58740 Federal Register / Vol. 71, No. 193 / Thursday, October 5, 2006 / Rules and Regulations 

and Research (HFD–310), Food and 

Drug Administration,11919 Rockville 

Pike, Rockville, MD 20852, 301–827–

8957. 

For products regulated by the Center for 

Biologics Evaluation and Research: 

Kathleen E. Swisher, Center for 

Biologics Evaluation and Research 

(HFM–17), Food and Drug 

Administration, 1401 Rockville Pike, 

suite 200N, Rockville, MD 20852–1448, 

301–827–6210. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of February 

26, 2004 (69 FR 9120), FDA published 

a final rule (the February 2004 final 

rule) requiring certain human drug and 

biological products to have on their 

labels a linear bar code that contains, at 

a minimum, the drug’s NDC number (21 

CFR 201.25). The February 2004 final 

rule requires also that the container 

label of blood and blood components 

intended for transfusion bear encoded 

information in a machine-readable 

format that must be approved for use by 

the Director, Center for Biologics 

Evaluation and Research (21 CFR 

606.121(c)(13)). 

In the Federal Register of April 27, 

2006 (71 FR 24856), FDA announced the 

availability of a final guidance 

‘‘Guidance for Industry: Bar Code Label 

Requirements—Questions and 

Answers.’’ The purpose of the April 

2006 guidance was to respond to 

questions about how the requirements 

in the February 2004 final rule applied 

to specific products or circumstances. 

The questions and answers in the April 

2006 guidance focused on bar codes, not 

machine-readable information on 

container labels of blood and blood 

components, because most of the 

questions we received at that time 

focused on bar codes. In the April 2006 

guidance, we stated that the guidance 

may be revised as we receive additional 

questions. 

Following publication of the February 

2004 final rule and issuance of the April 

2006 guidance, FDA received several 

additional questions concerning blood 

and blood components and the use of 

machine-readable information. The 

answers to these additional questions 

were provided in the preamble to the 

February 2004 final rule. We have 

updated the April 2006 guidance with 

this additional information to make the 

information more accessible and 

convenient. We consider the changes to 

the April 2006 guidance to be level 2 

changes because they set forth existing 

practices (21 CFR 10.115(c)(2)). 

Therefore, FDA is announcing the 

availability of additional questions and 

answers incorporated in the document 

entitled ‘‘Guidance for Industry: Bar 

Code Label Requirements—Questions 

and Answers,’’ and we are revising the 

date of the guidance to October 2006. 

The guidance is issued consistent 

with FDA’s good guidance practices 

regulation (21 CFR 10.115), particularly 

21 CFR 10.115(g)(4)(i). The guidance 

represents the FDA’s current thinking 

on this topic. It does not create or confer 

any rights for or on any person and does 

not operate to bind FDA or the public. 

An alternative approach may be used if 

such approach satisfies the 

requirements of the applicable statutes 

and regulations. 

II. Comments 

Interested persons may, at any time, 

submit written or electronic comments 

to the Division of Dockets Management 

(see ADDRESSES) regarding this 

guidance. Submit a single copy of 

electronic comments or two paper 

copies of any mailed comments, except 

that individuals may submit one paper 

copy. Comments are to be identified 

with the docket number found in the 

brackets in the heading of this 

document. A copy of the guidance and 

received comments are available for 

public examination in the Division of 

Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the guidance at http:// 

www.fda.gov/cber/guidelines.htm, 

http://www.fda.gov/cder/guidance/ 

index.htm, or http://www.fda.gov/ 

ohrms/dockets/default.htm. 

Dated: September 26, 2006. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E6–16436 Filed 10–4–06; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF THE TREASURY 

Internal Revenue Service 

26 CFR Part 300 

[TD 9288] 

RIN 1545–BF68 

User Fees Relating to Enrollment 

AGENCY: Internal Revenue Service (IRS), 

Treasury. 

ACTION: Final regulations. 

SUMMARY: This document contains 

amendments to the regulations relating 

to user fees for the special enrollment 

examination to become an enrolled 

agent, the application for enrollment of 

enrolled agents, and the renewal of this 

enrollment. The charging of user fees is 

authorized by the Independent Offices 

Appropriations Act (IOAA) of 1952. 

DATES: Effective Date: November 6, 

2006. 

Applicablity Date: For date of 

applicability, see § 300.0(c). 

FOR FURTHER INFORMATION CONTACT: 

Concerning cost methodology, Eva 

Williams, (202) 622–6400; concerning 

the regulations, Matthew Cooper, (202) 

622–4940 (not toll-free numbers). 

SUPPLEMENTARY INFORMATION: 

Background 

This document amends the 

regulations relating to user fees for the 

special enrollment examination to 

become an enrolled agent, the 

application for enrollment of enrolled 

agents, and the renewal of this 

enrollment. The charging of user fees is 

authorized by the IOAA of 1952, which 

is codified at 31 U.S.C. 9701. 

The IOAA of 1952 authorizes agencies 

to prescribe regulations that establish 

charges for services provided by the 

agency. The charges must be fair and be 

based on the costs to the government, 

the value of the service to the recipient, 

the public policy or interest served, and 

other relevant facts. The IOAA of 1952 

provides that regulations implementing 

user fees are subject to policies 

prescribed by the President, which are 

currently set forth in OMB Circular A–

25, 58 FR 38142 (July 15, 1993) (the 

OMB Circular). 

The OMB Circular encourages user 

fees for government-provided services 

that confer benefits on identifiable 

recipients over and above those benefits 

received by the general public. Under 

the OMB Circular, an agency that seeks 

to impose a user fee for Governmentprovided services must calculate its full 

cost of providing those services. In 

general, a user fee should be set at an 

amount in order for the agency to 

recover the cost of providing the special 

service, unless the Office of 

Management and Budget grants an 

exception. 

On August 29, 2006, a notice of 

proposed rulemaking (REG–145154–05) 

was published in the Federal Register. 

Approximately 40 written comments 

responding to the proposed regulations 

were received. A public hearing was 

held on September 29, 2006, but there 

were no requests to speak at the hearing. 

After consideration of the comments, 

the proposed regulations are adopted by 

this Treasury decision. 


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Federal Register / Vol. 71, No. 193 / Thursday, October 5, 2006 / Rules and Regulations 58741 

Enrolled Agent Program 

Section 330 of Title 31 of the United 

States Code authorizes the Secretary of 

the Treasury to regulate practice before 

the Treasury Department. Pursuant to 

section 330 of Title 31, the Secretary has 

published regulations governing 

practice before the IRS in 31 CFR part 

10 and reprinted them as Treasury 

Department Circular No. 230 (Circular 

230). These regulations are administered 

by the IRS Office of Professional 

Responsibility (OPR). 

Section 10.3 of Circular 230 generally 

authorizes attorneys, certified public 

accountants, enrolled agents and 

enrolled actuaries to practice before the 

IRS. An enrolled agent is defined as an 

individual enrolled as an agent pursuant 

to the provisions of Circular 230. The 

provisions of Circular 230 provide that 

an individual desiring to become an 

enrolled agent is eligible for enrollment 

through either the successful passing of 

a written examination or through 

demonstration of sufficient expertise in 

tax administration based on former 

employment with the IRS. Specifically, 

§ 10.4(a) authorizes the Director of OPR 

to grant enrollment to an applicant who 

demonstrates special competence in tax 

matters by passing a written 

examination administered by, or 

administered under the oversight of, the 

Director of OPR and who has not 

engaged in any conduct that would 

justify the censure, suspension, or 

disbarment of any practitioner under the 

provisions of Circular 230. Accordingly, 

every year OPR develops and 

administers a Special Enrollment 

Examination (SEE) that is given to all 

applicants desiring to become enrolled 

agents so that they can practice before 

the IRS. The IRS charged applicants a 

user fee of $55 ($45 if taking the 

examination in parts) in order to take 

the 2005 SEE. 

Section 10.4(b) authorizes the Director 

of OPR to grant enrollment for former 

IRS employees if the former employee 

meets certain requirements, including 

length of employment with the IRS and 

substantive tax expertise. Application 

for enrollment based on former 

employment with the IRS must be made 

within three years from the date of 

separation from such employment. 

Once eligible for enrollment, by either 

passing the examination or because of 

former employment with the IRS, an 

applicant must file an application for 

enrollment on Form 23, ‘‘Application 

for Enrollment to Practice before the 

Internal Revenue Service,’’ with the 

Director of OPR. As part of the 

application for enrollment process, the 

applicant must enclose a check or 

money order payable to the IRS in the 

amount set forth on Form 23, which 

constitutes a fee charged to each 

applicant for enrollment. The fee is 

nonrefundable regardless of whether the 

applicant is granted enrollment. The 

current user fee for enrollment on the 

Form 23 (Rev. February 2005) is $80. 

The Director of OPR will act upon an 

application for enrollment and issue an 

enrollment card to each individual 

whose application for enrollment to 

practice before the IRS is approved. 

Pursuant to § 10.6(d), each individual, 

once enrolled, is required to renew the 

enrollment every three years to maintain 

an active enrollment to practice before 

the IRS. In order to qualify for renewal, 

an applicant must certify the 

completion of the continuing 

professional education requirements set 

forth in § 10.6(e) of Circular 230. A 

nonrefundable user fee of $80 is 

currently charged for each application 

for renewal of enrollment filed with the 

Director of OPR on Form 8554, 

‘‘Application for Renewal of Enrollment 

to Practice Before the Internal Revenue 

Service.’’

Contracting Out of Special Enrollment 

Examination 

OPR has recently contracted out 

certain functions pertaining to the SEE 

to a private contractor. The contractor 

will furnish the resources, facilities, and 

services necessary to administer the 

entire SEE program, which includes 

examination development, 

administration of SEE, notification to 

IRS of candidates who took the 

examination, and the results of the 

examination. The contractor will receive 

payment for its services by charging a 

fee to examination applicants. OPR will, 

nonetheless, still maintain an oversight 

role with respect to the SEE. The 

contractor will collect a user fee on 

behalf of the IRS based on the full costs 

incurred by the IRS. These final 

regulations only establish a user fee 

with respect to the government costs for 

overseeing the SEE and do not include 

any fee that the contractor may charge 

for its services. Accordingly, while the 

user fee imposed pursuant to these 

regulations is less than the user fee that 

applicants were charged in 2005, the 

total fee that applicants will be charged 

is greater. The IRS estimates that the 

efficiencies resulting from using a 

contractor will reduce the total fees that 

would otherwise be charged by the IRS 

in order to recover the full cost of the 

IRS administering all aspects of the SEE. 

Further information about the 

contracting out of the SEE can be found 

at http://www.irs.gov/taxpros/agents/ 

index.html. 

Summary of Comments 

The final regulations establish an $11 

per part user fee for the SEE. The final 

regulations establish separate $125 user 

fees for the enrollment and renewal of 

enrollment process. Most of the 

comments on the proposed regulations 

did not favor the higher fees. These 

comments focused on the increased 

economic burden on enrolled agents 

resulting from the higher fees. Several 

comments also stated that the Request 

for Proposal (RFP) for the examination 

implied that the IRS would collect its 

fee from the amount that the contractor 

is charging for its services. One 

comment requested that the IRS 

publicly release the costing 

methodology and the schedule for 

reevaluating the user fees, as well as 

provide a clarification of the ‘‘Special 

Analyses’’ section of the preamble. For 

the following reasons, these final 

regulations follow the proposed 

regulations without change. 

The OMB Circular requires the IRS to 

calculate and recover its full cost of 

providing services under the enrolled 

agent program. In accordance with the 

OMB Circular, these final regulations 

increase the fees to bring them in line 

with actual costs based upon a recent 

review of the enrolled agent program. 

The IRS is in compliance with the OMB 

Circular in its methodology for 

computation of the actual cost and will 

follow the OMB Circular’s direction 

providing for a biennial reevaluation of 

the fees. 

The IRS has determined that the full 

cost to the IRS of overseeing the SEE is 

$11 per part per applicant. This revised 

user fee reflects the change in IRS costs 

of administering the examination 

program as a result of contracting out of 

the examination to a private contractor. 

For the first examination cycle (October 

5, 2006 to December 1, 2006), the 

contractor is not collecting any user fee 

on behalf of the IRS. In future years, 

consistent with the RFP, the contractor 

will collect the user fee based on the full 

costs incurred by the IRS in overseeing 

the examination, which is separate and 

distinct from the fee that the contractor 

is charging for its services. 

The IRS has determined that the full 

cost of administering the enrollment 

and renenrollment process is $125 per 

enrolled agent. Before this final 

regulation, the most recent increase in 

user fees for the enrollment and renewal 

of enrollment process was in September 

1995. 

The Chief Counsel for Advocacy of 

the Small Business Administration 

(SBA) commented that the certification 

in the proposed regulations regarding 


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58742 Federal Register / Vol. 71, No. 193 / Thursday, October 5, 2006 / Rules and Regulations 

the economic impact on small entities 

in the ‘‘Special Analyses’’ section of the 

preamble could be clearer. Specifically, 

the SBA requested that the certification 

identify the number of enrolled agents 

and the appropriate North American 

Industry Classification System (NAICS) 

codes for enrolled agents, estimate the 

percent of enrolled agents that are 

operating as or employed by small 

entities based upon the small business 

size standards established by the SBA, 

and further explain why the increased 

fees are not economically significant. 

The ‘‘Special Analyses’’ section of the 

final regulations adopts these 

recommended changes. 

Special Analyses 

It has been determined that this final 

rule is not a significant regulatory action 

as defined in Executive Order 12866. 

Therefore, a regulatory assessment is not 

required. It is hereby certified that these 

regulations will not have a significant 

economic impact on a substantial 

number of small entities. Accordingly, a 

regulatory flexibility analysis is not 

required. This certification is based on 

the information that follows. This final 

rule affects enrolled agents, of which 

there are currently 45,261 active. The 

economic impact of these regulations on 

any small entity would result from a 

small entity, including a sole proprietor, 

being required to pay a fee prescribed by 

these regulations in order to obtain a 

particular service. The appropriate 

NAICS codes for enrolled agents relate 

to tax preparation services (NAICS code 

541213) and other accounting services 

(NAICS code 541219). Entities 

identified under these codes are 

considered small under the SBA size 

standards (13 CFR 121.201) if their 

annual revenue is less than $6.5 million 

or $7.5 million respectively. The IRS 

estimates that 99 percent of enrolled 

agents are operating as or employed by 

small entities. Therefore, the IRS has 

determined that this final rule will 

affect a substantial number of small 

entities. The dollar amounts of the 

increases in fees are not, however, 

substantial enough to have a significant 

economic impact on any entity subject 

to the fees. The amounts of the fees are 

commensurate with, if not less than, the 

amount of fees charged for other 

professional examination and 

enrollment fees. Persons who elect to 

take the examination and apply for 

enrollment or renewal of enrollment 

also receive benefits from obtaining the 

enrolled agent designation. The Chief 

Counsel for Advocacy of the Small 

Business Administration submitted 

comments on the regulation, which are 

discussed elsewhere in this preamble. 

Drafting Information 

The principal author of these 

regulations is Matthew S. Cooper of the 

Office of the Associate Chief Counsel 

(Procedure & Administration), 

Administrative Provisions & Judicial 

Practice Division. 

List of Subjects in 26 CFR Part 300 

Reporting and recordkeeping 

requirements, User fees. 

Adoption of Amendments to the 

Regulations 

■ Accordingly, 26 CFR part 300 is 

amended as follows: 

PART 300—USER FEES 

■ Paragraph 1. The authority citation 

for part 300 continues to read in part as 

follows: 

Authority: 31 U.S.C. 9701. 

■ Par. 2. Section 300.0 is amended as 

follows: 

■ 1. Paragraphs (b)(4), (b)(5), and (b)(6) 

are added. 

■ 2. Paragraph (c) is revised. 

The additions and revision read as 

follows: 

§ 300.0 User fees; in general. 

* * * * * 

(b) * * * 

(4) Taking the special enrollment 

examination to become an enrolled 

agent. 

(5) Enrolling an enrolled agent. 

(6) Renewing the enrollment of an 

enrolled agent. 

(c) Effective date. This part 300 is 

applicable March 16, 1995, except that 

the user fee for processing offers in 

compromise is applicable November 1, 

2003, and the user fee for the special 

enrollment examination, enrollment, 

and renewal of enrollment for enrolled 

agents is applicable November 6, 2006. 

■ Par. 3. Section 300.4 is added to read 

as follows: 

§ 300.4 Special enrollment examination 

fee. 

(a) Applicability. This section applies 

to the special enrollment examination to 

become an enrolled agent pursuant to 31 

CFR 10.4(a). 

(b) Fee. The fee for taking the special 

enrollment examination is $11 per part, 

which is the government cost for 

overseeing the examination and does 

not include any fees charged by the 

examination administrator. 

(c) Person liable for the fee. The 

person liable for the special enrollment 

examination fee is the applicant taking 

the examination. 

■ Par. 4. Section 300.5 is added to read 

as follows: 

§ 300.5 Enrollment of enrolled agent fee. 

(a) Applicability. This section applies 

to the initial enrollment of enrolled 

agents with the IRS Office of 

Professional Responsibility pursuant to 

31 CFR 10.5(b). 

(b) Fee. The fee for initially enrolling 

as an enrolled agent with the IRS Office 

of Professional Responsibility is $125. 

(c) Person liable for the fee. The 

person liable for the enrollment fee is 

the applicant filing for enrollment as an 

enrolled agent with the IRS Office of 

Professional Responsibility. 

■ Par. 5. Section 300.6 is added to read 

as follows: 

§ 300.6 Renewal of enrollment of enrolled 

agent fee. 

(a) Applicability. This section applies 

to the renewal of enrollment of enrolled 

agents with the IRS Office of 

Professional Responsibility pursuant to 

31 CFR 10.6(d)(6). 

(b) Fee. The fee for renewal of 

enrollment as an enrolled agent with the 

IRS Office of Professional Responsibility 

is $125. 

(c) Person liable for the fee. The 

person liable for the renewal of 

enrollment fee is the person renewing 

their enrollment as an enrolled agent 

with the IRS Office of Professional 

Responsibility. 

Mark E. Matthews, 

Deputy Commissioner for Services and 

Enforcement. 

Approved: October 2, 2006, 

Eric Solomon, 

Acting Deputy Assistant Secretary for Tax 

Policy. 

[FR Doc. 06–8525 Filed 10–3–06; 10:00 am] 

BILLING CODE 4830–01–P 

DEPARTMENT OF THE TREASURY 

Office of Foreign Assets Control 

31 CFR Parts 594, 595, and 597 

Global Terrorism Sanctions 

Regulations; Terrorism Sanctions 

Regulations; Foreign Terrorist 

Organizations Sanctions Regulations 

AGENCY: Office of Foreign Assets 

Control, Treasury. 

ACTION: Final rule; amendment. 

SUMMARY: The Office of Foreign Assets 

Control of the U.S. Department of the 

Treasury (‘‘OFAC’’) is revising the 

Global Terrorism Sanctions Regulations, 

the Terrorism Sanctions Regulations, 

and the Foreign Terrorist Organizations 

Sanctions Regulations to authorize inkind donations of medical devices and 


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