Federal Register / Vol. 72, No. 43 / Tuesday, March 6, 2007 / Notices 9967 

Title: Certification Summary Form, 

Reporting Summary Form for Acreage 

Limitation, 43 CFR part 426 and 43 CFR 

part 428. 

Abstract: These forms are to be used 

by district offices to summarize 

individual landholder (direct or indirect 

landowner or lessee) and farm operator 

certification and reporting forms as 

required by the RRA, 43 CFR part 426, 

and 43 CFR part 428. This information 

allows us to establish water user 

compliance with Federal reclamation 

law. 

Changes to the RRA forms and the 

instructions to those forms. The changes 

made to the current Form 7–21SUMM–

C, Form 7–21SUMM–R, and the 

corresponding instructions clarify the 

completion instructions for these forms 

(for example, adding verbiage to clarify 

when requested acreages are to be 

provided on a westwide or districtspecific basis). Other changes to the 

forms and the corresponding 

instructions are editorial in nature and 

are designed to assist the respondents 

by increasing their understanding of the 

forms, and clarifying the instructions for 

use when completing the forms. The 

proposed revisions to the RRA forms 

will be effective in the 2008 water year. 

Frequency: Annually. 

Respondents: Contracting entities that 

are subject to the acreage limitation 

provisions of Federal reclamation law. 

Estimated Total Number of 

Respondents: 225. 

Estimated Number of Responses per 

Respondent: 1.25. 

Estimated Total Number of Annual 

Responses: 281. 

Estimated Total Annual Burden on 

Respondents: 11,240 hours. 

Estimate of Burden for Each Form: 

Form No. 

Burden estimate per form 

(in hours) 

Number of 

respondents 

Annual number of 

responses 

Annual burden 

on respondents 

(in hours) 

7–21SUMM–C and associated tabulation sheets ........................................... 40 188 235 9,400 

7–21SUMM–R and associated tabulation sheets ........................................... 40 37 46 1,840 

Totals ........................................................................................................ ........................ 225 281 11,240 

Comments 

Comments are invited on: 

(a) Whether the proposed collection of 

information is necessary for the proper 

performance of our functions, including 

whether the information will have 

practical use; 

(b) The accuracy of our burden 

estimate for the proposed collection of 

information; 

(c) Ways to enhance the quality, 

usefulness, and clarity of the 

information to be collected; and 

(d) Ways to minimize the burden of 

the collection of information on 

respondents, including the use of 

automated collection techniques or 

other forms of information technology. 

We will summarize all comments 

received regarding this notice. We will 

publish that summary in the Federal 

Register when the information 

collection request is submitted to OMB 

for review and approval. 

Before including your address, 

telephone number, e-mail address, or 

other personal identifying information 

in your comment, you should be aware 

that your entire comment—including 

your personal identifying information—

may be made publicly available at any 

time. While you can ask us in your 

comment to withhold your personal 

identifying information from public 

review, we cannot guarantee that we 

will be able to do so. 

Dated: January 29, 2007. 

Roseann Gonzales, 

Director, Office of Program and Policy 

Services, Denver Office. 

[FR Doc. E7–3847 Filed 3–5–07; 8:45 am] 

BILLING CODE 4310–MN–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

Manufacturer of Controlled 

Substances; Notice of Registration 

By Notice dated October 11, 2006, and 

published in the Federal Register on 

October 18, 2006, (71 FR 61511), Varian, 

Inc., Lake Forest, 25200 Commercentre 

Drive, Lake Forest, California 92630–

8810, made application by renewal to 

the Drug Enforcement Administration 

(DEA) to be registered as a bulk 

manufacturer of the basic classes of 

controlled substances listed in schedule 

II: 

Drug Schedule 

Phencyclidine (7471) .................... II 

1–Piperidinocyclohexanecarbonitrile (8603) II 

Benzoylecgonine (9180) ............... II 

The company plans to manufacture 

small quantities of the listed controlled 

substances for use in diagnostic 

products. 

No comments or objections have been 

received. DEA has considered the 

factors in 21 U.S.C. 823(a) and 

determined that the registration of 

Varian, Inc., Lake Forest to manufacture 

the listed basic classes of controlled 

substances is consistent with the public 

interest at this time. DEA has 

investigated Varian, Inc., Lake Forest to 

ensure that the company’s registration is 

consistent with the public interest. The 

investigation has included inspection 

and testing of the company’s physical 

security systems, verification of the 

company’s compliance with state and 

local laws, and a review of the 

company’s background and history. 

Therefore, pursuant to 21 U.S.C. 823, 

and in accordance with 21 CFR 1301.33, 

the above named company is granted 

registration as a bulk manufacturer of 

the basic classes of controlled 

substances listed. 

Dated: February 26, 2007. 

Joseph T. Rannazzisi, 

Deputy Assistant Administrator, Office of 

Diversion Control, Drug Enforcement 

Administration. 

[FR Doc. E7–3919 Filed 3–5–07; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

ATF Fitness Products, Inc.; Denial of 

Application 

On February 6, 2006, the Deputy 

Assistant Administrator, Office of 

Diversion Control, Drug Enforcement 

Administration, issued an Order to 

Show Cause to ATF Fitness Products, 

Inc. (Respondent) of Oakmont, Pa. The 

Show Cause Order proposed to deny 

Respondent’s pending application for 


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9968 Federal Register / Vol. 72, No. 43 / Tuesday, March 6, 2007 / Notices 

registration as a distributor of the list I 

chemical ephedrine, on the ground that 

its registration would be inconsistent 

with the public interest. Show Cause 

Order at 1. 

The Show Cause order alleged that 

ephedrine is a precursor chemical that 

is ‘‘commonly diverted’’ for use in the 

manufacture of methamphetamine, a 

Schedule II controlled substance Id. The 

Show Cause Order specifically alleged 

that Respondent was proposing to 

distribute combination ephedrine 

products to gyms, fitness shops, and 

dietary supplement dealers, and that 

only a very small amount of the 

legitimate commerce in these products 

occurs in such smaller retail 

establishments. Id. at 2. The Show 

Cause Order alleged that many smaller 

or non-traditional retailers of 

combination ephedrine products 

‘‘purchase inordinate amounts of these 

products and become conduits for the 

diversion of listed chemical[s] into 

illicit drug manufacturing.’’ Id. 

Relatedly, the Show Cause Order 

alleged that ‘‘[t]here is no legitimate 

therapeutic market for this type of 

product’’ at the type of stores 

Respondent ‘‘propose[s] to supply,’’ and 

that Respondent would be ‘‘fueling the 

diversion of precursor chemicals into 

the illicit manufacture of 

methamphetamine.’’ Id. at 3. The Show 

Cause Order also alleged that in 

conducting verifications of 

Respondent’s proposed customers, DEA 

investigators were unable to determine 

whether some of the proposed 

customers intended to buy ephedrine 

products from it. Id. at 2. 

Finally, the Show Cause Order alleged 

that in October 2004, the Food and Drug 

Administration conducted an inspection 

of Respondent. Id. at 2. The Show Cause 

Order alleged that during the 

inspection, FDA investigators found 

quantities of ephedra, a banned product. 

The Show Cause Order, which also 

informed Respondent of its right to a 

hearing, was served by certified mail, 

return receipt requested. On February 

13, 2006, Respondent received the Show 

Cause Order as evidenced by the signed 

return receipt card. Since that time, 

neither Respondent, nor anyone 

purporting to represent it, has 

responded. Because (1) more than thirty 

days have passed since Respondent’s 

receipt of the Show Cause Order, and (2) 

no request for a hearing has been 

received, I conclude that Respondent 

has waived its right to a hearing. See 21 

CFR 1309.53(c). I therefore enter this 

final order without a hearing based on 

relevant material found in the 

investigative file and make the 

following findings. 

Findings 

Ephedrine is a list I chemical that, 

while having a therapeutic use, is easily 

extracted from lawful products and used 

in the illicit manufacture of 

methamphetamine, a schedule II 

controlled substances. See 21 U.S.C. 

802(34); 21 CFR 1308.12(d). As noted in 

numerous DEA orders, 

methamphetamine is an extremely 

potent and addictive central nervous 

system stimulant. See T. Young 

Associates, Inc., 71 FR 60567 (2006). 

The illegal manufacture and abuse of 

methamphetamine pose a grave threat to 

this country. Methamphetamine abuse 

has destroyed numerous lives and 

families and has ravaged communities. 

Moreover, because of the toxic nature of 

the chemicals used in producing the 

drug, illicit methamphetamine 

laboratories cause serious 

environmental harms. Id. 

Respondent is a Pennsylvania 

corporation which is located at 140 

Pennsylvania Avenue, Oakmont, Pa. 

Respondent’s founder and president is 

Mr. James Vercellotti. 

Respondent previously held a DEA 

Certificate of Registration to distribute 

list I chemicals. The registration, 

however, expired on June 30, 2001. On 

September 5, 2001, two DEA Diversion 

Investigators (DIs) conducted a 

regulatory investigation at Respondent’s 

Oakmont facility. On that date, 

Respondent’s chief financial officer told 

the DIs that Respondent had submitted 

a renewal application. 

During the visit, William 

Charlesworth, Respondent’s vice 

president, informed the DIs that 

Respondent had previously purchased 

bulk ephedrine powder and 

manufactured a combination ephedrine 

product, Sci-Fit Ephedrine HCL, for 

Asthma Relief. Respondent’s officials 

further maintained that they were under 

the assumption that their distributor’s 

registration authorized them to engage 

in manufacturing. The DIs subsequently 

advised an official of Respondent that 

while a manufacturer’s registration 

authorizes its holder to distribute, a 

distributor’s registration does not 

authorize its holder to manufacture. 

On September 8, 2001, Mr. 

Charlesworth telephoned one of the DIs 

and informed him that Respondent was 

withdrawing its renewal application in 

part because list I products comprised 

less than one percent of its sales. 

Respondent subsequently submitted a 

letter to DEA withdrawing its 

application. 

On May 5, 2004, Respondent 

submitted a new application for a 

registration to distribute ephedrine. On 

September 28, 2004, two DIs returned to 

Respondent’s facility to conduct a preregistration investigation and met again 

with its president. Respondent’s 

president told the DIs that it was a 

wholesale distributor of over-thecounter fitness products including food 

supplements and that it had customers 

nationwide including GNC, a chain of 

nutritional supplement retailers, and 

Walgreens, a chain of pharmacies. 

Respondent’s president also told the DIs 

that the firm had been in business for 

fourteen years and that it expected that 

list I products would provide less than 

two percent of its sales. 

Respondent provided the DIs with a 

list of fifty potential list I customers. 

Subsequently, a DI contacted ten of 

Respondent’s customers. Seven of the 

stores stated that they did not plan to 

purchase ephedrine products; only two 

of the stores indicated that they would 

purchase the products from Respondent. 

Respondent’s president further stated 

that it would require its List I customers 

to provide complete identification 

information prior to selling the products 

to them and that its sales manager 

would verify the existence of each 

business and its need for the products. 

Following the on-site inspection, DEA 

was notified that the Food and Drug 

Administration (FDA) had conducted an 

inspection of Respondent’s facility. 

During the inspection, FDA found that 

Respondent had in its possession 

approximately $13,500 worth of 

products, which either contained 

MaHuang Extract, a source of ephedrine 

alkaloids, or claimed to when they did 

not. Eight months earlier, FDA had 

issued a final rule banning these 

products on the ground that they are 

adulterated and present an unreasonable 

risk of illness or injury under section 

402(f)(1)(A) of the Federal Food, Drug, 

and Cosmetic Act (FDA Act), 21 U.S.C. 

342(f)(1)(A). See 69 FR 6788 (2004). The 

FDA’s ban became effective on April 12, 

2004. 

According to the FDA, Respondent’s 

officials asserted that they intended to 

export the product. Respondent’s 

officials could not, however, provide the 

documentation required to demonstrate 

its compliance with section 801(e)(1) of 

the FDA Act, 21 U.S.C. 381(e)(1). FDA 

officials also concluded that some of the 

products were mislabeled in violation of 

federal law because they claimed to 

contain ingredients that were not 

actually present. On February 25, 2005, 

the U.S. Attorney’s Office for the 

Western District of Pennsylvania filed a 

complaint for forfeiture of the products 

and U.S. Marshals seized them. 

Subsequently, the FDA found that 

Respondent had in its possession 


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Federal Register / Vol. 72, No. 43 / Tuesday, March 6, 2007 / Notices 9969 

1The CSA imposes extensive recordkeeping 

requirements on List I chemical distributors. See 21 

CFR Pt. 1310. 

another product (Lipodrene), which also 

contained ephedrine alkaloids. On 

January 12, 2006, the U.S. Attorney’s 

Office filed an additional complaint 

which sought the forfeiture of these 

products. U.S. Marshalls seized these 

products, which were valued at 

approximately $ 16,000. 

Discussion 

Under 21 U.S.C. 823(h), an applicant 

to distribute List I chemicals is entitled 

to be registered unless the registration 

would be ‘‘inconsistent with the public 

interest.’’ In making this determination, 

Congress directed that I consider the 

following factors: 

(1) Maintenance by the applicant of 

effective controls against diversion of 

listed chemicals into other than 

legitimate channels; 

(2) Compliance by the applicant with 

applicable Federal, State, and local law; 

(3) Any prior conviction record of the 

applicant under Federal or State laws 

relating to controlled substances or to 

chemicals controlled under Federal or 

State law; 

(4) Any past experience of the 

applicant in the manufacture and 

distribution of chemicals; and 

(5) Such other factors as are relevant 

to and consistent with the public health 

and safety. 

Id. 

‘‘These factors are considered in the 

disjunctive.’’ Joy’s Ideas, 70 FR 33195, 

33197 (2005). I may rely on any one or 

a combination of factors, and may give 

each factor the weight I deem 

appropriate in determining whether an 

application for registration should be 

denied. See, e.g., David M. Starr, 71 FR 

39367 (2006); Energy Outlet, 64 FR 

14269 (1999). Moreover, I am ‘‘not 

required to make findings as to all of the 

factors.’’ Hoxie v. DEA, 419 F.3d 477, 

482 (6th Cir. 2005); Morall v. DEA, 412 

F.3d 165, 173–74 (D.C. Cir. 2005). 

Here, I conclude that an analysis of 

each factor is unnecessary and that 

Respondent’s application should be 

denied based on Factor Two, its record 

of non-compliance with applicable 

laws. 

As recognized in numerous final 

orders, the illicit manufacture and abuse 

of methamphetamine have had 

pernicious effects on families and 

communities throughout the nation. 

Preventing the diversion of list I 

chemicals into the illicit manufacture of 

methamphetamine is of critical 

importance in protecting the public 

from the devastation wreaked by this 

drug. 

While the investigative file in this 

case contains no evidence establishing 

the risk of diversion by establishments 

such as those which Respondent 

proposed to distribute its products to, 

the firm’s record of non-compliance 

with other federal laws does not inspire 

confidence in its willingness to 

faithfully obey DEA regulations. Here, 

the investigative file establishes two 

separate instances in which Respondent 

violated the FDA Act. Moreover, FDA 

found these violations well after the rule 

banning ephedrine alkaloids went into 

effect. 

In section 303(h) of the CSA, Congress 

broadly directed that the Attorney 

General consider ‘‘compliance by the 

applicant with applicable Federal, State, 

and local law,’’ 21 U.S.C. 823(h)(2), in 

determining whether to grant a list I 

distributor’s registration. In contrast to 

the provision applicable to a 

practitioner’s registration, Congress did 

not limit the subject matter of the laws 

that are properly considered in 

determining whether an applicant’s 

compliance record supports granting it 

a registration. Cf. id. § 823(f)(4) 

(directing consideration of a 

practitioner’s ‘‘[c]ompliance with 

applicable State, Federal, or local laws 

relating to controlled substances’’). 

Moreover, Respondent’s apparent 

willingness to sell products which have 

been banned (as evidenced by the fact 

that banned products were found not 

once, but twice at its facility) and/or its 

inability to properly document its 

compliance with the FDA act (with 

respect to its assertion that it intended 

to export the products found in the first 

incident), are sufficiently probative of 

the manner in which it would likely 

fulfill its obligations as a registrant 

under the Controlled Substances Act.1 I 

thus conclude that granting it a 

registration would ‘‘be inconsistent with 

the public interest.’’ Id. § 823(h). 

Order 

Pursuant to the authority vested in me 

by 21 U.S.C. 823(h), and 28 CFR 

0.100(b) & 0.104, I order that the 

application of Respondent ATF Fitness 

Products, Inc., for a DEA Certificate of 

Registration as a distributor of list I 

chemicals be, and it hereby is, denied. 

This order is effective April 5, 2007. 

Dated: February 23, 2007. 

Michele M. Leonhart, 

Deputy Administrator. 

[FR Doc. E7–3856 Filed 3–5–07; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

Georgia Convenience Wholesale, Inc.; 

Denial of Application 

On February 6, 2006, the Deputy 

Assistant Administrator, Office of 

Diversion Control, Drug Enforcement 

Administration, issued an Order to 

Show Cause to Georgia Convenience 

Wholesale, Inc., (Respondent) of 

Doraville, Georgia. The Show Cause 

Order proposed to deny Respondent’s 

pending application for a Certificate of 

Registration to distribute list I chemicals 

on the ground that its registration 

‘‘would be inconsistent with the public 

interest.’’ Show Cause Order at 1 (citing 

21 U.S.C. 823(h)). 

The Show Cause Order specifically 

alleged that on April 19, 2005, 

Respondent applied for a registration to 

distribute list I chemicals including 

pseudoephedrine, ephedrine and 

phenylpropanolamine (PPA), and that 

these products ‘‘are commonly used to 

illegally manufacture 

methamphetamine, a Schedule II 

controlled substance.’’ Show Cause 

Order at 1–2. The Show Cause Order 

alleged that Respondent was proposing 

to distribute these products to 

convenience stores, and that ‘‘law 

enforcement officials have observed that 

an overwhelming proportion of 

precursors found at illicit 

methamphetamine sites have involved 

non-traditional pseudoephedrine and 

ephedrine brands sold through 

convenience stores.’’ Id. at 2. The Show 

Cause Order also alleged that as nontraditional products ‘‘become more 

tightly regulated, even traditional 

products are subject to diversion.’’ Id. 

The Show Cause Order further alleged 

that during a pre-registration 

investigation, Respondent’s owner/ 

operator was not aware that PPA had 

been withdrawn from the over-thecounter market. Id. Relatedly, the Show 

Cause Order alleged that Respondent 

had also sought registration for other list 

I chemicals even though these 

chemicals ‘‘were not ingredients in any 

over-the-counter drug product.’’ Id. 

Finally, the Show Cause Order alleged 

that Respondent ‘‘does not have 

adequate experience or familiarity with 

products and the sales potentials in the 

industry to carry out the responsibilities 

of a registrant and prevent the diversion 

of listed chemical precursors into illicit 

activities.’’ Id. at 3. 

On or about February 24, 2006, the 

Show Cause Order, which also notified 

Respondent of its right to request a 

hearing, was served by certified mail, 


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