Federal Register / Vol. 74, No. 189 / Thursday, October 1, 2009 / Notices 50801 

Dated: September 20, 2009. 

Maryam I. Daneshvar, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. E9–23681 Filed 9–30–09; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2009–E–0017 and FDA– 

2009–E–0019] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; CLEVIPREX 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for 

CLEVIPREX 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 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 CLEVIPREX 

(clevidipine butyrate). CLEVIPREX is 

indicated for the reduction of blood 

pressure when oral therapy is not 

feasible or not desirable. Subsequent to 

this approval, the Patent and Trademark 

Office received patent term restoration 

applications for CLEVIPREX (U.S. 

Patent Nos. 5,739,152 and 5,856,346) 

from AstraZeneca AB, and the Patent 

and Trademark Office requested FDA’s 

assistance in determining the patents’ 

eligibilities for patent term restoration. 

In a letter dated February 18, 2009, FDA 

advised the Patent and Trademark 

Office that this human drug product had 

undergone a regulatory review period 

and that the approval of CLEVIPREX 

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 

CLEVIPREX is 4,475 days. Of this time, 

4,078 days occurred during the testing 

phase of the regulatory review period, 

while 397 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 CosmeticAct (the act) (21 U.S.C. 

355(i)) became effective: May 3, 1996. 

FDA has verified the applicant’s claim 

that the date the investigational new 

drug application became effective was 

on May 3, 1996. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 

505(b) of the act: July 2, 2007. FDA has 

verified the applicant’s claim that the 

new drug application (NDA) 22–156 

was submitted on July 2, 2007. 

3. The date the application was 

approved: August 1, 2008. FDA has 

verified the applicant’s claim that NDA 

22–156 was approved on August 1, 

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 1,314 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 30, 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 

March 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: June 23, 2009. 

Jane A. Axelrad, 

Associate Director for Policy, Center for Drug 

Evaluation and Research. 

[FR Doc. E9–23650 Filed 9–30–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–D–0461] 

Draft Guidance for Industry on Format 

and Content of Proposed Risk 

Evaluation and Mitigation Strategies 

(REMS), REMS Assessments, and 

Proposed REMS Modifications; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 


PWALKER on DSK8KYBLC1PROD with NOTICES
50802 Federal Register / Vol. 74, No. 189 / Thursday, October 1, 2009 / Notices 

1Section 505–1(b)(2) of the act (21 U.S.C. 

355(p)(1)) provides that section 505–1 of the act 

applies to applications for prescription drugs 

approved under section 505(b) or (j) of the act and 

applications approved under section 351 of the 

Public Health Service Act (42 U.S.C. 262). See 

Section 505(p)(1). 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘Format and Content 

of Proposed Risk Evaluation and 

Mitigation Strategies (REMS), REMS 

Assessments, and Proposed REMS 

Modifications.’’ The Food and Drug 

Administration Amendments Act of 

2007 (FDAAA) added new provisions to 

the Federal Food, Drug, and Cosmetic 

Act (the act) giving FDA the authority to 

require REMS. The draft guidance 

describes the format and content of a 

proposed risk evaluation and mitigation 

strategy, including REMS supporting 

documentation, the content of 

assessments and proposed 

modifications of approved REMS, what 

identifiers to use on REMS documents, 

and how to communicate with FDA 

about a REMS. 

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 December 30, 2009. 

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 the 

Office of Communication, Outreach, and 

Development (HFM–40), Center for 

Biologics Evaluation and Research 

(CBER), Food and Drug Administration, 

1401 Rockville Pike, Rockville, MD 

20852–1448. The draft guidance may 

also be obtained by mail by calling 

CBER at 1–800–835–4709 or 301–827– 

1800. 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. 

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: 

Regarding questions for the Center for 

Drug Evaluation and Research: 

Kathleen Frost, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, rm. 4316, 

Silver Spring, MD 20993–0002, 

301–796–2380. 

Regarding questions for the Center for 

Biologics Evaluation and Research: 

Stephen Ripley, Center for Biologics 

Evaluation and Research (HFM–17), 

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 

‘‘Format and Content of Proposed Risk 

Evaluation and Mitigation Strategies 

(REMS), REMS Assessments, and 

Proposed REMS Modifications.’’ On 

September 27, 2007, the President 

signed into law FDAAA (Public Law 

110–85). Title IX, Subtitle A, section 

901 of FDAAA created new section 505– 

1 of the Federal Food, Drug, and 

Cosmetic Act (the act) (21 U.S.C. 355– 

1). Section 505–1(a) of the act authorizes 

FDA to require persons who submit 

certain applications or hold certain 

approved applications1 to submit a 

proposed REMS if FDA determines that 

a REMS is necessary to ensure that the 

benefits of a drug outweigh the risks of 

the drug and informs the holder of the 

application for the drug of the 

determination. Sections 505–1(c) 

through (f) describe the content of a 

required strategy. Section 505–1(g) 

describes assessments and 

modifications of an approved strategy. 

The draft guidance provides 

information regarding FDA’s current 

thinking on the format and content that 

should be used for submissions of 

proposed REMS, including a description 

of REMS supporting documentation. It 

also includes preliminary information 

on the content of assessments and 

proposed modifications of approved 

REMS, information on identifiers that 

should be included on the first page of 

REMS submissions, and information on 

whom to contact to communicate with 

FDA about a REMS. 

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 the format and content of proposed 

REMS, REMS assessments, and 

proposed REMS modifications. 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. Paperwork Reduction Act of 1995 

This guidance contains information 

collection provisions that are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3520). The collection of information in 

the guidance was approved under OMB 

control numbers 0910–0001 and 0910– 

0338. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/cder/guidance/ 

index.htm or http:// 

www.regulations.gov. 

Dated: September 25, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–23616 Filed 9–30–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Eunice Kennedy Shriver National 

Institute of Child Health and Human 

Development; Notice of Meeting 

Pursuant to section 10(a) of the 

Federal Advisory Committee Act, as 

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

hereby given of a meeting of the 

National Children’s Study Advisory 

Committee. 

The meeting will be open to the 

public, with attendance limited to space 

available. Individuals who plan to 

attend and need special assistance, such 

as sign language interpretation or other 

reasonable accommodations, should 

notify the Contact Person listed below 

in advance of the meeting. 

Name of Committee: National Children’s 

Study Advisory Committee. 


PWALKER on DSK8KYBLC1PROD with NOTICES