9406 Federal Register / Vol. 74, No. 41 / Wednesday, March 4, 2009 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2007–E–0166] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; SOLIRIS 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for 

SOLIRIS and is publishing this notice of 

that determination as required by law. 

FDA has made the determination 

because of the submission of an 

application to the Director of Patents 

and Trademarks, Department of 

Commerce, for the extension of a patent 

which claims that human biological 

product. 

ADDRESSES: Submit written or electronic 

comments and petitions to the Division 

of Dockets Management (HFA–305), 

Food and Drug Administration, 5630 

Fishers Lane, rm. 1061, Rockville, MD 

20852. Submit electronic comments to 

http://www.regulations.gov. 

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 

biological products, the testing phase 

begins when the exemption to permit 

the clinical investigations of the 

biological becomes effective and runs 

until the approval phase begins. The 

approval phase starts with the initial 

submission of an application to market 

the human biological product and 

continues until FDA grants permission 

to market the biological 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 biological 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 biologic product, SOLIRIS 

(eculizumab). SOLIRIS is indicated for 

the treatment of patients with 

paroxysmal nocturnal hemoglobinuria 

(PNH) to reduce hemolysis. Subsequent 

to this approval, the Patent and 

Trademark Office received a patent term 

restoration application for SOLIRIS 

(U.S. Patent No. 6,355,245) from 

Alexion Pharmaceuticals, Inc., and the 

Patent and Trademark Office requested 

FDA’s assistance in determining this 

patent’s eligibility for patent term 

restoration. In a letter dated May 6, 

2008, FDA advised the Patent and 

Trademark Office that this human 

biological product had undergone a 

regulatory review period and that the 

approval of SOLIRIS represented the 

first permitted commercial marketing or 

use of the product. Shortly 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 

SOLIRIS is 1,360 days. Of this time, 

1,177 days occurred during the testing 

phase of the regulatory review period, 

while 183 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: June 27, 2003. 

FDA has verified the applicant’s claim 

that the date the investigational new 

drug application became effective was 

on June 27, 2003. 

2. The date the application was 

initially submitted with respect to the 

human biological product under section 

351 of the Public Health Service Act (42 

U.S.C. 262): September 15, 2006. FDA 

has verified the applicant’s claim that 

the biologics license application (BLA) 

for SOLIRIS (BLA 125166/0) was 

initially submitted on September 15, 

2006. 

3. The date the application was 

approved: March 16, 2007. FDA has 

verified the applicant’s claim that BLA 

125166/0 was approved on March 16, 

2007. 

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 735 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 May 4, 2009. 

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 31, 2009. 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 17, 2009. 

Jane A. Axelrad, 

Associate Director for Policy, Center for Drug 

Evaluation and Research. 

[FR Doc. E9–4526 Filed 3–3–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0664] 

Psychopharmacologic Drugs Advisory 

Committee; Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Federal Register / Vol. 74, No. 41 / Wednesday, March 4, 2009 / Notices 9407 

Name of Committee: 

Psychopharmacologic Drugs Advisory 

Committee. 

General Function of the Committee: 

To provide advice and 

recommendations to the agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on April 7 and 8, 2009, from 8 a.m. 

to 5 p.m. 

Location: Hilton Washington DC/ 

Silver Spring, The Ballrooms, 8727 

Colesville Rd, Silver Spring, MD. The 

hotel phone number is 301–589–5200. 

Contact Person: Yvette Waples, Center 

for Drug Evaluation and Research (HFD– 

21), Food and Drug Administration, 

5600 Fishers Lane (for express delivery, 

5630 Fishers Lane, rm. 1093), Rockville, 

MD 20857, 301–827–7001, fax: 301– 

827–6776, e-mail: 

yvette.waples@fda.hhs.gov, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area), code 

3014512544. Please call the Information 

Line for up-to-date information on this 

meeting. A notice in the Federal 

Register about last minute modifications 

that impact a previously announced 

advisory committee meeting cannot 

always be published quickly enough to 

provide timely notice. Therefore, you 

should always check the agency’s Web 

site and call the appropriate advisory 

committee hotline/phone line to learn 

about possible modifications before 

coming to the meeting. 

Agenda: On April 7, 2009, the 

committee will discuss safety and 

efficacy issues of new drug application 

(NDA) 20–644, sertindole (Serdolect) 

tablets, Lundbeck USA, proposed for the 

treatment of schizophrenia. On April 8, 

2009, the committee will discuss safety 

and efficacy issues of supplemental new 

drug applications (sNDAs) 22–047/S– 

010/S–011/S–012, quetiapine b6 

maleate (Seroquel XR), Astra Zeneca 

Pharmaceuticals LP, proposed for the 

treatment of major depressive disorder 

and 22–047/S–014/S–015, Seroquel XR 

(quetiapine maleate), Astra Zeneca 

Pharmaceuticals LP, proposed for the 

treatment of generalized anxiety 

disorder. Particular safety issues for 

discussion on April 8, 2009, regarding 

the Seroquel XR applications are 

concerns regarding exposing a greatly 

expanded population to a drug with 

known metabolic side effects and a 

possible risk of tardive dyskinesia. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its Web site prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 

the meeting. Background material is 

available at http://www.fda.gov/ohrms/ 

dockets/ac/acmenu.htm, click on the 

year 2009 and scroll down to the 

appropriate advisory committee link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before March 27, 2009. 

Oral presentations from the public will 

be scheduled between approximately 1 

p.m. and 2 p.m. on both days. Those 

desiring to make formal oral 

presentations should notify the contact 

person and submit a brief statement of 

the general nature of the evidence or 

arguments they wish to present, the 

names and addresses of proposed 

participants, and an indication of the 

approximate time requested to make 

their presentation on or before March 

18, 2009. Time allotted for each 

presentation may be limited. If the 

number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by March 23, 2009. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact John 

Lauttman at least 7 days in advance of 

the meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at 

http://www.fda.gov/oc/advisory/ 

default.htm for procedures on public 

conduct during advisory committee 

meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: February 26, 2009. 

Randall W. Lutter, 

Deputy Commissioner for Policy. 

[FR Doc. E9–4523 Filed 3–3–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Reimbursement of Travel and 

Subsistence Expenses Toward Living 

Organ Donation Eligibility Guidelines 

AGENCY: Health Resources and Services 

Administration (HRSA), HHS. 

ACTION: Request for comments on 

proposed change to the Reimbursement 

of Travel and Subsistence Expenses 

Program Eligibility criteria. 

SUMMARY: HRSA published the final 

eligibility guidelines for the 

Reimbursement of Travel and 

Subsistence Expenses Program in the 

Federal Register on October 5, 2007 (72 

FR 57049). A subsequent amendment to 

the Program guidelines was published 

in the Federal Register on June 20, 2008 

(73 FR 35143). HRSA is requesting 

public comments concerning 

recommended changes to a specific 

section of the reimbursement program 

eligibility guidelines. On page 35145, 

under the Qualifying Expenses Section, 

the first paragraph states: 

For the purposes of the Reimbursement of 

Travel and Subsistence Expenses toward 

Living Organ Donation Program, qualifying 

expenses presently include only travel, 

lodging, and meals and incidental expenses 

incurred by the donor and/or his/her 

accompanying person(s) as part of: 

(1) Donor evaluation, clinic visit or 

hospitalization, 

(2) Hospitalization for the living donor 

surgical procedure, and/or 

(3) Medical or surgical follow-up clinic 

visit or hospitalization within 90 days 

following the living donation procedure. 

HRSA wishes to amend the first item 

of this paragraph to read: ‘‘(1) Donor 

evaluation (including, if applicable, 

clinic visits or hospitalization) and/or’’. 

This is a technical change to clarify that 

the expenses referred to are all related 

to the donor evaluation. In addition, 

HRSA wishes to amend the third item 

of this paragraph to read: ‘‘(3) Medical 

or surgical follow-up, clinic visits, or 

hospitalization within 2 calendar years 

following the living donation procedure 

(or beyond the 2-year period if 

exceptional circumstances exist).’’ This 

change in the follow-up period would 

bring the National Living Donor 

Assistance Center follow-up period in 

line with the Organ Procurement and 

Transplantation Network policy 

requiring follow-up of living organ 

donors for a period of 2 years. Adding 

the exceptional circumstances language 

at the end of this item would allow 

reimbursement for post-surgical followVerDate Nov<24>2008 15:08 Mar 03, 2009 Jkt 217001 PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 E:\FR\FM\04MRN1.SGM 04MRN1