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, 

59570 Federal Register / Vol. 69, No. 192 / Tuesday, October 5, 2004 / Proposed Rules 

distribution, and localization) of a 

radioactive drug or regarding human 

physiology, pathophysiology, or 

biochemistry, but not those intended for 

immediate therapeutic, diagnostic, or 

similar purposes or those intended to 

determine the safety and effectiveness of 

the drug. When conducted in 

accordance with § 361.1, clinical 

investigations of radioactive drugs are 

not subject to the requirements for INDs 

stated in part 312 (21 CFR part 312).

In general, to conduct studies using 

radioactive drugs under § 361.1, an 

FDA-approved Radioactive Drug 

Research Committee (RDRC) must first 

conclude the following:

1. The pharmacological dose is 

limited such that the amount of active 

ingredient or ingredients administered 

is known not to cause any clinically 

detectable pharmacological effect, based 

on data available from published 

literature or from other valid human 

studies (§ 361.1(b)(2) and (d)(2)).

2. The radiation dose is limited such 

that the amount of radioactive material 

administered is the smallest radiation 

dose practical to perform the study 

without jeopardizing the benefits 

obtained from the study, and the dose, 

for adult subjects, does not exceed the 

following:

TABLE 1.—LIMITS OF RADIATION DOSE FOR ADULTS

Organ or System Single Dose 

Sieverts (Rems) 

Annual and Total 

Dose Sieverts 

(Rems) 

Whole body 0.03 (3) 0.05 (5)

Active blood-forming organs 0.03 (3) 0.05 (5)

Lens of the eye 0.03 (3) 0.05 (5)

Gonads 0.03 (3) 0.05 (5)

Other organs 0.05 (5) 0.15 (15)

For subjects under 18 years of age, the 

radiation dose must not exceed 10 

percent of the adult dose (§ 361.1(b)(3)).

3. The design and quality of the study 

and the importance of the information it 

seeks to obtain justify the exposure of 

research subjects to radiation 

(§ 361.1(b)(1)(iii)).

4. The investigator has appropriate 

qualifications for the conduct of a study 

involving radioactive drugs 

(§ 361.1(d)(3)).

5. The investigator has the 

appropriate licensure for handling 

radioactive materials (§ 361.1(d)(4)).

6. The mechanisms for selecting 

research subjects and obtaining 

informed consent are appropriate 

(§ 361.1(d)(5)).

7. The radioactive drug to be 

administered meets appropriate 

chemical, pharmaceutical, 

radiochemical, and radionuclidic 

standards for identity, strength, quality, 

and purity; and radioactive drugs for 

parenteral use are prepared in sterile 

and pyrogen-free form (§ 361.1(d)(6)).

8. The study is based on a sound 

rationale and is of sound design such 

that information of scientific value may 

result (§ 361.1(d)(7)).

9. There are mechanisms in place for 

identifying and reporting adverse 

reactions (§ 361.1(d)(8)).

10. The study has been reviewed and 

approved by an institutional review 

board (IRB) (§ 361.1(d)(9)).

Since we added § 361.1 in 1975, there 

have been numerous developments in 

imaging technology, pharmacology, 

toxicology, and dosimetry that have had 

a significant impact on the use of 

radioactive drugs. In light of these 

changes, we are considering whether 

issuance of guidance on, or even 

revision of, § 361.1 would be 

appropriate. To that end, we are holding 

a public meeting to obtain input on 

what actions we should take, if any, 

concerning the regulation of basic 

research involving radioactive drugs. To 

facilitate discussion at the public 

meeting and assist us in our review of 

this matter, we have the following 

questions concerning the application of 

§ 361.1:

1. Pharmacology Issues: Section 

361.1(b)(2) requires that the amount of 

radioactive drug to be administered be 

known not to cause any clinically 

detectable pharmacological effect in 

humans. According to § 361.1(d)(2), 

investigators must provide 

pharmacological dose calculations 

based on published literature or other 

human data to demonstrate an absence 

of a clinically detectable 

pharmacological effect (thus, no 

radioactive drug may be studied ‘‘first in 

humans’’ under current § 361.1).

a. For an active ingredient chemically 

manufactured in the laboratory that is 

also a body constituent (an endogenous 

substance), what percentage of 

estimated daily endogenous production 

could be considered to have no 

pharmacological effect? (Because 

heterogeneous biological products (e.g., 

monoclonal antibodies and therapeutic 

proteins such as interferon, interleukin, 

other cytokines, and enzymes) are 

foreign proteins and are assumed to 

have the potential to produce an 

antigenic response, they should be 

excluded from consideration unless 

they have been shown to have no 

immunologic response.)

b. For an active ingredient that is not 

endogenous, what animal, in vitro, and/

or in vivo data would be needed to 

demonstrate that there is no human 

pharmacological effect? Is there an 

absolute dose that would ensure no 

pharmacological effect? If so, what data 

would be needed to support that dose?

c. How may an investigator confirm 

that a radioactive drug causes no 

clinically detectable pharmacological 

effect in humans in accordance with 

§ 361.1(b)(2)? What parameters should 

be measured, how frequently, and what 

criteria should be used to determine if 

a pharmacologic effect has occurred?

2. Radiation Dose Limits for Adult 

Subjects: The radiation dose limits for 

adult subjects specified in 

§ 361.1(b)(3)(i) are based on the basic 

occupational radiation protection 

criteria established by the Nuclear 

Regulatory Commission under 10 CFR 

20.101. FDA’s thinking in 1975 was that 

these criteria would enable a potential 

research subject to make an informed 

decision regarding participation in a 

study under § 361.1 because the subject 

would, in effect, be deciding whether he 

or she was willing to assume the same 

risk as a radiation worker for the 

duration of the study. Considering the 

advances in scientific knowledge and 

regulatory changes that have occurred 

Federal Register / Vol. 69, No. 192 / Tuesday, October 5, 2004 / Proposed Rules 59571

since 1975, including new data on 

radiation effects (Ref. 1) and new 

recommendations on radiation dose 

limits (Refs. 2, 3, and 4), are the current 

dose limits for adults still appropriate 

for research conducted under § 361.1? If 

not, what dose limits are appropriate? 

Should there be different dose limits for 

different adult age groups?

3. Assurance of Safety for Pediatric 

Subjects: Currently, § 361.1 allows for 

the study of radioactive drugs in 

subjects less than 18 years of age 

without an IND if:

• The study presents a unique 

opportunity to gain information not 

currently available, requires the use of 

research subjects less than 18 years of 

age, is without significant risk to 

subjects, and is supported with review 

by qualified pediatric consultants to the 

RDRC;

• The radiation dose does not exceed 

10 percent of the adult radiation dose 

specified in § 361.1(b)(3)(i); and

• As with adult subjects, the following 

requirements, among others, are met: (1) 

The study is approved by an 

institutional review board (IRB) that 

conforms to 21 CFR part 56, (2) 

informed consent of the subjects’ legal 

representative is obtained in accordance 

with 21 CFR part 50, and (3) the study 

is approved by the RDRC that assures all 

other requirements of § 361.1 are met.

Alternatively, when a study is 

conducted under an IND in accordance 

with part 312, the sponsor must submit 

to FDA the study protocol, protocol 

changes and information amendments, 

pharmacology/toxicology and chemistry 

information, and information regarding 

prior human experience with the same 

or similar drugs (see §§ 312.22, 312.23, 

312.30, and 312.31). Additionally, 

§ 312.32 requires that sponsors 

promptly review all information 

relevant to the safety of the drug 

obtained or otherwise received by the 

sponsor from any source, foreign or 

domestic. This includes information 

derived from any clinical or 

epidemiological investigations, animal 

investigations, commercial marketing 

experience, reports in the scientific 

literature, and unpublished scientific 

papers, as well as reports from foreign 

regulatory authorities. Section 312.32 

also requires that sponsors submit IND 

safety reports to FDA.

a. Does § 361.1 provide adequate 

safeguards for pediatric subjects during 

the course of a research project intended 

to obtain basic information about a 

radioactive drug, or should these studies 

only be conducted under an IND?

b. If we assume that § 361.1 provides 

adequate safeguards for pediatric 

subjects during such studies, given our 

present knowledge about radiation and 

its effects, can we conclude that the 

current dose limits for pediatric subjects 

do not pose a significant risk? If not, 

what dose limits would be appropriate 

to ensure no significant risk for 

pediatric subjects? Should there be 

different dose limits for different 

pediatric age groups?

4. Quality and Purity: What standards 

for quality and purity should apply to 

radioactive drugs administered under 

§ 361.1 to ensure the safety of research 

subjects?

5. Exclusion of Pregnant Women: 

Section 361.1(d)(5) requires that each 

female research subject of childbearing 

potential state in writing that she is not 

pregnant or, on the basis of a pregnancy 

test, be confirmed as not pregnant before 

she may participate in any research 

study involving a radioactive drug 

under § 361.1. Is written attestation 

adequate assurance that female research 

subjects are not pregnant? If not, what 

other assurance should be provided?

6. RDRC Membership:

a. Under § 361.1(c)(1), an RDRC must 

include the following expertise: (1) A 

physician recognized as a specialist in 

nuclear medicine, (2) a person qualified 

to formulate radioactive drugs, and (3) 

a person with special competence in 

radiation safety and radiation 

dosimetry. Would an RDRC benefit from 

any additional expertise, such as a 

pharmacologist or toxicologist? Should 

such memberships be required?

b. Under § 361.1(c)(4), changes in the 

membership of an RDRC must be 

submitted to FDA as soon as, or before, 

vacancies occur on the committee. 

However, the regulations do not require 

approval of new members by FDA 

before a new member assumes 

committee responsibilities. We review 

the qualifications of new members when 

we receive them and contact the RDRC 

when we identify new members we 

consider to be unqualified, but we do 

not always receive notifications of 

changes in membership in a timely 

manner. At times, this has resulted in 

unqualified members serving on RDRCs 

for extended periods. Should the 

regulations specifically require that FDA 

approve RDRC membership changes 

before new members assume committee 

responsibilities? For example, would it 

be appropriate for the regulations to 

allow FDA 15 days to review the 

qualifications of a proposed new 

member before the member could 

assume committee responsibilities?

II. Registration and Presentations

No registration is required to attend 

the meeting. Seating is limited to 120 

and will be on a first-come, first-served 

basis. If you need special 

accommodations due to a disability, 

please inform Maria R. Walsh by 

November 2, 2004.

If you wish to present information at 

the public meeting, submit your 

electronic request and an abstract of 

your presentation by the close of 

business on October 19, 2004, to Maria 

Walsh (see FOR FURTHER INFORMATION

CONTACT).

The request to participate should 

contain the following information:

(1) Presenter’s name; (2) address; (3) 

telephone number; (4) e-mail address; 

(5) affiliation, if any; (6) abstract of the 

presentation; and (7) approximate 

amount of time requested for the 

presentation.

We request that persons and groups 

having similar interests consolidate 

their comments and present them 

through a single representative. We will 

allocate the time available for the 

meeting among the persons who request 

to present. Because of limited time, we 

will accept only one presenter per 

organization. We reserve the right to 

deny requests if the proposed topic is 

not germane. After reviewing the 

requests to present and abstracts, we 

will schedule each appearance and 

notify each participant by e-mail or 

telephone of the time allotted to the 

person and the approximate time the 

person’s presentation is scheduled to 

begin. Presenters planning to use 

electronic presentations in Microsoft 

PowerPoint, Microsoft Word, or Adobe 

Acrobat PDF must send them to us by 

the close of business on November 2, 

2004. Presenters who do not meet this 

deadline may provide handouts of their 

presentations at the meeting.

The meeting schedule will be 

available on the Internet at http://

www.fda.gov/cder/meeting/

clinicalResearch/default.htm and at the 

meeting. After the meeting, the schedule 

and presentations will be placed on file 

in the Division of Dockets Management 

under the docket number listed in the 

heading of this notice.

III. Comments

Interested persons may submit written 

or electronic comments on or before 

January 16, 2005, to the Division of 

Dockets Management (see ADDRESSES). 

You must submit two copies of 

comments identified with the docket 

number found in brackets in the 

heading of this document. The received 

comments may be seen at the Division 

of Dockets Management, Monday 

through Friday between 9 a.m. and 4 

p.m.

59572 Federal Register / Vol. 69, No. 192 / Tuesday, October 5, 2004 / Proposed Rules 

IV. Transcripts

Approximately 30 days after the 

public meeting, you can examine a 

transcript of the meeting on the Internet 

at http://www.fda.gov/ohrms/dockets/

default.htm or at the Division of Dockets 

Management (see ADDRESSES), 

Monday through Friday between 9 a.m. 

and 4 p.m. You may also request a copy 

of the transcript from the Freedom of 

Information Office (HFI–35), Food and 

Drug Administration, 5600 Fishers 

Lane, rm. 12A–16, Rockville, MD 20857, 

at a cost of 10 cents per page or on CD 

at a cost of $14.25 each.

V. References

The following references have been placed 

on display in the Division of Dockets 

Management and may be seen by interested 

persons between 9 a.m. and 4 p.m., Monday 

through Friday.

1. Preston, D.L., Y. Shimizu, D.A. Pierce, 

A. Suyama, and K. Mabuchi, ‘‘Studies of 

mortality of atomic bomb survivors, Report 

13: Solid cancer and noncancer disease 

mortality: 1950–1997,’’ Vol. 160, No. 4, pp. 

381–407, Radiation Research, 2003.

2. International Commission on 

Radiological Protection, ‘‘1990 

Recommendations of the International 

Commission on Radiological Protection,’’

Annals of the International Commission on 

Radiological Protection (ICRP), ICRP 

Publication 60, vol. 21, No. 1–3, pp. 1–201, 

1991.

3. National Council on Radiation 

Protection Measurements (NCRP), 

‘‘Limitation of Exposure to Ionizing 

Radiation,’’ NCRP Report no. 116, Bethesda, 

MD, 1993.

4. National Council on Radiation 

Protection and Measurements, ‘‘Principles 

and Application of Collective Dose in 

Radiation Protection,’’ NCRP Report No. 121, 

Bethesda, MD, 1995.

Dated: September 24, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–22354 Filed 10–4–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF THE TREASURY

Internal Revenue Service 

26 CFR Part 48 

[REG–120616–03] 

RIN 1545–BC08 

Entry of Taxable Fuel; Hearing

AGENCY: Internal Revenue Service (IRS), 

Treasury.

ACTION: Notice of public hearing on 

proposed rulemaking. 

SUMMARY: This document contains a 

notice of public hearing on proposed 

regulations relating to the tax on the 

entry of taxable fuel into the United 

States.

DATES: The public hearing is being held 

on January 12, 2005, at 10 a.m. The IRS 

must receive outlines of the topics to be 

discussed at the hearing by December 1, 

2004.

ADDRESSES: The public hearing is being 

held in the IRS Auditorium, Internal 

Revenue Building, 1111 Constitution 

Avenue, NW., Washington, DC. 

Mail outlines to: CC:PA:LPD:PR 

(REG–120616–03) , room 5203, Internal 

Revenue Service POB 7604, Ben 

Franklin Station, Washington, DC 

20044. Submissions may be handdelivered Monday through Friday 

between the hours of 8 a.m. and 4 p.m. 

to CC:PA:LPD:PR (REG–120616–03), 

Courier’s Desk, Internal Revenue 

Service, 1111 Constitution Avenue, 

NW., Washington, DC or sent 

electronically, via the IRS Internet site 

at http://www.irs.gov/regs or via the 

Federal eRulemaking Portal at http://

www.regulations.gov (IRS-REG–120616–

03).

FOR FURTHER INFORMATION CONTACT:

Concerning submissions of comments, 

the hearing, and/or to be placed on the 

building access list to attend the hearing 

LaNita Van Dyke, (202) 622–7180 (not a 

toll-free number).

SUPPLEMENTARY INFORMATION: The 

subject of the public hearing is the 

notice of proposed regulations (REG–

120616–03) that was published in the 

Federal Register on Friday, July 30, 

2004 (69 FR 45631). 

The rules of 26 CFR 601.601(a)(3) 

apply to the hearing. Persons who have 

submitted written comments and wish 

to present oral comments at the hearing 

must submit an outline of the topics to 

be discussed and the amount of time to 

be devoted to each topic (signed original 

and eight copies) by December 1, 2004. 

A period of 10 minutes is allotted to 

each person for presenting oral 

comments. After the deadline for 

receiving outlines has passed, the IRS 

will prepare an agenda containing the 

schedule of speakers. Copies of agenda 

will be made available, free of charge, at 

the hearing. Because of access 

restrictions, the IRS will not admit 

visitors beyond the immediate entrance 

area more than 30 minutes before the 

hearing. For information about having 

your name placed on the building 

access list to attend the hearing, see the 

FOR FURTHER INFORMATION CONTACT

section of this document.

Cynthia E. Grigsby, 

Acting Chief, Publications and Regulations 

Branch, Associate Chief Counsel, Legal 

Processing Division (Procedures and 

Administration).

[FR Doc. 04–22372 Filed 10–4–04; 8:45 am] 

BILLING CODE 4830–01–P

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[WI117–01–7347b; FRL–7637–1] 

Approval and Promulgation of 

Implementation Plans; Wisconsin

AGENCY: Environmental Protection 

Agency.

ACTION: Proposed rule.

SUMMARY: The Environmental Protection 

Agency (EPA) is proposing to approve a 

revision to the Wisconsin regulations as 

they pertain to Northern Engraving 

Corporation (NEC) facilities in 

Galesville and West Salem, Wisconsin 

as requested by the State of Wisconsin 

on June 27, 2003. This State 

Implementation Plan (SIP) revision 

makes changes to Wisconsin air 

pollution control rules federally 

enforceable. The rule revisions modify 

the emission limits adopted by the state 

that are part of the current Wisconsin 

SIP. The revised rules, specifically 

portions of the Environmental 

Cooperative Agreement with NEC, 

supercede portions of the rules in the 

Wisconsin SIP. 

In the ‘‘Rules and Regulations’’

section of this Federal Register, EPA is 

approving the State’s request as a direct 

final rule without prior proposal 

because EPA views this action as 

noncontroversial and anticipates no 

adverse comments. The rationale for 

approval is set forth in the direct final 

rule. If EPA receives no written adverse 

comments, EPA will take no further 

action on this proposed rule. If EPA 

receives written adverse comment, we 

will publish a timely withdrawal of the 

direct final rule in the Federal Register

and inform the public that the rule will 

not take effect. In that event, EPA will 

address all relevant public comments in 

a subsequent final rule based on this 

proposed rule. In either event, EPA will 

not institute a second comment period 

on this action. Any parties interested in 

commenting must do so at this time.

DATES: Comments on this action must be 

received by November 4, 2004.