[Federal Register Volume 84, Number 121 (Monday, June 24, 2019)]
[Notices]
[Pages 29522-29524]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-13350]


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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; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a final guidance for industry entitled ``Providing 
Regulatory Submissions in Electronic and Non-Electronic Format--
Promotional Labeling and Advertising Materials for Human Prescription 
Drugs.'' This guidance outlines the requirements and recommendations 
for various types of submissions of promotional materials for 
prescription drugs and biological products, including the specific 
formats needed for use in the electronic common technical document 
(eCTD) as well as non-eCTD and non-electronic formats. This guidance 
finalizes the draft guidance issued in April 2015.

DATES: The announcement of the guidance is published in the Federal 
Register on June 24, 2019.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such

[[Page 29523]]

as a manufacturing process. Please note that if you include your name, 
contact information, or other information that identifies you in the 
body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2015-D-1163 for ``Providing Regulatory Submissions in Electronic 
and Non-Electronic Format--Promotional Labeling and Advertising 
Materials for Human Prescription Drugs.'' Received comments will be 
placed in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at https://www.regulations.gov or at 
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through 
Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of this guidance to the 
Division of Drug Information, Center for Drug Evaluation and Research, 
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale 
Building, 4th Floor, Silver Spring, MD 20993-0002; or to the Office of 
Communication, Outreach and Development, Center for Biologics 
Evaluation and Research (CBER), 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 guidance document.

FOR FURTHER INFORMATION CONTACT: 
    Regarding prescription human drugs: Kemi Asante, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 3374, 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 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Providing Regulatory Submissions in Electronic and Non-
Electronic Format--Promotional Labeling and Advertising Materials for 
Human Prescription Drugs.'' Portions of this guidance are intended to 
be used in conjunction with the guidance for industry entitled 
``Providing Regulatory Submissions in Electronic Format--Certain Human 
Pharmaceutical Product Applications and Related Submissions Using the 
eCTD Specifications'' (eCTD Guidance) and the specifications for module 
1.\1\ This guidance 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 in the Center for 
Drug Evaluation and Research (CDER) and the Advertising and Promotional 
Labeling Branch in the Center for Biologics Evaluation and Research 
(CBER). References to ``drugs'' in this 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)).
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    \1\ The eCTD Guidance is available on the FDA website at https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM333969.pdf. The 
current version of the specification for industry entitled The eCTD 
Backbone Files Specification for Module 1 provides additional 
information and is available at https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/UCM163552.pdf.
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    This guidance describes various types of regulatory submissions of 
promotional materials that firms submit to CDER and CBER, along with 
general considerations and formats for such submissions. For example, 
the guidance describes the various types of voluntary submissions 
(e.g., launch and non-launch voluntary submissions of draft promotional 
materials for 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 guidance discusses specific aspects of the content 
and format for submitting promotional materials in paper 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 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 guidance provides 
recommendations for

[[Page 29524]]

presentation considerations such as appearance, layout, format, and 
visible impression of promotional materials submitted for all 
promotional submission types.
    This 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 scope of section 745A(a) of the FD&C Act (21 
U.S.C. 379k-1), such submissions must be made in the electronic format 
specified by FDA in this guidance and the guidance for industry 
``Providing Regulatory Submissions in Electronic Format--Certain Human 
Pharmaceutical Product Applications and Related Submissions Using the 
eCTD Specifications'' (eCTD Guidance), beginning no earlier than 24 
months after this guidance is issued. 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 
section 506(c)(2)(B) of the FD&C Act (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. The implementation date for the mandatory 
electronic submission is June 24, 2021. When the implementation date 
for the mandatory electronic submission requirement takes effect for 
these types of submissions, they will only be accepted in eCTD format 
using version 3.3 or higher of the us-regional-backbone file. The 
guidance also provides that, while only promotional submissions that 
fall under section 745A(a) of the FD&C Act will be required to be 
submitted electronically no sooner than 24 months after this guidance 
is issued, firms may choose--and are strongly encouraged, but not 
required--to submit electronically the other types of promotional 
submissions discussed in this guidance.
    In the Federal Register of April 22, 2015 (80 FR 22529), FDA 
announced the availability of the draft guidance of the same title. FDA 
received several comments regarding the need to provide clarity on 
submission expectations and technical aspects of electronic 
submissions, and those comments were considered as the guidance was 
finalized. A summary of changes made in this guidance include: (1) 
Changes to provide greater clarity on submission expectations, (2) 
changes to provide greater clarity around technical aspects related to 
electronic submissions, (3) changes to create consistency between terms 
used in the final guidance and the eCTD guidance, (4) changes to 
address unexpected technical issues that have been discovered since the 
eCTD software launched, and (5) changes to encourage the submission of 
a compact disc copy of paper submissions. In addition, editorial and 
formatting changes were made to improve clarity.
    This guidance is being issued under section 745A(a) of the FD&C 
Act; wherein Congress granted FDA authorization to require that 
submissions under section 505(b), (i), or (j) of the FD&C Act (21 
U.S.C. 355(b), 21 U.S.C. 355(i), or 21 U.S.C. 355(j), respectively) and 
submissions under section 351(a) or (k) of the Public Health Service 
Act (PHS Act); be submitted in an electronic format specified by FDA 
through guidance. Accordingly, insofar as this guidance requires that 
submissions under section 505(b), (i), or (j) of the FD&C Act and 
submissions under section 351(a) or (k) of the PHS Act be submitted in 
electronic format specified by FDA, this document is not subject to the 
usual restriction in FDA's good guidance practice regulations that 
guidances not establish legally enforceable responsibilities. (See 21 
CFR 10.115(d).) Therefore, the portion of this guidance that 
establishes the requirement for electronic submissions under section 
745A(a) of the FD&C Act has binding effect, as indicated by the use of 
the words must, shall, or required. This guidance is not subject to 
Executive Order 12866.

II. Paperwork Reduction Act of 1995

    This guidance contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collection of information in this guidance was approved under OMB 
control number 0910-0870.
    This guidance also refers to previously approved collections of 
information found in FDA regulations. The collections of information in 
21 CFR 202.1, including voluntary requests for advisory comments,\2\ 
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 Form FDA 2253 and 
the presubmission of promotional materials for accelerated approval 
products under part 314 have been approved under OMB control number 
0910-0001.
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    \2\ Reference in this guidance to the voluntary request for 
advisory comment(s) on proposed promotional materials by firms is 
distinct from and not to be confused with the process identified in 
21 CFR 10.85.
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III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or 
https://www.regulations.gov.

    Dated: June 18, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-13350 Filed 6-21-19; 8:45 am]
BILLING CODE 4164-01-P