[Federal Register Volume 84, Number 21 (Thursday, January 31, 2019)]
[Notices]
[Pages 749-752]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-00458]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-4615]


Marketing Status Notifications Under Section 506I of the Federal 
Food, Drug, and Cosmetic Act; Content and Format; Draft Guidance for 
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft guidance for industry entitled ``Marketing 
Status Notifications Under Section 506I of the Federal Food, Drug, and 
Cosmetic Act; Content and Format.'' This draft guidance is intended to 
assist holders of new drug applications (NDAs) and abbreviated new drug 
applications (ANDAs) approved under the Federal Food, Drug, and 
Cosmetic Act (FD&C Act) with their submission of required marketing 
status notifications.

DATES: Submit either electronic or written comments on the draft 
guidance by April 1, 2019 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance. Submit either electronic or written

[[Page 750]]

comments concerning the collection of information proposed in the draft 
guidance by April 1, 2019.

ADDRESSES: You may submit comments on any guidance at any time as 
follows:

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-2018-D-4615 for ``Marketing Status Notifications Under Section 506I 
of the Federal Food, Drug, and Cosmetic Act; Content and Format.'' 
Received comments 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 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.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to 
the Division of Drug Information, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10001 New Hampshire Ave., 
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one 
self-addressed adhesive label to assist that office in processing your 
requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Elizabeth Giaquinto Friedman, Center 
for Drug Evaluation and Research, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 75, Rm. 1670, Silver Spring, MD 20993-0002, 
240-402-7930, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Marketing Status Notifications Under Section 506I of the 
Federal Food, Drug, and Cosmetic Act; Content and Format.'' This draft 
guidance is intended to assist holders of NDAs and ANDAs approved under 
the FD&C Act with their submission of required marketing status 
notifications. The FDA Reauthorization Act of 2017 (Pub. L. 115-52) 
(FDARA) added section 506I to the FD&C Act (21 U.S.C. 356i), which 
imposes additional reporting requirements on NDA and ANDA holders 
regarding the marketing status of approved drug products. This draft 
guidance identifies the required content for these marketing status 
notifications and the format by which these notifications should be 
submitted to the Agency.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on ``Marketing 
Status Notifications Under Section 506I of the Federal Food, Drug, and 
Cosmetic Act; Content and Format.'' It does not establish any rights 
for any person and is not binding on FDA or the public. You can use an 
alternative approach if it satisfies the requirements of the applicable 
statutes and regulations. This guidance is not subject to Executive 
Order 12866.

II. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act (44 U.S.C. 3501-3520) (the PRA), 
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 before submitting the collection to OMB for approval. To 
comply with this requirement, FDA is publishing the proposed collection 
of information set forth in this notice of availability that would 
result from the submission of these FDARA notifications.
    With respect to the following collection of information, FDA 
invites comment on these topics: (1) Whether the proposed collection of 
information is necessary for the proper performance

[[Page 751]]

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 on respondents, including 
through the use of automated collection techniques, when appropriate, 
and other forms of information technology.
    Title: Marketing Status Notifications Under Section 506I of the 
Federal Food, Drug, and Cosmetic Act; Content and Format; Draft 
Guidance for Industry
    Description: The draft guidance describes the FDARA requirement 
that NDA and ANDA holders must notify FDA of the marketing status of 
drug products approved under an NDA and ANDA. Applicants must provide 
the following information:
    Notification of Withdrawal from Sale: NDA and ANDA holders must 
provide a written notification to FDA 180 days prior to withdrawing an 
approved drug from sale. Pursuant to section 506I(a) of the FD&C Act, 
the notification of a withdrawal from sale must include the following 
information:
    1. The National Drug Code(s) under which the drug is listed (21 CFR 
part 207).
    2. The established name of the drug.
    3. The proprietary name of the drug, if applicable.
    4. The NDA or ANDA number.
    5. The strength of the drug.
    6. The date on which the drug is expected to no longer be available 
for sale.
    7. The reason for the withdrawal.
    The applicant should submit the notification of a withdrawal from 
sale in a letter to the applicable NDA or ANDA file through the 
electronic submissions gateway, as described in the draft guidance. The 
notification should prominently identify the submission as an 
``ADMINISTRATIVE CHANGE/NOT AVAILABLE FOR SALE.''
    Notification of Drug Not Available For Sale: NDA and ANDA holders 
must provide a written notification to FDA within 180 days of the date 
of approval of a drug if that drug will not be available for sale 
within 180 days of the date of approval. Pursuant to section 506I(b) of 
the FD&C Act, the notification that a drug is not available for sale 
within 180 days of the date of approval of the drug must include the 
following information:
    1. The established name of the drug.
    2. The proprietary name of the drug, if applicable.
    3. The NDA or ANDA number.
    4. The strength of the drug.
    5. The date on which the drug will be available for sale, if known.
    6. The reason for not marketing the drug after approval.
    The applicant should submit the notification that a drug will not 
be available for sale in a letter to the applicable NDA or ANDA file 
through the electronic gateway. The notification should prominently 
identify the submission as an ``ADMINISTRATIVE CHANGE/NOT AVAILABLE FOR 
SALE.'' Once marketing begins, FDA recommends that the NDA or ANDA 
holder notify FDA of the commenced marketing in a letter to the 
applicable NDA or ANDA file through the electronic gateway to ensure 
that appropriate changes can be made in the Agency's publication, 
Approved Drug Products With Therapeutic Equivalence Evaluations (the 
Orange Book). The notification should prominently identify the 
submission as an ``ADMINISTRATIVE CHANGE/NOTIFICATION OF COMMERCIAL 
MARKETING.''
    One-Time Report on Marketing Status: NDA and ANDA holders were 
required to provide a written notification to FDA by February 14, 2018, 
stating whether the NDA and ANDA holder's drug(s) in the active section 
of the Orange Book are available for sale or if one or more of the NDA 
or ANDA holder's drugs in the active section have been withdrawn from 
sale or have never been available for sale. This report was required to 
indicate whether:
    1. All of the NDA or ANDA holder's drugs in the active section of 
the Orange Book were available for sale or
    2. One or more of the NDA or ANDA holder's drugs in the active 
section of the Orange Book had been withdrawn from sale or had never 
been available for sale.
    We estimate that a total of approximately 523 applicants (``number 
of respondents'' in table 1) will submit annually approximately 523 
Notifications of Withdrawal from Sale as described in the draft 
guidance (``total annual responses'' in table 1). We estimate that 
preparing and submitting each notification will take approximately 30 
minutes (``hours per response'' in table 1). We base our estimates for 
the number of applicants and the number of notifications on information 
from our database of NDA and ANDA submissions. Our estimate of the time 
applicants would need to prepare and submit each notification is based 
on our familiarity with receiving these types of notifications.
    We estimate that a total of approximately 30 applicants (``number 
of respondents'' in table 1) will submit annually approximately 30 
Notifications of Drug Not Available for Sale as described in the draft 
guidance (``total annual responses'' in table 1). We estimate that 
preparing and submitting each notification will take approximately 30 
minutes (``hours per response'' in table 1). We base our estimates for 
the number of applicants and the number of notifications on information 
from our database of NDA and ANDA submissions. Our estimate of the time 
applicants would need to prepare and submit each notification is based 
on our familiarity with receiving these types of notifications. Once 
marketing begins, we estimate that these applicants will notify FDA of 
commenced marketing by submitting Notifications of Commercial Marketing 
as described in the draft guidance. We estimate that preparing and 
submitting each notification that commercial marketing has commenced 
will take approximately 15 minutes (``hours per response'' in table 1).
    A total of approximately 925 applicants (``number of respondents'' 
in table 2) submitted approximately 10,319 One-Time Reports on 
Marketing Status as described in the draft guidance (``total annual 
responses'' in table 2). We estimate that preparing and submitting each 
notification as described in the draft guidance took approximately 30 
minutes (``hours per response'' in table 2). We base our estimates of 
the number of applicants and the number of notifications on the actual 
number of one-time reports on marketing status submitted prior to 
February 14, 2018. Our estimate of the time applicants needed to 
prepare and submit each notification is based on our familiarity with 
receiving these types of notifications.
    Under the PRA, FDA has already estimated and OMB has approved under 
control number 0910-0001 the collection of information contained in the 
submission of NDA and ANDA marketing status reports (e.g., notification 
of withdrawal from sale; notification of drug not available for sale) 
and related amendments, supplements, and other notifications required 
under subpart B and subpart C of part 314 in Title 21 of the Code of 
Federal Regulations (see, e.g., 21 CFR 314.81(b)(2)(ii)(a) and 
(b)(3)(iv)).

[[Page 752]]



                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                      Number of       Number of responses      Total annual
                                                     respondents         per respondent         responses        Hours per response      Total hours
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Notification of Withdrawal from Sale...........                  523                    1                  523     0.5 (30 minutes)                261.5
Notification of Drug Not Available for Sale,                      30                    1                   30    0.75 (45 minutes)                 22.5
 and Notification that Commercial Marketing Has
 Commenced.....................................
                                                --------------------------------------------------------------------------------------------------------
    Total......................................  ...................  ...................  ...................  ...................                  284
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


                                                    Table 2--Estimated One-Time Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                      Number of       Number of responses      Total annual
                                                     respondents         per respondent         responses        Hours per response      Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
One-Time Report on Marketing Status............                  925                11.16               10,319     0.5 (30 minutes)              5,159.5
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or 
https://www.regulations.gov.

    Dated: January 17, 2019.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2019-00458 Filed 1-30-19; 8:45 am]
 BILLING CODE 4164-01-P