[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]
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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Prescription Drugs, Draft Guidance for Industry; Availability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.
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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availability of a draft guidance for industry entitled ``Providing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 This draft guidance explains how manufacturers, packers, and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 This draft guidance describes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 In addition, this draft guidance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this draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by July 21, 2015.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 http://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\
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\1\ The draft guidance for industry is available on the FDA eCTD
Web page at http://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 http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm253101.htm.
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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:
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Table 1--Estimated Annual Reporting Burden
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Number of Average burden
Type of submission Number of responses per Total annual per response Total hours
respondents respondent responses (hours)
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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
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Total...................... .............. ............... .............. .............. 27,462
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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 http://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 http://www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet may obtain the document at
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or http://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