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, 89303-89305 [2023-28530]
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Federal Register / Vol. 88, No. 247 / Wednesday, December 27, 2023 / Rules and Regulations
(27) 16 U.S.C. 6905(c), Western and
Central Pacific Fisheries Convention
Implementation Act,13 violation,
maximum from $223,229 to $230,464.
(28) 16 U.S.C. 7009(c) and (d), Pacific
Whiting Act of 2006,14 violation,
maximum from $223,229 to $230,464.
(29) 22 U.S.C. 1978(e), Fishermen’s
Protective Act of 1967 (1971):
(i) Violation, maximum from $34,457
to $35,574.
(ii) Subsequent violation, maximum
from $101,805 to $105,105.
(30) 30 U.S.C. 1462(a), Deep Seabed
Hard Mineral Resources Act (1980),
violation, maximum, from $87,855 to
$90,702.
(31) 42 U.S.C. 9152(c), Ocean Thermal
Energy Conversion Act of 1980 (1980),
violation, maximum from $87,855 to
$90,702.
(32) 16 U.S.C. 1827a, Billfish
Conservation Act of 2012,15 violation,
maximum from $223,229 to $230,464.
(33) 16 U.S.C. 7407(b), Port State
Measures Agreement Act of 2015,16
violation, maximum from $223,229 to
$230,464.
(34) 16 U.S.C. 1826g(f), High Seas
Driftnet Fishing Moratorium Protection
Act,17 violation, maximum from
$223,229 to $230,464.
(35) 16 U.S.C. 7705, Ensuring Access
to Pacific Fisheries Act,18 violation,
maximum from $223,229 to $230,464.
(36) 16 U.S.C. 7805, Ensuring Access
to Pacific Fisheries Act,19 violation,
maximum from $223,229 to $230,464.
(37) 16 U.S.C. 1857 note, James M.
Inhofe National Defense Authorization
Act for Fiscal Year 2023,20 (newly
reported penalty), violation, maximum
$230,464.
(g) National Technical Information
Service. 42 U.S.C. 1306c(c), Bipartisan
Budget Act of 2013 (2013), violation,
minimum from $1,158 to $1,196;
maximum total penalty on any person
for any calendar year, excluding willful
or intentional violations, from $289,504
to $298,887.
(h) Office of the Under Secretary for
Economic Affairs. 15 U.S.C. 113,
Concrete Masonry Products Research,
Education, and Promotion Act of 2018,
violation, maximum from $5,000 to
$5,162.
§ 6.4 Effective date of adjustments for
inflation to civil monetary penalties.
ddrumheller on DSK120RN23PROD with RULES1
The Department of Commerce’s 2024
adjustments for inflation made by § 6.3,
13 See
footnote 7.
footnote 7.
15 See footnote 7.
16 See footnote 7.
17 See footnote 7.
18 See footnote 7.
19 See footnote 7.
20 See footnote 7.
14 See
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Jkt 262001
of the civil monetary penalties there
specified, are effective on January 15,
2024, and said civil monetary penalties,
as thus adjusted by the adjustments for
inflation made by § 6.3, apply only to
those civil monetary penalties,
including those whose associated
violation predated such adjustment,
which are assessed by the Department of
Commerce after the effective date of the
new civil monetary penalty level, and
before the effective date of any future
adjustments for inflation to civil
monetary penalties thereto made
subsequent to January 15, 2024 as
provided in § 6.5.
§ 6.5 Subsequent annual adjustments for
inflation to civil monetary penalties.
The Secretary of Commerce or his or
her designee by regulation shall make
subsequent adjustments for inflation to
the Department of Commerce’s civil
monetary penalties annually, which
shall take effect not later than January
15, notwithstanding section 553 of title
5, United States Code.
[FR Doc. 2023–28484 Filed 12–26–23; 8:45 am]
BILLING CODE 3510–DP–P
89303
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
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.
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing the availability of a
guidance for industry entitled ‘‘Directto-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
SUMMARY:
PO 00000
Frm 00029
Fmt 4700
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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
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89304
Federal Register / Vol. 88, No. 247 / Wednesday, December 27, 2023 / Rules and Regulations
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-201509-18/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
VerDate Sep<11>2014
15:06 Dec 26, 2023
Jkt 262001
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, CDER-OPDP-RPM@
fda.hhs.gov; 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 ‘‘Directto-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 (§ 10.115 (21 CFR 10.115)).
Consistent with the GGP regulation,
FDA is immediately implementing the
level 2 guidance and inviting public
comment (§ 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.
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Fmt 4700
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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 (§ 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.
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Federal Register / Vol. 88, No. 247 / Wednesday, December 27, 2023 / Rules and Regulations
III. Electronic Access
Persons with access to the internet
may obtain the SECG at https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
regulatory-information/search-fdaguidance-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
DEPARTMENT OF EDUCATION
34 CFR Chapter III
[ED–2023–OSERS–0177]
Final Waiver and Extension of the
Project Period With Funding for
Innovative Rehabilitation Training
Grants
Office of Special Education and
Rehabilitative Services (OSERS),
Department of Education.
ACTION: Final waiver and extension of
project period with funding.
AGENCY:
The Secretary waives the
requirements in the Education
Department General Administrative
Regulations that generally prohibit
project periods exceeding five years and
project period extensions involving the
obligation of additional Federal funds.
The waiver and extension enable seven
projects under Assistance Listing
Number (ALN) 84.263C to receive
funding for an additional period, not to
exceed September 30, 2025.
DATES: The waiver and extension of the
project periods are effective December
27, 2023.
FOR FURTHER INFORMATION CONTACT:
Felipe Lulli, U.S. Department of
Education, 400 Maryland Avenue SW,
Room 4A110, Washington, DC 20202.
Telephone: 202–987–0128. Email:
Felipe.Lulli@ed.gov.
If you are deaf, hard of hearing, or
have a speech disability and wish to
access telecommunications relay
services, please dial 7–1–1.
SUPPLEMENTARY INFORMATION:
ddrumheller on DSK120RN23PROD with RULES1
SUMMARY:
Background
On October 3, 2023, the Department
published a notice in the Federal
Register (84 FR 32135) proposing a
waiver and extension of the project
VerDate Sep<11>2014
15:06 Dec 26, 2023
Jkt 262001
period with funding in order to enable
seven projects under Assistance Listing
Number (ALN) 84.263C to receive
continuation funding for an additional
12-month period, not to exceed
September 30, 2025. The proposed
waiver and extension of the project
period with funding would allow the
Department to align those dates with
that of awards funded under ALNs
84.263E and 84.263F, which will each
receive their final year of funding in FY
2024, and end on September 30, 2025.
Due to the overlapping goals of these
three programs, the Department does
not believe that it would be in the
public interest to run a competition for
ALN 84.263C in FY 2024. Rather,
aligning the projects’ periods of
performance end dates for ALNs
84.263C, 84.263E, and 84.263F would
reduce financial and administrative
burden by allowing the Department to
conduct a single competition for all
84.263C, 84.263E, and 84.263F grants in
FY 2025, with a five-year performance
period that would run from October 1,
2025, through September 30, 2030.
There are no differences between the
notice of proposed waiver and extension
of the project period with funding and
this notice of final waiver and extension
of the project period with funding, as
discussed in the Analysis of Comments
and Changes section of this document.
Public Comment
In response to our invitation in the
notice of proposed waiver and extension
of the project period with funding, two
parties submitted comments.
Generally, we do not address
technical and other minor changes or
suggested changes the law does not
authorize us to make under the
applicable statutory authority. In
addition, we do not address general
comments that raised concerns not
directly related to the proposed waiver
and extension with funding.
Analysis of Comments and Changes
An analysis of the comments and of
any changes in the priority since
publication of the notice of proposed
waiver and extension of the project
period with funding follows.
Comment: One commenter expressed
strong support for the proposed waiver
and extension of the project period with
funding noting the vital importance of
the Innovation Rehabilitation Training
projects to the Vocational Rehabilitation
field. The commenter described firsthand experience serving on an advisory
board of one of the Innovative
Rehabilitation Training grants and
evaluating their products. The
commenter noted the value of the
PO 00000
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Fmt 4700
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89305
products to the vocational rehabilitation
field in meeting the needs of individuals
with disabilities.
Discussion: The Department
appreciates support for the proposed
waiver and extension of the project
period with funding for the Innovative
Rehabilitation Training grants.
Change: None.
Comment: One commenter analyzed
whether the proposed waiver and
extension of the project period with
funding would lead to more efficient
outcomes for the Innovative
Rehabilitation Training program. The
commenter presented one argument that
extending the project period and
providing additional funding would
offer the Department streamlined
decision-making and grantee flexibility
to ensure the delivery of
comprehensive, high-quality training
that effectively meets the needs of their
target populations. The commenter
presented a counterargument that
extending the project timeline might
cause grantees to delay project
milestones if they know extensions are
readily available, leading to
inefficiencies and prolonged timelines
that do not guarantee improved
outcomes. The commenter
recommended the Department
implement appropriate oversight
procedures to alleviate possible risks
and safeguard the effectiveness of the
waiver and extension of the project
period to alleviate financial and
administrative burden.
Discussion: The Department
appreciates the commenter’s analysis of
arguments for and against the proposed
notice of waiver and extension of the
project period with funding and
carefully considered them in its
decision making. The Department will
monitor grantees in accordance with
applicable regulations: (a) The
Education Department General
Administrative Regulations in 34 CFR
parts 75, 77, 79, 81, 82, 84, 86, 97, 98,
and 99; (b) The Office of Management
and Budget Guidelines to Agencies on
Governmentwide Debarment and
Suspension (Nonprocurement) in 2 CFR
part 180, as adopted and amended as
regulations of the Department in 2 CFR
part 3485; and (c) The Uniform
Administrative Requirements, Cost
Principles, and Audit Requirements for
Federal Awards in 2 CFR part 200, as
adopted and amended as regulations of
the Department in 2 CFR part 3474.
Additionally, the Department will
assess grant performance through
annual reporting and tracking of
expenditures to ensure that project
milestones for both the current budget
period and the additional budget period
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]]>Agencies
[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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.
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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
