54888 Federal Register / Vol. 75, No. 174 / Thursday, September 9, 2010 / Notices 

ADDRESSES) electronic or written 

comments and written petitions. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send three copies of mailed comments. 

However, if you submit a written 

petition, you must submit three copies 

of the petition. Identify comments with 

the docket number found in brackets in 

the heading of this document. 

Comments and petitions that have not 

been made publicly available on 

regulations.gov may be viewed in the 

Division of Dockets Management 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

Dated: August 13, 2010. 

Jane A. Axelrad, 

Associate Director for Policy, Center for Drug 

Evaluation and Research. 

[FR Doc. 2010–22496 Filed 9–8–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–E–0416] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; IXIARO 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for IXIARO 

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 electronic 

comments to http:// 

www.regulations.gov. Submit written 

petitions along with three copies and 

written comments to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852. 

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 IXIARO 

(Japanese Encephalitis Virus, Vaccine 

Inactivated, Adsorbed). IXIARO is 

indicated for active immunization for 

the prevention of disease caused by 

Japanese encephalitis virus in persons 

17 years of age and older. Subsequent to 

this approval, the Patent and Trademark 

Office received a patent term restoration 

application for IXIARO (U.S. Patent No. 

6,309,650) from Chiel Jedang Corp. and 

Walter Reed Army Institute of Research, 

and the Patent and Trademark Office 

requested FDA’s assistance in 

determining this patent’s eligibility for 

patent term restoration. In a letter dated 

February 17, 2010, FDA advised the 

Patent and Trademark Office that this 

human biological product had 

undergone a regulatory review period 

and that the approval of IXIARO 

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 

IXIARO is 3,461 days. Of this time, 

2,994 days occurred during the testing 

phase of the regulatory review period, 

while 467 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 (21 U.S.C. 355(i)) 

became effective: October 10, 1999. The 

applicant claims October 9, 1999, as the 

date the investigational new drug 

application (IND) became effective. 

However, FDA records indicate that the 

IND effective date was October 10, 1999, 

which was 30 days after FDA receipt of 

the IND. 

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): December 20, 2007. FDA 

has verified the applicant’s claim that 

the biologics license application (BLA) 

for IXIARO (BLA B125280/0) was 

initially submitted on December 20, 

2007. 

3. The date the application was 

approved: March 30, 2009. FDA has 

verified the applicant’s claim that BLA 

B125280/0 was approved on March 30, 

2009. 

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 1,588 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) either 

electronic or written comments and ask 

for a redetermination by November 8, 

2010. 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 8, 2011. 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. 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) electronic or written 

comments and written petitions. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send three copies of mailed comments. 

However, if you submit a written 

petition, you must submit three copies 

of the petition. Identify comments with 

mstockstill on DSKH9S0YB1PROD with NOTICES

Federal Register / Vol. 75, No. 174 / Thursday, September 9, 2010 / Notices 54889 

the docket number found in brackets in 

the heading of this document. 

Comments and petitions that have not 

been made publicly available on 

regulations.gov may be viewed in the 

Division of Dockets Management 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

Dated: August 13, 2010. 

Jane A. Axelrad, 

Associate Director for Policy, Center for Drug 

Evaluation and Research. 

[FR Doc. 2010–22394 Filed 9–8–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Toxic Substances and 

Disease Registry 

[ATSDR–265] 

Development of Set 24 Toxicological 

Profiles 

AGENCY: Agency for Toxic Substances 

and Disease Registry (ATSDR), 

Department of Health and Human 

Services (DHHS). 

ACTION: Notice. 

DATES: Profiles will be available to the 

public on or about October 17, 2010. 

SUMMARY: The Agency for Toxic 

Substances and Disease Registry 

(ATSDR) of the Department of Health 

and Human Services is developing Set 

24 Toxicological Profiles. Set 24 

Toxicological Profiles consists of one 

new draft and one updated draft. 

Electronic access to these documents 

will be available at the ATSDR Web site: 

http://www.atsdr.cdc.gov/toxpro2.html. 

Set 24 Toxicological Profiles 

The following toxicological profiles 

are now being developed: 

Toxicological profile CAS number 

Toxaphene ............................ 8001–35–2 

Trichlorobenzene* 

1,2,3–Trichlorobenzene 87–61–6 

1,2,4–Trichlorobenzene 120–82–1 

1,3,5–Trichlorobenzene 108–70–3 

Trichlorobenzene .... 12002–48–1 

* Denotes new profile. 

SUPPLEMENTARY INFORMATION: The 

Superfund Amendments and 

Reauthorization Act of 1986 (42 U.S.C. 

9601 et seq.) amended the 

Comprehensive Environmental 

Response, Compensation, and Liability 

Act of 1980 (CERCLA) (42 U.S.C. 9601 

et seq.) by establishing certain 

requirements for ATSDR and the U.S. 

Environmental Protection Agency (EPA) 

with regard to hazardous substances 

that are most commonly found at 

facilities on the CERCLA National 

Priorities List. Among these statutory 

requirements is a mandate for the 

Administrator of ATSDR to prepare 

toxicological profiles for each substance 

included on the Priority List of 

Hazardous Substances (http:// 

www.atsdr.cdc.gov/cercla/07list.html). 

This list names 275 hazardous 

substances that pose the most 

significant potential threat to human 

health as determined by ATSDR and 

EPA. The availability of the revised list 

of the 275 priority substances was 

announced in the Federal Register on 

March 6, 2008 (73 FR 12178). For prior 

versions of the list of substances, see 

Federal Register notices dated April 17, 

1987 (52 FR 12866); October 20, 1988 

(53 FR 41280); October 26, 1989 (54 FR 

43619); October 17, 1990 (55 FR 42067); 

October 17, 1991 (56 FR 52166); October 

28, 1992 (57 FR 48801); February 28, 

1994 (59 FR 9486); April 29, 1996 (61 

FR 18744; November 17, 1997 (62 FR 

61332); October 21, 1999 (64 FR 56792); 

October 25, 2001 (66 FR 54014); 

November 7, 2003 (68 FR 63098); and 

December 7, 2005 (70FR 70284). 

Notice of the availability of drafts of 

one updated and one new toxicological 

profile for public review and comment 

will be published in the Federal 

Register on or about October 17, 2010, 

with notice of a 90-day public comment 

period for each profile, starting from the 

actual release date. Following the close 

of the comment period, chemicalspecific comments will be addressed, 

and where appropriate, revisions will be 

incorporated into each profile. 

FOR FURTHER INFORMATION CONTACT: 

Commander Jessilynn B. Taylor, 

Division of Toxicology and 

Environmental Medicine, Agency for 

Toxic Substances and Disease Registry, 

1600 Clifton Road, NE., Mail Stop F–62, 

Atlanta, GA 30333; telephone (770) 

488–3313; e-mail: JBTaylor@cdc.gov. 

Dated: September 3, 2010. 

Ken Rose, 

Associate Director, Office of Policy, Planning 

and Evaluation, National Center for 

Environmental Health/Agency for Toxic 

Substances and Disease Registry. 

[FR Doc. 2010–22439 Filed 9–8–10; 8:45 am] 

BILLING CODE 4163–70–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–D–0451] 

Draft Guidance for Industry on 

Suicidality: Prospective Assessment of 

Occurrence in Clinical Trials; 

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 ‘‘Suicidality: 

Prospective Assessment of Occurrence 

in Clinical Trials.’’ The purpose of this 

guidance is to assist sponsors in 

prospectively assessing the occurrence 

of treatment-emergent suicidality in 

clinical trials of drug and biological 

products. Specifically, this guidance 

addresses FDA’s current thinking 

regarding the importance of suicidality 

assessment in psychiatric and 

nonpsychiatric drug trials and the 

general principles for how best to 

accomplish this assessment during drug 

development. 

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 

either electronic or written comments 

on the draft guidance by November 8, 

2010. 

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. Send 

one self-addressed adhesive label to 

assist that office in processing your 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance document. 

Submit electronic comments on the 

draft guidance to http:// 

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Thomas Laughren, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, rm. 4114, 

Silver Spring, MD 20993–0002, 301– 

796–2260. 

mstockstill on DSKH9S0YB1PROD with NOTICES