Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Providing Regulatory Submissions in Electronic and Non-Electronic Format-Promotional Labeling and Advertising Materials for Human Prescription Drugs, 13302-13304 [2019-06565]
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Federal Register / Vol. 84, No. 65 / Thursday, April 4, 2019 / Notices
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
Type of respondent
Total annual
records
Average
burden per
recordkeeping
Total hours
Manufacturers of an Unapproved EUA Product ..................
Public Health Authorities; Unapproved EUA Product ..........
12
30
2
3
24
90
25
3
600
270
Total ..............................................................................
........................
........................
........................
........................
870
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimated annual reporting
burden for the information collection
reflects an overall increase of 239 hours
since our last request for OMB approval.
We attribute this adjustment to an
increase in the number of submissions
we received.
Dated: March 29, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019–06553 Filed 4–3–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–D–1163]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Providing
Regulatory Submissions in Electronic
and Non-Electronic Format—
Promotional Labeling and Advertising
Materials for Human Prescription
Drugs
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by May 6,
2019.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–NEW and
title ‘‘Providing Regulatory Submissions
in Electronic and Non-Electronic
SUMMARY:
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Number of
records per
recordkeeper
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Format—Promotional Labeling and
Advertising Materials for Human
Prescription Drugs.’’ Also include the
FDA docket number found in brackets
in the heading of this document.
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, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Providing Regulatory Submissions in
Electronic and Non-Electronic
Format—Promotional Labeling and
Advertising Materials for Human
Prescription Drugs—OMB Control
Number 0910–NEW
This information collection request
supports recommendations found in the
Agency guidance document entitled,
‘‘Providing Regulatory Submissions in
Electronic and Non-Electronic Format—
Promotional Labeling and Advertising
Materials for Human Prescription
Drugs.’’ The guidance document
outlines the requirements and
recommendations for manufacturers,
packers, and distributors (firms) that
may either be the applicant or acting on
behalf of the applicant, to make
submissions pertaining to promotional
materials for human prescription drugs
(‘‘drugs’’) to the Office of Prescription
Drug Promotion (OPDP) in the Center
for Drug Evaluation and Research
(CDER) and the Advertising and
Promotional Labeling Branch (APLB) in
the Center for Biologics Evaluation and
Research (CBER). References to ‘‘drugs’’
in the guidance also include human
biological products that fall within the
definition of ‘‘drug’’ under section
201(g) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C.
321(g)).
The guidance describes the various
types of submissions of promotional
materials and general considerations for
submissions. The guidance discusses
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the specific aspects of submission of
promotional materials using module 1
of the electronic Common Technical
Document (eCTD) using version 3.3 or
higher of the us-regional-backbone file.
The guidance does not address the more
general requirements for a valid
electronic submission using eCTD or the
specifications for module 1 of the eCTD.
The guidance contains both binding and
nonbinding provisions. The provisions
that are binding implement section
745A(a) of the FD&C Act (21 U.S.C.
379k–1(a)), which requires that certain
submissions be submitted in electronic
format specified by FDA, beginning no
earlier than 24 months after FDA issues
a final guidance specifying such
electronic submission format.
The guidance provides
recommendations for what to include
with each type of submission and the
number of copies to include if it is a
paper submission. For promotional
labeling submitted for advisory
comments, including resubmissions, a
submission generally includes
correspondence stating that it is a
request for advisory comments, a clean
version of the draft promotional
materials, an annotated copy of the
promotional materials, and the most
current FDA-approved prescribing
information (PI); if applicable, a
submission also includes the FDAapproved patient labeling or Medication
Guide with annotations cross-referenced
to the proposed promotional materials
and annotated references to support
product and disease or epidemiology
claims not contained in the PI crossreferenced to the promotional material.
Amendments should be submitted if the
previous submission to FDA is missing
one or more promotional materials or if
an incorrect document file was included
with a submission in eCTD format.
Amendments should include
correspondence stating it is an
amendment and include the
accompanying materials that were
previously missing, an annotated copy
of the promotional materials that were
omitted from a previous submission to
FDA, the FDA-approved patient labeling
or Medication Guide with annotations
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Federal Register / Vol. 84, No. 65 / Thursday, April 4, 2019 / Notices
cross-referenced to the proposed
promotional materials, and annotated
references to support product and
disease or epidemiology claims not
contained in the PI cross-referenced to
the promotional material.
General correspondence submissions
and submissions requesting to withdraw
a previous submission to FDA include
correspondence stating the purpose of
the submission.
Responses to untitled or warning
letter submissions include
correspondence stating that it is a
response to an untitled or warning
letter, and include the firm’s initial or
subsequent responses and the corrective
piece(s), if applicable.
Responses to information request
submissions include the firm’s response
to the questions and issues raised in
FDA’s letter of inquiry, including any
materials that FDA has requested.
Reference document submissions
include correspondence stating that it is
a reference document submission and
the specific information regarding what
is in the submission along with the
annotated references, annotated
promotional materials, and/or annotated
labeling.
Promotional labeling submitted for
advisory comments, including
resubmissions and amendments; general
correspondence; requests to withdraw a
previous submission; responses to
untitled or warning letters; responses to
information requests; and reference
documents can be submitted in paper or
electronic form, and the burden
estimates for these submissions in table
1 apply to both paper and electronic
form.
Complaints include correspondence
stating that it is a complaint and
supporting information or
documentation, if available. Complaints
are not accepted in electronic form and
should be submitted as paper copies.
The burden estimate for complaints in
table 1 thus applies to paper copies
only.
The guidance also describes the
number of paper copies that should be
sent to OPDP and APLB for each
submission type (if applicable).
The guidance provides
recommendations for presentation
considerations such as appearance,
layout, format, and visible impression of
promotional materials submitted for all
promotional submission types.
The guidance also provides
instructions on how to submit
promotional labeling and advertising
materials to FDA electronically in eCTD
format. It explains that for submissions
of promotional materials that fall within
the ambit of section 745A(a) of the
FD&C Act (21 U.S.C. 379k–1(a)), as
amended by section 1136 of the Food
and Drug Administration Safety and
Innovation Act (Pub. L. 112–144), such
submissions must be made in the
electronic format specified by FDA in
the guidance, beginning no earlier than
24 months after the guidance is
finalized. Specifically, (1) postmarketing
submissions of promotional materials
using Form FDA 2253 (required by 21
CFR 314.81(b)(3)(i) and 601.12(f)(4)),
and (2) submissions of promotional
materials for accelerated approval
products (required by FD&C Act section
506(c)(2)(B) (21 U.S.C. 356(c)(2)(B)), and
21 CFR 314.550 and 601.45) and other
products where such submissions are
required for approval, fall within the
scope of section 745A(a) and are,
therefore, subject to the mandatory
electronic submission requirement.
When the mandatory electronic
submission requirement takes effect for
these types of submissions, they will be
accepted by CDER only in eCTD format
using version 3.3 or higher of the usregional-backbone file. CBER will be
able to accept eCTD submissions using
previous versions of the us-regionalbackbone file until 24 months after
publication of the guidance. The
guidance also provides that, while only
promotional submissions that fall under
section 745A(a) will be required to be
submitted electronically no sooner than
24 months after the guidance is
finalized, firms are strongly encouraged,
but not required, to submit
electronically the other types of
promotional submissions discussed in
the guidance.
In the Federal Register of April 22,
2015 (80 FR 22529), we published a 60day notice requesting public comment
on the proposed collection of
information. One comment was received
requesting clarification on the
submission of annotated versions of
promotional materials for Form FDA
2253 submissions. We appreciate the
comment and have revised the guidance
to further clarify that annotated versions
of promotional materials are
encouraged, not required. The guidance
was also revised to encourage the
submission of a CD copy of paper
submissions and burden estimates have
been updated accordingly. Any increase
in burden is expected to be nominal.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Type of submission
Total annual
responses
Average
burden per
response
(hours)
Total hours
Promotional labeling submitted for advisory comments, including resubmissions and amendments .........................
General correspondence submitted to FDA ........................
Requests to withdraw a previous submission to FDA .........
Responses to untitled or warning letters .............................
Responses to information requests .....................................
Reference documents ..........................................................
Complaints submitted to FDA ..............................................
76
84
15
7
6
7
82
13
4
1
2
1
2
1
1,024
359
22
13
3
14
117
51
3
3
13
13
13
13
52,224
1,077
66
169
39
182
1,521
Total ..............................................................................
........................
........................
........................
........................
55,278
1 There
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Number of
responses per
respondent
are no capital costs or operating and maintenance costs associated with this collection of information.
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Federal Register / Vol. 84, No. 65 / Thursday, April 4, 2019 / Notices
Our estimate is based on our
experience with the submission of
labeling materials for human
prescription drugs. Because this is a
new collection of information, we are
specifically interested in receiving
comments from respondents to the
information collection regarding our
burden estimate.
Dated: March 29, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019–06565 Filed 4–3–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–P–3883]
Determination That CORTISPORIN
(Hydrocortisone/Neomycin Sulfate/
Polymyxin B Sulfate) Otic Solution, 10
Milligrams/Milliliter Hydrocortisone, 3.5
Milligrams Base/Milliliter Neomycin
Sulfate, 10,000 Units/Milliliter
Polymyxin B Sulfate, Was Not
Withdrawn From Sale for Reasons of
Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) has
determined that CORTISPORIN
(hydrocortisone/neomycin sulfate/
polymyxin B sulfate) otic solution, 10
milligrams (mg)/milliliter (mL)
hydrocortisone, 3.5 mg base/mL
neomycin sulfate, 10,000 units/mL
polymyxin B sulfate, was not
withdrawn from sale for reasons of
safety or effectiveness. This
determination means that FDA will not
begin procedures to withdraw approval
of abbreviated new drug applications
(ANDAs) that refer to this drug product,
and it will allow FDA to continue to
approve ANDAs that refer to the
product as long as they meet relevant
legal and regulatory requirements.
FOR FURTHER INFORMATION CONTACT: Kate
Greenwood, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6286, Silver Spring,
MD 20993–0002, 240–402–1748.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
(the 1984 amendments), which
authorized the approval of duplicate
versions of drug products under an
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ANDA procedure. ANDA applicants
must, with certain exceptions, show that
the drug for which they are seeking
approval contains the same active
ingredient in the same strength and
dosage form as the ‘‘listed drug,’’ which
is a version of the drug that was
previously approved. ANDA applicants
do not have to repeat the extensive
clinical testing otherwise necessary to
gain approval of a new drug application
(NDA).
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)), which requires FDA to
publish a list of all approved drugs.
FDA publishes this list as part of the
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
which is known generally as the
‘‘Orange Book.’’ Under FDA regulations,
drugs are removed from the list if the
Agency withdraws or suspends
approval of the drug’s NDA or ANDA
for reasons of safety or effectiveness or
if FDA determines that the listed drug
was withdrawn from sale for reasons of
safety or effectiveness (21 CFR 314.162).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
from sale, but must be made prior to
approving an ANDA that refers to the
listed drug (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
CORTISPORIN (hydrocortisone/
neomycin sulfate/polymyxin B sulfate)
otic solution, 10 mg/mL hydrocortisone,
3.5 mg base/mL neomycin sulfate,
10,000 units/mL polymyxin B sulfate, is
the subject of NDA 050479, held by
Monarch Pharmaceuticals LLC, and
initially approved on December 9, 1975.
CORTISPORIN is indicated for the
treatment of superficial bacterial
infections of the external auditory canal
caused by organisms susceptible to the
action of the antibiotics.
CORTISPORIN (hydrocortisone/
neomycin sulfate/polymyxin B sulfate)
otic solution, 10 mg/mL hydrocortisone,
3.5 mg base/mL neomycin sulfate,
10,000 units/mL polymyxin B sulfate, is
currently listed in the ‘‘Discontinued
Drug Product List’’ section of the Orange
Book.
Foley & Lardner LLP submitted a
citizen petition dated October 11, 2018
(Docket No. FDA–2018–P–3883), under
§ 10.30 (21 CFR 10.30), requesting that
the Agency determine whether
CORTISPORIN (hydrocortisone/
neomycin sulfate/polymyxin B sulfate)
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Sfmt 4703
otic solution, 10 mg/mL hydrocortisone,
3.5 mg base/mL neomycin sulfate,
10,000 units/mL polymyxin B sulfate,
was withdrawn from sale for reasons of
safety or effectiveness.
After considering the citizen petition
and reviewing Agency records and
based on the information we have at this
time, FDA has determined under
§ 314.161 that CORTISPORIN
(hydrocortisone/neomycin sulfate/
polymyxin B sulfate) otic solution, 10
mg/mL hydrocortisone, 3.5 mg base/mL
neomycin sulfate, 10,000 units/mL
polymyxin B sulfate, was not
withdrawn for reasons of safety or
effectiveness. The petitioner has
identified no data or other information
suggesting that CORTISPORIN
(hydrocortisone/neomycin sulfate/
polymyxin B sulfate) otic solution, 10
mg/mL hydrocortisone, 3.5 mg base/mL
neomycin sulfate, 10,000 units/mL
polymyxin B sulfate, was withdrawn for
reasons of safety or effectiveness. We
have carefully reviewed our files for
records concerning the withdrawal of
CORTISPORIN (hydrocortisone/
neomycin sulfate/polymyxin B sulfate)
otic solution, 10 mg/mL hydrocortisone,
3.5 mg base/mL neomycin sulfate,
10,000 units/mL polymyxin B sulfate,
from sale. We have also independently
evaluated relevant literature and data
for possible postmarketing adverse
events. We have found no information
that would indicate that this drug
product was withdrawn from sale for
reasons of safety or effectiveness.
Accordingly, the Agency will
continue to list CORTISPORIN
(hydrocortisone/neomycin sulfate/
polymyxin B sulfate) otic solution, 10
mg/mL hydrocortisone, 3.5 mg base/mL
neomycin sulfate, 10,000 units/mL
polymyxin B sulfate, in the
‘‘Discontinued Drug Product List’’
section of the Orange Book. The
‘‘Discontinued Drug Product List’’
delineates, among other items, drug
products that have been discontinued
from marketing for reasons other than
safety or effectiveness. FDA will not
begin procedures to withdraw approval
of approved ANDAs that refer to this
drug product. Additional ANDAs for
this drug product may also be approved
by the Agency as long as they meet all
other legal and regulatory requirements
for the approval of ANDAs.
If FDA determines that labeling for
this drug product should be revised to
meet current standards, the Agency will
advise ANDA applicants to submit such
labeling.
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]]>Agencies
[Federal Register Volume 84, Number 65 (Thursday, April 4, 2019)]
[Notices]
[Pages 13302-13304]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06565]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-D-1163]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Providing Regulatory
Submissions in Electronic and Non-Electronic Format--Promotional
Labeling and Advertising Materials for Human Prescription Drugs
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by May 6,
2019.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax: 202-395-7285, or emailed to [email protected]. All
comments should be identified with the OMB control number 0910-NEW and
title ``Providing Regulatory Submissions in Electronic and Non-
Electronic Format--Promotional Labeling and Advertising Materials for
Human Prescription Drugs.'' Also include the FDA docket number found in
brackets in the heading of this document.
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: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Providing Regulatory Submissions in Electronic and Non-Electronic
Format--Promotional Labeling and Advertising Materials for Human
Prescription Drugs--OMB Control Number 0910-NEW
This information collection request supports recommendations found
in the Agency guidance document entitled, ``Providing Regulatory
Submissions in Electronic and Non-Electronic Format--Promotional
Labeling and Advertising Materials for Human Prescription Drugs.'' The
guidance document outlines the requirements and recommendations for
manufacturers, packers, and distributors (firms) that may either be the
applicant or acting on behalf of the applicant, to make submissions
pertaining to promotional materials for human prescription drugs
(``drugs'') to the Office of Prescription Drug Promotion (OPDP) in the
Center for Drug Evaluation and Research (CDER) and the Advertising and
Promotional Labeling Branch (APLB) in the Center for Biologics
Evaluation and Research (CBER). References to ``drugs'' in the guidance
also include human biological products that fall within the definition
of ``drug'' under section 201(g) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 321(g)).
The guidance describes the various types of submissions of
promotional materials and general considerations for submissions. The
guidance discusses the specific aspects of submission of promotional
materials using module 1 of the electronic Common Technical Document
(eCTD) using version 3.3 or higher of the us-regional-backbone file.
The guidance does not address the more general requirements for a valid
electronic submission using eCTD or the specifications for module 1 of
the eCTD. The guidance contains both binding and nonbinding provisions.
The provisions that are binding implement section 745A(a) of the FD&C
Act (21 U.S.C. 379k-1(a)), which requires that certain submissions be
submitted in electronic format specified by FDA, beginning no earlier
than 24 months after FDA issues a final guidance specifying such
electronic submission format.
The guidance provides recommendations for what to include with each
type of submission and the number of copies to include if it is a paper
submission. For promotional labeling submitted for advisory comments,
including resubmissions, a submission generally includes correspondence
stating that it is a request for advisory comments, a clean version of
the draft promotional materials, an annotated copy of the promotional
materials, and the most current FDA-approved prescribing information
(PI); if applicable, a submission also includes the FDA-approved
patient labeling or Medication Guide with annotations cross-referenced
to the proposed promotional materials and annotated references to
support product and disease or epidemiology claims not contained in the
PI cross-referenced to the promotional material. Amendments should be
submitted if the previous submission to FDA is missing one or more
promotional materials or if an incorrect document file was included
with a submission in eCTD format. Amendments should include
correspondence stating it is an amendment and include the accompanying
materials that were previously missing, an annotated copy of the
promotional materials that were omitted from a previous submission to
FDA, the FDA-approved patient labeling or Medication Guide with
annotations
[[Page 13303]]
cross-referenced to the proposed promotional materials, and annotated
references to support product and disease or epidemiology claims not
contained in the PI cross-referenced to the promotional material.
General correspondence submissions and submissions requesting to
withdraw a previous submission to FDA include correspondence stating
the purpose of the submission.
Responses to untitled or warning letter submissions include
correspondence stating that it is a response to an untitled or warning
letter, and include the firm's initial or subsequent responses and the
corrective piece(s), if applicable.
Responses to information request submissions include the firm's
response to the questions and issues raised in FDA's letter of inquiry,
including any materials that FDA has requested.
Reference document submissions include correspondence stating that
it is a reference document submission and the specific information
regarding what is in the submission along with the annotated
references, annotated promotional materials, and/or annotated labeling.
Promotional labeling submitted for advisory comments, including
resubmissions and amendments; general correspondence; requests to
withdraw a previous submission; responses to untitled or warning
letters; responses to information requests; and reference documents can
be submitted in paper or electronic form, and the burden estimates for
these submissions in table 1 apply to both paper and electronic form.
Complaints include correspondence stating that it is a complaint
and supporting information or documentation, if available. Complaints
are not accepted in electronic form and should be submitted as paper
copies. The burden estimate for complaints in table 1 thus applies to
paper copies only.
The guidance also describes the number of paper copies that should
be sent to OPDP and APLB for each submission type (if applicable).
The guidance provides recommendations for presentation
considerations such as appearance, layout, format, and visible
impression of promotional materials submitted for all promotional
submission types.
The guidance also provides instructions on how to submit
promotional labeling and advertising materials to FDA electronically in
eCTD format. It explains that for submissions of promotional materials
that fall within the ambit of section 745A(a) of the FD&C Act (21
U.S.C. 379k-1(a)), as amended by section 1136 of the Food and Drug
Administration Safety and Innovation Act (Pub. L. 112-144), such
submissions must be made in the electronic format specified by FDA in
the guidance, beginning no earlier than 24 months after the guidance is
finalized. Specifically, (1) postmarketing submissions of promotional
materials using Form FDA 2253 (required by 21 CFR 314.81(b)(3)(i) and
601.12(f)(4)), and (2) submissions of promotional materials for
accelerated approval products (required by FD&C Act section
506(c)(2)(B) (21 U.S.C. 356(c)(2)(B)), and 21 CFR 314.550 and 601.45)
and other products where such submissions are required for approval,
fall within the scope of section 745A(a) and are, therefore, subject to
the mandatory electronic submission requirement.
When the mandatory electronic submission requirement takes effect
for these types of submissions, they will be accepted by CDER only in
eCTD format using version 3.3 or higher of the us-regional-backbone
file. CBER will be able to accept eCTD submissions using previous
versions of the us-regional-backbone file until 24 months after
publication of the guidance. The guidance also provides that, while
only promotional submissions that fall under section 745A(a) will be
required to be submitted electronically no sooner than 24 months after
the guidance is finalized, firms are strongly encouraged, but not
required, to submit electronically the other types of promotional
submissions discussed in the guidance.
In the Federal Register of April 22, 2015 (80 FR 22529), we
published a 60-day notice requesting public comment on the proposed
collection of information. One comment was received requesting
clarification on the submission of annotated versions of promotional
materials for Form FDA 2253 submissions. We appreciate the comment and
have revised the guidance to further clarify that annotated versions of
promotional materials are encouraged, not required. The guidance was
also revised to encourage the submission of a CD copy of paper
submissions and burden estimates have been updated accordingly. Any
increase in burden is expected to be nominal.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of submission Number of responses per Total annual per response Total hours
respondents respondent responses (hours)
----------------------------------------------------------------------------------------------------------------
Promotional labeling submitted 76 13 1,024 51 52,224
for advisory comments,
including resubmissions and
amendments.....................
General correspondence submitted 84 4 359 3 1,077
to FDA.........................
Requests to withdraw a previous 15 1 22 3 66
submission to FDA..............
Responses to untitled or warning 7 2 13 13 169
letters........................
Responses to information 6 1 3 13 39
requests.......................
Reference documents............. 7 2 14 13 182
Complaints submitted to FDA..... 82 1 117 13 1,521
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Total....................... .............. .............. .............. .............. 55,278
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 13304]]
Our estimate is based on our experience with the submission of
labeling materials for human prescription drugs. Because this is a new
collection of information, we are specifically interested in receiving
comments from respondents to the information collection regarding our
burden estimate.
Dated: March 29, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-06565 Filed 4-3-19; 8:45 am]
BILLING CODE 4164-01-P
