Skip to Content

We invite you to try out our new beta eCFR site at https://ecfr.federalregister.gov. We’ve made big changes to make the eCFR easier to use. Be sure to leave feedback using the 'Feedback' button on the bottom right of each page!

Notice

The “Deemed To Be a License” Provision of the Biologics Price Competition and Innovation Act: Questions and Answers; Guidance for Industry; Availability

Document Details

Information about this document as published in the Federal Register.

Document Statistics
Document page views are updated periodically throughout the day and are cumulative counts for this document. Counts are subject to sampling, reprocessing and revision (up or down) throughout the day.
Enhanced Content

Relevant information about this document from Regulations.gov provides additional context. This information is not part of the official Federal Register document.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Start Preamble

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 final guidance for industry entitled “The `Deemed To Be a License' Provision of the BPCI Act: Questions and Answers.” This guidance is intended to provide answers to common questions about FDA's implementation of the statutory provision under which an application for a biological product approved under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as of March 23, 2020, will be deemed to be a license for the biological product under the Public Health Service Act (PHS Act) on March 23, 2020. This guidance also describes FDA's compliance policy for the labeling of biological products that will be the subject of deemed biologics license applications (BLAs). This guidance is intended to facilitate planning for the March 23, 2020, transition date and provide further clarity regarding the Agency's implementation of this statutory provision. This guidance finalizes the draft guidance of the same title issued on December 12, 2018.

DATES:

The announcement of the guidance is published in the Federal Register on March 5, 2020.

ADDRESSES:

You may submit either electronic or written comments on Agency guidances 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-2015-D-4750 for “The `Deemed To Be a License' Provision of the BPCI Act: 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.

  • 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 Start Printed Page 12931“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.

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.

Start Further Info

FOR FURTHER INFORMATION CONTACT:

Janice Weiner, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6270, Silver Spring, MD 20993-0002, 301-796-3475, Janice.Weiner@fda.hhs.gov; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7268, Silver Spring, MD 20993-0002, 240-402-7911, Stephen.Ripley@fda.hhs.gov.

End Further Info End Preamble Start Supplemental Information

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a guidance for industry entitled “The `Deemed to be a License' Provision of the BPCI Act: Questions and Answers.” This guidance is intended to provide answers to common questions about FDA's implementation of the “transition” provision of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) under which an application for a biological product approved under section 505 of the FD&C Act (21 U.S.C. 355) as of March 23, 2020, will be deemed to be a license for the biological product under section 351 of the PHS Act (42 U.S.C. 262) on March 23, 2020 (“the transition date”). This guidance also describes FDA's compliance policy for the labeling of biological products that will be the subject of deemed BLAs. This guidance is intended to facilitate planning for the transition date and provide further clarity regarding the Agency's implementation of this statutory provision.

Although the majority of therapeutic biological products have been licensed under section 351 of the PHS Act, some protein products historically have been approved under section 505 of the FD&C Act. On March 23, 2010, the BPCI Act was enacted as part of the Patient Protection and Affordable Care Act (Pub. L. 111-148). The BPCI Act clarified the statutory authority under which certain protein products will be regulated by amending the definition of a “biological product” in section 351(i) of the PHS Act to include a “protein (except any chemically synthesized polypeptide),” and describing procedures for submission of a marketing application for certain “biological products.” Section 605 of the Further Consolidated Appropriations Act, 2020 (Pub. L. 116-94), further amended the definition of a “biological product” in section 351(i) of the PHS Act to remove the parenthetical “(except any chemically synthesized polypeptide)” from the statutory category of “protein.” In the Federal Register of February 21, 2020, FDA issued a final rule that amends its regulation that defines “biological product” to incorporate changes made by the BPCI Act and the Further Consolidated Appropriations Act, 2020, and to provide its interpretation of the statutory term “protein” (85 FR 10057). This rule is effective on March 23, 2020. FDA also has previously stated its interpretation of the statutory term “protein” in the amended definition of “biological product” (see FDA's draft guidance for industry entitled “New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2)” (December 2018), available on FDA's website at https://www.fda.gov/​drugs/​guidance-compliance-regulatory-information/​guidances-drugs (“Biosimilar Q&A Draft Guidance”)).[1]

The BPCI Act requires that a marketing application for a “biological product” (that previously could have been submitted under section 505 of the FD&C Act) must be submitted under section 351 of the PHS Act; this requirement is subject to certain exceptions during a 10-year transition period ending on March 23, 2020 (see section 7002(e)(1) to (3) and (e)(5) of the BPCI Act). On March 23, 2020, an approved application for a biological product under section 505 of the FD&C Act shall be deemed to be a license for the biological product under section 351 of the PHS Act (see section 7002(e)(4) of the BPCI Act).[2]

In the Federal Register of December 12, 2018 (83 FR 63894), FDA invited comment on the preliminary list of approved applications for biological products under the FD&C Act that will be affected by the transition provision (“Preliminary List”) (available on FDA's website at https://www.fda.gov/​drugs/​guidance-compliance-regulatory-information/​deemed-be-license-provision-bpci-act). FDA explained that if an application holder or other person believes that an approved new drug application (NDA) should be added to the list or should not be included on the list, the application holder or other person should submit a comment to the public docket established for this Q&A guidance and the list. FDA posted updates to the Preliminary List on September 23, 2019, and January 15, 2020.

In the Federal Register of December 12, 2018, FDA also invited comment on the factors that FDA should consider in determining whether a combination product composed of a biological product constituent part and a drug constituent part will be subject to the transition provision. However, FDA did not receive any substantive comments on this topic. The current Preliminary List includes a small number of drug-biologic combination products and complex mixtures assigned to the Center for Drug Evaluation and Research, which reflects the Agency's current thinking that the approved NDAs for these products are appropriately subject Start Printed Page 12932to the transition provision. FDA's evaluation of each of these approved NDAs for drug-biologic combination products or complex mixtures was informed by a general consideration of the factors used to determine the appropriate marketing application type for antibody-drug conjugates (see FDA's guidance for industry entitled “Questions and Answers on Biosimilar Development and the BPCI Act” (December 2018), available on FDA's website at https://www.fda.gov/​drugs/​guidance-compliance-regulatory-information/​guidances-drugs).

To ensure that the Agency considers any additional comments on the list before the statutory transition date, the January 2020 update to the Preliminary List recommended that application holders or other interested persons submit either electronic or written comments no later than February 19, 2020.

This guidance finalizes the draft guidance entitled “The `Deemed to be a License' Provision of the BPCI Act: Questions and Answers” issued on December 12, 2018 (83 FR 63894). FDA considered comments received on the draft guidance as the guidance was finalized. Changes from the draft to the final guidance include: (1) Providing information on updating the listing information for the biological product in FDA's electronic Drug Registration and Listing System between March 23, 2020, and June 30, 2020; (2) clarifying that, in the absence of other changes made by the application holder that would require a new National Drug Code (NDC) number, biological products approved under the FD&C Act will retain their current NDC number after the NDA is deemed to be a BLA; (3) providing information on establishment standards for “non-specified biological products” that are the subject of deemed BLAs; (4) clarifying the process for submitting followup reports on or after March 23, 2020, for any initial field alert report submitted before March 23, 2020; and (5) clarifying certain aspects of FDA's compliance policy for the labeling of biological products that are the subject of deemed BLAs. In addition, technical changes were made for consistency with the revisions to the PHS Act and the BPCI Act enacted in sections 605 and 607 of the Further Consolidated Appropriations Act, 2020, and editorial changes were made to improve clarity.

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 `Deemed To Be a License' Provision of the BPCI Act: 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.

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) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections of information in 21 CFR part 314 have been approved under 0910-0001; the collections of information in 21 CFR parts 601 and 610 have been approved under 0910-0338; the collections of information in 21 CFR 600.80 through 600.90 have been approved under 0910-0308; and the collections of information in 21 CFR 201.56, 201.57, and 201.80 have been approved under 0910-0572. In addition, the collections of information for applications submitted under section 351(k) of the PHS Act have been approved under 0910-0719.

III. Electronic Access

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

Start Signature

Dated: March 2, 2020.

Lowell J. Schiller,

Principal Associate Commissioner for Policy.

End Signature End Supplemental Information

Footnotes

1.  FDA also described its interpretation of the statutory term “chemically synthesized polypeptide” in the Biosimilar Q&A Draft Guidance and the proposed rule entitled “Definition of the Term `Biological Product' ” (83 FR 63817, December 12, 2018); however, this interpretation is no longer necessary to our interpretation of the statutory term “biological product” in light of the amendment made by section 605 of the Further Consolidated Appropriations Act, 2020.

Back to Citation

2.  Section 607 of the Further Consolidated Appropriations Act, 2020, amended section 7002(e)(4) of the BPCI Act to provide that FDA will continue to review an application for a biological product under section 505 of the FD&C Act after March 23, 2020, so long as that application was submitted under section 505 of the FD&C Act, is filed not later than March 23, 2019, and is not approved as of March 23, 2020. If such an application is approved under section 505 of the FD&C Act before October 1, 2022, it will be deemed to be a license for the biological product under section 351 of the PHS Act upon approval (see section 7002(e)(4)(B)(iii) and (vi) of the BPCI Act).

Back to Citation

[FR Doc. 2020-04537 Filed 3-4-20; 8:45 am]

BILLING CODE 4164-01-P