Draft Guidance for Industry on Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments; Availability, 54052-54053 [E9-25235]

Download as PDF 54052 Federal Register / Vol. 74, No. 202 / Wednesday, October 21, 2009 / Notices proposal also offered Dr. Gonsalves an opportunity to request a hearing, providing him 30 days from the date of receipt of the letter in which to file the request, and advised him that failure to request a hearing constituted a waiver of the opportunity for a hearing and of any contentions concerning this action. Dr. Gonsalves did not request a hearing and has, therefore, waived his opportunity for a hearing and waived any contentions concerning his debarment (21 CFR part 12). Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: September 29, 2009. Brenda Holman, Acting Director, Office of Enforcement, Office of Regulatory Affairs. [FR Doc. E9–25322 Filed 10–20–09; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES jlentini on DSKJ8SOYB1PROD with NOTICES II. Findings and Order Food and Drug Administration Therefore, the Acting Director, Office of Enforcement, Office of Regulatory Affairs, under section 306(a)(2)(B) of the act and under authority delegated to the Acting Director (Staff Manual Guide 1410.35), finds that Dr. Gonsalves has been convicted of a felony under Federal law for conduct relating to the regulation of a drug product under the act. As a result of the foregoing finding, Dr. Gonsalves is permanently debarred from providing services in any capacity to a person with an approved or pending drug product application under sections 505, 512, or 802 of the act (21 U.S.C. 355, 360b, or 382), or under section 351 of the Public Health Service Act (42 U.S.C. 262), effective (see DATES) (see section 306(c)(1)(B) and (c)(2)(A)(ii) of the act and section 201(dd) of the act (21 U.S.C. 321(dd)). Any person with an approved or pending drug product application who knowingly employs or retains as a consultant or contractor, or otherwise uses the services of Dr. Gonsalves, in any capacity, during Dr. Gonsalves’ debarment, will be subject to civil money penalties (section 307(a)(6) of the act (21 U.S.C. 335b(a)(6)). If Dr. Gonsalves, during his period of debarment, provides services in any capacity to a person with an approved or pending drug product application, he will be subject to civil money penalties (section 307(a)(7) of the act). In addition, FDA will not accept or review any abbreviated new drug applications submitted by or with the assistance of Dr. Gonsalves during his debarment (section 306(c)(1)(B) of the act). Any application by Dr. Gonsalves for special termination of debarment under section 306(d)(4) of the act should be identified with Docket No. FDA–2009– N–0287 and sent to the Division of Dockets Management (see ADDRESSES). All such submissions are to be filed in four copies. The public availability of information in these submissions is governed by 21 CFR 10.20(j). Publicly available submissions may be seen in the Division of Dockets [Docket No. FDA–2009–D–0508] VerDate Nov<24>2008 17:33 Oct 20, 2009 Jkt 220001 Draft Guidance for Industry on Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments; 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 ‘‘Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments.’’ The draft guidance document is intended to assist persons making tobacco product establishment registration and product listing submissions to FDA under The Family Smoking Prevention and Tobacco Control Act (FSPTCA). 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 October 30, 2009. ADDRESSES: Submit written requests for single copies of the draft guidance document entitled ‘‘Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments’’ 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 draft guidance document may be sent. See the SUPPLEMENTARY INFORMATION section for 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 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 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: I. Background On June 22, 2009, the President signed the FSPTCA (Public Law 111–31) into law. The FSPTCA amended the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 301 et seq.) by, among other things, 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 905(b) of the act (21 U.S.C. 395(b)), as amended by the FSPTCA, requires that ‘‘every person who owns or operates any establishment in any State engaged in the manufacture, preparation, compounding, or processing of a tobacco product or tobacco products’’ register with FDA the name, places of business, and all establishments owned or operated by that person. Every person must register by December 31 of each year. Section 905(i)(1) of the act, as amended by the FSPTCA, requires that all registrants ‘‘shall, at the time of registration under any such subsection, file with [FDA] a list of all tobacco products which are being manufactured, prepared, compounded, or processed by that person for commercial distribution,’’ along with certain accompanying consumer information, such as all labeling and a representative sampling of advertisements. While electronic submission of registration and listing information is not required, FDA is strongly encouraging electronic submission to facilitate efficiency and timeliness of data management and collection. To that end, FDA designed the eSubmitter application to streamline the data entry process for registration and product listing. This tool allows for importation of large quantities of structured data, attachments of files (e.g., in portable document format (PDFs) and certain media files), and automatic acknowledgement of FDA’s receipt of submissions. E:\FR\FM\21OCN1.SGM 21OCN1 Federal Register / Vol. 74, No. 202 / Wednesday, October 21, 2009 / Notices II. Significance of Guidance FDA is issuing this draft guidance document 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 ‘‘Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments.’’ 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. The guidance document and 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 draft guidance contains proposed collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501–3520). As required by the PRA, FDA has published an analysis of, among others, the information collection concerning the submission of tobacco product establishment registration and product listing information (74 FR 45219, September 1, 2009, as corrected by 74 FR 47257, September 15, 2009) and will submit them for OMB approval. jlentini on DSKJ8SOYB1PROD with NOTICES 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: October 15, 2009. David Horowitz, Assistant Commissioner for Policy. [FR Doc. E9–25235 Filed 10–16–09; 11:15 am] BILLING CODE 4160–01–S VerDate Nov<24>2008 17:33 Oct 20, 2009 Jkt 220001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2009–D–0503] Draft Guidances for Industry and Food and Drug Administration Staff; Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data—Premarket Notification [510(k)] Submissions and Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data—Premarket Approval (PMA) and Premarket Notification [510(k)] Submissions; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of two related draft guidance documents. One is a draft guidance entitled, ‘‘Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data—Premarket Notification [510(k)] Submissions’’ (‘‘CADe 510(k) draft guidance’’). This draft guidance provides recommendations regarding premarket notification (510(k)) submissions of certain computer-assisted detection (CADe) devices applied to radiology images and radiology device data. The second draft guidance is entitled, ‘‘Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data— Premarket Approval (PMA) and Premarket Notification [510(k)] Submissions’’ (‘‘CADe clinical performance assessment draft guidance’’). This draft guidance provides recommendations on how to design and conduct clinical performance studies for CADe devices applied to radiology images and radiology device data. These studies may be part of a premarket submission to FDA, whether it is a 510(k) submission, an application for premarket approval (PMA), an application for a humanitarian device exemption (HDE), or an application for an investigational device exemption (IDE). These draft guidances are not final nor are they in effect at this time. 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 these draft guidances before it begins work on the final versions of these guidances, submit PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 54053 written or electronic comments on the draft guidances by January 19, 2010. ADDRESSES: Submit written requests for single copies of the draft guidance document entitled ‘‘Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data— Premarket Notification [510(k)] Submissions’’ or the draft guidance document entitled ‘‘Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data— Premarket Approval (PMA) and Premarket Notification [510(k)] Submissions’’ to the Division of Small Manufacturers, International, and Consumer Assistance, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., WO66–4613, Silver Spring, MD 20993. Send one selfaddressed adhesive label to assist that office in processing your request, or fax your request to 301–847–8149. See the SUPPLEMENTARY INFORMATION section for information on electronic access to these draft guidances. Submit written comments concerning either of these draft guidances and the questions found in the supplementary information 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. Please include your rationale and/or scientific justification with your comments. FOR FURTHER INFORMATION CONTACT: Nicholas Petrick, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., White Oak Bldg. 62, rm. 4116, Silver Spring, MD 20993, 301–796– 2563, and Joyce Whang, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., White Oak Bldg. 66, rm. G318, Silver Spring, MD 20993. SUPPLEMENTARY INFORMATION: I. Background CADe devices are computerized systems that incorporate pattern recognition and data analysis capabilities (i.e., combine values, measurements, or features extracted from the patient radiological data) intended to identify, mark, highlight, or in any other manner direct attention to portions of an image, or aspects of radiology device data, that may reveal abnormalities during interpretation of E:\FR\FM\21OCN1.SGM 21OCN1

Agencies

[Federal Register Volume 74, Number 202 (Wednesday, October 21, 2009)]
[Notices]
[Pages 54052-54053]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-25235]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0508]


Draft Guidance for Industry on Registration and Product Listing 
for Owners and Operators of Domestic Tobacco Product Establishments; 
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 ``Registration 
and Product Listing for Owners and Operators of Domestic Tobacco 
Product Establishments.'' The draft guidance document is intended to 
assist persons making tobacco product establishment registration and 
product listing submissions to FDA under The Family Smoking Prevention 
and Tobacco Control Act (FSPTCA).

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 October 30, 2009.

ADDRESSES:  Submit written requests for single copies of the draft 
guidance document entitled ``Registration and Product Listing for 
Owners and Operators of Domestic Tobacco Product Establishments'' 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 draft guidance document may be sent. 
See the SUPPLEMENTARY INFORMATION section for 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:

I. Background

    On June 22, 2009, the President signed the FSPTCA (Public Law 111-
31) into law. The FSPTCA amended the Federal Food, Drug, and Cosmetic 
Act (the act) (21 U.S.C. 301 et seq.) by, among other things, 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 905(b) of the act (21 U.S.C. 395(b)), as amended by the 
FSPTCA, requires that ``every person who owns or operates any 
establishment in any State engaged in the manufacture, preparation, 
compounding, or processing of a tobacco product or tobacco products'' 
register with FDA the name, places of business, and all establishments 
owned or operated by that person. Every person must register by 
December 31 of each year. Section 905(i)(1) of the act, as amended by 
the FSPTCA, requires that all registrants ``shall, at the time of 
registration under any such subsection, file with [FDA] a list of all 
tobacco products which are being manufactured, prepared, compounded, or 
processed by that person for commercial distribution,'' along with 
certain accompanying consumer information, such as all labeling and a 
representative sampling of advertisements.
    While electronic submission of registration and listing information 
is not required, FDA is strongly encouraging electronic submission to 
facilitate efficiency and timeliness of data management and collection. 
To that end, FDA designed the eSubmitter application to streamline the 
data entry process for registration and product listing. This tool 
allows for importation of large quantities of structured data, 
attachments of files (e.g., in portable document format (PDFs) and 
certain media files), and automatic acknowledgement of FDA's receipt of 
submissions.

[[Page 54053]]

II. Significance of Guidance

    FDA is issuing this draft guidance document 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 
``Registration and Product Listing for Owners and Operators of Domestic 
Tobacco Product Establishments.'' 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. The guidance document and 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 draft guidance contains proposed collections of information 
that are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520). 
As required by the PRA, FDA has published an analysis of, among others, 
the information collection concerning the submission of tobacco product 
establishment registration and product listing information (74 FR 
45219, September 1, 2009, as corrected by 74 FR 47257, September 15, 
2009) and will submit them for OMB approval.

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: October 15, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-25235 Filed 10-16-09; 11:15 am]
BILLING CODE 4160-01-S
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