Marketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic Act; Content and Format; Draft Guidance for Industry; Availability, 749-752 [2019-00458]
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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.’’ FDA
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://
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copies to the Dockets Management Staff.
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contact information be made publicly
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information on the cover sheet and not
in the body of your comments and you
must identify the 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/201523389.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:
Cindy Chee, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 31, Rm. 2417, Silver Spring,
MD 20993–0002, 301–796–9001, Fax:
301–847–8533, email: PADAC@
fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area). A notice in the
Federal Register about last minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
FDA’s website at https://www.fda.gov/
AdvisoryCommittees/default.htm and
scroll down to the appropriate advisory
committee meeting link, or call the
advisory committee information line to
learn about possible modifications
before coming to the meeting.
SUPPLEMENTARY INFORMATION:
Agenda: The committee will discuss
new drug application (NDA) 208646,
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submitted by AllerQuest, LLC, for a
skin-test kit (proposed trade name PRE–
PEN Plus) that combines the approved
product PRE–PEN (benzylpenicilloyl
polylysine for injection) with penicillin
G potassium, penicilloic acid, penilloic
acid, and amoxicillin sodium, for the
proposed indication to detect IgE
sensitization to penicillin antigens and
reliably rule out the potential for
immediate life-threatening penicillin
allergic reactions with a high degree of
probability in patients with history of
possible IgE-dependent penicillin
allergy. The discussion will include
study design considerations, the
contribution of each of the components,
and whether the submitted data provide
substantial evidence of efficacy.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its website prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s website after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. All electronic and
written submissions made to the Docket
(see ADDRESSES) on or before March 13,
2019, will be provided to the committee.
Oral presentations from the public will
be scheduled between approximately 1
p.m. and 2 p.m. Those individuals
interested in making formal oral
presentations should notify the contact
person and submit a brief statement of
the general nature of the evidence or
arguments they wish to present, the
names and addresses of proposed
participants, and an indication of the
approximate time requested to make
their presentation on or before March 5,
2019. Time allotted for each
presentation may be limited. If the
number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by March 6, 2019.
Persons attending FDA’s advisory
committee meetings are advised that
FDA is not responsible for providing
access to electrical outlets.
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For press inquiries, please contact the
Office of Media Affairs at fdaoma@
fda.hhs.gov or 301–796–4540.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with disabilities.
If you require accommodations due to a
disability, please contact Cindy Chee
(see FOR FURTHER INFORMATION CONTACT)
at least 7 days in advance of the
meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our website at
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: January 23, 2019.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2019–00492 Filed 1–30–19; 8:45 am]
BILLING CODE 4164–01–P
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.
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
SUMMARY:
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Federal Register / Vol. 84, No. 21 / Thursday, January 31, 2019 / Notices
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:
amozie on DSK3GDR082PROD with NOTICES1
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
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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/201523389.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, elizabeth.giaquinto@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
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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
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Federal Register / Vol. 84, No. 21 / Thursday, January 31, 2019 / Notices
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.
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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
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751
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)).
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TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
Total annual
responses
Hours per
response
Total hours
Notification of Withdrawal from Sale ...................
Notification of Drug Not Available for Sale, and
Notification that Commercial Marketing Has
Commenced ....................................................
523
1
523
0.5 (30 minutes)
261.5
30
1
30
0.75 (45 minutes)
22.5
Total .............................................................
..................................
..................................
..................................
..................................
284
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
responses per
respondent
Number of
respondents
One-Time Report on Marketing Status ...............
1 There
925
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
10,319
Food and Drug Administration
[Docket No. FDA–2019–N–0176]
Neurological Devices Panel of the
Medical Devices Advisory Committee;
Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
Notice.
The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
meeting of the Neurological Devices
Panel of the Medical Devices Advisory
Committee. The general function of the
committee is to provide advice and
recommendations to the Agency on
FDA’s regulatory issues. The meeting
will be open to the public.
DATES: The meeting will be held on
March 21, 2019, from 8 a.m. to 5 p.m.
ADDRESSES: Hilton Washington, DC
North/Gaithersburg, Salons A, B, C, and
D, 620 Perry Pkwy., Gaithersburg, MD
20877. The hotel’s phone number is
301–977–8900; additional information
available online at: https://
SUMMARY:
VerDate Sep<11>2014
20:21 Jan 30, 2019
www3.hilton.com/en/hotels/maryland/
hilton-washington-dc-northgaithersburg-GAIGHHF/
index.html?SEO_id=GMB-HIGAIGHHF%20. Answers to commonly
asked questions including information
regarding special accommodations due
to a disability, visitor parking, and
transportation may be accessed at:
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm408555.htm.
FOR FURTHER INFORMATION CONTACT:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
amozie on DSK3GDR082PROD with NOTICES1
11.16
Hours per
response
0.5 (30 minutes)
Total hours
5,159.5
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/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm or https://
www.regulations.gov.
ACTION:
Total annual
responses
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Aden Asefa, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. G642, Silver Spring,
MD 20993–0002, Aden.Asefa@
fda.hhs.gov, 301–796–0400, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area). A notice in the
Federal Register about last minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
Agency’s website at https://
www.fda.gov/AdvisoryCommittees/
default.htm and scroll down to the
appropriate advisory committee meeting
link, or call the advisory committee
information line to learn about possible
modifications before coming to the
meeting.
SUPPLEMENTARY INFORMATION:
Agenda: On March 21, 2019, the
committee will discuss and make
recommendations on clinical
information related to the de novo
request for the NeuroAD Therapy
System by Neuronix, Ltd. The NeuroAD
Therapy System is intended to provide
concurrent neurostimulation and
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cognitive training for the treatment of
mild to moderate Alzheimer’s dementia.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its website prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s website after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before March 1, 2019. Oral
presentations from the public will be
scheduled on March 21, 2019, between
approximately 1 p.m. and 2 p.m. Those
individuals interested in making formal
oral presentations should notify the
contact person and submit a brief
statement of the general nature of the
evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
requested to make their presentation on
or before February 21, 2019. Time
allotted for each presentation may be
limited. If the number of registrants
requesting to speak is greater than can
be reasonably accommodated during the
scheduled open public hearing session,
FDA may conduct a lottery to determine
the speakers for the scheduled open
public hearing session. The contact
person will notify interested persons
regarding their request to speak by
February 22, 2019.
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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, elizabeth.giaquinto@fda.hhs.gov.
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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Number of responses Total annual
respondents per respondent responses Hours per response Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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
