Federal Register / Vol. 69, No. 187 / Tuesday, September 28, 2004 / Notices 57937

Trans No. Acquiring Acquired Entities 

20041348 ......................... AGL Resources Inc. .......................... American Electric Power Company, 

Inc..

Jefferson Island Storage & Hub 

L.L.C. 

20041349 ......................... Ainsworth Lumber Co., Ltd ............... Potlatch Corporation .......................... Potlatch Corporation. 

20041355 ......................... HKW Capital Partners II, L.P. ........... Maxon Corporation ............................ Maxon Corporation. 

Transactions Granted Early Termination—09/09/2004

20041322 ......................... Michael E. Heisley, Sr ....................... Ivaco Inc. ........................................... Ifastgroupe and Company, Limited 

Partnership, Ifastgroupe Realty 

Inc., IFC (Fasteners) Inc. 

Transactions Granted Early Termination—09/10/2004

20041292 ......................... The Pepsi Bottling Group, Inc. .......... Seltzer & Rydholm, Inc. .................... Seltzer & Rydholm, Inc. 

20041311 ......................... Merck & Co., Inc. .............................. DOV Pharmaceutical, Inc. ................. DOV Pharmaceutical Inc. 

FOR FURTHER INFORMATION CONTACT:

Sandra M. Peay, Contact Representative; 

or Renee Hallman, Case Management 

Assistant, Federal Trade Commission, 

Premerger Notification Office, Bureau of 

Competition, Room H–303, Washington, 

DC 20580, (202) 326–3100.

By Direction of the Commission 

Donald S. Clark, 

Secretary.

[FR Doc. 04–21688 Filed 9–27–04; 8:45 am] 

BILLING CODE 6750–01–M

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N–0045]

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Health and Diet Survey—2004 

Supplement

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Health and Diet Survey—2004 

Supplement’’ has been approved by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995.

FOR FURTHER INFORMATION CONTACT:

Peggy Robbins, Office of Management 

Programs (HFA–250), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–1223.

SUPPLEMENTARY INFORMATION: In the 

Federal Register of May 19, 2004 (69 FR 

28928), the agency announced that the 

proposed information collection had 

been submitted to OMB for review and 

clearance under 44 U.S.C. 3507. An 

agency may not conduct or sponsor, and 

a person is not required to respond to, 

a collection of information unless it 

displays a currently valid OMB control 

number. OMB has now approved the 

information collection and has assigned 

OMB control number 0910–0545. The 

approval expires on September 30, 

2007. A copy of the supporting 

statement for this information collection 

is available on the Internet at http://

www.fda.gov/ohrms/dockets.

Dated: September 22, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–21674 Filed 9–27–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004E–0023]

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; REYATAZ

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for 

REYATAZ 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 

that 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.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT:

Claudia V. Grillo, Office of Regulatory 

Policy (HFD–013), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 240–453–6699.

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 REYATAZ 

(atazanavir sulfate). REYATAZ is 

indicated in combination with other

57938 Federal Register / Vol. 69, No. 187 / Tuesday, September 28, 2004 / Notices 

antiretroviral agents for the treatment of 

HIV–1 infection. Subsequent to this 

approval, the Patent and Trademark 

Office received a patent term restoration 

application for REYATAZ (U.S. Patent 

No. 5,849,911) from Novartis Corp., 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 6, 2004, FDA advised the Patent 

and Trademark Office that this human 

drug product had undergone a 

regulatory review period and that the 

approval of REYATAZ 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 

REYATAZ is 1,723 days. Of this time, 

1,540 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: October 3, 

1998. The applicant claims October 2, 

1998, as the date the investigational new 

drug application (IND) became effective. 

However, FDA records indicate that the 

IND effective date was October 3, 1998, 

which was 30 days after FDA receipt of 

the IND.

2. The date the application was 

initially submitted with respect to the 

human drug product under section 

505(b) of the act: December 20, 2002. 

FDA has verified the applicant’s claim 

that the new drug application (NDA) for 

REYATAZ (NDA 21–567) was initially 

submitted on December 20, 2002.

3. The date the application was 

approved: June 20, 2003. FDA has 

verified the applicant’s claim that NDA 

21–567 was approved on June 20, 2003.

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 72 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 November 29, 2004. 

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 

March 28, 2005. 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. Copies 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: August 30, 2004.

Jane A. Axelrad,

Associate Commissioner for Policy, Center for 

Drug Evaluation and Research.

[FR Doc. 04–21625 Filed 9–27–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2002E–0065]

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; KINERET

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for 

KINERET 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.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT:

Claudia V. Grillo, Office of Regulatory 

Policy (HFD–013), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 240–453–6699.

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 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 KINERET 

(anakinra). KINERET is indicated for the 

reduction of signs and symptoms of 

moderately to severely active 

rheumatoid arthritis, in patients 18 

years or older who have failed 1 or more 

disease modifying antirheumatic drugs 

(DMARDs). Subsequent to this approval, 

the Patent and Trademark Office 

received a patent term restoration 

application for Kineret (U.S. Patent No. 

5,075,222) from Amgen, 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 December 

30, 2002, FDA advised the Patent and 

Trademark Office that this human 

biologic product had undergone a 

regulatory review period and that the 

approval of KINERET represented the 

first permitted commercial marketing or 

use of the product. Shortly thereafter, 

the Patent and Trademark Office