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Federal Register / Vol. 86, No. 125 / Friday, July 2, 2021 / Notices
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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 HFA305, 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
2020D2323 for Assessment of Adhesion for Topical and Transdermal Systems Submitted in New Drug Applications. 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, 2404027500.
Confidential SubmissionsTo 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 FDAs 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-201509-18/pdf/2015-23389.pdf.

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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, 2404027500.
You may submit comments on any guidance at any time see 21 CFR
10.115g5.
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:
Margaret Kober, Center for Drug Evaluation and Research HFD580, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 22, Rm.
5376, Silver Spring, MD 209930002, 3017960934.
SUPPLEMENTARY INFORMATION:
I. Background FDA is announcing the availability of a draft guidance for industry entitled Assessment of Adhesion for Topical and Transdermal Systems Submitted in New Drug Applications. This draft guidance provides recommendations on the clinical assessment of the adhesive properties of topical and transdermal delivery systems collectively referred to as TDS intended for submission in an NDA or supplemental NDA. The amount of drug delivered into and through the patients skin from a TDS is dependent, in part, on the ability of the TDS to remain in direct contact with the skin adhesive properties. Adhesive properties are clinically important as a loss of TDS adhesion during wear can reduce the amount of drug delivered to the patient, potentially compromising effectiveness. Additionally, partial or full detachment of a TDS from a patients skin may result in unintentional exposure of the drug to others, potentially compromising safety.
This draft guidance includes key considerations for the design of the TDS
adhesion clinical study, including the selection of endpoints and FDAs current thinking on acceptable adhesion performance in the in vivo setting.
This draft guidance is being issued consistent with FDAs good guidance
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practices regulation 21 CFR 10.115.
The draft guidance, when finalized, will represent the current thinking of FDA
on Assessment of Adhesion for Topical and Transdermal Systems Submitted in New Drug Applications and will supersede in vivo recommendations in section V., Special Topics in the draft guidance for industry Transdermal and Topical Delivery SystemsProduct Development and Quality Considerations issued on November 21, 2019 84 FR 64319. 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. Paperwork Reduction Act of 1995
While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. Therefore, clearance by the Office of Management and Budget OMB under the Paperwork Reduction Act of 1995 PRA 44 U.S.C. 3501
3521 is not required for this guidance.
The previously approved collections of information are subject to review by OMB under the PRA. The collections of information in 21 CFR part 314 have been approved under OMB control number 09100001, and the collections of information for the electronic submission of drug establishment registration and drug listing information have been approved under OMB control number 09100045.
III. Electronic Access Persons with access to the internet may obtain the draft guidance at either https www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs or https
www.regulations.gov.
Dated: June 28, 2021.
Lauren K. Roth, Acting Principal Associate Commissioner for Policy.
FR Doc. 202114202 Filed 7121; 8:45 am BILLING CODE 416401P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration Docket No. FDA2020D0938

Evaluating Cancer Drugs in Patients With Central Nervous System Metastases; Guidance for Industry;
Availability AGENCY:

Food and Drug Administration,
HHS.

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