Federal Register / Vol. 77, No. 67 / Friday, April 6, 2012 / Notices 20831 

petitions along with three copies and 

written comments to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Beverly Friedman, Office of Regulatory 

Policy, Food and Drug Administration, 

10903 New Hampshire Ave. Bldg. 51, 

rm. 6222, Silver Spring, MD 20993– 

0002, 301–796–3602. 

SUPPLEMENTARY INFORMATION: The Drug 

Price Competition and Patent Term 

Restoration Act of 1984 (Pub. L. 98–417) 

and the Generic Animal Drug and Patent 

Term Restoration Act (Pub. L. 100–670) 

generally provide that a patent may be 

extended for a period of up to 5 years 

so long as the patented item (human 

drug product, animal drug product, 

medical device, food additive, or color 

additive) was subject to regulatory 

review by FDA before the item was 

marketed. Under these acts, a product’s 

regulatory review period forms the basis 

for determining the amount of extension 

an applicant may receive. 

A regulatory review period consists of 

two periods of time: A testing phase and 

an approval phase. For human drug 

products, the testing phase begins when 

the exemption to permit the clinical 

investigations of the drug becomes 

effective and runs until the approval 

phase begins. The approval phase starts 

with the initial submission of an 

application to market the human drug 

product and continues until FDA grants 

permission to market the drug product. 

Although only a portion of a regulatory 

review period may count toward the 

actual amount of extension that the 

Director of Patents and Trademarks may 

award (for example, half the testing 

phase must be subtracted as well as any 

time that may have occurred before the 

patent was issued), FDA’s determination 

of the length of a regulatory review 

period for a human drug product will 

include all of the testing phase and 

approval phase as specified in 35 U.S.C. 

156(g)(1)(B). 

FDA recently approved for marketing 

the human drug product VIIBRYD 

(vilazodone hydrochloride). VIIBRYD is 

indicated for the treatment of major 

depressive disorder. Subsequent to this 

approval, the Patent and Trademark 

Office received a patent term restoration 

application for VIIBRYD (U.S. Patent 

Nos. 5,532,241 and 7,834,020) from 

Merck Patent GmbH, and the Patent and 

Trademark Office requested FDA’s 

assistance in determining this patent’s 

eligibility for patent term restoration. In 

a letter dated June 22, 2011, FDA 

advised the Patent and Trademark 

Office that this human drug product had 

undergone a regulatory review period 

and that the approval of VIIBRYD 

represented the first permitted 

commercial marketing or use of the 

product. Thereafter, the Patent and 

Trademark Office requested that FDA 

determine the product’s regulatory 

review period. 

FDA has determined that the 

applicable regulatory review period for 

VIIBRYD is 4,778 days. Of this time, 

4,472 days occurred during the testing 

phase of the regulatory review period, 

while 306 days occurred during the 

approval phase. These periods of time 

were derived from the following dates: 

1. The date an exemption under 

section 505(i) of the Federal Food, Drug, 

and Cosmetic Act (the FD&C Act) (21 

U.S.C. 355(i)) became effective: 

December 24, 1997. FDA has verified 

the applicant’s claim that the date the 

investigational new drug application 

became effective was on December 24, 

1997. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 

505(b) of the FD&C Act: March 22, 2010. 

FDA has verified the applicant’s claim 

that the new drug application (NDA) for 

VIIBRYD (NDA 22–567) was submitted 

on March 22, 2010. 

3. The date the application was 

approved: January 21, 2011. FDA has 

verified the applicant’s claim that NDA 

22–567 was approved on January 21, 

2011. 

This determination of the regulatory 

review period establishes the maximum 

potential length of a patent extension. 

However, the U.S. Patent and 

Trademark Office applies several 

statutory limitations in its calculations 

of the actual period for patent extension. 

In its applications for patent extension, 

this applicant seeks either 67 days or 5 

years of patent term extension. 

Anyone with knowledge that any of 

the dates as published are incorrect may 

submit to the Division of Dockets 

Management (see ADDRESSES) either 

electronic or written comments and ask 

for a redetermination by June 5, 2012. 

Furthermore, any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period by 

October 3, 2012. To meet its burden, the 

petition must contain sufficient facts to 

merit an FDA investigation. (See H. 

Rept. 857, part 1, 98th Cong., 2d sess., 

pp. 41–42, 1984.) Petitions should be in 

the format specified in 21 CFR 10.30. 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) electronic or written 

comments and written petitions. It is 

only necessary to send one set of 

comments. However, if you submit a 

written petition, you must submit three 

copies of the petition. Identify 

comments with the docket number 

found in brackets in the heading of this 

document. 

Comments and petitions that have not 

been made publicly available on 

regulations.gov may be viewed in the 

Division of Dockets Management 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

Dated: March 19, 2012. 

Jane A. Axelrad, 

Associate Director for Policy, Center for Drug 

Evaluation and Research. 

[FR Doc. 2012–8341 Filed 4–5–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute; Notice of 

Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Cancer 

Institute Initial Review Group; Subcommittee 

A—Cancer Centers. 

Date: May 3, 2012 

Time: 8 a.m. to 5:20 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Courtyard by Marriott, 5520 

Wisconsin Avenue, Chevy Chase, MD 20815. 

Contact Person: Gail J Bryant, MD, Medical 

Officer, Resources and Training Review 

Branch, Division of Extramural Activities, 

National Cancer Institute, 6116 Executive 

Blvd., Room 8107, MSC 8328, Bethesda, MD 

20892–8328, (301) 402–0801, gb30t@nih.gov. 

Information is also available on the 

Institute’s/Center’s home page: http:// 

deainfo.nci.nih.gov/advisory/irg/irg.htm, 

where an agenda and any additional 

information for the meeting will be posted 

when available. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.392, Cancer Construction; 

93.393, Cancer Cause and Prevention 

Research; 93.394, Cancer Detection and 

mstockstill on DSK4VPTVN1PROD with NOTICES

20832 Federal Register / Vol. 77, No. 67 / Friday, April 6, 2012 / Notices 

Diagnosis Research; 93.395, Cancer 

Treatment Research; 93.396, Cancer Biology 

Research; 93.397, Cancer Centers Support; 

93.398, Cancer Research Manpower; 93.399, 

Cancer Control, National Institutes of Health, 

HHS) 

Dated: April 2, 2012. 

Anna P. Snouffer, 

Deputy Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2012–8353 Filed 4–5–12; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflict: Synaptic Vesicles and 

Synaptogenesis. 

Date: April 18, 2012. 

Time: 1:30 p.m. to 3 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892, 

(Telephone Conference Call). 

Contact Person: Toby Behar, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4136, 

MSC 7850, Bethesda, MD 20892, (301) 435– 

4433, behart@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflicts: Pain and Chemosensory 

Neuroscience. 

Date: April 25–26, 2012. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892, 

(Virtual Meeting). 

Contact Person: John Bishop, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5182, 

MSC 7844, Bethesda, MD 20892, (301) 408– 

9664, bishopj@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Molecular 

Genetics Program Projects. 

Date: May 1, 2012. 

Time: 12 p.m. to 6 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892, 

(Virtual Meeting). 

Contact Person: Ronald Adkins, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 2206, 

MSC 7890, Bethesda, MD 20892, 301–435– 

4511, ronald.adkins@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.306, Comparative Medicine; 

93.333, Clinical Research, 93.306, 93.333, 

93.337, 93.393–93.396, 93.837–93.844, 

93.846–93.878, 93.892, 93.893, National 

Institutes of Health, HHS) 

Dated: March 30, 2012. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2012–8352 Filed 4–5–12; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration 

Current List of Laboratories and 

Instrumented Initial Testing Facilities 

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 and 

Instrumented Initial Testing Facilities 

(IITF) currently certified to meet the 

standards 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); 

September 30, 1997 (62 FR 51118); 

April 13, 2004 (69 FR 19644); November 

25, 2008 (73 FR 71858); December 10, 

2008 (73 FR 75122); and on April 30, 

2010 (75 FR 22809). 

A notice listing all currently certified 

Laboratories and Instrumented Initial 

Testing Facilities (IITF) is published in 

the Federal Register during the first 

week of each month. If any Laboratory/ 

IITF’s certification is suspended or 

revoked, the Laboratory/IITF will be 

omitted from subsequent lists until such 

time as it is restored to full certification 

under the Mandatory Guidelines. 

If any Laboratory/IITF 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 initially 

developed in accordance with Executive 

Order 12564 and section 503 of Public 

Law 100–71. The ‘‘Mandatory 

Guidelines for Federal Workplace Drug 

Testing Programs,’’ as amended in the 

revisions listed above, requires strict 

standards that Laboratories and 

Instrumented Initial Testing Facilities 

(IITF) must meet in order to conduct 

drug and specimen validity tests on 

urine specimens for Federal agencies. 

To become certified, an applicant 

Laboratory/IITF must undergo three 

rounds of performance testing plus an 

on-site inspection. To maintain that 

certification, a Laboratory/IITF must 

participate in a quarterly performance 

testing program plus undergo periodic, 

on-site inspections. 

Laboratories and Instrumented Initial 

Testing Facilities (IITF) in the applicant 

stage of certification are not to be 

considered as meeting the minimum 

requirements described in the HHS 

Mandatory Guidelines. A Laboratory/ 

IITF must have its letter of certification 

from HHS/SAMHSA (formerly: HHS/ 

NIDA) which attests that it has met 

minimum standards. 

In accordance with the Mandatory 

Guidelines dated November 25, 2008 

(73 FR 71858), the following 

Laboratories and Instrumented Initial 

Testing Facilities (IITF) meet the 

minimum standards to conduct drug 

and specimen validity tests on urine 

specimens: 

Instrumented Initial Testing Facilities 

(IITF): None. 

Laboratories: 

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. 

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