[Federal Register Volume 78, Number 116 (Monday, June 17, 2013)]
[Notices]
[Pages 36193-36194]
From the Federal Register Online via the Government Publishing 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, [email protected].
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]
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