Document ID: FDA-2015-N-3037-0079
Agency: fda
Document Type: Notice
Title: Pediatric Studies of Lorazepam; Establishment of Public Docket
Posted Date: 2016-03-29T04:00Z

[Federal Register Volume 81, Number 60 (Tuesday, March 29, 2016)]
[Notices]
[Pages 17461-17463]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-07012]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-3037]

Pediatric Studies of Lorazepam; Establishment of Public Docket

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of docket.

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SUMMARY: The Food and Drug Administration (FDA) is establishing a 
public docket to make available to the public a report of the pediatric 
studies of Lorazepam that were conducted in accordance with the Public 
Health Service Act (PHS Act) and submitted to the Director of the 
National Institutes of Health (NIH) and the Commissioner of Food and 
Drugs.

DATES: Submit either electronic or written comments by April 28, 2016.

[[Page 17462]]

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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 submissions as follows:
     Mail/ Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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-2015-N-3037 for ``Pediatric Studies of Lorazepam; Establishment of 
Public Docket.'' Received comments will be placed in the docket and, 
except for those submitted as ``Confidential Submissions,'' publicly 
viewable at http://www.regulations.gov or at the Division of Dockets 
Management 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 http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Lori Gorski, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, rm. 6466, Silver Spring, MD 20993-0002, 
Lori.Gorski@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Under section 409I of the PHS Act (42 U.S.C. 
284m), the Secretary of the Department of Health and Human Services 
(the Secretary) acting through the Director of the NIH, in consultation 
with FDA and experts in pediatric research, must develop, prioritize, 
and publish a list of priority needs in pediatric therapeutics, 
including drugs and indications that require study.\1\ For drugs and 
indications on this list, FDA, acting in consultation with NIH, is 
authorized to issue a written request to holders of a new drug 
application or abbreviated new drug application for a drug for which 
pediatric studies are needed to provide safety and efficacy information 
for pediatric labeling. If the sponsors receiving the written request 
decline to conduct the studies or if FDA does not receive a response to 
the written request within 30 days of the date the written request was 
issued, the Secretary, acting through the Director of NIH, and in 
consultation with FDA, must publish a request for proposals to conduct 
the pediatric studies described in the written request and award funds 
to an entity with appropriate expertise for the conduct of the 
pediatric studies described in the written request. Upon completion of 
the pediatric studies, a study report that includes all data generated 
in connection with the studies must be submitted to FDA and NIH and 
placed in a public docket assigned by FDA.
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    \1\ Prior to the 2007 reauthorization of the Best 
Pharmaceuticals for Children Act (Pub. L. 107-109), the priority 
list included specific drugs instead of therapeutic areas.
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    Lorazepam is commonly used in pediatric practice as a first-line 
agent for the initial treatment of status epilepticus. However, there 
is limited information available about dosing, pharmacokinetics, 
effectiveness, and safety in pediatric patients treated with Lorazepam.
    A written request for pediatric studies of Lorazepam was issued on 
July 5, 2002, to Wyeth-Ayerst Research, the holder of the new drug 
applications for Lorazepam. FDA did not receive a response to the 
written request. On January 21, 2003, NIH published a Federal Register 
notice (68 FR 2789) announcing the addition of several drugs, including 
Lorazepam, to the priority list of drugs most in need of study for use 
by children to ensure their safety and efficacy. Accordingly, NIH 
issued a request for proposals to conduct the pediatric studies 
described in the written request and awarded funds to the Children's 
National Medical Center in September 2004, to complete the studies 
described in the written request. Upon completion of the pediatric 
studies, a report of the pediatric studies of Lorazepam was submitted 
to NIH and FDA. As required under section 409I of the PHS act, FDA 
opened a public docket and NIH placed in the docket the report of 
pediatric studies of Lorazepam that was submitted to NIH and FDA. The 
report includes all data generated in connection with the study, 
including the written request.
    We invite interested parties to review the report and submit 
comments to the docket. The public docket is available for public 
review in the Division of Dockets Management (see ADDRESSES) between 9 
a.m. and 4 p.m., Monday through Friday.

[[Page 17463]]

    Dated: March 23, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-07012 Filed 3-28-16; 8:45 am]
 BILLING CODE 4164-01-P