[Federal Register Volume 77, Number 192 (Wednesday, October 3, 2012)]
[Notices]
[Pages 60441-60442]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-24213]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0284]


Pediatric Studies of Sodium Nitroprusside 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 sodium nitroprusside that were conducted in 
accordance with the Public Health Service Act (the 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 November 2, 
2012.

ADDRESSES: You may submit comments, identified by FDA-2012-N-0284, 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: Akilah Green, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, rm. 6475, 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 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, biological products, and indications that require 
study.\1\ For drugs and biological products 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, or holders of a 
biologics license application (BLA) for a biological product, 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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    Sodium nitroprusside, a hypotensive agent, is labeled for the 
immediate reduction of blood pressure of patients in hypertensive 
crises, for producing controlled hypotension in order to reduce 
bleeding during surgery, and for the treatment of acute congestive 
heart failure. Off-label use of sodium nitroprusside in pediatric 
patients is significant, despite the lack of adequate pharmacokinetic, 
dosing, tolerability, and safety data for this age group.
    On January 21, 2003, NIH published a Federal Register notice (68 FR 
2789) announcing the addition of several drugs, including sodium 
nitroprusside, to the priority list of drugs most in need of study for 
use by children to ensure their safety and efficacy. A written request 
for pediatric studies of sodium nitroprusside was issued on July 8, 
2002, to Abbott Laboratories, the holder of the NDA for sodium 
nitroprusside. 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 in July 2004, and 
awarded funds to Duke University and Stanford University 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 sodium nitroprusside 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 sodium nitroprusside 
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

[[Page 60442]]

for public review in the Division of Dockets Management (see ADDRESSES) 
between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: September 26, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-24213 Filed 10-2-12; 8:45 am]
BILLING CODE 4160-01-P