Investigational New Drug Applications; Co-development of Investigational Drugs, 32482-32483 [2010-13769]
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Federal Register / Vol. 75, No. 109 / Tuesday, June 8, 2010 / Notices
domestic commerce unless its packaging
complies with section 3 of the
Smokeless Tobacco Act (Id.). Among the
requirements in section 3(b)(3) is that
the rotation of label statements on
packaging and advertising for each
brand of smokeless tobacco must be ‘‘in
accordance with a plan submitted by the
tobacco product manufacturer, importer,
distributor, or retailer’’ to, and approved
by, FDA (Id.).
At this time, as an exercise of
enforcement discretion, FDA does not
intend to commence or recommend
enforcement of the requirement that a
smokeless tobacco manufacturer,
distributor, importer, or retailer must
have an FDA-approved rotational
warning plan, so long as a rotational
warning plan has been submitted to
FDA by July 22, 2010. FDA believes that
allowing additional time for the review
of rotational warning plans will permit
an orderly transition of regulatory
authority from FTC to FDA to review
and approve rotational warning plans.
During such transition between June 22,
2010, and July 22, 2010, affected
companies may wish to contact FDA to
discuss the submission of their
rotational warning plans in order to
make the subsequent approval process
more orderly and efficient. FDA intends
to provide further public notice prior to
revising or rescinding this enforcement
policy after the transition from FTC to
FDA has been accomplished for the
submission and review of rotational
warning plans. This enforcement policy
pertains only to the requirement that
smokeless tobacco manufacturers,
distributors, importers, or retailers must
have an FDA-approved rotational
warning plan. FDA expects compliance
with regard to all other requirements of
section 3 of the Smokeless Tobacco Act,
including the requirements relating to
size, formatting, location, and use of
required warning statements.
emcdonald on DSK2BSOYB1PROD with NOTICES
II. Significance of Guidance
FDA is issuing this guidance
document as a level 1 guidance
consistent with FDA’s good guidance
practices regulations (21 CFR 10.115).
This guidance is being implemented
immediately without prior public
comment under 10.115(g)(2) because the
agency has determined that prior public
participation is not feasible or
appropriate. This document provides
guidance on statutory provisions that
take effect June 22, 2010. It is important
that FDA explain its enforcement policy
concerning the submission and approval
of rotational warning plans for
smokeless tobacco products before that
date.
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16:31 Jun 07, 2010
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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
An electronic version of this guidance
document is available on the Internet at
https://www.regulations.gov and https://
www.fda.gov/TobaccoProducts/
GuidanceComplianceRegulatory
Information/default.htm.
Dated: June 4, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–13819 Filed 6–4–10; 4:15 pm]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0247]
Investigational New Drug Applications;
Co-development of Investigational
Drugs
AGENCY:
Food and Drug Administration,
HHS.
ACTION: Notice; establishment of docket;
request for comments.
SUMMARY: The Food and Drug
Administration (FDA) is establishing a
public docket to obtain input on
methods to co-develop two or more
distinct investigational drugs intended
to be used in combination to treat a
disease or condition. FDA is planning to
develop guidance for industry and other
affected parties on the co-development
of two or more novel drugs intended to
be used in combination (but not as not
fixed-dose combinations) and is seeking
public input to identify the affected
parties’ information needs concerning
such co-development. Accordingly,
FDA is seeking comment on general
methodologic and regulatory issues that
arise in various scenarios when codeveloping two or more investigational
drugs intended to be used in
combination. FDA is also seeking
comment on methodologic and
regulatory issues when co-developing
two or more investigational drugs
PO 00000
Frm 00128
Fmt 4703
Sfmt 4703
intended to be used in combination for
specific therapeutic areas, including
oncology, anti-infectives, seizure
disorders, cardiovascular diseases, and
any other therapeutic category in which
such co-development is likely to occur.
DATES: Submit either electronic or
written comments by September 7,
2010.
ADDRESSES: Submit written comments
to the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Colleen L. Locicero, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 4200,
Silver Spring, MD 20993–0002, 301–
796–2270.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is aware of growing interest in
co-developing two or more distinct,
novel investigational drugs intended to
be used in combination to treat a disease
or condition (but not as fixed-dose
combinations under 21 CFR 300.50). At
a September 2009 conference co-hosted
by the ‘‘Friends of Cancer Research’’ in
partnership with the Engelberg Center
for Health Care Reform at the Brookings
Institution, and supported by the
American Society for Clinical Oncology
(ASCO), the American Association for
Cancer Research (AACR) Susan G.
Komen for the Cure, and the Lance
Armstrong Foundation (Brookings
Conference), which was attended by
FDA scientists, there was considerable
interest in approaches to developing
new oncology therapies intended to be
used in combination. In addition, on
April 30, 2010, FDA held a public
hearing in accordance with part 15 (21
CFR part 15) devoted, in part, to
obtaining information about study
designs and appropriate populations for
developing two or more novel, directacting antivirals intended to be used in
combination for the treatment of chronic
hepatitis C. FDA is also aware of efforts
to try to develop two or more
investigational drugs intended to be
used in combination to treat
tuberculosis. FDA is further aware of
general uncertainty about the
evidentiary requirements and regulatory
criteria applicable to such codevelopment efforts. Accordingly, FDA
is planning to develop generally
applicable guidance (not restricted to
oncology or any other specific
therapeutic category) to address
E:\FR\FM\08JNN1.SGM
08JNN1
Federal Register / Vol. 75, No. 109 / Tuesday, June 8, 2010 / Notices
methodologic and regulatory issues
related to the co-development of two or
more investigational drugs intended to
be used in combination.
emcdonald on DSK2BSOYB1PROD with NOTICES
II. Issues on Which FDA is Seeking
Comment
All material submitted to this docket
will be publicly available. To facilitate
development of guidance that
meaningfully addresses the concerns of
those who may co-develop drugs
intended to be used in combination,
FDA is seeking input on the following
issues, and any other issues relevant to
developing FDA guidance:
1. General methodologic and
regulatory issues that arise in the codevelopment of two or more drugs
intended to be used in combination
where the drugs are directed at
providing a therapeutic effect on the
same symptom or manifestation of the
disease or condition of interest,
including relevance and utility of
clinical or animal findings for either
drug alone;
2. General methodologic and
regulatory issues that arise in the codevelopment of two or more drugs
intended to be used in combination
where the drugs are directed at
providing a therapeutic effect for the
same disease or condition, but act on
different symptoms or manifestations of
that disease or condition, including
relevance and utility of clinical or
animal findings for either drug alone;
3. General methodologic and
regulatory issues that arise in the codevelopment of two or more drugs
intended to be used in combination
where one or more of the drugs is
intended to enhance the effectiveness of
the other, but one or more of the drugs
does not or may not have an
independent therapeutic effect,
including relevance and utility of
clinical or animal findings for either
drug alone; and
4. Methodologic and regulatory issues
that arise in the co-development of two
or more drugs intended to be used in
combination for specific therapeutic
categories, including oncology, antiinfectives, seizure disorders,
cardiovascular diseases, and any other
therapeutic category in which such codevelopment is likely to occur.
III. Submission of Comments
Interested parties may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necesary to send one set of
comments. It is no longer necessary to
send two copies of mailed comments.
Identify comments with the docket
VerDate Mar<15>2010
16:31 Jun 07, 2010
Jkt 220001
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: June 2, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–13769 Filed 6–7–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0128]
Prescription Drug User Fee Act;
Meetings on Reauthorization; Request
for Notification of Stakeholder
Intention to Participate
AGENCY:
Food and Drug Administration,
HHS.
ACTION: Notice; request for notification
of participation.
SUMMARY: The Food and Drug
Administration (FDA) is issuing this
notice to request that public
stakeholders—including patient and
consumer advocacy groups, health care
professionals, and scientific and
academic experts—notify FDA of their
intent to participate in periodic
consultation meetings on
reauthorization of the Prescription Drug
User Fee Act (PDUFA). The statutory
authority for PDUFA expires in
September 2012. At that time, new
legislation will be required for FDA to
continue collecting user fees for the
prescription drug program. The Federal
Food, Drug, and Cosmetic Act (the act)
requires that FDA consult with a range
of stakeholders in developing
recommendations for the next PDUFA
program. The act also requires that FDA
hold continued discussions with patient
and consumer advocacy groups at least
monthly during FDA’s negotiations with
the regulated industry. The purpose of
this request for notification is to ensure
continuity and progress in these
discussions by establishing consistent
stakeholder representation.
DATES: Submit notification of intention
to participate by June 25, 2010. The first
stakeholder meeting will be held on July
1, 2010, from 9 a.m. to 11 a.m.
Stakeholder discussions will continue at
least monthly during reauthorization
negotiations with the regulated
industry.
ADDRESSES: Submit notification of
intention to participate in monthly
stakeholder meetings by e-mail to
PO 00000
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Fmt 4703
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32483
PDUFAReauthorization@fda.hhs.gov.
The first stakeholder meeting will be
held at the FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31,
rm. 1503C, Silver Spring, MD 20993.
FOR FURTHER INFORMATION CONTACT:
Patrick Frey, Food and Drug
Administration, Center for Drug
Evaluation and Research, 10903 New
Hampshire Ave., Bldg. 51, rm. 1174,
Silver Spring, MD 20993, 301–796–
3844, FAX: 301–847–8443.
SUPPLEMENTARY INFORMATION:
I. Introduction
The authority for PDUFA expires in
September 2012. Without new
legislation to reauthorize the program,
FDA will no longer be able to collect
user fees to fund the human drug review
process. Section 736B(d)(1) (21 U.S.C.
379h-2(d)(1)) of the act requires that
FDA consult with a range of groups in
developing recommendations for the
next PDUFA program, including
scientific and academic experts, health
care professionals, and representatives
from patient and consumer groups. FDA
initiated this process of consultation on
April 12, 2010, by holding a public
meeting where stakeholders and other
members of the public were given an
opportunity to present their views on
reauthorization (75 FR 12555, March 16,
2010). This meeting and written
comments submitted to the docket have
provided critical input as the Agency
prepares for reauthorization
discussions. Section 736B(d)(3) of the
act further requires that FDA continue
meeting with these stakeholders at least
once every month during negotiations
with the regulated industry to continue
discussions of their views on the
reauthorization, including suggested
changes to the PDUFA program.
FDA is issuing this Federal Register
notice to request that stakeholders—
including patient and consumer
advocacy groups, health care
professionals, and scientific and
academic experts—notify FDA of their
intent to participate in periodic
consultation meetings on
reauthorization of PDUFA. FDA believes
that consistent stakeholder
representation at these meetings will be
important to ensuring progress in these
discussions. If you wish to participate in
this part of the reauthorization process,
please designate one or more
representatives from your organization
who will commit to attending these
meetings and preparing for the
discussions as needed. Stakeholders
who identify themselves through this
notice will be included in all future
stakeholder discussions while FDA
E:\FR\FM\08JNN1.SGM
08JNN1
]]>Agencies
[Federal Register Volume 75, Number 109 (Tuesday, June 8, 2010)]
[Notices]
[Pages 32482-32483]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-13769]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0247]
Investigational New Drug Applications; Co-development of
Investigational Drugs
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; establishment of docket; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is establishing a
public docket to obtain input on methods to co-develop two or more
distinct investigational drugs intended to be used in combination to
treat a disease or condition. FDA is planning to develop guidance for
industry and other affected parties on the co-development of two or
more novel drugs intended to be used in combination (but not as not
fixed-dose combinations) and is seeking public input to identify the
affected parties' information needs concerning such co-development.
Accordingly, FDA is seeking comment on general methodologic and
regulatory issues that arise in various scenarios when co-developing
two or more investigational drugs intended to be used in combination.
FDA is also seeking comment on methodologic and regulatory issues when
co-developing two or more investigational drugs intended to be used in
combination for specific therapeutic areas, including oncology, anti-
infectives, seizure disorders, cardiovascular diseases, and any other
therapeutic category in which such co-development is likely to occur.
DATES: Submit either electronic or written comments by September 7,
2010.
ADDRESSES: Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Submit electronic comments to https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Colleen L. Locicero, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 4200, Silver Spring, MD 20993-0002, 301-
796-2270.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is aware of growing interest in co-developing two or more
distinct, novel investigational drugs intended to be used in
combination to treat a disease or condition (but not as fixed-dose
combinations under 21 CFR 300.50). At a September 2009 conference co-
hosted by the ``Friends of Cancer Research'' in partnership with the
Engelberg Center for Health Care Reform at the Brookings Institution,
and supported by the American Society for Clinical Oncology (ASCO), the
American Association for Cancer Research (AACR) Susan G. Komen for the
Cure, and the Lance Armstrong Foundation (Brookings Conference), which
was attended by FDA scientists, there was considerable interest in
approaches to developing new oncology therapies intended to be used in
combination. In addition, on April 30, 2010, FDA held a public hearing
in accordance with part 15 (21 CFR part 15) devoted, in part, to
obtaining information about study designs and appropriate populations
for developing two or more novel, direct-acting antivirals intended to
be used in combination for the treatment of chronic hepatitis C. FDA is
also aware of efforts to try to develop two or more investigational
drugs intended to be used in combination to treat tuberculosis. FDA is
further aware of general uncertainty about the evidentiary requirements
and regulatory criteria applicable to such co-development efforts.
Accordingly, FDA is planning to develop generally applicable guidance
(not restricted to oncology or any other specific therapeutic category)
to address
[[Page 32483]]
methodologic and regulatory issues related to the co-development of two
or more investigational drugs intended to be used in combination.
II. Issues on Which FDA is Seeking Comment
All material submitted to this docket will be publicly available.
To facilitate development of guidance that meaningfully addresses the
concerns of those who may co-develop drugs intended to be used in
combination, FDA is seeking input on the following issues, and any
other issues relevant to developing FDA guidance:
1. General methodologic and regulatory issues that arise in the co-
development of two or more drugs intended to be used in combination
where the drugs are directed at providing a therapeutic effect on the
same symptom or manifestation of the disease or condition of interest,
including relevance and utility of clinical or animal findings for
either drug alone;
2. General methodologic and regulatory issues that arise in the co-
development of two or more drugs intended to be used in combination
where the drugs are directed at providing a therapeutic effect for the
same disease or condition, but act on different symptoms or
manifestations of that disease or condition, including relevance and
utility of clinical or animal findings for either drug alone;
3. General methodologic and regulatory issues that arise in the co-
development of two or more drugs intended to be used in combination
where one or more of the drugs is intended to enhance the effectiveness
of the other, but one or more of the drugs does not or may not have an
independent therapeutic effect, including relevance and utility of
clinical or animal findings for either drug alone; and
4. Methodologic and regulatory issues that arise in the co-
development of two or more drugs intended to be used in combination for
specific therapeutic categories, including oncology, anti-infectives,
seizure disorders, cardiovascular diseases, and any other therapeutic
category in which such co-development is likely to occur.
III. Submission of Comments
Interested parties may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necesary 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: June 2, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-13769 Filed 6-7-10; 8:45 am]
BILLING CODE 4160-01-S
