59562 Federal Register / Vol. 69, No. 192 / Tuesday, October 5, 2004 / Proposed Rules 

the compliance times specified, unless the 

actions have already been done. 

Modification 

(f) Within 30 months after the effective 

date of this AD: Modify the wiring for the 

master dim test system in accordance with 

the Accomplishment Instructions of Boeing 

Special Attention Service Bulletin 737–33–

1132, Revision 1, dated March 4, 2004 (for 

Model 737–300, –400, –500 series airplanes); 

and Boeing Service Bulletin 737–33–1133, 

Revision 2, dated December 4, 2003 (for 

Model 737–600, –700, –700C, –800, and –900 

series airplanes); as applicable. 

Actions Required To Be Accomplished Prior 

to or Concurrently With Paragraph (f) of 

This AD 

(g) Prior to or concurrently with 

accomplishment of paragraph (f) of this AD, 

do the actions specified in Table 1 of this AD, 

as applicable.

TABLE 1—PRIOR/CONCURRENT ACTIONS

For— Accomplish all actions associated with— According to the Accomplishment Instructions 

of—

Group 57 airplanes identified in Boeing Service 

Bulletin 737–33–1132, Revision 1, dated 

March 4, 2004.

Installing an engine instrument system (EIS) 

and.

Boeing Service Bulletin 737–77–1022, Revision 1, dated October 26, 1989. 

Modifying the advisory system for the EIS ...... Boeing Service Bulletin 737–77–1023, Revision 1, dated November 9, 1989. 

Group 4, 5, 7, 15, 16, 20, 24, 25, 29, 30, 33, 

37, 39, 40, 41, and 46 airplanes identified in 

Boeing Service Bulletin 737–33–1133, Revision 2, dated December 4, 2003.

Installing wiring for the test system for the 

audio control panel lamp.

Boeing Service Bulletin 737–33–1121, Revision 1, dated December 19, 2002. 

Group 2 airplanes identified in Boeing Service 

Bulletin 737–33–1121, Revision 1, dated December 19, 2002.

Installing splice SP896 ..................................... Boeing Service Bulletin 737–26A1083, Revision 1, dated November 15, 2001. 

Group 39 airplanes identified in Boeing Service 

Bulletin 737–33–1133, Revision 2, dated December 4, 2003.

Installing a smoke detection and fire extinguishing system in the cargo compartment.Boeing Service Bulletin 737–26A1083, Revision 1, dated November 15, 2001. 

Actions Accomplished per Previous Issue of 

Service Bulletins 

(h) Actions accomplished before the 

effective date of this AD in accordance with 

Boeing Special Attention Service Bulletin 

737–33–1132, dated March 20, 2003; Boeing 

Service Bulletin 737–33–1133, dated 

December 19, 2002; or Boeing Service 

Bulletin 737–33–1133, Revision 1, dated 

April 17, 2003, as applicable, are considered 

acceptable for compliance with the 

corresponding actions specified in this AD. 

Alternative Methods of Compliance 

(AMOCs) 

(i) The Manager, Seattle Aircraft 

Certification Office, FAA, has the authority to 

approve AMOCs for this AD, if requested in 

accordance with the procedures found in 14 

CFR 39.19.

Issued in Renton, Washington, on 

September 27, 2004. 

Ali Bahrami, 

Manager, Transport Airplane Directorate, 

Aircraft Certification Service.

[FR Doc. 04–22355 Filed 10–4–04; 8:45 am] 

BILLING CODE 4910–13–P

DEPARTMENT OF HOMELAND 

SECURITY 

Bureau of Customs and Border 

Protection 

19 CFR 133 

RIN 1505–AB51 

Recordation of Copyrights and 

Enforcement Procedures To Prevent 

the Importation of Piratical Articles

AGENCY: Bureau of Customs and Border 

Protection, Department of Homeland 

Security.

ACTION: Proposed rule.

SUMMARY: As a result of technological 

advances available to those pirating 

copyrighted works, there has been a 

global increase in the importation of 

piratical works. Because of this 

increased risk to owners of protected 

copyrighted works and because most 

owners of copyrights in non-U.S. works 

do not register their copyrights as a 

matter of course, the Bureau of Customs 

and Border Protection (CBP) is 

proposing regulations that allow CBP to 

be more responsive to claims of piracy. 

The CBP Regulations currently 

require that in order to be eligible for 

border protection all claims to 

copyright, foreign and domestic, be 

registered with the U.S. Copyright 

Office. This document proposes to allow 

sound recordings and motion pictures 

or similar audio-visual works to be 

recorded with CBP while pending 

registration with the U.S. Copyright 

Office. This document also proposes to 

amend the CBP Regulations to enhance 

the protection of all non-U.S. works by 

allowing recordation without requiring 

registration with the U.S. Copyright 

Office. Lastly, the proposed regulations 

set forth changes to CBP’s enforcement 

procedures, including, among other 

things, enhanced disclosure provisions, 

protection for live musical performances 

and provisions to enforce the Digital 

Millennium Copyright Act.

DATES: Written comments must be 

submitted on or before November 4, 

2005.

ADDRESSES: You may submit comments, 

identified by RIN 1505–AB51, by either 

of the following methods: 

• Federal eRulemaking Portal: http://

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Mail: Regulations Branch, Office of 

Regulations and Rulings, Bureau of 

Customs and Border Protection, 1300 

Pennsylvania Avenue, NW. (Mint 

Annex), Washington, DC 20229. 

Comments submitted may be 

inspected at the Regulations Branch, 

Office of Regulations and Rulings, 

Bureau of Customs and Border 

Protection, 799 9th Street, NW., 5th 

Floor, Washington, DC.

FOR FURTHER INFORMATION CONTACT: Paul 

Pizzeck, Esq. or George F. McCray, Esq., 

Intellectual Property Rights Branch, 

Office of Regulations and Rulings, (202) 

572–8710.

SUPPLEMENTARY INFORMATION: 

Federal Register / Vol. 69, No. 192 / Tuesday, October 5, 2004 / Proposed Rules 59563

Background 

Due to a global increase in piracy and 

an increased risk to owners of protected 

copyrighted works as a result of 

technological advances available to 

those pirating such works, the Bureau of 

Customs and Border Protection (CBP) is 

proposing regulations that allow CBP to 

be more responsive to claims of piracy. 

In this document, CBP is proposing 

changes designed to better facilitate the 

recordation process with CBP for certain 

works and to strengthen the 

enforcement procedures to protect those 

rights. 

Recordation of Protected Copyrighted 

Works 

CBP is proposing several changes to 

subpart D of part 133 of the CBP 

Regulations regarding the recordation 

process, as set forth below. 

Protection of Sound Recordings and 

Motion Pictures or Similar Audio-Visual 

Works Pending Registration With the 

U.S. Copyright Office 

Presently, the CBP Regulations 

provide that only those claims to 

copyright, foreign and domestic, which 

have been registered with the U.S. 

Copyright Office may be recorded with 

CBP. Subparts D and E of part 133, CBP 

Regulations (19 CFR part 133, subparts 

D and E) prohibit the importation of 

piratical works that have been properly 

registered and recorded. However, 

piratical copies of sound recordings and 

motion pictures or similar audio-visual 

works are often found in the market 

before the owner of a copyright in those 

works can effect registration of the 

copyright with the U.S. Copyright 

Office. Although the copyrightability of 

these types of works is rarely a 

substantive issue, because of the time 

lapse between the application for 

registration and the granting of 

registration with the U.S. Copyright 

Office, significant imports of piratical 

articles can often occur before the 

copyright owner is able to secure 

registration with the U.S. Copyright 

Office. 

For these types of works, it is during 

the periods of time prior to and 

immediately following the release of the 

work in which piracy is most likely to 

occur. As a result, pre-release copyright 

registration applications are generally 

avoided due to concerns about leaks 

arising from the sample copies 

submitted with the application which 

are made available to the public. 

Securing border protection 

simultaneously with (or in some cases 

prior to) the commercial release of 

sound recordings and motion pictures 

or similar audio-visual works should 

help to prevent the importation into the 

U.S. of piratical goods. As a result, CBP 

is proposing to revise subparts D and E 

of part 133, CBP Regulations, in order to 

provide for border enforcement of U.S. 

copyrights for sound recordings and 

motion pictures or similar audio-visual 

works in which copyrightability is 

rarely a substantive issue, that are 

pending registration with the U.S. 

Copyright Office. 

Concerning sound recordings and 

motion pictures or similar audio-visual 

works, CBP intends to accept a copy of 

a valid application for registration that 

has been filed with the U.S. Copyright 

Office as evidence of a copyrightable 

interest entitled to protection by CBP. 

The proposed regulations require that 

an applicant provide to CBP proof of 

registration with the U.S. Copyright 

Office no later than six months after the 

date of the application for recordation. 

If the applicant fails to provide proof of 

registration in a timely manner, CBP 

would cancel the related recordation. In 

addition, CBP proposes to reserve the 

right to cancel any recordation which it 

determines to have been obtained in any 

manner contrary to law. Permitting 

copyright owners of those certain 

categories of works for which 

copyrightability is rarely a substantive 

issue to make an initial recordation with 

CBP based on a filed, pending 

application for copyright registration 

rather than a perfected certificate of 

registration, will allow CBP to prevent 

the importation of piratical goods prior 

to the completion of the registration 

process. 

Accordingly, in § 133.32 which covers 

the recordation procedure for protected 

copyrighted works, a new paragraph 

(b)(4) is proposed to include claims to 

copyright in sound recordings and 

motion pictures or similar audio-visual 

works which are not yet registered with 

the U.S. Copyright Office. 

CBP notes that the above proposed 

change may result in an increased 

number of applications for recordation 

and, as each application is required to 

be accompanied by a $190 fee, an 

increased administrative burden in the 

processing of an increased number of 

individual payments. In order to 

mitigate processing costs for business 

and government, we are considering 

allowing alternative fee arrangements. 

For example, one annual payment may 

be made in lieu of individual 

application fees. The difference between 

the amount paid per recordation under 

the alternative arrangement and the 

standard single recordation fee 

(currently, $190) would not exceed the 

difference in processing costs. We are 

particularly interested in any comments 

on the fairness, equity, and potential 

administrative efficiency of such 

arrangements under 31 U.S.C. 9701. 

Non-U.S. Works Entitled to Border 

Enforcement Protection 

Under the current regulations, in 

order to seek protection from the 

importation of piratical copies, non-U.S. 

claimants holding a copyright entitled 

to enforcement are required to provide 

CBP with a valid certificate of 

registration issued by the U.S. Copyright 

Office and to record such registration 

with CBP. However, because most 

countries do not have registration 

systems and most non-U.S. copyright 

claimants do not register their works in 

the U.S. as a matter of course, and at the 

same time, due to technological 

advances available for pirating such 

works, there is an overall global increase 

in piracy and increased risk to owners 

of protected copyrighted works 

originating from throughout the world. 

Accordingly, CBP believes that it would 

be appropriate for non-U.S. claimants 

holding copyrights in such works to be 

entitled to record their claims with CBP 

regardless of whether they have 

registered their copyrights with the U.S. 

Copyright Office at the time of 

recordation. 

Accordingly, in § 133.31(a) covering 

protected copyrighted works eligible for 

recordation, new regulatory text is 

proposed to include, among other 

things, certain claims to copyright in 

non-U.S. works that have not been 

registered with the U.S. Copyright 

Office, but which are recognized under 

the Berne Convention for the Protection 

of Literary and Artistic Works (Berne 

Convention). 

Recordation Application Process

Based on the above described 

changes, CBP is also proposing to 

amend § 133.32 of the CBP Regulations 

(19 CFR 133.32) which outlines the 

procedure for recordation and the 

information required in all applications 

to record a copyright with CBP. To carry 

out CBP protection of claims to 

copyright in certain U.S. works pending 

registration with the U.S. Copyright 

Office and claims to copyright in nonU.S. works which are entitled to 

protection under 17 U.S.C. 104, new 

paragraphs (b)(3) and (4) are proposed to 

be added to expand § 133.32 to provide 

for such claims. 

New paragraph (b)(3) would permit 

owners of claims to copyrights in nonU.S. works to apply for recordation with 

CBP for the enforcement of such claims, 

even if not registered with the U.S. 

Copyright Office. This new paragraph 

59564 Federal Register / Vol. 69, No. 192 / Tuesday, October 5, 2004 / Proposed Rules 

sets forth that non-U.S. works will be 

entitled to border enforcement 

protection when sufficient evidence of 

ownership of copyright in those works 

is provided to CBP through recordation 

with CBP. Sufficient evidence of 

ownership consists of a written affidavit 

(in English), appropriately sworn to by 

a duly authorized party, validating the 

existence, ownership, and nature of the 

rights claimed. 

New paragraph (b)(4) would allow 

owners of claims to copyrights in U.S. 

sound recordings and motion pictures 

or similar audio-visual works for which 

copyrightability is rarely a substantive 

issue and for which securing border 

protection on an immediate basis is 

essential for purposes of preventing the 

importation of piratical articles, to 

record these works with CBP when 

registration is pending with the U.S. 

Copyright Office. The filing of such a 

claim will require the submission to 

CBP of a copy of a valid registration 

application officially filed with the U.S. 

Copyright Office for the specific work. 

Claims for protection made pursuant to 

either provision ((b)(3) or (4)) will be 

subject to independent verification by 

CBP, which will maintain sole 

discretion as to whether to accept such 

claims for enforcement. 

In addition, to further clarify and 

simplify the recordation process and 

reduce the burden on those applying for 

recordation of claims to copyright, CBP 

is proposing other changes to §§ 133.32 

and 133.33 which would: (1) Allow a 

‘‘duly appointed representative’’ to 

record a claim to copyright for the 

copyright owner thereby eliminating the 

need for the copyright owner to 

personally file the application; (2) 

eliminate the requirement that an 

applicant supply four additional 

photocopies (or likenesses) of the 

protected copyrighted work with the 

application; (3) update the address to 

which completed applications are 

submitted; and (4) update the name of 

the agency to which fees are submitted 

for recordation of copyright to reflect 

the new name of the former U.S. 

Customs Service. 

CBP is also proposing to require 

information regarding the citizenship of 

a copyright owner. Moreover, the 

current regulation requires that 

photographic or other likenesses be 

provided with an application for 

recordation in order to ensure that CBP 

has adequate information regarding a 

claim to copyright to enforce such 

rights. Works such as books, magazines, 

periodicals and sound recordings are 

excepted from this requirement. CBP is 

proposing to require that, as 

appropriate, either a sample, a digital 

image, or photograph of the protected 

work be submitted with the application 

to record the copyright. CBP is further 

proposing to require samples of sound 

recordings. 

Enforcing the Prohibition on the 

Importation of Piratical Articles 

CBP is proposing several changes to 

subpart E of part 133 of the CBP 

Regulations to achieve consistency with 

the above proposed changes concerning 

subpart D of part 133. The proposed 

changes, as set forth below, also serve to 

strengthen CBP’s ability to enforce the 

prohibition against the importation of 

piratical articles. 

Definition of ‘‘Protected Copyrighted 

Works’’

Section 133.42(a) currently provides 

that ‘‘Infringing copies or phonorecords 

are ‘piratical’ articles.’’ In order to more 

accurately and completely define 

‘‘piratical articles,’’ CBP is proposing to 

revise paragraph (a) of § 133.42 to define 

‘‘piratical articles’’ as those which 

constitute unlawful copies (made 

without the authorization of the 

copyright owner) or phonorecords of 

‘‘protected copyrighted works.’’ The 

proposed amended language defines 

‘‘protected copyrighted works’’ to 

encompass works registered with the 

U.S. Copyright Office and recorded with 

CBP, non-U.S. works which are entitled 

to protection under 17 U.S.C. 104 

(including sound recordings and motion 

pictures or similar audio-visual works) 

for which relevant ownership 

information is recorded with CBP, and 

certain U.S. works pending registration 

with the U.S. Copyright Office that are 

duly recorded with CBP. 

Disclosure to Copyright Owners Upon 

Infringement 

CBP has determined that, in order to 

pursue all avenues of relief from 

copyright infringement, including 

seeking criminal prosecution of 

violators and pursuing private civil 

remedies for copyright infringement, an 

affected copyright owner must have 

access to certain information regarding 

parties attempting to import infringing 

piratical articles. In cases involving 

seizures of articles that circumvent 

copyright protection systems 

(technological measures) under the 

Digital Millennium Copyright Act (Pub. 

L. 105–304, 112 Stat. 2860, DMCA) (see

Other Proposed Changes to the 

Regulations below), such information 

would be provided to the producers, or 

their duly authorized agents, of such 

copyright protection systems. 

Accordingly, CBP is proposing to amend 

its disclosure provisions regarding 

copyright violations in order to expand 

the information provided to copyright 

owners, or, in the case of articles seized 

pursuant to 19 CFR 133.42(c)(3) 

information provided to duly authorized 

agents of producers of copyright 

protection systems (technical measures), 

when merchandise violating their rights 

is seized at the border including 

information regarding articles seized for 

violation of the DMCA. 

Currently § 133.42(d) provides that, 

when CBP seizes goods under that 

section, CBP will disclose to the owner 

of the copyright: 

(1) The date of importation; 

(2) The port of entry; 

(3) A description of the merchandise; 

(4) The quantity involved; 

(5) The name and address of the 

manufacturer; 

(6) The country of origin of the 

merchandise;

(7) The name and address of the 

exporter; and 

(8) The name and address of the 

importer. 

CBP is proposing to amend 

§ 133.42(d) to provide that, in addition 

to the information above, when CBP 

seizes goods under that section, CBP 

will also disclose to the copyright owner 

or, for merchandise seized pursuant to 

§ 133.42(c)(3), to the producer of the 

copyright protection system: 

(9) Information from available 

shipping documents (such as manifests, 

air waybills, and bills of lading), 

including mode or method of shipping 

(such as airline carrier and flight 

number) and the intended final 

destination of the merchandise. 

Procedures on the Suspicion of Piratical 

Copies 

Section 133.43 contains the current 

procedures to be employed when CBP 

suspects that certain articles may be 

piratical articles. The current § 133.43 

provides for: (1) Notice of detention of 

suspected articles to an importer and to 

a copyright owner, including the 

disclosure of certain information; (2) the 

disclosure of samples of suspected 

articles to the copyright owner; (3) the 

release of the goods in the case of 

inaction by the copyright owner and in 

cases where the copyright owner makes 

a written demand for the exclusion of 

the suspected articles, a bonding 

requirement and exchange of briefs 

process; and (4) alternative procedures 

to the administrative process (court 

action). In general, the current 

regulations provide that upon 

notification by a port director that CBP 

has reason to believe that an imported 

article may be a piratical copy or 

phonorecord of a copyrighted work, the 

Federal Register / Vol. 69, No. 192 / Tuesday, October 5, 2004 / Proposed Rules 59565

copyright owner may file a written 

demand for exclusion of the suspected 

infringing copies. Additional evidence, 

legal briefs, and other pertinent material 

to substantiate a claim or denial of 

piracy are then exchanged between the 

parties and eventually submitted to CBP 

for administrative review. 

CBP believes that the existing 

procedures contained in § 133.43 are an 

outdated and inefficient mechanism to 

address the situation where CBP has a 

suspicion that certain goods may be 

piratical. These provisions are rarely 

used and unduly burdensome on CBP 

and all other parties involved. 

Essentially, these procedures interfere 

with CBP’s ability to conduct the 

required investigation in a timely and 

efficient manner. Moreover, the process 

inhibits CBP from applying its expertise 

in an expedient manner to determine 

whether or not merchandise is piratical. 

Most importantly, these procedures are 

ineffective in aiding CBP in resolving 

the issue of whether certain 

merchandise is indeed piratical. 

Likewise, § 133.44 outlines the 

actions to be taken when a claim of 

piracy under § 133.43 is sustained or 

denied. 

Accordingly, CBP is proposing to 

remove § 133.43 and § 133.44 in their 

entirety. Instead, CBP is proposing 

regulations allowing CBP to detain 

merchandise when CBP has reasonable 

suspicion to believe that the 

merchandise is piratical and to seize 

merchandise that it determines to be 

piratical. In addition, the proposed 

regulations would facilitate the 

exchange of information between the 

copyright owners and CBP in order to 

assist CBP in making this determination. 

Detention of Sound Recordings and 

Motion Pictures or Similar Audio Visual 

Works 

CBP is proposing to add regulatory 

text in a newly created paragraph (b)(2) 

to § 133.42 that specifies CBP’s power to 

detain articles that appear to be piratical 

copies of sound recordings, motion 

pictures, or similar audio-visual works 

to conduct further investigation. 

Accordingly, paragraph (b)(2) in 

§ 133.42 proposes to allow CBP to 

detain, for up to 30 days, sound 

recordings and motion pictures or 

similar audio-visual works prior to 

registration with the U.S. Copyright 

Office when CBP has reasonable 

suspicion to believe that they constitute 

piratical copies even though there is no 

underlying copyright registration or 

recordation on file with CBP. 

Reasonable suspicion that certain 

articles are piratical may be based upon 

factors such as poor product quality, 

substandard packaging, irregular 

invoicing, methods of shipment, or 

other indicia of piracy. 

Waiver of Bond Requirement for 

Samples Less Than $50.00 

Section 133.42(e) of the CBP 

Regulations (19 CFR 133.42(e)) allows 

CBP to provide a sample of suspect 

merchandise to the owner of the 

copyright. The copyright owner seeking 

to obtain a sample is required to furnish 

a bond to CBP. CBP is proposing to 

allow port directors, at their discretion, 

to waive the bond requirement where 

the value of the sample is less than 

$50.00. 

Other Proposed Changes to the 

Regulations 

Adding DMCA Violations to 

Enforcement Provisions of Subpart E 

In 1998, Congress enacted the DMCA. 

Among other things, the DMCA 

prohibits the circumvention of 

technological measures used by 

copyright owners to protect their works. 

A technological measure ’’effectively 

controls access to a work’’ if the 

measure, in the ordinary course of its 

operation, requires the application of 

information, or a process or a treatment, 

with the authority of the copyright 

owner, to gain access to the work. 

Although the current CBP Regulations 

do not specifically provide for detention 

and seizure of articles that constitute 

violations of the DMCA, CBP has 

implemented the DMCA by providing 

CBP personnel with internal 

enforcement guidelines and advice on 

how to enforce DMCA violations. Where 

CBP finds that certain devices violate 

the DMCA, the goods are subject to 

seizure and forfeiture under 19 U.S.C. 

1595a(c)(2)(C) for a violation of the 

DMCA (17 U.S.C. 1201(b)(1)). 

Accordingly, CBP is proposing to 

include provisions for the detention and 

seizure of articles that constitute 

violations under the DMCA to the 

enforcement provisions of subpart E. 

Specifically, CBP is proposing to add 

paragraph (b)(3) to § 133.42 to provide 

for the detention of articles that CBP 

reasonably believes constitute violations 

of 17 U.S.C. 1201(b)(1). Such detentions 

will be limited to 30 days in duration. 

In the event that the Intellectual 

Property Rights (IPR) Branch within 

CBP’s Office of Regulations & Rulings 

determines that such detained articles 

violate 17 U.S.C. 1201(b)(1), CBP will 

then seize them and institute forfeiture 

proceedings in accordance with part 162 

of chapter I of the CBP Regulations. 

Articles determined by the IPR Branch 

not to violate 17 U.S.C. 1201(b)(1), will 

be released.

CBP is also proposing to add 

paragraph (c)(3) to § 133.42 to provide 

for the seizure of articles that the IPR 

Branch determines to violate 17 U.S.C. 

1201(b)(1). Importers may petition for 

relief from the seizure and forfeiture 

under the provisions of part 171 of 

chapter I. Articles that have been seized 

and forfeited to the U.S. Government 

under part 133 will be disposed of in 

accordance with § 133.52(b). 

Adding Recordings of Live Musical 

Performances in Violation of 18 U.S.C. 

2319A to Enforcement Provisions of 

Subpart E 

Section 2319A of title 18 (18 U.S.C. 

2319A) states that copies of live musical 

performance that are ‘‘fixed’’ outside of 

the U.S. without the consent of the 

performer or performers involved are 

subject to seizure and forfeiture in the 

same manner as property imported in 

violation of the customs laws. Although 

CBP has had enforcement guidelines in 

place for several years, CBP has not 

promulgated regulations implementing 

section 2319A. 

Accordingly, CBP is proposing to add, 

at § 133.52(c)(2)(iii), recordings of live 

musical performances determined by 

CBP to be in violation of 18 U.S.C. 

2319A to the types of sound recordings 

subject to seizure. 

Comments 

Before adopting this proposed 

regulation as a final rule, consideration 

will be given to any written comments 

timely submitted to CBP, including 

comments on the clarity of this 

proposed rule and how it may be made 

easier to understand. Comments 

submitted will be available for public 

inspection in accordance with the 

Freedom of Information Act (5 U.S.C. 

552) and § 103.11(b), CBP Regulations 

(19 CFR 103.11(b)), on normal business 

days between the hours of 9 a.m. and 

4:30 p.m. at the Regulations Branch, 

Office of Regulations and Rulings, 

Bureau of Customs and Border 

Protection, 799 9th Street, NW., 5th 

Floor, Washington, DC. Arrangements to 

inspect submitted comments should be 

made in advance by calling Mr. Joseph 

Clark at (202) 572–8768. 

Executive Order 12866 

This document does not meet the 

criteria for a ‘‘significant regulatory 

action’’ as specified in E.O. 12866. 

Regulatory Flexibility Act 

Pursuant to the provisions of the 

Regulatory Flexibility Act (5 U.S.C. 601 

et seq.), it is certified that these 

59566 Federal Register / Vol. 69, No. 192 / Tuesday, October 5, 2004 / Proposed Rules 

proposed amendments will not have a 

significant economic impact on a 

substantial number of small entities. 

The regulatory amendments reflect, 

implement, or clarify existing statutory 

and regulatory requirements created to 

protect the rights of legitimate copyright 

owners. Accordingly, the amendments 

are not subject to the regulatory analysis 

or other requirements of 5 U.S.C. 603 

and 604. 

Signing Authority 

The authority to approve regulations 

concerning copyright enforcement, was 

retained by the Secretary of the 

Treasury. The signing authority for 

these amendments, therefore, falls 

under § 0.1(a)(1), CBP Regulations (19 

CFR 0.1(a)(1)). Accordingly, this 

document is signed by the Secretary of 

Homeland Security (or his or her 

delegate) and the Secretary of the 

Treasury (or his or her delegate). 

Paperwork Reduction Act 

The collection of information in this 

document is contained in § 133.32(b) of 

title 19 (19 CFR 133.32(b)). Under 

§ 133.32(b), the information would be 

required and used to record copyrights 

with CBP for border enforcement 

protection of copyrights. The collection 

of this information would ensure that 

CBP has adequate information regarding 

a claim to copyright in order to protect 

the copyright owner’s rights. 

The collection of information 

encompassed within this proposed rule 

has been submitted to the Office of 

Management and Budget (OMB) for 

review in accordance with the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3507). An agency may not 

conduct, and a person is not required to 

respond to, a collection of information 

unless the collection of information 

displays a valid control number 

assigned by OMB. 

Estimated annual reporting and/or 

recordkeeping burden: 4,000 hours. 

Estimated average annual burden per 

respondent/recordkeeper: 2 hours. 

Estimated number of respondents 

and/or recordkeepers: 2,000. 

Estimated annual frequency of 

responses: 1. 

Comments on the collection of 

information should be sent to the Office 

of Management and Budget, Attention: 

Desk Officer of the Department of the 

Treasury, Office of Information and 

Regulatory Affairs, Washington, DC 

20503. A copy should also be sent to the 

Regulations Branch, Office of 

Regulations and Rulings, Bureau of 

Customs and Border Protection, 1300 

Pennsylvania Avenue, NW. (Mint 

Annex), Washington, DC 20229. 

Comments should be submitted within 

the time frame that comments are due 

regarding the substance of the proposal. 

Comments are invited on: (a) Whether 

the collection is necessary for the proper 

performance of the functions of the 

agency, including whether the 

information will have practical utility; 

(b) the accuracy of the agency’s estimate 

of the burden of the collection of the 

information; (c) ways to enhance the 

quality, utility, and clarity of the 

information to be collected; (d) ways to 

minimize the burden of the collection of 

information on respondents, including 

through the use of automated collection 

techniques or other forms of information 

technology; and (e) estimates of capital 

or startup costs and costs of operations, 

maintenance, and purchases of services 

to provide information. 

Part 178, CBP Regulations (19 CFR 

part 178), containing the list of 

approved information collections, 

would be revised to add an appropriate 

reference to 133.32(b), upon adoption of 

the proposal as a final rule.

List of Subjects in 19 CFR Part 133 

Copying or simulating trademarks, 

Copyrights, Counterfeit trademarks, 

Customs duties and inspection, 

Detentions, Fees assessment, Imports, 

Labeling, Penalties, Piratical articles, 

Prohibited merchandise, Reporting and 

recordkeeping requirements, Restricted 

merchandise, Seizures and forfeitures, 

Trademarks.

Proposed Amendments to the 

Regulations 

It is proposed to amend part 133 of 

the Customs and Border Protection 

Regulations (19 CFR part 133), as 

discussed above and set forth below. For 

the reasons stated in the preamble, part 

133 of the CBP Regulations (19 CFR part 

133) is proposed to be amended to read 

as follows:

PART 133—TRADEMARKS, TRADE 

NAMES, AND COPYRIGHTS 

1. The general authority citation for 

part 133 and the specific citation for 

§ 133.42 is revised to read as follows:

Authority: 15 U.S.C. 1124, 1125; 17 U.S.C. 

101, 106, 501, 601, 602, 603; 19 U.S.C. 66, 

1499, 1595a, 1526, 1624; 31 U.S.C. 9701.

* * * * *

Section 133.42 also issued under 17 U.S.C. 

1201(b), 18 U.S.C. 2319A.

* * * * *

2. The heading to subpart D is revised 

to read as follows:

Subpart D—Recordation of Protected 

Copyrighted Works 

3. Section 133.31 is revised to read as 

follows:

§ 133.31 Recordation of protected 

copyrighted works. 

(a) Eligible works. The following 

works, collectively referred to in this 

part as ‘‘protected copyrighted works’’, 

when properly recorded with the 

Bureau of Customs and Border 

Protection (CBP) in accordance with the 

provisions of § 133.32, are eligible for 

border enforcement by CBP in 

accordance with the provisions of 

§ 133.42: 

(1) Non-expired claims to copyright in 

U.S. works which are registered with 

the U.S. Copyright Office and recorded 

with CBP; 

(2) Claims to copyright in non-U.S. 

works entitled to protection under 17 

U.S.C. 104 which are recorded with 

CBP; and 

(3) Claims to copyright in sound 

recordings and motion pictures or 

similar audio-visual works eligible for 

recordation under the provisions of 

§ 133.32. 

(b) Persons eligible to record. The 

owner of a copyright registered with the 

U.S. Copyright Office, including any 

person who has acquired copyright 

ownership through an exclusive license, 

assignment, or otherwise, who has 

registered that ownership interest with 

the U.S. Copyright Office, or their duly 

appointed representative may file an 

application to record that registered 

copyright. In addition, claimants to 

copyright in non-US works protected 

under 17 U.S.C. 104 and claimants to 

copyright in sound recordings and 

motion pictures or similar audio-visual 

works may also file an alternative 

application to record such claims in 

accordance with the provisions of 

§ 133.32 of this subpart. The term 

‘‘copyright owner,’’ with respect to any 

of the exclusive rights comprised in a 

copyright (see 17 U.S.C. 106), refers to 

the owner of a particular right protected 

under title 17. 

(c) Notice of recordation and other 

action. Applicants will be notified of 

the approval or denial of an application 

filed in accordance with § 133.32 upon 

completion of review. 

4. Section 133.32 is revised to read as 

follows:

§ 133.32 Procedure for recording 

protected copyrighted works. 

(a) Address. Applications to record 

protected copyrighted works under this 

section must be submitted in writing, 

addressed to the Intellectual Property 

Rights Branch, Office of Regulations and 

Federal Register / Vol. 69, No. 192 / Tuesday, October 5, 2004 / Proposed Rules 59567

Rulings, Bureau of Customs and Border 

Protection, 1300 Pennsylvania Avenue, 

NW., Washington, DC 20229. 

(b) Contents; format. (1) All 

recordation applications must include 

the following information (an electronic 

copyright recordation template can be 

found at the CBP Web site (http://

www.cbp.gov)): 

(i) The name, complete business 

address, and citizenship of the 

copyright owner (or owners) or 

claimants to copyright for protected 

works (if a partnership, the citizenship 

of each partner; if an association or 

corporation, the state, country, or other 

political jurisdiction within which it 

was organized, incorporated, or 

created); 

(ii) A complete description of the 

rights asserted which adequately 

identifies the work including, as 

appropriate, either: a sample of the 

article(s) containing the claimed 

protected work; a digital image of same; 

or a photograph of same reproduced on 

paper no larger than 8 1⁄2′′ x 11′′ in size 

(an application will be excepted from 

this requirement if the subject matter is 

a work such as a book, magazine, 

periodical, or similar copyrighted matter 

readily identifiable by title and author); 

(iii) The foreign title of the work, if 

different from the U.S. title;

(iv) In the case of copyright in a sound 

recording, a statement setting forth the 

name(s) of the performing artist(s) and 

any other information identifying the 

content thereof appearing on the 

reproduction surface of the sound 

recording or its label or container; and 

(v) The place(s) of manufacture of 

genuine copyrighted articles and the 

identity of the manufacturer(s). 

(2) For claims to copyright in U.S. 

works which have been registered with 

the U.S. Copyright Office, recordation 

applications must also contain an 

additional certificate of registration 

issued by the U.S. Copyright Office. 

Where the name of the applicant differs 

from the name of the copyright owner 

identified in the registration certificate 

issued by the U.S. Copyright Office, the 

application must be accompanied by a 

certified copy of any assignment, 

exclusive license, or other document 

showing that the applicant has acquired 

an ownership interest in the copyright. 

(3) For claims to copyright in nonU.S. works, including sound recordings 

and motion pictures or similar audiovisual works, entitled to protection 

under 17 U.S.C. 104, recordation 

applications must also contain a written 

affidavit (in English), appropriately 

sworn to by a duly authorized party, 

validating the existence, ownership, and 

nature of the rights claimed. Claims for 

protection made under this provision 

are subject to independent verification 

by CBP, which maintains sole discretion 

as to whether to accept such claims for 

enforcement. CBP may require 

additional information where the 

written affidavit fails to provide 

sufficient clarity as to the nature or 

ownership of the work for which 

enforcement is being sought. 

(4) For claims to copyright in U.S. 

sound recordings and motion pictures 

or similar audio-visual works pending 

registration with the U.S. Copyright 

Office, recordation applications must 

also contain a copy of a valid 

registration application with respect to 

the work and acceptable proof that such 

has been officially filed with the U.S. 

Copyright Office. Claims for protection 

made under this section are subject to 

independent verification by CBP, which 

maintains sole discretion as to whether 

to accept such claims for enforcement. 

CBP may require additional information 

where the copy of the registration 

application provided fails to provide 

sufficient clarity as to the nature or 

ownership of the work for which 

enforcement is being sought. The 

applicant must provide proof of 

registration with the U.S. Copyright 

Office no later than six months after the 

date of the application for recordation. 

Such proof will consist of an 

‘‘additional certificate of registration’’ 

(see 17 U.S.C. 706) issued by the U.S. 

Copyright Office. In the event that the 

applicant fails to provide CBP with 

proof that a registration has been issued 

by the U.S. Copyright Office, CBP will 

cancel the related recordation. Where 

the name of the applicant for CBP 

recordation differs from the name of the 

copyright owner identified in the 

registration application filed with the 

U.S. Copyright Office, the application 

for recordation must be accompanied by 

a certified copy of any assignment, 

exclusive license, or other document 

showing that the party applying for 

recordation has acquired an ownership 

interest in the copyright.

(c) CBP reserves the right to cancel 

any recordation which it determines has 

been obtained in any manner contrary to 

law. 

(d) Fee. Applications to record 

protected copyrighted works with CBP 

must be accompanied by a fee of $190 

in the form of a check or money order 

made payable to the Bureau of Customs 

and Border Protection for each claim to 

copyright to be recorded. In order to 

reduce processing costs for business and 

government, CBP may enter into 

alternative fee arrangements with 

persons, companies, agents, or 

associations. Such alternative fee 

structures will be subject to review on 

a periodic basis to ensure fairness, 

equity, and administrative efficiency. 

Fees in any such alternative structure 

will reflect costs for services provided 

in processing the applications for 

recordation, including data input, 

tracking of amounts paid, review for 

sufficiency, interface with field officers 

(principally, maintenance of intranet 

and internet databases for field and 

trade use), record maintenance, and any 

correspondence and associated 

administrative costs regarding filing, 

issue resolution, and recordation. Any 

recordation under such an alternative 

arrangement will remain in effect for 

twenty years or until the copyright 

ownership expires. Any lump sum fee 

arrangement will be valid only for 

renewable annual periods. No such 

alternative arrangement will become 

effective until published in the Federal 

Register by DHS/CBP, with Treasury 

concurrence. The difference in the per 

recordation rate under the alternative 

arrangement and the standard single 

recordation fee should not exceed the 

difference in processing costs. If the 

difference in the per recordation rate 

under the alternative arrangement and 

the standard single recordation fee 

exceeds the difference in processing 

costs, the alternative arrangement fees 

in the following year will be adjusted to 

compensate for that difference.

§ 133.33 [Removed] 

5. Section 133.33 is removed and 

reserved. 

6. The heading to subpart E is revised 

to read as follows:

Subpart E—Enforcement of the 

Prohibition on Importation of Infringing 

Copies or Phonorecords 

7. Section 133.42 is revised to read as 

follows:

§ 133.42 Piratical articles; Unlawful copies 

or phonorecords of protected copyrighted 

works. 

(a) Definition. ‘‘Piratical articles’’ are 

those which are unlawfully made 

(without the authorization of the 

copyright owner) copies or 

phonorecords of protected copyrighted 

works. ‘‘Protected copyrighted works’’ 

for these purposes refers to works falling 

into any of the following categories: 

(1) U.S. works registered with the U.S. 

Copyright Office and duly recorded 

with CBP pursuant to § 133.32; 

(2) Non-U.S. works that are protected 

under 17 U.S.C. 104 (including sound 

recordings and motion pictures or 

similar audio-visual works) and where 

relevant ownership information is 

recorded with CPB pursuant to § 133.32;

59568 Federal Register / Vol. 69, No. 192 / Tuesday, October 5, 2004 / Proposed Rules 

(3) U.S. sound recordings and motion 

pictures or similar audio-visual works 

which have been duly recorded with 

CBP pursuant to § 133.32. 

(b) Detention.

(1) Detention of suspected piratical 

articles (other than sound recordings 

and motion pictures or similar audiovisual works) that are recorded with 

CBP. Imported articles appearing to be 

piratical copies of protected copyrighted 

works, other than sound recordings and 

motion pictures or similar audio-visual 

works, for which a claim to copyright 

has previously been recorded with CBP 

pursuant to § 133.32, may be detained 

for a period not to exceed 30 days, if 

CBP has reasonable suspicion to believe 

that they constitute piratical copies. 

Upon determination by the IPR Branch, 

CBP Office of Regulations & Rulings, 

that such detained articles constitute 

piratical copies, CBP will seize them 

and institute forfeiture proceedings in 

accordance with part 162 of this 

chapter. Articles that are not determined 

by the IPR Branch within 30 days to be 

piratical copies will be released. 

(2) Detention of suspected piratical 

sound recordings and motion pictures 

or similar audio-visual works. Imported 

articles consisting of sound recordings 

and motion pictures or similar audiovisual works may be detained for a 

period not to exceed 30 days if CBP has 

reasonable suspicion to believe that they 

constitute piratical copies. Where the 

genuine works or sound recordings are 

not recorded with CBP at the time of 

detention of suspected piratical copies, 

recordation must take place no later 

than 30 days after the date on which the 

suspect articles were detained. Upon 

determination by CBP that such 

detained articles constitute piratical 

copies, CBP will seize them and 

institute forfeiture proceedings in 

accordance with part 162 of this 

chapter, provided that the copyright has 

been recorded with CBP pursuant to 

§ 133.32. Articles not recorded with CBP 

within 30 days or articles which are not 

determined by CBP to be piratical 

copies will be released.

(3) Detention of articles suspected of 

constituting violations of the Digital 

Millennium Copyright Act (17 U.S.C. 

1201(b)(1)). Imported articles appearing 

to constitute violations of 17 U.S.C. 

1201(b)(1) may be detained for a period 

not to exceed 30 days if CBP reasonably 

believes that such articles are primarily 

designed or produced for the purpose of 

circumventing protection afforded by a 

technological measure that effectively 

protects a right of a copyright owner; 

have only limited commercially 

significant purpose or use other than to 

circumvent such protection; or are 

marketed by the importer or trafficker, 

or another acting in concert with the 

importer or trafficker, for use in 

circumventing such protection. Upon 

determination by the IPR Branch, CBP 

Office of Regulations & Rulings, that 

such detained articles constitute 

violations of 17 U.S.C. 1201(b)(1) CBP 

will seize them and institute forfeiture 

proceedings in accordance with part 162 

of this chapter. Articles that are not 

determined by the IPR Branch to 

constitute violations of 17 U.S.C. 

1201(b)(1) will be released. 

(c) Seizure and forfeiture. Articles 

which have been seized and forfeited to 

the U.S. Government will be disposed of 

in accordance with § 133.52 of this part, 

subject to the importer’s right to petition 

for relief from the seizure and forfeiture 

under the provisions of part 171 of this 

chapter. 

(1) Seizure of copies of articles (other 

than sound recordings and motion 

pictures or similar audio-visual works).

(i) Imported articles which, at the time 

of presentment to CBP, clearly 

constitute piratical copies of protected 

copyrighted works other than sound 

recordings and audio-visual works, for 

which a claim to copyright has 

previously been recorded with CBP 

pursuant to § 133.32 are subject to 

immediate seizure. After seizure, 

piratical goods are subject to forfeiture 

proceedings in accordance with part 162 

of this chapter. CBP will notify the 

importer of the seizure in accordance 

with part 162 of this chapter. 

(ii) Imported articles detained 

pursuant to § 133.42(b)(1) that are 

determined by CBP to constitute 

piratical copies are subject to seizure. 

After seizure, piratical goods are subject 

to forfeiture proceedings in accordance 

with part 162 of this chapter. CBP will 

notify the importer of the seizure in 

accordance with part 162 of this 

chapter. 

(2) Seizure of sound recordings and 

motion pictures or similar audio-visual 

works. (i) Imported articles which, at the 

time of presentment to CBP, clearly 

constitute piratical copies or 

phonorecords of protected copyrighted 

works, for which a claim to copyright 

has previously been recorded with CBP 

pursuant to § 133.32 are subject to 

immediate seizure. After seizure, 

piratical goods are subject to forfeiture 

proceedings in accordance with part 162 

of this chapter. CBP will notify the 

importer of the seizure in accordance 

with part 162 of this chapter. 

(ii) Imported articles which have been 

detained pursuant to § 133.42(b)(2), for 

which a claim to copyright has been 

recorded with CBP within 30 days after 

the date on which the suspect articles 

were detained, that are determined by 

CBP to constitute piratical copies are 

subject to seizure. After seizure, 

piratical goods are subject to forfeiture 

proceedings in accordance with part 162 

of this chapter. CBP will notify the 

importer of the seizure in accordance 

with part 162 of this chapter. 

(iii) Recordings of live musical 

performances determined by CBP to be 

in violation of 18 U.S.C. 2319A will be 

subject to seizure regardless of the 

recordation of any right with CBP. After 

seizure, piratical goods are subject to 

forfeiture proceedings in accordance 

with part 162 of this chapter. CBP will 

notify the importer of the seizure in 

accordance with part 162 of this 

chapter. 

(3) Seizure of articles determined by 

CBP to constitute violations of the 

Digital Millennium Copyright Act (17 

U.S.C. 1201(b)(1)). Imported articles 

determined by the IPR Branch, CBP 

Office of Regulations & Rulings to 

constitute violations of 17 U.S.C. 

1201(b)(1) are subject to seizure 

regardless of the recordation of any right 

with CBP. After seizure, such goods are 

subject to forfeiture proceedings in 

accordance with part 162 of this 

chapter. CBP will notify the importer of 

the seizure in accordance with part 162 

of this chapter. 

(d) Disclosure. When merchandise is 

seized under this section, CBP will 

disclose to the owner of the protected 

copyrighted work (in the case of 

copyright piracy) or the producer, or 

duly authorized agent thereof, of 

circumvented copyright protection 

systems (in seizures effected for DMCA 

violations), the following information, if 

available, within 30 days, excluding 

weekends and holidays, of the date of 

the notice of seizure:

(1) The date of importation; 

(2) The port of entry; 

(3) A description of the merchandise; 

(4) The quantity involved; 

(5) The name and address of the 

manufacturer; 

(6) The country of origin of the 

merchandise, if known; 

(7) The name and address of the 

exporter; 

(8) The name and address of the 

importer; and 

(9) Information from available 

shipping documents (such as manifests, 

air waybills, and bills of lading), 

including mode or method of shipping 

(such as airline carrier and flight 

number) and the intended final 

destination of the merchandise. 

(e) Samples available to the copyright 

owner. At any time following detention 

or seizure of the merchandise, CBP may 

provide a sample of the suspect 

Federal Register / Vol. 69, No. 192 / Tuesday, October 5, 2004 / Proposed Rules 59569

merchandise to the owner of the 

protected work for examination, testing, 

or any other use in pursuit of a related 

private civil remedy for copyright 

infringement. To obtain a sample under 

this section, the owner of the protected 

work must furnish to CBP a bond in the 

form and amount specified by the port 

director at the port of importation, 

conditioned to hold the U.S., its officers 

and employees, and the importer or 

owner of the imported article harmless 

from any loss or damage resulting from 

the furnishing of a sample by CBP to the 

copyright owner. This requirement may 

be waived at the discretion of the port 

director where the value of the sample 

is less than $50.00. CBP may demand 

the return of the sample at any time. 

The owner of the protected work must 

return the sample to CBP upon demand 

or at the conclusion of the examination, 

testing, or other use in pursuit of a 

related private civil remedy for 

copyright infringement. In the event that 

the sample is damaged, destroyed, or 

lost while in the possession of the 

owner of the protected work, the owner 

of the protected work must, in lieu of 

return of the sample, certify to CBP that: 

‘‘The sample described as [insert 

description] provided by CBP pursuant 

to § 133.42(e) of the CBP Regulations 

was (damaged/destroyed/lost) during 

examination, testing, or other use.’’

(f) Parallel Imports. Copies or 

phonorecords made lawfully and 

imported into the U.S. without the 

consent of the owner of the protected 

copyrighted work, are not subject to 

detention, seizure, or forfeiture by CBP.

§ 133.43 [Removed] 

8. Section 133.43 is removed and 

reserved.

§ 133.44 [Removed] 

9. Section 133.44 is removed and 

reserved. 

10. Section 133.46 is revised to read 

as follows:

§ 133.46 Demand for redelivery of released 

articles. 

If CBP determines that articles which 

have been released from CBP custody 

are subject to the prohibitions or 

restrictions of this subpart, the 

appropriate field officer will promptly 

make demand for redelivery of the 

articles pursuant to § 141.113 of this 

chapter, under the terms of the bond on 

CBP Form 301, containing the bond 

conditions set forth in § 113.62 of this 

chapter. If the articles are not 

redelivered to CBP custody, a claim for 

liquidated damages may be made in 

accordance with § 141.113(h) of this 

chapter.

Dated: September 30, 2004. 

Robert C. Bonner, 

Commissioner of Customs and Border 

Protection. 

Timothy E. Skud, 

Deputy Assistant Secretary of the Treasury.

[FR Doc. 04–22334 Filed 10–4–04; 8:45 am] 

BILLING CODE 4820–02–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 361

[Docket No. 2004N–0432]

Radioactive Drugs for Certain 

Research Uses; Public Meeting

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice of public meeting; 

request for comments.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

public meeting to discuss the use of 

certain radioactive drugs for research 

purposes without an investigational 

new drug application (IND) under the 

conditions set forth in FDA regulations 

(typically, use of radioactive drugs to 

determine drug disposition in the body). 

We are seeking public input on the 

potential need to modify the conditions 

under which these radioactive drugs are 

studied in light of the scientific and 

technological developments since we 

adopted the regulations in 1975.

DATES: The public meeting will be held 

on November 16, 2004, from 8 a.m. to 

4 p.m. Submit electronic requests to 

speak plus a presentation abstract by 

October 19, 2004, to Maria R. Walsh. 

Submit final presentations and requests 

for special accommodations (due to 

disability) by November 2, 2004, to 

Maria R. Walsh. Submit written or 

electronic comments by January 16, 

2005, to Division of Dockets 

Management.

ADDRESSES: The public meeting will be 

held at the CDER Advisory Committee 

Conference Room, rm. 1066, 5630 

Fishers Lane, Rockville, MD 20857.

You may submit comments, identified 

by Docket No. 2004N–0432, by any of 

the following methods:

• Federal eRulemaking Portal: http://

www.regulations.gov. Follow the 

instructions for submitting comments.

• Agency Web site: http://

www.fda.gov/dockets/ecomments. 

Follow the instructions for submitting 

comments on the agency Web site.

• E-mail: fdadockets@oc.fda.gov. 

Include Docket No. 2004N–0432 in the 

subject line of your e-mail message.

• FAX: 301–827–6870.

• Mail/Hand delivery/Courier [For 

paper, disk, or CD-ROM submissions]: 

Division of Dockets Management (HFA–

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852.

Instructions: All submissions received 

must include the agency name and 

Docket No. All comments received will 

be posted without change to http://

www.fda.gov/ohrms/dockets/

default.htm, including any personal 

information provided. For detailed 

instructions on submitting comments 

and additional information on the 

rulemaking process, see the 

‘‘Comments’’ heading in the 

SUPPLEMENTARY INFORMATION section of 

this document.

Docket: For access to the docket to 

read background documents or 

comments received, go to http://

www.fda.gov/ohrms/dockets/

default.htm and insert the docket 

number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts, 

or go to the Division of Dockets 

Management, Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852.

Transcripts of the public meeting will 

be available for review at the Division 

of Dockets Management (see ADDRESSES) 

and on the Internet at http://

www.fda.gov/ohrms/dockets.

FOR FURTHER INFORMATION CONTACT:

Maria R. Walsh, Center for Drug 

Evaluation and Research (HFD–103), 

Food and Drug Administration, 5600 

Fishers Lane, Rockville, MD 20857, 

301–827–3139, FAX 301–480–3761, email: walsh@cder.fda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

We are announcing a public meeting 

to discuss research on radioactive drugs 

that is conducted under § 361.1 (21 CFR 

361.1). We added this section to FDA 

regulations in 1975 (40 FR 31298 at 

31308, July 25, 1975). Under § 361.1, 

certain radioactive drugs (drugs that 

exhibit spontaneous disintegration of 

unstable nuclei with the emission of 

nuclear particles or photons) are 

considered generally recognized as safe 

and effective under specified conditions 

of use when administered to human 

research subjects for certain basic 

research uses. These uses include 

studies intended to obtain basic 

information regarding the metabolism 

(including pharmacokinetics,