[Federal Register Volume 84, Number 65 (Thursday, April 4, 2019)]
[Notices]
[Pages 13302-13304]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06565]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-1163]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Providing Regulatory 
Submissions in Electronic and Non-Electronic Format--Promotional 
Labeling and Advertising Materials for Human Prescription Drugs

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by May 6, 
2019.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-NEW and 
title ``Providing Regulatory Submissions in Electronic and Non-
Electronic Format--Promotional Labeling and Advertising Materials for 
Human Prescription Drugs.'' Also include the FDA docket number found in 
brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Providing Regulatory Submissions in Electronic and Non-Electronic 
Format--Promotional Labeling and Advertising Materials for Human 
Prescription Drugs--OMB Control Number 0910-NEW

    This information collection request supports recommendations found 
in the Agency guidance document entitled, ``Providing Regulatory 
Submissions in Electronic and Non-Electronic Format--Promotional 
Labeling and Advertising Materials for Human Prescription Drugs.'' The 
guidance document outlines the requirements and recommendations for 
manufacturers, packers, and distributors (firms) that may either be the 
applicant or acting on behalf of the applicant, to make submissions 
pertaining to promotional materials for human prescription drugs 
(``drugs'') to the Office of Prescription Drug Promotion (OPDP) in the 
Center for Drug Evaluation and Research (CDER) and the Advertising and 
Promotional Labeling Branch (APLB) in the Center for Biologics 
Evaluation and Research (CBER). References to ``drugs'' in the guidance 
also include human biological products that fall within the definition 
of ``drug'' under section 201(g) of the Federal Food, Drug, and 
Cosmetic Act (FD&C Act) (21 U.S.C. 321(g)).
    The guidance describes the various types of submissions of 
promotional materials and general considerations for submissions. The 
guidance discusses the specific aspects of submission of promotional 
materials using module 1 of the electronic Common Technical Document 
(eCTD) using version 3.3 or higher of the us-regional-backbone file. 
The guidance does not address the more general requirements for a valid 
electronic submission using eCTD or the specifications for module 1 of 
the eCTD. The guidance contains both binding and nonbinding provisions. 
The provisions that are binding implement section 745A(a) of the FD&C 
Act (21 U.S.C. 379k-1(a)), which requires that certain submissions be 
submitted in electronic format specified by FDA, beginning no earlier 
than 24 months after FDA issues a final guidance specifying such 
electronic submission format.
    The guidance provides recommendations for what to include with each 
type of submission and the number of copies to include if it is a paper 
submission. For promotional labeling submitted for advisory comments, 
including resubmissions, a submission generally includes correspondence 
stating that it is a request for advisory comments, a clean version of 
the draft promotional materials, an annotated copy of the promotional 
materials, and the most current FDA-approved prescribing information 
(PI); if applicable, a submission also includes the FDA-approved 
patient labeling or Medication Guide with annotations cross-referenced 
to the proposed promotional materials and annotated references to 
support product and disease or epidemiology claims not contained in the 
PI cross-referenced to the promotional material. Amendments should be 
submitted if the previous submission to FDA is missing one or more 
promotional materials or if an incorrect document file was included 
with a submission in eCTD format. Amendments should include 
correspondence stating it is an amendment and include the accompanying 
materials that were previously missing, an annotated copy of the 
promotional materials that were omitted from a previous submission to 
FDA, the FDA-approved patient labeling or Medication Guide with 
annotations

[[Page 13303]]

cross-referenced to the proposed promotional materials, and annotated 
references to support product and disease or epidemiology claims not 
contained in the PI cross-referenced to the promotional material.
    General correspondence submissions and submissions requesting to 
withdraw a previous submission to FDA include correspondence stating 
the purpose of the submission.
    Responses to untitled or warning letter submissions include 
correspondence stating that it is a response to an untitled or warning 
letter, and include the firm's initial or subsequent responses and the 
corrective piece(s), if applicable.
    Responses to information request submissions include the firm's 
response to the questions and issues raised in FDA's letter of inquiry, 
including any materials that FDA has requested.
    Reference document submissions include correspondence stating that 
it is a reference document submission and the specific information 
regarding what is in the submission along with the annotated 
references, annotated promotional materials, and/or annotated labeling.
    Promotional labeling submitted for advisory comments, including 
resubmissions and amendments; general correspondence; requests to 
withdraw a previous submission; responses to untitled or warning 
letters; responses to information requests; and reference documents can 
be submitted in paper or electronic form, and the burden estimates for 
these submissions in table 1 apply to both paper and electronic form.
    Complaints include correspondence stating that it is a complaint 
and supporting information or documentation, if available. Complaints 
are not accepted in electronic form and should be submitted as paper 
copies. The burden estimate for complaints in table 1 thus applies to 
paper copies only.
    The guidance also describes the number of paper copies that should 
be sent to OPDP and APLB for each submission type (if applicable).
    The guidance provides recommendations for presentation 
considerations such as appearance, layout, format, and visible 
impression of promotional materials submitted for all promotional 
submission types.
    The guidance also provides instructions on how to submit 
promotional labeling and advertising materials to FDA electronically in 
eCTD format. It explains that for submissions of promotional materials 
that fall within the ambit of section 745A(a) of the FD&C Act (21 
U.S.C. 379k-1(a)), as amended by section 1136 of the Food and Drug 
Administration Safety and Innovation Act (Pub. L. 112-144), such 
submissions must be made in the electronic format specified by FDA in 
the guidance, beginning no earlier than 24 months after the guidance is 
finalized. Specifically, (1) postmarketing submissions of promotional 
materials using Form FDA 2253 (required by 21 CFR 314.81(b)(3)(i) and 
601.12(f)(4)), and (2) submissions of promotional materials for 
accelerated approval products (required by FD&C Act section 
506(c)(2)(B) (21 U.S.C. 356(c)(2)(B)), and 21 CFR 314.550 and 601.45) 
and other products where such submissions are required for approval, 
fall within the scope of section 745A(a) and are, therefore, subject to 
the mandatory electronic submission requirement.
    When the mandatory electronic submission requirement takes effect 
for these types of submissions, they will be accepted by CDER only in 
eCTD format using version 3.3 or higher of the us-regional-backbone 
file. CBER will be able to accept eCTD submissions using previous 
versions of the us-regional-backbone file until 24 months after 
publication of the guidance. The guidance also provides that, while 
only promotional submissions that fall under section 745A(a) will be 
required to be submitted electronically no sooner than 24 months after 
the guidance is finalized, firms are strongly encouraged, but not 
required, to submit electronically the other types of promotional 
submissions discussed in the guidance.
    In the Federal Register of April 22, 2015 (80 FR 22529), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. One comment was received requesting 
clarification on the submission of annotated versions of promotional 
materials for Form FDA 2253 submissions. We appreciate the comment and 
have revised the guidance to further clarify that annotated versions of 
promotional materials are encouraged, not required. The guidance was 
also revised to encourage the submission of a CD copy of paper 
submissions and burden estimates have been updated accordingly. Any 
increase in burden is expected to be nominal.
    We estimate the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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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                76              13           1,024              51          52,224
 for advisory comments,
 including resubmissions and
 amendments.....................
General correspondence submitted              84               4             359               3           1,077
 to FDA.........................
Requests to withdraw a previous               15               1              22               3              66
 submission to FDA..............
Responses to untitled or warning               7               2              13              13             169
 letters........................
Responses to information                       6               1               3              13              39
 requests.......................
Reference documents.............               7               2              14              13             182
Complaints submitted to FDA.....              82               1             117              13           1,521
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    Total.......................  ..............  ..............  ..............  ..............          55,278
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


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    Our estimate is based on our experience with the submission of 
labeling materials for human prescription drugs. Because this is a new 
collection of information, we are specifically interested in receiving 
comments from respondents to the information collection regarding our 
burden estimate.

    Dated: March 29, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-06565 Filed 4-3-19; 8:45 am]
 BILLING CODE 4164-01-P