[Federal Register Volume 85, Number 218 (Tuesday, November 10, 2020)]
[Notices]
[Pages 71658-71659]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-24941]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-5913]


Assessing User Fees Under the Prescription Drug User Fee 
Amendments of 2017; Revised Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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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of 2017,'' which supersedes the now withdrawn final guidance issued in 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.

[[Page 71659]]


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, 
[email protected]; 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.

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 
(Sec.  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 (Sec.  
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 (Sec.  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.

    Dated: November 5, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-24941 Filed 11-9-20; 8:45 am]
BILLING CODE 4164-01-P