Document ID: FDA-2015-N-2342-0046
Agency: fda
Document Type: Notice
Title: Pediatric Studies of Ampicillin Conducted in Accordance With the Public Health Service Act
Posted Date: 2017-04-25T04:00Z

[Federal Register Volume 82, Number 78 (Tuesday, April 25, 2017)]
[Notices]
[Pages 19065-19066]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-08301]

[[Page 19065]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-2342]

Pediatric Studies of Ampicillin Conducted in Accordance With the 
Public Health Service Act

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comment.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is making 
available to the public a report, submitted by Duke Clinical Research 
Institute on December 15, 2015, of the pediatric studies of ampicillin 
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. This notice is to 
announce the 30-day open public comment period on the report.

DATES: Submit either electronic or written comments by May 25, 2017. 
Late, untimely filed comments will not be considered. Electronic 
comments must be submitted on or before May 25, 2017. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of May 25, 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.

ADDRESSES: You may submit comments as follows:

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, 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 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 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-2342 for ``Pediatric Studies of Ampicillin Conducted in 
Accordance With Section 409I of the Public Health Service Act.'' 
Received comments, those filed in a timely manner (see DATES), will be 
placed in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at https://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 https://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: 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 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, 
email: Lori.Gorski@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

1. Background

    Under section 409I of the PHS Act (42 U.S.C. 284m), the Secretary 
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 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, 
under the Best Pharmaceuticals for Children Act, to holders of a new 
drug application or an abbreviated new drug application for a drug for 
which pediatric studies are needed, to provide safety and efficacy 
information for pediatric labeling. If the applicants or application 
holders 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

[[Page 19066]]

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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    Neonates are at risk for serious bacterial infections including 
meningitis, bacteremia, sepsis, and urinary tract infections. Most of 
these children are admitted to a hospital, where they receive 
antibiotics. Early onset of bacterial infection (less than 7 days of 
life) reflects vertical transmission, usually caused by group B 
streptococci (GBS), Escherichia coli, Listeria monocytogenes, or 
enterococcus species, and is a significant cause of illness and death 
among low birth weight infants. Late onset infections suggest 
nosocomial, community-acquired infections or late onset GBS; these may 
be caused by gram-negative organisms as well as staphylococcal species. 
The first line of antibiotic therapy is ampicillin in combination with 
gentamicin or a third-generation cephalosporin.
    In the Federal Register of February 13, 2004 (71 FR 23931), NIH 
published a notice announcing the addition of several drugs, including 
ampicillin, to the priority list of drugs most in need of study for use 
by children to ensure the drugs' safety and efficacy. A written request 
for pediatric studies of ampicillin was issued on August 5, 2005, to 
the holders of applications for ampicillin. 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 2006, and awarded funds to Pediatric Trials Network in 
December 2011 to complete the studies described in the written request. 
Upon completion of the pediatric studies, a report of the pediatric 
studies of ampicillin 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 ampicillin that was 
submitted to NIH and FDA. The report includes all data generated in 
connection with the study, including the written request.

II. Availability of Report for Public Comment

    FDA is announcing the 30-day open public comment period for the 
report of the pediatric studies of ampicillin that were conducted in 
accordance with section 409I of the PHS Act and submitted to NIH and 
FDA. We invite interested parties to review the Duke Clinical Research 
Institute report, which was posted to the docket on December 15, 2015, 
and submit comments to the docket (see ADDRESSES).

    Dated: April 19, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-08301 Filed 4-24-17; 8:45 am]
 BILLING CODE 4164-01-P