[Federal Register Volume 80, Number 208 (Wednesday, October 28, 2015)]
[Notices]
[Pages 66013-66014]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-27418]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-D-0142]
Nonclinical Safety Evaluation of Reformulated Drug Products and
Products Intended for Administration by an Alternate Route; Guidance
for Industry and Review Staff; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a guidance for industry and review staff entitled
``Nonclinical Safety Evaluation of Reformulated Drug Products and
Products Intended for Administration by an Alternate Route.'' The
guidance provides recommendations concerning the evaluation of the
nonclinical safety of reformulated drug products or products being used
by an alternate route. It is intended for use by interested individuals
in industry and reviewers within the Center for Drug Evaluation and
Research (CDER). The goals of this guidance are to foster and expedite
the development of reformulated drug products or the use of previously
approved drugs by alternate routes, communicate to industry current
CDER thoughts pertaining to safety data needed to support these drug
products, and increase uniformity within CDER on expectations for the
nonclinical development of reformulated drug products or products being
used by an alternate route. This guidance finalizes the draft guidance
of the same name published on March 7, 2008.
DATES: Submit either electronic or written comments on Agency guidances
at any time.
ADDRESSES: You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://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 http://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-2008-D-0142 for ``Nonclinical Safety Evaluation of Reformulated
Drug Products and Products Intended for Administration by an Alternate
Route; Guidance for Industry and Review Staff.'' Received comments will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at http://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 http://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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://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.
[[Page 66014]]
Submit written requests for single copies of this 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 20993-0002. 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.
FOR FURTHER INFORMATION CONTACT: Paul C. Brown, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg., 22, Rm. 6472, Silver Spring, MD 20993-0002, 301-
796-0856.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry and
review staff entitled ``Nonclinical Safety Evaluation of Reformulated
Drug Products and Products Intended for Administration by an Alternate
Route.'' This guidance provides recommendations regarding the
nonclinical evaluation of a new formulation containing a previously
approved drug substance and of a product proposed for use by an
alternate route of administration for which the product was not
previously approved.
Generally, nonclinical data support use of a drug product by a
particular route and also reflect the planned duration of use. Much of
the available nonclinical information used to support approval of the
initial formulation can be used to support the safety of additional
formulations assuming all legal rights to the information are met.
Information used to support an initial formulation, however, may not
always be sufficient to support such additional approvals because
changes in the formulation could produce a new toxicity. This is
particularly true if the drug product's route of administration is
different or the duration of use changes markedly. Therefore,
additional nonclinical studies might be recommended to ensure that the
toxicity of a new formulation is fully characterized.
This guidance provides general nonclinical considerations for all
reformulations or new routes of use and several route-specific
considerations. The considerations in this guidance can also be applied
to routes not specifically mentioned in the guidance.
This guidance finalizes the draft guidance of the same name
published on March 7, 2008. Changes to the guidance include the
addition of a recommendation that toxicology studies be conducted under
good laboratory practices, clarification that histopathology can be
limited in some cases to locally exposed tissues, the addition of a
reference to the International Conference on Harmonisation guidance for
industry entitled ``S10 Photosafety Evaluation of Pharmaceuticals,''
and other clarifications to the studies recommended for specific routes
such as dermal, ocular, and intranasal.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on nonclinical safety evaluation of
reformulated drug products and products intended for administration by
an alternate route. It does not establish any rights for any person and
is not binding on FDA or the public. You can use an alternative
approach if it satisfies the requirements of the applicable statutes
and regulations.
II. Electronic Access
Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.
Dated: October 21, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-27418 Filed 10-27-15; 8:45 am]
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