0233 SS for 2017 Extension

0233 SS for 2017 Extension.pdf

Patent Term Restoration, Due Diligence Petitions, Filing, Format, and Content of Petitions

OMB: 0910-0233

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Patent Term Restoration, Due Diligence Petitions,
Filing, Format, and Content of Petitions
OMB Control No. 0910-0233

Terms of Clearance: None.
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 have been promulgated under 21 CFR Part 60: Patent Term
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 apply to all respondents alike. FDA provides small
business assistance information on its Website at:
ce, and within various agency components including the Center for Drug Evaluation and
Research’s (CDER) Small Business and Industry Assistance Office (SBIA), available at:
Office of Communications
10001 New Hampshire Avenue
Hillandale Building, 4th Floor
Silver Spring, MD 20993
(866) 405-5367
(301) 796-6707
[email protected]
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.
8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the
In the Federal Register of November 1, 2016 (81 FR 75824), FDA published a 60-day notice for
public comment. We received no comments.
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
Since 1992, 17 requests for revision of the regulatory review period have been submitted
under § 60.24(a). In years 2013, 2014, and 2015, a total of two requests were received under
§ 60.24(a). During that same time period, there have been no requests under §§ 60.30 and 60.40;
however, for purposes of this information collection approval, we are estimating that we may
receive one submission annually.
We therefore estimate the burden of the information collection as follows:

Table 1 – Estimated Annual Reporting Burden1
21 CFR Section

60.24(a); revision of
regulatory review
60.30; due diligence
60.40; due diligence

No. of

No. of Responses
per Respondent



Burden per















There are no capital or operating and maintenance costs associated with the information collection.

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), the total cost burden to respondents is approximately $12,000.
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 the cost to the Federal government to be $1,000. We believe it takes an average of
16 hours to review a submission under the information collection. Using the hourly wage rate
for a GS-13/5 employee in the Washington/Metropolitan area of $51.48, and multiplying that by
16 hours equals $ 823.68. Adding additional costs for management review we have rounded the
estimated costs to $1,000 annually.
15. Explanation for Program Changes or Adjustments
A review of our records shows the number of respondents and the number of submissions per
respondent has increased since our last request for OMB approval. This results in corresponding
increases to both the number of annual responses and burden hours. Accordingly, we have made
appropriate adjustments in our estimate to reflect this fluctuation.


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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