Draft Guidance for Industry and FDA Staff; the Scope of the Prohibition Against Marketing a Tobacco Product in Combination With Another Article or Product Regulated Under the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, 51160-51161 [E9-23866]

Download as PDF 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CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2009–D–0470] Draft Guidance for Industry and FDA Staff; the Scope of the Prohibition Against Marketing a Tobacco Product in Combination With Another Article or Product Regulated Under the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. cprice-sewell on DSK2BSOYB1PROD with NOTICES 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 SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ‘‘The Scope of the Prohibition Against Marketing a Tobacco Product in Combination with Another Article or Product Regulated under the Federal Food,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 VerDate Nov<24>2008 14:59 Oct 02, 2009 Jkt 220001 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 https:// 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 PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 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 https:// www.fda.gov/tobaccoproducts. This guidance document is also available at https://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 E:\FR\FM\05OCN1.SGM 05OCN1 Federal Register / Vol. 74, No. 191 / Monday, October 5, 2009 / Notices 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. cprice-sewell on DSK2BSOYB1PROD with NOTICES 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 https:// www.regulations.gov. See the VerDate Nov<24>2008 14:59 Oct 02, 2009 Jkt 220001 51161 SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. used if such approach satisfies the requirements of the applicable statutes and regulations. 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: 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. 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 PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 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 https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or https:// 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 E:\FR\FM\05OCN1.SGM 05OCN1

Agencies

[Federal Register Volume 74, Number 191 (Monday, October 5, 2009)]
[Notices]
[Pages 51160-51161]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-23866]

-----------------------------------------------------------------------

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 self-addressed 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 https://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 https://www.fda.gov/tobaccoproducts. This guidance document is also available at https://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

[[Page 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

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.