Guidance for Industry – User Fee Waivers, Reductions, and Refunds
for Drug and Biological Products
0910-0693
SUPPORTING STATEMENT
Terms of Clearance : None.
A. Justification
Circumstances Making the Collection of Information Necessary.
The guidance provides recommendations for applicants planning to request waivers or reductions in user fees assessed under sections 735 and 736 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). The guidance describes the types of waivers and reductions permitted under the user fee provisions of the FD&C Act, and the procedures for submitting requests for waivers or reductions. It also includes recommendations for submitting information for requests for reconsideration of denials of waiver or reduction requests, and for requests for appeals. The guidance also provides clarification on related issues such as user fee exemptions for orphan drugs.
Under Section 736(d) of the FD&C Act, FDA will grant a waiver of or reduction in one or more user fees assessed under Section 736(a) of the FD&C Act when it finds that an applicant meets the eligibility criteria under one of the following provisions:
A waiver or reduction is necessary to protect the public health.
The assessment of the fee would present a significant barrier to innovation because of limited resources available to the person or other circumstances.
The applicant is a small business submitting its first human drug to the Secretary for review.
The guidance describes how to submit requests for waivers, reductions, and refunds of certain user fees. It also includes recommendations for submitting information for requests for reconsideration of denials of waiver or reductions requests, and for requests for appeals. The FD&C Act also provides for waiver or reduction of user fees if the fees would exceed the anticipated present and future costs incurred by the Secretary in conducting the process for the review of human drug applications for the applicant, but fees-exceed-the-costs waivers and reductions are not addressed in this guidance document.
Public Health Waivers
Under the guidance an applicant may qualify for a waiver of or reductions in application, product, and/or establishment fees if the waiver or reduction is necessary to protect the public health. Under this provision, FDA may grant a public health waiver of or reduction in user fees if the Agency finds that the following two criteria are met:
The product protects the public health; and
The applicant shows that a waiver or reduction is necessary to continue an activity that protects the public health.
To qualify for a waiver or reduction in user fees under this provision, an applicant must meet both criteria.
Barrier to Innovation Waivers
Under Section 736(d)(1)(B) of the FD&C Act, an applicant may qualify for a waiver of or reduction in application, product, and/or establishment fees when the assessment of the fees would present a significant barrier to innovation because of limited resources available to the applicant or other circumstances. Under this provision, FDA may grant a waiver or reduction in user fees if:
The product or other products or technologies under development by the applicant are innovative; and
The fee(s) would be a significant barrier to the applicant’s ability to develop, manufacture, or market innovative products or to pursue innovative technology.
To qualify for a waiver or reduction in user fees under this provision, an applicant must meet both criteria.
Financial Considerations for Public Health and Barrier-to-Innovation Waivers and Reductions
When evaluating requests for waivers of or reductions in user fees under the public health or barrier to innovation provisions, the Agency considers the financial resources of the applicant and its affiliates, regardless of who submits a request for a waiver or reduction of user fees. The limited financial resources of an applicant and its affiliates are an important indicator of whether user fees are a barrier to innovation or a waiver or reduction is necessary to protect the public health. FDA will consider the total annual revenue of an applicant and its affiliates in determining whether the applicant has limited financial resources. In addition to total annual revenue of the applicant and its affiliates, FDA considers other available assets, including net proceeds, cash, and total assets.
Small Business Waivers
Under Section 736(d)(1)(D) of the FD&C Act, an applicant is eligible for a waiver of the application fee if the applicant is a small business submitting its first human drug application to the Agency for review and does not have another product approved under a human drug application and introduced or delivered for introduction into interstate commerce. An applicant is eligible for a small business waiver when:
The applicant employs fewer than 500 employees, including employees of affiliates;
The applicant does not have a drug product that has been approved under a human drug application and introduced or delivered for introduction into interstate commerce; and
The applicant, including its affiliates, is submitting its first human drug application.
To qualify for a small business waiver, an applicant must meet all of these criteria.
The FDA works with the Small Business Administration (SBA), which makes the determinations on whether the applicant is a small business for purposes of user fee waivers. SBA asks the applicant to submit certain information. That submission of information to SBA is already approved by OMB under OMB control number 3245-0101.
Purpose and Use of the Information Collection
The guidance provides recommendations for applicants planning to request waivers or reductions in user fees, and describes the types of waivers and reductions permitted under the user fee provisions of the FD&C Act and the procedures for submitting requests for waivers or reductions.
Use of Improved Information Technology and Burden Reduction
The submissions noted in the guidance may be made electronically by e-mail or by fax.
Efforts to Identify Duplication and Use of Similar Information
The information requested under the guidance does not duplicate any other information collection.
Impact on Small Businesses or Other Small Entities
FDA works with the Small Business Administration (SBA), which makes the determinations on whether the applicant is a small business for purposes of user fee waivers. SBA asks the applicant to submit certain information. That submission of information to SBA is already approved by OMB under OMB control number 3245-0101. In addition, under the Regulatory Flexibility Act, FDA regularly analyzes regulatory options that would minimize any significant impact on small entities. FDA also assists small businesses in complying with regulatory requirements.
Consequences of Collecting the Information Less Frequently
The frequency of information submission recommended by this guidance is intended to provide applicants with the opportunity to request waivers, reductions, and refunds for user fees assessed under Sections 735 and 736 of the FD&C Act. The guidance provides procedures that will encourage open and prompt communication between pharmaceutical companies requesting waivers and FDA. Although the Agency may occasionally request additional data to complete its review of a request for a waiver, reduction, or refund, generally, this collection of information is a one-time collection.
Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
There are no special circumstances for this collection of information.
Comments in Response to the Federal Register Notice and Efforts to Consult Outside the Agency
In accordance with 5 CFR 1320.8(d), FDA published a 60 day notice for public comment in the Federal Register of March 4, 2014 (79 FR 12201). FDA received two comments. However, these comments did not address the information collection.
Explanation of Any Payment or Gift to Respondents
FDA has not provided and has no intention to provide any payment of gift to respondents under this guidance.
Assurance of Confidentiality Provided to Respondents
FDA plans to disclose to the public information about its actions granting or denying requests for waivers and reductions of user fees. This disclosure will be consistent with the laws and regulations governing the disclosure of confidential commercial or financial information.
Justification for Sensitive Questions
There are no questions of a sensitive nature.
Estimates of Annualized Burden Hours and Costs
12 a. Annualized Hour Burden Estimate
We estimate that the total annual number of waiver requests submitted for all of these categories will be 90, submitted by 75 different sponsors. We estimate that the average burden hours for preparation of a submission will total 16 hours. Because FDA may request additional information from the applicant during the review period, we have also included in this estimate time to prepare any additional information.
The reconsideration and appeal requests are not addressed in the FD&C Act but are discussed in the guidance. We estimate that we will receive 3 requests for reconsideration annually, and that the total average burden hours for a reconsideration request will be 24 hours. We estimate that we will receive 1 request annually for an appeal of a user fee waiver determination, and that the time needed to prepare an appeal would be approximately 12 hours. We have included in this estimate both the time needed to prepare the request for appeal and the time needed to create and send a copy of the request for an appeal to the Associate Director for Policy at CDER.
The burden for filling out and submitting Form FDA 3397 (Prescription Drug User Fee Coversheet) has not been included in the burden analysis, because that information collection is already approved under OMB control number 0910-0297. The collections of information associated with a new drug application or biologics license application have been approved under OMB control numbers 0910-0001 and 0910-0338, respectively.
We have included in the burden estimate the preparation and submission of application fee waivers for small businesses, because small businesses requesting a waiver must submit documentation to FDA on the number of their employees and must include the information that the application is the first human drug application, within the meaning of the FD&C Act, to be submitted to the Agency for approval. Because the Small Business Administration (SBA) makes the size determinations for FDA, small businesses must also submit information to the SBA. The submission of information to SBA is already approved under OMB control number 3245-0101.
FDA estimates the burden of this collection of information as follows: |
Table 1 -- Estimated Annual Reporting Burden
User Fee Waivers, Reductions, and Refunds for Drug and Biological Products |
Number of Respondents |
Number of Responses Per Respondent |
Total Annual Responses |
Average Burden Per Response |
Total Hours
|
FD&C Act Sections 735 and 736
|
100 |
1.2 |
120 |
16 |
1,920 |
Reconsideration Requests
|
3 |
1 |
3 |
24 |
72 |
Appeal Requests |
1 |
1 |
1 |
12 |
12 |
Total |
2,004 |
||||
12b. Annualized Cost Burden Estimate
FDA estimates an average industry wage of $75 per hour for preparing and submitting the information requirements in this guidance. Therefore, the total labor costs would be $150,300.
Estimates of Other Total Annual Costs to Respondents and/or Recordkeepers/Capital Costs
There are no capital, start-up, operating or maintenance costs associated with this information collection.
Annualized Cost to the Federal Government
There are approximately 8 FTEs devoted to the user fee waiver program. Approximately 50% of FTE time is devoted to review of and response to requests for waivers, reductions, and refunds for drug and biological products. If each FTE equals approximately $175,000, the total burden to the Federal Government would be approximately $700,000.
Explanation for Program Changes or Adjustments
The burden has increased from 1,524 to 2,004 as a result of updated data on submissions under this information collection request.
Plans for Tabulation and Publication and Project Time Schedule
None.
Reason(s) Display of OMB Expiration Date is Inappropriate
The Agency is not seeking to not display the expiration date for OMB approval of the information collection.
Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.
| File Type | application/msword |
| Author | Muller, Howard P |
| Last Modified By | Mizrachi, Ila |
| File Modified | 2014-07-22 |
| File Created | 2014-07-22 |