910 Federal Register / Vol. 74, No. 6 / Friday, January 9, 2009 / Notices 

SUPPLEMENTARY INFORMATION: 

I. Background 

In recent years, many important 

initiatives have been undertaken by 

regulatory authorities and industry 

associations to promote international 

harmonization of regulatory 

requirements. FDA has participated in 

many meetings designed to enhance 

harmonization and is committed to 

seeking scientifically based harmonized 

technical procedures for pharmaceutical 

development. One of the goals of 

harmonization is to identify and then 

reduce differences in technical 

requirements for drug development 

among regulatory agencies. 

ICH was organized to provide an 

opportunity for tripartite harmonization 

initiatives to be developed with input 

from both regulatory and industry 

representatives. FDA also seeks input 

from consumer representatives and 

others. ICH is concerned with 

harmonization of technical 

requirements for the registration of 

pharmaceutical products among three 

regions: The European Union, Japan, 

and the United States. The six ICH 

sponsors are the European Commission; 

the European Federation of 

Pharmaceutical Industries Associations; 

the Japanese Ministry of Health, Labour, 

and Welfare; the Japanese 

Pharmaceutical Manufacturers 

Association; the Centers for Drug 

Evaluation and Research and Biologics 

Evaluation and Research, FDA; and the 

Pharmaceutical Research and 

Manufacturers of America. The ICH 

Secretariat, which coordinates the 

preparation of documentation, is 

provided by the International 

Federation of Pharmaceutical 

Manufacturers Associations (IFPMA). 

The ICH Steering Committee includes 

representatives from each of the ICH 

sponsors and the IFPMA, as well as 

observers from the World Health 

Organization, Health Canada, and the 

European Free Trade Area. 

In the Federal Register of December 

17, 2007 (72 FR 71416), FDA published 

a notice announcing the availability of 

a draft tripartite guidance entitled ‘‘Q4B 

Evaluation and Recommendation of 

Pharmacopoeial Texts for Use in the 

ICH Regions; Annex 3: Test for 

Particulate Contamination: Subvisible 

Particles General Chapter.’’ The notice 

gave interested persons an opportunity 

to submit comments by February 15, 

2008. 

After consideration of the comments 

received and revisions to the guidance, 

a final draft guidance entitled ‘‘Q4B 

Evaluation and Recommendation of 

Pharmacopoeial Texts for Use in the 

ICH Regions; Annex 3: Test for 

Particulate Contamination: Subvisible 

Particles General Chapter’’ was 

submitted to the ICH Steering 

Committee and endorsed by the three 

participating regulatory agencies in June 

2008. 

The guidance provides the specific 

evaluation outcome from the ICH Q4B 

process for the Test for Particulate 

Contamination: Subvisible Particles 

General Chapter harmonization 

proposal originating from the threeparty PDG. This guidance is in the form 

of an annex to the core ICH Q4B 

guidance. When implemented, the 

annex will provide guidance for 

industry and regulators on the use of the 

specific pharmacopoeial texts evaluated 

by the ICH Q4B process. Following 

receipt of comments on the draft, no 

substantive changes were made to the 

annex. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the agency’s 

current thinking on this topic. It does 

not create or confer any rights for or on 

any person and does not operate to bind 

FDA or the public. An alternative 

approach may be used if such approach 

satisfies the requirements of the 

applicable statutes and regulations. 

II. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper copy. 

Comments are to be identified with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

Please note that on January 15, 2008, 

the FDA Division of Dockets 

Management Web site transitioned to 

the Federal Dockets Management 

System (FDMS). FDMS is a 

Government-wide, electronic docket 

management system. Electronic 

comments or submissions will be 

accepted by FDA only through FDMS at 

http://www.regulations.gov. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the document at http:// 

www.regulations.gov, http:// 

www.fda.gov/cder/guidance/index.htm, 

or http://www.fda.gov/cber/ 

guidelines.htm. 

Dated: December 30, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–214 Filed 1–8–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration 

Current List of Laboratories Which 

Meet Minimum Standards To Engage in 

Urine Drug Testing for Federal 

Agencies 

AGENCY: Substance Abuse and Mental 

Health Services Administration, HHS. 

ACTION: Notice. 

SUMMARY: The Department of Health and 

Human Services (HHS) notifies Federal 

agencies of the laboratories currently 

certified to meet the standards of 

Subpart C of the Mandatory Guidelines 

for Federal Workplace Drug Testing 

Programs (Mandatory Guidelines). The 

Mandatory Guidelines were first 

published in the Federal Register on 

April 11, 1988 (53 FR 11970), and 

subsequently revised in the Federal 

Register on June 9, 1994 (59 FR 29908), 

on September 30, 1997 (62 FR 51118), 

and on April 13, 2004 (69 FR 19644). 

A notice listing all currently certified 

laboratories is published in the Federal 

Register during the first week of each 

month. If any laboratory’s certification 

is suspended or revoked, the laboratory 

will be omitted from subsequent lists 

until such time as it is restored to full 

certification under the Mandatory 

Guidelines. 

If any laboratory has withdrawn from 

the HHS National Laboratory 

Certification Program (NLCP) during the 

past month, it will be listed at the end, 

and will be omitted from the monthly 

listing thereafter. 

This notice is also available on the 

Internet at http:// 

www.workplace.samhsa.gov and http:// 

www.drugfreeworkplace.gov. 

FOR FURTHER INFORMATION CONTACT: Mrs. 

Giselle Hersh, Division of Workplace 

Programs, SAMHSA/CSAP, Room 2– 

1042, One Choke Cherry Road, 

Rockville, Maryland 20857; 240–276– 

2600 (voice), 240–276–2610 (fax). 

SUPPLEMENTARY INFORMATION: The 

Mandatory Guidelines were developed 

in accordance with Executive Order 

12564 and section 503 of Public Law 

100–71. Subpart C of the Mandatory 

Guidelines, ‘‘Certification of 

Laboratories Engaged in Urine Drug 

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Federal Register / Vol. 74, No. 6 / Friday, January 9, 2009 / Notices 911 

Testing for Federal Agencies,’’ sets strict 

standards that laboratories must meet in 

order to conduct drug and specimen 

validity tests on urine specimens for 

Federal agencies. To become certified, 

an applicant laboratory must undergo 

three rounds of performance testing plus 

an on-site inspection. To maintain that 

certification, a laboratory must 

participate in a quarterly performance 

testing program plus undergo periodic, 

on-site inspections. 

Laboratories which claim to be in the 

applicant stage of certification are not to 

be considered as meeting the minimum 

requirements described in the HHS 

Mandatory Guidelines. A laboratory 

must have its letter of certification from 

HHS/SAMHSA (formerly: HHS/NIDA) 

which attests that it has met minimum 

standards. 

In accordance with Subpart C of the 

Mandatory Guidelines dated April 13, 

2004 (69 FR 19644), the following 

laboratories meet the minimum 

standards to conduct drug and specimen 

validity tests on urine specimens: 

ACL Laboratories, 8901 W. Lincoln 

Ave., West Allis, WI 53227, 414–328– 

7840 / 800–877–7016. (Formerly: 

Bayshore Clinical Laboratory) 

ACM Medical Laboratory, Inc., 160 

Elmgrove Park, Rochester, NY 14624, 

585–429–2264. 

Advanced Toxicology Network, 3560 

Air Center Cove, Suite 101, Memphis, 

TN 38118, 901–794–5770 / 888–290– 

1150. 

Aegis Sciences Corporation, 345 Hill 

Ave., Nashville, TN 37210, 615–255– 

2400, (Formerly: Aegis Analytical 

Laboratories, Inc.). 

Baptist Medical Center-Toxicology 

Laboratory, 9601 I–630, Exit 7, Little 

Rock, AR 72205–7299, 501–202–2783, 

(Formerly: Forensic Toxicology 

Laboratory Baptist Medical Center). 

Clinical Reference Lab, 8433 Quivira 

Road, Lenexa, KS 66215–2802, 800– 

445–6917. 

Diagnostic Services, Inc., dba DSI, 

12700 Westlinks Drive, Fort Myers, 

FL 33913, 239–561–8200 / 800–735– 

5416. 

Doctors Laboratory, Inc., 2906 Julia 

Drive, Valdosta, GA 31602, 229–671– 

2281. 

DrugScan, Inc., P.O. Box 2969, 1119 

Mearns Road, Warminster, PA 18974, 

215–674–9310. 

DynaLIFE Dx *, 10150–102 St., Suite 

200, Edmonton, Alberta, Canada T5J 

5E2, 780–451–3702/800–661–9876, 

(Formerly: Dynacare Kasper Medical 

Laboratories). 

ElSohly Laboratories, Inc., 5 Industrial 

Park Drive, Oxford, MS 38655, 662– 

236–2609. 

Gamma-Dynacare Medical 

Laboratories*, A Division of the 

Gamma-Dynacare Laboratory 

Partnership, 245 Pall Mall Street, 

London, ONT, Canada N6A 1P4, 519– 

679–1630. 

Kroll Laboratory Specialists, Inc., 1111 

Newton St., Gretna, LA 70053, 504– 

361–8989/800–433–3823. (Formerly: 

Laboratory Specialists, Inc.) 

Kroll Laboratory Specialists, Inc., 450 

Southlake Blvd., Richmond, VA 

23236, 804–378–9130 (Formerly: 

Scientific Testing Laboratories, Inc.; 

Kroll Scientific Testing Laboratories, 

Inc.). 

Laboratory Corporation of America 

Holdings, 7207 N. Gessner Road, 

Houston, TX 77040, 713–856–8288/ 

800–800–2387. 

Laboratory Corporation of America 

Holdings, 69 First Ave., Raritan, NJ 

08869, 908–526–2400/800–437–4986 

(Formerly: Roche Biomedical 

Laboratories, Inc.). 

Laboratory Corporation of America 

Holdings, 1904 Alexander Drive, 

Research Triangle Park, NC 27709, 

919–572–6900/800–833–3984 

(Formerly: LabCorp Occupational 

Testing Services, Inc., CompuChem 

Laboratories, Inc.; CompuChem 

Laboratories, Inc., A Subsidiary of 

Roche Biomedical Laboratory; Roche 

CompuChem Laboratories, Inc. A 

Member of the Roche Group). 

Laboratory Corporation of America 

Holdings, 1120 Main Street, 

Southaven, MS 38671, 866–827–8042/ 

800–233–6339 (Formerly: LabCorp 

Occupational Testing Services, Inc.; 

MedExpress/National Laboratory 

Center). 

LabOne, Inc. d/b/a Quest Diagnostics, 

10101 Renner Blvd., Lenexa, KS 

66219, 913–888–3927/800–873–8845 

(Formerly: Quest Diagnostics 

Incorporated; LabOne, Inc.; Center for 

Laboratory Services, a Division of 

LabOne, Inc.). 

Maxxam Analytics*, 6740 Campobello 

Road, Mississauga, ON, Canada L5N 

2L8, 905–817–5700 (Formerly: 

Maxxam Analytics Inc., NOVAMANN 

(Ontario), Inc.). 

MedTox Laboratories, Inc., 402 W. 

County Road D, St. Paul, MN 55112, 

651–636–7466/800–832–3244. 

MetroLab-Legacy Laboratory Services, 

1225 NE 2nd Ave., Portland, OR 

97232, 503–413–5295/800–950–5295. 

Minneapolis Veterans Affairs Medical 

Center, Forensic Toxicology 

Laboratory, 1 Veterans Drive, 

Minneapolis, MN 55417, 612–725– 

2088. 

National Toxicology Laboratories, Inc., 

1100 California Ave., Bakersfield, CA 

93304, 661–322–4250/800–350–3515. 

One Source Toxicology Laboratory, Inc., 

1213 Genoa-Red Bluff, Pasadena, TX 

77504, 888–747–3774 (Formerly: 

University of Texas Medical Branch, 

Clinical Chemistry Division; UTMB 

Pathology-Toxicology Laboratory). 

Pacific Toxicology Laboratories, 9348 

DeSoto Ave., Chatsworth, CA 91311, 

800–328–6942 (Formerly: Centinela 

Hospital Airport Toxicology 

Laboratory). 

Pathology Associates Medical 

Laboratories, 110 West Cliff Dr., 

Spokane, WA 99204, 509–755–8991/ 

800–541–7891 x7. 

Phamatech, Inc., 10151 Barnes Canyon 

Road, San Diego, CA 92121, 858–643– 

5555. 

Quest Diagnostics Incorporated, 3175 

Presidential Dr., Atlanta, GA 30340, 

770–452–1590/800–729–6432 

(Formerly: SmithKline Beecham 

Clinical Laboratories; SmithKline BioScience Laboratories). 

Quest Diagnostics Incorporated, 400 

Egypt Road, Norristown, PA 19403, 

610–631–4600/877–642–2216 

(Formerly: SmithKline Beecham 

Clinical Laboratories; SmithKline BioScience Laboratories). 

Quest Diagnostics Incorporated, 7600 

Tyrone Ave., Van Nuys, CA 91405, 

866–370–6699/818–989–2521 

(Formerly: SmithKline Beecham 

Clinical Laboratories). 

S.E.D. Medical Laboratories, 5601 Office 

Blvd., Albuquerque, NM 87109, 505– 

727–6300/800–999–5227. 

South Bend Medical Foundation, Inc., 

530 N. Lafayette Blvd., South Bend, 

IN 46601, 574–234–4176 x276. 

Southwest Laboratories, 4645 E. Cotton 

Center Boulevard, Suite 177, Phoenix, 

AZ 85040, 602–438–8507/800–279– 

0027. 

Sparrow Health System, Toxicology 

Testing Center, St. Lawrence Campus, 

1210 W. Saginaw, Lansing, MI 48915, 

517–364–7400 (Formerly: St. 

Lawrence Hospital & Healthcare 

System). 

St. Anthony Hospital Toxicology 

Laboratory, 1000 N. Lee St., 

Oklahoma City, OK 73101, 405–272– 

7052. 

Toxicology & Drug Monitoring 

Laboratory, University of Missouri 

Hospital & Clinics, 301 Business Loop 

70 West, Suite 208, Columbia, MO 

65203, 573–882–1273. 

Toxicology Testing Service, Inc., 5426 

N.W. 79th Ave., Miami, FL 33166, 

305–593–2260. 

U.S. Army Forensic Toxicology Drug 

Testing Laboratory, 2490 Wilson St., 

Fort George G. Meade, MD 20755– 

5235, 301–677–7085. 

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912 Federal Register / Vol. 74, No. 6 / Friday, January 9, 2009 / Notices 

The following laboratory will be 

voluntarily withdrawing from the NLCP 

on January 9, 2009: 

Oregon Medical Laboratories, 123 

International Way, Springfield, OR 

97477, 541–341–8092. 

*The Standards Council of Canada 

(SCC) voted to end its Laboratory 

Accreditation Program for Substance 

Abuse (LAPSA) effective May 12, 1998. 

Laboratories certified through that 

program were accredited to conduct 

forensic urine drug testing as required 

by U.S. Department of Transportation 

(DOT) regulations. As of that date, the 

certification of those accredited 

Canadian laboratories will continue 

under DOT authority. The responsibility 

for conducting quarterly performance 

testing plus periodic on-site inspections 

of those LAPSA-accredited laboratories 

was transferred to the U.S. HHS, with 

the HHS’ NLCP contractor continuing to 

have an active role in the performance 

testing and laboratory inspection 

processes. Other Canadian laboratories 

wishing to be considered for the NLCP 

may apply directly to the NLCP 

contractor just as U.S. laboratories do. 

Upon finding a Canadian laboratory to 

be qualified, HHS will recommend that 

DOT certify the laboratory (Federal 

Register, July 16, 1996) as meeting the 

minimum standards of the Mandatory 

Guidelines published in the Federal 

Register on April 13, 2004 (69 FR 

19644). After receiving DOT 

certification, the laboratory will be 

included in the monthly list of HHScertified laboratories and participate in 

the NLCP certification maintenance 

program. 

Elaine Parry, 

Acting Director, Office of Program Services, 

SAMHSA. 

[FR Doc. E9–176 Filed 1–8–09; 8:45 am] 

BILLING CODE 4160–20–P 

DEPARTMENT OF HOMELAND 

SECURITY 

U.S. Citizenship and Immigration 

Services 

[CIS No. 2462–08; DHS Docket No. USCIS– 

2008–0076] 

RIN 1615–ZA80 

Change in Filing Location for EB–5- 

Related Petitions and Applications and 

Regional Center Proposals 

AGENCY: U.S. Citizenship and 

Immigration Services, DHS. 

ACTION: Notice. 

SUMMARY: This Notice announces the 

requirement that petitions and 

applications related to the Alien 

Entrepreneur (EB–5) immigrant 

classification, and Regional Center 

Proposals under the EB–5 Immigrant 

Investor Pilot Program, must be filed at 

the California Service Center (CSC). 

Currently, EB–5-related petitions and 

applications are filed at either the Texas 

Service Center (TSC) or the CSC, 

depending on where the alien’s 

commercial enterprise is located. 

Regional center proposals are being 

submitted to the Chief of USCIS Service 

Centers at USCIS Headquarters. The 

change to one filing location for EB–5- 

related petitions, applications, and 

regional center proposals announced by 

this Notice is necessary to improve the 

efficiency in the processing of EB–5- 

related filings. 

DATES: This Notice is effective January 

26, 2009 for the filing of Forms I–526, 

I–829, and Forms I–485 based on an 

approved Form I–526. This Notice is 

effective January 26, 2009 for the filing 

of Regional Center Proposals under the 

Immigrant Investor Pilot Program. 

FOR FURTHER INFORMATION CONTACT: 

Joseph P. Whalen, Adjudications 

Officer, Service Center Operations, EB– 

5 Investor Program, U.S. Citizenship 

and Immigration Services, Department 

of Homeland Security, 20 Massachusetts 

Avenue, NW., Washington, DC 20529– 

2060, telephone (202) 272–8355. 

SUPPLEMENTARY INFORMATION: 

I. Background 

A. EB–5 Immigrant Classification 

The employment creation immigrant 

classification (referred to as the 

‘‘Employment Based (EB–5)’’ immigrant 

classification) allows qualifying aliens, 

and any accompanying spouses and 

children, to obtain lawful permanent 

resident (LPR) status if the qualifying 

aliens have invested, or are actively in 

the process of investing, $1 million in 

a new commercial enterprise. See 

Immigration and Nationality Act (INA) 

secs. 203(b)(5)(A) and (C), 8 U.S.C. 

1153(b)(5)(A) and (C). Their investment 

must benefit the U.S. economy and 

create full-time jobs for 10 or more 

qualifying employees. INA sec. 

203(b)(5)(A)(ii), 8 U.S.C. 

1153(B)(5)(A)(ii). If the investment is in 

a rural area or an area that has 

experienced high unemployment 

(referred to as ‘‘Targeted Employment 

Area’’), the required capital investment 

amount is $500,000 rather than $1 

million. INA sec. 203(b)(5)(C)(ii), 8 

U.S.C. 1153(b)(5)(C)(ii); 8 CFR 

204.6(f)(2). Also, under the Immigrant 

Investor Pilot Program, qualifying aliens 

may meet the job creation requirement 

through the creation of 10 indirect jobs. 

See Departments of Commerce, Justice, 

and State, the Judiciary, and Related 

Agencies Appropriations Act, 1993, sec. 

610(c), Public Law 102–395, 106 Stat. 

1874 (1992), 8 U.S.C. 1153 note. To 

qualify for the relaxed job creation 

requirement, an alien must invest in a 

new commercial enterprise that is 

located in a geographical region of the 

United States covered by a ‘‘regional 

center’’ (defined in 8 CFR 204.6(e)) 

approved by USCIS for participation in 

the pilot program. This pilot program is 

set to expire on March 6, 2009. See 

Consolidated Security, Disaster 

Assistance, and Continuing 

Appropriations Act, 2009, Div. A, sec. 

144, Public Law 110–329, 122 Stat. 

3574, 3581 (2008). USCIS approves a 

regional center based on the submission 

of a proposal which successfully: 

• Describes how the regional center 

will promote economic growth in a 

particular geographical region of the 

United States; 

• Describes how jobs will be 

indirectly created; 

• Specifies the amount and source of 

capital committed to the regional center; 

• Describes the manner in which the 

regional center will have a positive 

impact on the economy; and is 

• Supported by economically or 

statistically valid forecasting tools. 8 

CFR 204.6(m)(3). 

Obtaining LPR status under the EB–5 

immigrant classification is a three step 

process, as follows: 

(1) The alien must first be classified 

as an alien entrepreneur. This step 

requires the alien to obtain an approval 

of a Form I–526, ‘‘Immigrant Petition by 

Alien Entrepreneur.’’ See 8 CFR 

204.6(a). 

(2) The alien then applies to become 

a conditional resident on the basis of the 

approved Form I–526 petition. If the 

alien resides in the United States, he or 

she must obtain a grant of a Form I–485, 

‘‘Application to Register Permanent 

Residence or Adjust Status’’ from USCIS 

to become a conditional resident. See 8 

CFR 245.1(a). If the alien resides outside 

of the United States, he or she must 

obtain an immigrant visa issued by the 

Department of State (DOS) and gain 

admission to the United States on this 

basis. Foreign Affairs Manual 9 FAM 

42.32(e) N12. After completing one of 

these steps, the alien will obtain 

conditional resident status. INA section 

216A(f)(1), 8 U.S.C. 1186b(f)(1). 

(3) The last step to obtaining LPR 

status is triggered 90 days before the 

second anniversary of the alien 

entrepreneur’s conditional resident 

status. INA section 216A(d)(2), 8 U.S.C. 

1186b(d)(2). During this 90-day period, 

the alien entrepreneur must submit to 

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