Document ID: FDA-2010-N-0174-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Applications for Food and Drug Administration Approval to Market a New Drug: Patent Submission and Listing Requirements, etc.
Posted Date: 2010-07-09T04:00Z

[Federal Register: July 9, 2010 (Volume 75, Number 131)]
[Notices]               
[Page 39531-39533]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09jy10-40]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0174]

 
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 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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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: 202-395-7285, or e-mailed to oira_submission@omb.eop.gov. 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, 
Elizabeth.Berbakos@fda.hhs.gov.

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''

[[Page 39532]]

(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 Sec. Sec.  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 Sec.  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 Sec.  314.53.
    Section 314.53 requires that an applicant submitting an NDA, an 
amendment, or a supplement, except as provided in Sec.  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 Sec. Sec.  
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'' (Sec.  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 Burden\1\
----------------------------------------------------------------------------------------------------------------
  21 CFR
  Section
   Sec.
  314.50    No. of Respondents    Annual Frequency       Total Annual          Hours per          Total Hours
  (citing                           per Response           Responses           Response
   Sec.
  314.53)
----------------------------------------------------------------------------------------------------------------
Form FDA                   233                   2.6                 606              20                  12,120
 3542a
----------------------------------------------------------------------------------------------------------------
Form FDA                   154                   2.6                 400               5                   2,000
 3542
----------------------------------------------------------------------------------------------------------------
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 Sec.  
314.50(h) (citing Sec.  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

[[Page 39533]]

``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.
[FR Doc. 2010-16738 Filed 7-8-10; 8:45 am]
BILLING CODE 4160-01-S