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Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft ( printed page 50143) guidance for industry entitled “Assessing User Fees Under the Generic Drug User Fee Amendments of 2017.” This draft guidance provides stakeholders information regarding the implementation of the Generic Drug User Fee Amendments of 2017 (GDUFA II) and policies and procedures surrounding its application.
Submit either electronic or written comments on the guidance December 29, 2017 to ensure that the Agency considers your comment on this draft guidance.
You may submit comments on any guidance at any time as follows:
Submit electronic comments in the following way:
Submit written/paper submissions as follows:
Instructions: All submissions received must include the Docket No. FDA-2012-D-0880 for “Assessing User Fees Under the Generic Drug User Fee Amendments of 2017.” 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 Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
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Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th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 See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.
Mehrban Iranshad, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Rm. 4145, Silver Spring, MD 20993, 301-796-7900, CDERCollections@fda.hhs.gov.
FDA is announcing the availability of a draft guidance for industry entitled “Assessing User Fees Under the Generic Drug User Fee Amendments of 2017.” GDUFA II (Pub. L. 115-52, Title III) was signed into law by the President on August 18, 2017. GDUFA II continues FDA's and industry's goal to improve the public's access to safe and effective generic drugs and to improve upon the predictability of the review process. GDUFA II extends FDA's authority to collect user fees from fiscal year (FY) 2018 to FY 2022 and introduces a number of technical revisions that affect what fees are collected and how some fees are collected. GDUFA II authorizes fees for abbreviated new drug applications (ANDAs), drug master files (DMFs), annual facility fees, a one-time fee for original ANDAs pending with FDA on October 1, 2012 (backlog fees), and the Generic Drug Applicant Program Fee (GDUFA Program Fee).
The draft guidance announced in this notice addresses changes in user fee assessments from GDUFA I, user fees incurred by industry under GDUFA II, payment procedures, reconsideration and appeals, and other additional information to assist industry in complying with GDUFA II. FDA will issue separate guidance documents regarding GDUFA II non-user fee requirements and processes.
This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance, when finalized, will represent the Agency's current thinking on “Assessing User Fees Under the Generic 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. This guidance is not subject to Executive Order 12866.
This guidance contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501- ( printed page 50144) 3520). The guidance refers to collections of information for filling out and submitting Form FDA 3913 (User Fee Payment Refund Request), previously approved under OMB control number 0910-0805, and Form FDA 3914 (User Fee Payment Transfer Request), previously approved under OMB control number 0910-0805.
Persons with access to the internet may obtain the guidance at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.
Dated: October 25, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-23526 Filed 10-27-17; 8:45 am]
BILLING CODE 4164-01-P
3 comments have been received at Regulations.gov.
Agencies review all submissions and may choose to redact, or withhold, certain submissions (or portions thereof). Submitted comments may not be available to be read until the agency has approved them.