2010-16738. Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Applications for Food and Drug Administration Approval to Market a New Drug: Patent Submission and Listing Requirements and ...

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) 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 August 9, 2010.

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: [phone], or e-mailed to [e-mail]. All comments should be identified with the OMB control number 0910-0513. Also include the FDA docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:

Elizabeth Berbakos, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850, 301-796-3792, [e-mail].

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.

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—Extension

Section 505(b)(1) of the Federal Food, Drug, and Cosmetic Act (the 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 act 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 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 act directs us to publish the information upon its submission.

FDA regulations at §§ 314.50(h) and 314.53 (21 CFR 314.50(h) and 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 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 re-estimating these approved burdens in this document. Only the reporting burdens associated with patent submission and listing, as explained in the following paragraphs, are estimated in this document.

The information collection reporting 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.

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.

In the Federal Register of April 8, 2010 (75 FR 17924), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received on the information request.

FDA estimates the burden of this collection of information as follows:

Table 1.—Estimated Annual Reporting Burden¹

21 CFR Section § 314.50 (citing § 314.53)	No. of Respondents	Annual Frequency per Response	Total Annual Responses	Hours per Response	Total Hours
Form FDA 3542a	233	2.6	606	20	12,120
Form FDA 3542	154	2.6	400	5	2,000
Total					14,120
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

The numbers of patents submitted to FDA for listing in the Orange Book in 2007, 2008, and 2009 were 268, 347, and 335, respectively, for an annual average of 317 (268 patents + 347 patents + 335 patents) / 3 years = 317 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 patent declarations. Therefore, we estimate that 44 (317 patents x 14 percent) patents will be multiple listings, and there will be a total of 361 patents (317 patents + 44 patents = 361 patents) declared on Form FDA 3542. We approved 67, 73, and 77 NDAs in 2007, 2008, and 2009, respectively, of which approximately 71 percent 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 88, 96, and 62 NDA supplements in 2007, 2008, and 2009, respectively, for which submission of a patent declaration would be required. We estimate there will be 154 instances (based on an average of 72 NDA approvals and 82 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 2.6 declarations ((361 patent declarations + 45 no relevant patent declarations) / 154 instances = 2.6 declarations per instance) on Form FDA 3542. We filed 120, 113, and 118 NDAs in 2007, 2008, and 2009, respectively, and 145, 99, and 104 NDA supplements in 2007, 2008, and 2009, respectively, for which submission of a patent declaration would be required. We estimate there will be 233 instances (based on an average of 117 NDAs filed and 116 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 606 declarations (233 instances x 2.6 declarations per instance = 606 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 3542a and 3542 will be approximately 20 hours and 5 hours per response, respectively.

On December 3, 2008, FDA announced in the Federal Register (73 FR 73659) the availability of a draft guidance for industry entitled “Submission of Patent Information for Certain Old Antibiotics.” That draft guidance, if finalized, would provide information regarding FDA's current thinking on the implementation of section 4(b)(1) of the Q1 Program Supplemental Funding Act (Public Law 110-379). Section 4(b)(1) of the Q1 Act requires submission to FDA of patent information by sponsors of certain NDAs containing old antibiotics. Estimates on the number of Forms FDA 3542a and 3542 that might be submitted in accordance with a finalized guidance have been included in table 1 of this document.

Dated: July 1, 2010.

Leslie Kux,

Acting Assistant Commissioner for Policy.