[Federal Register Volume 85, Number 171 (Wednesday, September 2, 2020)]
[Notices]
[Pages 54580-54581]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-19385]



[[Page 54580]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1153]


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.

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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 September 
23, 2019, and September 1, 2020, on FDA's website but not presented at 
the September 15, 2020, Pediatric Advisory Committee (PAC) 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 September 22, 
2020.

ADDRESSES: FDA is establishing a docket for public comment on this 
document. The docket number is FDA-2020-N-1153. The docket will close 
on September 22, 2020. 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 
September 22, 2020. The https://www.regulations.gov electronic filing 
system will accept comments until 11:59 p.m. Eastern Time at the end of 
September 22, 2020. 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-2020-N-1153 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, 240-402-7500.
     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.govinfo.gov/content/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, 240-402-7500.

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-2020-N-1153, to 
receive input on post-marketing pediatric-focused safety reviews of 
products posted between September 23, 2019, and September 1, 2020, 
available on FDA's website at https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/PediatricAdvisoryCommittee/ucm510701.htm but 
not presented at the September 15, 2020, PAC 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,

[[Page 54581]]

consortia, and patient groups), and the general public. The docket 
number is FDA-2020-N-1153. The docket will open on September 1, 2020, 
and remain open until September 22, 2020. 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. AFSTYLA (antihemophilic factor (recombinant), single chain)
2. EPICEL (cultured epidermal autografts)
3. FLUCELVAX QUADRIVALENT (influenza vaccine)
4. FLUCELVAX (influenza vaccine)
5. FLULAVAL (influenza vaccine)
6. FLULAVAL QUADRIVALENT (influenza vaccine)
7. HIBERIX (Haemophilus b conjugate vaccine (tetanus toxoid conjugate))
8. KOVALTRY (antihemophilic factor (recombinant))
9. QPAN H5N1 Vaccine (Influenza A (H5N1) virus monovalent vaccine, 
adjuvanted)

Center for Drug Evaluation and Research

1. BUTRANS (buprenorphine transdermal system)
2. CANASA (mesalamine suppositories for rectal use)
3. DESCOVY (emtricitabine and tenofovir alafenamide)
4. DRAXIMAGE DTPA (technetium TC-99m pentetate kit) injection and 
inhalation
5. DYSPORT (abobotulinumtoxinA)
6. GENVOYA (elvitegravir, cobicistat, emtricitabine, and tenofovir 
alafenamide) oral tablets
7. LUMASON (sulfur hexafluoride lipid-type A microspheres) injectable 
suspension
8. LUMIFY (brimonidine tartrate) OTC
9. LUZU (luliconazole) cream, 1%
10. OMIDRIA (phenylephrine and ketorolac intraocular solution)
11. SENSIPAR (cinacalcet)
12. STELARA (ustekinumab) injection
13. SYMFI LO (efavirenz 400 milligram (mg) + lamivudine 300 mg + 
tenofovir disoproxil fumarate 300 mg) and SYMFI (efavirenz 600 mg + 
lamivudine 300 mg + tenofovir disoproxil fumarate 300 mg)
14. TRIUMEQ (abacavir, dolutegravir, and lamivudine)
15. XEPI (ozenoxacin)

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. LIPOSORBER LA-15 SYSTEM (HDE)
5. MEDTRONIC ACTIVA DYSTONIA THERAPY (HDE)
6. PLEXIMMUNE IN-VITRO DIAGNOSTIC TEST (HDE)
7. PULSERIDER ANEURYSM NECK RECONSTRUCTION DEVICE (HDE)

    Dated: August 28, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-19385 Filed 9-1-20; 8:45 am]
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