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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Federal Register / Vol. 72, No. 85 / Thursday, May 3, 2007 / Rules and Regulations 24533 

(1) Lisdexamfetamine has a high 

potential for abuse; 

(2) Lisdexamfetamine has a currently 

accepted medical use in treatment in the 

United States; and 

(3) Abuse of lisdexamfetamine may 

lead to severe psychological or physical 

dependence. 

Based on these findings, the Deputy 

Administrator of DEA concludes that 

lisdexamfetamine, including its salts, 

isomers, and salts of isomers, warrants 

control in schedule II of the CSA. The 

applicable regulations are as follows: 

Registration. Any person who 

manufactures, distributes, dispenses, 

imports, exports, engages in research or 

conducts instructional activities with 

lisdexamfetamine, or who desires to 

manufacture, distribute, dispense, 

import, export, engage in instructional 

activities or conduct research with 

lisdexamfetamine, must be registered to 

conduct such activities in accordance 

with Part 1301 of Title 21 of the Code 

of Federal Regulations. Any person who 

is currently engaged in any of the above 

activities and is not registered with DEA 

must submit an application for 

registration on or before June 4, 2007 

and may continue their activities until 

DEA has approved or denied that 

application. 

Security. Lisdexamfetamine is subject 

to schedule II security requirements and 

must be manufactured, distributed and 

stored in accordance with § § 1301.71, 

1301.72(a), (c), and (d), 1301.73, 

1301.74, 1301.75(b) and (c), 1301.76 and 

1301.77 of Title 21 of the Code of 

Federal Regulations on or after June 4, 

2007. 

Labeling and Packaging. All labels 

and labeling for commercial containers 

of lisdexamfetamine must comply with 

requirements of § § 1302.03–1302.07 of 

Title 21 of the Code of Federal 

Regulations on or after June 4, 2007. 

Quotas. Quotas for lisdexamfetamine 

must be established pursuant to part 

1303 of Title 21 of the Code of Federal 

Regulations. 

Inventory. Every registrant required to 

keep records and who possesses any 

quantity of lisdexamfetamine must keep 

an inventory of all stocks of 

lisdexamfetamine on hand pursuant to 

§ § 1304.03, 1304.04 and 1304.11 of 

Title 21 of the Code of Federal 

Regulations on or after June 4, 2007. 

Every registrant who desires registration 

in schedule II for lisdexamfetamine 

must conduct an inventory of all stocks 

of the substance on hand at the time of 

registration. 

Records. All registrants must keep 

records pursuant to § § 1304.03, 

1304.04, 1304.21, 1304.22, and 1304.23 

of Title 21 of the Code of Federal 

Regulations on or after June 4, 2007. 

Reports. All registrants required to 

submit reports to the Automation of 

Reports and Consolidated Order System 

(ARCOS) in accordance with § 1304.33 

of Title 21 of the Code of Federal 

Regulations must do so for 

lisdexamfetamine. 

Orders for Lisdexamfetamine. All 

registrants involved in the distribution 

of lisdexamfetamine must comply with 

the order requirements of part 1305 of 

Title 21 of the Code of Federal 

Regulations on or after June 4, 2007. 

Prescriptions. All prescriptions for 

lisdexamfetamine or prescriptions for 

products containing lisdexamfetamine 

must be issued pursuant to 21 CFR 

1306.03–1306.06 and 1306.11–1306.15. 

Importation and Exportation. All 

importation and exportation of 

lisdexamfetamine must be in 

compliance with part 1312 of Title 21 of 

the Code of Federal Regulations on or 

after June 4, 2007. 

Criminal Liability. Any activity with 

lisdexamfetamine not authorized by, or 

in violation of, the Controlled 

Substances Act or the Controlled 

Substances Import and Export Act shall 

be unlawful on or after June 4, 2007. 

Regulatory Certifications 

Executive Order 12866 

In accordance with the provisions of 

the CSA (21 U.S.C. 811(a)), this action 

is a formal rulemaking ‘‘on the record 

after opportunity for a hearing.’’ Such 

proceedings are conducted pursuant to 

the provisions of 5 U.S.C. 556 and 557 

and, as such, are exempt from review by 

the Office of Management and Budget 

pursuant to Executive Order 12866, 

section 3(d)(1). 

Regulatory Flexibility Act 

The Deputy Administrator, in 

accordance with the Regulatory 

Flexibility Act (5 U.S.C. 605(b)), has 

reviewed this final rule and by 

approving it certifies that it will not 

have a significant economic impact on 

a substantial number of small entities. 

Lisdexamfetamine products will be 

prescription drugs used for the 

treatment of Attention Deficit 

Hyperactivity Disorder (ADHD). 

Handlers of lisdexamfetamine also 

handle other controlled substances used 

to treat ADHD which are already subject 

to the regulatory requirements of the 

CSA. 

Executive Order 12988 

This regulation meets the applicable 

standards set forth in sections 3(a) and 

3(b)(2) of Executive Order 12988 Civil 

Justice Reform. 

Executive Order 13132 

This rulemaking does not preempt or 

modify any provision of state law; nor 

does it impose enforcement 

responsibilities on any state; nor does it 

diminish the power of any state to 

enforce its own laws. Accordingly, this 

rulemaking does not have federalism 

implications warranting the application 

of Executive Order 13132. 

Unfunded Mandates Reform Act of 1995 

This rule will not result in the 

expenditure by State, local and tribal 

governments, in the aggregate, or by the 

private sector, of $120,000,000 or more 

in any one year, and will not 

significantly or uniquely affect small 

governments. Therefore, no actions were 

deemed necessary under provisions of 

the Unfunded Mandates Reform Act of 

1995. 

Congressional Review Act 

This rule is not a major rule as 

defined by section 804 of the Small 

Business Regulatory Enforcement 

Fairness Act of 1996 (Congressional 

Review Act). This rule will not result in 

an annual effect on the economy of 

$100,000,000 or more; a major increase 

in costs or prices; or significant adverse 

effects on competition, employment, 

investment, productivity, innovation, or 

on the ability of United States-based 

companies to compete with foreignbased companies in domestic and 

export markets. 

List of Subjects in 21 CFR Part 1308 

Administrative practice and 

procedure, Drug traffic control, 

Narcotics, Prescription drugs. 

■ Under the authority vested in the 

Attorney General by section 201(a) of 

the CSA (21 U.S.C. 811(a)), and 

delegated to the Administrator of DEA 

by Department of Justice regulations (28 

CFR 0.100), and redelegated to the 

Deputy Administrator pursuant to 28 

CFR 0.104, the Deputy Administrator 

hereby amends 21 CFR part 1308 as 

follows: 

PART 1308—SCHEDULES OF 

CONTROLLED SUBSTANCES 

■ 1. The authority citation for 21 CFR 

part 1308 continues to read as follows: 

Authority: 21 U.S.C. 811, 812, 871(b) 

unless otherwise noted. 

■ 2. Section 1308.12 is amended by 

adding a new paragraph (d)(5) to read as 

follows: 

§ 1308.12 Schedule II. 

* * * * * 

(d) * * * 

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24534 Federal Register / Vol. 72, No. 85 / Thursday, May 3, 2007 / Rules and Regulations 

(5) Lisdexamfetamine, its salts, 

isomers, and salts of its isomers—1205. 

* * * * * 

Dated: April 25, 2007. 

Michele M. Leonhart, 

Deputy Administrator. 

[FR Doc. E7–8421 Filed 5–2–07; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 117 

[CGD05–07–047] 

RIN 1625–AA–09 

Drawbridge Operation Regulations; 

Intracoastal Waterway (ICW); Inside 

Thorofare, Atlantic City, NJ 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of temporary deviation 

from regulations. 

SUMMARY: The Commander, Fifth Coast 

Guard District, has approved a 

temporary deviation from the 

regulations governing the operation of 

the U.S. 40–322 (Albany Avenue) 

Bridge, at ICW mile 70.0, across Inside 

Thorofare at Atlantic City, New Jersey. 

This deviation allows the drawbridge to 

remain closed-to-navigation from 10 

a.m. to 5 p.m. on August 15, 2007, to 

facilitate traffic control during the 

Atlantic City Air Show. 

DATES: This deviation is effective from 

10 a.m. to 5 p.m. on August 15, 2007. 

ADDRESSES: Materials referred to in this 

document are available for inspection or 

copying at Commander (dpb), Fifth 

Coast Guard District, Federal Building, 

1st Floor, 431 Crawford Street, 

Portsmouth, VA 23704–5004 between 8 

a.m. and 4 p.m., Monday through 

Friday, except Federal holidays. The 

telephone number is (757) 398–6222. 

Commander (dpb), Fifth Coast Guard 

District maintains the public docket for 

this temporary deviation. 

FOR FURTHER INFORMATION CONTACT: 

Waverly W. Gregory, Jr., Bridge 

Administrator, Fifth Coast Guard 

District, at (757) 398–6222. 

SUPPLEMENTARY INFORMATION: The U.S. 

40–322 (Albany Avenue) Bridge, a lift 

drawbridge, has a vertical clearance in 

the closed position to vessels of 10 feet, 

above mean high water. 

The Atlantic City Regional Mainland 

Chamber of Commerce, on behalf of the 

bridge owner the New Jersey 

Department of Transportation, has 

requested a temporary deviation from 

the current operating regulation set out 

in 33 CFR 117.733(f) to close the 

drawbridge to navigation for the sole 

purpose of traffic control during the 

Atlantic City Air Show that is scheduled 

for Wednesday, August 15, 2007. 

To facilitate traffic control during the 

Atlantic City Air Show, the U.S. 40–322 

(Albany Avenue) Bridge will be 

maintained in the closed-to-navigation 

position from 10 a.m. to 5 p.m. on 

August 15, 2007. 

This deviation from the operating 

regulations is authorized under 33 CFR 

117.35. 

Dated: April 24, 2007. 

Waverly W. Gregory, Jr., 

Chief, Bridge Administration Branch, Fifth 

Coast Guard District. 

[FR Doc. E7–8493 Filed 5–2–07; 8:45 am] 

BILLING CODE 4910–15–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[CGD08–07–010] 

RIN 1625–AA11 

Regulated Navigation Area; 

Cumberland River, Clarksville, TN 

AGENCY: Coast Guard, DHS. 

ACTION: Temporary final rule. 

SUMMARY: The Coast Guard is 

establishing a Regulated Navigation 

Area (RNA) on the Cumberland River 

(CMR) mile marker (MM) 126 to mile 

marker MM 127. All vessel traffic 

transiting beneath the R.J. Corman 

Railroad Bridge at MM 126.5 is 

restricted to the right descending bank 

(RDB) on the CMR and tows transiting 

this RNA cannot be wider than 80 feet 

or longer than 800 feet, excluding the 

length of the tow boat. 

DATES: This temporary rule is effective 

from 4:40 p.m. on March 31, 2007 

through 11:30 a.m. August 2, 2007. 

ADDRESSES: The Coast Guard is not 

soliciting comments on this temporary 

RNA. However, you may mail 

comments and related material to Coast 

Guard Sector Ohio Valley, 600 Martin 

Luther King Drive, Louisville, KY 

40202, attention: Prevention 

Department. Comments and material 

received from the public, as well as 

documents indicated in this preamble as 

being available in the docket, will 

become part of this docket and will be 

available for inspection or copying at 

Coast Guard Sector Ohio Valley between 

8 a.m. and 4 p.m., Monday through 

Friday, except Federal holidays. 

FOR FURTHER INFORMATION CONTACT: CDR 

Greg Howard, Coast Guard Sector Ohio 

Valley, telephone (502) 779–5422. 

SUPPLEMENTARY INFORMATION: 

Regulatory Information 

We did not publish a notice of 

proposed rulemaking (NPRM) for this 

regulation. Under 5 United States Code 

(USC) 553(b)(B), the Coast Guard finds 

that good cause exists for not publishing 

a NPRM and under 5 U.S.C. 553(d)(3), 

good cause exists for making this rule 

effective immediately. The R.J. Corman 

Railroad Bridge on the Cumberland 

River was struck by a barge and was 

severely damaged. This RNA is needed 

to prevent further damage to the bridge 

and to protect vessels transiting under 

the bridge. 

Background and Purpose 

On March 29, 2007 at approximately 

11:15 p.m., the R.J. Corman Railroad 

Bridge, located at MM 126.5 on the 

Cumberland River (CMR) was struck by 

a barge being pushed by a towing vessel. 

The bridge sustained extensive damage. 

The Coast Guard set a safety zone at 7 

p.m. on March 30, 2007 on the CMR 

from MM 126 through MM 127 halting 

all vessel traffic until the structural 

integrity of the bridge was evaluated. 

The operator of the bridge reported to 

the Coast Guard that the bridge damage 

was isolated to the left descending bank 

(LDB) bridge pier of the bridge above the 

waterline. The bridge operator also 

informed the Coast Guard that vessels 

could safely transit under the bridge on 

the right descending bank (RDB) of the 

CMR. The Coast Guard is restricting 

vessel movements to the RDB and is 

limiting tow sizes to ensure that vessels 

pass safely under the bridge and do not 

cause additional damage to the bridge. 

Discussion of Rule 

The Coast Guard is establishing a 

Regulated Navigation Area (RNA) on the 

CMR mile marker (MM) 126 to mile 

marker MM 127. All vessel traffic 

transiting beneath the R.J. Corman 

Railroad Bridge at MM 126.5 is 

restricted to the RDB on the CMR and 

tows transiting this RNA cannot be 

wider than 80 feet or longer than 800 

feet, excluding the length of the tow 

boat. This RNA is effective from 4:40 

p.m. on March 31, 2007 through 11:30 

a.m. August 2, 2007. This RNA may be 

cancelled earlier if the Coast Guard 

determines that it is safe for vessel 

traffic to transit under the bridge span 

adjacent to the LDB. 

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