0297 PDUFA Cover Sheet SSA 2019 Ext

UNITED STATES FOOD & DRUG ADMINISTRATION
Prescription Drug User Fee Cover Sheet
Form FDA 3397
OMB Control No. 0910-0297
SUPPORTING STATEMENT Part A: Justification
1. Circumstances Making the Collection of Information Necessary
This information collection supports implementation of the Food and Drug Administration
(FDA, us or we) Prescription Drug User Fee program. Under the prescription drug user fee
provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (sections 735 and 736
(21 U.S.C. 379g and 379h)), as amended, we have the authority to assess and collect user fees for
certain new drug applications (NDAs) and new biologics license applications (BLAs). Under
this authority, pharmaceutical companies pay a fee for certain new NDAs and BLAs submitted to
FDA for review. Because the submission of user fees concurrently with applications is required,
review of an application by FDA cannot begin until the fee is submitted.
To assist respondents in this regard, we developed Form FDA 3397 entitled, “Prescription Drug
User Fee Cover Sheet.” Instructions are found on our internet site at
https://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm119184.htm. The
cover sheet (Form FDA 3397) need not be submitted for certain FDA-regulated products, e.g.,
generic drugs, and Whole Blood and blood components for transfusion. The list of exempted
products is included under the instructions on this form. We have also established a PDUFA
page on our internet site - https://www.fda.gov/forindustry/userfees/prescriptiondruguserfee/ that
includes resources to assist respondents with questions regarding PDUFA topics.
We therefore request OMB approval of the information collection provisions included in Form
FDA 3397 and associated instructions as discussed in this supporting statement.
2. Purpose and Use of the Information Collection
The purpose of the information collection is to collect the minimum necessary information to
determine whether a fee is required for the review of an application, to determine the amount of
the fee required, and to account for and track user fees. The form provides a cross-reference of
the fee submitted for an application utilizing a unique number tracking system. It also identifies
pertinent statutory provisions under which the application may qualify for a fee exemption. The
information collected is used by FDA’s Center for Drug Evaluation and Research (CDER) and
FDA’s Center for Biologics Evaluation and Research (CBER) to initiate the administrative
screening of NDAs and BLAs.

3. Use of the Improved Information Technology and Burden Reduction
The Prescription Drug User Fee Cover Sheet, Form FDA 3397, is accessed and submitted
electronically. We are not aware of any other improved technology, nor legal obstacles to reduce
the burden, although we continue to pursue methods of reporting that will facilitate submissions.
4. Efforts to Identify Duplication and Use of Similar Information
Although we administer a number of user fee programs, this information collection specifically
supports user fees associated with certain new drug applications (NDAs) and new biologics
license applications (BLAs).
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 statutory requirements and waivers are granted for respondents who qualify as a
small business. To assist respondents in understanding user fees associated with the information
collection we have developed the guidance document entitled, “Assessing User Fees Under the
Prescription Drug User Fee Amendments of 2017.” The guidance explains the various fee
assessments, procedures for payments and refunds, as well as other topics, and is available on
our website at:
https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/
UCM580099.pdf Finally, CBER’s Office of Communication, Outreach, and Development,
Division of Manufacturers Assistance and Training, and CDER’s Office of Communication,
Division of Drug Information provide assistance to small businesses subject to FDA’s regulatory
requirements.
6. Consequences of Collecting the Information Less Frequently
The Prescription Drug User Fee Cover Sheet is not used for the periodic collection of
information. Rather, the form is to be used once for each specific application at the time of
submission. Its intent is to provide specific information to allow us to determine that the correct
fee, if any, has been paid to allow prompt acceptance and initiation of the review of NDAs and
BLAs. There can be no less frequent information collection than one request per application
without the consequence of potential delay of acceptance of applications for which information
necessary to process them is not provided.
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
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 accordance with 5 CFR 1320.8(d), we published a 60 day notice for public comment in the
Federal Register of August 24, 2018 (83 FR 42900). No comments were received.

9. Explanation of Any Payment or Gift to Respondents
No payment or gift is provided to respondents.
10. Assurance of Confidentiality Provided to Respondents
The confidentiality of information submitted to FDA is consistent with the Freedom of
Information Act (FOIA) and FDA’s published regulations regarding “Public Information” (21
CFR Part 20). Proprietary or trade secret information is deleted from any information released
by under the Freedom of Information Act.
11. Justification for Sensitive Questions
There are no questions of a sensitive nature applicable to the information collection.
12. Estimates of Annualized Burden Hours and Costs
The total estimated annual burden for this collection of information is 131 hours as reflected
below.
12a. Annualized Hour Burden Estimate
Table 1. – Estimated Annual Reporting Burden
FDA Form No.

No. of
respondents

Number of
responses per
respondent

Total
annual
responses

Average
burden per
response

Total
hours

FDA 3397

155

1.6903

262

0.50
(30 minutes)

131

Respondents to this collection of information are new drug and biologics manufacturers. Based
on our database system for fiscal year FY 2017, there are an estimated 155 manufacturers of
products subject to the Prescription Drug User Fee Act (Pub. L. 105-115). The total number of
annual responses is based on the number of submissions we received in FY 2017. CDER
received 250 annual responses that include 218 NDAs and 32 BLAs: CBER received 12 BLAs.
The estimated hours per response are based on past our experience with the various submissions.
12b. Annualized Cost Burden Estimate
Activity
Reporting

Table 2. – Estimated Cost to Respondents
Total Burden Hours
Hourly Wage Rate
131

$72

Total Respondent Cost
$9,432

The cost to respondents is based on the salary of a regulatory affairs specialist, at a pay rate of
$72 per hour, who is responsible for filling out and submitting the Prescription Drug User Fee
Cover Sheet. This salary estimate includes benefits, but no overhead costs.
13. Estimates of Other Total Annual Costs to Respondents and/or Recordkeepers/Capital Costs
There are no capital, operating or maintenance costs associated with this information collection.
14. Annualized Cost to the Federal Government
The estimated annual cost to FDA is $14,934.
Table 3. – Estimated Cost to Federal Government
Number of
Hours per
Cost per
Responses
Response
Hour
Form FDA 3397
262
1.0
$57
Activity

Total Cost
$14,934

The estimated cost assumes User Fee staff at an average grade of GS12-5. The estimate of one
hour includes the time associated with the support, review, data entry, and tracking related to the
Prescription Drug User Fee Cover Sheet. The salary includes benefits but no overhead costs.
15. Explanation for Program Changes or Adjustments
The information collection reflects adjustments. We have decreased the burden estimate by
1,724 hours and 3,447 responses to reflect a decrease in submissions. We attribute the reduction
to the restructuring of the Prescription Drug Use Fee Program fees. The FD&C Act, as amended
by the Prescription Drug User Fee Amendments of 2017 (PDUFA VI), authorizes FDA to collect
application fees for certain applications for the review of human drug and biological products
and discontinued the supplement fee. This resulted in the removal of supplements from the
Prescription Drug User Fee Cover Sheet, therefore reducing the burden for this collection of
information.
16. Plans for Tabulation and Publication and Project Time Schedule
There are no tabulated results to publish for this information collection.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
Display of the OMB expiration date as required by 5 CFR 1320.5 is appropriate.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.