Federal Register / Vol. 88, No. 247 / Wednesday, December 27, 2023 / Rules and Regulations 89303 

13See footnote 7. 14See footnote 7. 15See footnote 7. 

16See footnote 7. 

17See footnote 7. 

18See footnote 7. 

19See footnote 7. 

20See footnote 7. 

(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. 

The Department of Commerce’s 2024 

adjustments for inflation made by § 6.3, 

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 

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 ‘‘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 

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 


ddrumheller on DSK120RN23PROD with RULES1
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-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, 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. 

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 89305 

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 

AGENCY: Office of Special Education and 

Rehabilitative Services (OSERS), 

Department of Education. 

ACTION: Final waiver and extension of 

project period with funding. 

SUMMARY: 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: 

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 

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 

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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