0513 Patent Declarations SSA 2019 Ext

0513 Patent Declarations SSA 2019 Ext.pdf

Applications for FDA Approval to Market a New Drug: Patent Listing Requirements and Application of 30-month Stays on Approval of Abbreviated New Drug Applications Certifying That...

OMB: 0910-0513

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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 – Part A: Justification
1. Circumstances Making the Collection of Information Necessary
This information collection supports Food and Drug Administration (FDA, the agency, us or we)
regulations and associated forms. 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 to make a detailed patent declaration. To assist respondents in this regard, we have
developed the following forms:

Form FDA 3542 – Patent Information Submitted Upon and After Approval of an NDA or
Supplement; and


Form FDA 3542a - Patent Information Submitted With the Filing of an NDA,
Amendment, or Supplement.

As set forth in the regulations, patent information must be submitted on Form FDA 3542 within
30 days following approval of an NDA or supplemental application. For patents issued after
approval of the NDA or supplement, the NDA holder must submit the required patent
information within 30 days of the issuance of the patent for it to be considered timely filed. If


the NDA holder timely submits the required patent information, but FDA notifies the NDA
holder that its Form FDA 3542 is incomplete or shows that the patent is not eligible for listing,
the NDA holder must submit an acceptable Form FDA 3542 within 15 days of FDA’s
notification to be considered timely filed as of the date of the original submission of patent
information. New patent information may still be submitted after 30 days of the issuance of the
patent, but such information is not considered timely filed.
We therefore request OMB approval of the information collection provisions in the applicable
regulations and associated forms, as discussed in this supporting statement.
2. Purpose and Use of the Information Collection
The information collection is required by statute and agency regulations 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. As discussed above, we use the patent information
provided in Form 3542 to list patents in 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
Forms FDA 3542 and FDA 3542a may be filled-out electronically and submitted to FDA.
4. Efforts to Identify Duplication and Use of Similar Information
Information collection associated with applications to market a new drug provided for in 21 CFR
part 314 are approved under OMB Control No. 0910-0001. This information collection accounts
for burden specifically ascribed to Forms FDA 3542 and 3542a, instruments used for collecting
patent information for publication in the Orange Book. We are unaware of any duplicative
information collection.
5. Impact on Small Businesses or Other Small Entities
The information collection poses no undue impact on small entities. At the same time, we
provide resources to small business through contacts within the agency including 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). We also
provide small business compliance guidances on our website at:


6. Consequences of Collecting the Information Less Frequently
The information collection schedule is determined by respondents and consistent with statutory
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
In accordance with 5 CFR 1320.8(d), we published a 60 day notice inviting public comment in
the Federal Register of May 20, 2019. 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 is protected under 21 CFR 314.430 and 21 CFR part
20. To address this element of the supporting statement, we consulted with our Privacy Office to
ensure appropriate handling of information collected. Information collected does include
personally identifiable information (PII) and other data of a personal nature: patent information
(including patent numbers and expiration dates); name; address; country; fax number; telephone
number; and email address. We have determined, however, that the collection is not subject to
the Privacy Act of 1974 and therefore notice and other requirements of the Privacy Act do not
apply. Specifically, we do not use the name or any other personal identifier to routinely retrieve
records from the information collected. Also, we have minimized the PII to be collected to
protect the privacy of the individuals.
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 –
We estimate the burden of the information collection as follows:


Table 1. – Estimated Annual Reporting Burden1
Patent declaration as prescribed by
21 CFR parts 314.50 and 314.53

Number of

Number of
Responses per

Responses Response

Form FDA 3542a






Form FDA 3542











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

For this analysis, we consider the number of respondents to correspond to the number of NDAs
and efficacy supplements submitted or approved, respectively, in calendar year (CY) 2017, even
though one company may submit or hold multiple NDAs or may submit multiple efficacy
supplements to one or more NDAs. During calendar year 2017, we received 141 original NDAs
and 169 efficacy supplements for review and approval from 310 respondents, for a total of 646
Form FDA 3542a submissions during CY 2017. This is reflected in row 1. Similarly, we
approved 127 NDAs and 154 efficacy supplements to NDAs during CY 2017, which
corresponds with 281 respondents. Based on our records, a total of 808 Form FDA 3542
submissions we received during CY 2017, as reflected in row 2.
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

Total Respondent Costs

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 as a result of the information collection.
14. Annualized Cost to the Federal Government
Costs to operate the information collection are absorbed through agency resources allocated in
support of our new drug application program.


15. Explanation for Program Changes or Adjustments
The information collection reflects adjustment. Based on fewer submissions we have decreased
our cumulative estimate by 45 annual hours and 2,010 responses. At the same time, we have
uploaded previously reported costs at question 12b to be reflected at www.reginfo.gov.
16. Plans for Tabulation and Publication and Project Time Schedule
As described above, we use the information collected to publish patent lists in the Orange Book.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
Display of OMB expiration date is appropriate and is included on the applicable forms.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

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