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Notice

Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017; Revised 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 we) is announcing the availability of a revised final guidance for industry entitled “Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017,” which supersedes the now withdrawn final guidance issued in May 2018 (May 2018 guidance). This revised final guidance concerns FDA's implementation of the Prescription Drug User Fee Amendments of 2017. In particular, this revised final guidance removes section VI.B. contained in the May 2018 guidance, regarding the “same product as another product” prescription drug program fee exception for certain prescription drug products under the Federal Food, Drug, and Cosmetic Act.

DATES:

The announcement of the guidance is published in the Federal Register on November 10, 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-2017-D-5913 for “Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017; 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, 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 revised 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; or to the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send two self-addressed adhesive labels to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document.

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FOR FURTHER INFORMATION CONTACT:

Peter Chen, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Rm. 2185, Silver Spring, MD 20993, 301-796-7900, CDERCollections@fda.hhs.gov; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.

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SUPPLEMENTARY INFORMATION:

I. Background

We are announcing the availability of a revised guidance for industry entitled “Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017.” We are issuing this revised final guidance consistent with our good guidance practices (GGP) regulation (§ 10.115 (21 CFR 10.115)). We are implementing this revised guidance without prior public comment because we have determined that prior public participation is not feasible or appropriate (§ 10.115(g)(2)). The change reflected in the revised guidance needs to be implemented and communicated in a timely manner in light of the ongoing user fee billing process. Although this revised guidance document is immediately in effect, it remains subject to comment in accordance with FDA's GGP regulation.

In May 2018, FDA issued guidance concerning the Agency's implementation of the Prescription Drug User Fee Amendments of 2017 (PDUFA VI) and clarifying certain changes in policies and procedures surrounding its application (83 FR 19564). Section VI.B. of the May 2018 guidance provided an interpretation of the term “same product” as it is used in the prescription drug program fee exception for certain prescription drug products under section 736(a)(2)(B)(ii) (21 U.S.C. 379h(a)(2)(B)(ii)) of the Federal Food, Drug, and Cosmetic Act. After further consideration of the issue, we have decided to withdraw the interpretation in our May 2018 guidance and return to our prior practice. Accordingly, for FY 2020 and FY 2021 billing we are considering drug products to be the “same product” if they were pharmaceutically equivalent to a prescription drug product as determined through the process for assigning therapeutic equivalence codes. Therefore, this revised guidance removes section VI.B. as described in the May 2018 guidance. There are no other changes to the guidance.

This revised guidance is being issued consistent with FDA's good guidance practices regulation (§ 10.115). The revised guidance represents the current thinking of FDA on Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017. 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 contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.

III. Electronic Access

Persons with access to the internet may obtain the document at https://www.fda.gov/​RegulatoryInformation/​Guidances/​default.htm, https://www.fda.gov/​vaccines-blood-biologics/​guidance-compliance-regulatory-information-biologics/​biologics-guidances or https://www.regulations.gov. Use the FDA website listed in the previous sentence to find the most current version of the guidance.

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Dated: November 5, 2020.

Lauren K. Roth,

Acting Principal Associate Commissioner for Policy.

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[FR Doc. 2020-24941 Filed 11-9-20; 8:45 am]

BILLING CODE 4164-01-P