Pediatric Studies of Ampicillin Conducted in Accordance With the Public Health Service Act, 19065-19066 [2017-08301]
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Federal Register / Vol. 82, No. 78 / Tuesday, April 25, 2017 / Notices
• 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’’).
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.
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:
asabaliauskas on DSK3SPTVN1PROD with NOTICES
SUMMARY:
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.
VerDate Sep<11>2014
17:42 Apr 24, 2017
Jkt 241001
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
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
19065
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/201523389.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
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.
E:\FR\FM\25APN1.SGM
25APN1
19066
Federal Register / Vol. 82, No. 78 / Tuesday, April 25, 2017 / Notices
NIH and placed in a public docket
assigned by FDA.
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, communityacquired 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.
asabaliauskas on DSK3SPTVN1PROD with NOTICES
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).
VerDate Sep<11>2014
17:42 Apr 24, 2017
Jkt 241001
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–0001]
Food and Drug Administration Small
Business and Industry Assistance
Regulatory Education for Industry
Spring Conference; Public Conference
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public conference.
The Food and Drug
Administration (FDA) Center for Drug
Evaluation and Research (CDER),
together with the Center for Devices and
Radiological Health (CDRH), is
sponsoring a 2-day public conference
entitled ‘‘FDA Small Business and
Industry Assistance Regulatory
Education for Industry (REdI) Spring
Conference.’’ The goal of this public
conference is to provide direct, relevant,
and helpful information on the key
aspects of drug and medical device
regulations in order to increase
regulatory certainty and predictability
for pharmaceutical and/or medical
device industry. Our primary audience
is that of small manufacturers of drug
and/or medical devices who want to
learn about how FDA approaches the
regulation of drugs and medical devices
and for whom increased certainty and
predictability will help to decrease the
regulatory burdens that can be
associated with a lack of understanding
of, or familiarity with, FDA’s drug and
medical device regulations. However,
anyone involved in the pharmaceutical
and/or medical device industry may
attend.
DATES: The public conference will be
held May 9 and 10, 2017, from 8:30 a.m.
to 4:30 p.m. See the SUPPLEMENTARY
INFORMATION section for registration
information.
ADDRESSES: The public conference will
be held in the High Ballroom, located on
the Lobby Level of the Renaissance
Atlanta Midtown Hotel, 866 W.
Peachtree St. NW., Atlanta, GA 30308.
The hotel’s phone number is 678–412–
2400.
FOR FURTHER INFORMATION CONTACT:
Brenda Stodart, Center for Drug
Evaluation and Research, Food and
SUMMARY:
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
Drug Administration, 10001 New
Hampshire Ave., Silver Spring, MD
20993–0002, 301–796–6707, email:
cdersbia@fda.hhs.gov; or Elias Mallis,
Center for Devices and Radiological
Health, 10903 New Hampshire Ave.,
Silver Spring, MD 20993–0002, 301–
796–7100, email: DICE@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing a public
conference entitled ‘‘FDA Small
Business and Industry Assistance
Regulatory Education for Industry
Spring Conference.’’ This public
conference is intended to increase the
drug and medical device industry’s
awareness of applicable FDA
regulations. There will be an
opportunity for questions and answers
following each presentation.
II. Topics for Discussion at the
Conference
This 2-day, FDA-led forum offers the
opportunity to interact with FDA
subject matter experts from across CDER
and CDRH. The following information
will be discussed:
• CDER Investigational New Drug
Application (IND) Review Process:
Types of IND; Content and Format of
an IND; Chemistry Manufacturing and
Controls; Pharmacology/Toxicology;
Drug Inspections
• CDRH: 510(k); Biocompatibility in
Premarket Submissions; NonConforming Product; Device
Inspections
III. Participating in the Public
Conference
Registration: There is no fee to attend
the public conference. Space is limited,
and registration will be on a first-come,
first-served basis. To register, please
complete registration online at: https://
www.fda.gov/Drugs/
DevelopmentApprovalProcess/
SmallBusinessAssistance/
ucm545309.htm. Early registration is
recommended. Registrants will receive
email confirmation when they have
been accepted, and reminder emails will
be sent to registrants 2 days before the
conference. If time and space permit,
onsite registration will be available
beginning at 7:30 a.m. on each day of
the public conference. If you need
special accommodations due to
disability, please contact info@
sbiaevents.com at least 7 days in
advance.
Streaming Webcast of the Public
Conference: This public conference will
also be Webcast. Persons interested in
viewing the Webcast must register to
E:\FR\FM\25APN1.SGM
25APN1
Agencies
[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]]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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