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
*Federal eRulemaking Portal: http://www.regulations.gov.Follow the instructions for submitting comments.Written Submissions
Submit written submissions in the following ways:
*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 tohttp://www.regulations.gov,including any personal information provided.
Docket:For access to the docket to read background documents or comments received, go tohttp://www.regulations.govand 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.
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.