[Federal Register Volume 77, Number 38 (Monday, February 27, 2012)]
[Notices]
[Pages 11556-11557]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-4426]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0918]


Pediatric Studies of Meropenem Conducted in Accordance With 
Section 409I of the Public Health Service Act; Establishment of Public 
Docket

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
opening of a public docket to make available to the public a report of 
the pediatric studies of meropenem that were conducted in accordance 
with section 409I of 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 March 28, 2012.

ADDRESSES: You may submit comments, identified by FDA-2011-N-0918, by 
any of the following methods.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     Fax: 301-827-6870.
     Mail/Hand delivery/Courier (for paper or CD-ROM 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency name 
and Docket No. for this rulemaking. All comments received may be posted 
without change to http://www.regulations.gov, including any personal 
information provided.
    Docket: For access to the docket to read background documents or 
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: Denise Pica-Branco, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, rm. 6402, Silver Spring, MD 20993-0002, 
Email: [email protected].

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 (NDA) or abbreviated new drug application (ANDA) 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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    Meropenem, an antibiotic medication, is labeled for pediatric 
patients from 3 months of age through adolescence as a single agent 
antimicrobial therapy for meningitis and complicated intra-abdominal 
infections, and is a recommended option for monotherapy of high 
severity complicated intra-abdominal infections in adults. Off-label 
use of meropenem in newborn and infant patients younger than 3 months 
of age is significant, despite the lack of adequate pharmacokinetic, 
dosing, tolerability, and safety data for this age group.
    On August 13, 2003, NIH published a Federal Register notice (68 FR 
48402) announcing the addition of several drugs, including meropenem, 
to the priority list of drugs most in need of

[[Page 11557]]

study for use by children to ensure their safety and efficacy. A 
written request for pediatric studies of meropenem was issued on 
September 10, 2004, to AstraZeneca Pharmaceuticals, the holder of the 
new drug application for meropenem. FDA did not receive a response to 
the written request. Accordingly, NIH issued a request for proposals to 
conduct the pediatric studies described in the written request on 
August 15, 2005, and awarded funds to Duke University on September 28, 
2007, to complete the studies described in the written request. Upon 
completion of the pediatric studies, a report of the pediatric studies 
of meropenem 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 meropenem 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.

    Dated: February 21, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-4426 Filed 2-24-12; 8:45 am]
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