
[Federal Register Volume 75, Number 67 (Thursday, April 8, 2010)]
[Notices]
[Pages 17924-17925]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-7891]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
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 Valid 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 an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the reporting requirements for 
submission and listing of patent information associated with a new drug 
application (NDA), an amendment, or a supplement.

DATES: Submit written or electronic comments on the collection of 
information by June 7, 2010.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the 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: 
Elizabeth.Berbakos@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

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 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 (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 act, we publish patent 
information after approval of an NDA application 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 Sec. Sec.  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 
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

[[Page 17925]]

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

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                              No. of       No. of Responses per     Total Annual        Hours per
  21 CFR Section Sec.   314.50 (citing Sec.   314.53)      Respondents          Respondent           Responses           Response         Total Hours
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Form FDA 3542a                                                        233                   2.6                606                 20             12,120
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Form FDA 3542                                                         154                   2.6                400                  5              2,000
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Total Reporting Burden Hours:                                                                                                                     14,120
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\1\ There are no operating and maintenance costs or capital 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% 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 
``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: April 2, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-7891 Filed 4-7-10; 8:45 am]
BILLING CODE 4160-01-S


