83 FR 7058 - Pediatric Advisory Committee; Establishment of a Public Docket; Request for Comments; Amendment of Notice
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 | 7058-7059 | |
| FR Document | 2018-03231 |
[Federal Register Volume 83, Number 33 (Friday, February 16, 2018)] [Notices] [Pages 7058-7059] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-03231] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-6928] Pediatric Advisory Committee; Establishment of a Public Docket; Request for Comments; Amendment of Notice AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the Pediatric Advisory Committee (PAC). This meeting was announced in the Federal Register of January 2, 2018. The amendment is being made to reflect a change in the Center for Devices and Radiological Health (CDRH) products portion of the document and to include the topics that will be discussed during the meeting. There are no other changes. FOR FURTHER INFORMATION 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 protected], or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). Please call the Information Line for up-to-date information on this meeting. SUPPLEMENTARY INFORMATION: In the Federal Register of January 2, 2018 (83 FR 125), FDA announced that a meeting [[Page 7059]] of the Pediatric Advisory Committee would be held on March 23, 2018. FDA will provide updates on the following topics without vote by the committee:Update regarding labeling change for inhaled corticosteroid long-acting [beta]-2 agonists (ICS/LABAs); Safety labeling for gadolinium products; Overview of the FDA Adverse Event Reporting System (FAERS) and reports on reduced or lack of efficacy for certain generic drugs; and Generic drug approval process; and discussion on the differences in the approval process for brand name drugs versus generic drugs; exceptions. On page 126, in the third column, the CDRH products portion of the document is changed to read as follows: The PAC will meet to discuss the following products (listed by FDA Center): (2) Center for Devices and Radiological Health a. MEDTRONIC ACTIVA DYSTONIA THERAPY (Humanitarian Device Exemption (HDE)) b. LIPOSORBER LA-15 SYSTEM (HDE) CDRH will update the committee on the regulatory status of a previously reviewed HDE. This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees. Dated: February 12, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-03231 Filed 2-15-18; 8:45 am] BILLING CODE 4164-01-P
![7058 Federal Register / Vol. 83, No. 33 / Friday, February 16, 2018 / Notices
do not wish to be made available to the the information at: https://www.gpo.gov/ Seizures: Full Extrapolation of Efficacy
public, submit the comment as a fdsys/pkg/FR-2015-09-18/pdf/2015- From Adults to Pediatric Patients 4
written/paper submission and in the 23389.pdf. Years of Age and Older.’’ It does not
manner detailed (see ‘‘Written/Paper Docket: For access to the docket to establish any rights for any person and
Submissions’’ and ‘‘Instructions’’). read background documents or the is not binding on FDA or the public.
electronic and written/paper comments You can use an alternative approach if
Written/Paper Submissions
received, go to https:// it satisfies the requirements of the
Submit written/paper submissions as www.regulations.gov and insert the applicable statutes and regulations. This
follows: docket number, found in brackets in the guidance is not subject to Executive
• Mail/Hand delivery/Courier (for heading of this document, into the Order 12866.
written/paper submissions): Dockets ‘‘Search’’ box and follow the prompts
Management Staff (HFA–305), Food and II. Electronic Access
and/or go to the Dockets Management
Drug Administration, 5630 Fishers Staff, 5630 Fishers Lane, Rm. 1061, Persons with access to the internet
Lane, Rm. 1061, Rockville, MD 20852. Rockville, MD 20852. may obtain the draft guidance at either
• For written/paper comments You may submit comments on any https://www.fda.gov/Drugs/Guidance
submitted to the Dockets Management guidance at any time (see 21 CFR ComplianceRegulatoryInformation/
Staff, FDA will post your comment, as 10.115(g)(5)). Guidances/default.htm or https://
well as any attachments, except for Submit written requests for single www.regulations.gov.
information submitted, marked and copies of the draft guidance to the
identified, as confidential, if submitted Dated: February 12, 2018.
Division of Drug Information, Center for Leslie Kux,
as detailed in ‘‘Instructions.’’
Drug Evaluation and Research, Food
Instructions: All submissions received Associate Commissioner for Policy.
and Drug Administration, 10001 New
must include the Docket No. FDA– [FR Doc. 2018–03223 Filed 2–15–18; 8:45 am]
2018–D–0178 for ‘‘Drugs for Treatment Hampshire Ave., Hillandale Building,
BILLING CODE 4164–01–P
of Partial Onset Seizures: Full 4th Floor, Silver Spring, MD 20993–
Extrapolation of Efficacy from Adults to 0002. Send one self-addressed adhesive
Pediatric Patients 4 Years of Age and label to assist that office in processing
DEPARTMENT OF HEALTH AND
Older; Draft Guidance for Industry.’’ your requests. See the SUPPLEMENTARY
HUMAN SERVICES
INFORMATION section for electronic
Received comments will be placed in
the docket and, except for those access to the draft guidance document. Food and Drug Administration
submitted as ‘‘Confidential FOR FURTHER INFORMATION CONTACT:
Submissions,’’ publicly viewable at Billy Dunn, Center for Drug Evaluation [Docket No. FDA–2017–N–6928]
https://www.regulations.gov or at the and Research, Food and Drug
Dockets Management Staff between 9 Administration, 10903 New Hampshire Pediatric Advisory Committee;
a.m. and 4 p.m., Monday through Ave., Bldg. 22, Rm. 4332, Silver Spring, Establishment of a Public Docket;
Friday. MD 20993–0002, 301–796–2250. Request for Comments; Amendment of
• Confidential Submissions—To SUPPLEMENTARY INFORMATION: Notice
submit a comment with confidential
information that you do not wish to be I. Background AGENCY: Food and Drug Administration,
made publicly available, submit your FDA is announcing the availability of HHS.
comments only as a written/paper a draft guidance for industry entitled ACTION: Notice.
submission. You should submit two ‘‘Drugs for Treatment of Partial Onset
copies total. One copy will include the Seizures: Full Extrapolation of Efficacy SUMMARY: The Food and Drug
information you claim to be confidential from Adults to Pediatric Patients 4 Administration (FDA) is announcing an
with a heading or cover note that states Years of Age and Older.’’ The draft amendment to the notice of meeting of
‘‘THIS DOCUMENT CONTAINS guidance provides recommendations to the Pediatric Advisory Committee
CONFIDENTIAL INFORMATION.’’ The sponsors on the clinical development of (PAC). This meeting was announced in
Agency will review this copy, including drugs for the treatment of POS in the Federal Register of January 2, 2018.
the claimed confidential information, in pediatric patients. Specifically, it The amendment is being made to reflect
its consideration of comments. The addresses FDA’s thinking regarding a change in the Center for Devices and
second copy, which will have the clinical development programs that can Radiological Health (CDRH) products
claimed confidential information support extrapolation of evidence of portion of the document and to include
redacted/blacked out, will be available effectiveness in treatment of POS in the topics that will be discussed during
for public viewing and posted on adults to pediatric patients 4 years of the meeting. There are no other changes.
https://www.regulations.gov. Submit age and older. FOR FURTHER INFORMATION CONTACT:
both copies to the Dockets Management This draft guidance explains how Marieann Brill, Office of the
Staff. If you do not wish your name and efficacy can be extrapolated from adults Commissioner, Food and Drug
contact information to be made publicly to children when it is reasonable to Administration, 10903 New Hampshire
available, you can provide this assume that children, compared with Ave., Bldg. 32, Rm. 5154, Silver Spring,
information on the cover sheet and not adults, have a similar progression of MD 20993, 240–402–3838,
in the body of your comments and you disease, similar response of the disease marieann.brill@fda.hhs.gov, or FDA
must identify this information as to treatment, and similar exposure- Advisory Committee Information Line,
daltland on DSKBBV9HB2PROD with NOTICES
‘‘confidential.’’ Any information marked response relationship. 1–800–741–8138 (301–443–0572 in the
as ‘‘confidential’’ will not be disclosed This draft guidance is being issued Washington, DC area). Please call the
except in accordance with 21 CFR 10.20 consistent with FDA’s good guidance Information Line for up-to-date
and other applicable disclosure law. For practices regulation (21 CFR 10.115). information on this meeting.
more information about FDA’s posting The draft guidance, when finalized, will SUPPLEMENTARY INFORMATION: In the
of comments to public dockets, see 80 represent the current thinking of FDA Federal Register of January 2, 2018 (83
FR 56469, September 18, 2015, or access on ‘‘Drugs for Treatment of Partial Onset FR 125), FDA announced that a meeting
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![Federal Register / Vol. 83, No. 33 / Friday, February 16, 2018 / Notices 7059
of the Pediatric Advisory Committee Department of Commerce, for the • Mail/Hand delivery/Courier (for
would be held on March 23, 2018. extension of a patent which claims that written/paper submissions): Dockets
FDA will provide updates on the medical device. Management Staff (HFA–305), Food and
following topics without vote by the DATES: Anyone with knowledge that any Drug Administration, 5630 Fishers
committee: of the dates as published (see the Lane, Rm. 1061, Rockville, MD 20852.
• Update regarding labeling change SUPPLEMENTARY INFORMATION section) are • For written/paper comments
for inhaled corticosteroid long-acting b- incorrect may submit either electronic submitted to the Dockets Management
2 agonists (ICS/LABAs); or written comments and ask for a Staff, FDA will post your comment, as
• Safety labeling for gadolinium redetermination by April 17, 2018. well as any attachments, except for
products; Furthermore, any interested person may information submitted, marked and
• Overview of the FDA Adverse Event petition FDA for a determination identified, as confidential, if submitted
Reporting System (FAERS) and reports regarding whether the applicant for as detailed in ‘‘Instructions.’’
on reduced or lack of efficacy for certain extension acted with due diligence Instructions: All submissions received
generic drugs; and during the regulatory review period by must include the Docket No. FDA–
• Generic drug approval process; and August 15, 2018. See ‘‘Petitions’’ in the 2016–E–2477 for ‘‘Determination of
discussion on the differences in the Regulatory Review Period for Purposes
SUPPLEMENTARY INFORMATION section for
approval process for brand name drugs of Patent Extension; HYMOVIS.’’
more information.
versus generic drugs; exceptions. Received comments, those filed in a
On page 126, in the third column, the ADDRESSES: You may submit comments timely manner (see ADDRESSES), will be
CDRH products portion of the document as follows. Please note that late, placed in the docket and, except for
is changed to read as follows: untimely filed comments will not be those submitted as ‘‘Confidential
The PAC will meet to discuss the considered. Electronic comments must Submissions,’’ publicly viewable at
following products (listed by FDA be submitted on or before April 17, https://www.regulations.gov or at the
Center): 2018. The https://www.regulations.gov Dockets Management Staff between 9
electronic filing system will accept a.m. and 4 p.m., Monday through
(2) Center for Devices and Radiological
comments until midnight Eastern Time Friday.
Health
at the end of April 17, 2018. Comments • Confidential Submissions—To
a. MEDTRONIC ACTIVA DYSTONIA
received by mail/hand delivery/courier submit a comment with confidential
THERAPY (Humanitarian Device
(for written/paper submissions) will be information that you do not wish to be
Exemption (HDE))
considered timely if they are made publicly available, submit your
b. LIPOSORBER LA–15 SYSTEM
postmarked or the delivery service comments only as a written/paper
(HDE)
acceptance receipt is on or before that submission. You should submit two
CDRH will update the committee on the date. copies total. One copy will include the
regulatory status of a previously information you claim to be confidential
reviewed HDE. Electronic Submissions with a heading or cover note that states
This notice is issued under the Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS
Federal Advisory Committee Act (5 following way: CONFIDENTIAL INFORMATION.’’ The
U.S.C. app. 2) and 21 CFR part 14, • Federal eRulemaking Portal: Agency will review this copy, including
relating to the advisory committees. https://www.regulations.gov. Follow the the claimed confidential information, in
Dated: February 12, 2018. instructions for submitting comments. its consideration of comments. The
Leslie Kux, Comments submitted electronically, second copy, which will have the
Associate Commissioner for Policy. including attachments, to https:// claimed confidential information
[FR Doc. 2018–03231 Filed 2–15–18; 8:45 am]
www.regulations.gov will be posted to redacted/blacked out, will be available
the docket unchanged. Because your for public viewing and posted on
BILLING CODE 4164–01–P
comment will be made public, you are https://www.regulations.gov. Submit
solely responsible for ensuring that your both copies to the Dockets Management
DEPARTMENT OF HEALTH AND comment does not include any Staff. If you do not wish your name and
HUMAN SERVICES confidential information that you or a contact information to be made publicly
third party may not wish to be posted, available, you can provide this
Food and Drug Administration such as medical information, your or information on the cover sheet and not
anyone else’s Social Security number, or in the body of your comments and you
[Docket No. FDA–2016–E–2477] must identify this information as
confidential business information, such
as a manufacturing process. Please note ‘‘confidential.’’ Any information marked
Determination of Regulatory Review
that if you include your name, contact as ‘‘confidential’’ will not be disclosed
Period for Purposes of Patent
information, or other information that except in accordance with § 10.20 (21
Extension; HYMOVIS
identifies you in the body of your CFR 10.20) and other applicable
AGENCY: Food and Drug Administration, comments, that information will be disclosure law. For more information
HHS. posted on https://www.regulations.gov. about FDA’s posting of comments to
ACTION: Notice. • If you want to submit a comment public dockets, see 80 FR 56469,
with confidential information that you September 18, 2015, or access the
SUMMARY: The Food and Drug do not wish to be made available to the information at: https://www.gpo.gov/
Administration (FDA) has determined public, submit the comment as a fdsys/pkg/FR-2015-09-18/pdf/2015-
daltland on DSKBBV9HB2PROD with NOTICES
the regulatory review period for written/paper submission and in the 23389.pdf.
HYMOVIS and is publishing this notice manner detailed (see ‘‘Written/Paper Docket: For access to the docket to
of that determination as required by Submissions’’ and ‘‘Instructions’’). read background documents or the
law. FDA has made the determination electronic and written/paper comments
because of the submission of an Written/Paper Submissions received, go to https://
application to the Director of the U.S. Submit written/paper submissions as www.regulations.gov and insert the
Patent and Trademark Office (USPTO), follows: docket number, found in brackets in the
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Document Created: 2018-02-16 00:55:37
Document Modified: 2018-02-16 00:55:37
| 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. | |
| 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 protected], or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). Please call the Information Line for up-to-date information on this meeting. | |
| FR Citation | 83 FR 7058 |
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