[Federal Register Volume 82, Number 170 (Tuesday, September 5, 2017)]
[Notices]
[Pages 41969-41970]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-18690]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-4866]


Pediatric Post-Marketing Pharmacovigilance and Drug Utilization 
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 pediatric post-
marketing pharmacovigilance and drug utilization reviews of products 
posted between March 11, 2017, and September 12, 2017, on FDA's Web 
site but not presented at the September 12, 2017, 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 October 20, 
2017.

ADDRESSES: You may submit your comments as follows. Please note that 
late, untimely filed comments will not be considered. Electronic 
comments must be submitted on or before October 20, 2017. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of October 20, 2017. 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.

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, you 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 submission 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.

[[Page 41970]]

     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-2017-N-4866 for the ``Pediatric Post-Marketing Pharmacovigilance 
and Drug Utilization Reviews'' that have been posted on FDA's Web site 
between March 11, 2017, and September 12, 2017, but not presented at 
the September 12, 2017, PAC meeting. 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 office 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.'' The Agency 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: Kenneth Quinto, Office of the 
Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 32, Rm. 5145, Silver Spring, MD 20993, 240-402-2221, email: 
[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 is establishing a public docket, Docket No. FDA-2017-N-4866, to 
receive input on pediatric post-marketing pharmacovigilance and drug 
utilization reviews posted between March 11, 2017, and September 12, 
2017, available on FDA's Web site at https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/PediatricAdvisoryCommittee/ucm510701.htm, but not presented at the 
September 12, 2017, 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 (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-2017-N-4866. The docket will open on October 9, 2017, and 
remain open until October 20, 2017. These pediatric post-marketing 
pharmacovigilance and drug utilization reviews are for the following 
products from the following centers at FDA:

Center for Biologics Evaluation and Research

1. GRASTEK (Timothy Grass Pollen Allergen Extract) Tablet for 
Sublingual Use
2. ORALAIR (Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky 
Blue Grass Mixed Pollens Allergen Extract) Tablet for Sublingual Use

Center for Drug Evaluation and Research

1. ALOXI (palonosetron hydrochloride)
2. ARNUITY ELLIPTA (fluticasone furoate)
3. ASMANEX HFA and ASMANEX TWISTHALER (mometasone furoate inhalation)
4. CYMBALTA (duloxetine)
5. EMSAM (selegiline transdermal system)
6. LATISSE (bimatoprost ophthalmic solution) 0.03%
7. NAMENDA (memantine hydrochloride) and NAMENDA XR (memantine 
hydrochloride) extended-release
8. PRIFTIN (rifapentine)
9. REYATAZ (atazanavir)
10. TACLONEX (betamethasone dipropionate/calcipotriene hydrate) Topical 
Suspension 0.064%/0.005% and TACLONEX (betamethasone dipropionate/
calcipotriene hydrate) Topical Ointment 0.064%/0.005%
11. ZETONNA (ciclesonide)

    Dated: August 30, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-18690 Filed 9-1-17; 8:45 am]
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