24530 Federal Register / Vol. 72, No. 85 / Thursday, May 3, 2007 / Rules and Regulations 

(3) For which you fail to meet the 

requirements contained in section 13(h); 

or 

(4) That is damaged solely by 

uninsured causes. 

(n) Acreage for which a Winter 

Coverage Option payment has been 

made is no longer insurable under the 

Crop Provisions for the current crop 

year. Any mint production subsequently 

harvested from uninsured acreage for 

the crop year and not kept separate from 

production from insured acreage will be 

considered production to count. 

(o) Acreage for which a Winter 

Coverage Option payment has been 

made will receive an amount of 

production of zero when computing 

subsequent year’s approved yield. 

(p) Sections 11(e), (f), and (g) of these 

Crop Provisions do not apply to this 

option. 

Signed in Washington, DC, on April 25, 

2007. 

Eldon Gould, 

Manager, Federal Crop Insurance 

Corporation. 

[FR Doc. E7–8340 Filed 5–2–07; 8:45 am] 

BILLING CODE 3410–08–P 

DEPARTMENT OF AGRICULTURE 

Agricultural Marketing Service 

7 CFR Part 966 

[Docket No. AMS–FV–06–0208; FV07–966– 

1 FIR] 

Tomatoes Grown in Florida; Change in 

Handling Requirements 

AGENCY: Agricultural Marketing Service, 

USDA. 

ACTION: Final rule. 

SUMMARY: The Department of 

Agriculture (USDA) is adopting, as a 

final rule, without change, an interim 

final rule changing the handling 

requirements currently prescribed under 

the Florida Tomato marketing order 

(order). The order regulates the handling 

of tomatoes grown in Florida, and is 

administered locally by the Florida 

Tomato Committee (Committee). This 

rule continues in effect the action that 

limited the use of inverted lids on 

tomato containers to the handler whose 

information initially appeared on the 

lid. This rule helps ensure that lids do 

not contain the information for more 

than one active handler and aids in 

maintaining the positive identification 

and traceability of Florida tomatoes. 

EFFECTIVE DATE: June 4, 2007. 

FOR FURTHER INFORMATION CONTACT: 

William Pimental, Marketing Specialist; 

or Christian Nissen, Regional Manager, 

Southeast Marketing Field Office, 

Marketing Order Administration 

Branch, Fruit and Vegetable Programs, 

AMS, USDA; Telephone: (863) 324– 

3375, Fax: (863) 325–8793, or E-mail: 

William.Pimental@usda.gov or 

Christian.Nissen@usda.gov. 

Small businesses may request 

information on complying with this 

regulation by contacting Jay Guerber, 

Marketing Order Administration 

Branch, Fruit and Vegetable Programs, 

AMS, USDA, 1400 Independence 

Avenue SW., STOP 0237, Washington, 

DC 20250–0237; Telephone: (202) 720– 

2491, Fax: (202) 720–8938, or E-mail: 

Jay.Guerber@usda.gov. 

SUPPLEMENTARY INFORMATION: This rule 

is issued under Marketing Agreement 

No. 125 and Order No. 966, both as 

amended (7 CFR part 966), regulating 

the handling of tomatoes grown in 

Florida, hereinafter referred to as the 

‘‘order.’’ The order is effective under the 

Agricultural Marketing Agreement Act 

of 1937, as amended (7 U.S.C. 601–674), 

hereinafter referred to as the ‘‘Act.’’ 

USDA is issuing this rule in 

conformance with Executive Order 

12866. 

This rule has been reviewed under 

Executive Order 12988, Civil Justice 

Reform. This rule is not intended to 

have retroactive effect. This rule will 

not preempt any State or local laws, 

regulations, or policies, unless they 

present an irreconcilable conflict with 

this rule. 

The Act provides that administrative 

proceedings must be exhausted before 

parties may file suit in court. Under 

section 608c(15)(A) of the Act, any 

handler subject to an order may file 

with USDA a petition stating that the 

order, any provision of the order, or any 

obligation imposed in connection with 

the order is not in accordance with law 

and request a modification of the order 

or to be exempted therefrom. A handler 

is afforded the opportunity for a hearing 

on the petition. After the hearing USDA 

would rule on the petition. The Act 

provides that the district court of the 

United States in any district in which 

the handler is an inhabitant, or has his 

or her principal place of business, has 

jurisdiction to review USDA’s ruling on 

the petition, provided an action is filed 

not later than 20 days after the date of 

the entry of the ruling. 

This rule continues in effect the 

action that changed the handling 

requirements currently prescribed under 

the order. This rule continues to limit 

the use of inverted lids on tomato 

containers to the handler whose 

information initially appeared on the 

lid. This rule helps ensure that lids do 

not contain the information for more 

than one active handler and aids in 

maintaining the positive identification 

and traceability of Florida tomatoes. 

This action was unanimously 

recommended by the Committee at a 

meeting on October 4, 2006. 

Section 966.52 of the order provides 

the authority to establish pack and 

container requirements for tomatoes 

grown under the order. This includes 

fixing the size, weight, capacity, 

dimensions, markings, or pack of the 

container or containers which may be 

used in the handling of tomatoes. 

Section 966.323 of the order’s 

administrative rules prescribes the 

handling regulations for Florida 

tomatoes. Section 966.323(a)(3) 

delineates the requisite container 

requirements for weight, markings, and 

appearance. The section specifies, in 

part, that each container or lid must 

show the name and address of the 

registered handler. 

The majority of Florida tomatoes are 

packed in containers that have a 

separate lid. Most lids are preprinted 

with the handler’s name and address. In 

addition, most lids can be inverted by 

reversing the lid so the blank side is on 

the outside, and the preprinted 

information is flipped to the underside 

of the lid. This is done so new 

information can be printed on the lid. 

This rule amends § 966.323(a)(3) by 

limiting the use of inverted lids on 

tomato containers to the handler whose 

information first appeared on the lid. 

Inverted lids have been used in 

minimal quantities in past seasons, 

usually when a tomato packing 

operation was purchased by another 

entity. Any containers included in the 

purchase could be used by the 

purchasing handler by inverting the lids 

so the purchaser’s information could be 

affixed on the clean side. Usually there 

were not many containers remaining, so 

the containers requiring inverted lids 

were fairly limited in quantity. 

Recently, container sales companies 

have started offering their container 

overruns at discounted prices to tomato 

handlers. These containers usually have 

preprinted handler and product 

information on the lids. The Committee 

is concerned this could significantly 

increase the number of inverted lids 

being used by the industry and could 

pose problems with the positive 

identification and traceability of 

tomatoes. 

In their discussion of this issue, the 

Committee agreed the ability to 

positively identify product is a necessity 

in today’s marketplace. The Committee 

expressed concern that the practice of 

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Federal Register / Vol. 72, No. 85 / Thursday, May 3, 2007 / Rules and Regulations 24531 

inverting lids could result in 

misidentification and confusion in cases 

where tomatoes need to be traced back 

to their origin. The Committee 

recognized that in the past, most of the 

containers being used with an inverted 

lid were associated with a handler 

purchasing another operation. 

Consequently, the original owner of the 

lid was no longer in business, and the 

container was only printed with the 

information for one active handler. 

This would not be the case with 

handlers using overrun containers. The 

overrun containers being made available 

are containers produced in excess of 

orders, with the majority preprinted 

with handler information. Therefore, 

once inverted, the lids on the overrun 

containers would be printed with the 

information for two active handlers. The 

Committee is concerned that having 

multiple handler information on a 

container, even with the lid inverted, 

could pose problems when trying to 

track tomatoes back to the original 

handler. 

The Committee believes it is of 

critical importance that Florida 

tomatoes can be traced from the farm to 

the end-user. Proper handler 

identification on a container is an 

important part of this traceability. 

Allowing the use of containers with an 

active registered handler’s information 

on the exterior of the lid and another on 

the interior could allow for 

misidentification and confusion in 

product identification. The Committee 

believes by limiting the use of inverted 

lids to the handler whose name 

originally appeared on the lid, positive 

identification and traceability is better 

maintained. 

In addition, in cases related to 

marketing order compliance, it is also 

important to be able to identify the 

original source of tomatoes. Allowing 

the use of inverted lids could result in 

the intentional misrepresentation of the 

origin of the tomatoes. The box lids 

could be re-inverted to display the 

handler information originally printed 

on the box without that handler’s 

knowledge. Limiting the use of inverted 

lids on tomato containers by anyone 

other than the handler whose 

information first appeared on the lid 

helps alleviate any misidentification or 

uncertainty in product identification. 

Section 8e of the Act provides that 

when certain domestically produced 

commodities, including tomatoes, are 

regulated under a Federal marketing 

order, imports of that commodity must 

meet the same or comparable grade, 

size, quality, and maturity requirements. 

As this rule changes the container 

requirements under the domestic 

handling regulations, no corresponding 

change to the import regulations is 

required. 

Final Regulatory Flexibility Analysis 

Pursuant to requirements set forth in 

the Regulatory Flexibility Act (RFA), the 

Agricultural Marketing Service (AMS) 

has considered the economic impact of 

this action on small entities. 

Accordingly, AMS has prepared this 

final regulatory flexibility analysis. 

The purpose of the RFA is to fit 

regulatory actions to the scale of 

business subject to such actions in order 

that small businesses will not be unduly 

or disproportionately burdened. 

Marketing orders issued pursuant to the 

Act, and the rules issued thereunder, are 

unique in that they are brought about 

through group action of essentially 

small entities acting on their own 

behalf. Thus, both statutes have small 

entity orientation and compatibility. 

There are approximately 100 

producers of tomatoes in the production 

area and approximately 70 handlers 

subject to regulation under the 

marketing order. Small agricultural 

producers are defined by the Small 

Business Administration (SBA) as those 

having annual receipts less than 

$750,000, and small agricultural service 

firms are defined as those whose annual 

receipts are less than $6,500,000 (13 

CFR 121.201). 

Based on industry and Committee 

data, the average annual price for fresh 

Florida tomatoes during the 2005–06 

season was approximately $10.27 per 

25-pound container, and fresh 

shipments totaled 47,880,303 25-pound 

cartons of tomatoes. Committee data 

indicates approximately 27 percent of 

the handlers handle 95 percent of the 

total volume shipped outside the 

regulated area. Based on the average 

price, about 75 percent of handlers 

could be considered small businesses 

under SBA’s definition. In addition, 

based on production, grower prices as 

reported by the National Agricultural 

Statistics Service, and the total number 

of Florida tomato growers, the average 

annual grower revenue is below 

$750,000. Thus, the majority of handlers 

and producers of Florida tomatoes may 

be classified as small entities. 

This rule continues in effect the 

action that changed the handling 

requirements currently prescribed under 

the order. This rule continues to limit 

the use of inverted lids on tomato 

containers to the handler whose 

information initially appeared on the 

lid. This rule helps ensure that lids do 

not contain the information for more 

than one active handler and aids in 

maintaining the positive identification 

and traceability of Florida tomatoes. 

This rule revises § 966.323(a)(3), which 

specifies the requisite container 

requirements. Authority for this action 

is provided in § 966.52 of the order. 

The Committee unanimously 

recommended this change at a meeting 

held on October 4, 2006. 

At the meeting, the Committee 

discussed the impact of this change on 

handlers in terms of cost. This rule 

could result in a slight increase in cost 

for handlers that were considering 

purchasing the container overruns. 

However, Committee members stated 

that plain containers are readily 

available on the market at reasonable 

prices. Consequently, the difference in 

cost between a discounted overrun 

container and a plain blank container 

should be minimal. 

In addition, last season the industry 

packed more than 47 million cartons of 

tomatoes. The available quantities of 

overrun containers are limited, 

confining the cost benefit to those 

containers available. When compared to 

the total containers needed, the overall 

cost savings associated with using 

overrun cartons would be negligible. 

Also, in previous seasons, overrun 

containers were not available for 

purchase. Therefore, container cost for 

all handlers should be similar to those 

in previous seasons. 

Further, this rule provides the benefit 

of helping to maintain the traceability 

and proper identification of Florida 

tomatoes, which outweighs the minor 

cost savings associated with using 

overrun containers. The costs and 

benefits of this rule are not expected to 

be disproportionately different for small 

or large entities. 

One alternative to this action was to 

allow the use of inverted lids. However, 

Committee members agreed that having 

the information for more than one active 

handler appear on a carton was 

confusing and could make traceability 

and proper identification difficult. 

Therefore, this alternative was rejected. 

The AMS is committed to complying 

with the E-Government Act, to promote 

the use of the Internet and other 

information technologies to provide 

increased opportunities for citizen 

access to Government information and 

services, and for other purposes. 

This action will not impose any 

additional reporting or recordkeeping 

requirements on either small or large 

tomato handlers. As with all Federal 

marketing order programs, reports and 

forms are periodically reviewed to 

reduce information requirements and 

duplication by industry and public 

sector agencies. In addition, as noted in 

the initial regulatory flexibility analysis, 

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24532 Federal Register / Vol. 72, No. 85 / Thursday, May 3, 2007 / Rules and Regulations 

USDA has not identified any relevant 

Federal rules that duplicate, overlap or 

conflict with this rule. 

Further, the Committee’s meeting was 

widely publicized throughout the 

Florida tomato industry and all 

interested persons were invited to 

attend the meeting and participate in 

Committee deliberations. Like all 

Committee meetings, the October 4, 

2006, meeting was a public meeting and 

all entities, both large and small, were 

able to express views on this issue. 

An interim final rule concerning this 

action was published in the Federal 

Register on February 6, 2007. Copies of 

the rule were mailed by the Committee’s 

staff to all Committee members and 

tomato handlers. In addition, the rule 

was made available through the Internet 

by USDA and the Office of the Federal 

Register. That rule provided for a 60- 

day comment period which ended April 

9, 2007. No comments were received. 

A small business guide on complying 

with fruit, vegetable, and specialty crop 

marketing agreements and orders may 

be viewed at: http://www.ams.usda.gov/ 

fv/moab.html. Any questions about the 

compliance guide should be sent to Jay 

Guerber at the previously mentioned 

address in the FOR FURTHER INFORMATION

CONTACT section. 

After consideration of all relevant 

material presented, including the 

Committee’s recommendation, and 

other information, it is found that 

finalizing the interim final rule, without 

change, as published in the Federal 

Register (72 FR 5327, February 6, 2007) 

will tend to effectuate the declared 

policy of the Act. 

List of Subjects in 7 CFR Part 966 

Marketing agreements, Reporting and 

recordkeeping requirements, Tomatoes. 

PART 966—TOMATOES GROWN IN 

FLORIDA 

■ Accordingly, the interim final rule 

amending 7 CFR part 966 which was 

published at 72 FR 5327 on February 6, 

2007, is adopted as a final rule without 

change. 

Dated: April 27, 2007. 

Lloyd C. Day, 

Administrator, Agricultural Marketing 

Service. 

[FR Doc. E7–8459 Filed 5–2–07; 8:45 am] 

BILLING CODE 3410–02–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Part 1308 

[Docket No. DEA–301F] 

Schedules of Controlled Substances: 

Placement of Lisdexamfetamine Into 

Schedule II 

AGENCY: Drug Enforcement 

Administration, Department of Justice. 

ACTION: Final Rule. 

SUMMARY: With the issuance of this final 

rule, the Deputy Administrator of the 

Drug Enforcement Administration 

(DEA) places the substance 

lisdexamfetamine, including its salts, 

isomers and salts of isomers into 

schedule II of the Controlled Substances 

Act (CSA). As a result of this rule, the 

regulatory controls and criminal 

sanctions of schedule II will be 

applicable to the manufacture, 

distribution, dispensing, importation 

and exportation of lisdexamfetamine 

and products containing 

lisdexamfetamine. 

EFFECTIVE DATE: June 4, 2007. 

FOR FURTHER INFORMATION CONTACT: 

Christine A. Sannerud, PhD, Chief, Drug 

and Chemical Evaluation Section, Office 

of Diversion Control, Drug Enforcement 

Administration, Washington, DC 20537, 

(202) 307–7183. 

SUPPLEMENTARY INFORMATION: 

Lisdexamfetamine is a central nervous 

system stimulant drug. On February 23, 

2007, the Food and Drug Administration 

(FDA) approved lisdexamfetamine for 

marketing under the trade name 

Vyvanse TM. Lisdexamfetamine will be 

marketed as a prescription drug product 

for the treatment of Attention Deficit 

Hyperactivity Disorder (ADHD). 

Lisdexamfetamine is an amide ester 

conjugate comprised of the amino acid 

L-lysine covalently bound to the amino 

group of d-amphetamine. The chemical 

name of its dimesylate salt form is (2S)- 

2,6-diamino-N-[(1S)-1-methyl-2- 

phenethyl]hexanamide 

dimethanesulfonate (CAS number 

608137–32–3). Lisdexamfetamine per se 

is pharmacologically inactive and its 

effects are due to its in vivo metabolic 

conversion to d-amphetamine. 

Lisdexamfetamine is a new molecular 

entity and has not been marketed in the 

United States or other countries. 

Therefore, there has been no evidence of 

diversion, abuse, or law enforcement 

encounters involving lisdexamfetamine. 

On November 14, 2006, the Assistant 

Secretary for Health, Department of 

Health and Human Services (DHHS), 

sent the Deputy Administrator of DEA a 

scientific and medical evaluation and a 

letter recommending that 

lisdexamfetamine be placed into 

schedule II of the CSA. Enclosed with 

the November 14, 2006, letter was a 

document prepared by the FDA entitled, 

‘‘Basis for the Recommendation for 

Control of Lisdexamfetamine in 

Schedule II of the Controlled Substances 

Act (CSA).’’ The document contained a 

review of the factors which the CSA 

requires the Secretary to consider (21 

U.S.C. 811(b)). 

After a review of the available data, 

including the scientific and medical 

evaluation and the scheduling 

recommendation received from DHHS, 

the Deputy Administrator of the DEA, in 

a February 22, 2007, Notice of Proposed 

Rulemaking (72 FR 7945), proposed 

placement of lisdexamfetamine into 

schedule II of the CSA. The proposed 

rule provided an opportunity for all 

interested persons to submit their 

written comments to be postmarked and 

electronic comments be sent on or 

before March 26, 2007. 

Comments Received 

The DEA received two comments in 

response to the Notice of Proposed 

Rulemaking. One commenter stated that 

monthly visits to obtain refills for 

Concerta [supreg]—like drugs used in 

children are very expensive and the law 

needs to be changed. DEA notes that 

statutory requirements for schedule II 

drugs do not permit prescription refills. 

DEA does not regulate the size of each 

prescription or the frequency of medical 

visits; these matters are within the 

purview of prescribing physician. DEA 

has no authority regarding either the 

cost of medical care or the cost of the 

medications a prescribing practitioner 

may prescribe. Another commenter 

requested the name of the company that 

filed the New Drug Application for 

lisdexamfetamine in order to obtain 

standard analytical reference material 

and/or analytical data from the 

company. This comment is not relevant 

to the present scheduling action. 

Scheduling of Lisdexamfetamine 

Relying on the scientific and medical 

evaluation and the recommendation of 

the Acting Assistant Secretary for 

Health, received in accordance with 

section 201(b) of the Act (21 U.S.C. 

811(b)), and the independent review of 

the available data by DEA, and after a 

review of the comments received in 

response to the Notice of Proposed 

Rulemaking, the Deputy Administrator 

of DEA, pursuant to sections 201(a) and 

201(b) of the Act (21 U.S.C. 811(a) and 

811(b)), finds that: 

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