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Active Ingredients Being Considered for Inclusion in an Over-the-Counter Monograph: Study Elements and Considerations; Draft Guidance for Industry; Availability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)
Food and Drug Administration
Federal Register Volume 83, Issue 100 (May 23, 2018)
| Page Range | 23918-23920 | |
| FR Document | 2018-10993 |
[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] ----------------------------------------------------------------------- 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Active Ingredients Being Considered for Inclusion in an Over-the-Counter Monograph: Study Elements and Considerations; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Maximal Usage Trials for Topical Active Ingredients Being Considered for Inclusion in an Over-the-Counter Monograph: Study Elements and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 This draft guidance addresses FDA's current thinking on the conduct of in vivo absorption trials for topical active ingredients that are under [[Page 23919]] consideration for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 DATES: Submit either electronic or written comments on the draft guidance by July 23, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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.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
![23918 Federal Register / Vol. 83, No. 100 / Wednesday, May 23, 2018 / Notices
confidential business information, such must identify this information as policy for OTC sunscreen drug products
as a manufacturing process. Please note ‘‘confidential.’’ Any information marked marketed without an approved
that if you include your name, contact as ‘‘confidential’’ will not be disclosed application. It does not establish any
information, or other information that except in accordance with 21 CFR 10.20 rights for any person and is not binding
identifies you in the body of your and other applicable disclosure law. For on FDA or the public. You can use an
comments, that information will be more information about FDA’s posting alternative approach if it satisfies the
posted on https://www.regulations.gov. of comments to public dockets, see 80 requirements of the applicable statutes
• If you want to submit a comment FR 56469, September 18, 2015, or access and regulations. This guidance is not
with confidential information that you the information at: https://www.gpo.gov/ subject to Executive Order 12866.
do not wish to be made available to the fdsys/pkg/FR-2015-09-18/pdf/2015-
public, submit the comment as a II. Paperwork Reduction Act of 1995
23389.pdf.
written/paper submission and in the Docket: For access to the docket to This guidance refers to previously
manner detailed (see ‘‘Written/Paper read background documents or the approved collections of information
Submissions’’ and ‘‘Instructions’’). electronic and written/paper comments found in FDA regulations. These
Written/Paper Submissions received, go to https:// collections of information are subject to
www.regulations.gov and insert the review by the Office of Management and
Submit written/paper submissions as docket number, found in brackets in the Budget (OMB) and under the Paperwork
follows: heading of this document, into the Reduction Act of 1995 (44 U.S.C. 3501–
• Mail/Hand delivery/Courier (for 3520). The collections of information in
‘‘Search’’ box and follow the prompts
written/paper submissions): Dockets 21 CFR 201.327 and 201.66, and 21 CFR
and/or go to the Dockets Management
Management Staff (HFA–305), Food and part 330 have been approved under
Staff, 5630 Fishers Lane, Rm. 1061,
Drug Administration, 5630 Fishers OMB control numbers 0910–0717,
Rockville, MD 20852.
Lane, Rm. 1061, Rockville, MD 20852. 0910–0340, and 0910–0688,
• For written/paper comments You may submit comments on any
guidance at any time (see 21 CFR respectively.
submitted to the Dockets Management
Staff, FDA will post your comment, as 10.115(g)(5)). III. Electronic Access
well as any attachments, except for Submit written requests for single
copies of this guidance to the Division Persons with access to the internet
information submitted, marked and may obtain the guidance at either http://
identified, as confidential, if submitted of Drug Information, Center for Drug
Evaluation and Research, Food and www.fda.gov/Drugs/Guidance
as detailed in ‘‘Instructions.’’ ComplianceRegulatoryInformation/
Instructions: All submissions received Drug Administration, 10001 New
Hampshire Ave., Hillandale Building, Guidances/default.htm or https://
must include the Docket No. FDA–
4th Floor, Silver Spring, MD 20993– www.regulations.gov.
2010–D–0509 for ‘‘Enforcement Policy—
Over-the-Counter Sunscreen Drug 0002. Send one self-addressed adhesive Dated: May 17, 2018.
Products Marketed Without an label to assist that office in processing Leslie Kux,
Approved Application; Guidance for your requests. See the SUPPLEMENTARY Associate Commissioner for Policy.
Industry; Availability.’’ Received INFORMATION section for electronic
[FR Doc. 2018–10994 Filed 5–22–18; 8:45 am]
comments will be placed in the docket access to the guidance document.
BILLING CODE 4164–01–P
and, except for those submitted as FOR FURTHER INFORMATION CONTACT:
‘‘Confidential Submissions,’’ publicly Kristen Hardin, Center for Drug
viewable at https://www.regulations.gov Evaluation and Research, Food and DEPARTMENT OF HEALTH AND
or at the Dockets Management Staff Drug Administration, 10903 New HUMAN SERVICES
between 9 a.m. and 4 p.m., Monday Hampshire Ave., Bldg. 22, Rm. 5443,
through Friday. Silver Spring, MD 20993–0002, 240– Food and Drug Administration
• Confidential Submissions—To 402–4246.
submit a comment with confidential [Docket No. FDA–2018–D–1456]
SUPPLEMENTARY INFORMATION:
information that you do not wish to be
I. Background Maximal Usage Trials for Topical
made publicly available, submit your
Active Ingredients Being Considered
comments only as a written/paper FDA is announcing the availability of
for Inclusion in an Over-the-Counter
submission. You should submit two a guidance for industry entitled
Monograph: Study Elements and
copies total. One copy will include the ‘‘Enforcement Policy—OTC Sunscreen
Considerations; Draft Guidance for
information you claim to be confidential Drug Products Marketed Without an
Industry; Availability
with a heading or cover note that states Approved Application.’’ This guidance
‘‘THIS DOCUMENT CONTAINS applies to OTC sunscreen products AGENCY: Food and Drug Administration,
CONFIDENTIAL INFORMATION.’’ The marketed without approved HHS.
Agency will review this copy, including applications and describes FDA’s ACTION: Notice of availability.
the claimed confidential information, in approach to enforcement for these
its consideration of comments. The products until a final OTC sunscreen SUMMARY: The Food and Drug
second copy, which will have the monograph becomes effective. This Administration (FDA or Agency) is
claimed confidential information guidance finalizes a draft guidance that announcing the availability of a draft
redacted/blacked out, will be available was issued under the same title on June guidance for industry entitled ‘‘Maximal
for public viewing and posted on 17, 2011 (76 FR 35665) and reflects Usage Trials for Topical Active
daltland on DSKBBV9HB2PROD with NOTICES
https://www.regulations.gov. Submit FDA’s consideration of public Ingredients Being Considered for
both copies to the Dockets Management comments on the draft guidance. Inclusion in an Over-the-Counter
Staff. If you do not wish your name and This guidance is being issued Monograph: Study Elements and
contact information to be made publicly consistent with FDA’s good guidance Considerations.’’ This draft guidance
available, you can provide this practices regulation (21 CFR 10.115). addresses FDA’s current thinking on the
information on the cover sheet and not The guidance represents the current conduct of in vivo absorption trials for
in the body of your comments and you thinking of FDA on the enforcement topical active ingredients that are under
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![23920 Federal Register / Vol. 83, No. 100 / Wednesday, May 23, 2018 / Notices
the requirements of the applicable supports it, and to keep pace with the HIV Curriculum e-Learning Platform
statutes and regulations. This guidance latest HIV science, federal guidelines, into Health Care Provider Professional
is not subject to Executive Order 12866. and treatment protocols and practices Education. Recipients under HRSA–18–
for educating health professionals on 045 will be collaborating with multiple
II. Paperwork Reduction Act of 1995
the optimal care and treatment of people health professions’ academic and
This draft guidance contains living with HIV over its four-year training institutions to incorporate the
collections of information that are project period. NHC into their curricula, including
exempt from the Paperwork Reduction FOR FURTHER INFORMATION CONTACT: activities to train and orient faculty on
Act of 1995 (PRA) (44 U.S.C. 3501– Sherrillyn Crooks, Chief, HIV Education effective methods to integrate the NHC.
3520). Section 586D(a)(1)(C) of the Branch, Office of Training and Capacity Though the University of Washington
Federal Food, Drug, and Cosmetic Act Development, HAB/HRSA, 5600 Fishers will gather feedback on the NHC from
(21 U.S.C. 360fff–4(a)(1)(C)) as amended Lane, Room 9N110, Rockville, MD a wide variety of users, a collaboration
by the Sunscreen Innovation Act states 20857, by email at scrooks@hrsa.gov or with recipients under HRSA–18–045
that the PRA shall not apply to by phone at (301) 443–7662. will facilitate consistent collection, in
collections of information made for real time, of integration practices that
SUPPLEMENTARY INFORMATION:
purposes of guidance under that are proving most effective, and
Intended Recipient of the Award: The
subsection. discussion of recommendations for
University of Washington.
disseminating those practices. This
III. Electronic Access Period of Supplemental Funding:
collaboration will influence and inform
Persons with access to the internet September 1, 2018–August 31, 2022.
enhancements to the NHC e-Learning
may obtain the draft guidance at either Funding Amount: Subject to the
platform and further HRSA’s goal to
https://www.fda.gov/Drugs/Guidance availability of appropriated funds,
ensure that health professions academic
ComplianceRegulatoryInformation/ $300,000 each in FY 2018 to FY 2022.
Authority: Section 2692(a) of the and training institutions routinely use
Guidances/default.htm or https:// this state-of-the-art curriculum thus
www.regulations.gov. Public Health Service (PHS) Act (42
U.S.C. 300ff–111(a)) and section 2693 of increasing the number of competent HIV
Dated: May 17, 2018. the PHS Act, as amended by the Ryan treatment providers.
Leslie Kux, White HIV/AIDS Treatment Extension Dated: May 17, 2018.
Associate Commissioner for Policy. Act of 2009 (Pub. L. 111–87). George Sigounas,
[FR Doc. 2018–10993 Filed 5–22–18; 8:45 am] CFDA Number: 93.145. Administrator.
BILLING CODE 4164–01–P Justification: The Enhancement and [FR Doc. 2018–11033 Filed 5–22–18; 8:45 am]
Update of the National HIV Curriculum BILLING CODE 4165–15–P
e-Learning Platform project responds to
DEPARTMENT OF HEALTH AND the need to update and enhance the
HUMAN SERVICES NHC and the electronic platform that DEPARTMENT OF HEALTH AND
supports it, and to keep pace with the HUMAN SERVICES
Health Resources and Services latest HIV science, federal guidelines,
Administration treatment protocols, and practices for Health Resources and Services
educating health professionals on the Administration
Enhancement and Update of the optimal care and treatment of people
National HIV Curriculum e-Learning living with HIV (PLWH). With the Notice of Correction
Platform ultimate goal of addressing the shortage AGENCY: Health Resources and Services
AGENCY: Health Resources and Services of health professionals who care for Administration (HRSA), Department of
Administration (HRSA), Department of people living with or who are at risk for Health and Human Services (HHS).
Health and Human Services. HIV (PLWH), the University of ACTION: Notice; correction.
ACTION: Notice of a single source award. Washington convened a
multidisciplinary panel of clinical and SUMMARY: HRSA is correcting a notice
SUMMARY: HRSA’s HIV/AIDS Bureau learning technology experts under the published in the September 26, 2017
(HAB) intends to issue a single source auspices of the AIDS Education and issue of the Federal Register entitled
award to the University of Washington Training Centers Program network, to Improving Care for Children and
for $300,000 for activities authorized create the national HIV curriculum. Youth—Incentive Prize. This correction
under Section 2692(a) of the Public Released in July 2017, this free, online amends the subject of the challenge and
Health Service (PHS) Act as amended by curriculum targets multidisciplinary the timeline. Please note, however, that
the Ryan White HIV/AIDS Treatment novice-to-expert health professionals, this correction notice, along with future
Extension Act of 2009. This notice is students, and faculty who treat or aspire updates, as needed and pursuant to
subject to the appropriation of funds to treat PLWH. As the developer and recent changes to the applicable law,
and is a contingency action taken to proprietor of the NHC, the University of will be posted on challenge.gov and
ensure that, should funds become Washington is the only entity suitable mchbgrandchallenges.hrsa.gov.
available for this purpose, HRSA can for receiving a single source award to FOR FURTHER INFORMATION CONTACT:
award funds in a timely manner. accomplish the critical task of ensuring Jessie Buerlein, Public Health Analyst,
Subject to the availability of funds that the NHC remains a relevant and Maternal and Child Health Bureau,
and the University of Washington’s important tool to educate HIV care Health Resources and Services
daltland on DSKBBV9HB2PROD with NOTICES
satisfactory performance, HAB will also providers in the United States. Administration, 5600 Fishers Lane,
issue non-competitive, single source Throughout the period of Rockville, MD 20852, jbuerlein@
awards of $300,000 each in fiscal years performance, the University of hrsa.gov, 301–443–8931.
(FYs) 2019 to 2022. This will allow the Washington will work in close
University of Washington to update and coordination with recipients of awards Correction
enhance the National HIV Curriculum under Notice of Funding Opportunity In the Federal Register at 82 FR 44812
(NHC) and the electronic platform that HRSA–18–045, Integrating the National (September 26, 2017) please make the
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Document Created: 2018-05-22 23:48:39
Document Modified: 2018-05-22 23:48:39
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability. | |
| 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. | |
| 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. | |
| FR Citation | 83 FR 23918 |
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