2022-24432. Sameness Evaluations in an Abbreviated New Drug Application-Active Ingredients; Draft Guidance for Industry; Availability  

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    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    The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Sameness Evaluations in an ANDA—Active Ingredients.” This guidance is intended to assist applicants preparing an abbreviated new drug application (ANDA) by providing recommendations on demonstrating sameness between the active ingredient in a proposed generic drug product and its reference listed drug (RLD).

    DATES:

    Submit either electronic or written comments on the draft guidance by January 9, 2023 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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-2022-D-0697 for “Sameness Evaluations in an ANDA—Active Ingredients.” 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.

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    FOR FURTHER INFORMATION CONTACT:

    Susan Levine, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1674, Silver Spring, MD 20993-0002, 240-402-7936.

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    SUPPLEMENTARY INFORMATION:

    I. Background

    FDA is announcing the availability of a draft guidance for industry entitled “Sameness Evaluations in an ANDA—Active Ingredients.” This guidance is intended to assist applicants preparing an ANDA by providing recommendations on demonstrating sameness between the active ingredient in a proposed generic drug product and its RLD as required under section 505(j)(2)(ii) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)(2)(ii)) and FDA's regulations at 21 CFR 314.94(a)(3)(i).

    The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) (Hatch-Waxman Amendments) created an approval pathway for generic drug products under which applicants can submit an ANDA under section 505(j) of the FD&C Act. An ANDA relies on the Agency's previous finding of safety and effectiveness for an RLD and, as a result, may be approved without submission of the same type and extent of information that is required for approval of a new drug application to establish the safety and effectiveness of the proposed product. Among other things, an ANDA must contain information to show that the active ingredient of the proposed generic drug product is the “same as” that of the RLD (21 U.S.C. 355(j)(2)(A)(ii); 21 CFR 314.94(a)(5)). FDA may not approve an ANDA unless the ANDA contains sufficient information to show that, among other things, the active ingredient is the same as that of the reference listed drug (21 CFR 314.127(a)(3)). Accordingly, the ANDA applicant is responsible for providing sufficient information to demonstrate that the proposed generic drug product is the “same as” the RLD with respect to the active ingredient. To assist prospective applicants in evaluating and demonstrating sameness, this guidance provides information on active ingredient sameness considerations.

    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 “Sameness Evaluations in an ANDA—Active Ingredients.” 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 0910-0001.

    III. Electronic Access

    Persons with access to the internet may obtain the draft guidance at https://www.fda.gov/​drugs/​guidance-compliance-regulatory-information/​guidances-drugs, https://www.fda.gov/​regulatory-information/​search-fda-guidance-documents, or https://www.regulations.gov.

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    Dated: November 3, 2022.

    Lauren K. Roth,

    Associate Commissioner for Policy.

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    [FR Doc. 2022-24432 Filed 11-8-22; 8:45 am]

    BILLING CODE 4164-01-P

Document Information

Published:
11/09/2022
Department:
Food and Drug Administration
Entry Type:
Notice
Action:
Notice of availability.
Document Number:
2022-24432
Dates:
Submit either electronic or written comments on the draft guidance by January 9, 2023 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
Pages:
67701-67702 (2 pages)
Docket Numbers:
Docket No. FDA-2022-D-0697
PDF File:
2022-24432.pdf
Supporting Documents:
» Sameness Evaluations in an Abbreviated New Drug Application—Active Ingredients; Draft Guidance for Industry; Availability
» Sameness Evaluations in an Abbreviated New Drug Application—Active Ingredients; Draft Guidance for Industry; Availability