Forms FDA 3542a and FDA 3542: Questions and Answers; Draft Guidance for Industry; Availability

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Use the PDF linked in the document sidebar for the official electronic format. 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 SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry titled “Forms FDA 3542a and FDA 3542: Questions and Answers.” This draft guidance is intended to answer commonly asked questions regarding Forms FDA 3542a and FDA 3542, and to assist applicants in preparing and submitting these forms to FDA. DATES: Submit either electronic or written comments on the draft guidance by August 14, 2026 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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: ( printed page 35986) 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”). 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-2026-D-2698 for “Forms FDA 3542a and FDA 3542: Questions and Answers.” 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, 240-402-7500. 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, 240-402-7500. 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: Rachel Erdman, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Rm. 1715, Silver Spring, MD 20993-0002, 301-651-8301. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled “Forms FDA 3542a and FDA 3542: Questions and Answers.” This guidance is intended to assist New Drug Application (NDA) applicants and NDA holders in submitting patent information to their NDA using the appropriate forms, Form FDA 3542a or Form FDA 3542, under 21 CFR 314.53(d). This guidance provides answers to commonly asked questions regarding Forms FDA 3542a and FDA 3542. Section 505(b)(1)(A)(viii) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(b)(1)(A)(viii)) requires an NDA applicant to submit, as part of its NDA, certain information for “each patent for which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner of the patent engaged in the manufacture, use, or sale of the drug, and that—(I) claims the drug for which the applicant submitted the application and is a drug substance (active ingredient) patent or a drug product (formulation or composition) patent; or (II) claims a method of using such drug for which approval is sought . . . in the application.” Section 505(c)(2) of the FD&C Act (21 U.S.C. 355(c)(2)) requires an NDA holder to submit, no later than 30 days after the date of approval, certain information for “each patent for which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner of the patent engaged in the manufacture, use, or sale of the drug, and that—(I) claims the drug for which the applicant submitted the application and is a drug substance (active ingredient) patent or a drug product (formulation or composition) patent; or (II) claims a method of using such drug for which approval . . . has been granted in the application.” Section 505(c)(2) further requires that “a patent that is identified as claiming a method of using such drug shall be filed only if the patent claims a method of use approved in the application.” Form FDA 3542a must be used when an NDA applicant submits information on a patent that claims a drug substance (active ingredient), drug product (formulation or composition), or method of using the drug that is the subject of an unapproved original NDA, amendment to an NDA, or supplement to an NDA. Form FDA 3542 must be used when an NDA holder submits information on a patent that claims a drug substance (active ingredient), drug product (formulation or composition), or method of using the drug to that is the subject of an approved NDA or approved supplement to an NDA. (see 21 CFR 314.53(c)). This draft guidance provides answers to questions that have been received regarding Forms FDA 3542a and FDA ( printed page 35987) 3542. The questions and answers are divided into three topics: (1) Obtaining and Filling out Forms FDA 3542a and FDA 3542, (2) Section 6 of Forms FDA 3542a and FDA 3542 (“Declaration Certification”), and (3) Submitting Patent Information to FDA. 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 “Forms FDA 3542a and FDA 3542: Questions and Answers.” 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. As we develop final guidance on this topic, FDA will consider comments on costs or cost savings the guidance may generate, relevant for Executive Order 14192. II. Paperwork Reduction Act of 1995 While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. The previously approved collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information relating to the submission of NDAs under 21 CFR 314 have been approved under OMB control number 0910-0001. The collections of information from Form FDA 356h have been approved under OMB control number 0910-0001.