[Federal Register Volume 85, Number 46 (Monday, March 9, 2020)]
[Notices]
[Pages 13657-13659]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-04753]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-D-0043]
Contact Dermatitis From Topical Drug Products for Cutaneous
Application: Human Safety Assessment; Draft Guidance for Industry;
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the availability of a draft guidance for industry entitled ``Contact
Dermatitis From Topical Drug Products for Cutaneous Application: Human
Safety Assessment.'' This draft guidance provides recommendations for
the characterization, during product development, of local safety of
topical drug products regarding the risk for contact dermatitis. These
recommendations are specifically directed to development of topical new
drug products intended for cutaneous application.
DATES: Submit either electronic or written comments on the draft
guidance
[[Page 13658]]
by May 8, 2020 to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance.
ADDRESSES: You may submit comments on any guidance at any time 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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, 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-2020-D-0043 for ``Contact Dermatitis From Topical Drug Products for
Cutaneous Application: Human Safety Assessment.'' Received comments
will be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 Dockets Management Staff. 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.govinfo.gov/content/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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
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 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT: Jennifer Harmon, Center for Drug
Evaluation and Research (HFD-540), Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 22, Rm. 5239, Silver Spring, MD 20993; 240-
402-4880.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Contact Dermatitis From Topical Drug Products for Cutaneous
Application: Human Safety Assessment.''
Historically, FDA requested sponsors of new topical drug products
to characterize local safety with regard to cutaneous irritation,
sensitization, phototoxicity, and photoallergy (the latter two only for
products that absorb ultraviolet radiation at relevant wavelengths)
through the conduct of dedicated ``dermal safety studies.'' These
studies were conducted in healthy volunteers by repeated application of
the drug product under occlusion on the skin of the back or upper arm.
The studies are considered provocative in that the test condition of
occlusion is used to evoke the adverse reaction at a greater rate than
might be observed under labeled conditions of use.
The Division of Dermatology and Dental Products (DDDP) became
concerned that these provocative studies, conducted under augmented
conditions, were not informative for drug development, did not provide
information that was useful for labeling, and induced adverse reactions
in study subjects that might result in permanent harm. DDDP convened a
scientific workshop in September 2018 during which outside experts
provided input on the utility of these studies for development of new
topical drugs. The consensus of the workshop was that the dedicated
dermal safety studies, previously requested by FDA, were not needed to
evaluate local cutaneous safety of topical new drug products.
DDDP intends to publish this draft guidance to inform sponsors of
new topical drug products intended for cutaneous application of our
recommendations for evaluating local (cutaneous) safety of topical drug
products with regard to contact dermatitis. These recommendations will
be specifically directed to developing topical new drug products; the
draft guidance will not address over-the-counter drugs under monograph,
generic drugs, or nondrug cosmetic products or ingredients.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Contact
Dermatitis From Topical Drug Products for Cutaneous Application: Human
Safety Assessment.'' It does not establish any rights for any person
and is not binding
[[Page 13659]]
on FDA or the public. You can use an alternative approach if it
satisfies the requirements of the applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
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 parts 312 and 314 have been
approved under OMB control numbers 0910-0014 and 0910-0001,
respectively.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs or https://www.regulations.gov.
Dated: March 2, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-04753 Filed 3-6-20; 8:45 am]
BILLING CODE 4164-01-P