
[Federal Register Volume 78, Number 116 (Monday, June 17, 2013)]
[Notices]
[Pages 36193-36194]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-14299]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0662]


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

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 either electronic or written comments on the collection 
of information by August 16, 2013.

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: Ila S. Mizrachi, Office of Information 
Management, Food and Drug Administration, 1350 Piccard Dr., P150-400B, 
Rockville, MD 20850, 301-796-7726, Ila.Mizrachi@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 
FD&C 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 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 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 Forms FDA 3542 
and 3542a.
    The reporting burden for submitting an NDA, an amendment, or a 
supplement in accordance with Sec.  314.50

[[Page 36194]]

(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 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 FDA 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 FDA 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 FDA 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 FDA 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 FDA 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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                                                     Number of                        Average
   21 CFR 314.50  (citing Sec.       Number of     responses per   Total annual     burden per      Total hours
             314.53)                respondents     respondent       responses       response
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Form FDA 3542...................             183             2.8             512               5           2,560
Form FDA 3542a..................             201             2.8             563              20          11,260
    Total.......................          13,820
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\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 2010, 2011, and 2012 were 351, 329, and 458, respectively, for 
an annual average of 379 (351 patents + 329 patents + 458 patents)/3 
years = 379 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 53 (379 
patents x 14 percent) patents will be multiple listings, and there will 
be a total of 432 patents (379 patents + 53 patents = 432 patents) 
declared on Form FDA 3542. We approved 84, 93, and 86 NDAs in 2010, 
2011, and 2012, respectively, of which approximately 71 percent 
submitted patent information for listing in the Orange Book. The 
remaining NDAs submitted Form FDA 3542 as required and declared that 
there were no relevant patents. We also approved approximately 101, 83, 
and 101 NDA supplements in 2010, 2011, and 2012, respectively, for 
which submission of a patent declaration would be required. We estimate 
there will be 183 instances (based on an average of 88 NDA approvals 
and 95 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 2.8 declarations (432 patent 
declarations + 76 no relevant patent declarations)/183 instances = 2.8 
declarations per instance) on Form FDA 3542. We filed 96, 91, and 112 
NDAs in 2010, 2011, and 2012, respectively, and 100, 91, and 112 NDA 
supplements in 2010, 2011, and 2012, respectively, for which submission 
of a patent declaration would be required. We estimate there will be 
201 instances (based on an average of 100 NDAs filed and 101 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 563 declarations (201 
instances x 2.8 declarations per instance = 563 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 Forms FDA 3542 and 3542a will be 
approximately 5 hours and 20 hours per response, respectively.

    Dated: June 11, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-14299 Filed 6-14-13; 8:45 am]
BILLING CODE 4160-01-P


