Providing Regulatory Submissions in Electronic and Non-Electronic Format-Promotional Labeling and Advertising Materials for Human Prescription Drugs, Draft Guidance for Industry; Availability, 22529-22532 [2015-09297]
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Federal Register / Vol. 80, No. 77 / Wednesday, April 22, 2015 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–P–1896]
Determination That OXYTOCIN in 5%
Dextrose Injection Products Were 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Withdrawn From Sale for Reasons of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 OXYTOCIN 5 United
States Pharmacopeia (USP) Units in
Dextrose 5% (oxytocin), injectable,
injection, 5 USP Units in 500 milliliters
(mL), (1 USP Unit/100 mL); OXYTOCIN
10 USP Units in Dextrose 5%
(oxytocin), injectable, injection, 10 USP
Units in 500 mL, (2 USP Units/100 mL);
OXYTOCIN 10 USP Units in Dextrose
5% (oxytocin), injectable, injection, 10
USP Units in 1000 mL, (1 USP Unit/100
mL); and OXYTOCIN 20 USP Units in
Dextrose 5% (oxytocin), injectable,
injection, 20 USP Units in 1000 mL, (2
USP Units/100 mL), (hereinafter ‘‘these
oxytocin drug products’’) were not
withdrawn from sale for reasons of
safety or effectiveness. This
determination will allow FDA to
approve an abbreviated new drug
application (ANDA) for these oxytocin
drug products, if all other legal and
regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT:
Robin Fastenau, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6236,
Silver Spring, MD 20993–0002, 240–
402–4510.
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
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
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SUMMARY:
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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.
These oxytocin drug products are the
subject of NDA 019–185, held by Abbott
Laboratories, and initially approved on
March 29, 1985. These oxytocin drug
products are indicated for the initiation
or improvement of uterine contractions.
In a December 26, 1995, letter, Abbott
Laboratories notified FDA that these
oxytocin drug products were being
discontinued and requested withdrawal
of NDA 019–185. In the Federal
Register of March 27, 1996 (61 FR
13506), FDA announced that it was
withdrawing approval of NDA 019–185,
effective April 26, 1996. FDA has moved
these oxytocin drug products to the
‘‘Discontinued Drug Product List’’
section of the Orange Book.
TechReg Services, Inc. (TechReg),
submitted a citizen petition dated
November 12, 2014 (Docket No. FDA–
2014–P–1896), under 21 CFR 10.30,
requesting that the Agency determine
whether Oxytocin in Dextrose 5%,
injection, available as strengths 5, 10,
and 20 units under Abbott NDA 019–
185, were withdrawn from sale for
reasons of safety or effectiveness.
Although the citizen petition did not
specify the concentrations of the three
strengths associated with NDA 019–185,
we have considered whether any of
these oxytocin drug products approved
under NDA 019–185 were withdrawn
for safety or effectiveness reasons.
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 these oxytocin drug
products were not withdrawn for
reasons of safety or effectiveness.
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22529
TechReg has identified no data or other
information suggesting that these
oxytocin drug products were withdrawn
for reasons of safety or effectiveness. We
have carefully reviewed our files for
records concerning the withdrawal of
these oxytocin drug products 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 these oxytocin drug
products were withdrawn from sale for
reasons of safety or effectiveness.
Accordingly, the Agency will
continue to list these oxytocin drug
products 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.
ANDAs that refer to these oxytocin drug
products may be approved by the
Agency as long as they meet all other
legal and regulatory requirements for
the approval of ANDAs. FDA has
determined that labeling for these
oxytocin drug products should be
revised to meet current standards and
will advise ANDA applicants how to
submit such labeling.
Dated: April 16, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–09299 Filed 4–21–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–D–1163]
Providing Regulatory Submissions in
Electronic and Non-Electronic
Format—Promotional Labeling and
Advertising Materials for Human
Prescription Drugs, Draft Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Providing Regulatory
Submissions in Electronic and NonElectronic Format—Promotional
Labeling and Advertising Materials for
Human Prescription Drugs.’’ This draft
guidance explains how manufacturers,
packers, and distributors (firms) that
may either be the applicant or acting on
SUMMARY:
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Federal Register / Vol. 80, No. 77 / Wednesday, April 22, 2015 / Notices
behalf of the applicant, should make
submissions pertaining to promotional
materials for human prescription drugs
and biologic products (‘‘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). This draft guidance describes
the various types of submissions of
promotional materials and general
considerations for submissions. In
addition, this draft 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.
This guidance does not address the
more general requirements for a valid
electronic submission using eCTD or the
specifications for module 1 of the eCTD.
This guidance contains both binding
and nonbinding provisions.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comments on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by July 21, 2015.
Submit either electronic or written
comments on the proposed collection of
information by June 22, 2015.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Office of Communications, Division of
Drug Information, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10001 New
Hampshire Ave., Hillandale Bldg., 4th
Floor, Silver Spring, MD 20993–0002; or
to the Office of Communication,
Outreach and Development, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
3128, 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.
Submit electronic comments to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Regarding human prescription drugs:
Marci Kiester, Center for Drug
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Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 3368,
Silver Spring, MD 20993–0002, 301–
796–1200.
Regarding prescription human
biological products: Stephen Ripley,
Center for Biologics Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 71, Rm. 7301, Silver Spring,
MD 20993, 240–402–7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Providing Regulatory Submissions in
Electronic and Non-Electronic Format—
Promotional Labeling and Advertising
Materials for Human Prescription
Drugs.’’ This draft guidance is intended
to be used in conjunction with the draft
guidance for industry ‘‘Providing
Regulatory Submissions in Electronic
Format—Certain Human Pharmaceutical
Product Applications and Related
Submissions Using the eCTD
Specifications’’ 1 (eCTD Revised Draft
Guidance) and in conjunction with the
specification to industry ‘‘The eCTD
Backbone Files Specification for Module
1 Version 2.3.’’ 2
This draft guidance describes various
types of regulatory submissions of
promotional materials that firms submit
to CDER and CBER and general
considerations for such submissions.
For example, the draft guidance
describes the various types of voluntary
submissions (e.g., launch and nonlaunch voluntary submissions of draft
promotional materials for advisory
comments) and required submissions of
promotional labeling and advertising
materials (e.g., fulfillment of the
regulatory requirements for
postmarketing submissions of
promotional materials and submission
of promotional materials for accelerated
approval products). In addition, this
draft guidance discusses specific aspects
of the content and format for submitting
promotional materials in paper hard
copy and electronic format, including
how to submit promotional materials
electronically in module 1 of the eCTD
using version 3.3 or higher of the usregional-backbone file. This draft
1 The draft guidance for industry is available on
the FDA eCTD Web page at https://www.fda.gov/
downloads/Drugs/
GuidanceComplianceRegulatoryInformation/
Guidances/UCM333969.pdf.
2 The specification for industry is available on the
FDA eCTD Module 1 Web page at https://
www.fda.gov/Drugs/DevelopmentApprovalProcess/
FormsSubmissionRequirements/
ElectronicSubmissions/ucm253101.htm.
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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. This
draft guidance provides
recommendations for presentation
considerations such as appearance,
layout, format, and visible impression of
promotional materials submitted for all
promotional submission types.
This draft 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, 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 this guidance and the eCTD Revised
Draft Guidance, beginning no earlier
than 24 months after this guidance is
finalized. Specifically, (1) postmarketing
submissions of promotional materials
using Form FDA 2253 (required by 21
CFR 314.81(b)(3)(i) and 21 CFR
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 §§ 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 only be accepted by CDER 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 usregional-backbone file until 24 months
after publication of the final version of
this guidance. The draft 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 this guidance is finalized, firms
may choose—and are strongly
encouraged—to submit electronically
the other types of promotional
submissions discussed in this guidance.
This draft guidance is being issued
under section 745A(a) of the FD&C Act,
which explicitly authorizes FDA to
implement the statutory electronic
submission requirement for certain
types of submissions by specifying the
format for such submissions in
guidance. Accordingly, to the extent
that the draft guidance provides such
requirements under section 745A(a), it
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is not subject to the usual restrictions in
FDA’s good guidance practices
regulation (21 CFR 10.115). However, to
the extent that the draft guidance
includes provisions regarding
submission of promotional materials
that do not pertain to the electronic
format requirements for submissions
under section 745A(a), it will represent
the Agency’s current thinking on the
submission of promotional materials
and will not create or confer any rights
for or on any person or bind FDA or the
public. An alternative approach may be
used if such approach satisfies the
requirements of the applicable statutes
and regulations.
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II. The Paperwork Reduction Act of
1995
Under the Paperwork Reduction Act
of 1995 (PRA) (44 U.S.C. 3501–3520),
Federal Agencies must obtain approval
from the Office of Management and
Budget (OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
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Title: Providing Regulatory
Submissions in Electronic and NonElectronic Format—Promotional
Labeling and Advertising Materials for
Human Prescription Drugs.
Description of Respondents:
Respondents to this collection of
information are firms who make
regulatory submissions pertaining to
promotional materials for human
prescription drug and biologic products
to OPDP and APLB.
Burden Estimate: The draft guidance
pertains to regulatory submissions of
promotional materials. The draft
guidance describes the types of
submissions of promotional materials,
general considerations for submissions,
and certain considerations for how to
submit promotional materials
electronically and in hard copy.
The draft guidance includes
recommendations for when sponsors
make submissions to OPDP or APLB.
These recommendations include the
types of documents that generally
should be included (e.g.,
correspondence describing the type of
submission) for promotional labeling
submitted for advisory comments,
resubmissions, general correspondence,
amendments, withdrawal requests,
responses to untitled letters or warning
letters, responses to information
requests, reference documents, and
complaints.
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.
Amendments should include
correspondence stating it is an
amendment and include the
accompanying materials that were
previously missing, an annotated copy
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22531
of the promotional materials that were
omitted from a previous submission to
FDA, 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.
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 hard
copies. The burden estimate for
complaints in table 1 thus applies to
paper hard copies only.
The draft guidance also describes the
number of paper hard copies that
should be sent to OPDP and APLB for
each submission type (if applicable).
FDA estimates the burden of this
collection of information as follows:
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Federal Register / Vol. 80, No. 77 / Wednesday, April 22, 2015 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN
Number of
responses per
respondent
Number of
respondents
Type of submission
Total annual
responses
Average
burden per
response
(hours)
Total hours
199
200
6
26
4
7
60
2.5
2.5
1
2
1.5
1
1
499
500
6
52
6
7
60
50
2
2
12
12
12
12
24,950
1,000
12
624
72
84
720
Total ............................................................................
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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 OPDP .........................................
........................
..........................
........................
........................
27,462
This draft guidance also refers to
previously approved collections of
information found in FDA regulations
and collections of information that are
currently under OMB review. The
collections of information in 21 CFR
202.1, including requests for advisory
comments, resubmissions, and
amendments for advertisements, have
been approved under OMB control
number 0910–0686; the collections of
information in 21 CFR 601.45
(presubmission of promotional materials
for accelerated approval products under
part 601) have been approved under
OMB control number 0910–0338; the
collections of information for FDA Form
2253 and the presubmission of
promotional materials for accelerated
approval products under part 314 have
been approved under OMB control
number 0910–0001. FDA has also
published in the Federal Register a 60day notice soliciting public comments
on the collections of information that
result from the submission of television
advertisements under section 503C of
the FD&C Act (21 U.S.C. 353c) (77 FR
14811, March 13, 2012). These burden
estimates do not change as a result of
this guidance. This is because new
burdens for establishing the means for
submitting materials in electronic form
to comply with this guidance would be
negated by the savings in burden from
not having to print out the materials and
mail them to FDA.
Some firms may incur costs
associated with upgrading technology or
changing the method of submitting
information to FDA, and these have
been described in the Federal Register
notice for the revised draft guidance for
industry entitled ‘‘Providing Regulatory
Submissions in Electronic Format—
Certain Human Pharmaceutical Product
Applications and Related Submissions
Using the Electronic Common Technical
Document Specifications’’ (79 FR 43494,
July 25, 2014).
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III. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at https://
www.fda.gov/Drugs/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm, https://www.fda.gov/
BiologicsBloodVaccines/Guidance
ComplianceRegulatoryInformation/
default.htm, or https://
www.regulations.gov.
Dated: April 16, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–09297 Filed 4–21–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0093]
Interim Assessment of the Program for
Enhanced Review Transparency and
Communication; Public Meeting and
Establishment of Docket
AGENCY:
Food and Drug Administration,
HHS.
Notice of public meeting and
establishment of docket; request for
comments.
ACTION:
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The Food and Drug
Administration (FDA) is announcing the
establishment of a docket to obtain
comments on the interim assessment of
the Program for Enhanced Review
Transparency and Communication for
New Molecular Entity (NME) New Drug
Applications (NDAs) and Original
Biologics License Applications (BLAs)
(the Program). FDA is also announcing
a public meeting where the interim
assessment will be discussed and public
stakeholders may present their views on
the Program to date.
The Program is part of the FDA
performance commitments under the
fifth authorization of the Prescription
Drug User Fee Act (PDUFA), which
enables FDA to collect user fees for the
review of human drug and biologics
applications for fiscal years (FYs) 2013–
2017. The Program is described in detail
in section II.B entitled ‘‘PDUFA
Reauthorization Performance Goals and
Procedures Fiscal Years 2013 through
2017.’’ The Program is being evaluated
by an independent contractor with
expertise in assessing the quality and
efficiency of pharmaceutical and
biopharmaceutical development and
regulatory review programs. As part of
FDA’s performance commitments, FDA
is providing a period for public
comment on the interim assessment of
the Program.
SUMMARY:
See Section III, ‘‘How to
Participate in the Public Meeting’’ in the
SUPPLEMENTARY INFORMATION section of
this document for dates and times of the
public meeting, closing dates for
advance registration, requesting special
accommodations due to disability, and
information on deadlines for submitting
either electronic or written comments to
FDA’s Division of Dockets Management.
DATES:
See Section III, ‘‘How to
Participate in the Public Meeting’’ in the
SUPPLEMENTARY INFORMATION section of
this document.
ADDRESSES:
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]]>Agencies
[Federal Register Volume 80, Number 77 (Wednesday, April 22, 2015)]
[Notices]
[Pages 22529-22532]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-09297]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-D-1163]
Providing Regulatory Submissions in Electronic and Non-Electronic
Format--Promotional Labeling and Advertising Materials for Human
Prescription Drugs, Draft Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Providing
Regulatory Submissions in Electronic and Non-Electronic Format--
Promotional Labeling and Advertising Materials for Human Prescription
Drugs.'' This draft guidance explains how manufacturers, packers, and
distributors (firms) that may either be the applicant or acting on
[[Page 22530]]
behalf of the applicant, should make submissions pertaining to
promotional materials for human prescription drugs and biologic
products (``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). This draft guidance describes
the various types of submissions of promotional materials and general
considerations for submissions. In addition, this draft 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. This guidance
does not address the more general requirements for a valid electronic
submission using eCTD or the specifications for module 1 of the eCTD.
This guidance contains both binding and nonbinding provisions.
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comments on
this draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by July 21, 2015. Submit either electronic or written comments
on the proposed collection of information by June 22, 2015.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Communications, Division of Drug Information,
Center for Drug Evaluation and Research, Food and Drug Administration,
10001 New Hampshire Ave., Hillandale Bldg., 4th Floor, Silver Spring,
MD 20993-0002; or to the Office of Communication, Outreach and
Development, Center for Biologics Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128,
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.
Submit electronic comments to https://www.regulations.gov. Submit
written comments to the Division of Dockets Management (HFA-305), Food
and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD
20852. All comments should be identified with the docket number found
in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT:
Regarding human prescription drugs: Marci Kiester, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 3368, Silver Spring, MD 20993-0002, 301-
796-1200.
Regarding prescription human biological products: Stephen Ripley,
Center for Biologics Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver
Spring, MD 20993, 240-402-7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Providing Regulatory Submissions in Electronic and Non-
Electronic Format--Promotional Labeling and Advertising Materials for
Human Prescription Drugs.'' This draft guidance is intended to be used
in conjunction with the draft guidance for industry ``Providing
Regulatory Submissions in Electronic Format--Certain Human
Pharmaceutical Product Applications and Related Submissions Using the
eCTD Specifications'' \1\ (eCTD Revised Draft Guidance) and in
conjunction with the specification to industry ``The eCTD Backbone
Files Specification for Module 1 Version 2.3.'' \2\
---------------------------------------------------------------------------
\1\ The draft guidance for industry is available on the FDA eCTD
Web page at https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM333969.pdf.
\2\ The specification for industry is available on the FDA eCTD
Module 1 Web page at https://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm253101.htm.
---------------------------------------------------------------------------
This draft guidance describes various types of regulatory
submissions of promotional materials that firms submit to CDER and CBER
and general considerations for such submissions. For example, the draft
guidance describes the various types of voluntary submissions (e.g.,
launch and non-launch voluntary submissions of draft promotional
materials for advisory comments) and required submissions of
promotional labeling and advertising materials (e.g., fulfillment of
the regulatory requirements for postmarketing submissions of
promotional materials and submission of promotional materials for
accelerated approval products). In addition, this draft guidance
discusses specific aspects of the content and format for submitting
promotional materials in paper hard copy and electronic format,
including how to submit promotional materials electronically in module
1 of the eCTD using version 3.3 or higher of the us-regional-backbone
file. This draft 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. This draft guidance provides recommendations for
presentation considerations such as appearance, layout, format, and
visible impression of promotional materials submitted for all
promotional submission types.
This draft 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, 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 this guidance and the eCTD
Revised Draft Guidance, beginning no earlier than 24 months after this
guidance is finalized. Specifically, (1) postmarketing submissions of
promotional materials using Form FDA 2253 (required by 21 CFR
314.81(b)(3)(i) and 21 CFR 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 Sec. Sec.
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 only be accepted by
CDER 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 final version of this guidance. The draft
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 this guidance is
finalized, firms may choose--and are strongly encouraged--to submit
electronically the other types of promotional submissions discussed in
this guidance.
This draft guidance is being issued under section 745A(a) of the
FD&C Act, which explicitly authorizes FDA to implement the statutory
electronic submission requirement for certain types of submissions by
specifying the format for such submissions in guidance. Accordingly, to
the extent that the draft guidance provides such requirements under
section 745A(a), it
[[Page 22531]]
is not subject to the usual restrictions in FDA's good guidance
practices regulation (21 CFR 10.115). However, to the extent that the
draft guidance includes provisions regarding submission of promotional
materials that do not pertain to the electronic format requirements for
submissions under section 745A(a), it will represent the Agency's
current thinking on the submission of promotional materials and will
not create or confer any rights for or on any person or bind FDA or the
public. An alternative approach may be used if such approach satisfies
the requirements of the applicable statutes and regulations.
II. The Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-
3520), Federal Agencies must obtain approval from the Office of
Management and Budget (OMB) for each collection of information they
conduct or sponsor. ``Collection of information'' is defined in 44
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or
requirements that members of the public submit reports, keep records,
or provide information to a third party. Section 3506(c)(2)(A) of the
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a
60-day notice in the Federal Register concerning each proposed
collection of information before submitting the collection to OMB for
approval. To comply with this requirement, FDA is publishing notice of
the proposed collection of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Title: Providing Regulatory Submissions in Electronic and Non-
Electronic Format--Promotional Labeling and Advertising Materials for
Human Prescription Drugs.
Description of Respondents: Respondents to this collection of
information are firms who make regulatory submissions pertaining to
promotional materials for human prescription drug and biologic products
to OPDP and APLB.
Burden Estimate: The draft guidance pertains to regulatory
submissions of promotional materials. The draft guidance describes the
types of submissions of promotional materials, general considerations
for submissions, and certain considerations for how to submit
promotional materials electronically and in hard copy.
The draft guidance includes recommendations for when sponsors make
submissions to OPDP or APLB. These recommendations include the types of
documents that generally should be included (e.g., correspondence
describing the type of submission) for promotional labeling submitted
for advisory comments, resubmissions, general correspondence,
amendments, withdrawal requests, responses to untitled letters or
warning letters, responses to information requests, reference
documents, and complaints.
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. 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 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
hard copies. The burden estimate for complaints in table 1 thus applies
to paper hard copies only.
The draft guidance also describes the number of paper hard copies
that should be sent to OPDP and APLB for each submission type (if
applicable).
FDA estimates the burden of this collection of information as
follows:
[[Page 22532]]
Table 1--Estimated Annual Reporting Burden
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of submission Number of responses per Total annual per response Total hours
respondents respondent responses (hours)
----------------------------------------------------------------------------------------------------------------
Promotional labeling submitted 199 2.5 499 50 24,950
for advisory comments,
including resubmissions and
amendments....................
General correspondence 200 2.5 500 2 1,000
submitted to FDA..............
Requests to withdraw a previous 6 1 6 2 12
submission to FDA.............
Responses to untitled or 26 2 52 12 624
warning letters...............
Responses to information 4 1.5 6 12 72
requests......................
Reference documents............ 7 1 7 12 84
Complaints submitted to OPDP... 60 1 60 12 720
--------------------------------------------------------------------------------
Total...................... .............. ............... .............. .............. 27,462
----------------------------------------------------------------------------------------------------------------
This draft guidance also refers to previously approved collections
of information found in FDA regulations and collections of information
that are currently under OMB review. The collections of information in
21 CFR 202.1, including requests for advisory comments, resubmissions,
and amendments for advertisements, have been approved under OMB control
number 0910-0686; the collections of information in 21 CFR 601.45
(presubmission of promotional materials for accelerated approval
products under part 601) have been approved under OMB control number
0910-0338; the collections of information for FDA Form 2253 and the
presubmission of promotional materials for accelerated approval
products under part 314 have been approved under OMB control number
0910-0001. FDA has also published in the Federal Register a 60-day
notice soliciting public comments on the collections of information
that result from the submission of television advertisements under
section 503C of the FD&C Act (21 U.S.C. 353c) (77 FR 14811, March 13,
2012). These burden estimates do not change as a result of this
guidance. This is because new burdens for establishing the means for
submitting materials in electronic form to comply with this guidance
would be negated by the savings in burden from not having to print out
the materials and mail them to FDA.
Some firms may incur costs associated with upgrading technology or
changing the method of submitting information to FDA, and these have
been described in the Federal Register notice for the revised draft
guidance for industry entitled ``Providing Regulatory Submissions in
Electronic Format--Certain Human Pharmaceutical Product Applications
and Related Submissions Using the Electronic Common Technical Document
Specifications'' (79 FR 43494, July 25, 2014).
III. Comments
Interested persons may submit either electronic comments regarding
this document to https://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at https://www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet may obtain the document at
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or https://www.regulations.gov.
Dated: April 16, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-09297 Filed 4-21-15; 8:45 am]
BILLING CODE 4164-01-P
