[Federal Register Volume 84, Number 97 (Monday, May 20, 2019)]
[Notices]
[Pages 22858-22860]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-10421]


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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 or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(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 reporting requirements for submission and 
listing of patent information associated with a new drug application 
(NDA), an amendment or a supplement to an NDA.

DATES: Submit either electronic or written comments on the collection 
of information by July 19, 2019.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before July 19, 2019. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of July 19, 2019. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, 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.'' Received comments, those filed in a timely 
manner (see ADDRESSES), will be placed in the docket and, except for 
those submitted as ``Confidential Submissions,'' publicly viewable at 
https://www.regulations.gov or at the Dockets Management Staff 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

[[Page 22859]]

for public viewing and posted on https://www.regulations.gov. Submit 
both copies to the Dockets Management Staff. 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: 
https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
[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 Food and Drug Administration Approval To Market a New 
Drug: Patent Submission and Listing Requirements

OMB Control Number 0910-0513--Extension

    Section 505(b)(1) of the Federal Food, Drug, and Cosmetic Act (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 
that claims the drug for which the applicant submitted the application 
or that 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 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. 
After approval of an NDA, under section 505(b)(1) of the FD&C Act, FDA 
publishes the patent information in the list entitled ``Approved Drug 
Products with Therapeutic Equivalence Evaluations'' (the Orange Book). 
When the patent information is submitted after NDA approval, section 
505(c)(2) of the FD&C Act directs FDA to publish the patent information 
upon its submission.
    FDA regulations in 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 to an NDA, and also require persons submitting an NDA, 
an amendment, or a supplement to make a detailed patent declaration on 
Form FDA 3542a, or when submitting information on a patent after 
approval of the NDA or supplement, to make a detailed patent 
declaration using Form FDA 3542.
    The reporting burden for submitting an NDA, an amendment, or a 
supplement to an NDA in accordance with Sec.  314.50(a) through (f), 
(i), (h), and (k) has been estimated by FDA and the collection of 
information has been approved by OMB under control number 0910-0001. In 
addition, the reporting burden for submitting an appropriate patent 
certification or statement for each patent listed in the Orange Book 
for one drug product approved in an NDA that is pharmaceutically 
equivalent to the proposed drug product for which the original 
505(b)(2) application was submitted (if certain criteria are met) in 
accordance with Sec.  314.50(i)(1)(i)(C) and the reporting burden for 
submitting an amended patent certification in certain circumstances in 
accordance with Sec.  314.50(i)(6) are approved by OMB under OMB 
control number 0910-0786. In addition, the reporting burden for 
responding to a patent listing dispute in accordance with Sec.  
314.53(f)(1) and the reporting burden for submitting corrections, 
changes, or withdrawal of patent information in accordance with Sec.  
314.53(f)(2) also are approved by OMB under OMB control number 0910-
0786. We are not re-estimating these approved burdens in this document. 
Only the reporting burdens associated with patent submission and 
listing, as described below, are estimated in this document.
    The information collection reporting requirements are as follows:
    Section 314.50(h) requires that an NDA, or an amendment or a 
supplement to an NDA, contain patent information described under Sec.  
314.53. Section 314.53 requires that an applicant submitting an NDA, or 
an amendment or a supplement to an NDA, except as provided in Sec.  
314.53(d)(2), submit on Forms FDA 3542 and 3542a the required patent 
information described in this section. Section 314.53(d)(2) requires 
submission of patent information only for a supplement that seeks 
approval to add or change the dosage form or route of administration, 
to add or change the strength, to change the drug product from 
prescription to over-the-counter use, or to revise previously submitted 
patent information that differently or no longer claims the product as 
changed by the supplement.
    Compliance with the information collection burdens under Sec. Sec.  
314.50(h) and 314.53 consists of submitting with an NDA, or an 
amendment or a supplement to an NDA (collectively referred to as an 
``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

[[Page 22860]]

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(s) 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(s) of use of the product for listing 
in the Orange Book. 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. In addition, an NDA applicant's amendment to 
the description of the approved method(s) of use claimed by the patent 
must be submitted within the timeframes described in Sec. Sec.  
314.50(i)(4) and 314.94(a)(12)(vi) (21 CFR 314.94(a)(12)(vi)) to be 
considered timely filed.
    Description of Respondents: The respondents to this collection of 
information are NDA applicants for original applications, amendments, 
or supplements to an NDA or NDA applicants submitting information on a 
patent after approval of the NDA or supplement.
    The final rule ``Abbreviated New Drug Applications and 505(b)(2) 
Applications,'' implemented portions of Title XI of the Medicare 
Prescription Drug, Improvement and Modernization Act of 2003 (MMA) and 
also amended certain regulations regarding 505(b)(2) applications and 
abbreviated new drug applications (ANDAs) to facilitate compliance with 
and efficient enforcement of the FD&C Act (81 FR 69580; October 6, 
2016) (MMA Final Rule). In the MMA Final Rule, we estimated that the 
burden for Form FDA 3542a would be reduced by 5 hours from 20 hours to 
15 hours per response; we further estimated that the burden for Form 
FDA 3542 would increase by 5 hours from 5 to 10 hours per response. The 
burden hours were adjusted to shift a portion of the time spent 
preparing Form FDA 3542a to the estimated time spent preparing Form FDA 
3542 to reflect the additional time spent by the NDA holder to develop 
the use code in accordance with FDA's revised regulations and identify 
the specific section(s) and subsection(s) of labeling that describe the 
specific approved method of use claimed by the patent. The burden hours 
of Forms FDA 3542 and 3542a in this notice reflect the reporting burden 
approved by OMB under OMB control number 0910-0786 in connection with 
the MMA Final Rule. The effective date of the MMA Final Rule was 
December 5, 2016. Consequently, the annual reporting burden estimated 
below is based on calendar year 2017 data only to reflect the post-MMA 
Final Rule regulatory requirements and reporting burden estimate.
    FDA requests OMB approval for the following information collection:

                                   Table 1--Estimated Annual Reporting Burden
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                                                     Number of     Total annual
   21 CFR 314.50 (citing Sec.        Number of     responses per   responses CY      Hours per      Total hours
             314.53)                respondents     respondent         2017          response
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Form FDA 3542...................             281           2.875             808              10           8,080
Form FDA 3542a..................             310           2.084             646              15           9,690
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    Total.......................  ..............  ..............  ..............  ..............          17,770
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    For purposes of this analysis, we consider the number of 
respondents to correspond to the number of NDAs and efficacy 
supplements submitted or approved, respectively, in calendar year (CY) 
2017, even though one company may submit or hold multiple NDAs or may 
submit multiple efficacy supplements to one or more NDAs. FDA approved 
127 NDAs and 154 efficacy supplements to NDAs during CY 2017, which 
corresponds to 281 respondents. Based on information provided by the 
Orange Book staff, approximately 623 patent records were created in CY 
2017, which corresponds to an estimated 513 Forms FDA 3542 submitted to 
FDA for listing of patent information in the Orange Book for NDAs 
approved in CY 2017 and an estimated 110 Forms FDA 3542 submitted to 
FDA for listing of patent information in the Orange Book for efficacy 
supplements approved in CY 2017. In addition, based on information 
provided by the Orange Book staff and FDA's experience, we estimate 
that approximately 185 Forms FDA 3542 were submitted in CY 2017 to 
modify patent information, which results in an estimated total of 808 
Forms FDA 3542 submitted in CY 2017.
    During calendar year 2017, FDA received 141 original NDAs and 169 
efficacy supplements to NDAs for FDA review and approval. We estimate 
that applicants submitted approximately 405 Forms FDA 3542a for the 
original NDAs submitted during CY 2017. In addition, based on a review 
of the submitted efficacy supplements, FDA received 241 Forms FDA 3542a 
with the efficacy supplements received during CY 2017, resulting in a 
total of 646 Forms FDA 3542a submitted in CY 2017.
    Our estimated burden for the information collection reflects an 
overall decrease. We attribute this adjustment to a decrease in the 
number of duplicative submissions of Forms FDA 3542a and 3542 in 
connection with supplements submitted or approved after the effective 
date of the MMA final rule, and improved data collection from upgraded 
data software tools.

    Dated: May 14, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-10421 Filed 5-17-19; 8:45 am]
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