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
Federal Register / Vol. 76, No. 79 / Monday, April 25, 2011 / Notices 22907 

56 have been approved under OMB 

control number 0910–0130. 

V. 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. 

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. 

Dated: April 19, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–9898 Filed 4–22–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meetings 

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 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Integrative, 

Functional and Cognitive Neuroscience 

Integrated Review Group; Auditory 

System Study Section. 

Date: June 1–2, 2011. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Embassy Suites at the Chevy 

Chase Pavilion, 4300 Military Road, 

NW., Washington, DC 20015. 

Contact Person: Lynn E Luethke, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 

5166, MSC 7844, Bethesda, MD 20892, 

(301) 806–3323, luethkel@csr.nih.gov. 

Name of Committee: Endocrinology, 

Metabolism, Nutrition and Reproductive 

Sciences; Integrated Review Group. 

Molecular and Cellular Endocrinology 

Study Section. 

Date: June 1, 2011. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Doubletree Hotel Bethesda, 

8120 Wisconsin Avenue, Bethesda, MD 

20814. 

Contact Person: John Bleasdale, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 

6170 MSC 7892, Bethesda, MD 20892, 

301–435–4514, bleasdaleje@csr.nih.gov. 

Name of Committee: Genes, Genomes, 

and Genetics Integrated Review Group; 

Molecular Genetics B Study Section. 

Date: June 1–2, 2011. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Avenue Crowne Plaza Hotel 

and Suites, 160 E. Huron Street, 

Chicago, IL 60611. 

Contact Person: Richard A Currie, 

PhD, Scientific Review Officer, Center 

for Scientific Review, National Institutes 

of Health, 6701 Rockledge Drive, Room 

5128, MSC 7840, Bethesda, MD 20892, 

(301) 435–1219, currieri@csr.nih.gov. 

Name of Committee: Integrative, 

Functional and Cognitive Neuroscience 

Integrated Review Group; Cognitive 

Neuroscience Study Section. 

Date: June 1, 2011. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: One Washington Circle Hotel, 

One Washington Circle, NW., 

Washington, DC 20037. 

Contact Person: Kirk Thompson, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 

5184, MSC 7844, Bethesda, MD 20892, 

301–435–1242, kgt@mail.nih.gov. 

Name of Committee: Biological 

Chemistry and Macromolecular 

Biophysics Integrated Review Group; 

Macromolecular Structure and Function 

E Study Section. 

Date: June 1, 2011. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Hotel Monticello, 1075 Thomas 

Jefferson Street, NW., Washington, DC 

20007. 

Contact Person: Nitsa Rosenzweig, 

PhD, Scientific Review Officer, Center 

for Scientific Review, National Institutes 

of Health, 6701 Rockledge Drive, Room 

1102, MSC 7760, Bethesda, MD 20892, 

(301) 435–1747, 

rosenzweign@csr.nih.gov. 

Name of Committee: Biological 

Chemistry and Macromolecular 

Biophysics Integrated Review Group; 

Synthetic and Biological Chemistry B 

Study Section. 

Date: June 1–2, 2011. 

Time: 8:30 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: The Dupont Hotel, 1500 New 

Hampshire Avenue, NW., Washington, 

DC 20036. 

Contact Person: Kathryn M Koeller, 

PhD, Scientific Review Officer, Center 

for Scientific Review, National Institutes 

of Health, 6701 Rockledge Drive, Room 

4166, MSC 7806, Bethesda, MD 20892, 

301–435–2681, koellerk@csr.nih.gov. 

Name of Committee: Surgical 

Sciences, Biomedical Imaging and 

Bioengineering Integrated Review 

Group; Surgery, Anesthesiology and 

Trauma Study Section. 

Date: June 1–2, 2011. 

Time: 9 a.m. to 3 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: The Allerton Hotel, 701 North 

Michigan Avenue, Chicago, IL 60611. 

Contact Person: Weihua Luo, MD, 

PhD, Scientific Review Officer, Center 

for Scientific Review, National Institutes 

of Health, 6701 Rockledge Drive, Room 

5114, MSC 7854, Bethesda, MD 20892, 

(301) 435–1170, luow@csr.nih.gov. 

Name of Committee: Endocrinology, 

Metabolism, Nutrition and Reproductive 

Sciences Integrated Review Group; 

Cellular, Molecular and Integrative 

Reproduction Study Section. 

Date: June 2, 2011. 

Time: 7 a.m. to 7 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: The Allerton Hotel, 701 North 

Michigan Avenue, Chicago, IL 60611. 

Contact Person: Gary Hunnicutt, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 

6164, MSC 7892, Bethesda, MD 20892, 

301–435–0229, gary.hunnicutt@nih.gov. 

Name of Committee: Oncology 1– 

Basic Translational Integrated Review 

Group; Cancer Molecular Pathobiology 

Study Section. 

Date: June 2–3, 2011. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: The Fairmont Washington, DC, 

2401 M Street, NW., Washington, DC 

20037. 

Contact Person: Manzoor Zarger, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 

6208, MSC 7804, Bethesda, MD 20892, 

(301) 435–2477, zargerma@csr.nih.gov. 


jdjones on DSKHWCL6B1PROD with NOTICES