Federal Register / Vol. 74, No. 191 / Monday, October 5, 2009 / Notices 51159 

Technical assistance provider organizations Amount of 

award Location 

Family Violence Prevention Fund ................................................................................................................ $175,000 San Francisco, CA. 

Domestic Abuse Intervention Programs ...................................................................................................... 50,000 Minneapolis, MN. 

Hektoen Institute, LLC ................................................................................................................................. 50,000 Chicago, IL. 

National Network to End Domestic Violence .............................................................................................. 100,000 Washington, DC. 

A $25,000 expansion supplement 

grant is awarded to the Institute on 

Domestic Violence in the African 

American Community (IDVAAC), 

Minneapolis, MN, for the period of July 

1, 2009 through September 30, 2009, to 

support development of conference 

materials, a scholarly publication on 

healing after domestic violence, and 

conference scholarships. 

Contact for Further Information: 

Marylouise Kelley, Ph.D., Director, 

Family Violence Prevention and 

Services Program, 1250 Maryland 

Avenue, SW., Suite 8216, Washington, 

DC, 20024. Telephone: 202–104–5756 Email: Marylouise.kelley@acf.hhs.gov. 

Dated: September 28, 2009. 

Maiso L. Bryant, 

Acting Commissioner, Administration on 

Children, Youth and Families. 

[FR Doc. E9–23922 Filed 10–2–09; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–E–0057] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; EMEND FOR INJECTION 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for EMEND 

FOR INJECTION 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 EMEND FOR 

INJECTION (fosaprepitant meglumine). 

EMEND FOR INJECTION, in 

combination with other antiemetic 

agents, is indicated for the prevention of 

acute and delayed nausea and vomiting 

associated with initial and repeat 

courses of highly emetogenic cancer 

chemotherapy including high-dose 

cisplatin, and for prevention of nausea 

and vomiting associated with initial and 

repeat courses of moderately emetogenic 

cancer chemotherapy. Subsequent to 

this approval, the Patent and Trademark 

Office received a patent term restoration 

application for EMEND FOR INJECTION 

(U.S. Patent No. 5,691,336) from Merck 

& Co., 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 February 26, 2009, FDA 

advised the Patent and Trademark 

Office that this human drug product had 

undergone a regulatory review period 

and that the approval of EMEND FOR 

INJECTION 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 

EMEND FOR INJECTION is 4,473 days. 

Of this time, 3,810 days occurred during 

the testing phase of the regulatory 

review period, while 663 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 29, 

1995. The applicant claims October 28, 

1995, as the date the investigational new 

drug application (IND) became effective. 

However, FDA records indicate that the 

IND effective date was October 29, 1995, 

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: April 3, 2006. The 

applicant claims March 31, 2006, as the 

date the new drug application (NDA) for 

Emend for Injection (NDA 22–023) was 

initially submitted. However, FDA 

records indicate that NDA 22–023 was 

submitted on April 3, 2006. 

3. The date the application was 

approved: January 25, 2008. FDA has 

verified the applicant’s claim that NDA 

22–023 was approved on January 25, 

2008. 

This determination of the regulatory 

review period establishes the maximum 

potential length of a patent extension. 

However, the U.S. Patent and 


cprice-sewell on DSK2BSOYB1PROD with NOTICES
51160 Federal Register / Vol. 74, No. 191 / Monday, October 5, 2009 / Notices 

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 1,826 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 December 4, 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 

April 5, 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. E9–23900 Filed 10–2–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–D–0470] 

Draft Guidance for Industry and FDA 

Staff; the Scope of the Prohibition 

Against Marketing a Tobacco Product 

in Combination With Another Article or 

Product Regulated Under the Federal 

Food, Drug, and Cosmetic Act; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the draft guidance 

entitled ‘‘The Scope of the Prohibition 

Against Marketing a Tobacco Product in 

Combination with Another Article or 

Product Regulated under the Federal 

Food, Drug, and Cosmetic Act.’’ This 

guidance is intended for manufacturers, 

retailers, importers, and FDA staff. The 

Federal Food, Drug, and Cosmetic Act 

(FDCA), as amended by the Family 

Smoking Prevention and Tobacco 

Control Act (FSPTCA), states ‘‘A 

tobacco product shall not be marketed 

in combination with any other article or 

product regulated under this Act 

(including a drug, biologic, food, 

cosmetic, medical device, or a dietary 

supplement).’’ The guidance discusses 

certain activities that FDA believes do 

or do not fall within the scope of the 

prohibition. The guidance is not 

intended to be an exhaustive analysis of 

all activities that may or may not fall 

within the scope of the prohibition. 

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 January 4, 2010. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance 

document entitled ‘‘The Scope of the 

Prohibition Against Marketing a 

Tobacco Product in Combination with 

Another Article or Product Regulated 

under the Federal Food, Drug, and 

Cosmetic Act’’ to the Center for Tobacco 

Products, Food and Drug 

Administration, 9200 Corporate Blvd., 

Rockville, MD 20850. Send one selfaddressed adhesive label to assist that 

office in processing your request, or fax 

your request to 301–595–7946. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance. 

Submit written comments concerning 

this 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. Identify 

comments with the docket number 

found in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Michele Mital, Center for Tobacco 

Products, Food and Drug 

Administration, 9200 Corporate Blvd., 

Rockville, MD 0850–3229, 301–796– 

4800, Michele.Mital@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On June 22, 2009, the President 

signed the FSPTCA (Public Law 111–31) 

into law. The FSPTCA amended the 

FDCA (21 U.S.C. 301 et seq.) by adding 

a new chapter granting FDA important 

new authority to regulate the 

manufacture, marketing, and 

distribution of tobacco products to 

protect the public health generally and 

to reduce tobacco use by minors. 

Section 201(rr)(4) of the FDCA, as 

amended by the FSPTCA, states ‘‘A 

tobacco product shall not be marketed 

in combination with any other article or 

product regulated under this Act 

(including a drug, biologic, food, 

cosmetic, medical device, or a dietary 

supplement).’’ 

This guidance discusses certain 

activities that FDA believes do or do not 

fall within the scope of the prohibition. 

The guidance is not intended to be an 

exhaustive analysis of all activities that 

may or may not fall within the scope of 

the prohibition. 

II. Significance of Guidance 

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 Scope of the Prohibition 

Against Marketing a Tobacco Product in 

Combination with Another Article or 

Product Regulated under the Federal 

Food, Drug, and Cosmetic Act.’’ 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 statute and regulations. 

III. Electronic Access 

Persons interested in obtaining a copy 

of the draft guidance may do so by using 

the Internet. The guidance document 

may be accessed at the Center for 

Tobacco Products’ Web site at http:// 

www.fda.gov/tobaccoproducts. This 

guidance document is also available at 

http://www.regulations.gov. To receive 

‘‘The Scope of the Prohibition Against 

Marketing a Tobacco Product in 

Combination with Another Article or 

Product Regulated under the Federal 

Food, Drug, and Cosmetic Act,’’ you 

may either send an e-mail request to 

michele.mital@fda.hhs.gov to receive an 

electronic copy of the document or send 

a fax request to 301–595–7946 to receive 

a hard copy. 

IV. 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 


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