21696 Federal Register / Vol. 74, No. 88 / Friday, May 8, 2009 / Notices 

TABLE 6.—TOTALS FOR ESTIMATED

ANNUAL REPORTING AND RECORDKEEPING BURDENS FOR CDER 

AND CBER 

Reporting Burden 130,190,510 

Recordkeeping 11,301,652 

Total 141,492,162 

Dated: May 1, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–10730 Filed 5–7–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2007–E–0048] (formerly 

Docket No. 2007E–0445) 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; NEUPRO TRANSDERMAL 

SYSTEM 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for 

NEUPRO TRANSDERMAL SYSTEM 

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 drug product. 

ADDRESSES: Submit written 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 drug 

products, the testing phase begins when 

the exemption to permit the clinical 

investigations of the human drug 

product 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 NEUPRO 

TRANSDERMAL SYSTEM (rotigotine). 

NEUPRO TRANSDERMAL SYSTEM is 

indicated for the treatment of the signs 

and symptoms of early-stage idiopathic 

Parkinson’s disease. Subsequent to this 

approval, the Patent and Trademark 

Office received a patent term restoration 

application for NEUPRO 

TRANSDERMAL SYSTEM (U.S. Patent 

No. 6,884,434) from Schwarz Pharma 

Limited, and the Patent and Trademark 

Office requested FDA’s assistance in 

determining this patent’s eligibility for 

patent term restoration. In a letter dated 

April 28, 2008, FDA advised the Patent 

and Trademark Office that this human 

drug product had undergone a 

regulatory review period and that the 

approval of NEUPRO TRANSDERMAL 

SYSTEM 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 

NEUPRO TRANSDERMAL SYSTEM is 

4,367 days. Of this time, 3,535 days 

occurred during the testing phase of the 

regulatory review period, while 832 

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: May 27, 1995. 

FDA has verified the applicant’s claim 

that the date the investigational new 

drug application became effective was 

on May 27, 1995. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 

505(b) of the act: January 28, 2005. The 

applicant claims January 19, 2005, as 

the date the new drug application 

(NDA) for NEUPRO TRANSDERMAL 

SYSTEM (NDA 21–829) was initially 

submitted. However, FDA records 

indicate that NDA 21–829 was initially 

submitted on January 28, 2005, the date 

of receipt by the Agency of a 

resubmission following a refusal to file. 

3. The date the application was 

approved: May 9, 2007. FDA has 

verified the applicant’s claim that NDA 

21–829 was approved on May 9, 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 744 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 July 7, 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 

November 4, 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. 


hsrobinson on PROD1PC76 with NOTICES
Federal Register / Vol. 74, No. 88 / Friday, May 8, 2009 / Notices 21697 

Dated: April 6, 2009. 

Jane A. Axelrad, 

Associate Director for Policy, Center for Drug 

Evaluation and Research. 

[FR Doc. E9–10818 Filed 5–7–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention (CDC) 

Board of Scientific Counselors, 

National Center for Public Health 

Informatics (BSC, NCPHI) 

In accordance with section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), the CDC announces 

the following meeting of the 

aforementioned committee: 

Time and Date: 8:30 a.m.–5 p.m., May 26, 

2009. 

Place: Swan & Dolphin Hotel, 1500 Epcot 

Resorts Boulevard, Lake Buena Vista, Florida 

32830. Audio conference call via FTS 

conferencing. The USA toll free dial in 

number is 1–866–713–5586, with a 

participant pass code of 4624038. 

Status: Open to the public, limited only by 

the space available. 

Purpose: The committee will meet to 

conduct BSC, NCPHI business. 

The Director, Management Analysis and 

Services Office, has been delegated the 

authority to sign Federal Register notices 

pertaining to announcements of meetings and 

other committee management activities, for 

both CDC and the Agency for Toxic 

Substances and Disease Registry. 

Dated: May 4, 2009. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

Matters To Be Discussed: To discuss BSC, 

NCPHI-related matters including: update on 

BioSense; re-formation of three BSC working 

groups; and various other BSC-related 

activities. Agenda items are subject to change 

as priorities dictate. 

Contact Person for More Information: Scott 

McNabb, Ph.D., Designated Federal Officer, 

NCPHI, CDC, 1600 Clifton Road, NE., 

Mailstop E–78, Atlanta, Georgia 30333, 

Telephone: (404)498–6427, Fax (404)498– 

6235. 

[FR Doc. E9–10738 Filed 5–7–09; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Neurological 

Disorders and Stroke; 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: Neurological Sciences 

Training Initial Review Group; NST–1 

Subcommittee. 

Date: May 11–12, 2009. 

Time: 8 a.m. to 6 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: The Tuscan Inn, 495 Jefferson Street, 

San Francisco, CA 94109. 

Contact Person: Raul A. Saavedra, PhD, 

Scientific Review Officer, Scientific Review 

Branch, Division of Extramural Research, 

NINDS/NIH/DHHS, NSC; 6001 Executive 

Blvd., Ste. 3208, Bethesda, MD 20892–9529, 

301–496–9223, saavedrr@ninds.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.853, Clinical Research 

Related to Neurological Disorders; 93.854, 

Biological Basis Research in the 

Neurosciences, National Institutes of Health, 

HHS) 

Dated: May 4, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–10803 Filed 5–7–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0664] 

Arthritis 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. 

Name of Committee: Arthritis 

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 June 16, 2009, from 8:30 a.m. 

to 4 p.m. 

Location: Hilton Washington DC/ 

Silver Spring, The Ballrooms, 8727 

Colesville Rd., Silver Spring, MD. The 

hotel telephone number is 301–589– 

5200. 

Contact Person: Nicole Vesely, 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, 301–827–6793, FAX: 301– 

827–6776, e-mail: 

nicole.vesely@fda.hhs.gov, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area), code 

3014512532. 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. 

Agenda: The committee will discuss 

biologics license application (BLA) 

125293, KRYSTEXXA (pegloticase), 

Savient Pharmaceuticals, Inc., as a 

therapy for patients with refractory gout. 

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 June 2, 2009. Oral 

presentations from the public will be 

scheduled between approximately 1 

p.m. to 2 p.m. Those desiring to make 

formal oral presentations should notify 

the contact person and submit a brief 


hsrobinson on PROD1PC76 with NOTICES