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Guideline 170
V. Procedures and Timing for Requesting Fee Waivers or Reductions
This section of the guidance document describes the procedures that FDA recommends for submitting a fee waiver or reduction request, and the information that the Agency believes it needs from a person to determine whether it can grant the request for a fee waiver or reduction. Adherence to these procedures will help to minimize time-consuming efforts by the Agency to obtain additional necessary information, and will enable the Agency to grant fee waivers or reductions to qualifying persons in a timely manner. Please note that you must submit a written request to the Agency for a waiver or reduction not later than 180 days after the fee is due. Section 740(i) of the FD&C Act. FDA does not intend to consider any requests made later than 180 days after the fee is due.
A. Procedures Applicable To All Requests for Waivers or Reductions
1. Submitting a Waiver or Reduction Request
Because waivers and reductions apply to specific fees due for a specific application or fiscal year, new requests should be submitted for each application or fiscal year. The request must be submitted in writing. Section 704(i) of the FD&C Act. Requests for fee waivers and reductions, other than those made on the basis that fees exceed costs, will be reviewed and granted or denied by FDA’s Center for Veterinary Medicine (CVM) ADUFA Waiver Officer. Requests for waivers made on the basis that fees exceed costs will be reviewed and granted or denied by the Director of FDA’s Office of Financial Management. To facilitate timely review and processing, these requests should contain the following information:
a. The name and address of the entity requesting the waiver or reduction (requestor), including the company name and address if the requestor is an agent for the company.
b. The name, telephone number, and e-mail address of a contact person.
c. The specific fee or fees for which a waiver or reduction is requested, including:
i. For application or supplement fees:
a) the number of the NADA or supplemental NADA for which a waiver or reduction is being requested;
b) the trade and established names of animal drug products covered by the application; and
c) the date the application or supplement was submitted.
ii. For product fees:
a) the trade and established names of the animal drug product, its applicable National Drug Code (NDC) number, and the number of the NADA or supplemental NADA under which the product was approved;
b) the name of the person holding the approved application for the animal drug product;
c) the specific strength or potency of the product and its final dosage form; and
d) the product fee invoice number and invoice date, if available. A photocopy of FDA’s invoice to the person may be submitted to provide this information, though you should clearly state for which specific animal drug product the fee waiver or reduction is requested.
iii. For establishment fees:
a) the name, address, and FEI/CFN number of the establishment for which the waiver or reduction is requested;
b) the establishment number as listed on the fee invoice, and the invoice number and date, if available. A copy of the invoice is acceptable.
iv. For sponsor fees:
a) the name and address of the animal drug sponsor requesting the waiver or reduction;
b) the invoice number and invoice date if available. A copy of the invoice is acceptable.
d. If payment has been made, the date on which payment was made;
e. The particular grounds on which the waiver or reduction is requested (i.e., one or more of the provisions specified in section IV above); and
f. Information and analyses showing why the requestor believes it qualifies for the waiver or reduction.
If submitting a fee waiver or reduction request in advance of the date the fees are due, you should provide any new or updated information as soon as it becomes available.
A request for a fee waiver or reduction should be sent to:
ADUFA Waiver Officer
Office of New Animal Drug Evaluation, HFV-100
7500 Standish Place
Rockville, MD 20855
FDA will send a written acknowledgement of receipt of the waiver or reduction request to the requestor. The acknowledgement letter will include the date on which the waiver or reduction request was received, and will request any additional information the FDA believes, at the time, will be necessary to evaluate the request. The Waiver Officer will forward fees exceed costs requests to the Director of the Office of Financial Management.
2. Timing of a Fee Waiver Or Reduction Request
If you plan to request a waiver or reduction and wish to minimize the likelihood that you will have to pay the fee and then wait for a refund, FDA encourages you to submit your requests at least 90 days before the fees are due. For animal drug application and supplemental animal drug application fees, this would be 90 days before the expected submission of the application or supplement. For sponsor, product, and establishment fees, this would normally be by November 1 of each fiscal year because after FY 2004 these fees are due on or before January 31 of the fiscal year. This recommendation does not apply to "Fees Exceed Costs" waivers and reductions since FDA expects that it will not be able to make a decision on them until after the associated fees are due.
3. The Waiver Officer's or Office of Financial Management Director’s Review of the Request
The Waiver Officer will review the waiver or reduction request and consult with relevant Agency officials as appropriate. The Waiver Officer may request additional information from, or a meeting with, the requestor during the review period. The Agency expects to notify the requestor of the Waiver Officer’s decision and the reasons for it within 90 days of the receipt of a waiver or reduction request, except for Fees Exceed Costs waiver or reduction requests, which will not be decided by the Director of FDA’s Office of Financial Management until approximately 6 months after the end of the fiscal year for which the waiver or reduction is requested. These time periods may vary depending on, among other things, the number of fee waiver or reduction requests submitted and whether the request contains sufficient supporting information.
4. Requesting Reconsideration of a Decision
If the Waiver Officer, or Director of FDA’s Office of Financial Management in the case of fees exceed costs requests, fully or partially denies your request for a fee waiver or reduction, you may request reconsideration of that decision. FDA encourages persons to make such requests for reconsideration promptly, and suggests that they be made within 15 days of receiving the decision. A request for reconsideration should state the person’s reasons for believing that the decision is in error, and should include any additional information necessary to support the person’s position. The Waiver Officer or Office of Financial Management Director will issue a decision upon reconsideration, setting forth the reasons for it. A request for reconsideration is decided by the original decision maker, and is different from a request for review, which is described in the next two sections. You may, but are not required to, request reconsideration of the initial decision by the Waiver Officer or Office of Financial Management Director before seeking review of that decision.
You should send the request for reconsideration to:
CVM ADUFA Waiver Officer
Office of New Animal Drug Evaluation, HFV-100
7500 Standish Place
Rockville, MD 20855
5. Requesting Review of the ADUFA Waiver Officer’s Decision
If the ADUFA Waiver Officer denies your waiver or reduction request or denies your request for reconsideration, you may seek review by CVM’s ADUFA Appeals Officer. Please note that this does not apply to fees exceed costs waiver or reduction requests. Your request for review should contain a copy of the Waiver Officer’s original decision; the Waiver Officer’s decision upon reconsideration, if any; and the reasons you believe the decisions are in error. The review will be based on information in the administrative file, which includes information and analyses already submitted to the Agency, as provided by 21 CFR 10.75(d).
The request for review should be sent to:
CVM ADUFA Appeals Officer (HFV-1)
Center for Veterinary Medicine
Food and Drug Administration
7519 Standish Place
Rockville, MD 20855
After reviewing the request, the CVM ADUFA Appeals Officer will issue a written decision.
6. Requesting Review of the CVM ADUFA Appeals Officer’s Decision or the Office of Financial Management Director’s Decision
If the Director of the Office of Financial Management denies your fees exceed costs waiver or reduction request or denies your request for reconsideration, you may seek review by FDA's User Fee Appeals Officer. You may likewise seek review by FDA's User Fee Appeals Officer if the CVM ADUFA Appeals Officer upholds the ADUFA Waiver Officer's decision. Your request for review should contain a copy of the original decision, any decisions upon reconsideration or review, and the reasons you believe those decisions are in error. The review will be based only on information in the administrative file, which includes information and analyses already submitted to the Agency, as provided by 21 CFR 10.75(d).
The request for review should be sent to:
The FDA User Fee Appeals Officer (HF-3)
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857
After reviewing the request, FDA’s User Fee Appeals Officer will issue a written decision.
B. Additional Procedures for Small Business Waiver Requests
1. Submitting the Waiver Request
In addition to the information requested in section V (A)(1) of this document, a request for a small business waiver must contain a certification that the requestor qualifies for the waiver. Section 740(d)(3)(C) of the FD&C Act. For this, we recommend that a responsible officer of the entity certify:
a) that the entity has fewer than 500 employees, including employees of affiliates; and
b) that this is the first animal drug application the entity or any one of its affiliates has submitted to FDA for review.
2. FDA's Review of the Waiver Request
In evaluating whether the entity meets the size criteria for the small business waiver, FDA intends to ask the Small Business Administration (SBA) to make a formal size determination under 13 CFR 121.1001(b)(6). The requestor will have to respond to information requested by the SBA in this process. If the requestor wishes to appeal SBA’s determination, it should follow the procedures in 13 CFR 121.1101.
The Agency encourages requestors to time their small business waiver requests carefully to reduce the potential that the information provided as the basis of the request is no longer current when the animal drug application is submitted.
C. Additional Procedures for Significant Barrier to Innovation Waiver or Reduction Requests
In addition to the information requested in section V(A)(1) of this document, a request for a fee waiver or reduction on the basis that the fee would present a significant barrier to innovation should contain the following information:
1. a statement of what the innovation is relating to the animal drug product for which the waiver is being requested, or other animal drug products or technologies the requestor is pursuing);
2. an explanation of why the requestor believes it is innovative;
3. an analysis of why the fee or fees would present a significant barrier to the requestor's ability to develop, manufacture, or market the innovative product or technology; and
4. if the request is based on limited resources:
a. an estimate of the total fees that the requestor, including its affiliates, would be required to pay in the fiscal year; and
b. the annual gross revenues and all other resources available to the requestor, including its affiliates.
D. Additional Procedures for Fees Exceed Costs Waiver or Reduction Requests
In addition to the information requested in section V(A)(1) of this document, a request for a fee waiver or reduction on the basis of fees exceeding costs should include a list of affiliates, as defined in section 735(9) of the FD&C Act. The information will be used to estimate the fees paid and the anticipated costs. For each affiliate on the list, you should include the name, address, and phone number of the affiliate’s counsel or head of regulatory affairs so that FDA may contact the affiliate if necessary in reviewing the request.
If a waiver or reduction is also requested under other provisions of ADUFA, then FDA intends to evaluate the other waiver or reduction requests first. Only if it denies the other waiver or reduction requests would the Agency review the fees exceed costs request.
