69946 Federal Register / Vol. 69, No. 230 / Wednesday, December 1, 2004 / Notices 

vaccines with the VICP even before such 

vaccines are added as a separate and 

distinct category to the Table through 

rulemaking.

DATES: This Notice is effective on 

December 1, 2004. As described below, 

Hepatitis A vaccines will be covered 

under the VICP on December 1, 2004.

FOR FURTHER INFORMATION CONTACT:

Geoffrey Evans, M.D., Medical Director, 

Division of Vaccine Injury 

Compensation, Healthcare Systems 

Bureau, Health Resources and Services 

Administration, Parklawn Building, 

Room 11C–26, 5600 Fishers Lane, 

Rockville, Maryland 20857; telephone 

number (301) 443–4198.

SUPPLEMENTARY INFORMATION: The 

statute authorizing the VICP provides 

for the inclusion of additional vaccines 

in the VICP when they are 

recommended by the Centers for Disease 

Control and Prevention (CDC) to the 

Secretary for routine administration to 

children. See section 2114(e)(2) of the 

Public Health Service (PHS) Act, 42 

U.S.C. 300aa–14(e)(2). Consistent with 

section 13632(a)(3) of Public Law 103–

66, the regulations governing the VICP 

provide that such vaccines will be 

included in the Table as covered 

vaccines as of the effective date of an 

excise tax to provide funds for the 

payment of compensation with respect 

to such vaccines (42 CFR 100.3(c)(5)). 

The two prerequisites for adding 

Hepatitis A vaccines to the VICP as 

covered vaccines as well as to the Table 

have been satisfied. First, the CDC 

published its recommendation that 

Hepatitis A vaccines be routinely 

administered to certain children in the 

October 1, 1999, issue of the Morbidity 

and Mortality Weekly Report (MMWR). 

Specifically, the CDC recommended that 

all children in States, counties, and 

communities with rates of Hepatitis A 

that are twice the 1987–1997 national 

average or greater (i.e., greater than or 

equal to 20 cases per 100,000 

population) receive the Hepatitis A 

vaccine. 

Second, on October 22, 2004, the 

excise tax for Hepatitis A vaccines was 

enacted by Public Law 108–357, the 

‘‘American Jobs Creation Act of 2004.’’

Section 889 of this Act adds all vaccines 

against Hepatitis A to section 4132(a)(1) 

of the Internal Revenue Code of 1986, 

which defines all taxable vaccines. 

Unlike the CDC’s recommendation, the 

American Jobs Creation Act of 2004 

does not distinguish between Hepatitis 

A vaccines administered in areas in 

which rates of Hepatitis A are at least 

twice the national average and Hepatitis 

A vaccines administered in other areas 

of the country. For this reason, all 

Hepatitis A vaccines manufactured or 

produced in the United States, or 

entered into the United States for 

consumption, use, or warehousing, will 

be subject to this excise tax (26 U.S.C. 

4132(a)(1)). 

Under the regulations governing the 

VICP, Item XIV of the Table specifies 

that ‘‘[a]ny new vaccine recommended 

by the Centers for Disease Control and 

Prevention for routine administration to 

children, after publication by the 

Secretary of a notice of coverage’’ is a 

covered vaccine under the Table. (42 

CFR 100.3(a), Item XIV.) As explained 

above, the CDC’s recommendation was 

accepted. This notice serves to satisfy 

the regulation’s publication 

requirement. Through this notice, 

Hepatitis A vaccines are included as 

covered vaccines under Category XIV of 

the Table. As explained above, because 

the American Jobs Creation Act of 2004 

enacted an excise tax for Hepatitis A 

vaccines administered throughout the 

United States, all Hepatitis A vaccines 

will be covered under the VICP and 

under the Table. 

Under section 2114(e) of the PHS Act, 

as amended by section 13632(a) of the 

Omnibus Budget Reconciliation Act of 

1993, coverage for a vaccine 

recommended by the CDC for routine 

administration to children shall take 

effect upon the effective date of the tax 

enacted to provide funds for 

compensation with respect to the 

vaccine included as a covered vaccine 

in the Table. The American Jobs 

Creation Act of 2004 provides that the 

addition of Hepatitis A vaccines to the 

list of taxable vaccines applies to sales 

and uses on or after the first day of the 

first month which begins more than 4 

weeks after the date of the enactment of 

the Act. It further provides that if the 

vaccines were sold before or on the 

effective date of the excise tax, but 

delivered after this date, the delivery 

date of such vaccines shall be 

considered the sale date. Because the 

American Jobs Creation Act of 2004 was 

enacted on October 22, 2004, the 

effective date of the excise tax adding 

Hepatitis A vaccines as taxable vaccines 

is December 1, 2004. Thus, Hepatitis A 

vaccines are included as covered 

vaccines under Category XIV of the 

Table as of December 1, 2004. 

Petitioners may file petitions related to 

Hepatitis A vaccines as of December 1, 

2004. 

Petitions filed concerning vaccinerelated injuries or deaths associated 

with Hepatitis A vaccines must, of 

course, be filed within the applicable 

statute of limitations. The statutes of 

limitations applicable to petitions filed 

with the VICP are set out in section 

2116(a) of the PHS Act (42 U.S.C. 

300aa–16(a)). In addition, section 

2116(b) of the PHS Act lays out specific 

exceptions to these statutes of 

limitations that apply when the effect of 

a revision to the Table makes a 

previously ineligible person eligible to 

receive compensation or when an 

eligible person’s likelihood of obtaining 

compensation significantly increases. 

Under this provision, a person who may 

be eligible to file a petition based on the 

addition of a new vaccine under 

Category XIV of the Table may file a 

petition for compensation not later than 

2 years after the effective date of the 

revision if the injury or death occurred 

not more than 8 years before the 

effective date of the revision of the 

Table (42 U.S.C. 300aa–16(b)). Thus, 

persons whose petitions may not satisfy 

the limitations periods described in 

section 2116(a) of the PHS Act may still 

file petitions concerning vaccine-related 

injuries or deaths associated with 

Hepatitis A vaccines until December 1, 

2006, as long as the vaccine-related 

injury or death occurred on or after 

December 1, 1996 (8 years prior to the 

effective date of the addition that 

included Hepatitis A as a covered 

vaccine). 

The Secretary plans to amend the 

Table through the rulemaking process 

by including Hepatitis A vaccines as a 

separate category of vaccines in the 

Table. December 1, 2004, will remain 

the applicable effective date when the 

Secretary makes a corresponding 

amendment to add Hepatitis A vaccines 

as a separate category on the Table 

through rulemaking.

Dated: November 22, 2004. 

Elizabeth M. Duke, 

Administrator, HRSA.

[FR Doc. 04–26273 Filed 11–30–04; 8:45 am] 

BILLING CODE 4165–15–P

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 

Federal Register / Vol. 69, No. 230 / Wednesday, December 1, 2004 / Notices 69947

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://workplace.samhsa.gov

and http://www.drugfreeworkplace.gov.

FOR FURTHER INFORMATION CONTACT: Mrs. 

Giselle Hersh or Dr. Walter Vogl, 

Division of Workplace Programs, 

SAMHSA/CSAP, Room 2–1035, 1 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 Pub. L. 100–

71. Subpart C of the Mandatory 

Guidelines, ‘‘Certification of 

Laboratories Engaged in Urine Drug 

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 Analytical Laboratories, Inc., 345 

Hill Ave., Nashville, TN 37210, 615–

255–2400. 

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 

Rd., Lenexa, KS 66215–2802, 800–

445–6917. 

Diagnostic Services Inc., dba DSI, 12700 

Westlinks Dr., Fort Myers, FL 33913, 

239–561–8200/800–735–5416. 

Doctors Laboratory, Inc., 2906 Julia 

Drive, Valdosta, GA 31602, 229–671–

2281. 

DrugProof, Division of Dynacare/

Laboratory of Pathology, LLC, 1229 

Madison St., Suite 500, Nordstrom 

Medical Tower, Seattle, WA 98104, 

206–386–2661/800–898–0180, 

(Formerly: Laboratory of Pathology of 

Seattle, Inc., DrugProof, Division of 

Laboratory of Pathology of Seattle, 

Inc.). 

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

Mearns Rd., Warminster, PA 18974, 

215–674–9310. 

Dynacare Kasper Medical Laboratories*, 

10150–102 St., Suite 200, Edmonton, 

Alberta, Canada T5J 5E2, 780–451–

3702/800–661–9876.

ElSohly Laboratories, Inc., 5 Industrial 

Park Dr., Oxford, MS 38655, 662–236–

2609. 

Express Analytical Labs, 3405 7th Ave., 

Suite 106, Marion, IA 52302, 319–

377–0500. 

General Medical Laboratories, 36 South 

Brooks St., Madison, WI 53715, 608–

267–6225. 

Kroll Laboratory Specialists, Inc., 1111 

Newton St., Gretna, LA 70053, 504–

361–8989/800–433–3823, (Formerly: 

Laboratory Specialists, Inc.). 

LabOne, Inc., 10101 Renner Blvd., 

Lenexa, KS 66219, 913–888–3927/

800–873–8845, (Formerly: Center for 

Laboratory Services, a Division of 

LabOne, Inc.). 

LabOne, Inc., d/b/a Northwest 

Toxicology, 1141 E. 3900 S., Salt Lake 

City, UT 84124, 801–293–2300/800–

322–3361, (Formerly: NWT Drug 

Testing, NorthWest Toxicology, Inc.; 

Northwest Drug Testing, a division of 

NWT Inc.). 

Laboratory Corporation of America 

Holdings, 7207 N. Gessner Rd., 

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 Dr., 

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, 10788 Roselle St., San 

Diego, CA 92121, 800–882–7272 

(Formerly: Poisonlab, Inc.). 

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). 

Marshfield Laboratories, Forensic 

Toxicology Laboratory, 1000 North 

Oak Ave., Marshfield, WI 54449, 715–

389–3734/800–331–3734. 

MAXXAM Analytics Inc.,* 6740 

Campobello Road, Mississauga, ON, 

Canada L5N 2L8, 905–817–5700, 

(Formerly: NOVAMANN (Ontario) 

Inc.). 

MedTox Laboratories, Inc., 402 W. 

County Rd. 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 Dr., 

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). 

Oregon Medical Laboratories, P.O. Box 

972, 722 East 11th Ave., Eugene, OR 

97440–0972, 541–687–2134. 

Pacific Toxicology Laboratories, 9348 

DeSoto Ave., Chatsworth, CA 91311, 

800–328–6942, (Formerly: Centinela 

Hospital Airport Toxicology 

Laboratory). 

69948 Federal Register / Vol. 69, No. 230 / Wednesday, December 1, 2004 / Notices 

* 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 LAPSAaccredited 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 HHS certified laboratories and 

participate in the NLCP certification maintenance 

program.

Pathology Associates Medical 

Laboratories, 110 West Cliff Dr., 

Spokane, WA 99204, 509–755–8991/

800–541–7897 x7. 

Physicians Reference Laboratory, 7800 

West 110th St., Overland Park, KS 

66210, 913–339–0372/800–821–3627. 

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, 4770 

Regent Blvd., Irving, TX 75063, 800–

824–6152, (Moved from the Dallas 

location on 03/31/01; Formerly: 

SmithKline Beecham Clinical 

Laboratories; SmithKline Bio-Science 

Laboratories). 

Quest Diagnostics Incorporated, 4230 

South Burnham Ave., Suite 250, Las 

Vegas, NV 89119–5412, 702–733–

7866/800–433–2750, (Formerly: 

Associated Pathologists Laboratories, 

Inc.). 

Quest Diagnostics Incorporated, 400 

Egypt Rd., Norristown, PA 19403, 

610–631–4600/877–642–2216, 

(Formerly: SmithKline Beecham 

Clinical Laboratories; SmithKline BioScience Laboratories). 

Quest Diagnostics Incorporated, 506 E. 

State Pkwy., Schaumburg, IL 60173, 

800–669–6995/847–885–2010, 

(Formerly: SmithKline Beecham 

Clinical Laboratories; International 

Toxicology Laboratories). 

Quest Diagnostics Incorporated, 7600 

Tyrone Ave., Van Nuys, CA 91405, 

818–989–2520/800–877–2520, 

(Formerly: SmithKline Beecham 

Clinical Laboratories). 

Scientific Testing Laboratories, Inc., 450 

Southlake Blvd., Richmond, VA 

23236, 804–378–9130. 

Sciteck Clinical Laboratories, Inc., 317 

Rutledge Rd., Fletcher, NC 28732, 

828–650–0409. 

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.

Anna Marsh, 

Executive Officer, SAMHSA.

[FR Doc. 04–26426 Filed 11–30–04; 8:45 am] 

BILLING CODE 4160–20–P

DEPARTMENT OF THE INTERIOR

Bureau of Land Management 

[NV–912–05–1990–PO–241A–006F] 

Sierra Front-Northwestern Great Basin 

Resource Advisory Council; Notice of 

Meeting Location and Time

AGENCY: Bureau of Land Management, 

Interior.

ACTION: Notice of meeting location and 

time for the Sierra Front-Northwestern 

Great Basin Resource Advisory Council 

(Nevada). 

SUMMARY: In accordance with the 

Federal Land Policy and Management 

Act and the Federal Advisory 

Committee Act of 1972 (FACA), a 

meeting of the U.S. Department of the 

Interior, Bureau of Land Management 

(BLM) Sierra Front-Northwestern Great 

Basin Resource Advisory Council 

(RAC), Nevada, will be held as indicated 

below. Topics for discussion at the 

meeting will include, but are not limited 

to: Manager’s reports of current field 

office activities; review of the BLM’s 

Resource Management Planning 

Process; review of the Pine Nut 

Mountain RMP Amendment DEIS; a 

review of Native American tribe 

consultation procedures; review of 

proposed 2005 Wild Horse Herd 

Management Area gathers in the 

Northwest Great Basin; a panel 

discussion on water resources 

transportation issues in Nevada; and 

additional topics the council may raise 

during the meeting. 

Date & Time: The RAC will meet on 

Thursday, January 27, 2005, from 9 a.m. 

to 5 p.m., at the BLM-Carson City Field 

Office, 5665 Morgan Mill Road, Carson 

City, Nevada; and on Friday, January 28, 

2005, from 8 a.m. to 12 p.m., at the 

BLM-Nevada State Office, Great Basin 

A&B Conference Room, 1340 Financial 

Blvd., Reno, Nevada. All meetings are 

open to the public. A general public 

comment period, where the public may 

submit oral or written comments to the 

RAC, will be held at 4 p.m. on January 

27, 2005. 

A final detailed agenda, with any 

additions/corrections to agenda topics, 

will be available on the Internet no later 

than January 13, 2005, at http://

www.nv.blm.gov/rac; hard copies can 

also be mailed or sent via FAX. 

Individuals who need special assistance 

such as sign language interpretation or 

other reasonable accommodations, or 

who wish a hard copy of the agenda, 

should contact Mark Struble, Carson 

City Field Office, 5665 Morgan Mill 

Road, Carson City, NV 89701, telephone 

(775) 885–6107, no later than January 

13, 2005.

FOR FURTHER INFORMATION CONTACT:

Mark Struble, Public Affairs Officer, 

BLM Carson City Field Office, 5665 

Morgan Mill Road, Carson City, NV 

89701. Telephone: (775) 885–6107. Email: mstruble@nv.blm.gov.

Dated: November 23, 2004. 

Don Hicks, 

Field Office Manager, BLM-Carson City Field 

Office.

[FR Doc. 04–26491 Filed 11–30–04; 8:45 am] 

BILLING CODE 4310–HC–P