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Draft Guidance for Industry and FDA 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availability of the draft guidance 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 


cprice-sewell on DSK2BSOYB1PROD with NOTICES
Federal Register / Vol. 74, No. 191 / Monday, October 5, 2009 / Notices 51161 

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. 

Dated: September 30, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–23866 Filed 9–30–09; 11:15 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–D–0447] 

Draft Guidance for Industry on 

Helicobacter pylori-Associated 

Duodenal Ulcer Disease in Adults: 

Developing Drugs for Treatment; 

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 ‘‘Helicobacter pyloriAssociated Duodenal Ulcer Disease in 

Adults: Developing Drugs for 

Treatment.’’ The purpose of this draft 

guidance is to assist sponsors in clinical 

drug development for the treatment of 

adults with duodenal ulcers caused by 

H. pylori for the reduction of duodenal 

ulcer recurrence. Specifically, this 

guidance addresses FDA’s current 

thinking regarding the overall 

development program and clinical trial 

designs to support antimicrobialcontaining H. pylori treatment regimens. 

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 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. 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: 

Joette M. Meyer, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, rm. 6130, 

Silver Spring, MD 20993–0002, 301– 

796–1600. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Helicobacter pylori-Associated 

Duodenal Ulcer Disease in Adults: 

Developing Drugs for Treatment.’’ The 

purpose of this draft guidance is to 

assist sponsors in clinical antimicrobial 

drug development for the treatment of 

adults with duodenal ulcers caused by 

H. pylori for the reduction of duodenal 

ulcer recurrence. This guidance, when 

finalized, will supersede advice given in 

the draft guidance for industry entitled 

‘‘Evaluating Clinical Studies of 

Antimicrobials in the Division of AntiInfective Drug Products,’’ published in 

1997, which contains section V, 

regarding indication 25 H. pylori. 

This draft guidance pertains to 

development of drugs for the treatment 

of adults with duodenal ulcers. It does 

not address treatment of children, or 

those with other conditions also 

associated with H. pylori, including 

gastric ulcers and non-ulcer dyspepsia. 

Currently approved regimens for the 

treatment of adults with duodenal 

ulcers consist of multiple drugs used in 

combination. We anticipate that drug 

development for new drugs or regimens 

will occur in one of three ways: (1) 

Substitution of a new drug for one 

component of an approved regimen, (2) 

addition of a new drug to an approved 

regimen, and (3) development of a new 

regimen not studied previously. The 

draft guidance provides information on 

the type of study design and supportive 

information that should be provided for 

each of these development paths. 

Information is also provided regarding 

microbiological procedures and use of 

diagnostic testing to determine subject 

evaluability. 

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 developing drugs for the treatment of 

H. pylori-associated duodenal ulcer 

disease in adults. 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. The Paperwork Reduction Act of 

1995 

This guidance refers to previously 

approved collections of information 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 collections 

of information in 21 CFR parts 312 and 

314 have been approved under OMB 

control numbers 0910–0014 and 0910– 

0001, respectively. 

III. 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. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/ 

Guidances/default.htm or http:// 

www.regulations.gov. 

Dated: September 29, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–23875 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–N–0247] 

Food and Drug Administration 

Transparency Task Force; Public 

Meeting; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

second public meeting to discuss issues 

related to transparency at the agency. 

The purpose of this public meeting is to 

receive detailed and in-depth comments 

on three specific issues related to 


cprice-sewell on DSK2BSOYB1PROD with NOTICES