
[Federal Register Volume 81, Number 157 (Monday, August 15, 2016)]
[Notices]
[Pages 54097-54099]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-19385]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


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 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 or we) 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 (the PRA).

DATES: Fax written comments on the collection of information by 
September 14, 2016.

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 emailed 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: Food and Drug Administration, 8455 
Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, 
PRAStaff@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.

[[Page 54098]]

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 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.'' Under section 
505(b)(1), we publish the patent information after approval of the NDA 
in the list entitled ``Approved Drug Products with Therapeutic 
Equivalence Evaluations'' (the Orange Book). 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 that requires patent information 
be submitted after NDA approval when the NDA holder could not have 
submitted the patent information with its application. Under section 
505(c)(2) of the FD&C Act, we publish the patent information upon its 
submission.
    FDA regulations at Sec.  314.50(h) and Sec.  314.53 (21 CFR 
314.50(h) and 314.53) implement these statutory requirements and 
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. The 
regulations under Sec.  314.53 direct sponsors of an NDA, an amendment, 
or a supplement, to make detailed patent declarations using Forms FDA 
3542 and 3542a as appropriate. While the information collection burden 
for submitting other required elements of an NDA, an amendment, or 
supplement in accordance with Sec.  314.50(a) through (f), and (k) is 
approved under OMB control number 0910-0001, this information 
collection identifies burden associated with patent submission and 
listing, as explained below.
    Specifically, a patent declaration is required 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. 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. 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.
    Description of Respondents: The respondents to this collection of 
information are sponsors of an NDA, an amendment, or a supplement, or 
submitting information on a patent after NDA approval.
    In the Federal Register of February 2, 2016 (81 FR 5465), we 
published a 60-day notice requesting public comment on the proposed 
extension of this collection of information. One comment was received 
but was not responsive to the four collection of information topics 
solicited and is therefore not addressed.
    We estimate the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of
    21 CFR 314.50 and 314.53         Number of     responses per   Total annual     Burden per      Total hours
                                    respondents     respondent       responses       response
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Form FDA 3542; patent                        200             3.4             680               5           3,400
 information submitted upon and
 after approval of an NDA or
 supplement.....................
Form FDA 3542a; patent                       241             3.4             819              20          16,380
 information submitted with the
 filing of an NDA, amendment, or
 supplement.....................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          19,780
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The number of patents submitted to FDA for listing in the Orange 
Book in 2012, 2013, and 2014 were 458, 509, and 617, respectively, for 
an annual average of 528 patents ([458 + 509 + 617]/3 years = 528). 
Because many of these individual patents are included in multiple NDA 
submissions, there may be multiple declarations for a single patent. 
From our 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 74 patents (528 x 14 percent) will be multiple 
listings for a total of 602 patents (528 + 74 = 602) as declared on 
Form FDA 3542. We approved 86, 94, and 107 NDAs in calendar years 2012, 
2013, and 2014, respectively, of which we estimate 71 percent submitted 
patent information for listing in the Orange Book. The remaining Form 
FDA 3542 submissions declared that there were no relevant patents.
    We also approved approximately 101, 101, and 110 NDA supplements in 
FYs 2012, 2013, and 2014, respectively, for which submission of a 
patent declaration would be required. Based on an average of 96 NDA 
approvals and 104 supplement approvals annually, we estimate there will 
be 200 instances where an NDA holder would be affected by the patent 
declaration requirements, and that each of these NDA holders would, on 
average, submit 3.4 declarations (602 patent declarations + 74 no 
relevant patent declarations)/200 instances = 3.4 declarations per 
instance) on Form FDA 3542. We filed 112, 116, and 113 NDAs in 2012, 
2013, and 2014, respectively, and 112, 112, 156 NDA supplements in 
2012, 2013, and 2014, respectively, for which submission of a patent 
declaration would be required. Based upon informal communications with 
industry and our experience with the collection, we

[[Page 54099]]

estimate it will take 5 hours to complete Form FDA 3542.
    We estimate there will be 241 instances (based on an average of 114 
NDAs filed and 127 NDA supplements filed per year) where an NDA holder 
would comply with 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 819 such 
declarations (241 x 3.4 declarations per instance = 819). Based upon 
informal communications with industry and our experience with the 
collection, we estimate it will take 20 hours to complete Form FDA 
3542a.

    Dated: August 5, 2016.
Jeremy Sharp,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2016-19385 Filed 8-12-16; 8:45 am]
BILLING CODE 4164-01-P


