Federal Register / Vol. 71, No. 182 / Wednesday, September 20, 2006 / Notices 54999 

approval, the Patent and Trademark 

Office received a patent term restoration 

application for MACUGEN (U.S. Patent 

No. 6,051,698) from Gilead Sciences, 

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 

June 28, 2005, FDA advised the Patent 

and Trademark Office that this human 

drug product had undergone a 

regulatory review period and that the 

approval of MACUGEN 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 

MACUGEN is 2,312 days. Of this time, 

2,128 days occurred during the testing 

phase of the regulatory review period, 

while 184 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 21, 

1998. The applicant claims August 20, 

1998, as the date the investigational new 

drug application (IND) became effective. 

However, FDA records indicate that the 

IND effective date was August 21, 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 

of the act: June 17, 2004. The applicant 

claims March 17, 2004, as the date the 

new drug application (NDA) for 

MACUGEN (NDA 21–756) was initially 

submitted. The applicant claims this is 

the date it submitted the first module of 

NDA 21–756, which was submitted in 

several modules as part of a rolling NDA 

submission procedure. It is FDA’s 

position that the approval phase begins 

when the marketing application is 

complete. A review of FDA records 

reveals that the final module of the 

marketing application was submitted on 

June 17, 2004, which is considered to be 

the NDA initially submitted date. 

3. The date the application was 

approved: December 17, 2004. FDA has 

verified the applicant’s claim that NDA 

21–756 was approved on December 17, 

2004. 

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 990 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 20, 2006. 

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 19, 2007. 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: September 1, 2006. 

Jane A. Axelrad, 

Associate Director for Policy, Center for Drug 

Evaluation and Research. 

[FR Doc. E6–15556 Filed 9–19–06; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2006D–0303] 

Draft Guidance for Industry on Public 

Availability of Labeling Changes in 

‘‘Changes Being Effected’’

Supplements; 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 ‘‘Public Availability of 

Labeling Changes in ‘Changes Being 

Effected’ Supplements.’’ The guidance 

announces to holders of a new drug 

application (NDA), an abbreviated new 

drug application (ANDA), or a biologics 

license application (BLA), who intend 

to submit a ‘‘Changes Being Effected’’

supplement (CBE supplement) to make 

a postapproval labeling change, that 

FDA will make labeling revisions 

identified in a CBE supplement publicly 

available upon receipt of the 

supplement by FDA. The guidance does 

not have any bearing on supplements 

that relate to chemistry, manufacturing, 

and controls changes, nor does it 

expand the circumstances in which an 

ANDA holder may effect labeling 

changes via a CBE supplement. 

DATES: Submit written or electronic 

comments on the draft guidance by 

November 20, 2006. General comments 

on agency guidance documents are 

welcome at any time. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Division of Drug Information (HFD–

240), Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857. Send one selfaddressed 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.fda.gov/dockets/ecomments. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the draft 

guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Meredith S. Francis, Center for Drug 

Evaluation and Research (HFD–7), Food 

and Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857, 301–594–

2041. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Public Availability of Labeling 

Changes in ‘Changes Being Effected’

Supplements.’’ FDA has begun an 

initiative to facilitate computerized 

access to drug information by 

consumers, pharmacists, and health care 

providers so that they will have faster 

and more comprehensive access to drug 

information. As part of this initiative, 

the agency has been involved in the 

development of a computerized 

repository of a broad array of drug 

information, known as ‘‘DailyMed.’’

Among other things, DailyMed contains 

the information referred to as ‘‘content 

of labeling,’’ which includes all the 

information found in prescription drug 

labeling and over-the-counter (OTC) 

drug facts labeling, including all text, 

tables, and figures (see 21 CFR 

314.50(l)(1)(i)). To maximize its ability 

to serve as a useful resource to 

consumers, pharmacists, and health care 

providers, DailyMed must contain the 


jlentini on PROD1PC65 with NOTICES
55000 Federal Register / Vol. 71, No. 182 / Wednesday, September 20, 2006 / Notices 

most up-to-date and comprehensive 

drug information available. 

Sections 314.70 and 601.12 (21 CFR 

314.70 and 601.12) of FDA regulations 

identify the types of supplemental 

applications that must be submitted to 

FDA to effect a labeling change to 

approved NDAs, ANDAs, and BLAs. 

Certain types of changes to labeling 

should receive FDA approval before the 

changes are implemented. These 

include all labeling changes that do not 

fall under § 314.70(c)(6)(iii), (d)(2)(ix), 

or (d)(2)(x), or under § 601.12(f)(2) or 

(f)(3). Other changes may be 

implemented by a sponsor upon the 

agency’s receipt of a CBE supplement. 

These changes are identified in 

§§ 314.70(c)(6)(iii) and 601.12(f)(2)(i). 

In the past, FDA has not made 

labeling publicly available until it has 

been approved, either under a preapproval supplement or under a CBE 

supplement. To make the most current 

labeling submitted to FDA available to 

health care practitioners and the public, 

and to facilitate the DailyMed initiative, 

FDA will make the revised labeling 

proposed in a CBE supplement publicly 

available on its Web site and through 

DailyMed shortly after the CBE 

supplement is received and before FDA 

has necessarily reviewed or approved it. 

If, after reviewing the CBE supplement, 

FDA decides it should not be approved, 

FDA will either: (1) Remove the labeling 

submitted with the CBE supplement 

from FDA’s Web site and from 

DailyMed and replace that labeling with 

the previous labeling; or (2) recommend 

the sponsor amend its labeling and, after 

the sponsor submits the amended 

labeling, post the amended labeling on 

FDA’s Web site and provide it to 

DailyMed promptly. 

A sponsor should not submit a CBE 

supplement to FDA until the sponsor is 

ready to distribute the labeling that it 

proposes in that CBE supplement. FDA 

will consider the submission of a CBE 

supplement to be consent by the 

sponsor to post the proposed labeling on 

FDA’s Web site and on DailyMed. 

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 public availability of labeling 

changes in CBE supplements. 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 on the draft guidance. 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. The draft guidance and 

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/cder/guidance/ 

index.htm or http://www.fda.gov/ 

ohrms/dockets/default.htm. 

Dated: September 13, 2006. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 06–7983 Filed 9–19–06; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HOMELAND 

SECURITY 

U.S. Citizenship and Immigration 

Services 

[CIS No. 2384–06; DHS Docket No. USCIS–

2006–0048] 

RIN 1615–ZA39 

Termination of the Designation of 

Liberia for Temporary Protected 

Status; Automatic Extension of 

Employment Authorization 

Documentation for Liberia TPS 

Beneficiaries 

AGENCY: U.S. Citizenship and 

Immigration Services, Department of 

Homeland Security. 

ACTION: Notice of termination of 

temporary protected status for Liberia. 

SUMMARY: Following a review of country 

conditions and consultations with the 

appropriate Government agencies, the 

Secretary of the Department of 

Homeland Security (DHS) has 

determined that the temporary protected 

status (TPS) designation of Liberia 

should be terminated. This termination 

will not take effect until October 1, 

2007, to provide for an orderly 

transition. This Notice informs the 

public of the termination of the Liberia 

TPS designation and sets forth 

procedures for nationals of Liberia (or 

aliens having no nationality who last 

habitually resided in Liberia) with TPS 

to re-register for TPS benefits. Reregistration is limited to persons who 

have previously registered for TPS 

under the designation of Liberia and 

whose application was granted or 

remains pending. Liberians (or aliens 

having no nationality who last 

habitually resided in Liberia) who have 

not previously been granted TPS, or 

who do not already have a pending 

application for TPS under the 

designation for Liberia, may not file 

under late initial filing provisions. Late 

initial filings (LIFs) are only allowed 

during an extension of a designation of 

TPS. 

Given the timeframes involved with 

processing TPS re-registrants, DHS 

recognizes that re-registrants might not 

receive a new EAD until after their 

current EAD expires on October 1, 2006. 

Accordingly, this Notice automatically 

extends the validity of EADs issued 

under the designation of TPS for Liberia 

for six months through April 1, 2007, 

and explains how TPS beneficiaries and 

their employers may determine which 

EADs are automatically extended. New 

EADs with an expiration date of 

September 30, 2007, will be issued to 

eligible TPS beneficiaries who timely reregister and apply for an EAD. 

DATES: Effective Dates: The termination 

of Liberia’s TPS designation is effective 

12:01 a.m., local time, October 1, 2007. 

To maintain TPS benefits through the 12 

months leading up to the effective date 

of the termination, Liberian TPS 

beneficiaries must comply with the reregistration requirements described in 

this Notice. The 60-day re-registration 

period begins September 20, 2006 and 

ends November 20, 2006. 

FOR FURTHER INFORMATION CONTACT: 

Matthew Horner, Status and Family 

Branch, Service Center Operations, U.S. 

Citizenship and Immigration Services, 

Department of Homeland Security, 20 

Massachusetts Avenue, NW., 2nd Floor, 

Washington, DC 20529, telephone (202) 

272–1505. This is not a toll free number. 

SUPPLEMENTARY INFORMATION: 

Abbreviations and Terms Used in This 

Document 

Act—Immigration and Nationality Act 

ASC—USCIS Application Support 

Center 

DHS—Department of Homeland 

Security 

DOS—Department of State 

EAD—Employment Authorization 

Document 

Secretary—Secretary of Homeland 

Security 

TPS—Temporary Protected Status 

USCIS—U.S. Citizenship and 

Immigration Services 


jlentini on PROD1PC65 with NOTICES