Federal Register / Vol. 76, No. 79 / Monday, April 25, 2011 / Notices 22905 

consequent presence in byproduct 

distiller grains used as an animal feed 

or feed ingredient. 

The potential environmental impact 

of this action is being reviewed. To 

encourage public participation 

consistent with regulations issued under 

the National Environmental Policy Act 

(40 CFR 1501.4(b)), the Agency is 

placing the environmental assessment 

submitted with the petition that is the 

subject of this notice on public display 

at the Division of Dockets Management 

(see DATES and ADDRESSES) for public 

review and comment. 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send two copies of mailed comments. 

Identify comments 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. 

FDA will also place on public display 

any amendments to, or comments on, 

the petitioner’s environmental 

assessment without further 

announcement in the Federal Register. 

If, based on its review, the Agency finds 

that an environmental impact statement 

is not required and this petition results 

in a regulation, the notice of availability 

of the Agency’s finding of no significant 

impact and the evidence supporting that 

finding will be published with the 

regulation in the Federal Register in 

accordance with 21 CFR 25.51(b). 

Dated: April 15, 2011. 

Bernadette Dunham, 

Director, Center for Veterinary Medicine. 

[FR Doc. 2011–9913 Filed 4–22–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–D–0431] 

Guidance for Food and Drug 

Administration Staff and Tobacco 

Retailers on Civil Money Penalties and 

No-Tobacco-Sale Orders for Tobacco 

Retailers; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance entitled ‘‘Civil 

Money Penalties and No-Tobacco-Sale 

Orders for Tobacco Retailers.’’ This 

guidance document describes FDA’s 

current policies with respect to civil 

money penalties and no-tobacco-sale 

orders for retailers who violate 

requirements of the Federal Food, Drug, 

and Cosmetic Act (the FD&C Act) 

relating to tobacco products, including 

the FD&C Act requirement that tobacco 

products may not be sold or distributed 

in violation of FDA’s ‘‘Regulations 

Restricting the Sale and Distribution of 

Cigarettes and Smokeless Tobacco to 

Protect Children and Adolescents.’’ With 

the release of this final guidance 

document, several provisions in the 

Family Smoking Prevention and 

Tobacco Control Act (the Tobacco 

Control Act) that relate to civil money 

penalties and no-tobacco-sale orders 

become effective. 

DATES: Submit either electronic or 

written comments on Agency guidances 

at any time. 

ADDRESSES: Submit written requests for 

single copies of the guidance entitled 

‘‘Civil Money Penalties and No-TobaccoSale Orders for Tobacco Retailers’’ 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 electronic 

access to the guidance document. 

Submit electronic comments on the 

guidance to http://www.regulations.gov. 

Submit written comments to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, Rm. 1061, Rockville, 

MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Gerie A. Voss, Center for Tobacco 

Products, Food and Drug 

Administration, 9200 Corporate Blvd., 

Rockville, MD 20850, 1–877–287–1373, 

gerie.voss@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for FDA staff and tobacco 

retailers entitled ‘‘Civil Money Penalties 

and No-Tobacco-Sale Orders for 

Tobacco Retailers.’’ On June 22, 2009, 

President Obama signed the Tobacco 

Control Act (Pub. L. 111–31) into law. 

The Tobacco Control Act grants 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. 

Among its many provisions, the 

Tobacco Control Act authorizes FDA to 

impose civil money penalties for 

violations of the FD&C Act requirements 

that relate to tobacco products (section 

303(f)(9) of the FD&C Act (21 U.S.C. 

333(f)(9)). Of special interest to retailers, 

one of the FD&C Act’s requirements is 

that tobacco products may not be sold 

or distributed in a manner that violates 

regulations issued under section 906(d) 

of the FD&C Act (21 U.S.C. 387f(d)), 

such as the ‘‘Regulations Restricting the 

Sale and Distribution of Cigarettes and 

Smokeless Tobacco to Protect Children 

and Adolescents’’ that were published 

by FDA on March 19, 2010 (75 FR 

13225) (21 CFR part 1140). The Tobacco 

Control Act also authorizes FDA to 

impose a no-tobacco-sale order on a 

retail outlet for repeated violations of 

regulations issued under section 906(d) 

of the FD&C Act, and discusses a 

number of technical and procedural 

issues relating to civil money penalties 

and no-tobacco-sale orders. 

This guidance document describes the 

penalty structure and FDA policies with 

respect to civil money policies and notobacco-sale orders. With the release of 

this final guidance document, several 

Tobacco Control Act provisions that 

relate to civil money penalties and notobacco-sale orders become effective 

(section 103(q)(3) of the Tobacco 

Control Act). 

In the Federal Register of August 31, 

2010 (75 FR 53316), FDA announced the 

availability of the draft guidance of the 

same title dated August 2010. FDA 

received a few comments on the draft 

guidance, and those comments were 

considered as the guidance was 

finalized. In addition, editorial changes 

were made to improve clarity. 

II. Significance of Guidance 

This level 1 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 ‘‘Civil Money 

Penalties and No-Tobacco-Sale Orders 

for Tobacco Retailers.’’ 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) either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send two copies of mailed comments. 


jdjones on DSKHWCL6B1PROD with NOTICES
22906 Federal Register / Vol. 76, No. 79 / Monday, April 25, 2011 / Notices 

Identify comments 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 guidance at either 

http://www.fda.gov/TobaccoProducts/

GuidanceComplianceRegulatory

Information/default.htm or http:// 

www.regulations.gov. 

Dated: April 15, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–9938 Filed 4–22–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2006–D–0094] 

Guidance for Industry and Food and 

Drug Administration Staff; Class II 

Special Controls Guidance Document: 

Topical Oxygen Chamber for 

Extremities; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the guidance entitled, 

‘‘Class II Special Controls Guidance 

Document: Topical Oxygen Chamber for 

Extremities.’’ This guidance document 

was developed as a special control to 

support the reclassification of the 

topical oxygen chamber for extremities 

(TOCE) from class III (premarket 

approval) into class II (special controls). 

This guidance document describes a 

means by which manufacturers of TOCE 

may comply with the requirement of 

special controls for class II devices. 

Elsewhere in this issue of the Federal 

Register, FDA is publishing a final rule 

reclassifying these devices from class III 

into class II (special controls). 

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, ‘‘Class II Special Controls 

Guidance Document: Topical Oxygen 

Chamber for Extremities,’’ to the 

Division of Small Manufacturers, 

International, and Consumer Assistance 

(HFZ–220), Center for Devices and 

Radiological Health, Food and Drug 

Administration, 1350 Piccard Dr., 

Rockville, MD 20850. Send one selfaddressed adhesive label to assist that 

office in processing your request, or fax 

your request to 240–276–3151. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance. 

Submit written comments concerning 

this 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: 

Charles N. Durfor, Center for Devices 

and Radiological Health (HFZ–410), 

Food and Drug Administration, 9200 

Corporate Blvd., Rockville, MD 20850, 

240–276–3555. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of April 6, 

2006 (71 FR 17390), FDA’s Center for 

Devices and Radiological Health (CDRH) 

published a proposed rule to reclassify 

the TOCE device type from class III 

(premarket approval) into class II 

(special controls) after reviewing current 

technological and scientific 

developments. To support the 

reclassification, CDRH issued a draft 

class II special controls guidance 

document entitled ‘‘Class II Special 

Controls Guidance Document: Topical 

Oxygen Chamber for Extremities’’ (71 FR 

17476). Interested persons were invited 

to comment on the proposed rule and 

guidance by July 5, 2006. FDA received 

11 comments on the proposed rule. The 

comments received discussed academic 

literature, clinical experiences, and 

patient outcomes that support the 

proposed reclassification’s 

determinations of the safety and 

effectiveness of the TOCE device. The 

comments did not recommend any 

changes to the proposed regulation. 

FDA is now identifying the guidance 

document entitled ‘‘Class II Special 

Controls Guidance Document: Topical 

Oxygen Chamber for Extremities’’ as the 

special control for these devices. This 

guidance document provides a means 

by which manufacturers of TOCE 

devices may comply with the 

requirement of special controls for class 

II devices. Following the effective date 

of the final reclassification rule, any 

manufacturer submitting a premarket 

notification submission under section 

510(k) of the Federal Food, Drug, and 

Cosmetic Act (the FD&C act) (21 U.S.C. 

360(k)) for a TOCE device will need to 

address the issues covered in the special 

controls guidance document. However, 

the manufacturer need only show that 

its device meets the recommendations 

in the guidance document or in some 

other way provides equivalent 

assurances of safety and effectiveness. 

II. Significance of Special Controls 

Guidance 

FDA believes that adherence to the 

recommendations described in this 

guidance document, in addition to the 

general controls, will provide 

reasonable assurance of the safety and 

effectiveness of TOCE classified under 

§ 878.5650 (21 CFR 878.5650). The final 

rule establishing this guidance 

document as a special control will be 

effective May 25, 2011. Following the 

effective date of the final rule, TOCE 

classified under § 878.5650 must 

comply with the requirement of special 

controls; manufacturers must address 

the issues requiring special controls as 

identified in the guidance, either by 

following the recommendations in the 

guidance or by some other means that 

provides equivalent assurances of safety 

and effectiveness. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/ 

RegulatoryInformation/Guidances/ 

default.htm or http:// 

www.regulation.gov. Always access an 

FDA guidance document by using 

FDA’s Web site listed previously to find 

the most current version of the 

guidance. 

IV. Paperwork Reduction Act of 1995 

This guidance refers to previously 

approved collections of information 

found in FDA regulations. These 

collections of information were 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). 

The collections of information in 21 

CFR part 807, subpart E, have been 

approved under OMB control number 

0910–0120; the collections of 

information in 21 CFR part 801 have 

been approved under OMB control 

number 0910–0485; the collections of 

information in 21 CFR part 820 have 

been approved under OMB control 

number 0910–0073; the collections of 

information in 21 CFR part 812 have 

been approved under OMB control 

number 0910–0078; and the collections 

of information in 21 CFR parts 50 and 


jdjones on DSKHWCL6B1PROD with NOTICES