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Active Ingredients Being Considered for Inclusion in an Over-the-Counter Monograph: Study Elements and Considerations; Draft Guidance for Industry; Availability, 23918-23920 [2018-10993]

Download as PDF 23918 Federal Register / Vol. 83, No. 100 / Wednesday, May 23, 2018 / Notices daltland on DSKBBV9HB2PROD with NOTICES 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– 2010–D–0509 for ‘‘Enforcement Policy— Over-the-Counter Sunscreen Drug Products Marketed Without an Approved Application; Guidance for Industry; Availability.’’ 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 VerDate Sep<11>2014 17:33 May 22, 2018 Jkt 244001 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.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.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 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: 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: policy for OTC sunscreen drug products marketed without an approved application. 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. This guidance is not subject to Executive Order 12866. I. Background 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 FDA is announcing the availability of a guidance for industry entitled ‘‘Enforcement Policy—OTC Sunscreen Drug Products Marketed Without an Approved Application.’’ This guidance applies to OTC sunscreen products marketed without approved applications and describes FDA’s approach to enforcement for these products until a final OTC sunscreen monograph becomes effective. This guidance finalizes a draft guidance that was issued under the same title on June 17, 2011 (76 FR 35665) and reflects FDA’s consideration of public comments on the draft guidance. 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 the enforcement PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 II. Paperwork Reduction Act of 1995 This 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) and under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501– 3520). The collections of information in 21 CFR 201.327 and 201.66, and 21 CFR part 330 have been approved under OMB control numbers 0910–0717, 0910–0340, and 0910–0688, respectively. III. Electronic Access Persons with access to the internet may obtain the guidance at either https:// www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or https:// www.regulations.gov. Dated: May 17, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–10994 Filed 5–22–18; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–D–1456] AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. 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 SUMMARY: E:\FR\FM\23MYN1.SGM 23MYN1 Federal Register / Vol. 83, No. 100 / Wednesday, May 23, 2018 / Notices consideration for inclusion in an overthe-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’’). daltland on DSKBBV9HB2PROD with NOTICES 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-theCounter Monograph: Study Elements and Considerations; Draft Guidance for Industry.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential VerDate Sep<11>2014 17:33 May 22, 2018 Jkt 244001 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.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.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 PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 23919 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-theCounter 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 E:\FR\FM\23MYN1.SGM 23MYN1 23920 Federal Register / Vol. 83, No. 100 / Wednesday, May 23, 2018 / Notices 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/Guidance ComplianceRegulatoryInformation/ 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Enhancement and Update of the National HIV Curriculum e-Learning Platform Health Resources and Services Administration (HRSA), Department of Health and Human Services. ACTION: Notice of a single source award. AGENCY: HRSA’s HIV/AIDS Bureau (HAB) intends to issue a single source award to the University of Washington for $300,000 for activities authorized under Section 2692(a) of the Public Health Service (PHS) Act as amended by the Ryan White HIV/AIDS Treatment Extension Act of 2009. This notice is subject to the appropriation of funds and is a contingency action taken to ensure that, should funds become available for this purpose, HRSA can award funds in a timely manner. Subject to the availability of funds and the University of Washington’s satisfactory performance, HAB will also issue non-competitive, single source awards of $300,000 each in fiscal years (FYs) 2019 to 2022. This will allow the University of Washington to update and enhance the National HIV Curriculum (NHC) and the electronic platform that daltland on DSKBBV9HB2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:33 May 22, 2018 Jkt 244001 supports it, and to keep pace with the latest HIV science, federal guidelines, and treatment protocols and practices for educating health professionals on the optimal care and treatment of people living with HIV over its four-year project period. FOR FURTHER INFORMATION CONTACT: Sherrillyn Crooks, Chief, HIV Education Branch, Office of Training and Capacity Development, HAB/HRSA, 5600 Fishers Lane, Room 9N110, Rockville, MD 20857, by email at scrooks@hrsa.gov or by phone at (301) 443–7662. SUPPLEMENTARY INFORMATION: Intended Recipient of the Award: The University of Washington. Period of Supplemental Funding: September 1, 2018–August 31, 2022. Funding Amount: Subject to the availability of appropriated funds, $300,000 each in FY 2018 to FY 2022. Authority: Section 2692(a) of the Public Health Service (PHS) Act (42 U.S.C. 300ff–111(a)) and section 2693 of the PHS Act, as amended by the Ryan White HIV/AIDS Treatment Extension Act of 2009 (Pub. L. 111–87). CFDA Number: 93.145. Justification: The Enhancement and Update of the National HIV Curriculum e-Learning Platform project responds to the need to update and enhance the NHC and the electronic platform that supports it, and to keep pace with the latest HIV science, federal guidelines, treatment protocols, and practices for educating health professionals on the optimal care and treatment of people living with HIV (PLWH). With the ultimate goal of addressing the shortage of health professionals who care for people living with or who are at risk for HIV (PLWH), the University of Washington convened a multidisciplinary panel of clinical and learning technology experts under the auspices of the AIDS Education and Training Centers Program network, to create the national HIV curriculum. Released in July 2017, this free, online curriculum targets multidisciplinary novice-to-expert health professionals, students, and faculty who treat or aspire to treat PLWH. As the developer and proprietor of the NHC, the University of Washington is the only entity suitable for receiving a single source award to accomplish the critical task of ensuring that the NHC remains a relevant and important tool to educate HIV care providers in the United States. Throughout the period of performance, the University of Washington will work in close coordination with recipients of awards under Notice of Funding Opportunity HRSA–18–045, Integrating the National PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 HIV Curriculum e-Learning Platform into Health Care Provider Professional Education. Recipients under HRSA–18– 045 will be collaborating with multiple health professions’ academic and training institutions to incorporate the NHC into their curricula, including activities to train and orient faculty on effective methods to integrate the NHC. Though the University of Washington will gather feedback on the NHC from a wide variety of users, a collaboration with recipients under HRSA–18–045 will facilitate consistent collection, in real time, of integration practices that are proving most effective, and discussion of recommendations for disseminating those practices. This collaboration will influence and inform enhancements to the NHC e-Learning platform and further HRSA’s goal to ensure that health professions academic and training institutions routinely use this state-of-the-art curriculum thus increasing the number of competent HIV treatment providers. Dated: May 17, 2018. George Sigounas, Administrator. [FR Doc. 2018–11033 Filed 5–22–18; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Notice of Correction Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS). ACTION: Notice; correction. AGENCY: HRSA is correcting a notice published in the September 26, 2017 issue of the Federal Register entitled Improving Care for Children and Youth—Incentive Prize. This correction amends the subject of the challenge and the timeline. Please note, however, that this correction notice, along with future updates, as needed and pursuant to recent changes to the applicable law, will be posted on challenge.gov and mchbgrandchallenges.hrsa.gov. FOR FURTHER INFORMATION CONTACT: Jessie Buerlein, Public Health Analyst, Maternal and Child Health Bureau, Health Resources and Services Administration, 5600 Fishers Lane, Rockville, MD 20852, jbuerlein@ hrsa.gov, 301–443–8931. SUMMARY: Correction In the Federal Register at 82 FR 44812 (September 26, 2017) please make the E:\FR\FM\23MYN1.SGM 23MYN1

Agencies

[Federal Register Volume 83, Number 100 (Wednesday, May 23, 2018)]
[Notices]
[Pages 23918-23920]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-10993]

-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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.gpo.gov/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

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