83 FR 3156 - Pediatric Advisory Committee and the 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 15 (January 23, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 15 (January 23, 2018)
| Page Range | 3156-3157 | |
| FR Document | 2018-01120 |
[Federal Register Volume 83, Number 15 (Tuesday, January 23, 2018)] [Notices] [Pages 3156-3157] From the Federal Register Online [www.thefederalregister.org] [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.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: 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
![3156 Federal Register / Vol. 83, No. 15 / Tuesday, January 23, 2018 / Notices
collection of information between 30 docket number is FDA–2018–N–0045. identified, as confidential, if submitted
and 60 days after publication of this The docket will close on March 23, as detailed in ‘‘Instructions.’’
document in the Federal Register. 2018. Submit either electronic or Instructions: All submissions received
Therefore, a comment is best assured of written comments on this public must include Docket No. FDA–2018–N–
having its full effect if OMB receives it meeting by that date. Please note that 0045 for ‘‘Pediatric Advisory Committee
within 30 days of publication. Written late, untimely comments will not be and the Endocrinologic and Metabolic
comments and recommendations for the considered. The https:// Drugs Advisory Committee; Notice of
proposed information collection should www.regulations.gov electronic filing Meeting; Establishment of a Public
be sent directly to the following: Office system will accept comments until Docket; Request for Comments.’’
of Management and Budget, Paperwork midnight Eastern Time at the end of Received comments, those filed in a
Reduction Project, Email: OIRA_ March 23, 2018. Comments received by timely manner (see ADDRESSES), will be
SUBMISSION@OMB.EOP.GOV. Attn: mail/hand delivery/courier (for written/ placed in the docket and, except for
Desk Officer for the Administration for paper submissions) will be considered those submitted as ‘‘Confidential
Children and Families. timely if they are postmarked or the Submissions,’’ publicly viewable at
delivery service acceptance receipt is on https://www.regulations.gov or at the
Mary Jones,
or before that date. Dockets Management Staff between 9
ACF/OPRE Certifying Officer. Comments received on or before a.m. and 4 p.m., Monday through
[FR Doc. 2018–01140 Filed 1–22–18; 8:45 am] March 8, 2018, will be provided to the Friday.
BILLING CODE 4184–09–P committee. Comments received after • Confidential Submissions—To
that date will be taken into submit a comment with confidential
consideration by FDA. information that you do not wish to be
DEPARTMENT OF HEALTH AND You may submit comments as made publicly available, submit your
HUMAN SERVICES follows: comments only as a written/paper
Food and Drug Administration Electronic Submissions submission. You should submit two
copies total. One copy will include the
[Docket No. FDA–2018–N–0045] Submit electronic comments in the information you claim to be confidential
following way: with a heading or cover note that states
Pediatric Advisory Committee and the • Federal eRulemaking Portal: ‘‘THIS DOCUMENT CONTAINS
Endocrinologic and Metabolic Drugs https://www.regulations.gov. Follow the CONFIDENTIAL INFORMATION.’’ FDA
Advisory Committee; Notice of instructions for submitting comments. will review this copy, including the
Meeting; Establishment of a Public Comments submitted electronically, claimed confidential information, in its
Docket; Request for Comments including attachments, to https:// consideration of comments. The second
www.regulations.gov will be posted to copy, which will have the claimed
AGENCY: Food and Drug Administration,
the docket unchanged. Because your confidential information redacted/
HHS.
comment will be made public, you are blacked out, will be available for public
ACTION: Notice; establishment of a solely responsible for ensuring that your
public docket; request for comments. viewing and posted on https://
comment does not include any www.regulations.gov. Submit both
SUMMARY: The Food and Drug confidential information that you or a copies to the Dockets Management Staff.
Administration (FDA) announces a third party may not wish to be posted, If you do not wish your name and
forthcoming public advisory committee such as medical information, your or contact information be made publicly
meeting of the Pediatric Advisory anyone else’s Social Security number, or available, you can provide this
Committee (PAC) and the confidential business information, such information on the cover sheet and not
Endocrinologic and Metabolic Drugs as a manufacturing process. Please note in the body of your comments and you
Advisory Committee (EMDAC). At least that if you include your name, contact must identify the information as
one portion of the meeting will be information, or other information that ‘‘confidential.’’ Any information marked
closed to the public. The general identifies you in the body of your as ‘‘confidential’’ will not be disclosed
function of the committees is to provide comments, that information will be except in accordance with 21 CFR 10.20
advice and recommendations to FDA on posted on https://www.regulations.gov. and other applicable disclosure law. For
regulatory issues. FDA is establishing a • If you want to submit a comment
more information about FDA’s posting
docket for public comments on this with confidential information that you
of comments to public dockets, see 80
document. do not wish to be made available to the
FR 56469, September 18, 2015, or access
public, submit the comment as a
DATES: The meeting will be held on the information at: https://www.gpo.gov/
written/paper submission and in the
March 22, 2018, from 8:30 a.m. to 5:30 fdsys/pkg/FR-2015-09-18/pdf/2015-
manner detailed (see ‘‘Written/Paper
p.m. 23389.pdf.
Submissions’’ and ‘‘Instructions’’).
ADDRESSES: FDA White Oak Campus, Docket: For access to the docket to
10903 New Hampshire Ave., Building Written/Paper Submissions read background documents or the
31 Conference Center, the Great Room Submit written/paper submissions as electronic and written/paper comments
(Rm. 1503), Silver Spring, MD 20993– follows: received, go to https://
0002. Answers to commonly asked • Mail/Hand delivery/Courier (for www.regulations.gov and insert the
questions including information written/paper submissions): Dockets docket number, found in brackets in the
heading of this document, into the
sradovich on DSK3GMQ082PROD with NOTICES
regarding special accommodations due Management Staff (HFA–305), Food and
to a disability, visitor parking, and Drug Administration, 5630 Fishers ‘‘Search’’ box and follow the prompts
transportation may be accessed at: Lane, Rm. 1061, Rockville, MD 20852. and/or go to the Dockets Management
https://www.fda.gov/Advisory • For written/paper comments Staff, 5630 Fishers Lane, Rm. 1061,
Committees/AboutAdvisoryCommittees/ submitted to the Dockets Management Rockville, MD 20852.
ucm408555.htm. Staff, FDA will post your comment, as FOR FURTHER INFORMATION CONTACT:
FDA is establishing a docket for well as any attachments, except for Marieann Brill, Office of the
public comment on this meeting. The information submitted, marked and Commissioner, Food and Drug
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![Federal Register / Vol. 83, No. 15 / Tuesday, January 23, 2018 / Notices 3157
Administration, 10903 New Hampshire presentations should notify the contact DEPARTMENT OF HEALTH AND
Ave., Bldg. 32, Rm. 5154, Silver Spring, person and submit a brief statement of HUMAN SERVICES
MD 20993, 240–402–3838, email: the general nature of the evidence or
marieann.brill@fda.hhs.gov, or FDA arguments they wish to present, the Food and Drug Administration
Advisory Committee Information Line, names and addresses of proposed [Docket No. FDA–2011–N–0021]
1–800–741–8138 (301–443–0572 in the participants, and an indication of the
Washington, DC area). A notice in the approximate time requested to make Watson Laboratories, Inc.; Withdrawal
Federal Register about last minute their presentation on or before March 7, of Approval of Abbreviated New Drug
modifications that impact a previously 2018. Time allotted for each Applications for Prescription Pain
announced advisory committee meeting presentation may be limited. If the Medications Containing More Than 325
cannot always be published quickly number of registrants requesting to Milligrams of Acetaminophen
enough to provide timely notice. speak is greater than can be reasonably
Therefore, you should always check the AGENCY: Food and Drug Administration,
accommodated during the scheduled HHS.
Agency’s website at https://
open public hearing session, FDA may ACTION: Notice.
www.fda.gov/AdvisoryCommittees/
default.htm and scroll down to the conduct a lottery to determine the
appropriate advisory committee meeting speakers for the scheduled open public SUMMARY: The Food and Drug
link, or call the advisory committee hearing session. The contact person will Administration (FDA and Agency) is
information line to learn about possible notify interested persons regarding their withdrawing approval of an abbreviated
modifications before coming to the request to speak by March 8, 2017. new drug application (ANDA), held by
meeting. Closed Committee Deliberations: On Watson Laboratories, Inc. (Watson), for
prescription pain medications that
SUPPLEMENTARY INFORMATION: March 22, 2018, from 8:30 a.m. to 10
contain more than 325 milligrams (mg)
Agenda: The PAC and EMDAC will a.m., the meeting will be closed to
of acetaminophen. Watson has
meet to discuss the major objectives of permit committee review and
voluntarily requested that approval of
a phase 3 drug development program discussion of trade secret and/or this application be withdrawn and has
indicated for the treatment of children confidential commercial information (5 waived its opportunity for a hearing.
with achondroplasia (ACH). The U.S.C. 552b(c)(4)) included in an
DATES: Approval is withdrawn as of
following elements of a phase 3 program Investigational New Drug application
January 23, 2018.
should be considered for discussion: for an investigational product indicated
Evidence required to establish dose- FOR FURTHER INFORMATION CONTACT: Jane
for the treatment of children with ACH.
response, study design, e.g., placebo Baluss, Center for Drug Evaluation and
Persons attending FDA’s advisory Research, Food and Drug
control, study duration, intended
committee meetings are advised that Administration, 10903 New Hampshire
population, e.g., infants and toddlers
FDA is not responsible for providing Ave., Bldg. 51, Rm. 6278, Silver Spring,
and/or older children and adolescents,
access to electrical outlets. MD 20993–0002, 301–796–3469.
and endpoints that have a clinically
meaningful impact on the patient’s FDA welcomes the attendance of the SUPPLEMENTARY INFORMATION: In the
functional or psychological well-being. public at its advisory committee Federal Register of January 14, 2011 (76
Comments about the upcoming advisory meetings and will make every effort to FR 2691), FDA announced its plans to
committee meeting should be submitted accommodate persons with disabilities. reduce the maximum dosage unit
to Docket No. FDA–2018–N–0045. If you require accommodations due to a strength of acetaminophen in
FDA intends to make background disability, please contact Marieann Brill prescription drug products. The
material available to the public no later (See, FOR FURTHER INFORMATION document announced FDA’s conclusion
than 2 business days before the meeting. CONTACT) at least 7 days in advance of that, based on a reevaluation of the
If FDA is unable to post the background the meeting. relative risks and benefits of
material on its website prior to the prescription acetaminophen products,
meeting, the background material will FDA is committed to the orderly fixed-combination prescription drugs
be made publicly available at the conduct of its advisory committee containing more than 325 mg of
location of the advisory committee meetings. Please visit our website at acetaminophen per dosage unit (tablet
meeting, and the background material https://www.fda.gov/Advisory or capsule) do not provide a sufficient
will be posted on FDA’s website after Committees/AboutAdvisoryCommittees/ margin of safety to protect the public
the meeting. Background material is ucm111462.htm for procedures on against the serious risk of
available at https://www.fda.gov/ public conduct during advisory acetaminophen-induced liver injury.
AdvisoryCommittees/Calendar/ committee meetings. Accordingly, we asked product sponsors
default.htm. Scroll down to the Notice of this meeting is given under to limit the maximum amount of
appropriate advisory committee meeting the Federal Advisory Committee Act (5 acetaminophen per dosage unit to 325
link. U.S.C. app. 2). mg and, for those products containing
Procedure: On March 22, 2018, from more than 325 mg of acetaminophen per
10:30 a.m. to 5:30 p.m., the meeting is Dated: January 17, 2018. dosage unit, to submit requests that FDA
open to the public. Interested persons Leslie Kux, withdraw approval of their applications
may present data, information, or views, Associate Commissioner for Policy. under § 314.150(d) (21 CFR 314.150(d)).
orally or in writing, on issues pending FDA asked that all such requests be
sradovich on DSK3GMQ082PROD with NOTICES
[FR Doc. 2018–01120 Filed 1–22–18; 8:45 am]
before the committee. Written BILLING CODE 4164–01–P
made before January 14, 2014, after
submissions may be made to the contact which date the Agency planned to
person on or before March 15, 2018. initiate proceedings under section
Oral presentations from the public will 505(e) of the Federal Food, Drug, and
be scheduled between approximately 1 Cosmetic Act (FD&C Act) (21 U.S.C.
p.m. and 2 p.m. Those individuals 355(e)). In a Federal Register document
interested in making formal oral dated March 27, 2014 (79 FR 17613),
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Document Created: 2018-01-23 01:09:07
Document Modified: 2018-01-23 01:09:07
| 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 March 22, 2018, from 8:30 a.m. to 5:30 p.m. | |
| Contact | Marieann Brill, Office of the Commissioner, Food and Drug 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. | |
| FR Citation | 83 FR 3156 |
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