number 0910–0581.
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the Billy Dunn, Center for Drug Evaluation III. Electronic Access
Dockets Management Staff between 9 and Research, Food and Drug
Administration, 10903 New Hampshire Persons with access to the internet
a.m. and 4 p.m., Monday through may obtain the draft guidance at either
Friday. Ave., Bldg. 22, Rm. 4332, Silver Spring,
MD 20993–0002, 301–796–2250. https://www.fda.gov/Drugs/Guidance
• Confidential Submissions—To ComplianceRegulatoryInformation/
SUPPLEMENTARY INFORMATION:
submit a comment with confidential Guidances/default.htm or https://
information that you do not wish to be I. Background www.regulations.gov.
made publicly available, submit your Dated: February 12, 2018.
FDA is announcing the availability of
comments only as a written/paper a draft guidance for industry entitled Leslie Kux,
submission. You should submit two ‘‘Amyotrophic Lateral Sclerosis: Associate Commissioner for Policy.
copies total. One copy will include the Developing Drugs for Treatment.’’ ALS [FR Doc. 2018–03222 Filed 2–15–18; 8:45 am]
information you claim to be confidential is a progressive neurodegenerative BILLING CODE 4164–01–P
with a heading or cover note that states disease that primarily affects motor
‘‘THIS DOCUMENT CONTAINS neurons in the cerebral motor cortex,
CONFIDENTIAL INFORMATION.’’ The brainstem, and spinal cord, leading to DEPARTMENT OF HEALTH AND
Agency will review this copy, including loss of voluntary movement and HUMAN SERVICES
the claimed confidential information, in difficulty in swallowing, speaking, and
its consideration of comments. The breathing. The purpose of this guidance Food and Drug Administration
second copy, which will have the is to assist sponsors in the clinical
claimed confidential information [Docket No. FDA–2018–N–0468]
development of drugs for the treatment
redacted/blacked out, will be available of ALS. Specifically, it addresses FDA’s
for public viewing and posted on Endocrinologic and Metabolic Drugs
current thinking regarding the clinical Advisory Committee; Notice of
https://www.regulations.gov. Submit development program and clinical trial
both copies to the Dockets Management Meeting; Establishment of a Public
designs for drugs to support an Docket; Request for Comments
Staff. If you do not wish your name and indication for the treatment of ALS.
contact information to be made publicly This guidance addresses the clinical AGENCY: Food and Drug Administration,
available, you can provide this development of drugs intended to treat HHS.
information on the cover sheet and not the main neuromuscular aspects of ALS ACTION: Notice; request for comments.
in the body of your comments and you (i.e., muscle weakness and its direct
must identify this information as consequences, including shortened SUMMARY: The Food and Drug
‘‘confidential.’’ Any information marked survival). Administration (FDA) announces a
as ‘‘confidential’’ will not be disclosed This draft guidance is being issued forthcoming public advisory committee
except in accordance with 21 CFR 10.20 consistent with FDA’s good guidance meeting of the Endocrinologic and
and other applicable disclosure law. For practices regulation (21 CFR 10.115). Metabolic Drugs Advisory Committee.
more information about FDA’s posting The draft guidance, when finalized, will The general function of the committee is
of comments to public dockets, see 80 represent the current thinking of FDA to provide advice and recommendations
FR 56469, September 18, 2015, or access on developing drugs for the treatment of to FDA on regulatory issues. The
the information at: https://www.gpo.gov/ ALS. It does not establish any rights for meeting will be open to the public. FDA
fdsys/pkg/FR-2015-09-18/pdf/2015- any person and is not binding on FDA is establishing a docket for public
23389.pdf. or the public. You can use an alternative comment on this document.
Docket: For access to the docket to approach if it satisfies the requirements DATES: The meeting will be held on May
read background documents or the of the applicable statutes and 10, 2018, from 8 a.m. to 5 p.m.
electronic and written/paper comments regulations. This guidance is not subject ADDRESSES: Tommy Douglas Conference
received, go to https:// to Executive Order 12866. Center, the Ballroom, 10000 New
daltland on DSKBBV9HB2PROD with NOTICES
www.regulations.gov and insert the Hampshire Ave., Silver Spring, MD
docket number, found in brackets in the II. Paperwork Reduction Act of 1995 20903. The conference center’s
heading of this document, into the This guidance refers to previously telephone number is 240–645–4000.
‘‘Search’’ box and follow the prompts approved collections of information that Answers to commonly asked questions
and/or go to the Dockets Management are subject to review by the Office of about FDA Advisory Committee
Staff, 5630 Fishers Lane, Rm. 1061, Management and Budget (OMB) under meetings may be accessed at: https://
Rockville, MD 20852. the Paperwork Reduction Act of 1995 www.fda.gov/AdvisoryCommittees/
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![7050 Federal Register / Vol. 83, No. 33 / Friday, February 16, 2018 / Notices
statement of the general nature of the announcing the availability of a 2015–D–1884 for ‘‘Duchenne Muscular
evidence or arguments they wish to guidance for industry entitled Dystrophy and Related
present, the names and addresses of ‘‘Duchenne Muscular Dystrophy and Dystrophinopathies: Developing Drugs
proposed participants, and an Related Dystrophinopathies: Developing for Treatment; Guidance for Industry;
indication of the approximate time Drugs for Treatment.’’ The purpose of Availability.’’ Received comments will
requested to make their presentation on this guidance is to assist sponsors in the be placed in the docket and, except for
or before April 18, 2018. Time allotted clinical development of drugs for the those submitted as ‘‘Confidential
for each presentation may be limited. If treatment of X-linked Duchenne Submissions,’’ publicly viewable at
the number of registrants requesting to muscular dystrophy (DMD) and related https://www.regulations.gov or at the
speak is greater than can be reasonably dystrophinopathies. This guidance Dockets Management Staff between 9
accommodated during the scheduled finalizes the draft guidance of the same a.m. and 4 p.m., Monday through
open public hearing session, FDA may name issued on June 10, 2015. Friday.
conduct a lottery to determine the DATES: The announcement of the • Confidential Submissions—To
speakers for the scheduled open public guidance is published in the Federal submit a comment with confidential
hearing session. The contact person will Register on February 16, 2018. information that you do not wish to be
notify interested persons regarding their ADDRESSES: You may submit either made publicly available, submit your
request to speak by April 19, 2018. electronic or written comments on comments only as a written/paper
Persons attending FDA’s advisory Agency guidances at any time as submission. You should submit two
committee meetings are advised that follows: copies total. One copy will include the
FDA is not responsible for providing information you claim to be confidential
access to electrical outlets. Electronic Submissions with a heading or cover note that states
For press inquiries, please contact the Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS
Office of Media Affairs at fdaoma@ following way: CONFIDENTIAL INFORMATION.’’ The
fda.hhs.gov or 301–796–4540. • Federal eRulemaking Portal: Agency will review this copy, including
FDA welcomes the attendance of the https://www.regulations.gov. Follow the the claimed confidential information, in
public at its advisory committee instructions for submitting comments. its consideration of comments. The
meetings and will make every effort to Comments submitted electronically, second copy, which will have the
accommodate persons with disabilities. including attachments, to https:// claimed confidential information
If you require accommodations due to a www.regulations.gov will be posted to redacted/blacked out, will be available
disability, please contact LaToya Bonner the docket unchanged. Because your for public viewing and posted on
(see FOR FURTHER INFORMATION CONTACT) comment will be made public, you are https://www.regulations.gov. Submit
at least 7 days in advance of the solely responsible for ensuring that your both copies to the Dockets Management
meeting. comment does not include any Staff. If you do not wish your name and
FDA is committed to the orderly confidential information that you or a contact information to be made publicly
conduct of its advisory committee third party may not wish to be posted, available, you can provide this
meetings. Please visit our website at such as medical information, your or information on the cover sheet and not
https://www.fda.gov/ anyone else’s Social Security number, or in the body of your comments and you
AdvisoryCommittees/ confidential business information, such must identify this information as
AboutAdvisoryCommittees/ as a manufacturing process. Please note ‘‘confidential.’’ Any information marked
ucm111462.htm for procedures on that if you include your name, contact as ‘‘confidential’’ will not be disclosed
public conduct during advisory information, or other information that except in accordance with 21 CFR 10.20
committee meetings. identifies you in the body of your and other applicable disclosure law. For
Notice of this meeting is given under comments, that information will be more information about FDA’s posting
the Federal Advisory Committee Act (5 posted on https://www.regulations.gov. of comments to public dockets, see 80
U.S.C. app. 2). • If you want to submit a comment FR 56469, September 18, 2015, or access
Dated: February 9, 2018. with confidential information that you the information at: https://www.gpo.gov/
Leslie Kux, do not wish to be made available to the fdsys/pkg/FR-2015-09-18/pdf/2015-
public, submit the comment as a 23389.pdf.
Associate Commissioner for Policy.
written/paper submission and in the Docket: For access to the docket to
[FR Doc. 2018–03237 Filed 2–15–18; 8:45 am] read background documents or the
manner detailed (see ‘‘Written/Paper
BILLING CODE 4164–01–P
Submissions’’ and ‘‘Instructions’’). electronic and written/paper comments
received, go to https://
Written/Paper Submissions www.regulations.gov and insert the
DEPARTMENT OF HEALTH AND docket number, found in brackets in the
Submit written/paper submissions as
HUMAN SERVICES heading of this document, into the
follows:
Food and Drug Administration • Mail/Hand delivery/Courier (for ‘‘Search’’ box and follow the prompts
written/paper submissions): Dockets and/or go to the Dockets Management
[Docket No. FDA–2015–D–1884] Management Staff (HFA–305), Food and Staff, 5630 Fishers Lane, Rm. 1061,
Drug Administration, 5630 Fishers Rockville, MD 20852.
Duchenne Muscular Dystrophy and Lane, Rm. 1061, Rockville, MD 20852. You may submit comments on any
Related Dystrophinopathies: • For written/paper comments guidance at any time (see 21 CFR
Developing Drugs for Treatment; submitted to the Dockets Management 10.115(g)(5)).
daltland on DSKBBV9HB2PROD with NOTICES
Guidance for Industry; Availability Staff, FDA will post your comment, as Submit written requests for single
AGENCY: Food and Drug Administration, well as any attachments, except for copies of this guidance to the Division
HHS. information submitted, marked and of Drug Information, Center for Drug
ACTION: Notice of availability. identified, as confidential, if submitted Evaluation and Research, Food and
as detailed in ‘‘Instructions.’’ Drug Administration, 10001 New
SUMMARY: The Food and Drug Instructions: All submissions received Hampshire Ave., Hillandale Building,
Administration (FDA or Agency) is must include the Docket No. FDA– 4th Floor, Silver Spring, MD 20993–
VerDate Sep<11>2014 19:24 Feb 15, 2018 Jkt 244001 PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 E:\FR\FM\16FEN1.SGM 16FEN1](https://thefederalregister.org/doc/83_FR_7081/page/3.svg)
Document Created: 2018-02-16 00:55:29
Document Modified: 2018-02-16 00:55:29
| 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; request for comments. | |
| Dates | The meeting will be held on May 10, 2018, from 8 a.m. to 5 p.m. | |
| Contact | LaToya Bonner, 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 7048 |
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