[Federal Register Volume 84, Number 185 (Tuesday, September 24, 2019)]
[Notices]
[Pages 50038-50039]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-20658]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-1215]
Post-Marketing Pediatric-Focused Product Safety Reviews;
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) is establishing a
public docket to collect comments related to the post-marketing
pediatric-focused safety reviews of products posted between April 12,
2019, and September 23, 2019, on FDA's website but not presented at the
September 26 or 27, 2019, Joint Pediatric Advisory Committee (PAC) and
Drug Safety and Risk Management (DSaRM) Advisory Committee meeting.
These reviews are intended to be available for review and comment by
members of the PAC, interested parties (such as academic researchers,
regulated industries, consortia, and patient groups), and the general
public.
DATES: Submit either electronic or written comments by October 7, 2019.
ADDRESSES: FDA is establishing a docket for public comment on this
document. The docket number is FDA-2019-N-1215. The docket will close
on October 7, 2019. Submit either electronic or written comments by
that date. Please note that late, untimely comments will not be
considered. Electronic comments must be submitted on or before October
7, 2019. The https://www.regulations.gov electronic filing system will
accept comments until midnight Eastern Time at the end of October 7,
2019. 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.
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 make 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-2019-N-1215 for ``Post-Marketing Pediatric-Focused Product Safety
Reviews; 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 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.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 Administration, 10903 New Hampshire Ave.,
Bldg. 32, Rm. 5154, Silver Spring, MD 20993, 240-402-3838,
[email protected].
SUPPLEMENTARY INFORMATION: FDA is responsible for protecting the public
health by assuring the safety, efficacy, and security of human and
veterinary drugs, biological products, medical devices, our Nation's
food supply, cosmetics, and products that emit radiation. FDA also has
responsibility for regulating the manufacturing, marketing, and
distribution of tobacco products to protect the public health and to
reduce tobacco use by minors.
FDA is establishing a public docket, Docket No. FDA-2019-N-1215, to
receive input on post-marketing pediatric-focused safety reviews of
[[Page 50039]]
products posted between April 12, 2019, and September 23, 2019,
available on FDA's website at https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/PediatricAdvisoryCommittee/ucm510701.htm but
not presented at the September 26 or 27, 2019, Joint PAC or DSaRM
meeting. FDA welcomes comments by members of the PAC, as mandated by
the Best Pharmaceuticals for Children Act (Pub. L. 107-109) and the
Pediatric Research Equity Act of 2003 (Pub. L. 108-155), interested
parties (such as academic researchers, regulated industries, consortia,
and patient groups), and the general public. The docket number is FDA-
2019-N-1215. The docket will open on September 23, 2019, and remain
open until October 7, 2019. The post-marketing pediatric-focused safety
reviews are for the following products from the following centers at
FDA:
Center for Biologics Evaluation and Research
(1) GAMMAPLEX--Immune Globulin Intravenous (Human) 5% Liquid
(2) NUWIQ[supreg]--(simoctocog alfa)
(3) TACHOSIL[supreg]--Absorbable Fibrin Sealant Patch
(4) WILATE--von Willebrand Factor/Coagulation Factor VIII Complex
(Human)
Center for Drug Evaluation and Research
(1) ATIVAN INJECTION--(lorazepam injection)
(2) E-Z-HD--(barium sulfate)
(3) LIQUID E-Z-PAQUE--(barium sulfate)
(4) READI-CAT 2 and READI-CAT 2 SMOOTHIE--(barium sulfate)
(5) VARIBAR PUDDING--(barium sulfate)
(6) CALCIUM GLUCONATE INJECTION--(calcium gluconate)
(7) CEREBYX[supreg]--(fosphenytoin sodium)
(8) DOTAREM--(gadoterate meglumine)
(9) FYCOMPA ORAL TABLETS AND SUSPENSION--(perampanel)
(10) HARVONI--(ledipasvir and sofosbuvir)
(11) ISENTRESS AND ISENTRESS HD--(raltegravir)
(12) LATUDA--(lurasidone hydrochloride)
(13) RAPIVAB[supreg]--(peramivir)
(14) RYZODEG 70/30--(insulin degludec and insulin aspart injection) for
subcutaneous use 100 units/mL (U-100) in 3ml FlexTouch Pen
(15) SIMPONI--(golimumab SC) and SIMPONI ARIA (golimumab IV)
(16) SOVALDI--(sofosbuvir)
(17) STRIBILD--(elvitegravir, cobicistat, emtricitabine/tenofovir
disoproxil fumarate)
(18) TRESIBA--(insulin degludec injection), for subcutaneous use, 100
units/mL (U-100) in 3ml single-patient-use FlexTouch Pen; 200 units/mL
(U-200) in 3mL single-patient-use FlexTouch Pen; 100 units/mL (U-100)
10mL in multiple-dose vial
(19) VIGAMOX--(moxifloxacin hydrocholoride ophthalmic solution 0.5%)
(20) VISIPAQUE INJECTION--(iodixanol)
(21) ZEMPLAR--(paricalcitol)
(22) ZYMAR[supreg] 0.3%--(gatifloxacin ophthalmic solution)
Center for Devices and Radiological Health
(1) CONTEGRA PULMONARY VALVED CONDUIT--(Humanitarian Device Exemption
[HDE])
(2) ELANA SURGICAL KIT--(HDE)
(3) ENTERRA THERAPY SYSTEM--(HDE)
(4) PLEXIMMUNETM IN-VITRO DIAGNOSTIC TEST--(HDE)
(5) PULSERIDER ANEURYSM NECK RECONSTRUCTION DEVICE--(HDE)
Dated: September 19, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-20658 Filed 9-23-19; 8:45 am]
BILLING CODE 4164-01-P