Source: https://fr.scribd.com/document/2784310/Notice-Registration-revocations-restrictions-denials-reinstatements-ATF-Fitness-Products-Inc
Timestamp: 2019-11-21 06:25:04
Document Index: 419501106

Matched Legal Cases: ['art 426', 'art 428', 'art 426', 'art 428', '§ 823', '§ 823']

Notice: Registration revocations, restrictions, denials, reinstatements: ATF Fitness Products, Inc. | Drug Enforcement Administration | Controlled Substances Act
Notice: Registration revocations, restrictions, denials, reinstatements: ATF Fitness Products, Inc., 9967-9969 [E7-3856] Drug Enforcement Administration
enregistrerEnregistrer Notice: Registration revocations, restrictions, de... pour plus tard
01765-5787p
US White House Federal Register: 03-28684
43 / Tuesday, March 6, 2007 / Notices 9967
Title: Certification Summary Form, made to the current Form 7–21SUMM– proposed revisions to the RRA forms
Reporting Summary Form for Acreage C, Form 7–21SUMM–R, and the will be effective in the 2008 water year.
Limitation, 43 CFR part 426 and 43 CFR corresponding instructions clarify the Frequency: Annually.
part 428. completion instructions for these forms Respondents: Contracting entities that
Abstract: These forms are to be used (for example, adding verbiage to clarify are subject to the acreage limitation
by district offices to summarize when requested acreages are to be provisions of Federal reclamation law.
individual landholder (direct or indirect provided on a westwide or district- Estimated Total Number of
landowner or lessee) and farm operator specific basis). Other changes to the Respondents: 225.
certification and reporting forms as
forms and the corresponding Estimated Number of Responses per
required by the RRA, 43 CFR part 426,
instructions are editorial in nature and Respondent: 1.25.
and 43 CFR part 428. This information
allows us to establish water user are designed to assist the respondents Estimated Total Number of Annual
compliance with Federal reclamation by increasing their understanding of the Responses: 281.
law. forms, and clarifying the instructions for Estimated Total Annual Burden on
Changes to the RRA forms and the use when completing the forms. The Respondents: 11,240 hours.
instructions to those forms. The changes Estimate of Burden for Each Form:
Burden esti- Annual num-
Number of on respond-
Form No. mate per form ber of
respondents ents
(in hours) responses (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 Dated: January 29, 2007. the listed basic classes of controlled
Roseann Gonzales, substances is consistent with the public
Comments are invited on: Director, Office of Program and Policy interest at this time. DEA has
(a) Whether the proposed collection of Services, Denver Office. investigated Varian, Inc., Lake Forest to
information is necessary for the proper [FR Doc. E7–3847 Filed 3–5–07; 8:45 am] ensure that the company’s registration is
performance of our functions, including BILLING CODE 4310–MN–P consistent with the public interest. The
whether the information will have investigation has included inspection
practical use; and testing of the company’s physical
DEPARTMENT OF JUSTICE security systems, verification of the
(b) The accuracy of our burden
company’s compliance with state and
estimate for the proposed collection of local laws, and a review of the
information; company’s background and history.
(c) Ways to enhance the quality, Manufacturer of Controlled Therefore, pursuant to 21 U.S.C. 823,
usefulness, and clarity of the Substances; Notice of Registration and in accordance with 21 CFR 1301.33,
information to be collected; and By Notice dated October 11, 2006, and the above named company is granted
(d) Ways to minimize the burden of published in the Federal Register on registration as a bulk manufacturer of
the collection of information on October 18, 2006, (71 FR 61511), Varian, the basic classes of controlled
respondents, including the use of Inc., Lake Forest, 25200 Commercentre substances listed.
automated collection techniques or Drive, Lake Forest, California 92630– Dated: February 26, 2007.
other forms of information technology. 8810, made application by renewal to Joseph T. Rannazzisi,
the Drug Enforcement Administration Deputy Assistant Administrator, Office of
We will summarize all comments
(DEA) to be registered as a bulk Diversion Control, Drug Enforcement
received regarding this notice. We will
manufacturer of the basic classes of Administration.
publish that summary in the Federal
controlled substances listed in schedule [FR Doc. E7–3919 Filed 3–5–07; 8:45 am]
Register when the information II: BILLING CODE 4410–09–P
collection request is submitted to OMB
for review and approval. Drug Schedule
Before including your address, DEPARTMENT OF JUSTICE
Phencyclidine (7471) .................... II
telephone number, e-mail address, or
1–Piperidinocyclohexane- II Drug Enforcement Administration
other personal identifying information carbonitrile (8603)
in your comment, you should be aware Benzoylecgonine (9180) ............... II ATF Fitness Products, Inc.; Denial of
that your entire comment—including Application
your personal identifying information— The company plans to manufacture
may be made publicly available at any small quantities of the listed controlled On February 6, 2006, the Deputy
substances for use in diagnostic Assistant Administrator, Office of
time. While you can ask us in your
comment to withhold your personal products. Diversion Control, Drug Enforcement
identifying information from public No comments or objections have been Administration, issued an Order to
review, we cannot guarantee that we received. DEA has considered the Show Cause to ATF Fitness Products,
will be able to do so. factors in 21 U.S.C. 823(a) and Inc. (Respondent) of Oakmont, Pa. The
determined that the registration of Show Cause Order proposed to deny
Varian, Inc., Lake Forest to manufacture Respondent’s pending application for
VerDate Aug<31>2005 15:35 Mar 05, 2007 Jkt 211001 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 E:\FR\FM\06MRN1.SGM 06MRN1
9968 Federal Register / Vol. 72, No. 43 / Tuesday, March 6, 2007 / Notices
registration as a distributor of the list I Findings September 28, 2004, two DIs returned to
chemical ephedrine, on the ground that Ephedrine is a list I chemical that, Respondent’s facility to conduct a pre-
its registration would be inconsistent while having a therapeutic use, is easily registration investigation and met again
with the public interest. Show Cause extracted from lawful products and used with its president. Respondent’s
Order at 1. in the illicit manufacture of president told the DIs that it was a
The Show Cause order alleged that wholesale distributor of over-the-
methamphetamine, a schedule II
ephedrine is a precursor chemical that counter fitness products including food
controlled substances. See 21 U.S.C.
is ‘‘commonly diverted’’ for use in the supplements and that it had customers
802(34); 21 CFR 1308.12(d). As noted in
manufacture of methamphetamine, a nationwide including GNC, a chain of
numerous DEA orders,
Schedule II controlled substance Id. The nutritional supplement retailers, and
methamphetamine is an extremely
Show Cause Order specifically alleged Walgreens, a chain of pharmacies.
potent and addictive central nervous
that Respondent was proposing to Respondent’s president also told the DIs
system stimulant. See T. Young
distribute combination ephedrine that the firm had been in business for
products to gyms, fitness shops, and Associates, Inc., 71 FR 60567 (2006).
fourteen years and that it expected that
dietary supplement dealers, and that The illegal manufacture and abuse of
list I products would provide less than
only a very small amount of the methamphetamine pose a grave threat to
two percent of its sales.
legitimate commerce in these products this country. Methamphetamine abuse Respondent provided the DIs with a
occurs in such smaller retail has destroyed numerous lives and list of fifty potential list I customers.
establishments. Id. at 2. The Show families and has ravaged communities. Subsequently, a DI contacted ten of
Cause Order alleged that many smaller Moreover, because of the toxic nature of Respondent’s customers. Seven of the
or non-traditional retailers of the chemicals used in producing the stores stated that they did not plan to
combination ephedrine products drug, illicit methamphetamine purchase ephedrine products; only two
‘‘purchase inordinate amounts of these laboratories cause serious of the stores indicated that they would
products and become conduits for the environmental harms. Id. purchase the products from Respondent.
diversion of listed chemical[s] into Respondent is a Pennsylvania Respondent’s president further stated
illicit drug manufacturing.’’ Id. corporation which is located at 140 that it would require its List I customers
Relatedly, the Show Cause Order Pennsylvania Avenue, Oakmont, Pa. to provide complete identification
alleged that ‘‘[t]here is no legitimate Respondent’s founder and president is information prior to selling the products
therapeutic market for this type of Mr. James Vercellotti. to them and that its sales manager
product’’ at the type of stores Respondent previously held a DEA would verify the existence of each
Respondent ‘‘propose[s] to supply,’’ and Certificate of Registration to distribute business and its need for the products.
that Respondent would be ‘‘fueling the list I chemicals. The registration, Following the on-site inspection, DEA
diversion of precursor chemicals into however, expired on June 30, 2001. On was notified that the Food and Drug
the illicit manufacture of September 5, 2001, two DEA Diversion Administration (FDA) had conducted an
methamphetamine.’’ Id. at 3. The Show Investigators (DIs) conducted a inspection of Respondent’s facility.
Cause Order also alleged that in regulatory investigation at Respondent’s During the inspection, FDA found that
conducting verifications of Oakmont facility. On that date, Respondent had in its possession
Respondent’s proposed customers, DEA Respondent’s chief financial officer told approximately $13,500 worth of
investigators were unable to determine the DIs that Respondent had submitted products, which either contained
whether some of the proposed a renewal application. MaHuang Extract, a source of ephedrine
customers intended to buy ephedrine During the visit, William alkaloids, or claimed to when they did
products from it. Id. at 2. Charlesworth, Respondent’s vice not. Eight months earlier, FDA had
Finally, the Show Cause Order alleged president, informed the DIs that issued a final rule banning these
that in October 2004, the Food and Drug Respondent had previously purchased products on the ground that they are
Administration conducted an inspection bulk ephedrine powder and adulterated and present an unreasonable
of Respondent. Id. at 2. The Show Cause manufactured a combination ephedrine risk of illness or injury under section
Order alleged that during the product, Sci-Fit Ephedrine HCL, for 402(f)(1)(A) of the Federal Food, Drug,
inspection, FDA investigators found Asthma Relief. Respondent’s officials and Cosmetic Act (FDA Act), 21 U.S.C.
quantities of ephedra, a banned product. further maintained that they were under 342(f)(1)(A). See 69 FR 6788 (2004). The
The Show Cause Order, which also the assumption that their distributor’s FDA’s ban became effective on April 12,
informed Respondent of its right to a registration authorized them to engage 2004.
hearing, was served by certified mail, in manufacturing. The DIs subsequently According to the FDA, Respondent’s
return receipt requested. On February advised an official of Respondent that officials asserted that they intended to
13, 2006, Respondent received the Show while a manufacturer’s registration export the product. Respondent’s
Cause Order as evidenced by the signed authorizes its holder to distribute, a officials could not, however, provide the
return receipt card. Since that time, distributor’s registration does not documentation required to demonstrate
neither Respondent, nor anyone authorize its holder to manufacture. its compliance with section 801(e)(1) of
purporting to represent it, has On September 8, 2001, Mr. the FDA Act, 21 U.S.C. 381(e)(1). FDA
responded. Because (1) more than thirty Charlesworth telephoned one of the DIs officials also concluded that some of the
days have passed since Respondent’s and informed him that Respondent was products were mislabeled in violation of
receipt of the Show Cause Order, and (2) withdrawing its renewal application in federal law because they claimed to
no request for a hearing has been part because list I products comprised contain ingredients that were not
received, I conclude that Respondent less than one percent of its sales. actually present. On February 25, 2005,
has waived its right to a hearing. See 21 Respondent subsequently submitted a the U.S. Attorney’s Office for the
CFR 1309.53(c). I therefore enter this letter to DEA withdrawing its Western District of Pennsylvania filed a
final order without a hearing based on application. complaint for forfeiture of the products
relevant material found in the On May 5, 2004, Respondent and U.S. Marshals seized them.
investigative file and make the submitted a new application for a Subsequently, the FDA found that
following findings. registration to distribute ephedrine. On Respondent had in its possession
VerDate Aug<31>2005 15:35 Mar 05, 2007 Jkt 211001 PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 E:\FR\FM\06MRN1.SGM 06MRN1
Federal Register / Vol. 72, No. 43 / Tuesday, March 6, 2007 / Notices 9969
another product (Lipodrene), which also the risk of diversion by establishments DEPARTMENT OF JUSTICE
contained ephedrine alkaloids. On such as those which Respondent
January 12, 2006, the U.S. Attorney’s proposed to distribute its products to, Drug Enforcement Administration
Office filed an additional complaint the firm’s record of non-compliance
which sought the forfeiture of these with other federal laws does not inspire Georgia Convenience Wholesale, Inc.;
products. U.S. Marshalls seized these confidence in its willingness to Denial of Application
products, which were valued at faithfully obey DEA regulations. Here, On February 6, 2006, the Deputy
approximately $ 16,000. the investigative file establishes two Assistant Administrator, Office of
Discussion separate instances in which Respondent Diversion Control, Drug Enforcement
violated the FDA Act. Moreover, FDA Administration, issued an Order to
Under 21 U.S.C. 823(h), an applicant found these violations well after the rule Show Cause to Georgia Convenience
to distribute List I chemicals is entitled banning ephedrine alkaloids went into Wholesale, Inc., (Respondent) of
to be registered unless the registration effect. Doraville, Georgia. The Show Cause
would be ‘‘inconsistent with the public Order proposed to deny Respondent’s
interest.’’ In making this determination, In section 303(h) of the CSA, Congress
broadly directed that the Attorney pending application for a Certificate of
Congress directed that I consider the Registration to distribute list I chemicals
following factors: General consider ‘‘compliance by the
applicant with applicable Federal, State, on the ground that its registration
(1) Maintenance by the applicant of ‘‘would be inconsistent with the public
effective controls against diversion of and local law,’’ 21 U.S.C. 823(h)(2), in
determining whether to grant a list I interest.’’ Show Cause Order at 1 (citing
listed chemicals into other than 21 U.S.C. 823(h)).
legitimate channels; distributor’s registration. In contrast to
the provision applicable to a The Show Cause Order specifically
(2) Compliance by the applicant with alleged that on April 19, 2005,
applicable Federal, State, and local law; practitioner’s registration, Congress did
not limit the subject matter of the laws Respondent applied for a registration to
(3) Any prior conviction record of the distribute list I chemicals including
applicant under Federal or State laws that are properly considered in
determining whether an applicant’s pseudoephedrine, ephedrine and
relating to controlled substances or to phenylpropanolamine (PPA), and that
chemicals controlled under Federal or compliance record supports granting it
a registration. Cf. id. § 823(f)(4) these products ‘‘are commonly used to
State law; illegally manufacture
(4) Any past experience of the (directing consideration of a
practitioner’s ‘‘[c]ompliance with methamphetamine, a Schedule II
applicant in the manufacture and controlled substance.’’ Show Cause
distribution of chemicals; and applicable State, Federal, or local laws
relating to controlled substances’’). Order at 1–2. The Show Cause Order
(5) Such other factors as are relevant alleged that Respondent was proposing
to and consistent with the public health Moreover, Respondent’s apparent to distribute these products to
and safety. willingness to sell products which have convenience stores, and that ‘‘law
Id. been banned (as evidenced by the fact enforcement officials have observed that
‘‘These factors are considered in the that banned products were found not an overwhelming proportion of
disjunctive.’’ Joy’s Ideas, 70 FR 33195, once, but twice at its facility) and/or its precursors found at illicit
33197 (2005). I may rely on any one or inability to properly document its methamphetamine sites have involved
a combination of factors, and may give compliance with the FDA act (with non-traditional pseudoephedrine and
each factor the weight I deem respect to its assertion that it intended ephedrine brands sold through
appropriate in determining whether an to export the products found in the first convenience stores.’’ Id. at 2. The Show
application for registration should be incident), are sufficiently probative of Cause Order also alleged that as non-
denied. See, e.g., David M. Starr, 71 FR the manner in which it would likely traditional products ‘‘become more
39367 (2006); Energy Outlet, 64 FR fulfill its obligations as a registrant tightly regulated, even traditional
14269 (1999). Moreover, I am ‘‘not under the Controlled Substances Act.1 I products are subject to diversion.’’ Id.
required to make findings as to all of the thus conclude that granting it a The Show Cause Order further alleged
factors.’’ Hoxie v. DEA, 419 F.3d 477, registration would ‘‘be inconsistent with that during a pre-registration
482 (6th Cir. 2005); Morall v. DEA, 412 the public interest.’’ Id. § 823(h). investigation, Respondent’s owner/
F.3d 165, 173–74 (D.C. Cir. 2005). operator was not aware that PPA had
Here, I conclude that an analysis of been withdrawn from the over-the-
each factor is unnecessary and that Pursuant to the authority vested in me counter market. Id. Relatedly, the Show
Respondent’s application should be by 21 U.S.C. 823(h), and 28 CFR Cause Order alleged that Respondent
denied based on Factor Two, its record 0.100(b) & 0.104, I order that the had also sought registration for other list
of non-compliance with applicable application of Respondent ATF Fitness I chemicals even though these
laws. Products, Inc., for a DEA Certificate of chemicals ‘‘were not ingredients in any
As recognized in numerous final Registration as a distributor of list I over-the-counter drug product.’’ Id.
orders, the illicit manufacture and abuse chemicals be, and it hereby is, denied. Finally, the Show Cause Order alleged
of methamphetamine have had This order is effective April 5, 2007. that Respondent ‘‘does not have
pernicious effects on families and adequate experience or familiarity with
communities throughout the nation. Dated: February 23, 2007. products and the sales potentials in the
Preventing the diversion of list I Michele M. Leonhart, industry to carry out the responsibilities
chemicals into the illicit manufacture of of a registrant and prevent the diversion
methamphetamine is of critical [FR Doc. E7–3856 Filed 3–5–07; 8:45 am] of listed chemical precursors into illicit
importance in protecting the public BILLING CODE 4410–09–P activities.’’ Id. at 3.
from the devastation wreaked by this On or about February 24, 2006, the
drug. 1 The CSA imposes extensive recordkeeping Show Cause Order, which also notified
While the investigative file in this requirements on List I chemical distributors. See 21 Respondent of its right to request a
case contains no evidence establishing CFR Pt. 1310. hearing, was served by certified mail,
VerDate Aug<31>2005 15:35 Mar 05, 2007 Jkt 211001 PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 E:\FR\FM\06MRN1.SGM 06MRN1
Documents similaires à Notice: Registration revocations, restrictions, denials, reinstatements: ATF Fitness Products, Inc.
Prohibiting Medical Marijuana 12-01-2015
FDADueDiligenceForPharmaceuticals