9228 Federal Register / Vol. 75, No. 39 / Monday, March 1, 2010 / Notices 

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 (Public Law 98– 

417) and the Generic Animal Drug and 

Patent Term Restoration Act (Public 

Law 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 FIRMAGON 

(degarelix acetate). FIRMAGON is 

indicated for treatment of patients with 

advanced prostate cancer. Subsequent to 

this approval, the Patent and Trademark 

Office received a patent term restoration 

application for FIRMAGON (U.S. Patent 

No. 5,925,730) from Ferring BV, and the 

Patent and Trademark Office requested 

FDA’s assistance in determining this 

patent’s eligibility for patent term 

restoration. In a letter dated September 

29, 2009, FDA advised the Patent and 

Trademark Office that this human drug 

product had undergone a regulatory 

review period and that the approval of 

FIRMAGON 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 

FIRMAGON is 2,695 days. Of this time, 

2,394 days occurred during the testing 

phase of the regulatory review period, 

while 301 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 act) (21 U.S.C. 

355(i)) became effective: August 10, 

2001. FDA has verified the applicant’s 

claim that the date the investigational 

new drug application became effective 

was on August 10, 2001. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 

505(b) of the act: February 28, 2008. 

FDA has verified the applicant’s claim 

that the new drug application (NDA) 

22–201 was submitted on February 28, 

2008. 

3. The date the application was 

approved: December 24, 2008. FDA has 

verified the applicant’s claim that NDA 

22–201 was approved on December 24, 

2008. 

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 application for patent extension, 

this applicant seeks 1,498 days 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) written or 

electronic comments and ask for a 

redetermination by April 30, 2010. 

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 

August 30, 2010. 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. 

Comments and petitions should be 

submitted to the Division of Dockets 

Management. Three copies of any 

mailed information are to be submitted, 

except that individuals may submit one 

copy. Comments are to be identified 

with the docket number found in 

brackets in the heading of this 

document. 

Comments and petitions may be seen 

in the Division of Dockets Management 

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

through Friday. 

Dated: February 9, 2010. 

Jane A. Axelrad, 

Associate Director for Policy, Center for Drug 

Evaluation and Research. 

[FR Doc. 2010–4159 Filed 2–26–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–D–0075] 

Draft Guidance for Industry on NonInferiority Clinical Trials; 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 ‘‘Non-Inferiority 

Clinical Trials.’’ This draft guidance 

provides sponsors and review staff in 

the Center for Drug Evaluation and 

Research (CDER) and the Center for 

Biologics Evaluation and Research 

(CBER) with the agency’s interpretation 

of the underlying principles involved in 

the use of non-inferiority (NI) study 

designs to provide evidence of the 

effectiveness of a drug or therapeutic 

biologic product. The draft guidance 

offers advice on when NI studies can be 

interpretable, how to choose the NI 

margin, and how to analyze the results. 

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 

written or electronic comments on the 

draft guidance by June 1, 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, or to the 

Office of Communication, Outreach and 

Development, 1401 Rockville Pike, suite 

200N, Rockville, MD 20852–1448. Send 

one self-addressed adhesive label to 

assist that office in processing your 

requests. Submit written comments on 

the draft guidance to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852. 

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Federal Register / Vol. 75, No. 39 / Monday, March 1, 2010 / Notices 9229 

Submit electronic comments to http:// 

www.regulations.gov. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the draft guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Robert Temple, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, rm. 4212, 

Silver Spring, MD 20993–0002, 

301–796–2270; or 

Robert T. O’Neill, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 21, rm. 3554, 

Silver Spring, MD 20993–0002, 

301–796–1700; or 

Stephen Ripley, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 1401 

Rockville Pike, suite 200N, 

Rockville, MD 20852–1448, 301– 

827–6210. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Non-Inferiority Clinical Trials.’’ The 

draft guidance includes four parts. The 

first part is a discussion of regulatory, 

study design, scientific, and statistical 

issues associated with the use of noninferiority studies when these are used 

to establish the effectiveness of a new 

drug or therapeutic biologic product. 

The second part focuses on some of 

these issues in more detail, notably the 

quantitative analytical and statistical 

approaches used to determine the noninferiority margin for use in NI studies, 

as well as the advantages and 

disadvantages of available methods. The 

third part addresses commonly asked 

questions about NI studies and provides 

practical advice about various 

approaches. The fourth part includes 

five examples of successful and 

unsuccessful efforts to define noninferiority margins and conduct NI 

studies. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the agency’s current thinking 

on non-inferiority clinical trials. 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. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/ 

Guidances, http://www.fda.gov/ 

BiologicsBloodVaccines/Guidance

ComplianceRegulatoryInformation/ 

default.htm, or http:// 

www.regulations.gov. 

Dated: February 23, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–4109 Filed 2–26–10; 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 

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, 345 Hill 

Ave., Nashville, TN 37210, 615–255– 

2400. (Formerly: Aegis Sciences 

Corporation, Aegis Analytical 

Laboratories, Inc.) 

Baptist Medical Center-Toxicology 

Laboratory, 9601 I–630, Exit 7, Little 

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