Federal Register / Vol. 88, No. 223 / Tuesday, November 21, 2023 / Rules and Regulations 80955 

(2) All airplanes specified in paragraphs 

(c)(2)(i) through (xi) of this AD, type 

certificated in the restricted category. 

(i) LeSEA Model C–130A airplanes 

(transferred from Central Air Services, Inc.), 

Type Certificate Data Sheet (TCDS) A34SO, 

Revision 1. 

(ii) T.B.M., Inc., Model C–130A airplanes, 

TCDS A39CE, Revision 3. 

(iii) Western International Aviation, Inc., 

Model C–130A airplanes, TCDS A33NM. 

(iv) USDA Forest Service Model C–130A 

airplanes, TCDS A15NM, Revision 4. 

(v) Snow Aviation International, Inc., 

Model C–130A airplanes, TCDS TQ3CH, 

Revision 1. 

(vi) International Air Response (transferred 

from Rogers Helicopters, Inc., and Heavylift 

Helicopters Inc.) Model C–130A airplanes, 

TCDS A31NM, Revision 3. 

(vii) Heavylift Helicopters, Inc., Model C– 

130B airplanes, TCDS A35NM, Revision 1. 

(viii) Hawkins & Powers Aviation, Inc., 

Model HP–C–130A airplanes, TCDS A30NM, 

Revision 1. 

(ix) Coulson Aviation (USA), Inc., Model 

EC–130Q and C–130H airplanes, TCDS 

T00019LA, Revision 4. 

(x) Lockheed-Georgia Company Model 

282–44A–05 (C–130B) airplanes, TCDS 

A5SO. 

(xi) Surplus Model C–130A airplanes. 

(d) Subject 

Air Transport Association (ATA) of 

America Code 71, Powerplant. 

(e) Unsafe Condition 

This AD was prompted by reports of 

fatigue cracking of an upper lug of the engine 

truss mount, and by reports of cracks found 

prior to the initial inspection times required 

by AD 96–12–20. The FAA is issuing this AD 

to address such fatigue cracking. Fatigue 

cracking of a single engine truss mount upper 

lug could reduce the static strength of an 

engine mount to limit load, while cracking of 

both lugs can lead to separation of the 

engine, catastrophic structural damage, and 

loss of control of the airplane. 

(f) Compliance 

Comply with this AD within the 

compliance times specified, unless already 

done. 

(g) Required Actions 

Within 35 days after the effective date of 

this AD, do the inspections specified in 

paragraphs (g)(1) and (2) of this AD, using a 

method approved in accordance with the 

procedures specified in paragraph (i) of this 

AD. If any cracked or severed engine truss 

mount upper lug is found, the engine truss 

mount must be replaced before further flight, 

using a method approved in accordance with 

the procedures specified in paragraph (i) of 

this AD. 

(1) Do a one-time detailed visual 

inspection for cracking of the No. 1 and No. 

4 engine truss mount upper lugs, lower 

surfaces, at outer wing station (OWS) 162 and 

OWS 197; and for severed engine truss 

mount upper lugs; at a total of four locations: 

two locations per engine mount, one mount 

assembly at each OWS. 

(2) Do a one-time borescope inspection for 

cracking of the No. 1 and No. 4 engine truss 

mount upper lug side surfaces, inboard and 

outboard, at OWS 162 and OWS 197; and for 

severed engine truss mount upper lugs; at a 

total of eight locations: two locations per 

engine truss mount lug, two lugs per engine, 

one mount assembly at each OWS. 

Note 1 to paragraph (g): Guidance for 

accomplishing the inspections and 

replacement can be found in Lockheed 

Martin Aeronautics Company Alert Service 

Bulletin A382–57–103, dated October 19, 

2023. 

(h) Special Flight Permit 

Special flight permits may be issued in 

accordance with 14 CFR 21.197 and 21.199 

to operate the airplane to a location where 

the inspections required by this AD can be 

performed, but special flight permits may not 

be issued to operate the airplane after a 

visual or borescope inspection has identified 

a cracked or severed lug, unless the operator 

contacts the Manager, East Certification 

Branch, FAA, for specific limitations that 

must be followed and complies with those 

limitations. 

(i) Alternative Methods of Compliance 

(AMOCs) 

(1) The Manager, East Certification Branch, 

FAA, has the authority to approve AMOCs 

for this AD, if requested using the procedures 

found in 14 CFR 39.19. In accordance with 

14 CFR 39.19, send your request to your 

principal inspector or responsible Flight 

Standards Office, as appropriate. If sending 

information directly to the manager of the 

certification office, send it to the attention of 

the person identified in paragraph (j) of this 

AD. 

(2) Before using any approved AMOC, 

notify your appropriate principal inspector, 

or lacking a principal inspector, the manager 

of the responsible Flight Standards Office. 

(j) Related Information 

(1) For more information about this AD, 

contact Fred Caplan, Aviation Safety 

Engineer, FAA, 1701 Columbia Avenue, 

College Park, GA 30337; phone: 404–474– 

5507; email: 9-ASO-ATLACO-ADs@faa.gov. 

(2) For Lockheed Martin Aeronautics 

Company service information identified in 

this AD that is not incorporated by reference, 

contact Lockheed Martin Corporation/ 

Lockheed Martin Aeronautics Company, 

Airworthiness Office, Dept. 6A0M, Zone 

0252, Column P–58, 86 S Cobb Drive, 

Marietta, GA 30063; telephone 770–494– 

5444; fax 770–494–5445; email ams.portal@

lmco.com. You may view this service 

information at the FAA, Airworthiness 

Products Section, Operational Safety Branch, 

2200 South 216th St., Des Moines, WA. For 

information on the availability of this 

material at the FAA, call 206–231–3195. 

(k) Material Incorporated by Reference 

None. 

Issued on November 16, 2023. 

Ross Landes, 

Deputy Director for Regulatory Operations, 

Compliance & Airworthiness Division, 

Aircraft Certification Service. 

[FR Doc. 2023–25762 Filed 11–17–23; 4:15 pm] 

BILLING CODE 4910–13–P 

DEPARTMENT OF COMMERCE 

Bureau of Industry and Security 

15 CFR Part 744 

[Docket No. 231115–0270] 

RIN 0694–AJ45 

Additions to the Entity List 

AGENCY: Bureau of Industry and 

Security, Department of Commerce. 

ACTION: Final rule. 

SUMMARY: In this rule, the Bureau of 

Industry and Security (BIS) amends the 

Export Administration Regulations 

(EAR) by adding four entities under 

nine entries to the Entity List. These 

entities are listed under the destinations 

of Costa Rica (1), Ecuador (1), India (1) 

Panama (2), Spain (1), Russia (1), and 

Venezuela (2). These entities have been 

determined by the U.S. Government to 

be acting contrary to the national 

security or foreign policy interests of the 

United States. Some entities are added 

under multiple entries, accounting for 

the difference in the totals. 

DATES: This rule is effective November 

17, 2023. 

FOR FURTHER INFORMATION CONTACT: 

Chair, End-User Review Committee, 

Office of the Assistant Secretary for 

Export Administration, Bureau of 

Industry and Security, Department of 

Commerce, Phone: (202) 482–5991, 

Email: ERC@bis.doc.gov. 

SUPPLEMENTARY INFORMATION: 

Background 

The Entity List (supplement no. 4 to 

part 744 of the EAR (15 CFR parts 730– 

774)) identifies entities for which there 

is reasonable cause to believe, based on 

specific and articulable facts, that the 

entities have been involved, are 

involved, or pose a significant risk of 

being or becoming involved in activities 

contrary to the national security or 

foreign policy interests of the United 

States, pursuant to § 744.11(b). The EAR 

impose additional license requirements 

on, and limit the availability of, most 

license exceptions for exports, 

reexports, and transfers (in-country) 

when a listed entity is a party to the 

transaction. The license review policy 

for each listed entity is identified in the 


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80956 Federal Register / Vol. 88, No. 223 / Tuesday, November 21, 2023 / Rules and Regulations 

1On February 24, 2023 (88 FR 12150), BIS also 

expanded controls to include certain foreign-made 

items classified under the same HTS–6 codes 

destined to Russia, due to their demonstrated use 

in weapons found on the battlefield in Ukraine. 

Such foreign-made items are subject to the EAR and 

the license requirements of § 746.8(a)(2) when a 

reexport, export from abroad, or transfer (incountry) meets the destination scope of the Russia/ 

Belarus/Temporarily occupied Crimea region of 

Ukraine FDP (Foreign Direct Product) rule 

described in § 734.9(f) of the EAR. 

‘‘License Review Policy’’ column on the 

Entity List, and the impact on the 

availability of license exceptions is 

described in the relevant Federal 

Register document that added the entity 

to the Entity List. The Bureau of 

Industry and Security (BIS) places 

entities on the Entity List pursuant to 

parts 744 (Control Policy: End-User and 

End-Use Based) and 746 (Embargoes 

and Other Special Controls) of the EAR. 

The End-User Review Committee 

(ERC), composed of representatives of 

the Departments of Commerce (Chair), 

State, Defense, Energy and, where 

appropriate, the Treasury, makes all 

decisions regarding additions to, 

removals from, or other modifications to 

the Entity List. The ERC makes all 

decisions to add an entry to the Entity 

List by majority vote and makes all 

decisions to remove or modify an entry 

by unanimous vote. 

Entity List Decisions 

Additions to the Entity List 

The ERC determined to add 

Aerofalcon S.L., under the destination 

of Spain; Novax Group S.A., under the 

destinations of Costa Rica, Ecuador, 

Panama, Venezuela, and Russia; and 

Zero Waste Global SA, under the 

destinations of Panama and Venezuela, 

to the Entity List. These entities are 

added to the Entity List pursuant to 

§ 744.11 of the EAR for engaging in 

activities contrary to U.S. national 

security and foreign policy interests. 

Specifically, these entities were used by 

their principals to circumvent U.S. 

sanctions, supplying the representatives 

of Nicola ́s Maduro in Venezuela with 

U.S. origin aircraft parts. This 

circumvention was conducted by, 

among other efforts, concealing the true 

end user and end destination of the 

exports using misrepresentations and 

fraudulent documents, including the 

filing of false Electronic Export 

Information. These entities will be 

added with a license requirement for all 

items subject to the EAR and a license 

review policy of presumption of denial. 

The ERC determined to add Si2 

Microsystems Private Limited, under 

the destination of India, to the Entity 

List. This entity is added to the Entity 

List for providing support to Russia’s 

military and/or defense industrial base. 

Specifically, this entity supplied 

Russian consignees connected to the 

Russian defense sector with U.S.-origin 

integrated circuits after March 1, 2023. 

These integrated circuits are classified 

under Harmonized Tariff System (HTS)- 

6 codes 854231, 854232, 854233, and/or 

854239. These HTS–6 codes are 

identified under supplement no. 4 to 

part 746 (Russian and Belarusian 

Industry Sector Sanctions Pursuant to 

§ 746.5(a)(1)(ii)). All U.S.-origin items 

classified under these HTS–6 codes 

have been controlled for export and 

reexport and transfer within Russia 

since September 15, 2022. Such U.S.- 

origin items require a license under 

§ 746.5(a)(1)(ii) of the EAR when 

destined to Russia or Belarus.1

Therefore, the documented shipments 

by this entity to Russia of such U.S.- 

origin items are contrary to U.S. 

national security and foreign policy 

interests under § 744.11(b) of the EAR. 

This entity will be added with a license 

requirement for all items subject to the 

EAR and a license review policy of 

denial. 

For the reasons described above, this 

final rule adds the following four 

entities, including aliases where 

appropriate, to the Entity List: 

Costa Rica 

• Novax Group S.A. 

Ecuador 

• Novax Group S.A. 

India 

• Si2 Microsystems Private Limited. 

Panama 

• Novax Group S.A.; and 

• Zero Waste Global SA. 

Spain 

• Aerofalcon S.L. 

Russia 

• Novax Group S.A. 

Venezuela 

• Novax Group S.A.; and 

• Zero Waste Global SA. 

Savings Clause 

For the changes being made in this 

final rule, shipments of items removed 

from eligibility for a License Exception 

or export, reexport, or transfer (incountry) without a license (NLR) as a 

result of this regulatory action that were 

en route aboard a carrier to a port of 

export, reexport, or transfer (in-country), 

on November 17, 2023, pursuant to 

actual orders for export, reexport, or 

transfer (in-country) to or within a 

foreign destination, may proceed to that 

destination under the previous 

eligibility for a License Exception or 

export, reexport, or transfer (in-country) 

without a license (NLR) before 

December 18, 2023. Any such items not 

actually exported, reexported or 

transferred (in-country) before midnight, 

on December 18, 2023, require a license 

in accordance with this final rule. 

Export Control Reform Act of 2018 

On August 13, 2018, the President 

signed into law the John S. McCain 

National Defense Authorization Act for 

Fiscal Year 2019, which included the 

Export Control Reform Act of 2018 

(ECRA) (50 U.S.C. 4801–4852). ECRA 

provides the legal basis for BIS’s 

principal authorities and serves as the 

authority under which BIS issues this 

rule. 

Rulemaking Requirements 

1. This rule has been determined to be 

not significant for purposes of Executive 

Order 12866. 

2. Notwithstanding any other 

provision of law, no person is required 

to respond to or be subject to a penalty 

for failure to comply with a collection 

of information, subject to the 

requirements of the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501 

et seq.) (PRA), unless that collection of 

information displays a currently valid 

Office of Management and Budget 

(OMB) Control Number. This regulation 

involves an information collection 

approved by OMB under control 

number 0694–0088, Simplified Network 

Application Processing System. BIS 

does not anticipate a change to the 

burden hours associated with this 

collection as a result of this rule. 

Information regarding the collection, 

including all supporting materials, can 

be accessed at https://www.reginfo.gov/ 

public/do/PRAMain. 

3. This rule does not contain policies 

with federalism implications as that 

term is defined in Executive Order 

13132. 

4. Pursuant to section 1762 of the 

Export Control Reform Act of 2018, this 

action is exempt from the 

Administrative Procedure Act (5 U.S.C. 

553) requirements for notice of 

proposed rulemaking, opportunity for 

public participation, and delay in 

effective date. 

5. Because a notice of proposed 

rulemaking and an opportunity for 

public comment are not required to be 

given for this rule by 5 U.S.C. 553, or 

by any other law, the analytical 

requirements of the Regulatory 

Flexibility Act, 5 U.S.C. 601, et seq., are 

not applicable. Accordingly, no 


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Federal Register / Vol. 88, No. 223 / Tuesday, November 21, 2023 / Rules and Regulations 80957 

regulatory flexibility analysis is 

required, and none has been prepared. 

List of Subjects in 15 CFR Part 744 

Exports, Reporting and recordkeeping 

requirements, Terrorism. 

Accordingly, part 744 of the Export 

Administration Regulations (15 CFR 

parts 730–774) is amended as follows: 

PART 744—END-USE AND END-USER 

CONTROLS 

■ 1. The authority citation for part 744 

is revised to read as follows: 

Authority: 50 U.S.C. 4801–4852; 50 U.S.C. 

4601 et seq.; 50 U.S.C. 1701 et seq.; 22 U.S.C. 

3201 et seq.; 42 U.S.C. 2139a; 22 U.S.C. 7201 

et seq.; 22 U.S.C. 7210; E.O. 12058, 43 FR 

20947, 3 CFR, 1978 Comp., p. 179; E.O. 

12851, 58 FR 33181, 3 CFR, 1993 Comp., p. 

608; E.O. 12938, 59 FR 59099, 3 CFR, 1994 

Comp., p. 950; E.O. 13026, 61 FR 58767, 3 

CFR, 1996 Comp., p. 228; E.O. 13099, 63 FR 

45167, 3 CFR, 1998 Comp., p. 208; E.O. 

13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 

783; E.O. 13224, 66 FR 49079, 3 CFR, 2001 

Comp., p. 786; Notice of November 8, 2022, 

87 FR 68015, 3 CFR, 2022 Comp., p. 563; 

Notice of September 7, 2023, 88 FR 62439 

(September 11, 2023). 

■ 2. Supplement no. 4 is amended: 

■ a. Under COSTA RICA, by adding, in 

alphabetical order, an entry for ‘‘Novax 

Group S.A.;’’ 

■ b. Under ECUADOR, by adding, in 

alphabetical order, an entry for ‘‘Novax 

Group S.A.;’’ 

■ c. Under INDIA, by adding, in 

alphabetical order, an entry for ‘‘Si2 

Microsystems Private Limited.;’’ 

■ d. Under PANAMA, by adding, in 

alphabetical order, entries for ‘‘Novax 

Group S.A.;’’ and ‘‘Zero Waste Global 

SA;’’ 

■ e. Under SPAIN, by adding, in 

alphabetical order, an entry for 

‘‘Aerofalcon S.L.;’’ 

■ f. Under RUSSIA, by adding in 

alphabetical order, an entry for ‘‘Novax 

Group S.A.;’’ and 

■ g. Under VENEZUELA, by adding in 

alphabetical order, entries for ‘‘Novax 

Group S.A.,’’ and ‘‘Zero Waste Global 

SA.’’ to read as follows: 

Supplement No. 4 to Part 744—Entity 

List 

* * * * * 

Country Entity License, 

requirement 

License 

review policy 

Federal Register 

citation 

*******

COSTA RICA ......... ******

Novax Group S.A., Centro Corporative 

Lindora, Oficina Nro. 2–10, Pozos de 

Santa Ana, San Jose, 10903, Costa Rica. 

(See alternate addresses under Ecuador, 

Panama, Russia, and Venezuela). 

For all items subject to the 

EAR. (See § 744.11 of the 

EAR).

Presumption of denial ............ 88 FR [INSERT FR PAGE 

NUMBER AND 11/21/ 

2023]. 

******

ECUADOR ............. ******

Novax Group S.A., Avenida Joaquin Orrantia 

y Juan Tanca Marengo, Torres del Mall del 

Sol Piso 4, Torre B, Guayaquil, Ecuador. 

(See alternate addresses under Costa 

Rica, Panama, Russia, and Venezuela). 

For all items subject to the 

EAR. (See § 744.11 of the 

EAR).

Presumption of denial ............ 88 FR [INSERT FR PAGE 

NUMBER AND 11/21/ 

2023]. 

******

INDIA ...................... ******

Si2 Microsystems Private Limited, 84, Deep 

Towers, EPIP Industrial Area, Whitefield, 

Bangalore, Karnataka, 560066, India; and 

#52/A, 1st Cross, 3rd Main KIADB Industrial Area, Hoskote, Bangalore, Karnataka, 

562114, India; and 3796, 7th Main, Hal II 

Stage, Bangalore, Karnataka, 560008, 

India; and 493/3 Bramhalingeshwara Complex, Airport Road, Bangalore, Karnataka, 

560008, India; and 177/2 Bannerghatta 

Road, Begur Hobli Bilekahalli Industrial 

Area, Bangalore, Karnataka, 560076, 

India. 

For all items subject to the 

EAR (See § 744.11 of the 

EAR).

Policy of denial ....................... 88 FR [INSERT FR PAGE 

NUMBER AND 11/21/ 

2023]. 

******

PANAMA ................ ******

Novax Group S.A., Avenida Aquilino de la 

Guardia con Calle 47, Edificio Ocean 

Plaza, Piso 16, Oficina 8, Ciudad de Panama, Panama. (See alternate addresses 

under Costa Rica, Ecuador, Russia, and 

Venezuela). 

For all items subject to the 

EAR. (See § 744.11 of the 

EAR).

Presumption of denial ............ 88 FR [INSERT FR PAGE 

NUMBER AND 11/21/ 

2023]. 

******

Zero Waste Global S.A., 58 Street Obarrios 

Office One Building, Suite 1302, Panama 

City, Panama. (See alternate address 

under Venezuela). 

For all items subject to the 

EAR. (See § 744.11 of the 

EAR).

Presumption of denial ............ 88 FR [INSERT FR PAGE 

NUMBER AND 11/21/ 

2023]. 

******

RUSSIA .................. ******

Novax Group S.A., Koptevskaya Ulitsa 67, 

Moscow, 125239, Russia. (See alternate 

addresses under Costa Rica, Ecuador, 

Panama, and Venezuela). 

For all items subject to the 

EAR. (See § 744.11 of the 

EAR).

Presumption of denial ............ 88 FR [INSERT FR PAGE 

NUMBER AND 11/21/ 

2023]. 

******

SPAIN .................... ******

Aerofalcon S.L., Calle A ́ ngel Cavero 28, Madrid, 28043, Spain. For all items subject to the 

EAR. (See § 744.11 of the 

EAR).

Presumption of denial ............ 88 FR [INSERT FR PAGE 

NUMBER AND 11/21/ 

2023]. 

******

VENEZUELA .......... ******


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80958 Federal Register / Vol. 88, No. 223 / Tuesday, November 21, 2023 / Rules and Regulations 

Country Entity License, 

requirement 

License 

review policy 

Federal Register 

citation 

Novax Group S.A., Caracas, Venezuela. 

(See alternate addresses under Costa 

Rica, Ecuador, Panama, and Russia). 

For all items subject to the 

EAR. (See § 744.11 of the 

EAR).

Presumption of denial ............ 88 FR [INSERT FR PAGE 

NUMBER AND 11/21/ 

2023]. 

Zero Waste Global S.A., Between Avenida 

Beethoven and Avenida Principal de Bello 

Monte, Edificio El Cigarral PH–A, Caracas, 

CP 1050, Venezuela. (See alternate address under Panama). 

For all items subject to the 

EAR. (See § 744.11 of the 

EAR).

Presumption of denial ............ 88 FR [INSERT FR PAGE 

NUMBER AND 11/21/ 

2023]. 

******

* * * * * 

Matthew S. Borman, 

Deputy Assistant Secretary for Export 

Administration. 

[FR Doc. 2023–25684 Filed 11–17–23; 8:45 am] 

BILLING CODE 3510–33–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 202 

[Docket No. FDA–2009–N–0582] 

RIN 0910–AG27 

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 

AGENCY: Food and Drug Administration, 

Department of Health and Human 

Services (HHS). 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is issuing a final rule to amend its 

regulations concerning direct-toconsumer (DTC) advertisements (ads) 

for human prescription drugs presented 

in television or radio format and stating 

the name of the drug and its conditions 

of use (DTC TV/radio ads). Specifically, 

the final rule implements a requirement 

of the Federal Food, Drug, and Cosmetic 

Act (FD&C Act), added by the Food and 

Drug Administration Amendments Act 

of 2007 (FDAAA), that in such DTC TV/ 

radio ads, the major statement relating 

to side effects and contraindications 

must be presented in a clear, 

conspicuous, and neutral manner. As 

directed by FDAAA, FDA is establishing 

standards to determine whether the 

major statement in DTC TV/radio ads is 

presented in a clear, conspicuous, and 

neutral manner. 

DATES: This rule is effective May 20, 

2024. The compliance date of this rule 

is November 20, 2024. 

ADDRESSES: For access to the docket to 

read background documents or 

comments received, go to https://

www.regulations.gov and insert the 

docket number found in brackets in the 

heading of this final rule 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. 

FOR FURTHER INFORMATION CONTACT: 

With regard to human drug products: 

Suzanna Boyle, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Silver Spring, MD 

20993–0002, 301–796–1200, CDEROPDP-RPM@fda.hhs.gov. 

With regard to human biological 

products: 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. 

With regard to the information 

collection: 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, PRAStaff@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Table of Contents 

I. Executive Summary 

A. Purpose of the Final Rule 

B. Summary of the Major Provisions of the 

Final Rule 

C. Legal Authority 

D. Costs and Benefits 

II. Table of Abbreviations/Commonly Used 

Acronyms in This Document 

III. Background 

A. Overview of Direct-to-Consumer 

Prescription Drug Advertising and Its 

Regulation 

B. History of the Rulemaking 

C. Summary of Comments to the Proposed 

Rule 

D. General Overview of Final Rule and 

Changes to the Proposed Rule 

IV. Legal Authority 

V. Comments on the Proposed Rule and FDA 

Response 

A. Introduction 

B. General Comments 

C. Research Studies—Comments and FDA 

Response 

D. The Major Statement—Comments and 

FDA Response 

E. Standards To Determine a Clear, 

Conspicuous, and Neutral Manner— 

General Comments and FDA Response 

F. Consumer/Audience—Comments and 

FDA Response 

G. Proposed Standard #1 (Final Standard 

#1) (Language)—Comments and FDA 

Response 

H. Proposed Standard #2 (Final Standard 

#2) (Audio)—Comments and FDA 

Response 

I. Proposed Standard #3 (Final Standard 

#4) (Presentation of Text)—Comments 

and FDA Response 

J. Proposed Standard #4 (Final Standard 

#5) (Elements That Interfere)— 

Comments and FDA Response 

K. Dual Modality (Final Standard #3)— 

Comments and FDA Response 

L. First Amendment Freedom of Speech— 

Comments and FDA Response 

M. Role of Healthcare Professional— 

Comments and FDA Response 

N. Costs—Comments and FDA Response 

O. Enforcement—Comments and FDA 

Response 

VI. Effective/Compliance Dates 

VII. Economic Analysis of Impacts 

A. Introduction 

B. Summary of Costs and Benefits 

VIII. Analysis of Environmental Impact 

IX. Paperwork Reduction Act of 1995 

X. Federalism 

XI. Consultation and Coordination With 

Indian Tribal Governments 

XII. References 

I. Executive Summary 

A. Purpose of the Final Rule 

This final rule implements a statutory 

requirement that in human prescription 

drug advertisements presented directly 

to consumers in television or radio 

format and stating the name of the drug 

and its conditions of use (DTC TV/radio 

ads), the major statement relating to side 

effects and contraindications (major 

statement) (Ref. 1) must be presented in 

a clear, conspicuous, and neutral 

manner. (As used in this document, 

unless specifically stated otherwise, 

references to DTC ads and similar terms 

encompass ads for human prescription 

drugs only.) In enacting that 

requirement, Congress directed FDA to 

issue regulations establishing standards 

for determining whether a major 

statement is presented in a clear, 


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