Draft Guidance for Industry on Clinical Pharmacogenomics: Premarketing Evaluation in Early Phase Clinical Studies; Availability, 9583-9584 [2011-3679]
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Federal Register / Vol. 76, No. 34 / Friday, February 18, 2011 / Notices
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[FR Doc. 2011–3664 Filed 2–17–11; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–D–0082]
Draft Guidance for Industry on Clinical
Pharmacogenomics: Premarketing
Evaluation in Early Phase Clinical
Studies; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Clinical
Pharmacogenomics: Premarketing
Evaluation in Early Phase Clinical
Studies.’’ The draft guidance is intended
to assist the pharmaceutical industry
and other investigators engaged in new
drug development in evaluating how
variations in the human genome could
affect the clinical pharmacology
WReier-Aviles on DSKGBLS3C1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
13:57 Feb 17, 2011
Jkt 223001
properties and clinical responses of
drugs.
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considers your comment on this draft
guidance before it begins work on the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on the draft guidance by April 19, 2011.
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single copies of the draft guidance to the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, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201,
Silver Spring, MD 20993–0002 or the
Office of Communication, Outreach and
Development (HFM–40), Center for
Biologics Evaluation and Research
(CBER), Food and Drug Administration,
1401 Rockville Pike, suite 200N,
Rockville, MD 20852–1448. Send one
self-addressed adhesive label to assist
that office in processing your requests.
See the SUPPLEMENTARY INFORMATION
section for electronic access to the
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draft guidance to https://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:
Lawrence J. Lesko, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 3178,
Silver Spring, MD 20993–0002, 301–
796–1565; or
Shiew-Mei Huang, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 3188,
Silver Spring, MD 20993–0002, 301–
796–1541; or
Stephen Ripley, Center for Biologics
Evaluation and Research, Food and
Drug Administration (HFM–17), 1401
Rockville Pike, suite 200N, Rockville,
MD 20852–1448, 301–827–6210.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance entitled ‘‘Clinical
Pharmacogenomics: Premarketing
Evaluation in Early Phase Clinical
Studies.’’ Pharmacogenomics (PGx)
broadly refers to the study of variations
of DNA and RNA characteristics and
their relation to drug exposure and/or
response. Drug exposure refers to either
the administered dose or levels in a
body tissue or fluid (e.g., blood, plasma,
cerebrospinal fluid). Drug response
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
9583
results from the interplay of
pharmacokinetics (e.g., drug absorption,
metabolism, and excretion), and
pharmacodynamics (i.e., all of the
effects of the drug on various
physiologic and pathologic processes,
including effectiveness and adverse
effects). Genetic variations can also
influence the exposure-response (E/R)
relationship of drugs. PGx studies can
enhance the understanding of
interindividual differences in the
efficacy and safety of investigational
drugs.
Drug development is commonly
described as going through ‘‘phases’’
(21 CFR 312.21). The first two phases
collect information about safety and
dosing, so that the larger, later (phase 3)
studies (the adequate and wellcontrolled studies needed to support
marketing approval) can gather the
additional information about
effectiveness and safety that is needed
to evaluate the overall benefit-risk
relationship of the drug and to provide
an adequate basis for physician labeling.
Much of the genomic information
collected and assessed during the early
phases is often described as
‘‘exploratory.’’ Phase 2 studies that
suggest genomic influences can lead to
phase 3 trials that incorporate findings
into prespecified hypotheses, such as
enriching the study with genomically
defined individuals, determining dose
based on demonstrated variability in
earlier studies, and defining a priori
hypothesis testing of a primary endpoint
in a genomic subset.
PGx information obtained from
genomic investigations during the
course of drug development (and from
postmarketing studies) can improve the
effectiveness and safety of drugs by
identifying patients at high risk for a
serious adverse event or absence of
benefit; improving the benefit/risk
relationship of drugs by using genomic
tests to identify patients most likely to
respond, or unable to respond to a drug;
and by helping to select optimal doses
based on genotype-driven differences in
PK (pharmacodynamics) and/or PD
(pharmacodynamics) of a drug. An
important prerequisite to successful use
of genetic information in drug
development is appropriate collection
and storage of DNA samples from all
clinical trials, both exploratory and the
adequate and well-controlled studies
intended to support effectiveness and
safety.
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
conducting pharmacogenomic studies in
E:\FR\FM\18FEN1.SGM
18FEN1
9584
Federal Register / Vol. 76, No. 34 / Friday, February 18, 2011 / Notices
early phase clinical studies. 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 refers to
previously approved collections of
information that are subject to review by
the Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501–3520). The
collections of information in 21 CFR
201.57 have been approved under OMB
control number 0910–0572.
III. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. It is no longer necessary to
send two copies of mailed 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.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/
GuidanceCompliance
RegulatoryInformation/Guidances, or
https://www.fda.gov/
BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/Guidances, or https://
www.regulations.gov.
Dated: February 14, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–3679 Filed 2–17–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
WReier-Aviles on DSKGBLS3C1PROD with NOTICES
[Docket No. FDA–2010–N–0528]
Unapproved Animal Drugs; Extension
of Comment Period
AGENCY:
Food and Drug Administration,
HHS.
the notice that appeared in the Federal
Register of December 20, 2010 (75 FR
79383). In the notice FDA requested
comments on strategies to address the
prevalence of animal drug products
marketed in the United States without
approval or other legal marketing status.
The Agency is taking this action in
response to requests for an extension to
allow interested persons additional time
to submit comments.
DATES: Submit electronic or written
comments by April 19, 2011.
ADDRESSES: You may submit comments,
identified by Docket No. FDA–2010–N–
0528 by any of the following methods:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
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, disk, 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. FDA–2010–N–0528. All
comments received may be posted
without change to https://
www.regulations.gov, including any
personal information provided. For
additional information on submitting
comments, see the ‘‘Request for
Comments’’ heading of the
SUPPLEMENTARY INFORMATION section of
this document.
Docket: For access to the docket to
read background documents or
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:
Tracey H. Forfa, Center for Veterinary
Medicine (HFV–1), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–9000,
e-mail: Tracey.Forfa@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
Request for comments;
extension of comment period.
I. Background
The Food and Drug
Administration (FDA) is extending to
April 19, 2011, the comment period for
In the Federal Register of December
20, 2010 (75 FR 79383), FDA published
a notice with a 60-day comment period
ACTION:
SUMMARY:
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13:57 Feb 17, 2011
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PO 00000
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to request comments from stakeholders
on strategies to address the prevalence
of animal drug products marketed in the
United States without approval or other
legal marketing status. The notice
expressed FDA’s interest in receiving
comments on strategies that utilize
FDA’s existing regulatory framework for
addressing this issue as well as on novel
strategies not currently employed by the
Agency.
The Agency has received requests for
a 60-day extension of the comment
period. The requests conveyed concern
that the current 60-day comment period
does not allow respondents sufficient
time to address fully the many
important issues FDA raised in the
notice.
FDA has considered the requests and
is extending the comment period for the
notice for 60 days, until April 19, 2011.
The Agency believes that a 60-day
extension allows adequate time for
interested persons to submit comments
without significantly delaying the
Agency’s consideration of these
important issues.
II. Request for Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. It is no longer necessary to
send two copies of mailed 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.
Dated: February 15, 2011.
David Dorsey,
Acting Deputy Commissioner for Policy,
Planning and Budget.
[FR Doc. 2011–3712 Filed 2–17–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Health Resources and Services
Administration, HHS.
ACTION: Correction of Burden Table.
AGENCY:
The Health Resources and
Services Administration published an
Agency Information Collection
document in the Federal Register of
SUMMARY:
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E:\FR\FM\18FEN1.SGM
18FEN1
Agencies
[Federal Register Volume 76, Number 34 (Friday, February 18, 2011)]
[Notices]
[Pages 9583-9584]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-3679]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-D-0082]
Draft Guidance for Industry on Clinical Pharmacogenomics:
Premarketing Evaluation in Early Phase Clinical Studies; 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 ``Clinical
Pharmacogenomics: Premarketing Evaluation in Early Phase Clinical
Studies.'' The draft guidance is intended to assist the pharmaceutical
industry and other investigators engaged in new drug development in
evaluating how variations in the human genome could affect the clinical
pharmacology properties and clinical responses of drugs.
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 April 19, 2011.
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, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002 or the
Office of Communication, Outreach and Development (HFM-40), Center for
Biologics Evaluation and Research (CBER), Food and Drug Administration,
1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the 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:
Lawrence J. Lesko, Center for Drug Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 3178,
Silver Spring, MD 20993-0002, 301-796-1565; or
Shiew-Mei Huang, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 3188, Silver
Spring, MD 20993-0002, 301-796-1541; or
Stephen Ripley, Center for Biologics Evaluation and Research, Food and
Drug Administration (HFM-17), 1401 Rockville Pike, suite 200N,
Rockville, MD 20852-1448, 301-827-6210.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance entitled
``Clinical Pharmacogenomics: Premarketing Evaluation in Early Phase
Clinical Studies.'' Pharmacogenomics (PGx) broadly refers to the study
of variations of DNA and RNA characteristics and their relation to drug
exposure and/or response. Drug exposure refers to either the
administered dose or levels in a body tissue or fluid (e.g., blood,
plasma, cerebrospinal fluid). Drug response results from the interplay
of pharmacokinetics (e.g., drug absorption, metabolism, and excretion),
and pharmacodynamics (i.e., all of the effects of the drug on various
physiologic and pathologic processes, including effectiveness and
adverse effects). Genetic variations can also influence the exposure-
response (E/R) relationship of drugs. PGx studies can enhance the
understanding of interindividual differences in the efficacy and safety
of investigational drugs.
Drug development is commonly described as going through ``phases''
(21 CFR 312.21). The first two phases collect information about safety
and dosing, so that the larger, later (phase 3) studies (the adequate
and well-controlled studies needed to support marketing approval) can
gather the additional information about effectiveness and safety that
is needed to evaluate the overall benefit-risk relationship of the drug
and to provide an adequate basis for physician labeling. Much of the
genomic information collected and assessed during the early phases is
often described as ``exploratory.'' Phase 2 studies that suggest
genomic influences can lead to phase 3 trials that incorporate findings
into prespecified hypotheses, such as enriching the study with
genomically defined individuals, determining dose based on demonstrated
variability in earlier studies, and defining a priori hypothesis
testing of a primary endpoint in a genomic subset.
PGx information obtained from genomic investigations during the
course of drug development (and from postmarketing studies) can improve
the effectiveness and safety of drugs by identifying patients at high
risk for a serious adverse event or absence of benefit; improving the
benefit/risk relationship of drugs by using genomic tests to identify
patients most likely to respond, or unable to respond to a drug; and by
helping to select optimal doses based on genotype-driven differences in
PK (pharmacodynamics) and/or PD (pharmacodynamics) of a drug. An
important prerequisite to successful use of genetic information in drug
development is appropriate collection and storage of DNA samples from
all clinical trials, both exploratory and the adequate and well-
controlled studies intended to support effectiveness and safety.
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 conducting pharmacogenomic
studies in
[[Page 9584]]
early phase clinical studies. 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 refers to previously approved collections of
information that are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information in 21 CFR 201.57 have been
approved under OMB control number 0910-0572.
III. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed 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.
IV. Electronic Access
Persons with access to the Internet may obtain the document at
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances, or https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances, or https://www.regulations.gov.
Dated: February 14, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-3679 Filed 2-17-11; 8:45 am]
BILLING CODE 4160-01-P