Guidance for Industry on Listing of Ingredients in Tobacco Products; Availability, 62795-62796 [E9-28747]

Download as PDF Federal Register / Vol. 229, No. 74 / Tuesday, December 1, 2009 / Notices Dated: November 20, 2009. David Horowitz, Assistant Commissioner for Policy. [FR Doc. E9–28593 Filed 11–30–09; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2009–D–0466] Draft Compliance Policy Guide Sec. 527.300 Dairy Products—Microbial Contaminants and Alkaline Phosphatase Activity (Compliance Policy Guide 7106.08); Availability AGENCY: Food and Drug Administration, HHS. mstockstill on DSKH9S0YB1PROD with NOTICES ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of draft Compliance Policy Guide Sec. 527.300 Dairy Products— Microbial Contaminants and Alkaline Phosphatase Activity (CPG 7106.08) (the draft CPG). The draft CPG, when finalized, will provide guidance for FDA staff on its enforcement policies for pathogens and other indicators of inadequate pasteurization or postpasteurization contamination of dairy products. DATES: Although you can comment on any CPG at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comment on the draft CPG before it begins work on the final version of the CPG, submit written or electronic comments on the draft CPG by February 1, 2010. ADDRESSES: Submit written comments on the draft CPG to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments on the draft CPG to https://www.regulations.gov. Submit written requests for single copies of the draft CPG to the Division of Compliance Policy (HFC–230), Office of Enforcement, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Send two selfaddressed adhesive labels to assist that office in processing your request. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft CPG. FOR FURTHER INFORMATION CONTACT: Monica Metz, Center for Food Safety and Applied Nutrition (HFS–316), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301–436–2041. SUPPLEMENTARY INFORMATION: VerDate Nov<24>2008 20:14 Nov 30, 2009 Jkt 220001 I. Background The draft CPG is intended to provide guidance for FDA staff regarding pathogens and indicators of inadequate pasteurization or post-pasteurization contamination of dairy products. The draft CPG outlines regulatory enforcement policies for FDA staff to use to initiate legal action recommendations based on analytical determinations that a dairy product contains a pathogenic micro-organism (i.e., Salmonella species, enterohemorrhagic Escherichia coli (EHEC) O157:H7, Campylobacter jejuni, Yersinia enterocolitica, or Clostridium botulinum); toxins produced by Clostridium botulinum, enterotoxigenic Staphylococcus, or Bacillus cereus; Staphylococcus aureus; Bacillus cereus, nontoxigenic Escherichia coli; or alkaline phosphatase. The draft CPG also contains information that may be useful to the regulated industry and to the public. FDA is issuing the draft CPG as level 1 draft guidance consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft CPG, when finalized, will represent the agency’s current thinking on pathogens and indicators of inadequate pasteurization or post-pasteurization contamination of dairy products. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternate 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 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. III. Electronic Access Persons with access to the Internet may obtain the draft CPG at https:// www.fda.gov/ora/compliance_ref/cpg/ default.htm or https:// www.regulations.gov. PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 62795 Dated: November 24, 2009. Michael A. Chappell, Acting Associate Commissioner for Regulatory Affairs. [FR Doc. E9–28756 Filed 11–30–09; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2009–D–0524] Guidance for Industry on Listing of Ingredients in Tobacco Products; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ‘‘Listing of Ingredients in Tobacco Products.’’ The guidance document is intended to assist persons making tobacco product ingredient submissions to FDA under the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). DATES: Submit written or electronic comments on this guidance at any time. General comments on agency guidance documents are welcome at any time. ADDRESSES: Submit written requests for single copies of the guidance document entitled ‘‘Listing of Ingredients in Tobacco Products’’ to the Center for Tobacco Products, Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850–3229. Send one self-addressed adhesive label to assist that office in processing your request or include a fax number to which the guidance document may be sent. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance document. Submit written comments on the 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 20850–3229, 301–796– 4800, Michele.Mital@fda.hhs.gov. SUPPLEMENTARY INFORMATION: E:\FR\FM\01DEN1.SGM 01DEN1 62796 Federal Register / Vol. 229, No. 74 / Tuesday, December 1, 2009 / Notices mstockstill on DSKH9S0YB1PROD with NOTICES I. Background In the Federal Register of November 3, 2009 (74 FR 56842), FDA announced the availability of a draft guidance document entitled ‘‘Listing of Ingredients in Tobacco Products.’’ The agency considered received comments as it finalized this guidance. This guidance document is designed to assist tobacco product manufacturers and importers with making tobacco product ingredient submissions to FDA. Under section 904(a)(1) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 387d(a)(1)), as amended by the Tobacco Control Act, each tobacco product manufacturer or importer, or agent thereof, is required to submit ‘‘a listing of all ingredients, including tobacco, substances, compounds, and additives that are * * * added by the manufacturer to the tobacco, paper, filter, or other part of each tobacco product by brand and by quantity in each brand and subbrand.’’ For tobacco products on the market as of June 22, 2009, information must be submitted to FDA by December 22, 2009, and include the ingredients added as of the date of submission. FDA does not, however, intend to enforce the statutory deadline of this subsection provided the ingredient list is submitted on or before June 22, 2010. For tobacco products not on the market as of June 22, 2009, section 904(c)(1) requires that the list of ingredients be submitted at least 90 days prior to delivery for introduction into interstate commerce. Section 904(c) of the act also requires submission of information whenever additives, or the quantities of additives, are changed. FDA does not, however, intend to enforce the statutory deadlines for ingredient reporting under section 904(c) of the act for additive changes or the initial introduction of products into interstate commerce occurring between June 22, 2009, and 90 days after the section 904(a)(1) ingredient list is submitted, provided that these report(s) are submitted at the time of the section 904(a)(1) submission and the report(s) include the date, or planned date, of making the change to the additive or introducing the product into interstate commerce. II. Significance of Guidance This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the agency’s current thinking on ‘‘Listing of Ingredients in Tobacco Products.’’ It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An VerDate Nov<24>2008 20:14 Nov 30, 2009 Jkt 220001 alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations. 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. Paperwork Reduction Act of 1995 This guidance contains information collection provisions 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 collection of information in this guidance was approved under OMB control number 0910–0650. V. Electronic Access An electronic version of the guidance document is available on the Internet at https://www.regulations.gov and https:// www.fda.gov/TobaccoProducts/ GuidanceComplianceRegulatory Information/default.htm. Dated: November 25, 2009. David Horowitz, Assistant Commissioner for Policy. [FR Doc. E9–28747 Filed 11–27–09; 11:15 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Center for Scientific Review Special Emphasis Panel, Drug Targeting. Date: December 15, 2009. Time: 1 p.m. to 2:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Hungyi Shau, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6186, MSC 7804, Bethesda, MD 20892, 301–435– 1720, shauhung@csr.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: Center for Scientific Review Special Emphasis Panel, OBT Review Panel Member Applications. Date: January 7–8, 2010. Time: 9 a.m. to 10 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Nywana Sizemore, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6204, MSC 7804, Bethesda, MD 20892, 301–435– 1718, sizemoren@csr.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393–93.396, 93.837–93.844, 93.846–93.878, 93.892, 93.893, National Institutes of Health, HHS) Dated: November 24, 2009. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. E9–28732 Filed 11–30–09; 8:45 am] BILLING CODE 4140–01–P National Institutes of Health DEPARTMENT OF HEALTH AND HUMAN SERVICES Center For Scientific Review; Notice of Closed Meetings National Institutes of Health Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which Center for Scientific Review; Amended Notice of Meeting PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 Notice is hereby given of a change in the meeting of the Center for Scientific Review Special Emphasis Panel, November 24, 2009, 3 p.m. to November 24, 2009, 5 p.m., National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD, 20892 which was published in the Federal Register on November 18, 2009, 74 FR 59569. The meeting will be held December 9, 2009, from 12 p.m. to 2 p.m. The meeting location remains the same. The meeting is closed to the public. E:\FR\FM\01DEN1.SGM 01DEN1

Agencies

[Federal Register Volume 74, Number 229 (Tuesday, December 1, 2009)]
[Notices]
[Pages 62795-62796]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-28747]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0524]


Guidance for Industry on Listing of Ingredients in Tobacco 
Products; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance entitled ``Listing of Ingredients in Tobacco 
Products.'' The guidance document is intended to assist persons making 
tobacco product ingredient submissions to FDA under the Family Smoking 
Prevention and Tobacco Control Act (Tobacco Control Act).

DATES: Submit written or electronic comments on this guidance at any 
time. General comments on agency guidance documents are welcome at any 
time.

ADDRESSES: Submit written requests for single copies of the guidance 
document entitled ``Listing of Ingredients in Tobacco Products'' to the 
Center for Tobacco Products, Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850-3229. Send one self-addressed 
adhesive label to assist that office in processing your request or 
include a fax number to which the guidance document may be sent. See 
the SUPPLEMENTARY INFORMATION section for information on electronic 
access to the guidance document.
    Submit written comments on the 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 20850-3229, 301-796-4800, Michele.Mital@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

[[Page 62796]]

I. Background

    In the Federal Register of November 3, 2009 (74 FR 56842), FDA 
announced the availability of a draft guidance document entitled 
``Listing of Ingredients in Tobacco Products.'' The agency considered 
received comments as it finalized this guidance. This guidance document 
is designed to assist tobacco product manufacturers and importers with 
making tobacco product ingredient submissions to FDA. Under section 
904(a)(1) of the Federal Food, Drug, and Cosmetic Act (the act) (21 
U.S.C. 387d(a)(1)), as amended by the Tobacco Control Act, each tobacco 
product manufacturer or importer, or agent thereof, is required to 
submit ``a listing of all ingredients, including tobacco, substances, 
compounds, and additives that are * * * added by the manufacturer to 
the tobacco, paper, filter, or other part of each tobacco product by 
brand and by quantity in each brand and subbrand.'' For tobacco 
products on the market as of June 22, 2009, information must be 
submitted to FDA by December 22, 2009, and include the ingredients 
added as of the date of submission. FDA does not, however, intend to 
enforce the statutory deadline of this subsection provided the 
ingredient list is submitted on or before June 22, 2010. For tobacco 
products not on the market as of June 22, 2009, section 904(c)(1) 
requires that the list of ingredients be submitted at least 90 days 
prior to delivery for introduction into interstate commerce. Section 
904(c) of the act also requires submission of information whenever 
additives, or the quantities of additives, are changed. FDA does not, 
however, intend to enforce the statutory deadlines for ingredient 
reporting under section 904(c) of the act for additive changes or the 
initial introduction of products into interstate commerce occurring 
between June 22, 2009, and 90 days after the section 904(a)(1) 
ingredient list is submitted, provided that these report(s) are 
submitted at the time of the section 904(a)(1) submission and the 
report(s) include the date, or planned date, of making the change to 
the additive or introducing the product into interstate commerce.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
agency's current thinking on ``Listing of Ingredients in Tobacco 
Products.'' 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. 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. Paperwork Reduction Act of 1995

    This guidance contains information collection provisions 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 
collection of information in this guidance was approved under OMB 
control number 0910-0650.

V. Electronic Access

    An electronic version of the guidance document is available on the 
Internet at https://www.regulations.gov and https://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm.

    Dated: November 25, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-28747 Filed 11-27-09; 11:15 am]
BILLING CODE 4160-01-S
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