[Federal Register Volume 82, Number 150 (Monday, August 7, 2017)]
[Pages 36795-36796]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-16580]



Food and Drug Administration

[Docket No. FDA-2014-N-0222]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Guidance for 
Industry--User Fee Waivers, Reductions, and Refunds for Drug and 
Biological Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA, Agency or we) is 
announcing that a proposed collection of information has been submitted 
to the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by 
September 6, 2017.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-0693. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A63, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Guidance for Industry--User Fee Waivers, Reductions, and Refunds for 
Drug and Biological Products OMB Control Number 0910-0693--Extension

    The guidance provides recommendations for applicants planning to 
request waivers or reductions in prescription drug user fees assessed 
under sections 735 and 736 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 379g and 21 U.S.C. 379h) (the FD&C Act). The guidance 
describes the types of waivers and reductions permitted under the 
prescription drug

[[Page 36796]]

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.
    Based on Agency records, we estimate that the total annual number 
of waiver requests submitted for all of these categories will be 150, 
submitted by 115 different applicants. 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. 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.
    Previously, after receipt of a small business waiver request, FDA 
would request a small business size determination from the Small 
Business Administration (SBA). Waiver applicants would submit their 
supporting documentation directly to SBA for evaluation and after 
completing their review, SBA provided FDA with a determination whether 
a waiver applicant qualified as a small business for purposes of 
evaluating user fee waivers. The burden for submission of this 
information to SBA is approved under OMB control number 3245-0101.
    Beginning fiscal year 2015, the SBA declined to conduct further 
size determinations for evaluation of small business user fee waivers 
and as a result, a processing change at FDA occurred. The new FDA 
process requires waiver applicants to submit documentation directly to 
FDA. In addition, fewer supporting documents than previously requested 
by SBA are required. As a result, we estimate that the 4 burden hours 
per small business waiver previously attributed to SBA and approved 
under OMB control number 3245-0101, should now be attributed to FDA 
because SBA is no longer conducting size determinations for FDA. Also, 
because FDA is asking that applicants submit fewer supporting 
documents, we estimate that these burden hours should be reduced to 2 
hours instead of 4 hours. We understand that SBA plans to submit a 
revised burden estimate to OMB control number 3245-0101 to account for 
this redistribution.
    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 seven requests for reconsideration annually, and that the total 
average burden hours for a reconsideration request will be 24 hours. In 
addition, we estimate that we will receive one 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 to 
the Chief Scientist, User Fee Appeals Officer, Office of the 
Commissioner, and the time needed to create and send a copy of the 
request for an appeal to the Director, Division of User Fee Management, 
Office of Management, Center for Drug Evaluation and Research.
    The burden for completing and submitting Form FDA 3397 
(Prescription Drug User Fee Coversheet) is not included in this 
analysis as the burden is included under OMB control number 0910-0297. 
The collections of information associated with submission of a new drug 
application or biologics license application are approved under OMB 
control numbers 0910-0001 and 0910-0338, respectively.
    In the Federal Register of May 23, 2017 (82 FR 23581), FDA 
published a 60-day notice requesting public comment on the proposed 
extension of this collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 

                                 Table 1--Estimated Annual Reporting Burden \1\
User fee waivers, reductions, &                     Number of                         Average
 refunds for  drug & biological     Number of     responses per    Total annual     burden per      Total hours
            products               respondents      respondent       responses       response
FD&C Act sections 735 and 736..             115              1.3             150              16           2,400
FD&C Act section                             25                1              25               2              50
Reconsideration requests.......               7                1               7              24             168
Appeal requests................               1                1               1              12              12
Total..........................  ..............  ...............  ..............  ..............           2,630
\1\ There are no capital costs or operating and maintenance costs associated with this collection of

    Dated: August 2, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-16580 Filed 8-4-17; 8:45 am]