[Federal Register Volume 81, Number 21 (Tuesday, February 2, 2016)]
[Notices]
[Pages 5465-5467]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-01782]


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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 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 either electronic or written comments on the collection 
of information by April 4, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2013-N-0662 for ``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.'' Received comments will be placed 
in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at http://www.regulations.gov or at 
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, [email protected].

[[Page 5466]]


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 Sec.  
505(b)(1) of the FD&C 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, Sec.  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 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 
below, 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.
    FDA requests OMB approval for the following information collection:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                  Number of
  21 CFR 314.50 (citing Sec.      Number of     responses per   Total annual      Hours per       Total hours
           314.53)               respondents     respondent       responses       response
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Form FDA 3542a...............             241             3.4             819              20             16,380
Form FDA 3542................             200             3.4             680               5              3,400
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    Total....................  ..............  ..............  ..............  ..............             19,780
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\1\ There are no capital costs, operating and maintenance costs associated with this collection of information.


[[Page 5467]]

    The numbers 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 (458 patents + 509 patents + 617 patents)/3 
years = 528 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 74 (528 
patents x 14 percent) patents will be multiple listings, and there will 
be a total of 602 patents (528 patents + 74 patents = 602 patents) 
declared on Form FDA 3542. We approved 86, 94, and 107 NDAs in calendar 
years 2012, 2013, and 2014, respectively, of which we estimate based on 
our previous review that 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, 101, and 110 NDA 
supplements in FYs 2012, 2013, and 2014, respectively, for which 
submission of a patent declaration would be required. We estimate there 
will be 200 instances (based on an average of 96 NDA approvals and 104 
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 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. 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 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 819 declarations (241 instances x 3.4 declarations 
per instance = 819 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: January 27, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-01782 Filed 2-1-16; 8:45 am]
BILLING CODE 4164-01-P