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). 

II. Findings and Order 

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 

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 

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 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 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. 


jlentini on DSKJ8SOYB1PROD with NOTICES
Federal Register / Vol. 74, No. 202 / Wednesday, October 21, 2009 / Notices 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 

http://www.regulations.gov and http:// 

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 

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 

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 http:// 

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 


jlentini on DSKJ8SOYB1PROD with NOTICES