0727 Generic Drug User Fee Program SS Ext 2019

UNITED STATES FOOD & DRUG ADMINISTRATION
Generic Drug User Fee Program
OMB Control Number 0910-0727; Extension
SUPPORTING STATEMENT Part A: Justification
1. Circumstances Making the Collection of Information Necessary
This information collection supports the Food and Drug Administration’s (FDA) Generic
Drug User Fee Program. On July 9, 2012, the FDA Safety and Innovation Act (FDASIA)
(Pub. L. 112-144) was signed into law. Title III of FDASIA established the Generic Drug
User Fee Amendments (GDUFA), designed to speed the delivery of safe and effective
generic drugs to the public and reduce costs to industry. Section 744B of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 379f, et seq.), as added by GDUFA,
authorized FDA to assess and collect the fees related to generic drugs, beginning fiscal year
(FY) 2013 and expiring at the close of FY 2017 on September 30, 2017. GDUFA was
reauthorized on August 18, 2017 (GDUFA II), and is effective beginning October 1, 2017,
through September 30, 2022. GDUFA II enables us to assess industry user fees to bring
greater predictability and timeliness to the review of generic drug applications. Performance
goals associated with GDUFA II are set forth in our commitment letter, which is available
from our internet site at
https://www.fda.gov/downloads/ForIndustry/UserFees/GenericDrugUserFees/UCM525234.
pdf.
To assist respondents to the information collection we have developed Form FDA 3794
entitled, “Generic Drug User Fee Cover Sheet,” which is completed and submitted
electronically, and available at https://www.ipqpubs.com/wpcontent/uploads/2012/09/GDUFA-cover-sheet.pdf, along with instruction at
https://www.fda.gov/downloads/aboutfda/reportsmanualsforms/forms/ucm322676.pdf. We
have also developed a “Generic Drug User Fee Amendments” implementation activities
page on our internet site that includes agency guidance and other resources intended to assist
respondents with understanding the content and format requirements for GDUFA
submissions, as well as understanding fee determinations, refunds, waivers, and other related
topics.
We therefore request approval of the information collection provisions associated with
implementation of GDUFA II, including the GDUFA cover sheet Form FDA 3794, as
discussed in this supporting statement.

2. Purpose and Use of the Information Collection
Respondents to the collection of information are potential or actual generic drug application
holders or related Active Pharmaceutical Ingredient and Finished Dosage Form
manufacturers. Companies with multiple user fee obligations will submit a cover sheet for
each user fee obligation. Applicants complete the cover sheets to accompany payments.
While applicants may submit payment through multiple means, all cover sheets are prepared
using our web-based electronic User Fee System. Upon submitting the completed cover
sheet, the User Fee System generates a user fee identification number, which is provided to
applicants at the bottom of the cover sheet. It also notes the correct FY user fee assessment
that is due for the submission/program. We request that applicants submit a copy of this
completed cover sheet along with the abbreviated new drug application, and other GDUFA
fees, so we can verify that the applicant has paid the correct user fee.
3. Use of Improved Information Technology and Burden Reductions
Respondents create and/or submit Form FDA 3794 (Generic Drug User Fee Cover Sheet)
electronically by accessing the User Fee System. Information such as the applicant’s name
and address, as well as the name, telephone number, and email address of the applicant’s
representative and/or United States agent, are auto-populated if the organization has
registered and has an existing user fee account in the User Fee System. In addition, we have
enabled new users to locate their organizations in the Dun &Bradstreet (D&B) database. If
an organization is found in the D&B database, certain fields are auto-populated as the new
user completes the registration process. We are unaware of any other improved technology
that would facilitate the information collection.
4. Efforts to Identify Duplication and Use of Similar Information
Although FDA administers a number of user fee programs, this information collection
specifically supports user fees associated with our generic drug program.
5. Impact on Small Businesses or Other Small Entities
The information collection imposes no undue burden on small entities. User fees are
assessed in accordance with GDUFA II. To assist respondents in understanding user fees
associated with generic drug applications we have developed the draft guidance document
entitled, “Assessing User Fees Under the Generic Drug User Fee Amendments of 2017.”
The guidance explains the various fee assessments, procedures for payments and refunds, as
well as other topics. The guidance is available on our internet at
https://www.fda.gov/downloads/ForIndustry/UserFees/GenericDrugUserFees/UCM593422.
pdf along with other information relating to implementation of GDUFA II.
6. Consequences of Collecting the Information Less Frequently
The information collection schedule is determined by respondents. Potential or actual
human generic drug application holders are required to complete the proposed form for each

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abbreviated new drug application (ANDA), applicable amendment to an ANDA or a PAS,
backlog ANDA, or type II API DMF referenced for the first time on or after October 1,
2012, and new contract manufacturing organizations. In addition, a generic drug facility
which is identified or intended to be identified in at least one generic drug submission that is
pending or approved to produce a final dosage form of a human generic drug or an API
contained in a human generic drug is required to complete the proposed form annually. A
collection of information that is less frequent than that proposed will result in delays in
reviewing of generic drug applications and supplements, and completeness assessment of
type II API DMFs.
7. Special Circumstances Relating to the Guidelines in 5 CFR 1320.5(d)(2)
There are no special circumstances for this collection of information.
8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the
Agency
In the Federal Register of September 25, 2018 (83 FR 48430), we published a 60-day notice
requesting public comment on the collection of information. One comment was received
asking whether the information was “essential for FDA to conduct its duties,” and whether
“there is a way to reduce burden” on respondents. As discussed in both the 60-day notice
and this notice, the information collection implements statutory provisions FDA must fulfill
under GDUFA II. The information requested from respondents on Form FDA 3794
represents what we consider to be the minimum necessary for us to efficiently and
electronically assess, collect, and track user fees associated with generic drug applications.
9. Explanation of Any Payment or Gift to Respondents
No payment or gift is provided to respondents.
10. Assurance of Confidentiality Provided to Respondents
Confidentiality of the information submitted is protected under 21 CFR 314.430 and under
21 CFR part 20 and information will be handled consistent with these regulations.
Additionally, the unauthorized use or disclosure of trade secrets that are required in
applications is specifically prohibited under section 310(j) of the FD&C Act.
11. Justification for Sensitive Questions
There are no questions of a sensitive nature associated with the information collection.

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12. Estimates of Annualized Burden Hours and Costs
We estimate the burden of the collection of information as follows:
12a. Annualized Hour Burden Estimate
Table 1.--Estimated Annual Reporting Burden
Form FDA 3794
Generic Drug User Fee
Cover Sheet

No. of
Respondents
500

No. of
Responses per
Respondent
7.616

Total
Annual
Responses
3,808

Average
Burden per
Response
0.5
(30 minutes)

Total
Hours
1,904

We base our estimate on the average number of submissions received since last OMB
review of the information collection.
12b. Annualized Estimated Cost Burden Estimate
The estimated annual costs to respondents for all applicable applications and fees is
$87,584. The costs are based on a regulatory affairs specialist’s pay rate at $46/hour. The
estimated average hourly pay rate includes benefits but no overhead costs.
13. Estimates of Other Total Annual Cost Burden to Respondents and
Recordkeepers/Capital Costs
There are no capital costs, or operating and maintenance costs, associated with the collection
of information.
14. Annualized Cost to the Federal Government
We estimate annual costs to the Federal government in the amount of $87,584 for the
administration of applicable applications and fees. These costs are based on staff allocations
assuming a pay rate for a grade GS 12-5 employee. The estimate includes time and
activities associated with the support, review, data entry, and tracking of submissions. The
estimated hourly pay rate includes benefits but not overhead costs.
15. Explanation for Program Changes or Adjustments
The information collection reflects adjustments. Specifically, we have increased our
estimate by 266 responses and 133 hours, consistent with an increase in submissions over
the past three years.
16. Plans for Tabulation and Publication and Project Time Schedule
There are no plans for publication of the information received and therefore no associated
tabulation or time schedules.

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17. Reason(s) Display of OMB Expiration Date is Inappropriate
Display of the OMB Expiration Date is appropriate.
18. Exceptions to the Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

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