55796 Federal Register / Vol. 75, No. 177 / Tuesday, September 14, 2010 / Notices 

Gamma-Dynacare Medical 

Laboratories*, A Division of the 

Gamma-Dynacare Laboratory 

Partnership, 245 Pall Mall Street, 

London, ONT, Canada N6A 1P4, 519– 

679–1630. 

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/ 

800–541–7891x7. 

Phamatech, Inc., 10151 Barnes Canyon 

Road, San Diego, CA 92121, 858–643– 

5555. 

Quest Diagnostics Incorporated, 1777 

Montreal Circle, Tucker, GA 30084, 

800–729–6432 (Formerly: SmithKline 

Beecham Clinical Laboratories; 

SmithKline Bio-Science 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, 8401 

Fallbrook Ave., West Hills, CA 91304, 

800–877–2520 (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 x1276. 

Southwest Laboratories, 4625 E. Cotton 

Center Boulevard, Suite 177, Phoenix, 

AZ 85040, 602–438–8507/800–279– 

0027. 

St. Anthony Hospital Toxicology 

Laboratory, 1000 N. Lee St., 

Oklahoma City, OK 73101, 405–272– 

7052. 

STERLING Reference Laboratories, 2617 

East L Street, Tacoma, Washington 

98421, 800–442–0438. 

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. 

*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. 

Dated: September 8, 2010. 

Elaine Parry, 

Director, Office of Management, Technology, 

and Operations, SAMHSA. 

[FR Doc. 2010–22818 Filed 9–13–10; 8:45 am] 

BILLING CODE 4160–20–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–P–0157] 

Determination That VESANOID 

(Tretinoin) Capsules, 10 Milligrams, 

Were Not Withdrawn From Sale for 

Reasons of Safety or Effectiveness 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

that VESANOID (tretinoin) Capsules, 10 

milligrams (mg), were not withdrawn 

from sale for reasons of safety or 

effectiveness. This determination means 

that FDA will not begin procedures to 

withdraw approval of the abbreviated 

new drug application (ANDA) that 

refers to this drug product, and it will 

allow FDA to continue to approve 

ANDAs that refer to the product as long 

as they meet relevant legal and 

regulatory requirements. 

FOR FURTHER INFORMATION CONTACT: 

Molly Flannery, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 6237, 

Silver Spring, MD 20993–0002, 301– 

796–3543. 

SUPPLEMENTARY INFORMATION: In 1984, 

Congress enacted the Drug Price 

Competition and Patent Term 

Restoration Act of 1984 (Public Law 98– 


jlentini on DSKJ8SOYB1PROD with NOTICES
Federal Register / Vol. 75, No. 177 / Tuesday, September 14, 2010 / Notices 55797 

417) (the 1984 amendments), which 

authorized the approval of duplicate 

versions of drug products approved 

under an ANDA procedure. ANDA 

applicants must, with certain 

exceptions, show that the drug for 

which they are seeking approval 

contains the same active ingredient in 

the same strength and dosage form as 

the ‘‘listed drug,’’ which is a version of 

the drug that was previously approved. 

ANDA applicants do not have to repeat 

the extensive clinical testing otherwise 

necessary to gain approval of a new 

drug application (NDA). The only 

clinical data required in an ANDA are 

data to show that the drug that is the 

subject of the ANDA is bioequivalent to 

the listed drug. 

The 1984 amendments include what 

is now section 505(j)(7) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

355(j)(7)), which requires FDA to 

publish a list of all approved drugs. 

FDA publishes this list as part of the 

‘‘Approved Drug Products With 

Therapeutic Equivalence Evaluations,’’ 

which is known generally as the 

‘‘Orange Book.’’ Under FDA regulations, 

drugs are removed from the list if the 

agency withdraws or suspends approval 

of the drug’s NDA or ANDA for reasons 

of safety or effectiveness or if FDA 

determines that the listed drug was 

withdrawn from sale for reasons of 

safety or effectiveness (21 CFR 314.162). 

Under § 314.161(a)(1) (21 CFR 

314.161(a)(1)), the agency must 

determine whether a listed drug was 

withdrawn from sale for reasons of 

safety or effectiveness before an ANDA 

that refers to that listed drug may be 

approved. FDA may not approve an 

ANDA that does not refer to a listed 

drug. 

VESANOID (tretinoin) Capsules, 10 

mg, are the subject of NDA 20–438, held 

by Hoffman-La Roche Inc. (Roche), and 

initially approved on November 22, 

1995. VESANOID is indicated for the 

‘‘induction of remission in patients with 

acute promyelocytic leukemia (APL), 

French-American-British (FAB) 

classification M3 (including the M3 

variant), characterized by the presence 

of the t(15;17) translocation and/or the 

presence of the PML/RARa 

[promyelocytic leukemia/retinoic acid 

receptor alpha] gene who are refractory 

to, or who have relapsed from, 

anthracycline chemotherapy, or for 

whom anthracycline-based 

chemotherapy is contraindicated’’ 

(VESANOID labeling). 

In a letter dated December 2, 2009, 

Roche notified FDA that VESANOID 

(tretinoin) Capsules, 10 mg, were being 

discontinued, and FDA moved the drug 

product to the ‘‘Discontinued Drug 

Product List’’ section of the Orange 

Book. There is one approved ANDA for 

tretinoin capsules, 10 mg (ANDA No. 

77–684); this drug product is listed in 

the Orange Book and, following the 

discontinuation of VESANOID, was 

designated as the reference listed drug 

to which new ANDAs should refer. 

Rakoczy Molino Mazzochi Siwik LLP 

submitted a citizen petition dated 

March 17, 2010 (Docket No. FDA–2010– 

P–0157), under 21 CFR 10.30, 

requesting that the agency determine 

whether VESANOID (tretinoin) 

Capsules, 10 mg, were withdrawn from 

sale for reasons of safety or 

effectiveness. 

After considering the citizen petition 

and reviewing agency records, FDA has 

determined under § 314.161 that 

VESANOID (tretinoin) Capsules, 10 mg, 

were not withdrawn for reasons of 

safety or effectiveness. The petitioner 

has identified no data or other 

information suggesting that VESANOID 

(tretinoin) Capsules, 10 mg, were 

withdrawn for reasons of safety or 

effectiveness. We have carefully 

reviewed our files for records 

concerning the withdrawal of 

VESANOID (tretinoin) Capsules, 10 mg, 

from sale. We have also independently 

evaluated relevant literature and data 

for possible postmarketing adverse 

events and have found no information 

that would indicate that this product 

was withdrawn from sale for reasons of 

safety or effectiveness. 

Accordingly, the agency will continue 

to list VESANOID (tretinoin) Capsules, 

10 mg, in the ‘‘Discontinued Drug 

Product List’’ section of the Orange 

Book. The ‘‘Discontinued Drug Product 

List’’ delineates, among other items, 

drug products that have been 

discontinued from marketing for reasons 

other than safety or effectiveness. FDA 

will not begin procedures to withdraw 

approval of the approved ANDA that 

refers to VESANOID. Additional ANDAs 

for tretinoin capsules, 10 mg, may also 

be approved by the agency as long as 

they meet all other legal and regulatory 

requirements for the approval of 

ANDAs. If FDA determines that labeling 

for this drug product should be revised 

to meet current standards, the agency 

will advise ANDA applicants to submit 

such labeling. 

Dated: September 8, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–22807 Filed 9–13–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–D–0462] 

Draft Guidance for Industry on Chronic 

Hepatitis C Virus Infection: Developing 

Direct-Acting Antiviral Agents for 

Treatment; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘Chronic Hepatitis C 

Virus Infection: Developing DirectActing Antiviral Agents for Treatment.’’ 

The purpose of this guidance is to assist 

sponsors in all phases of development 

of direct-acting antiviral agents (DAAs), 

defined as agents that interfere with 

specific steps in the hepatitis C virus 

(HCV) replication cycle. The guidance 

outlines the types of nonclinical studies 

and clinical trials recommended 

throughout the drug development 

process to support approval of 

treatments for chronic hepatitis C 

(CHC), including in patients with 

compensated and decompensated 

cirrhosis and those co-infected with 

human immunodeficiency virus (HIV). 

The guidance also addresses preapproval access in the form of treatment 

investigational new drug applications 

(INDs) and intermediate-sized safety 

protocols. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

either electronic or written comments 

on the draft guidance by November 15, 

2010. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 2201, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance document. 

Submit electronic comments on the 

draft guidance to http:// 

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. 


jlentini on DSKJ8SOYB1PROD with NOTICES