[Federal Register Volume 84, Number 63 (Tuesday, April 2, 2019)]
[Notices]
[Pages 12623-12624]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06385]


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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.

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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 October 12, 
2018, and April 1, 2019, on FDA's website but not presented at the 
April 8, 2019, 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 April 15, 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 April 15, 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 April 15, 2019. The 
https://www.regulations.gov electronic filing system will accept 
comments until midnight Eastern Time at the end of April 15, 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

[[Page 12624]]

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: Amy Odegaard, Office of the 
Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 32, Rm. 5151, Silver Spring, MD 20993, 301-796-8627, 
[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 has established a public docket, Docket No. FDA-2019-N-1215, to 
receive input on post-marketing pediatric-focused safety reviews of 
products posted between October 12, 2018, and April 1, 2019, available 
on FDA's website at https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/PediatricAdvisoryCommittee/ucm510701.htm but 
not presented at the April 8, 2019, 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, consortia, and patient groups), and 
the general public. The docket number is FDA-2019-N-1215. The docket 
will open on April 2, 2019, and remain open until April 15, 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. ADYNOVATE (Antihemophilic Factor [recombinant])
2. IXINITY (Coagulation Factor IX [Recombinant])
3. EPICEL (cultured epidermal autografts) (Humanitarian Device 
Exemption [HDE])

Center for Drug Evaluation and Research

1. ACZONE GEL (dapsone)
2. AIRDUO RESPICLICK (fluticasone propionate and salmeterol) and 
ARMONAIR RESPICLICK (fluticasone propionate)
3. AVELOX (moxifloxacin hydrochloride)
4. CALDOLOR INJECTION (ibuprofen)
5. CUBICIN INJECTION (daptomycin)
6. DEXILANT (dexlansoprazole)
7. EUCRISA OINTMENT (crisaborole)
8. LILETTA (levonorgestrel-releasing intrauterine system)
9. LYRICA (pregabalin)
10. NARCAN NASAL SPRAY (naloxone hydrochloride)
11. OFIRMEV (acetaminophen)
12. SELZENTRY (maraviroc)
13. SPIRIVA RESPIMAT (tiotropium bromide)
14. SYMBICORT INHALATION AEROSOL (budesonide/formoterol fumarate 
dehydrate)
15. TARCEVA (erlotinib hydrochloride)
16. VELCADE (bortezomib)

Center for Devices and Radiological Health

1. FLOURISHTM PEDIATRIC ESOPHAGEAL ATRESIA DEVICE (HDE)
2. LIPOSORBER LA-15 SYSTEM (HDE)
3. MEDTRONIC ACTIVA DYSTONIA THERAPY (HDE)

    Dated: March 28, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-06385 Filed 4-1-19; 8:45 am]
 BILLING CODE 4164-01-P