16000 Federal Register / Vol. 75, No. 61 / Wednesday, March 31, 2010 / Rules and Regulations 

adverse economic impacts, the 

Commission will, as appropriate, also 

follow its Small Business Enforcement 

Policy set forth at § 1020.5. 

(b) Other factors as appropriate. In 

determining the amount of any civil 

penalty to be sought for a violation of 

the CPSA, FHSA, or FFA, the 

Commission may consider, as 

appropriate, such other factors in 

addition to those listed in the statutes. 

Both the Commission and a person may 

raise any factors they believe are 

relevant in determining an appropriate 

penalty amount. A person will be 

notified of any factors beyond those 

enumerated in the statutes that the 

Commission relies on as aggravating 

factors for purposes of determining a 

civil penalty amount. Additional factors 

that may be considered in a case 

include, but are not limited to, the 

following: 

(1) Safety/compliance program and/or 

system relating to a violation. The 

Commission may consider, when a 

safety/compliance program and/or 

system as established is relevant to a 

violation, whether a person had at the 

time of the violation a reasonable and 

effective program or system for 

collecting and analyzing information 

related to safety issues. Examples of 

such information would include 

incident reports, lawsuits, warranty 

claims, and safety-related issues related 

to repairs or returns. The Commission 

may also consider whether a person 

conducted adequate and relevant 

premarket and production testing of the 

product at issue; had a program in place 

for continued compliance with all 

relevant mandatory and voluntary safety 

standards; and other factors as the 

Commission deems appropriate. The 

burden to present clear, reliable, 

relevant, and sufficient evidence of such 

program, system, or testing rests on the 

person seeking consideration of this 

factor. 

(2) History of noncompliance. The 

Commission may consider whether or 

not a person’s history of noncompliance 

with the CPSA, FHSA, FFA, and other 

laws that the CPSC enforces, and the 

regulations thereunder, should increase 

the amount of the penalty. A person’s 

history of noncompliance may be 

indicated by, for example, multiple 

violations of one or more laws or 

regulations that the CPSC enforces, 

including repeated violations of the 

same law or regulation. History of 

noncompliance may include the number 

of previous violations or how recently a 

previous violation occurred. 

(3) Economic gain from 

noncompliance. The Commission may 

consider whether a person benefitted 

economically from a failure to comply, 

including a delay in complying, with 

the CPSA, FHSA, FFA, and other laws 

that the CPSC enforces, and the 

regulations thereunder. 

(4) Failure to respond in a timely and 

complete fashion to the Commission’s 

requests for information or remedial 

action. The Commission may consider 

whether a person’s failure to respond in 

a timely and complete fashion to 

requests from the Commission for 

information or for remedial action 

should increase a penalty. This factor is 

intended to address a person’s dilatory 

and egregious conduct in responding to 

written requests for information or 

remedial action sought by the 

Commission, but not to impede any 

person’s lawful rights. 

§ 1119.5 Enforcement notification. 

A person will be informed in writing 

if it is believed that the person has 

violated the law and if the Commission 

intends to seek a civil penalty. Any 

person who receives such a writing will 

have an opportunity to submit evidence 

and arguments that it should not pay a 

penalty or should not pay a penalty in 

the amount sought by the Commission. 

Dated: March 24, 2010. 

Todd A. Stevenson, 

Secretary, Consumer Product Safety 

Commission. 

[FR Doc. 2010–6940 Filed 3–30–10; 8:45 am] 

BILLING CODE 6355–01–P 

DEPARTMENT OF LABOR 

Employment and Training 

Administration 

20 CFR Part 655 

Temporary Employment of Foreign 

Workers in the United States 

CFR Correction 

In Title 20 of the Code of Federal 

Regulations, Part 500 to End, revised as 

of April 1, 2009, on page 466, remove 

§ 655.0 and correctly reinstate it to read 

as follows: 

§ 655.0 Scope and purpose of part. 

(a) Subparts A, B, and C—(1) General. 

Subparts A, B, and C of this part set out 

the procedures adopted by the Secretary 

to secure information sufficient to make 

factual determinations of: (i) Whether 

U.S. workers are available to perform 

temporary employment in the United 

States, for which an employer desires to 

employ nonimmigrant foreign workers, 

and (ii) whether the employment of 

aliens for such temporary work will 

adversely affect the wages or working 

conditions of similarly employed U.S. 

workers. These factual determinations 

(or a determination that there are not 

sufficient facts to make one or both of 

these determinations) are required to 

carry out the policies of the Immigration 

and Nationality Act (INA), that a 

nonimmigrant alien worker not be 

admitted to fill a particular temporary 

job opportunity unless no qualifed U.S. 

worker is available to fill the job 

opportunity, and unless the 

employment of the foreign worker in the 

job opportunity will not adversely affect 

the wages or working conditions of 

similarly employed U.S. workers. 

(2) The Secretary’s determinations. 

Before any factual determination can be 

made concerning the availability of U.S. 

workers to perform particular job 

opportunities, two steps must be taken. 

First, the minimum level of wages, 

terms, benefits, and conditions for the 

particular job opportunities, below 

which similarly employed U.S. workers 

would be adversely affected, must be 

established. (The regulations in this part 

establish such minimum levels for 

wages, terms, benefits, and conditions of 

employment.) Second, the wages, terms, 

benefits, and conditions offered and 

afforded to the aliens must be compared 

to the established minimum levels. If it 

is concluded that adverse effect would 

result, the ultimate determination of 

availability within the meaning of the 

INA cannot be made since U.S. workers 

cannot be expected to accept 

employment under conditions below 

the established minimum levels. Florida 

Sugar Cane League, Inc. v. Usery, 531 F. 

2d 299 (5th Cir. 1976). 

Once a determination of no adverse 

effect has been made, the availability of 

U.S. workers can be tested only if U.S. 

workers are actively recruited through 

the offer of wages, terms, benefits, and 

conditions at least at the minimum level 

or the level offered to the aliens, 

whichever is higher. The regulations in 

this part set forth requirements for 

recruiting U.S. workers in accordance 

with this principle. 

(3) Construction. This part and its 

subparts shall be construed to effectuate 

the purpose of the INA that U.S. 

workers rather than aliens be employed 

wherever possible. Elton Orchards, Inc. 

v. Brennan, 508 F. 2d 493, 500 (1st Cir. 

1974), Flecha v. Quiros, 567 F. 2d 1154 

(1st Cir. 1977). Where temporary alien 

workers are admitted, the terms and 

conditions of their employment must 

not result in a lowering of the terms and 

conditions of domestic workers 

similarly employed, Williams v. Usery, 

531 F. 2d 305 (5th Cir. 1976); Florida 

Sugar Cane League, Inc. v. Usery, 531 F. 


erowe on DSK5CLS3C1PROD with RULES
Federal Register / Vol. 75, No. 61 / Wednesday, March 31, 2010 / Rules and Regulations 16001 

2d 299 (5th Cir. 1976), and the job 

benefits extended to any U.S. workers 

shall be at least those extended to the 

alien workers. 

(b) Subparts D and E. Subparts D and 

E of this part set forth the process by 

which health care facilities can file 

attestations with the Department of 

Labor for the purpose of employing or 

otherwise using nonimmigrant 

registered nurses under H–1A visas. 

(c) Subparts F and G. Subparts F and 

G of this part set forth the process by 

which employers can file attestations 

with the Department of Labor for the 

purpose of employing alien 

crewmembers in longshore work under 

D-visas and enforcement provisions 

relating thereto. 

(d) Subparts H and I of this part. 

Subpart H of this part sets forth the 

process by which employers can file 

labor condition applications (LCAs) 

with, and the requirements for obtaining 

approval from, the Department of Labor 

to temporarily employ the following 

three categories of nonimmigrants in the 

United States: (1) H–1B visas for 

temporary employment in specialty 

occupations or as fashion models of 

distinguished merit and ability; (2) H– 

1B1 visas for temporary employment in 

specialty occupations of nonimmigrant 

professionals from countries with which 

the United States has entered into 

certain agreements identified in section 

214(g)(8)(A) of the INA; and (3) E–3 

visas for nationals of the 

Commonwealth of Australia for 

temporary employment in specialty 

occupations. Subpart I of this part 

establishes the enforcement provisions 

that apply to the H–1B, H–1B1, and E– 

3 visa programs. 

(e) Subparts J and K of this part. 

Subparts J and K of this part set forth 

the process by which employers can file 

attestations with the Department of 

Labor for the purpose of employing 

nonimmigrant alien students on F-visas 

in off-campus employment and 

enforcement provisions relating thereto. 

[43 FR 10312, Mar. 10, 1978, as amended at 

52 FR 20507, June 1, 1987; 55 FR 50510, Dec. 

6, 1990; 56 FR 24667, May 30, 1991; 56 FR 

54738, Oct. 22, 1991; 56 FR 56875, Nov. 6, 

1991; 57 FR 1337, Jan. 13, 1992; 57 FR 40989, 

Sept. 8, 1992; 69 FR 68226, Nov. 23, 2004; 

73 FR 19947, Apr. 11, 2008] 

[FR Doc. 2010–7380 Filed 3–30–10; 8:45 am] 

BILLING CODE 1505–01–D 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 558 

[Docket No. FDA–2003–N–0446] (formerly 

Docket No. 2003N–0324) 

New Animal Drugs; Removal of 

Obsolete and Redundant Regulations 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is removing 

portions of a regulation that required 

sponsors to submit data regarding the 

subtherapeutic use of certain antibiotic, 

nitrofuran, and sulfonamide drugs 

administered in animal feed as these 

regulations have been determined to be 

obsolete or redundant. The portions of 

the regulation being removed are 

provisions listing certain feed use 

combinations for oxytetracycline and 

neomycin in the tables contained in that 

regulation. This rule does not finalize 

the provisions of the proposed rule 

regarding removing the remainder of the 

regulation. 

DATES: This rule is effective April 30, 

2010. 

FOR FURTHER INFORMATION CONTACT: 

William T. Flynn, Center for Veterinary 

Medicine (HFV–50), 7519 Standish Pl., 

Rockville, MD 20855, 240–276–9090, email: william.flynn@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of August 8, 

2003 (68 FR 47272), FDA published a 

notice of proposed rulemaking to 

remove 21 CFR 558.15 Antibiotic, 

nitrofuran, and sulfonamide drugs in 

the feed of animals (§ 558.15 (21 CFR 

558.15)) on the grounds that these 

regulations were obsolete or redundant. 

The proposed rule explained the nature 

and purpose of § 558.15, and noted that 

most of the products and use 

combinations subject to the listings in 

that section had approvals that were 

already codified in part 558, subpart B 

(21 CFR part 558, subpart B). 

In the same issue of the Federal 

Register as the proposed rule, FDA’s 

Center for Veterinary Medicine (CVM) 

published a Notice of Opportunity for 

Hearing (NOOH), which announced 

CVM’s findings of effectiveness for nine 

products and use combinations that 

were listed in § 558.15, but which were 

subject to the Drug Efficacy Study 

Implementation (DESI) program (68 FR 

47332). CVM proposed to withdraw the 

new animal drug applications (NADAs) 

for those nine products and use 

combinations lacking substantial 

evidence of effectiveness, following an 

opportunity to supplement the NADAs 

with labeling conforming to the relevant 

findings of effectiveness. For 

applications proposed to be withdrawn, 

the agency provided an opportunity for 

hearing. 

FDA received hearing requests 

regarding two products owned by 

Pennfield Oil Co. (Pennfield). One is a 

bacitracin methylene disalicylate (BMD) 

Type A medicated article, NADA 141– 

137, that is listed in the table in 

§ 558.15(g)(1). This listing is under 

Fermenta Animal Health Co., which is 

a predecessor in interest to Pennfield. 

The other is a two-way, fixedcombination Type A medicated article 

containing oxytetracycline and 

neomycin sulfate, NADA 138–939, that 

is listed in the table in § 558.15(g)(2). 

The agency received only one set of 

comments on the 2003 proposed rule, 

from Pennfield. The comment objected 

to the removal of § 558.15 until the 

issues in the NOOH are addressed. It 

argued that the BMD listing in § 558.15 

provides evidence of Pennfield’s 

approval, and that removal of that 

section, without updating the BMD 

listing in part 558, subpart B, would 

result in a lack of recognition in the 

regulations of the approval that 

Pennfield currently has. 

In 2006, FDA finalized portions of the 

2003 proposed rule. In that final rule (71 

FR 16219, March 31, 2006), FDA 

removed from the tables in § 558.15(g) 

products and use combinations that 

were not approved, and products and 

use combinations whose approval was 

reflected in part 558, subpart B. FDA 

retained only the listings for NADA 

141–137 and NADA 138–939 in those 

tables. In addition, FDA retained 

§ 558.15(a) through (f). FDA stated it 

intended to finalize the proposed rule to 

remove all of § 558.15 once, as part of 

the DESI program, either the approvals 

for NADA 141–137 and NADA 138–939 

have been withdrawn or part 558, 

subpart B has been amended to reflect 

their approvals. 

Subsequently, Pennfield filed a 

supplement to NADA 138–939 for its 

fixed-combination oxytetracycline/ 

neomycin Type A medicated articles. 

The supplemental NADA, which 

provided labeling conforming to the 

relevant findings of effectiveness 

announced in the NOOH, was approved 

on July 2, 2009, and the regulations 

were amended in § 558.455 of subpart B 

to reflect that approval (74 FR 40723, 

August 13, 2009). 


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