0513 Supporting Statement 2016

Applications for FDA Approval to Market a New Drug: Patent Submission and Listing
Requirements and Application of 30-month Stays on Approval of Abbreviated New Drug
Applications Certifying That a Patent Claiming a Drug Is Invalid or Will Not Be Infringed
OMB Control Number 0910-0513
SUPPORTING STATEMENT
A. Justification
1. Circumstances Making the Collection of Information Necessary
Section 505(b)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C.
355(b)(1)) requires all new drug application (NDA) applicants to file, as part of the NDA, “the
patent number and the expiration date of any patent which claims the drug for which the
applicant submitted the application or which claims a method of using such drug and with
respect to which a claim of patent infringement could reasonably be asserted if a person not
licensed by the owner engaged in the manufacture[,] use, or sale of the drug.” Section 505(c)(2)
of the FD&C Act (21 U.S.C. 355(c)(2)) imposes a similar patent submission obligation on
holders of approved NDAs when the NDA holder could not have submitted the patent
information with its application. Under section 505(b)(1) of the FD&C Act, we publish patent
information after approval of an NDA in the list entitled “Approved Drug Products with
Therapeutic Equivalence Evaluations” (the Orange Book). If patent information is submitted
after NDA approval, section 505(c)(2) of the FD&C Act directs us to publish the information
upon its submission.
FDA regulations at §§ 314.50(h) (21 CFR 314.50(h)) and 314.53 (21 CFR 314.53) clarify the
types of patent information that must and must not be submitted to FDA as part of an NDA, an
amendment, or a supplement, and require persons submitting an NDA, an amendment, or a
supplement, or submitting information on a patent after NDA approval, to make a detailed patent
declaration using Form FDA 3542a and Form FDA 3542.
The reporting burden for submitting an NDA, an amendment, or a supplement in accordance
with § 314.50 (a) through (f), and (k) has been estimated by FDA and the collection of
information has been approved by OMB under OMB control number 0910-0001. We are not reestimating these approved burdens in this document. Only the reporting burdens associated with
patent submission and listing, as explained below, are estimated in this document.
The information collection requirements are as follows:
Section 314.50(h) requires that an NDA, an amendment, or a supplement contain patent
information described under § 314.53.
Section 314.53 requires that an applicant submitting an NDA, an amendment, or a
supplement, except as provided in § 314.53(d)(2), submit on Forms 3542 and 3542a, the required
patent information described in this section.

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Compliance with the information collection burdens under §§ 314.50(h) and 314.53 consists of
submitting with an NDA, an amendment, or a supplement (collectively referred to as
“application”) the required patent declaration(s) on Form 3542a for each “patent that claims the
drug or a method of using the drug that is the subject of the new drug application or amendment
or supplement to it and with respect to which a claim of patent infringement could reasonably be
asserted if a person not licensed by the owner of the patent engaged in the manufacture, use, or
sale of the drug product” (§ 314.53(b)). Such patents claim the drug substance (active
ingredient), drug product (formulation and composition), or method of use. If a patent is issued
after the application is filed with FDA but before the application is approved, the applicant must
submit the required patent information on Form 3542a as an amendment to the application,
within 30 days of the date of issuance of the patent.
Within 30 days after the date of approval of an application, the applicant must submit Form 3542
for each patent that claims the drug substance (active ingredient), drug product (formulation and
composition), or approved method of use for listing in the Orange Book. In addition, for patents
issued after the date of approval of an application, Form 3542 must be submitted within 30 days
of the date of issuance of the patent.
2. Purpose and Use of the Information Collection
We collect this information as part of the NDA or, in the case of subsequently issued patents, as
amendments to the unapproved NDA. When the NDA is approved, we collect this information
in a separate submission that lists the patents that claim the drug substance or drug product
described in the approved NDA or supplement or that claim an approved method of using the
drug. We use the patent information provided in Form 3542 to list patents in the list of approved
drug products titled, “Approved Drug Products with Therapeutic Equivalence Evaluations” (the
Orange Book). Federal law specifically requires us to publish such patent information. ANDA
and 505(b)(2) applicants that rely upon FDA’s finding of safety and/or effectiveness for a listed
drug are required to submit an appropriate patent certification or statement for each patent listed
in the Orange Book.
3. Use of Improved Information Technology and Burden Reduction
The regulations do not specifically require the use of automated, electronic, mechanical, or other
technological collection techniques or other forms of information technology.
4. Efforts to Identify Duplication and Use of Similar Information
We are unaware of any duplicative information collection.
5. Impact on Small Businesses or Other Small Entities
We estimate no impact on small entities. The regulations apply to small and large businesses

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alike. FDA provides small business and industry assistance to respondents through the Center
for Drug Evaluation and Research (CDER) and through the Division of Manufacturers
Assistance and Training component in the Center for Biologics Evaluation and Research
(CBER).
6. Consequences of Collecting the Information Less Frequently
Information collection schedule is consistent with statutory requirements.
7. Special Circumstances Relating to the Guidelines in 5 CFR 1320.5
There are no special circumstances for this collection of information.
8. 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 February 2, 2016 (81 FR 5465). No comments were received.
9. Explanation of Any Payment or Gift to Respondents
No payments or gifts are provided to respondents.
10. Assurance of Confidentiality Provided to Respondents
Confidentiality of the information submitted under these reporting requirements is protected
under 21 CFR 314.430 and under 21 CFR part 20.
11. Justification for Sensitive Questions
The information collection does not contain questions of a sensitive nature.
12. Estimates of Annualized Hour Burden and Costs

12a. Annualized Hour Burden Estimate –
The numbers of patents submitted to FDA for listing in the Orange Book in 2012, 2013,
and 2014 were 458, 509, and 617 respectively, for an annual average of 528 (458 patents + 509
patents + 617 patents) / 3 years = 528 patents / year). Because many of these individual patents
are included in multiple NDA submissions, there could be multiple declarations for a single
patent. From our previous review of submissions, we believe that approximately 14 percent of
the patents submitted are included in multiple NDA submissions, and thus require multiple

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patent declarations. Therefore, we estimate that 74 (528 patents x 14 percent) patents will be
multiple listings, and there will be a total of 602 patents (528 patents + 74 patents = 602 patents)
declared on Form FDA 3542. We approved 86, 94, and 107 NDAs in 2012, 2013, and 2014
respectively, of which we estimate approximately 71% submitted patent information for listing
in the Orange Book. The remaining NDAs submitted Form 3542 as required and declared that
there were no relevant patents.
We also approved approximately 101, 101, and 110 NDA supplements in 2012, 2013, and 2014
respectively, for which submission of a patent declaration would be required. We estimate there
will be 200 instances (based on an average of 96 NDA approvals and 104 supplement approvals
per year) where an NDA holder would be affected by the patent declaration requirements, and
that each of these NDA holders would, on average, submit 3.4 declarations (602 patent
declarations + 74 no relevant patent declarations) /200 instances = 3.4 declarations per instance)
on Form FDA 3542.
We filed 112, 116, and 113 NDAs in 2012, 2013, and 2014, respectively, and 112, 112, and 156
NDA supplements in 2012, 2013, and 2014 respectively, for which submission of a patent
declaration would be required. We estimate there will be 241 instances (based on an average of
114 NDAs filed and 127 NDA supplements filed per year) where an NDA holder would be
affected by the patent declaration requirements. We estimate, based on a proportional increase
from the number of declarations for approved NDAs, that there will be an annual total of 819
declarations (241 instances x 3.4 declarations per instance = 819 declarations) on Form FDA
3542a submitted with these applications.
Based upon information provided by regulated entities and other information, we previously
estimated that the information collection burden associated with § 314.50(h) (citing § 314.53)
and FDA Forms 3542 and 3542a will be approximately 5 hours and 20 hours per response,
respectively.
FDA requests OMB approval for the following information collection:
Table 1. – Estimated Annual Reporting Burden1
21 CFR Section
§ 314.50 (citing § 314.53)

Number of
Respondents

Number of
Responses per
Respondent

Total
Annual
Responses

Hours per
Response

Total
Hours

Form FDA 3542a

241

3.4

819

20

16,380

Form FDA 3542

200

3.4

680

5

3,400

TOTAL
1

19,780

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

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12b. Annualized Cost Burden Estimates –
Based on the hours estimated above, the burden hour costs for the reporting requirements
would be as follows:
Type of Respondent

NDA applicants

Total Burden Hours

Hourly Wage Rate

19,780

$86

Total Respondent Costs

$1,701,080

13. Estimates of Other Total Annual Cost Burden to Respondents and Recordkeepers
There are no capital costs or operating and maintenance costs (or start-up costs or service costs)
projected due to the minimal nature of the reporting requirements.
14. Annualized Cost to the Federal Government
CDER project managers devote approximately 15 minutes to the review of each application
submitted to the agency to record that the patent form has been included. CDER’s document
room staff devote approximately 2 hours per day loading application-related data into our
computers. CDER “Orange Book staff” devote approximately 2 hours per day transmitting the
data from the forms into our database and then generating reports and other related tasks.
CDER’s Internet team devotes approximately 2 hours per month to the Internet publication of the
data. Costs associated with the collection are captured under OMB Control No. 0910-0001.
15. Explanation for Program Changes or Adjustments
The information collection reflects an increase in burden of 424 additional responses and 5,960
hours, corresponding to an increase in the number of incoming NDAs, amendments and
supplements detailing patent declarations using Forms FDA 3542a and 3542, as well as
projections on the number of forms received and those we expect to receive. As a result we have
adjusted our estimate accordingly.
16. Plans for Tabulation and Publication and Project Time Schedule
Information collected under this requirement will not be published.
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.