General Clinical Pharmacology Considerations for Pediatric Studies for Drugs and Biological Products; Draft Guidance for Industry; Availability, 73079-73080 [2014-28716]
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Federal Register / Vol. 79, No. 236 / Tuesday, December 9, 2014 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Food and Drug Administration
[Docket No. FDA–2013–D–1275]
[Docket No. FDA–2014–N–0987]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Generic Clearance
for the Collection of Qualitative Data
on Tobacco Products and
Communications; Correction
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; correction.
The Food and Drug
Administration (FDA) is correcting a
document entitled ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Generic
Clearance for the Collection of
Qualitative Data on Tobacco Products
and Communications’’ that appeared in
the Federal Register of August 1, 2014.
The document announced the generic
clearance for the collection of
qualitative data on tobacco products and
communications. The document was
published with the incorrect docket
number. This document corrects that
error.
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002,
PRAStaff@fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
In FR Doc.
2014–18195, appearing on page 44779
in the Federal Register of August 1,
2014 (79 FR 44779), FDA is making the
following correction:
1. On page 44779, in the second
column, in the Docket No. heading,
‘‘FDA–2014–N–0005’’ is corrected to
read ‘‘FDA–2014–N–0987.’’
SUPPLEMENTARY INFORMATION:
Dated: December 3, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014–28714 Filed 12–8–14; 8:45 am]
BILLING CODE 4164–01–P
VerDate Sep<11>2014
14:48 Dec 08, 2014
Jkt 235001
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘General Clinical
Pharmacology Considerations for
Pediatric Studies for Drugs and
Biological Products.’’ The draft
guidance is intended to assist those
sponsors of new drug applications
(NDAs), biologics license applications
(BLAs) for therapeutic biologics, and
supplements to such applications who
are planning to conduct clinical studies
in pediatric populations. Effectiveness,
safety, or dose finding studies in
pediatric patients involve gathering
clinical pharmacology information, such
as information regarding a product’s
pharmacokinetics and
pharmacodynamics pertaining to dose
selection and individualization. This
draft guidance addresses general clinical
pharmacology considerations for
conducting studies so that the dosing
and safety information for drugs and
biologic products can be sufficiently
characterized, leading to well-designed
trials to evaluate effectiveness.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by February 9,
2015.
Submit written requests for
single copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993.
Send one self-addressed adhesive label
to assist those offices in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
ADDRESSES:
PO 00000
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Gilbert J. Burckart, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 3184,
Silver Spring, MD 20993–0002, 301–
796–2065.
SUPPLEMENTARY INFORMATION:
I. Background
Notice.
SUMMARY:
SUMMARY:
rljohnson on DSK3VPTVN1PROD with NOTICES
General Clinical Pharmacology
Considerations for Pediatric Studies
for Drugs and Biological Products;
Draft Guidance for Industry;
Availability
73079
Frm 00054
Fmt 4703
Sfmt 4703
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘General Clinical Pharmacology
Considerations for Pediatric Studies for
Drugs and Biological Products.’’ During
the past two decades, FDA has worked
to address the problem of inadequate
pediatric testing and inadequate
pediatric use information in drug and
biological product labeling. The Food
and Drug Administration Modernization
Act of 1997 (Pub. L. 105–115) addressed
the need for improved information
about drug use in the pediatric
population (codified at 21 U.S.C. 355a)
by establishing incentives for
conducting pediatric studies on drugs
while exclusivity or patent protection
exists. Congress subsequently passed
the Best Pharmaceuticals for Children
Act (BPCA) in 2002 and the Pediatric
Research Equity Act (PREA) in 2003.
Both BPCA and PREA were
reauthorized in 2007 and were made
permanent under Title V of the Food
and Drug Administration Safety and
Innovation Act of 2012 (Public Law
112–144).
Under BPCA, sponsors of certain
applications and supplements filed
under section 505 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355)
(the FD&C Act) can obtain an additional
6 months of exclusivity if, in accordance
with the requirements of the statute, the
sponsor submits information responding
to a written request from the Secretary
relating to the use of a drug in the
pediatric population.
Under PREA, sponsors of certain
applications and supplements filed
under section 505 of the FD&C Act or
section 351 of the Public Health Service
Act are required to submit pediatric
assessments, unless they receive an
applicable waiver or deferral of this
requirement. If applicable, sponsors
must submit a request for a deferral or
waiver as part of an initial pediatric
study plan.
This draft guidance focuses on the
clinical pharmacology information (e.g.,
exposure-response, pharmacokinetics,
and pharmacodynamics) needed to
E:\FR\FM\09DEN1.SGM
09DEN1
73080
Federal Register / Vol. 79, No. 236 / Tuesday, December 9, 2014 / Notices
support findings of effectiveness and
safety and helps identify appropriate
doses in pediatric populations. The
draft guidance also describes the use of
quantitative approaches (i.e.,
pharmacometrics) to employ disease
and exposure-response knowledge from
relevant prior clinical studies to design
and evaluate future pediatric studies.
The draft guidance does not describe:
(1) Standards for approval of drugs and
biological products in the pediatric
population, (2) criteria to allow a
determination that the course of a
disease and the effects of a drug or a
biologic are the same in adults and
pediatric populations, or (3) clinical
pharmacology studies for vaccine
therapy, blood products, or other
products not regulated by the Center for
Drug Evaluation and Research.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance represents the
Agency’s current thinking on the
general clinical pharmacology
considerations for pediatric studies for
drugs and biological products. It does
not create or confer any rights for or on
any person and does not operate to bind
FDA or the public. An alternative
approach may be used if such approach
satisfies the requirement of the
applicable statutes and regulations.
approved collections of information
found in FDA regulations or guidances.
III. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at https://www.
fda.gov/Drugs/GuidanceCompliance
RegulatoryInformation/Guidances or
https://www.regulations.gov.
Dated: December 2, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014–28716 Filed 12–8–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
rljohnson on DSK3VPTVN1PROD with NOTICES
II. Paperwork Reduction Act of 1995
Food and Drug Administration
This draft guidance includes
information collection provisions that
are subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act (PRA) of
1995 (44 U.S.C. 3501–3520) (PRA). The
collections of information referenced in
this draft guidance that are related to the
burden for the submission of
investigational new drug applications
are covered under 21 CFR part 312 and
have been approved under OMB control
number 0910–0014. The collections of
information referenced in this draft
guidance that are related to the burden
for the submission of new drug
applications are covered under 21 CFR
part 314 and have been approved under
OMB control number 0910–0001. The
submission of prescription drug product
labeling under 21 CFR 201.56 and
201.57 is approved under OMB control
number 0910–0572.
In accordance with the PRA, prior to
publication of any final guidance
document, FDA intends to solicit public
comment and obtain OMB approval for
any information collections
recommended in this guidance that are
new or that would represent material
modifications to those previously
[Docket No. FDA–2014–D–1492]
VerDate Sep<11>2014
14:48 Dec 08, 2014
Jkt 235001
Two-Phased Chemistry,
Manufacturing, and Controls Technical
Sections; Draft Guidance for Industry;
Extension of Comment Period
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; extension of comment
period.
The Food and Drug
Administration (FDA) is extending the
comment period for a notice of
availability of draft guidance for
industry (GFI #227) entitled ‘‘TwoPhased Chemistry, Manufacturing, and
Controls Technical Sections’’ that
appeared in the Federal Register of
October 20, 2014. In that notice, FDA
made available for comment the draft
guidance, which provides
recommendations to sponsors
submitting chemistry, manufacturing,
and controls (CMC) data submissions.
The Agency is taking this action in
response to a request for an extension to
allow interested persons additional time
to submit comments.
DATES: FDA is extending the comment
period on the draft guidance. Submit
SUMMARY:
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
either electronic or written comments
on the draft guidance by February 17,
2015.
ADDRESSES: Submit electronic
comments on the draft guidance to
https://www.regulations.gov. Submit
written comments on the draft guidance
to the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. Identify
comments with the docket number
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Heather Longstaff, Center for Veterinary
Medicine (HFV–145), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–402–0651,
email: heather.longstaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of October 20,
2014 (79 FR 62635) FDA published a
notice announcing the availability of
draft guidance for industry (GFI #227)
entitled ‘‘Two-Phased Chemistry,
Manufacturing, and Controls (CMC)
Technical Sections.’’ It is intended to
provide recommendations to industry
regarding CMC data submitted to the
Center for Veterinary Medicine to
support approval of a new animal drug
or abbreviated new animal drug. The
notice invited comments on the draft
guidance by December 19, 2014.
The Agency received a request for a
60-day extension of the comment period
for the draft guidance. The request
conveyed concern that the current 60day comment period does not allow
sufficient time to respond.
FDA has considered the request and
is extending the comment period for the
draft guidance for 60 days, until
February 17, 2015. The Agency believes
that a 60-day extension allows adequate
time for interested persons to submit
comments without significantly
delaying further FDA action on this
guidance document.
II. Request for Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
E:\FR\FM\09DEN1.SGM
09DEN1
]]>Agencies
[Federal Register Volume 79, Number 236 (Tuesday, December 9, 2014)]
[Notices]
[Pages 73079-73080]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-28716]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-D-1275]
General Clinical Pharmacology Considerations for Pediatric
Studies for Drugs and Biological Products; Draft Guidance for Industry;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``General
Clinical Pharmacology Considerations for Pediatric Studies for Drugs
and Biological Products.'' The draft guidance is intended to assist
those sponsors of new drug applications (NDAs), biologics license
applications (BLAs) for therapeutic biologics, and supplements to such
applications who are planning to conduct clinical studies in pediatric
populations. Effectiveness, safety, or dose finding studies in
pediatric patients involve gathering clinical pharmacology information,
such as information regarding a product's pharmacokinetics and
pharmacodynamics pertaining to dose selection and individualization.
This draft guidance addresses general clinical pharmacology
considerations for conducting studies so that the dosing and safety
information for drugs and biologic products can be sufficiently
characterized, leading to well-designed trials to evaluate
effectiveness.
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by February 9, 2015.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD
20993. Send one self-addressed adhesive label to assist those offices
in processing your requests. See the SUPPLEMENTARY INFORMATION section
for electronic access to the draft guidance document.
Submit electronic comments on the draft guidance to https://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Gilbert J. Burckart, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 3184, Silver Spring, MD 20993-0002, 301-
796-2065.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``General Clinical Pharmacology Considerations for Pediatric
Studies for Drugs and Biological Products.'' During the past two
decades, FDA has worked to address the problem of inadequate pediatric
testing and inadequate pediatric use information in drug and biological
product labeling. The Food and Drug Administration Modernization Act of
1997 (Pub. L. 105-115) addressed the need for improved information
about drug use in the pediatric population (codified at 21 U.S.C. 355a)
by establishing incentives for conducting pediatric studies on drugs
while exclusivity or patent protection exists. Congress subsequently
passed the Best Pharmaceuticals for Children Act (BPCA) in 2002 and the
Pediatric Research Equity Act (PREA) in 2003. Both BPCA and PREA were
reauthorized in 2007 and were made permanent under Title V of the Food
and Drug Administration Safety and Innovation Act of 2012 (Public Law
112-144).
Under BPCA, sponsors of certain applications and supplements filed
under section 505 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355) (the FD&C Act) can obtain an additional 6 months of
exclusivity if, in accordance with the requirements of the statute, the
sponsor submits information responding to a written request from the
Secretary relating to the use of a drug in the pediatric population.
Under PREA, sponsors of certain applications and supplements filed
under section 505 of the FD&C Act or section 351 of the Public Health
Service Act are required to submit pediatric assessments, unless they
receive an applicable waiver or deferral of this requirement. If
applicable, sponsors must submit a request for a deferral or waiver as
part of an initial pediatric study plan.
This draft guidance focuses on the clinical pharmacology
information (e.g., exposure-response, pharmacokinetics, and
pharmacodynamics) needed to
[[Page 73080]]
support findings of effectiveness and safety and helps identify
appropriate doses in pediatric populations. The draft guidance also
describes the use of quantitative approaches (i.e., pharmacometrics) to
employ disease and exposure-response knowledge from relevant prior
clinical studies to design and evaluate future pediatric studies. The
draft guidance does not describe: (1) Standards for approval of drugs
and biological products in the pediatric population, (2) criteria to
allow a determination that the course of a disease and the effects of a
drug or a biologic are the same in adults and pediatric populations, or
(3) clinical pharmacology studies for vaccine therapy, blood products,
or other products not regulated by the Center for Drug Evaluation and
Research.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance
represents the Agency's current thinking on the general clinical
pharmacology considerations for pediatric studies for drugs and
biological products. It does not create or confer any rights for or on
any person and does not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
requirement of the applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
This draft guidance includes information collection provisions that
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520)
(PRA). The collections of information referenced in this draft guidance
that are related to the burden for the submission of investigational
new drug applications are covered under 21 CFR part 312 and have been
approved under OMB control number 0910-0014. The collections of
information referenced in this draft guidance that are related to the
burden for the submission of new drug applications are covered under 21
CFR part 314 and have been approved under OMB control number 0910-0001.
The submission of prescription drug product labeling under 21 CFR
201.56 and 201.57 is approved under OMB control number 0910-0572.
In accordance with the PRA, prior to publication of any final
guidance document, FDA intends to solicit public comment and obtain OMB
approval for any information collections recommended in this guidance
that are new or that would represent material modifications to those
previously approved collections of information found in FDA regulations
or guidances.
III. Comments
Interested persons may submit either electronic comments regarding
this document to https://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at https://www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet may obtain the document at
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances or https://www.regulations.gov.
Dated: December 2, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-28716 Filed 12-8-14; 8:45 am]
BILLING CODE 4164-01-P
