Document ID: FDA-2009-N-0582-0130
Agency: fda
Document Type: Rule
Title: Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear,
Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Final Rule: Questions and Answers; Guidance for Industry; Small Entity Compliance Guide; Availability
Posted Date: 2023-12-27T05:00Z

[Federal Register Volume 88, Number 247 (Wednesday, December 27, 2023)]
[Rules and Regulations]
[Pages 89303-89305]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-28530]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 202

Docket No. FDA-2009-N-0582]

Direct-to-Consumer Prescription Drug Advertisements: Presentation 
of the Major Statement in a Clear, Conspicuous, and Neutral Manner in 
Advertisements in Television and Radio Format Final Rule: Questions and 
Answers; Guidance for Industry; Small Entity Compliance Guide; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of availability.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
announcing the availability of a guidance for industry entitled 
``Direct-to-Consumer Prescription Drug Advertisements: Presentation of 
the Major Statement in a Clear, Conspicuous, and Neutral Manner in 
Advertisements in Television and Radio Format Final Rule: Questions and 
Answers.'' We are issuing this small entity compliance guide (SECG) in 
accordance with the Small Business Regulatory Enforcement Fairness Act 
to help small businesses understand and comply with the ``Direct-to-
Consumer Prescription Drug Advertisements: Presentation of the Major 
Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements 
in Television and Radio Format Final Rule'' (CCN Final Rule). The CCN 
Final Rule modifies FDA regulations to reflect the requirement in the 
Federal Food, Drug, and Cosmetic Act (FD&C Act) that human prescription 
drug advertisements presented directly to consumers (DTC) in television 
or radio format and stating the name of the drug and its conditions of 
use (DTC TV/radio ads) present the major statement relating to side 
effects and contraindications (major statement) in a clear, 
conspicuous, and neutral manner and establishes standards to help 
ensure this requirement is met. The term ``drugs'' in this guidance 
refers to prescription human drug and biological products.

DATES: The announcement of the guidance is published in the Federal 
Register on December 27, 2023.

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 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

[[Page 89304]]

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-2009-N-0582 for ``Direct-to-Consumer Prescription Drug 
Advertisements: Presentation of the Major Statement in a Clear, 
Conspicuous, and Neutral Manner in Advertisements in Television and 
Radio Format Final Rule: Questions and Answers.'' 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, 240-402-7500.
     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.govinfo.gov/content/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, 240-402-7500.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of the SECG 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, 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 SECG.

FOR FURTHER INFORMATION CONTACT: Suzanna Boyle, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 3214, Silver Spring, MD 20993-0002, 301-
796-1200, [email protected]; or Anne Taylor, 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

    We are announcing the availability of a guidance for industry 
entitled ``Direct-to-Consumer Prescription Drug Advertisements: 
Presentation of the Major Statement in a Clear, Conspicuous, and 
Neutral Manner in Advertisements in Television and Radio Format Final 
Rule: Questions and Answers.'' FDA is issuing this SECG as a level 2 
guidance, consistent with FDA's good guidance practices (GGP) 
regulation (Sec.  10.115 (21 CFR 10.115)). Consistent with the GGP 
regulation, FDA is immediately implementing the level 2 guidance and 
inviting public comment (Sec.  10.115(g)(4)).
    We are issuing this guidance in accordance with section 212 of the 
Small Business Regulatory Enforcement Fairness Act (Pub. L. 104-121, as 
amended by Pub. L. 110-28) to help small businesses understand and 
comply with the CCN Final Rule (88 FR 80958, November 21, 2023). The 
CCN Final Rule modifies 21 CFR 202.1(e)(1) to reflect the requirement 
in section 502(n) of the FD&C Act (21 U.S.C. 352(n)) that human 
prescription drug advertisements presented directly to consumers (DTC) 
in television or radio format and stating the name of the drug and its 
conditions of use (DTC TV/radio ads) present the major statement 
relating to side effects and contraindications in a clear, conspicuous, 
and neutral manner. The CCN Final Rule also establishes standards to 
help ensure that this requirement is met.
    This guidance addresses the content and effect of the CCN Final 
Rule, including identifying which drugs and advertisements are covered 
by the rule. The term ``drugs'' in this guidance refers to prescription 
human drug and biological products. In addition, this guidance explains 
when firms are expected to comply with the CCN Final Rule and how they 
can do so. The term ``firms'' in this guidance refers to manufacturers, 
packers, and distributors of any human prescription drug that, in any 
State, is distributed or offered for sale and who advertise that drug, 
and to all persons who they cause to issue any advertisement with 
respect to their human prescription drug(s), including both individuals 
and corporate entities.
    This level 2 guidance is being issued consistent with FDA's good 
guidance practices regulation (Sec.  10.115). The SECG represents the 
current thinking of FDA on how small businesses can better understand 
and comply with the ``Direct-to-Consumer Prescription Drug 
Advertisements: Presentation of the Major Statement in a Clear, 
Conspicuous, and Neutral Manner in Advertisements in Television or 
Radio Format Final Rule.'' It does not establish any rights for any 
person and is not binding on FDA or the public. You can use an 
alternative approach if it satisfies the requirements of the applicable 
statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does 
refer to previously approved FDA collections of information. The 
previously approved collections of information are subject to review by 
the Office of Management and Budget (OMB) under the Paperwork Reduction 
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information 
in 21 CFR 202.1 have been approved under OMB control number 0910-0686. 
The collections of information in 21 CFR 314.81(b)(3)(i) relating to 
the submission of advertisements and promotional labeling have been 
approved under OMB control number 0910-0001.

[[Page 89305]]

III. Electronic Access

    Persons with access to the internet may obtain the SECG at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov. Use the FDA websites listed 
in the previous sentence to find the most current version of the 
guidance.

    Dated: December 21, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-28530 Filed 12-26-23; 8:45 am]
BILLING CODE 4164-01-P