[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Prescription Drugs, Draft Guidance for Industry; Availability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availability of a draft guidance for industry entitled ``Providing 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 This draft guidance explains how manufacturers, packers, and 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 This draft guidance describes 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 In addition, this draft guidance 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this draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by July 21, 2015.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:

[[Page 22532]]



                                   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