83 FR 23918 - Maximal Usage Trials for Topical Active Ingredients Being Considered for Inclusion in an Over-the-Counter Monograph: Study Elements and Considerations; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 100 (May 23, 2018)

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Maximal Usage Trials for Topical Active Ingredients Being Considered for Inclusion in an Over-the-Counter Monograph: Study Elements and Considerations.'' This draft guidance addresses FDA's current thinking on the conduct of in vivo absorption trials for topical active ingredients that are under consideration for inclusion in an over-the-counter (OTC) monograph.

[Federal Register Volume 83, Number 100 (Wednesday, May 23, 2018)]
[Notices]
[Pages 23918-23920]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-10993]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-1456]


Maximal Usage Trials for Topical Active Ingredients Being 
Considered for Inclusion in an Over-the-Counter Monograph: Study 
Elements and Considerations; Draft Guidance for Industry; Availability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the availability of a draft guidance for industry entitled ``Maximal 
Usage Trials for Topical Active Ingredients Being Considered for 
Inclusion in an Over-the-Counter Monograph: Study Elements and 
Considerations.'' This draft guidance addresses FDA's current thinking 
on the conduct of in vivo absorption trials for topical active 
ingredients that are under

[[Page 23919]]

consideration for inclusion in an over-the-counter (OTC) monograph.

DATES: Submit either electronic or written comments on the draft 
guidance by July 23, 2018 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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-2018-D-1456 for ``Maximal Usage Trials for Topical Active 
Ingredients Being Considered for Inclusion in an Over-the-Counter 
Monograph: Study Elements and Considerations; Draft Guidance for 
Industry.'' 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.thefederalregister.org/fdsys/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: Kristen Hardin, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 5443, Silver Spring, MD 20993-0002, 240-
402-4246.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Maximal Usage Trials for Topical Active Ingredients Being 
Considered for Inclusion in an Over-the-Counter Monograph: Study 
Elements and Considerations.'' This draft guidance addresses the 
current thinking of FDA on the conduct of in vivo absorption trials for 
topical active ingredients that are under consideration for inclusion 
in an OTC monograph. A Maximal Usage Trial (MUsT) is a standard 
approach to assessing the in vivo bioavailability of topical drug 
products. The methodology described in this draft guidance adapts MUsT 
principles for active ingredients being considered for inclusion in an 
OTC monograph. Because information from a MUsT can help identify the 
potential for systemic exposure to a topically applied active 
ingredient, such information can help inform an FDA determination of 
whether additional safety data are needed to support a finding that an 
OTC drug containing that active ingredient is generally recognized as 
safe and effective for its intended use.
    This draft guidance was written in response to comments submitted 
to Docket No. FDA-2015-D-4021 for the draft guidance entitled ``Over-
the-Counter Sunscreens: Safety and Effectiveness Data'' (80 FR 72975, 
November 23, 2015) and the final guidance that replaced it, entitled 
``Nonprescription Sunscreen Drug Products--Safety and Effectiveness 
Data'' (81 FR 84594, November 23, 2016), requesting that FDA provide 
further guidance and details on the MUsT. It provides additional 
information on the study elements, data analysis, and considerations 
when designing a MUsT for a topical active ingredient being considered 
for inclusion in an OTC monograph.
    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 ``Maximal 
Usage Trials for Topical Active Ingredients Being Considered for 
Inclusion in an Over-the-Counter Monograph: Study Elements and 
Considerations.'' 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

[[Page 23920]]

the requirements of the applicable statutes and regulations. This 
guidance is not subject to Executive Order 12866.

II. Paperwork Reduction Act of 1995

    This draft guidance contains collections of information that are 
exempt from the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-
3520). Section 586D(a)(1)(C) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360fff-4(a)(1)(C)) as amended by the Sunscreen 
Innovation Act states that the PRA shall not apply to collections of 
information made for purposes of guidance under that subsection.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or 
https://www.regulations.gov.

    Dated: May 17, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-10993 Filed 5-22-18; 8:45 am]
 BILLING CODE 4164-01-P