Federal Register / Vol. 74, No. 81 / Wednesday, April 29, 2009 / Notices 19599 

Avenue, Rensselaer, New York 12144, 

made application by renewal to the 

Drug Enforcement Administration 

(DEA) as a bulk manufacturer of the 

basic classes of controlled substances 

listed in schedules I and II: 

Drug Schedule 

Marihuana (7360) ......................... I 

Tetrahydrocannabinols (7370) ..... I 

Amphetamine (1100) .................... II 

Lisdexamfetamine (1205) ............. II 

Methylphenidate (1724) ................ II 

Pentobarbital (2270) ..................... II 

Hydrocodone (9193) ..................... II 

Meperidine (9230) ........................ II 

Dextropropoxyphene, bulk (nondosage form) (9273).II 

Oxymorphone (9652) ................... II 

Fentanyl (9801) ............................ II 

The company plans to manufacture 

bulk controlled substances for use in 

product development and for 

distribution to its customers. 

In reference to drug code 7360 

(Marihuana), the company plans to bulk 

manufacture cannabidiol as a synthetic 

intermediate. This controlled substance 

will be further synthesized to bulk 

manufacture a synthetic THC (7370). No 

other activity for this drug code is 

authorized for this registration. 

Any other such applicant, and any 

person who is presently registered with 

DEA to manufacture such substances, 

may file comments or objections to the 

issuance of the proposed registration 

pursuant to 21 CFR 1301.33(a). 

Any such written comments or 

objections should be addressed, in 

quintuplicate, to the Drug Enforcement 

Administration, Office of Diversion 

Control, Federal Register Representative 

(ODL), 8701 Morrissette Drive, 

Springfield, Virginia 22152; and must be 

filed no later than June 29, 2009. 

Dated: April 17, 2009. 

Joseph T. Rannazzisi, 

Deputy Assistant Administrator, Office of 

Diversion Control, Drug Enforcement 

Administration. 

[FR Doc. E9–9799 Filed 4–28–09; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

Manufacturer of Controlled 

Substances; Notice of Application 

Pursuant to § 1301.33(a) of Title 21 of 

the Code of Federal Regulations (CFR), 

this is notice that on May 22, 2008, 

Norac Inc., 405 S. Motor Avenue, P.O. 

Box 577, Azusa, California 91702–3232, 

made application by letter to the Drug 

Enforcement Administration (DEA) to 

be registered as a bulk manufacturer of 

Methamphetamine (1105), a basic class 

of controlled substance listed in 

schedule II. 

The company plans to manufacture 

bulk controlled substances for use in 

product development and for 

distribution to its customers. 

Any other such applicant, and any 

person who is presently registered with 

DEA to manufacture such a substance, 

may file comments or objections to the 

issuance of the proposed registration 

pursuant to 21 CFR 1301.33(a). 

Any such written comments or 

objections should be addressed, in 

quintuplicate, to the Drug Enforcement 

Administration, Office of Diversion 

Control, Federal Register Representative 

(ODL), 8701 Morrissette Drive, 

Springfield, Virginia 22152; and must be 

filed no later than June 29, 2009. 

Dated: April 17, 2009. 

Joseph T. Rannazzisi, 

Deputy Assistant Administrator, Office of 

Diversion Control, Drug Enforcement 

Administration. 

[FR Doc. E9–9804 Filed 4–28–09; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

Manufacturer of Controlled 

Substances; Notice of Application 

Pursuant to § 1301.33(a) of Title 21 of 

the Code of Federal Regulations (CFR), 

this is notice that on February 20, 2009, 

Stepan Company, Natural Products 

Dept., 100 W. Hunter Avenue, 

Maywood, New Jersey 07607, made 

application by renewal to the Drug 

Enforcement Administration (DEA) as a 

bulk manufacturer of the basic classes of 

controlled substances listed in schedule 

II: 

Drug Schedule 

Cocaine (9041) ............................. II 

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

The company plans to manufacture 

the listed controlled substances in bulk 

for distribution to its customers. 

Any other such applicant, and any 

person who is presently registered with 

DEA to manufacture such substances, 

may file comments or objections to the 

issuance of the proposed registration 

pursuant to 21 CFR 1301.33(a). 

Any such written comments or 

objections being sent via regular mail 

should be addressed, in quintuplicate, 

to the Drug Enforcement 

Administration, Office of Diversion 

Control, Federal Register Representative 

(ODL), 8701 Morrissette Drive, 

Springfield, Virginia 22152; and must be 

filed no later than June 29, 2009. 

Dated: April 17, 2009. 

Joseph T. Rannazzisi, 

Deputy Assistant Administrator, Office of 

Diversion Control, Drug Enforcement 

Administration. 

[FR Doc. E9–9807 Filed 4–28–09; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

Bob’s Pharmacy and Diabetic 

Supplies; Revocation of Registration 

On August 15, 2008, I, the Deputy 

Administrator of the Drug Enforcement 

Administration, issued an Order to 

Show Cause and Immediate Suspension 

of Registration to Bob’s Pharmacy and 

Diabetic Supplies (Respondent), of 

Winter Haven, Florida. The Show Cause 

Order proposed the revocation of 

Respondent’s DEA Certificate of 

Registration, FB0181216, as a retail 

pharmacy, and the denial of any 

pending application to renew or modify 

its registration, on the ground that 

Respondent has committed acts which 

render its ‘‘continued registration 

inconsistent with the public interest.’’ 

Show Cause Order at 1 (citing 21 U.S.C. 

824(a)(4)). 

The Show Cause Order alleged that 

Respondent was ‘‘knowingly engaging 

in a scheme to distribute controlled 

substances based on * * * prescriptions 

that [were] issued for other than 

legitimate medical purpose and by 

physicians acting outside [of] the usual 

course of professional practice, in 

violation of * * * Federal and State 

law.’’ Id. (citing 21 CFR 1306.04; United 

Prescriptions Servs., Inc., 72 FR 50397 

(2007)). More specifically, the Show 

Cause Order alleged that Respondent 

was ‘‘dispensing controlled substances 

into states in which it is not licensed to 

do so,’’ and that it was ‘‘aiding 

physicians in the unauthorized practice 

of medicine in those states that require 

physicians to be licensed by the state 

before prescribing controlled substances 

to state residents.’’ Id. at 2 (citing 

United, 72 FR 50407–08). The Show 

Cause Order also alleged that 

Respondent had ‘‘dispensed large 

quantities of controlled substances 

based on prescriptions purportedly 

written by Sheila Soman, M.D., a 

physician who was not authorized by 

DEA to prescribe controlled 

substances.’’ Id. Based on the above, I 

further found that there was a 

‘‘substantial likelihood that [Respondent 


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19600 Federal Register / Vol. 74, No. 81 / Wednesday, April 29, 2009 / Notices 

1The Show Cause Order also informed 

Respondent of its right to request a hearing on the 

allegations; the date, time, and place of the 

hearings; its right to submit a written statement in 

lieu of a hearing; and the consequences if it failed 

to request a hearing. Show Cause Order at 2. 

would] continue to divert large 

quantities of controlled substances,’’ 

and concluded that Respondent’s 

continued registration during the 

pendency of the proceeding ‘‘would 

constitute an imminent danger to the 

public health and safety.’’ Id. I therefore 

ordered that Respondent’s registration 

be immediately suspended.1 Id. 

On August 20, 2008, a DEA 

Investigator personally served the Order 

on Respondent. Since that time neither 

Respondent, nor anyone purporting to 

represent it, has requested a hearing. 

Because more than thirty days have 

elapsed since Respondent was served 

with the Order, and Respondent has not 

requested a hearing, I conclude that 

Respondent has waived its right to a 

hearing. 21 CFR 1301.43(d). I therefore 

enter this Decision and Final Order 

based on relevant material contained in 

the investigative file and make the 

following findings. Id. 1301.43(e). 

Findings 

Respondent is the holder of DEA 

Certificate of Registration, FB0181216, 

which authorizes it to dispense, as a 

retail pharmacy, controlled substances 

in schedules II through V, at the 

registered location of 2860 Highway 17 

N., Winter Haven, Florida 33881. 

Respondent was first registered with the 

Agency on or about March 14, 2007; its 

registration does not expire until July 

31, 2009. Respondent is owned by Mr. 

Robert L. Grable. 

In August 2007, a DEA Investigator 

(DI) obtained a report which indicated 

that between April 15 and June 28, 

2007, Respondent had purchased 

767,900 dosage units of drugs 

containing hydrocodone, a controlled 

substance highly popular with drug 

abusers. Moreover, between June 28 and 

September 12, 2007, Respondent 

ordered a further 258,000 dosage units 

of hydrocodone from just one of its 

suppliers. Subsequent reports further 

showed that between April 25 and 

December 28, 2007, Respondent had 

purchased 2.3 million dosage units of 

drugs containing hydrocodone, or 

approximately 287,000 dosage units per 

month. By way of contrast, I have 

previously found that the national 

average purchase of combination 

hydrocodone drugs by retail pharmacies 

is approximately 6,000 dosage units. See 

Southwood Pharmaceuticals, Inc., 71 FR 

36487, 36490 (2007). 

On January 10, 2008, the DEA 

Nashville Diversion Group received a 

letter from the compliance officer for 

Top Rx, Inc., a registered distributor. 

The letter indicated that Respondent 

had applied to become a customer of 

Top Rx and had completed a 

questionnaire on which it indicated that 

it did not dispense controlled 

substances through the internet. Top 

Rx’s compliance office determined, 

however, that Respondent may have 

been affiliated with a Web site which 

provided illegal prescriptions for 

controlled substances. 

Approximately a week later, the DI 

received information from the New York 

Diversion Group that Respondent had 

ordered 700 grams of pure hydrocodone 

powder (a schedule II controlled 

substance) from another distributor. 

Finally, in a December 27, 2007 letter, 

a third distributor identified 

Respondent as having placed excessive 

orders. 

On June 27, 2008, two DIs visited 

Respondent. During the visit, the DIs 

obtained prescriptions which had been 

issued by two physicians (one based in 

Tampa, Florida; the other based in 

Deridder, Louisiana) which had been 

issued to persons throughout the United 

States, and which were dispensed by 

Respondent. Ninety-seven percent of the 

prescriptions were for schedule III 

controlled substances containing 

hydrocodone and were typically for 

ninety tablets; some of the remaining 

prescriptions were for alprazolam, a 

schedule IV controlled substance. 

On August 20, 2008, an 

Administrative Inspection Warrant was 

served on Respondent. Pursuant to the 

search, the DIs obtained numerous 

prescription records. According to the 

sworn declaration of a DI who reviewed 

the records, between May 3, 2007, and 

the date that the warrant was executed, 

Respondent had filled in excess of 

38,000 prescriptions for controlled 

substances, the great majority of which 

were for schedule III drugs containing 

hydrocodone. 

The DI found that Respondent had 

filled more than 6,000 prescriptions 

issued by Dr. Celeste Lujan, who was 

authorized to practice medicine and 

prescribe controlled substances only in 

Louisiana and Texas. According to the 

DI, most of the prescriptions were 

issued to persons who resided in States 

where Dr. Lujan was not authorized to 

practice medicine including Alaska, 

Alabama, Arkansas, Arizona, California, 

Colorado, Connecticut, Delaware, 

Florida, Georgia, Hawaii, Iowa, Idaho, 

Illinois, Indiana, Kansas, Massachusetts, 

Maryland, Maine, Michigan, Minnesota, 

Missouri, Mississippi, Montana, New 

Hampshire, New Jersey, New Mexico, 

New York, Ohio, Oklahoma, Oregon, 

Pennsylvania, Rhode Island, South 

Carolina, South Dakota, Utah, Virginia, 

Washington, Wisconsin, West Virginia, 

and Wyoming. 

The DI further found that between 

January 1 and August 18, 2008, 

Respondent filled more than 3,000 

prescriptions which were written under 

the DEA registration issued to Dr. Sheila 

Soman of New York, NY. Dr. Soman 

had, however, previously voluntarily 

surrendered her registration; on 

December 17, 2007, the Agency retired 

her registration. 

Discussion 

Section 304(a) of the Controlled 

Substance Act provides that ‘‘[a] 

registration * * * to * * * dispense a 

controlled substance * * * may be 

suspended or revoked by the Attorney 

General upon a finding that the 

registrant * * * has committed such 

acts as would render his registration 

under section 823 of this title 

inconsistent with the public interest as 

determined under such section.’’ 21 

U.S.C. 824(a). In determining the public 

interest, the Act directs that the 

Attorney General consider the following 

factors: 

(1) The recommendation of the appropriate 

State licensing board or professional 

disciplinary authority. 

(2) The applicant’s experience in 

dispensing * * * controlled substances. 

(3) The applicant’s conviction record under 

Federal or State laws relating to the 

manufacture, distribution, or dispensing of 

controlled substances. 

(4) Compliance with applicable State, 

Federal, or local laws relating to controlled 

substances. 

(5) Such other conduct which may threaten 

the public health and safety. 

Id. § 823(f). 

‘‘[T]hese factors are * * * considered 

in the disjunctive.’’ Robert A. Leslie, 

M.D., 68 FR 15227, 15230 (2003). I ‘‘may 

rely on any one or a combination of 

factors, and may give each factor the 

weight [I] deem[] appropriate in 

determining whether a registration 

should be revoked.’’ Id. Moreover, case 

law establishes that I am ‘‘not required 

to make findings as to all of the factors.’’ 

Hoxie v. DEA, 419 F.3d 477, 482 (6th 

Cir. 2005); see also Morall v. DEA, 412 

F.3d 165, 173–74 (D.C. Cir. 2005). 

Finally, where the Government has 

made out its prima facie case, the 

burden shifts to the Respondent to show 

why its continued registration would be 

consistent with the public interest. See, 

e.g., Theodore Neujahr, 65 FR 5680, 

5682 (2000); Service Pharmacy, Inc., 61 

FR 10791, 10795 (1996). 


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Federal Register / Vol. 74, No. 81 / Wednesday, April 29, 2009 / Notices 19601 

2The Supreme Court has recently explained that 

‘‘the prescription requirement * * * ensures 

patients use controlled substances under the 

supervision of a doctor so as to prevent addiction 

and recreational abuse. As a corollary, [it] also bars 

doctors from peddling to patients who crave the 

drugs for those prohibited uses.’’ Gonzales v. 

Oregon, 546 U.S. 243, 274 (2006) (citing United 

States v. Moore, 423 U.S. 122, 135 (1975)). 

3 In Hageseth, the California Court of Appeal 

upheld the State’s jurisdiction to criminally 

prosecute an out-of-state physician, who prescribed 

a drug to a California resident over the internet, for 

the unauthorized practice of medicine. 

Moreover, the Medical Board of California has 

issued numerous Citation Orders to out-of-state 

physicians for internet prescribing to state 

residents. See, e.g., Citation Order Harry Hoff (June 

17, 2003); Citation Order Carlos Gustavo Levy (Nov. 

30, 2001). It has also issued press releases 

announcing its position on the issuance of 

prescriptions by physicians who do not hold a 

California license. See Medical Board of California, 

Record Fines Issued by Medical Board to Physicians 

in Internet Prescribing Cases (News Release, Feb. 

10, 2003) (available at http://www.mbc.ca.gov/ 

NR_2003_02–10_Internetdrugs.htm). 

4 It is unclear whether the prescriptions issued 

under Dr. Soman’s expired registration were 

actually issued by her. What is clear is that no 

prescription could be lawfully issued (or filled) 

under her registration number. 

In this case, having considered all of 

the factors, I conclude that the 

Government’s evidence with respect to 

factors two and four establishes a prima 

facie case that Respondent’s continued 

registration is ‘‘inconsistent with the 

public interest.’’ 21 U.S.C. 823(f). 

Accordingly, Respondent’s registration 

will be revoked and any pending 

applications for renewal of its 

registration will be denied. 

Factor Two—Respondent’s Experience 

in Dispensing Controlled Substances 

Under DEA’s regulation, a 

prescription for a controlled substance 

is unlawful unless it has been ‘‘issued 

for a legitimate medical purpose by an 

individual practitioner acting in the 

usual course of his professional 

practice.’’ 21 CFR 1306.04(a). The 

regulation further provides that while 

‘‘[t]he responsibility for the proper 

prescribing and dispensing of controlled 

substances is upon the prescribing 

practitioner, * * * a corresponding 

responsibility rests with the pharmacist 

who fills the prescription.’’ Id. 

(emphasis added). Continuing, the 

regulation states that ‘‘the person 

knowingly filling such a purported 

prescription, as well as the person 

issuing it, [is] subject to the penalties 

provided for violations of the provisions 

of law relating to controlled 

substances.’’ Id. 

DEA has long interpreted this 

provision ‘‘as prohibiting a pharmacist 

from filling a prescription for a 

controlled substance when he either 

‘knows or has reason to know that the 

prescription was not written for a 

legitimate medical purpose.’ ’’ Medicine 

Shoppe-Jonesborough, 73 FR 363, 381 

(2008) (quoting Medic-Aid Pharmacy, 55 

FR 30043, 30044 (1990)), aff’d Medicine 

Shoppe-Jonesborough v. DEA, 2008 WL 

4899525 (6th Cir. 2008); see also Frank’s 

Corner Pharmacy, 60 FR 17574, 17576 

(1995); Ralph J. Bertolino, 55 FR 4729, 

4730 (1990); United States v. Seelig, 622 

F.2d 207, 213 (6th Cir. 1980). This 

Agency has further held that ‘‘[w]hen 

prescriptions are clearly not issued for 

legitimate medical purposes, a 

pharmacist may not intentionally close 

his eyes and thereby avoid [actual] 

knowledge of the real purpose of the 

prescription.’’ Bertolino, 55 FR at 4730 

(citations omitted).2

In United Prescription Services, Inc., 

I further held that ‘‘[a] physician who 

engages in the unauthorized practice of 

medicine is not a ‘practitioner acting in 

the usual course of * * * professional 

practice.’ ’’ 21 CFR 1306.04(a). This rule 

derives from the text of the CSA, which 

defines ‘‘[t]he term ‘practitioner’ [to] 

mean[ ] a physician * * * licensed, 

registered, or otherwise permitted, by 

the United States or the jurisdiction in 

which he practices * * * to * * * 

dispense * * * a controlled substance.’’ 

21 U.S.C. 802(21). See also 21 U.S.C. 

823(f) (‘‘The Attorney General shall 

register practitioners * * * to dispense 

* * * if the applicant is authorized to 

dispense * * * controlled substances 

under the laws of the State in which he 

practices.’’). As the Supreme Court has 

explained: ‘‘In the case of a physician 

[the CSA] contemplates that he is 

authorized by the State to practice 

medicine and to dispense drugs in 

connection with his professional 

practice.’’ United States v. Moore, 423 

U.S. 122, 140–41 (1975) (emphasis 

added). A controlled-substance 

prescription issued by a physician who 

lacks the license necessary to practice 

medicine within a State is therefore 

unlawful under the CSA. Cf. 21 CFR 

1306.03(a)(1) (‘‘A prescription for a 

controlled substance may be issued only 

by an individual practitioner who is 

* * * [a]uthorized to prescribe 

controlled substances by the jurisdiction 

in which he is licensed to practice his 

profession[.]’’). 

Respondent had ample reason to 

know that the prescriptions issued by 

Dr. Lujan were unlawful under both 

Federal and state law. As the California 

Court of Appeal has noted: The 

‘‘proscription of the unlicensed practice 

of medicine is neither an obscure nor an 

unusual state prohibition of which 

ignorance can reasonably be claimed, 

and certainly not by persons * * * who 

are licensed health care providers. Nor 

can such persons reasonably claim 

ignorance of the fact that authorization 

of a prescription pharmaceutical 

constitutes the practice of medicine.’’ 

Hageseth v. Superior Court, 59 Cal. 

Rptr. 3d 385, 403 (Ct. App. 2007); 3 see 

Cal. Bus. & Prof. Code § 2052 

(prohibiting unlicensed practice of 

medicine); Cal. Health & Safety Code 

§ 11352(a) (prohibiting furnishing a 

controlled substance ‘‘unless upon the 

written prescription of a physician 

* * * licensed to practice in this 

state’’). See also e.g., Ala. Code § 34–24– 

501(a) (defining practice of medicine 

across state lines); id. § 34–24–502(a) 

(requiring special purpose license to 

practice medicine across state lines); Ga. 

Code Ann. § 43–34.31.1(a) (defining 

practice of medicine to include 

electronic prescribing by ‘‘[a] person 

who is physically located in another 

state’’ and requiring Georgia license); 

225 Ill. Comp. Stat. Ann. § 60/3 

(licensure requirement); id. § 60/3.5 

(prohibiting unlicensed practice); id. 

§ 60/49 (listing acts constituting holding 

oneself out to the public as a physician); 

id. § 60/49.5 (requiring persons engaged 

in telemedicine to hold Illinois license); 

N.H. Rev. Stat. § 329:1 (defining practice 

of medicine); id. § 329:24 (unlicensed 

practice). 

As I have previously explained, an 

entity which voluntary engages in 

commerce by shipping controlled 

substances to persons located in other 

States is properly charged with 

knowledge of the laws regarding both 

the practice of medicine and pharmacy 

in those States. United, 72 FR at 50408. 

In short, given that Dr. Lujan was 

licensed to practice medicine and 

prescribe in only Louisiana and Texas, 

and yet was prescribing to persons who 

did not reside in those States and lived 

hundreds of—and in many instances 

more than a thousand—miles away, 

Respondent had ample reason to know 

that the prescriptions were unlawful 

under both the CSA and the laws of 

numerous States. See id. at 50409. 

Moreover, under DEA regulations, a 

prescription for a controlled substance 

can be issued only by a practitioner who 

holds a registration with the Agency. 21 

CFR 1306.03(a) (‘‘A prescription for a 

controlled substance may be issued only 

by an individual practitioner who is 

* * * registered.’’).4 Respondent thus 

also violated the CSA when it filled 

more than 3,000 prescriptions which 

were purportedly issued by Dr. Soman, 

a physician who had previously 

voluntarily surrendered her registration. 


pwalker on PROD1PC71 with NOTICES
19602 Federal Register / Vol. 74, No. 81 / Wednesday, April 29, 2009 / Notices 

As the foregoing demonstrates, 

Respondent’s experience in dispensing 

controlled substances is characterized 

by its repeated and flagrant violations of 

the CSA and state laws. Indeed, within 

less than one month of obtaining its 

registration, Respondent proceeded to 

purchase hundreds of thousands of 

dosage units of hydrocodone, quantities 

which exceeded by nearly fifty times the 

average purchase of this drug by 

legitimate pharmacies. As this evidence 

shows, Respondent was engaged in a 

criminal scheme to divert controlled 

substances. 

I therefore hold that Respondent’s 

continued registration is ‘‘inconsistent 

with the public interest’’ and that its 

registration should be revoked. 21 

U.S.C. 823(f). For the same reasons that 

I ordered the immediate suspension of 

Respondent’s registration, I further hold 

that this Order shall be effective 

immediately. 

Order 

Pursuant to the authority vested in me 

by 21 U.S.C. 823(f) & 824(a), as well as 

28 CFR 0.100(b) & 0.104, I hereby order 

that DEA Certificate of Registration, 

FB0181216, issued to Bob’s Pharmacy 

and Diabetic Supplies be, and it hereby 

is, revoked. I further order that any 

pending applications for renewal or 

modification of such registration be, and 

they hereby are, denied. This Order is 

effective immediately. 

Dated: April 3, 2009. 

Michele M. Leonhart, 

Deputy Administrator. 

[FR Doc. E9–9797 Filed 4–28–09; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF LABOR 

Employment and Training 

Administration Submission for OMB 

Emergency Review: Revision of OMB 

Control No. 1205–0342, Petition and 

Investigative Forms To Assess Group 

Eligibility for Trade Adjustment 

Assistance, Comment Request 

April 24, 2009. 

The Department of Labor (DOL) has 

submitted the following information 

collection request (ICR), utilizing the 

Paperwork Reduction Act (PRA) 

emergency review procedures, to the 

Office of Management and Budget 

(OMB) for review and clearance in 

accordance with the Paperwork 

Reduction Act of 1995 (Pub. L. 104–13, 

44 U.S.C. Chapter 35) and 5 CFR 

1320.13. OMB approval is requested by 

May 6, 2009. A copy of this ICR, with 

applicable supporting documentation; 

including among other things a 

description of the likely respondents, 

proposed frequency of response, and 

estimated total burden may be obtained 

from the RegInfo.gov Web site at 

http://www.reginfo.gov/public/do/ 

PRAMain or by contacting Darrin King 

on 202–693–4129 (this is not a toll-free 

number)/e-mail: 

DOL_PRA_PUBLIC@dol.gov. Interested 

parties are encouraged to send 

comments to the Office of Information 

and Regulatory Affairs, Attn: OMB Desk 

Officer for the Department of Labor— 

ETA, Office of Management and Budget, 

Room 10235, Washington, DC 20503, 

Telephone: 202–395–7316/Fax: 202– 

395–6974 (these are not toll-free 

numbers), E-mail: 

OIRA_submission@omb.eop.gov. 

Comments and questions about the ICR 

listed below should be received by no 

later than the requested OMB approval 

date. An additional opportunity to 

comment on this ICR will also be 

provided when DOL seeks approval 

under standard PRA clearance 

procedures. 

The OMB is particularly interested in 

comments which: 

• Evaluate whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information will have 

practical utility; 

• Evaluate the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information, 

including the validity of the 

methodology and assumptions used; 

• Enhance the quality, utility, and 

clarity of the information to be 

collected; and 

• Minimize the burden of the 

collection of information on those who 

are to respond, including through the 

use of appropriate automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology, 

e.g., permitting electronic submissions 

of responses. 

Agency: Employment and Training 

Administration. 

Title of Collection: Investigative Data 

Collection Requirements for the Trade 

Act of 1974 as amended by the Trade 

and Globalization Adjustment 

Assistance Act of 2009. 

OMB Control Number: 1205–0342. 

Affected Public: Individuals or 

Households; Businesses or other forprofits; and State, Local or Tribal 

Governments. 

Total Estimated Annual Burden 

Hours: 18,642. 

Total Estimated Annual Costs Burden 

(excluding hourly wage costs: $0. 

Description: On February 17, 2009, 

the President signed into law the 

American Recovery and Reinvestment 

Act (ARRA). Section 221 (a) of Title II, 

Chapter 2 of the Trade Act of 1974, as 

amended by ARRA (19 U.S.C. 2271), 

authorizes the Secretary of Labor and 

the Governor of each State to accept 

petitions for certification of eligibility to 

apply for adjustment assistance. ARRA 

amended Section 222 of the Trade Act 

of 1974 to provide for new eligibility 

criteria designed to expand the number 

of petitioning worker groups assessed as 

adversely affected by trade and therefore 

determined eligible to apply for Trade 

Adjustment Assistance. To solicit the 

data needed to address the new 

eligibility criteria, ETA is significantly 

expanding the petition and investigation 

forms currently approved under OMB 

No. 1205–0342. 

The Forms ETA–9042 Petition for 

Trade Adjustment Assistance and its 

Spanish translation, and ETA–9042a 

Solicitud De Asistencia Para Ajuste, 

establish a format that may be used for 

filing such petitions. The Department’s 

regulations regarding petitions for 

worker adjustment assistance may be 

found at 29 CFR 90. Investigative forms 

designed to assess eligibility are 

undertaken in accordance with §§ 222, 

223 and 249 of the Trade Act of 1974, 

as amended (19 U.S.C., 2272 and 2273), 

are used by the Secretary of Labor to 

certify groups of workers as eligible to 

apply for worker trade adjustment 

assistance. The Forms include: ETA– 

9043a—Business Confidential Data 

Request Firms that Produce an Article 

(CDR–A); ETA–9043b—Business 

Confidential Data Request Firms that 

Supply a Service (CDR–S); ETA– 

9043c—Business Confidential Data 

Request Firms Who Work on a 

Contractual Basis; ETA–8562a— 

Business Confidential Customer Survey; 

ETA–8562a—Business Confidential 

Customer Survey; ETA–8562a— 

Business Confidential Customer Survey 

First Tier Purchases of Articles; ETA– 

8562a-1—Business Confidential 

Customer Survey Second Tier Purchases 

of Articles; ETA–8562b—Business 

Confidential Customer Survey Services; 

ETA–8562c—Business Confidential 

Customer Survey Firms who Work on a 

Contractual Basis; ETA–8562d— 

Business Confidential Customer Survey; 

and ETA–9118—Business Confidential 

Information Request. 

Why are we requesting Emergency 

Processing? This collection is submitted 

on an emergency clearance basis 

because ARRA (Section 1891) mandates 

the implementation of the new criteria 

listed in Section 222 of the Trade Act 


pwalker on PROD1PC71 with NOTICES