This section of the FEDERAL REGISTER

contains notices to the public of the proposed

issuance of rules and regulations. The

purpose of these notices is to give interested

persons an opportunity to participate in the

rule making prior to the adoption of the final

rules.

Proposed Rules Federal Register

72257 

Vol. 70, No. 231 

Friday, December 2, 2005 

DEPARTMENT OF AGRICULTURE 

Agricultural Marketing Service 

7 CFR Part 1220 

[No. LS–05–07] 

Soybean Promotion and Research 

Program; Section 610 Review 

AGENCY: Agricultural Marketing Service, 

USDA. 

ACTION: Notice of review and request for 

comments. 

SUMMARY: This action announces the 

Agricultural Marketing Service’s (AMS) 

review of the Soybean Promotion and 

Research Program (conducted under the 

Soybean Promotion and Research 

Order), under the criteria contained in 

section 610 of the Regulatory Flexibility 

Act (RFA). 

DATES: Written comments on this notice 

must be received by January 31, 2006. 

ADDRESSES: Interested persons are 

invited to submit written comments 

concerning this notice of review. 

Comments must be sent to Kenneth R. 

Payne, Chief, Marketing Programs, 

Livestock and Seed Program, AMS, 

USDA, Room 2638–S, STOP 0251, 1400 

Independence Avenue, SW., 

Washington, DC 20250–0251; Fax: (202) 

720–1125; or via e-mail at 

soybeancomments@usda.gov. All 

comments should reference the docket 

number, the date, and the page number 

of this issue of the Federal Register. 

Comments will be available for public 

inspection via the Internet at http:// 

www.ams.usda.gov/lsg/mpb/rp-soy.htm 

or during regular business hours. 

FOR FURTHER INFORMATION CONTACT: 

Kenneth R. Payne, Chief; Marketing 

Programs Branch; Livestock and Seed 

Program, AMS, USDA; STOP–0251; 

1400 Independence Avenue, SW., 

Washington, DC 20250–0251. 

Telephone number 202/720–1115. 

SUPPLEMENTARY INFORMATION: The 

Soybean Promotion and Research Order 

(Order) (7 CFR 1220) is authorized 

under the Soybean Promotion, Research, 

and Consumer Information Act (Act) (7 

U.S.C. 6301 et seq.). This program is a 

national producer program for soybean 

and soybean product promotion, 

research, consumer information, and 

industry information as part of a 

comprehensive strategy to strengthen 

the soybean industry’s position in the 

marketplace by maintaining and 

expanding existing domestic and foreign 

markets and uses for soybeans and 

soybean products, and to develop new 

markets and uses for soybean and 

soybean products. Soybean producers 

fund this program through a mandatory 

assessment of one-half of one percent 

(0.5 percent) of the net market price per 

bushel on soybeans marketed. 

Assessments collected under this 

program are used for promotion, 

research, consumer information, and 

industry information. 

The national program is administered 

by the United Soybean Board (Board), 

which has 64 producer members. Board 

members serve 3-year terms and 

represent one of 30 geographic units. 

The Order became effective on July 9, 

1991. 

AMS published in the Federal 

Register (64 FR 8014; February 18, 

1999), its plan to review certain 

regulations. 

On January 4, 2002, AMS published 

in the Federal Register (67 FR 525), an 

update to its plan to review regulations, 

including the Soybean Promotion and 

Research Program (conducted under the 

Soybean Promotion and Research 

Order), under criteria contained in 

section 610 of the Regulatory Flexibility 

Act (RFA; 5 U.S.C. 601–612). Because 

many AMS regulations impact small 

entities, AMS decided, as a matter of 

policy, to review certain regulations 

which, although they may not meet the 

threshold requirement under section 

610 of the RFA, warrant review. 

Accordingly, this notice and request for 

comments is made for the Order. 

The purpose of the review is to 

determine whether the Order should be 

continued without change, amended, or 

rescinded (consistent with the 

objectives of the Act) to minimize the 

impacts on small entities. AMS will 

consider the continued need for the 

Order; the nature of complaints or 

comments received from the public 

concerning the Order; the complexity of 

the Order; the extent to which the 

promotion Order overlaps, duplicates, 

or conflicts with other Federal rules, 

and, to the extent feasible, with State 

and local government rules; and the 

length of time since the Order has been 

evaluated or the degree to which 

technology, economic conditions, or 

other factors have changed in the area 

affected by the Order. 

Written comments, views, opinions, 

and other information regarding the 

Order’s impact on small businesses are 

invited. 

Authority: 7 U.S.C. 6301–6311. 

Dated: November 28, 2005. 

Lloyd C. Day, 

Administrator, Agricultural Marketing 

Service. 

[FR Doc. E5–6786 Filed 12–1–05; 8:45 am] 

BILLING CODE 3410–02–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 610 

[Docket No. 2005N–0355] 

RIN 0910–AF20 

Revocation of Status of Specific 

Products; Group A Streptococcus; 

Companion Document to Direct Final 

Rule 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Proposed rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is proposing to 

remove the regulation applicable to the 

status of specific products; Group A 

streptococcus. FDA is proposing to 

remove the regulation because the 

existing requirement for Group A 

streptococcus organisms and derivatives 

is both obsolete and a perceived 

impediment to the development of 

Group A streptococcus vaccines. The 

regulation was written to apply to a 

group of products that are no longer on 

the market. We are taking this action as 

part of our continuing effort to reduce 

the burden of unnecessary regulations 

on industry and to revise outdated 

regulations without diminishing public 

health protection. This proposed rule is 

a companion to the direct final rule 

published elsewhere in this issue of the 

Federal Register. We are taking this 

72258 Federal Register / Vol. 70, No. 231 / Friday, December 2, 2005 / Proposed Rules 

action because the proposed change is 

noncontroversial, and we do not 

anticipate any significant adverse 

comments. If we receive any significant 

adverse comments that warrant 

terminating the direct final rule, we will 

consider such comments on the 

proposed rule in developing the final 

rule. 

DATES: Submit written or electronic 

comments on or before February 15, 

2006. 

ADDRESSES: You may submit comments, 

identified by Docket No. 2005N–0335 

and/or RIN number 0910–AF20, by any 

of the following methods: 

Electronic Submissions 

Submit electronic comments in the 

following ways: 

• 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. 

Written Submissions 

Submit written submissions in the 

following ways: 

• 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. 

To ensure more timely processing of 

comments, FDA is no longer accepting 

comments submitted to the agency by email. FDA encourages you to continue 

to submit electronic comments by using 

the Federal eRulemaking Portal or the 

agency Web site, as described in the 

Electronic Submissions portion of this 

paragraph. 

Instructions: All submissions received 

must include the agency name and 

docket number or regulatory 

information number (RIN) for this 

rulemaking. All comments received may 

be posted without change to http:// 

www.fda.gov/ohrms/dockets/ 

default.htm, including any personal 

information provided. For additional 

information on submitting comments, 

see the ‘‘Comments’’ heading of 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 

and/or go to the Division of Dockets 

Management, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Valerie A. Butler, 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 

This proposed rule is a companion to 

the direct final rule published elsewhere 

in this issue of the Federal Register. 

This companion proposed rule provides 

the procedural framework to finalize the 

rule in the event that the direct final 

rule receives any significant adverse 

comments and is withdrawn. The 

comment period for this companion 

proposed rule runs concurrently with 

the comment period for the direct final 

rule. Any comments received under this 

companion rule will also be considered 

as comments regarding the direct final 

rule. We are publishing the direct final 

rule because the rule is 

noncontroversial, and we do not 

anticipate that it will receive any 

significant adverse comments. 

A significant adverse comment is 

defined as a comment that explains why 

the rule would be inappropriate, 

including challenges to the rule’s 

underlying premise or approach, or 

would be ineffective or unacceptable 

without a change. In determining 

whether an adverse comment is 

significant and warrants terminating a 

direct final rulemaking, we will 

consider whether the comment raises an 

issue serious enough to warrant a 

substantive response in a notice-andcomment process in accordance with 

section 553 of the Administrative 

Procedure Act (5 U.S.C. 553). Comments 

that are frivolous, insubstantial, or 

outside the scope of the rule will not be 

considered significant or adverse under 

this procedure. A comment 

recommending a regulation change in 

addition to those in the rule would not 

be considered a significant adverse 

comment unless the comment states 

why the rule would be ineffective 

without additional change. In addition, 

if a significant adverse comment applies 

to an amendment, paragraph, or section 

of this rule and that provision can be 

severed from the remainder of the rule, 

we may adopt as final those provisions 

of the rule that are not subjects of a 

significant adverse comment. 

If no significant adverse comment is 

received in response to the direct final 

rule, no further action will be taken 

related to this proposed rule. Instead, 

we will publish a confirmation 

document, before the effective date of 

the direct final rule, confirming that the 

direct final rule will go into effect on 

June 2, 2006. Additional information 

about direct rulemaking procedures is 

set forth in a guidance published in the 

Federal Register of November 21, 1997 

(62 FR 62466). 

Section 610.19 Status of specific 

products; Group A streptococcus (21 

CFR 610.19), was published in the 

Federal Register of January 5, 1979 (44 

FR 1544). FDA issued that regulation 

after reviewing and considering the 

findings of the independent advisory 

Panel on Review of Bacterial Vaccines 

and Bacterial Antigens with ‘‘No U.S. 

Standard of Potency’’ (the Panel). The 

preamble to the proposed rule for 

§ 610.19, which was published in the 

Federal Register of November 8, 1977 

(42 FR 58266), contained the findings of 

the Panel, including the Panel’s specific 

findings about then-licensed products 

that contained Group A streptococcus 

(42 FR 58266 at 58277 to 58278). The 

regulation was a part of the Panel’s 

review of the safety, effectiveness, and 

labeling of biological products licensed 

before July 1, 1972. In 1972, the 

regulatory authority of these biological 

products was transferred from the 

National Institutes of Health (NIH) to 

FDA. The Panel reviewed those licensed 

biological bacterial products that were 

labeled, ‘‘No U.S. Standard of Potency.’’

(There was a separate review for the 

‘‘Bacterial Vaccines and Toxoids with 

Standards of Potency.’’) Products 

considered by the Panel included 

primarily mixtures of bacterial 

preparations, e.g., Mixed Vaccine 

Respiratory, which was described as 

containing chemically killed organisms 

consisting of Streptococcus (pyrogenes, 

viridans, and nonhemolytic), 

Staphylococcus (aureus and albus), 

Diplococcus pneumoniae, Neiserria 

catarrhalis, Klebsiella pneumoniae, and 

Haemophilus influenzae manufactured 

by Hollister-Stier, Division of Cutter 

Laboratories (42 FR 58266 at 58268). 

Many of the products considered by the 

Panel were indicated as treatments for 

diverse ailments such as colds, asthma, 

arthritis, and uveitis (42 FR 58266 at 

58270). 

The Panel report listed a number of 

major concerns with this group of 

products (‘‘No U.S. Standard of 

Potency’’) (42 FR 58266 at 58269). One 

of the major concerns was that no 

defined standards of potency existed for 

any of the products, so it was not 

possible to establish that the microbial 

factors manufacturers claimed to be 

present in the products were indeed 

Federal Register / Vol. 70, No. 231 / Friday, December 2, 2005 / Proposed Rules 72259 

there or in what concentration (42 FR 

58266 at 58270). Many of these products 

were developed years before specific 

etiologic agents were associated with 

the cause of specific diseases. Moreover, 

the labeled indications for these 

products were for diseases of obscure 

etiology (Id.). Manufacturers could 

provide to the Panel neither clinical 

data to support the safety or efficacy of 

the products, nor any justification for 

using the products as described other 

than uncontrolled and unconfirmed 

clinical impressions (Id.). Additional 

safety questions arose from the fact that 

the products were administered 

repeatedly over extended periods of 

time with no evidence of systematic 

followup for the types of adverse effects 

that might be associated with repeated 

inoculations (Id.). The Panel stated in 

their report, that in view of what was 

known from laboratory studies about 

potential risks associated with repeated 

inoculations of foreign substances, they 

had reservations about the long-term 

safety of this group of products (42 FR 

58266 at 58270 through 58271). In fact, 

the Panel did not classify any of these 

products into category I (those 

biological products determined to be 

safe, effective, and not misbranded) (42 

FR 58266 at 58315). 

In the Panel report, the section 

specifically concerning Group A 

streptococcal vaccines describes the 

history, dating back to the 1930s, of 

major attempts to immunize humans 

with hemolytic streptococci (42 FR 

58266 at 58277). These early studies 

demonstrated severe systemic toxicities 

(Id.). One study (Ref. 1) described the 

occurrence of acute rheumatic fever in 

siblings of rheumatic fever patients 

following vaccination with a partially 

purified preparation (Id.). In addition, 

immunological cross-reactivity between 

streptococcal cell wall protein and 

mammalian myocardium was 

demonstrated in vitro (Id.) (Ref. 2). 

However, the Panel report differentiated 

between the licensed products under 

review and highly purified preparations, 

which were at the research stage. The 

Panel report stated that the safety profile 

for a highly purified preparation was 

quite different, noting that no anti-heart 

reactive antibody has been observed in 

the post immunization sera of infants or 

adults receiving the purified preparation 

(Id.) (Ref. 3). The Panel concluded, 

based on demonstrated safety concerns, 

that the uncontrolled use of the Group 

A streptococcal antigens in bacterial 

vaccines with ‘‘No U.S. Standard of 

Potency’’ represented unacceptable risks 

(42 FR 58266 at 58278). In fact, the 

Panel stated: 

In view of the carefully conducted 

controlled studies currently under way with 

purified chemically defined antigenic 

preparations, one finds it difficult to justify 

the use of uncontrolled, poorly defined 

preparations presumed to contain antigens 

that have been demonstrated in earlier 

studies to produce local and systemic 

reactions. The hypothetical and theoretical 

objections stemming from laboratory studies 

linking mammalian and streptococcal 

antigens have been given serious 

consideration in the design and conduct of 

present studies treating humans with the 

newer purified streptococcal antigens. 

(42 FR 58266 at 58277). In contrast to 

the uncontrolled, poorly defined 

preparations, the Panel made clear at 

the time that they were not condemning 

the use of purified or characterized 

streptococcal antigens (Id.). Further, 

FDA reviews each biological product 

and determines whether the risk-benefit 

relationship is acceptable for the stage 

of investigation and for licensure (see 21 

CFR parts 312 and 601). This review is 

performed under the authority of the 

Federal Food, Drug, and Cosmetic Act 

and the Public Health Service Act (see 

21 U.S.C. 355(i); 42 U.S.C. 262(a)(3) and 

(a)(2)(A)). FDA’s review is adequate to 

assess the safety, purity, and potency of 

products that companies seek to license, 

and to ensure that human subjects in 

clinical trials of investigational products 

are not exposed to unreasonable and 

significant risk of illness or injury. 

Therefore, FDA concludes that 

§ 610.19, which was codified following 

the Panel report, was meant to apply 

only to those bacterial vaccines which 

the Panel had under their review—

licensed but poorly characterized 

products labeled ‘‘No U.S. Standard of 

Potency’’—and not to more 

characterized preparations under 

investigation then or now. Because there 

are no bacterial mixtures with ‘‘No U.S. 

Standard of Potency’’ containing Group 

A streptococcal antigens licensed at this 

time, and current manufacturing 

technology allows for characterization 

and purification of Group A 

streptococcal products, this regulation is 

obsolete. Although it was never 

intended to apply to the development of 

Group A streptococcal vaccines that had 

adequate testing, FDA has determined 

that it has been perceived to cover these 

products as well, and therefore should 

be removed. 

II. Highlights of the Proposed Rule 

We are proposing to remove § 610.19 

because the existing requirement is 

obsolete and perceived to be impeding 

the development of Group A 

streptococcal vaccines using purified or 

characterized streptococcal antigens. 

The regulation is obsolete because it 

was written to apply to a group of 

products that are no longer on the 

market. Certain parties interested in 

developing new Group A streptococcal 

vaccines perceive the regulation as an 

impediment, voiced during public 

meetings and workshops, e.g., the Group 

A streptococcus workshop sponsored by 

the National Institute of Allergy and 

Infectious Diseases, NIH, held in 

Bethesda, MD on March 29 and 30, 

2004. Group A streptococci are 

responsible for significant morbidity 

and mortality worldwide, including 

rheumatic fever and glomerulonephritis, 

as well as pharyngitis, impetigo, and 

other clinical manifestations. Therefore, 

a vaccine to prevent diseases caused by 

this organism would have a public 

health benefit. We are taking this action 

as part of our continuing effort to reduce 

the burden of unnecessary regulations 

on industry and to revise outdated 

regulations without diminishing public 

health protection. 

III. Analysis of Impacts 

A. Review Under Executive Order 

12866, the Regulatory Flexibility Act, 

and the Unfunded Mandates Act of 

1995 

FDA has examined the impacts of the 

proposed rule under Executive Order 

12866 and the Regulatory Flexibility Act 

(5 U.S.C. 601–612), and the Unfunded 

Mandates Reform Act of 1995 (Public 

Law 104–4). Executive Order 12866 

directs agencies to assess all costs and 

benefits of available regulatory 

alternatives and, when regulation is 

necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety, 

and other advantages; distributive 

impacts; and equity). The agency 

believes that this proposed rule is not a 

significant regulatory action as defined 

by the Executive order. 

The Regulatory Flexibility Act 

requires agencies to analyze regulatory 

options that would minimize any 

significant impact of a rule on small 

entities. Because the proposed rule is 

removing a regulation, it would not 

result in any increased burden or costs 

on small entities. Therefore, the agency 

certifies that the proposed rule will not 

have a significant economic impact on 

a substantial number of small entities. 

Section 202(a) of the Unfunded 

Mandates Reform Act of 1995 requires 

that agencies prepare a written 

statement, which includes an 

assessment of anticipated costs and 

benefits, before proposing ‘‘any rule that 

includes any Federal mandate that may 

result in the expenditure by State, local, 

72260 Federal Register / Vol. 70, No. 231 / Friday, December 2, 2005 / Proposed Rules 

1Section 302 of ERISA sets forth funding rules 

that are parallel to those in section 412 of the Code. 

Under section 101 of Reorganization Plan No. 4 of 

1978 (43 FR 47713) and section 302 of ERISA, the 

Secretary of the Treasury has interpretive 

jurisdiction over the subject matter addressed in 

these proposed regulations for ERISA, as well as the 

Code. Thus, these proposed Treasury regulations 

issued under section 412 of the Code apply as well 

for purposes of section 302 of ERISA. 

and tribal governments, in the aggregate, 

or by the private sector, of $100,000,000 

or more (adjusted annually for inflation) 

in any one year.’’ The current threshold 

after adjustment for inflation is $115 

million, using the most current (2003) 

Implicit Price Deflator for the Gross 

Domestic Product. FDA does not expect 

this proposed rule to result in any 1- 

year expenditure that would meet or 

exceed this amount. 

B. Environmental Impact 

The agency has determined, under 21 

CFR 25.31(h), that this action is of a 

type that does not individually or 

cumulatively have a significant effect on 

the human environment. Therefore, 

neither an environmental assessment 

nor an environmental impact statement 

is required. 

C. Federalism 

FDA has analyzed this proposed rule 

in accordance with the principles set 

forth in Executive Order 13132. FDA 

has determined that the proposed rule 

does not contain policies that have 

substantial direct effects on the States, 

on the relationship between the 

National Government and the States, or 

on the distribution of power and 

responsibilities among the various 

levels of government. Accordingly, the 

agency has concluded that the proposed 

rule does not contain policies that have 

federalism implications as defined in 

the Executive order and, consequently, 

a federalism summary impact statement 

is not required. 

IV. Paperwork Reduction Act of 1995 

This proposed rule contains no 

collections of information. Therefore, 

clearance by the Office of Management 

and Budget under the Paperwork 

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

3520) is not required. 

V. Request for Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

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 brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

VI. References 

The following references have been 

placed on display in the Division of 

Dockets Management (see ADDRESSES), 

and may be seen by interested persons 

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

through Friday. 

1. Massell, B.F., L.H. Honikman, and J. 

Amezcua, ‘‘Rheumatic Fever Following 

Streptococcal Vaccination. Report of Three 

Cases,’’ Journal of the American Medical 

Association, 207(6): 1115–1119, 1969. 

2. Kaplan, M.H. and M. Meyeserian, ‘‘An 

Immunological Cross-Reaction Between 

Group A Streptococcal Cells and Human 

Heart Tissue,’’ Lancet, 1:706–710, 1962. 

3. Fox, E.N., L.M. Pachman, M.K. Wittner, 

and A. Dorfman, ‘‘Primary Immunization of 

Infants and Children with Group A 

Streptococcal M Protein,’’ Journal of 

Infectious Diseases, 120:598–604, 1969. 

List of Subjects in 21 CFR Part 610 

Biologics, Labeling, Reporting and 

recordkeeping requirements. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and the Public 

Health Service Act, and under authority 

delegated by the Commissioner of Food 

and Drugs, it is proposed that 21 CFR 

part 610 be amended as follows: 

PART 610—GENERAL BIOLOGICAL 

PRODUCTS STANDARDS 

1. The authority citation for 21 CFR 

part 610 continues to read as follows: 

Authority: 21 U.S.C. 321, 331, 351, 352, 

353, 355, 360, 360c, 360d, 360h, 360i, 371, 

372, 374, 381; 42 U.S.C. 216, 262, 263, 263a, 

264. 

§ 610.19 [Removed] 

2. Remove § 610.19. 

Dated: November 21, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–23545 Filed 12–1–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF THE TREASURY 

Internal Revenue Service 

26 CFR Part 1 

[REG–124988–05] 

RIN 1545–BE72 

Updated Mortality Tables for 

Determining Current Liability 

AGENCY: Internal Revenue Service (IRS), 

Treasury. 

ACTION: Notice of proposed rulemaking 

and notice of public hearing. 

SUMMARY: This document contains 

proposed regulations under section 

412(l)(7)(C)(ii) of the Internal Revenue 

Code (Code) and section 302(d)(7)(C)(ii) 

of the Employee Retirement Income 

Security Act of 1974 (ERISA) (Pub. L. 

93–406, 88 Stat. 829). These regulations 

provide the public with guidance 

regarding mortality tables to be used in 

determining current liability under 

section 412(l)(7) of the Code and section 

302(d)(7) of ERISA. These regulations 

affect plan sponsors and administrators, 

and participants in and beneficiaries of, 

certain retirement plans. 

DATES: Written or electronic comments 

and requests to speak and outlines of 

topics to be discussed at the public 

hearing scheduled for April 19, 2006, at 

10 a.m., must be received by March 29, 

2006. 

ADDRESSES: Send submissions to: 

CC:PA:LPD:PR (REG–124988–05), room 

5226, 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–124988–05), 

Courier’s Desk, Internal Revenue 

Service, 1111 Constitution Avenue, 

NW., Washington, DC. Alternatively, 

taxpayers may submit comments 

electronically directly to the IRS 

Internet site at http://www.irs.gov/regs. 

The public hearing will be held in the 

Auditorium, Internal Revenue Building, 

1111 Constitution Avenue, NW., 

Washington, DC. 

FOR FURTHER INFORMATION CONTACT: 

Concerning the regulations, Bruce Perlin 

or Linda Marshall at (202) 622–6090 

(not a toll-free number); concerning 

submissions and the hearing and/or to 

be placed on the building access list to 

attend the hearing, Treena Garrett at 

(202) 622–7180 (not toll-free numbers). 

SUPPLEMENTARY INFORMATION: 

Background 

Section 412 of the Internal Revenue 

Code provides minimum funding 

requirements with respect to certain 

defined benefit pension plans.1 Section 

412(l) provides additional funding 

requirements for certain of these plans, 

based in part on a plan’s unfunded 

current liability, as defined in section 

412(l)(8). 

Pursuant to section 412(c)(6), if the 

otherwise applicable minimum funding 

requirement exceeds the plan’s full 

funding limitation (defined in section 

412(c)(7) as the excess of a specified 

measure of plan liability over the plan 

assets), then the minimum funding for