Pediatric Advisory Committee and the Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments, 3156-3157 [2018-01120]

Download as PDF 3156 Federal Register / Vol. 83, No. 15 / Tuesday, January 23, 2018 / Notices collection of information between 30 and 60 days after publication of this document in the Federal Register. Therefore, a comment is best assured of having its full effect if OMB receives it within 30 days of publication. Written comments and recommendations for the proposed information collection should be sent directly to the following: Office of Management and Budget, Paperwork Reduction Project, Email: OIRA_ SUBMISSION@OMB.EOP.GOV. Attn: Desk Officer for the Administration for Children and Families. Mary Jones, ACF/OPRE Certifying Officer. [FR Doc. 2018–01140 Filed 1–22–18; 8:45 am] BILLING CODE 4184–09–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–N–0045] Pediatric Advisory Committee and the Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments AGENCY: Food and Drug Administration, HHS. Notice; establishment of a public docket; request for comments. ACTION: The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Pediatric Advisory Committee (PAC) and the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC). At least one portion of the meeting will be closed to the public. The general function of the committees is to provide advice and recommendations to FDA on regulatory issues. FDA is establishing a docket for public comments on this document. DATES: The meeting will be held on March 22, 2018, from 8:30 a.m. to 5:30 p.m. ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Building 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/Advisory Committees/AboutAdvisoryCommittees/ ucm408555.htm. FDA is establishing a docket for public comment on this meeting. The sradovich on DSK3GMQ082PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:59 Jan 22, 2018 Jkt 244001 docket number is FDA–2018–N–0045. The docket will close on March 23, 2018. Submit either electronic or written comments on this public meeting by that date. Please note that late, untimely comments will not be considered. The https:// www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of March 23, 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 March 8, 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 PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include Docket No. FDA–2018–N– 0045 for ‘‘Pediatric Advisory Committee and the 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.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.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: Marieann Brill, Office of the Commissioner, Food and Drug E:\FR\FM\23JAN1.SGM 23JAN1 Federal Register / Vol. 83, No. 15 / Tuesday, January 23, 2018 / Notices Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5154, Silver Spring, MD 20993, 240–402–3838, email: marieann.brill@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 Agency’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. sradovich on DSK3GMQ082PROD with NOTICES SUPPLEMENTARY INFORMATION: Agenda: The PAC and EMDAC will meet to discuss the major objectives of a phase 3 drug development program indicated for the treatment of children with achondroplasia (ACH). The following elements of a phase 3 program should be considered for discussion: Evidence required to establish doseresponse, study design, e.g., placebo control, study duration, intended population, e.g., infants and toddlers and/or older children and adolescents, and endpoints that have a clinically meaningful impact on the patient’s functional or psychological well-being. Comments about the upcoming advisory committee meeting should be submitted to Docket No. FDA–2018–N–0045. 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: On March 22, 2018, from 10:30 a.m. to 5:30 p.m., the meeting is open to the public. Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before March 15, 2018. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. Those individuals interested in making formal oral VerDate Sep<11>2014 17:59 Jan 22, 2018 Jkt 244001 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 March 7, 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 March 8, 2017. Closed Committee Deliberations: On March 22, 2018, from 8:30 a.m. to 10 a.m., the meeting will be closed to permit committee review and discussion of trade secret and/or confidential commercial information (5 U.S.C. 552b(c)(4)) included in an Investigational New Drug application for an investigational product indicated for the treatment of children with ACH. Persons attending FDA’s advisory committee meetings are advised that FDA 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 accommodations due to a disability, please contact Marieann Brill (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/Advisory Committees/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: January 17, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–01120 Filed 1–22–18; 8:45 am] BILLING CODE 4164–01–P PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 3157 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0021] Watson Laboratories, Inc.; Withdrawal of Approval of Abbreviated New Drug Applications for Prescription Pain Medications Containing More Than 325 Milligrams of Acetaminophen AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA and Agency) is withdrawing approval of an abbreviated new drug application (ANDA), held by Watson Laboratories, Inc. (Watson), for prescription pain medications that contain more than 325 milligrams (mg) of acetaminophen. Watson has voluntarily requested that approval of this application be withdrawn and has waived its opportunity for a hearing. DATES: Approval is withdrawn as of January 23, 2018. FOR FURTHER INFORMATION CONTACT: Jane Baluss, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6278, Silver Spring, MD 20993–0002, 301–796–3469. SUPPLEMENTARY INFORMATION: In the Federal Register of January 14, 2011 (76 FR 2691), FDA announced its plans to reduce the maximum dosage unit strength of acetaminophen in prescription drug products. The document announced FDA’s conclusion that, based on a reevaluation of the relative risks and benefits of prescription acetaminophen products, fixed-combination prescription drugs containing more than 325 mg of acetaminophen per dosage unit (tablet or capsule) do not provide a sufficient margin of safety to protect the public against the serious risk of acetaminophen-induced liver injury. Accordingly, we asked product sponsors to limit the maximum amount of acetaminophen per dosage unit to 325 mg and, for those products containing more than 325 mg of acetaminophen per dosage unit, to submit requests that FDA withdraw approval of their applications under § 314.150(d) (21 CFR 314.150(d)). FDA asked that all such requests be made before January 14, 2014, after which date the Agency planned to initiate proceedings under section 505(e) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(e)). In a Federal Register document dated March 27, 2014 (79 FR 17613), SUMMARY: E:\FR\FM\23JAN1.SGM 23JAN1

Agencies

[Federal Register Volume 83, Number 15 (Tuesday, January 23, 2018)]
[Notices]
[Pages 3156-3157]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-01120]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-0045]


Pediatric Advisory Committee and the 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; establishment of a public docket; request for comments.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming 
public advisory committee meeting of the Pediatric Advisory Committee 
(PAC) and the Endocrinologic and Metabolic Drugs Advisory Committee 
(EMDAC). At least one portion of the meeting will be closed to the 
public. The general function of the committees is to provide advice and 
recommendations to FDA on regulatory issues. FDA is establishing a 
docket for public comments on this document.

DATES: The meeting will be held on March 22, 2018, from 8:30 a.m. to 
5:30 p.m.

ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Building 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-2018-N-0045. The docket will close on March 
23, 2018. Submit either electronic or written comments on this public 
meeting by that date. Please note that late, untimely comments will not 
be considered. The https://www.regulations.gov electronic filing system 
will accept comments until midnight Eastern Time at the end of March 
23, 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 March 8, 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 Docket No. FDA-
2018-N-0045 for ``Pediatric Advisory Committee and the 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.gpo.gov/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: Marieann Brill, Office of the 
Commissioner, Food and Drug

[[Page 3157]]

Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5154, Silver 
Spring, MD 20993, 240-402-3838, 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 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 PAC and EMDAC will meet to discuss the major objectives 
of a phase 3 drug development program indicated for the treatment of 
children with achondroplasia (ACH). The following elements of a phase 3 
program should be considered for discussion: Evidence required to 
establish dose-response, study design, e.g., placebo control, study 
duration, intended population, e.g., infants and toddlers and/or older 
children and adolescents, and endpoints that have a clinically 
meaningful impact on the patient's functional or psychological well-
being. Comments about the upcoming advisory committee meeting should be 
submitted to Docket No. FDA-2018-N-0045.
    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: On March 22, 2018, from 10:30 a.m. to 5:30 p.m., the 
meeting is open to the public. Interested persons may present data, 
information, or views, orally or in writing, on issues pending before 
the committee. Written submissions may be made to the contact person on 
or before March 15, 2018. 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 March 7, 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 March 8, 2017.
    Closed Committee Deliberations: On March 22, 2018, from 8:30 a.m. 
to 10 a.m., the meeting will be closed to permit committee review and 
discussion of trade secret and/or confidential commercial information 
(5 U.S.C. 552b(c)(4)) included in an Investigational New Drug 
application for an investigational product indicated for the treatment 
of children with ACH.
    Persons attending FDA's advisory committee meetings are advised 
that FDA 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 accommodations due to a disability, please 
contact Marieann Brill (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: January 17, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-01120 Filed 1-22-18; 8:45 am]
 BILLING CODE 4164-01-P
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