0233 Patent term restoration SSA 2020 EXT

UNITED STATES FOOD & DRUG ADMINISTRATION
Patent Term Restoration, Due Diligence Petitions,
Filing, Format, and Content of Petitions
OMB Control No. 0910-0233

SUPPORTING STATEMENT – Part A: Justification
1. Circumstances Making the Collection of Information Necessary
The information collection supports Food and Drug Administration (FDA) regulations
regarding patent extension under the Drug Price Competition and Patent Term Restoration
Act of 1984 (21 U.S.C. 355(j)) and the Generic Animal Drug and Patent Term Restoration
Act of 1988 (35 U.S.C. 156). The regulations are codified in 21 CFR Part 60: Patent Term
Restoration
New human drug, animal drug, human biological, medical device, food additive, or color
additive products regulated by the FDA must undergo FDA safety, or safety and effectiveness
review before marketing is permitted. Where the product is covered by a patent, part of the
patent's term may be consumed during this review period, which diminishes the value of the
patent. In enacting the Drug Price Competition and Patent Term Restoration Act of 1984 and
the Generic Animal Drug and Patent Term Restoration Act of 1988, Congress sought to
encourage development of new, safer, and more effective medical and food additive products.
It did so by authorizing the U.S. Patent and Trademark Office (PTO) to extend the patent term
by a portion of the time during which FDA's safety and effectiveness review prevented
marketing of the product. The length of the patent term extension is generally limited to a
maximum of 5 years, and is calculated by PTO based on a statutory formula. When a patent
holder submits an application for patent term extension to PTO, PTO requests information
from FDA, including the length of the regulatory review period for the patented product. If
PTO concludes that the product is eligible for patent term extension, FDA publishes a notice
that describes the length of the regulatory review period and the dates used to calculate that
period. Interested parties may request, under § 60.24 (21 CFR 60.24), revision of the length
of the regulatory review period, or may petition under § 60.30 (21 CFR 60.30) to reduce the
regulatory review period by any time where marketing approval was not pursued with “due
diligence.”
The statute defines due diligence as “that degree of attention, continuous directed effort, and
timeliness as may reasonably be expected from, and are ordinarily exercised by, a person
during a regulatory review period.” As provided in § 60.30(c), a due diligence petition “shall
set forth sufficient facts, including dates if possible, to merit an investigation by FDA of
whether the applicant acted with due diligence.” Upon receipt of a due diligence petition,
FDA reviews the petition and evaluates whether any change in the regulatory review period is
necessary. If so, the corrected regulatory review period is published in the Federal Register.
A due diligence petitioner may, under § 60.40 (21 CFR 60.40), request an informal hearing

for reconsideration of the due diligence determination.
Accordingly, we are requesting information collection approval for the provisions found in 21
CFR Part 60, and as discussed in more detail below.
2. Purpose and Use of Information Collection
Under agency regulations, respondents requesting patent extension must submit: (1) requests
for revision of the regulatory review period under 21 CFR 60.24; (2) due diligence petitions
under 21 CFR 60.30; and requests for hearings under 21 CFR 60.40 regarding decisions on
the petitions. FDA uses the information to determine whether such petitions may be granted.

3. Use of Improved Information Technology and Burden Reduction
Submissions to the agency may be made electronically.
4. Efforts to Identify Duplication and Use of Similar Information
We are unaware of duplicative information collection.
5. Impact on Small Businesses or Other Small Entities
The information collection requirements pose no undue burden on small entities. At the same
time, we provide assistance to small business through resources on our website at
www.fda.gov; through agency staff upon request to CDERSBIA@fda.hhs.gov; and have
developed a questions and answers page for patent term restoration at
https://www.fda.gov/drugs/cder-small-business-industry-assistance-sbia/small-businessassistance-frequently-asked-questions-patent-term-restoration-program.
6. Consequences of Collecting the Information Less Frequently
The information collection schedule is consistent with existing laws and regulations.
Collection occurs occasionally.
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
There are no special circumstances that require the information to be collected in a manner
inconsistent with the guidelines set forth in 5 CFR 1320.5.

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8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the
Agency
In the Federal Register of August 21, 2019 (84 FR 43606), we published a 60-day notice
requesting public comment on the proposed collection of information. No comments were
received.
9. Explanation of Any Payment or Gift to Respondents
No payment or gift is provided to respondents to the information collection.
10. Assurance of Confidentiality Provided to Respondents
No assurance of confidentiality for the petitions is made because none of the information in
the application for patent term extension is confidential. When FDA is asked by PTO to make
a determination of a regulatory review period under the Patent Term Restoration Act, FDA
must publish in the Federal Register “a notice of such determination together with the factual
and legal basis for such determination.” Any person is permitted to comment on the FDA
determination and to file comments to the docket. For this reason, when FDA receives a copy
of a patent term extension application from PTO, a public docket is opened for each
application and the public is permitted to examine the application and make comments.
Therefore, confidentiality for the petitions is not guaranteed.
11. Justification for Sensitive Questions
No information of a sensitive nature is collected.
12. Estimates of Annualized Burden Hours and Costs
12a. Annualized Hour Burden Estimate:
21 CFR part 60--Patent
Term Restoration

Table 1.--Estimated Annual Reporting Burden1
No. of
No. of
Total
Average
Respondent
Responses
Responses
Burden
s
per
(2016-per
Respondent
2018)
Response
12
1.333
16
100

Total
Hours
(2016-2018)
1,600

Average
Annual
Burden
Hours
533.33

60.24; revision of
regulatory review
period determinations
60.30; due diligence
1
1
3
50
150
50
petitions
60.40; due diligence
1
1
1
10
10
10
hearings
Total
593.33
1
There are no capital costs or operating and maintenance costs associated with this collection of information.

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12b. Annualized Cost Burden Estimate:
There are labor costs resulting from this information. Based on an average industry
wage rate of $75 per hour (averaged from wages for upper management, middle management,
and clerical support, plus overhead and personnel benefits using data provided by the Bureau
of Labor Statistics: https://www.bls.gov/), and multiplied by the average burden per response
estimated above (160), we assume the total cost burden to respondents is $44,550.
13. Estimates of Other Total Annual Costs to Respondents and/or Recordkeepers/Capital
Costs
There are no capital costs, start-up, operating or maintenance costs associated with this
collection of information.
14. Annualized Cost to the Federal Government
We estimate no annual cost to the Federal government as the information collection is
managed through existing resource allocations.
15. Explanation for Program Changes or Adjustments
The information collection includes an adjustment of 11 annual responses and 34 annual
hours. This reflects an an increase in submissions since our last review.
16. Plans for Tabulation and Publication and Project Time Schedule
The information collected under these regulations and the FDA determination on the petitions
will be published individually in the Federal Register as provided for in the regulations.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
Display of OMB Expiration Date is appropriate.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

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