82_FR_44369 82 FR 44187 - Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments

82 FR 44187 - Dermatologic and Ophthalmic 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 82, Issue 182 (September 21, 2017)

Page Range44187-44188
FR Document2017-20105

The Food and Drug Administration (FDA or Agency) announces a forthcoming public advisory committee meeting of the Dermatologic and Ophthalmic Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.

Federal Register, Volume 82 Issue 182 (Thursday, September 21, 2017) 
[Federal Register Volume 82, Number 182 (Thursday, September 21, 2017)]
[Notices]
[Pages 44187-44188]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-20105]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-5255]


Dermatologic and Ophthalmic 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.

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SUMMARY: The Food and Drug Administration (FDA or Agency) announces a 
forthcoming public advisory committee meeting of the Dermatologic and 
Ophthalmic Drugs Advisory Committee. The general function of the 
committee is to provide advice and recommendations to the Agency on 
FDA's regulatory issues. The meeting will be open to the public. FDA is 
establishing a docket for public comment on this document.

DATES: The public meeting will be held on October 13, 2017, from 8:30 
a.m. to 4 p.m.

ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 
Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-
0002. Answers to commonly asked questions including information 
regarding special accommodations due to a disability, visitor parking, 
and transportation may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    FDA is establishing a docket for public comment on this meeting. 
The docket number is FDA-2017-N-5255. The docket will close on October 
12, 2017. Submit either electronic or written comments on this public 
meeting by October 12, 2017. Late, untimely filed comments will not be 
considered. Electronic comments must be submitted on or before October 
12, 2017. The https://www.regulations.gov electronic filing system will 
accept comments until midnight Eastern Time at the end of October 12, 
2017. 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 September 28, 2017, will be provided 
to the committee. Comments received after that date will be taken into 
consideration by the Agency.
    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-2017-N-5255 for ``Dermatologic and Ophthalmic 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.'' 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

[[Page 44188]]

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: 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 Agency's Web site 
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) 208254, for netarsudil ophthalmic solution 
0.02%, submitted by Aerie Pharmaceuticals Inc., for the proposed 
indication to reduce elevated intraocular pressure (IOP) in patients 
with open-angle glaucoma (OAG) or ocular hypertension (OHT).
    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 Web site 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 Web site 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 the 
ADDRESSES section) on or before September 28, 2017, 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 September 20, 2017. 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 September 21, 2017.
    Persons attending FDA's advisory committee meetings are advised 
that the Agency is not responsible for providing access to electrical 
outlets.
    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 LaToya Bonner at least 7 days in advance of 
the meeting.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our Web site 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 15, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-20105 Filed 9-20-17; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 82, No. 182 / Thursday, September 21, 2017 / Notices 44187 TABLE 1—Continued Application No. Drug Applicant ANDA 091201 ...................... Meropenem for Injection USP, 500 mg/vial and 1 g/vial Sandoz Inc., 100 College Rd. West, Princeton, NJ 08540. ANDA 200156 ...................... Armodafinil Tablets, 100 mg and 200 mg ...................... Watson Laboratories, Inc., Subsidiary of Teva Pharma- ceuticals USA, Inc. Therefore, approval of the ADDRESSES: FDA White Oak Campus, that if you include your name, contact applications listed in table 1, and all 10903 New Hampshire Ave., Bldg. 31 information, or other information that amendments and supplements thereto, Conference Center, the Great Room (Rm. identifies you in the body of your is hereby withdrawn, effective October 1503), Silver Spring, MD 20993–0002. comments, that information will be 23, 2017. Introduction or delivery for Answers to commonly asked questions posted on https://www.regulations.gov. introduction into interstate commerce of including information regarding special • If you want to submit a comment products without approved new drug accommodations due to a disability, with confidential information that you applications violates section 301(a) and visitor parking, and transportation may do not wish to be made available to the (d) of the Federal Food, Drug, and be accessed at: https://www.fda.gov/ public, submit the comment as a Cosmetic Act (21 U.S.C. 331(a) and (d)). AdvisoryCommittees/ written/paper submission and in the Drug products that are listed in table 1 AboutAdvisoryCommittees/ manner detailed (see ‘‘Written/Paper that are in inventory on the date that ucm408555.htm. Submissions’’ and ‘‘Instructions’’). this notice becomes effective (see the FDA is establishing a docket for Written/Paper Submissions DATES section) may continue to be public comment on this meeting. The dispensed until the inventories have docket number is FDA–2017–N–5255. Submit written/paper submissions as been depleted or the drug products have The docket will close on October 12, follows: reached their expiration dates or 2017. Submit either electronic or • Mail/Hand delivery/Courier (for otherwise become violative, whichever written comments on this public written/paper submissions): Dockets occurs first. meeting by October 12, 2017. Late, Management Staff (HFA–305), Food and untimely filed comments will not be Drug Administration, 5630 Fishers Dated: September 15, 2017. Lane, Rm. 1061, Rockville, MD 20852. considered. Electronic comments must Anna K. Abram, be submitted on or before October 12, • For written/paper comments Deputy Commissioner for Policy, Planning, submitted to the Dockets Management 2017. The https://www.regulations.gov Legislation, and Analysis. Staff, FDA will post your comment, as electronic filing system will accept [FR Doc. 2017–20107 Filed 9–20–17; 8:45 a.m.] comments until midnight Eastern Time well as any attachments, except for BILLING CODE 4164–01–P at the end of October 12, 2017. information submitted, marked and Comments received by mail/hand identified, as confidential, if submitted delivery/courier (for written/paper as detailed in ‘‘Instructions.’’ DEPARTMENT OF HEALTH AND Instructions: All submissions received submissions) will be considered timely HUMAN SERVICES must include the Docket No. FDA– if they are postmarked or the delivery service acceptance receipt is on or 2017–N–5255 for ‘‘Dermatologic and Food and Drug Administration Ophthalmic Drugs Advisory Committee; before that date. [Docket No. FDA–2017–N–5255] Comments received on or before Notice of Meeting; Establishment of a September 28, 2017, will be provided to Public Docket; Request for Comments.’’ Dermatologic and Ophthalmic Drugs the committee. Comments received after Received comments, those filed in a Advisory Committee; Notice of that date will be taken into timely manner (see ADDRESSES), will be Meeting; Establishment of a Public consideration by the Agency. placed in the docket and, except for Docket; Request for Comments You may submit comments as those submitted as ‘‘Confidential follows: Submissions,’’ publicly viewable at AGENCY: Food and Drug Administration, https://www.regulations.gov or at the HHS. Electronic Submissions Dockets Management Staff between 9 ACTION: Notice; establishment of a Submit electronic comments in the a.m. and 4 p.m., Monday through public docket; request for comments. following way: Friday. • Federal eRulemaking Portal: • Confidential Submissions—To SUMMARY: The Food and Drug https://www.regulations.gov. Follow the submit a comment with confidential Administration (FDA or Agency) instructions for submitting comments. information that you do not wish to be announces a forthcoming public Comments submitted electronically, made publicly available, submit your advisory committee meeting of the including attachments, to https:// comments only as a written/paper Dermatologic and Ophthalmic Drugs www.regulations.gov will be posted to submission. You should submit two Advisory Committee. The general the docket unchanged. Because your copies total. One copy will include the function of the committee is to provide asabaliauskas on DSKBBXCHB2PROD with NOTICES comment will be made public, you are information you claim to be confidential advice and recommendations to the solely responsible for ensuring that your with a heading or cover note that states Agency on FDA’s regulatory issues. The comment does not include any ‘‘THIS DOCUMENT CONTAINS meeting will be open to the public. FDA confidential information that you or a CONFIDENTIAL INFORMATION.’’ The is establishing a docket for public third party may not wish to be posted, Agency will review this copy, including comment on this document. such as medical information, your or the claimed confidential information, in DATES: The public meeting will be held anyone else’s Social Security number, or its consideration of comments. The on October 13, 2017, from 8:30 a.m. to confidential business information, such second copy, which will have the 4 p.m. as a manufacturing process. Please note claimed confidential information VerDate Sep<11>2014 17:52 Sep 20, 2017 Jkt 241001 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 E:\FR\FM\21SEN1.SGM 21SEN1

44188 Federal Register / Vol. 82, No. 182 / Thursday, September 21, 2017 / Notices redacted/blacked out, will be available than 2 business days before the meeting. Dated: September 15, 2017. for public viewing and posted on If FDA is unable to post the background Anna K. Abram, https://www.regulations.gov. Submit material on its Web site prior to the Deputy Commissioner for Policy, Planning, both copies to the Dockets Management meeting, the background material will Legislation, and Analysis. Staff. If you do not wish your name and be made publicly available at the [FR Doc. 2017–20105 Filed 9–20–17; 8:45 am] contact information to be made publicly location of the advisory committee BILLING CODE 4164–01–P available, you can provide this meeting, and the background material information on the cover sheet and not will be posted on FDA’s Web site after in the body of your comments and you the meeting. Background material is DEPARTMENT OF HEALTH AND must identify this information as available at https://www.fda.gov/ HUMAN SERVICES ‘‘confidential.’’ Any information marked AdvisoryCommittees/Calendar/default. as ‘‘confidential’’ will not be disclosed htm. Scroll down to the appropriate Food and Drug Administration except in accordance with 21 CFR 10.20 advisory committee meeting link. and other applicable disclosure law. For Procedure: Interested persons may [Docket No. FDA–2017–N–0001] more information about FDA’s posting present data, information, or views, of comments to public dockets, see 80 orally or in writing, on issues pending Drug Development in Pediatric Heart FR 56469, September 18, 2015, or access before the committee. All electronic and Failure: Extrapolation, Clinical Trial the information at: https://www.gpo.gov/ written submissions submitted to the Design, and Endpoints; Public fdsys/pkg/FR-2015-09-18/pdf/2015- Docket (see the ADDRESSES section) on Workshop 23389.pdf. or before September 28, 2017, will be Docket: For access to the docket to AGENCY: Food and Drug Administration, provided to the committee. Oral read background documents or the HHS. presentations from the public will be electronic and written/paper comments scheduled between approximately 1 ACTION: Notice of public workshop. received, go to https:// p.m. and 2 p.m. Those individuals www.regulations.gov and insert the interested in making formal oral SUMMARY: The Food and Drug docket number, found in brackets in the presentations should notify the contact Administration (FDA) is announcing the heading of this document, into the person and submit a brief statement of following public workshop entitled ‘‘Search’’ box and follow the prompts the general nature of the evidence or ‘‘FDA-University of Maryland CERSI and/or go to the Dockets Management arguments they wish to present, the Drug Development in Pediatric Heart Staff, 5630 Fishers Lane, Rm. 1061, names and addresses of proposed Failure: Extrapolation, Clinical Trial Rockville, MD 20852. participants, and an indication of the Design, and Endpoints.’’ The purpose of FOR FURTHER INFORMATION CONTACT: approximate time requested to make the public workshop is to address LaToya Bonner, Center for Drug their presentation on or before challenges related to the evaluation of Evaluation and Research, Food and September 20, 2017. Time allotted for products in pediatric heart failure Drug Administration, 10903 New each presentation may be limited. If the including population to study, Hampshire Ave., Bldg. 31, Rm. 2417, number of registrants requesting to endpoints, and extrapolation of adult Silver Spring, MD 20993–0002, 301– speak is greater than can be reasonably efficacy data. The workshop will also 796–9001, FAX: 301–847–8533, email: accommodated during the scheduled provide a forum for discussion on the DODAC@fda.hhs.gov, or FDA Advisory open public hearing session, FDA may use of registry data, as well as Committee Information Line, 1–800– conduct a lottery to determine the alternative trial designs and statistical 741–8138 (301–443–0572 in the speakers for the scheduled open public methods. Washington, DC area). A notice in the hearing session. The contact person will Federal Register about last minute notify interested persons regarding their DATES: The public workshop will be modifications that impact a previously request to speak by September 21, 2017. held on Friday, October 27, 2017, from announced advisory committee meeting 8 a.m. to 5 p.m. Persons attending FDA’s advisory cannot always be published quickly committee meetings are advised that the ADDRESSES: The public workshop will enough to provide timely notice. Agency is not responsible for providing be held at FDA’s White Oak Campus, Therefore, you should always check the access to electrical outlets. 10903 New Hampshire Ave., Bldg. 31, Agency’s Web site at https://www.fda. Rm. 1503A, Silver Spring, MD 20993– gov/AdvisoryCommittees/default.htm FDA welcomes the attendance of the public at its advisory committee 0002. Entrance for the public workshop and scroll down to the appropriate participants (non-FDA employees) is advisory committee meeting link, or call meetings and will make every effort to accommodate persons with disabilities. through Building 1, where routine the advisory committee information line security check procedures will be to learn about possible modifications If you require special accommodations due to a disability, please contact performed. For parking and security before coming to the meeting. information, please refer to https:// LaToya Bonner at least 7 days in SUPPLEMENTARY INFORMATION: www.fda.gov/AboutFDA/ advance of the meeting. Agenda: The committee will discuss WorkingatFDA/BuildingsandFacilities/ the safety and efficacy of new drug FDA is committed to the orderly WhiteOakCampusInformation/ application (NDA) 208254, for conduct of its advisory committee ucm241740.htm. meetings. Please visit our Web site at asabaliauskas on DSKBBXCHB2PROD with NOTICES netarsudil ophthalmic solution 0.02%, submitted by Aerie Pharmaceuticals https://www.fda.gov/ FOR FURTHER INFORMATION CONTACT: Inc., for the proposed indication to AdvisoryCommittees/AboutAdvisory Jacquline Yancy, Center for Drug reduce elevated intraocular pressure Committees/ucm111462.htm for Evaluation and Research, Food and (IOP) in patients with open-angle procedures on public conduct during Drug Administration, 10903 New glaucoma (OAG) or ocular hypertension advisory committee meetings. Hampshire Ave., Bldg. 22, Rm. 6319, (OHT). Notice of this meeting is given under Silver Spring, MD 20993–0002, 301– FDA intends to make background the Federal Advisory Committee Act (5 796–7068, Jacquline.Yancy@ material available to the public no later U.S.C. app. 2). fda.hhs.gov. VerDate Sep<11>2014 17:52 Sep 20, 2017 Jkt 241001 PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 E:\FR\FM\21SEN1.SGM 21SEN1


Document Created: 2018-10-24 14:33:29
Document Modified: 2018-10-24 14:33:29
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice; establishment of a public docket; request for comments.
DatesThe public meeting will be held on October 13, 2017, from 8:30 a.m. to 4 p.m.
ContactLaToya 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 Agency's Web site 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 Citation82 FR 44187 
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