This section of the FEDERAL REGISTER

contains notices to the public of the proposed

issuance of rules and regulations. The

purpose of these notices is to give interested

persons an opportunity to participate in the

rule making prior to the adoption of the final

rules.

Proposed Rules Federal Register

55748 

Vol. 71, No. 185 

Monday, September 25, 2006 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 807, 868, 870, 872, 874, 

876, 878, 880, 882, 884, 886, and 892 

[Docket No. 2006N–0335] 

Medical Devices; Reprocessed SingleUse Devices; Requirement for 

Submission of Validation Data; 

Companion to Direct Final Rule 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Proposed rule. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

proposing to amend certain 

classification regulations to reflect the 

termination of certain device 

exemptions and the requirement to 

submit validation data for specific 

reprocessed single-use devices (SUDs), 

as required by the Medical Device User 

Fee and Modernization Act of 2002 

(MDUFMA). This proposed rule is a 

companion document to a direct final 

rule published elsewhere in this issue of 

the Federal Register. This proposed rule 

will provide a procedural framework to 

finalize the rule in the event we receive 

any significant adverse comment and 

withdraw the direct final rule. This 

proposed rule would codify actions 

taken in previous Federal Register 

notices in accordance with MDUFMA. 

DATES: Submit written or electronic 

comments by December 11, 2006. 

ADDRESSES: You may submit comments, 

identified by Docket No. 2006N–0335, 

by any of the following methods: 

Electronic Submissions 

Submit electronic comments in the 

following ways: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Agency Web site: http:// 

www.fda.gov/dockets/ecomments. 

Follow the instructions for submitting 

comments on the agency Web site. 

Written Submissions 

Submit written submissions in the 

following ways: 

• FAX: 301–827–6870. 

• Mail/Hand delivery/Courier [For 

paper, disk, or CD–ROM submissions]: 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

To ensure more timely processing of 

comments, FDA is no longer accepting 

comments submitted to the agency by email. FDA encourages you to continue 

to submit electronic comments by using 

the Federal eRulemaking Portal or the 

agency Web site, as described in the 

Electronic Submissions portion of this 

paragraph. 

Instructions: All submissions received 

must include the agency name and 

Docket No(s). and Regulatory 

Information Number (RIN) (if a RIN 

number has been assigned) for this 

rulemaking. All comments received may 

be posted without change to http:// 

www.fda.gov/ohrms/dockets/ 

default.htm, including any personal 

information provided. For additional 

information on submitting comments, 

see the ‘‘Comments’’ heading of the 

SUPPLEMENTARY INFORMATION section of 

this document. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http:// 

www.fda.gov/ohrms/dockets/ 

default.htm and insert the docket 

number(s), found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Division of Dockets 

Management, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Heather S. Rosecrans, Center for Devices 

and Radiological Health (HFZ–404), 

Food and Drug Administration, 9200 

Corporate Blvd., Rockville, MD 20850, 

301–594–1190, ext. 143. 

SUPPLEMENTARY INFORMATION: 

I. Why Is This Rule Being Issued as a 

Companion Proposed Rule? 

This proposed rule is a companion to 

the direct final rule that is published in 

the final rules section of this issue of the 

Federal Register. The direct final rule 

would amend certain classification 

regulations for reprocessed single-use 

devices (SUDs) whose exemption from 

premarket notification (510(k)) 

requirements have been terminated and 

other reprocessed SUDs already subject 

to premarket notification for which 

validation data, as specified under 

MDUFMA, are necessary in a 510(k). 

The direct final rule and this companion 

proposed rule are identical. We are 

publishing the direct final rule because 

we believe the rule contains 

noncontroversial changes and minor 

corrections to existing regulations, and 

we anticipate that it will receive no 

significant adverse comment. A detailed 

discussion of the rule is set forth in the 

preamble of the direct final rule. If no 

significant adverse comment is received 

in response to the direct final rule, no 

further action will be taken related to 

this proposed rule. Instead, we will 

publish a confirmation document 

within 30 days after the comment 

period ends confirming when the direct 

final rule will go into effect. You can 

find additional information about FDA’s 

direct final rulemaking procedures in 

the guidance document entitled 

‘‘Guidance for FDA and Industry: Direct 

Final Rule Procedures’’ (62 FR 62466, 

November 21, 1977). This guidance 

document may be accessed at http:// 

www.fda.gov/opacom/morechoices/ 

industry/guidance.htm. 

If we receive any significant adverse 

comment regarding the direct final rule, 

we will withdraw the direct final rule 

within 30 days after the comment 

period ends and proceed to respond to 

all of the comments under this 

companion proposed rule using usual 

notice-and-comment rulemaking 

procedures under the Administrative 

Procedure Act (APA) (5 U.S.C. 552a et 

seq). The comment period for this 

companion proposed rule runs 

concurrently with the direct final rule’s 

comment period. Any comments 

received under this companion 

proposed rule will also be considered as 

comments regarding the direct final 

rule. A significant adverse comment is 

defined as a comment that explains why 

the rule would be inappropriate, 

including challenges to the rule’s 

underlying premise or approach, or 

would be ineffective or unacceptable 

without a change. In determining 

whether an adverse comment is 

significant and warrants terminating a 

direct final rulemaking, we will 

consider whether the comment raises an 

issue serious enough to warrant a 

substantive response in a notice-andVerDate Aug<31>2005 16:51 Sep 22, 2006 Jkt 208001 PO 00000 Frm 00001 Fmt 4702 Sfmt 4702 E:\FR\FM\25SEP1.SGM 25SEP1

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Federal Register / Vol. 71, No. 185 / Monday, September 25, 2006 / Proposed Rules 55749 

comment process in accordance with 

section 553 of the APA (5 U.S.C. 553). 

Comments that are frivolous, 

insubstantial, or outside the scope of the 

rule will not be considered adverse 

under this procedure. For example, a 

comment recommending an additional 

change to the rule will not be 

considered a significant adverse 

comment, unless the comment states 

why the rule would be ineffective 

without the additional change. In 

addition, if a significant adverse 

comment applies to part of a rule and 

that part can be severed from the 

remainder of the rule, we may adopt as 

final those parts of the rule that are not 

the subject of a significant adverse 

comment. 

II. What Is the Background of the Rule? 

On October 26, 2002, MDUFMA 

(Public Law 107–250), amended the 

Federal Food, Drug, and Cosmetic Act 

(the act) by adding section 510(o) (21 

U.S.C. 360(o)), which provided new 

regulatory requirements for reprocessed 

SUDs. The new provision requires 

validation data to be included in the 

premarket notification (510(k)) for 

certain reprocessed SUDs, to ensure that 

reprocessed SUDs are substantially 

equivalent to predicate devices. The 

validation data includes cleaning and 

sterilization data, and functional 

performance data demonstrating that 

each SUD will remain substantially 

equivalent to its predicate device after 

the maximum number of times the 

device is reprocessed. 

Before enactment of the new law, a 

manufacturer of a reprocessed SUD was 

required to obtain premarket approval 

or premarket clearance for the device, 

unless the device was exempt from 

premarket submission requirements. 

Under MDUFMA, some previously 

exempt reprocessed SUDs are no longer 

exempt from premarket notification 

requirements. Manufacturers of these 

identified devices were required to 

submit 510(k)s that included validation 

data specified by FDA. Reprocessors of 

certain SUDs already subject to cleared 

510(k)s were also required to submit the 

validation data specified by the agency. 

A. Definitions 

Under section 201(ll)(2)(A) of the act 

(21 U.S.C. 321(ll)(2)(A)), a reprocessed 

SUD is defined as an ‘‘original device 

that has previously been used on a 

patient and has been subjected to 

additional processing and 

manufacturing for the purpose of an 

additional single use on a patient. The 

subsequent processing and manufacture 

of a reprocessed single-use device shall 

result in a device that is reprocessed 

within the meaning of this definition.’’

FDA is amending § 807.3 (21 CFR 807.3) 

by adding paragraph (t) to incorporate 

this definition into the regulations. 

Reprocessed SUDs are divided into 

three groups: (1) Critical, (2) 

semicritical, and (3) noncritical. The 

first two categories are set forth in the 

act and all three reflect a categorization 

scheme recognized in the industry (Ref. 

1). In the Federal Register of April 30, 

2003 (68 FR 23139), FDA describes in 

more detail the development of this 

scheme and its use in the 

implementation of section 510(o) of the 

act. The act defines critical and 

semicritical reprocessed single use 

devices at section 201(mm) as amended 

by MDUFMA. FDA defined noncritical 

devices in the Federal Register of April 

30, 2003. The definitions are as follows: 

• A critical reprocessed SUD is 

intended to contact normally sterile 

tissue or body spaces during use. 

• A semicritical reprocessed SUD is 

intended to contact intact mucous 

membranes and not penetrate normally 

sterile areas of the body. 

• A noncritical reprocessed SUD is 

intended to make topical contact and 

not penetrate intact skin. 

B. Critical and Semicritical Reprocessed 

SUDs Previously Exempt from 

Premarket Notification 

MDUFMA required FDA to review the 

critical and semicritical reprocessed 

SUDs that were previously exempt from 

premarket notification requirements and 

determine which of these devices 

required premarket notification to 

ensure their substantial equivalence to 

predicate devices. Under MDUFMA, 

FDA was required to identify in a 

Federal Register notice those critical 

reprocessed SUDs whose exemption 

from premarket notification would be 

terminated and for which FDA 

determined that validation data, as 

specified under MDUFMA, was 

necessary in a 510(k). FDA published a 

list of these devices on April 30, 2003. 

According to the law, manufacturers of 

the devices whose exemptions from 

premarket notification were terminated 

were required to submit 510(k)s that 

included validation data regarding 

cleaning, sterilization, and functional 

performance, in addition to all the other 

required elements of a 510(k) identified 

in § 807.87 (21 CFR 807.87), within 15 

months of publication of the notice or 

no longer market their devices. 

In accordance with section 510(o) of 

the act, FDA must revise the list of 

devices subject to this requirement as 

appropriate. In the Federal Register of 

June 26, 2003 (68 FR 38071), FDA 

recategorized nine device types from 

semicritical to critical, and added 

nonelectric gastroenterology-urology 

biopsy forceps to the list of critical 

reprocessed SUDs whose exemption 

from premarket notification 

requirements was being terminated. In 

the Federal Register of September 29, 

2005 (70 FR 56911), FDA announced 

that it was adding devices to the list of 

critical reprocessed SUDs whose 510(k) 

exemption is terminated and for which 

validation data is necessary. 

By April 26, 2004, FDA was required 

to identify in a Federal Register notice 

those semicritical reprocessed SUDs 

whose exemption from premarket 

notification would be terminated and 

for which FDA determined that 

validation data, as specified under 

MDUFMA, was necessary in a 510(k). 

FDA published this list in the Federal 

Register of April 13, 2004 (69 FR 

19433). As discussed previously in this 

document, manufacturers of the devices 

whose exemptions from premarket 

notification were terminated were 

required to submit 510(k)s that included 

validation data regarding cleaning, 

sterilization, and functional 

performance, in addition to all the other 

required elements of a 510(k) identified 

in § 807.87, within 15 months of 

publication of the notice or no longer 

market their devices. In accordance with 

section 510(o) of the act, FDA must 

revise the list of devices subject to this 

requirement as appropriate. 

C. Reprocessed SUDs Already Subject to 

Premarket Notification Requirements 

MDUFMA also required FDA to 

review the types of reprocessed SUDs 

already subject to premarket notification 

requirements and to identify which of 

these devices required the submission of 

validation data to ensure their 

substantial equivalence to predicate 

devices. FDA published a list of these 

devices in the Federal Register of April 

30, 2003. As described previously in 

this document, FDA must revise the list 

of devices subject to this requirement as 

appropriate. In the Federal Register of 

September 29, 2005, FDA announced 

that it was adding laparoscopic and 

endoscopic electrosurgical accessories 

to this list of reprocessed SUDs already 

subject to premarket notification. 

For devices identified on this list that 

had already been cleared through the 

510(k) process, manufacturers were 

required to submit validation data 

regarding cleaning, sterilization, and 

functional performance within 9 months 

of publication of the list or no longer 

market their devices. 

For devices on this list that were not 

yet cleared through the 510(k) process, 

manufacturers were required to submit 


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510(k)s with validation data regarding 

cleaning, sterilization, and functional 

performance, in addition to all the other 

required elements identified in § 807.87. 

III. What Does This Proposed Rule Do? 

As described previously in this 

document, we have already taken 

actions required under section 510(o) of 

the act. This proposed rule would 

codify these actions, including 

revocations of exemption from 

premarket notification for SUDs and the 

requirement to submit validation data, 

and add definitions based on the statute 

to 21 CFR part 807. The proposed rule 

does not make any substantive changes 

to existing requirements. We have 

included a detailed description of 

specific changes in the rule in the 

preamble to the direct final rule, 

published elsewhere in this issue of the 

Federal Register. 

FDA has made available previously a 

guidance document on the submission 

of validation data entitled ‘‘Medical 

Device User Fee and Modernization Act 

of 2002, Validation Data in Premarket 

Notification Submissions (510(k)s) for 

Reprocessed Single-Use Medical 

Devices’’ (69 FR 30943, June 1, 2004). 

This guidance document may be 

accessed on the Internet at http:// 

www.fda.gov/cdrh/ode/guidance/ 

1216.html. 

IV. What Is the Legal Authority for This 

Proposed Rule? 

This proposed rule is authorized by 

sections 201, 301, 501, 502, 510, 513, 

515, 519, 520, 701, 704, 801, and 903 of 

the act and sections 264 and 271 of the 

Public Health Service Act (21 U.S.C. 

321, 331, 351, 352, 360, 360c, 360e, 

360i, 360j, 371, 374, 381, 393; 42 U.S.C. 

264 and 271) . 

V. What Is the Environmental Impact of 

This Proposed Rule? 

We have determined under 21 CFR 

25.30(h) and 25.34(a) that this action is 

of a type that does not individually or 

cumulatively have a significant effect on 

the human environment. Therefore, 

neither an environmental assessment 

nor an environmental impact statement 

is required. 

VI. What Is the Economic Impact of 

This Proposed Rule? 

We have examined the impacts of the 

rule under Executive Order 12866 and 

the Regulatory Flexibility Act (5 U.S.C. 

601–612), and the Unfunded Mandates 

Reform Act of 1995 (Public Law 104–4). 

Executive Order 12866 directs agencies 

to assess all costs and benefits of 

available regulatory alternatives and, 

when regulation is necessary, to select 

regulatory approaches that maximize 

net benefits (including potential 

economic, environmental, public health 

and safety, and other advantages; 

distributive impacts; and equity). We 

believe that this proposed rule is not a 

significant regulatory action as defined 

by the Executive order. 

The Regulatory Flexibility Act 

requires agencies to analyze regulatory 

options that would minimize any 

significant impact of a rule on small 

entities. Because this proposed rule will 

not change any existing requirements or 

impose any new requirements, we 

certify that the proposed rule, if 

finalized, will not have a significant 

economic impact on a substantial 

number of small entities. 

Section 202(a) of the Unfunded 

Mandates Reform Act of 1995 requires 

that agencies prepare a written 

statement, which includes an 

assessment of anticipated costs and 

benefits, before proposing ‘‘any rule that 

includes any Federal mandate that may 

result in the expenditure by State, local, 

and tribal governments, in the aggregate, 

or by the private sector, of $100,000,000 

or more (adjusted annually for inflation) 

in any one year.’’ The current threshold 

after adjustment for inflation is $118 

million, using the most current (2004) 

Implicit Price Deflator for the Gross 

Domestic Product. FDA does not expect 

this proposed rule to result in any 1- 

year expenditure that would meet or 

exceed this amount. 

VII. How Does the Paperwork 

Reduction Act of 1995 Apply to This 

Rule? 

This proposed rule contains 

information collection provisions that 

are subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(the PRA) (44 U.S.C. 3501–3520). The 

collections of information addressed in 

the proposed rule have been approved 

by OMB in accordance with the PRA 

under the regulations governing 

premarket notifications (21 CFR part 

807, OMB control number 0910–0120). 

VIII. What Are the Federalism Impacts 

of This Proposed Rule? 

We have analyzed this proposed rule 

in accordance with the principles set 

forth in Executive Order 13132. We 

have determined that the rule does not 

contain policies that have substantial 

direct effects on the States, on the 

relationship between the National 

Government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government. Accordingly, we 

have concluded that the rule does not 

contain policies that have federalism 

implications as defined in the Executive 

order and, consequently, a federalism 

summary impact statement is not 

required. 

IX. How Do You Submit Comments on 

This Proposed Rule? 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this proposed rule. 

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. 

X. What Is the Reference for This Rule? 

The following reference has been 

placed on display in the Division of 

Dockets Management (see ADDRESSES) 

and may be seen by interested persons 

between 9 am. and 4 pm., Monday 

through Friday. 

1. Spaulding, E. H., ‘‘The Role of Chemical 

Disinfection in the Prevention of 

Nonsocomial Infections.’’ Edited by P. S. 

Brachman and T. C. Eickof, Proceedings of 

International Conference on Nonsocomial 

Infections, 1970, American Hospital 

Association, Chicago, 254–274, 1971. 

List of Subjects 

21 CFR Part 807 

Confidential business information, 

Imports, Medical devices, Reporting and 

recordkeeping requirements. 

21 CFR Parts 868, 870, 872, 874, 876, 

878, 880, 882, and 884 

Medical devices. 

21 CFR Part 886 

Medical devices, Opthalmic goods 

and services. 

21 CFR Part 892 

Medical devices, Radiation 

protection, X-rays. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, it is proposed that 

21 CFR parts 807, 868, 870, 872, 874, 

876, 878, 880, 882, 884, 886, and 892 be 

amended as follows: 

PART 807—ESTABLISHMENT 

REGISTRATION AND DEVICE LISTING 

FOR MANUFACTURERS AND INITIAL 

IMPORTERS OF DEVICES 

1. The authority citation for 21 CFR 

part 807 continues to read as follows: 


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Authority: 21 U.S.C. 321, 331, 351, 352, 

360, 360c, 360e, 360i, 360j, 371, 374, 381, 

393; 42 U.S.C. 264, 271 

2. Section 807.3 is amended by 

adding new paragraphs (t), (u), and (v) 

to read as follows: 

§ 807.3 Definitions. 

* * * * * 

(t) A single use device (SUD) means 

a device that is intended for one use or 

on a single patient during a single 

procedure. 

(u) A reprocessed SUD is an original 

device that has previously been used on 

a patient and has been subjected to 

additional processing and 

manufacturing for the purpose of an 

additional single use on a patient. The 

subsequent processing and manufacture 

of a reprocessed SUD shall result in a 

device that is reprocessed within the 

meaning of this definition. 

(v) Validation data for the purposes of 

this part means cleaning and 

sterilization data, and functional 

performance data demonstrating that an 

SUD will remain substantially 

equivalent to its predicate device after 

the maximum number of times the 

device is reprocessed as intended by the 

person submitting the premarket 

notification. 

3. Section 807.87 is amended by 

redesignating paragraphs (h), (i), (j), (k), 

and (l) as paragraphs (i), (j), (k), (l), and 

(m), respectively, and by adding new 

paragraph (h) to read as follows: 

§ 807.87 Information required in a 

premarket notification submission. 

* * * * * 

(h) If the device is a reprocessed SUD 

that FDA has identified as requiring 

validation data, the premarket 

notification submission must include 

validation data as defined in § 807.3(v). 

* * * * * 

PART 868—ANESTHESIOLOGY 

DEVICES 

4. The authority citation for 21 CFR 

part 868 continues to read as follows: 

Authority: 21 U.S.C. 351, 360, 360c, 360e, 

360j, 371. 

5. Section 868.5150 is amended by 

revising paragraph (b) to read as follows: 

§ 868.5150 Anesthesia conduction needle. 

* * * * * 

(b) Classification. Class II (special 

controls). If the device is an anesthetic 

conduction needle (with/without 

introducer) or a short term spinal needle 

and it is a reprocessed single use device 

(SUD) as defined in § 807.3(u) of this 

chapter, a premarket notification 

submission for the device must include 

validation data as described in 

§ 807.3(v). 

6. Section 868.5730 is amended by 

revising paragraph (b) to read as follows: 

§ 868.5730 Tracheal tube. 

* * * * * 

(b) Classification. Class II (special 

controls). If the device is a reprocessed 

single use device (SUD) as defined in 

§ 807.3(u) of this chapter, a premarket 

notification submission for the device 

must include validation data as 

described in § 807.3(v). 

7. Section 868.5905 is amended by 

revising paragraph (b) to read as follows: 

§ 868.5905 Noncontinuous ventilator 

(IPPB). 

* * * * * 

(b) Classification. Class II (special 

controls). If the device is a 

noncontinuous ventilator (respirator) 

mask that is a reprocessed single use 

device (SUD) as defined in § 807.3(u) of 

this chapter, a premarket notification 

submission for the device must include 

validation data as described in 

§ 807.3(v). 

8. Section 868.6810 is amended by 

revising paragraph (b) to read as follows: 

§ 868.6810 Tracheobronchial suction 

catheter. 

* * * * * 

(b) Classification. Class I (general 

controls). The device is exempt from the 

premarket notification procedures in 

subpart E of part 807 of this chapter 

subject to the limitations in § 868.9. If 

the device is a reprocessed single use 

device (SUD) as defined in § 807.3(u) of 

this chapter, the exemption from 

premarket notification does not apply 

and the manufacturer must submit a 

premarket notification that includes 

validation data as described in 

§ 807.3(v). 

PART 870—CARDIOVASCULAR 

DEVICES 

9. The authority citation for 21 CFR 

part 870 continues to read as follows: 

Authority: 21 U.S.C. 351, 360, 360c, 360e, 

360j, 371. 

10. Section 870.1200 is amended by 

revising paragraph (b) to read as follows: 

§ 870.1200 Diagnostic intravascular 

catheter. 

* * * * * 

(b) Classification. Class II (special 

controls). If the device is an angiography 

catheter that is a reprocessed single use 

device (SUD) as defined in § 807.3(u) of 

this chapter, a premarket notification 

submission for the device must include 

validation data as described in 

§ 807.3(v). 

11. Section 870.1220 is amended by 

revising paragraph (b) to read as follows: 

§ 870.1220 Electrode recording catheter or 

electrode recording probe. 

* * * * * 

(b) Classification. Class II (special 

controls). If the device is an electrode 

recording catheter or intracardiac 

mapping catheter that is a reprocessed 

single use device (SUD) as defined in 

§ 807.3(u) of this chapter, a premarket 

notification submission for the device 

must include validation data as 

described in § 807.3(v). 

12. Section 870.1230 is amended by 

revising paragraph (b) to read as follows: 

§ 870.1230 Fiberoptic oximeter catheter. 

* * * * * 

(b) Classification. Class II (special 

controls). If the device is a reprocessed 

single use device (SUD) as defined in 

§ 807.3(u) of this chapter, a premarket 

notification submission for the device 

must include validation data as 

described in § 807.3(v). 

13. Section 870.1280 is amended by 

revising paragraph (b) to read as follows: 

§ 870.1280 Steerable catheter. 

* * * * * 

(b) Classification. Class II (special 

controls). If the device is a reprocessed 

single use device (SUD) as defined in 

§ 807.3(u) of this chapter, a premarket 

notification submission for the device 

must include validation data as 

described in § 807.3(v). 

14. Section 870.1290 is amended by 

revising paragraph (b) to read as follows: 

§ 870.1290 Steerable catheter control 

system. 

* * * * * 

(b) Classification. Class II (special 

controls). If the device is a reprocessed 

single use device (SUD) as defined in 

§ 807.3(u) of this chapter, a premarket 

notification submission for the device 

must include validation data as 

described in § 807.3(v). 

15. Section 870.1330 is amended by 

revising paragraph (b) to read as follows: 

§ 870.1330 Catheter guide wire. 

* * * * * 

(b) Classification. Class II (special 

controls). If the device is a reprocessed 

single use device (SUD) as defined in 

§ 807.3(u) of this chapter, a premarket 

notification submission for the device 

must include validation data as 

described in § 807.3(v). 

16. Section 870.1390 is amended by 

revising paragraph (b) to read as follows: 

§ 870.1390 Trocar. 

* * * * * 

(b) Classification. Class II (special 

controls). If the device is a 


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cardiovascular trocar that is a 

reprocessed single use device (SUD) as 

defined in § 807.3(u) of this chapter, a 

premarket notification submission for 

the device must include validation data 

as described in § 807.3(v). 

17. Section 870.1650 is amended by 

revising paragraph (b) to read as follows: 

§ 870.1650 Angiographic injector and 

syringe. 

* * * * * 

(b) Classification. Class II (special 

controls). If the device is a reprocessed 

single use device (SUD) as defined in 

§ 807.3(u) of this chapter, a premarket 

notification submission for the device 

must include validation data as 

described in § 807.3(v). 

18. Section 870.1670 is amended by 

revising paragraph (b) to read as follows: 

§ 870.1670 Syringe actuator for an injector. 

* * * * * 

(b) Classification. Class II (special 

controls). If the device is a reprocessed 

single use device (SUD) as defined in 

§ 807.3(u) of this chapter, a premarket 

notification submission for the device 

must include validation data as 

described in § 807.3(v). 

19. Section 870.2700 is amended by 

revising paragraph (b) to read as follows: 

§ 870.2700 Oximeter. 

* * * * * 

(b) Classification. Class II (special 

controls). If the device is a tissue 

saturation oximeter or an oximeter and 

it is a reprocessed single use device 

(SUD) as defined in § 807.3(u) of this 

chapter, a premarket notification 

submission for the device must include 

validation data as described in 

§ 807.3(v). 

20. Section 870.3535 is amended by 

revising paragraph (b) to read as follows: 

§ 870.3535 Intra-aortic balloon and control 

system. 

* * * * * 

(b) Classification. Class III (premarket 

approval). If the device is a reprocessed 

single use device (SUD) as defined in 

§ 807.3(u) of this chapter, a premarket 

notification submission for the device 

must include validation data as 

described in § 807.3(v). 

* * * * * 

21. Section 870.4450 is amended by 

revising paragraph (b) to read as follows: 

§ 870.4450 Vascular clamp. 

* * * * * 

(b) Classification. Class II (special 

controls). If the device is a reprocessed 

single use device (SUD) as defined in 

§ 807.3(u) of this chapter, a premarket 

notification submission for the device 

must include validation data as 

described in § 807.3(v). 

22. Section 870.4500 is amended by 

revising paragraph (b) to read as follows: 

§ 870.4500 Cardiovascular surgical 

instruments. 

* * * * * 

(b) Classification. Class I (general 

controls). The device is exempt from the 

premarket notification procedures in 

subpart E of part 807 of this chapter 

subject to the limitations in § 870.9. If 

the device is a noncompression heart 

stabilizer that is a reprocessed single use 

device (SUD) as defined in § 807.3(u) of 

this chapter, the exemption from 

premarket notification does not apply 

and the manufacturer must submit a 

premarket notification that includes 

validation data as described in 

§ 807.3(v). 

23. Section 870.4885 is amended by 

revising paragraph (b) to read as follows: 

§ 870.4885 External vein stripper. 

* * * * * 

(b) Classification. Class II (special 

controls). If the device is a reprocessed 

single use device (SUD) as defined in 

§ 807.3(u) of this chapter, a premarket 

notification submission for the device 

must include validation data as 

described in § 807.3(v). 

PART 872—DENTAL DEVICES 

24. The authority citation for 21 CFR 

part 872 continues to read as follows: 

Authority: 21 U.S.C. 351, 360, 360c, 360e, 

360j, 371. 

25. Section 872.3240 is amended by 

revising paragraph (b) to read as follows: 

§ 872.3240 Dental bur. 

* * * * * 

(b) Classification. Class I (general 

controls). The device is exempt from the 

premarket notification procedures in 

subpart E of part 807 of this chapter 

subject to the limitations in § 872.9. If 

the device is a dental diamond coated 

bur that is a reprocessed single use 

device (SUD) as defined in § 807.3(u) of 

this chapter, the exemption from 

premarket notification does not apply 

and the manufacturer must submit a 

premarket notification submission that 

includes validation data as described in 

§ 807.3(v). 

26. Section 872.4535 is amended by 

revising paragraph (b) to read as follows: 

§ 872.4535 Dental diamond instrument. 

* * * * * 

(b) Classification. Class I (general 

controls). The device is exempt from the 

premarket notification procedures in 

subpart E of part 807 of this chapter 

subject to the limitations in § 872.9. If 

the device is a reprocessed single use 

device (SUD) as defined in § 807.3(u) of 

this chapter, the exemption from 

premarket notification does not apply 

and the manufacturer must submit a 

premarket notification that includes 

validation data as described in 

§ 807.3(v). 

27. Section 872.4730 is amended by 

revising paragraph (b) to read as follows: 

§ 872.4730 Dental injecting needle. 

* * * * * 

(b) Classification. Class I (general 

controls). The device is exempt from the 

premarket notification procedures in 

subpart E of part 807 of this chapter 

subject to the limitations in § 872.9. If 

the device is a reprocessed single use 

device (SUD) as defined in § 807.3(u) of 

this chapter, the exemption from 

premarket notification does not apply 

and the manufacturer must submit a 

premarket notification that includes 

validation data as described in 

§ 807.3(v). 

28. Section 872.5410 is amended by 

revising paragraph (b) to read as follows: 

§ 872.5410 Orthodontic appliance and 

accessories. 

* * * * * 

(b) Classification. Class I (general 

controls). The device is exempt from the 

premarket notification procedures in 

subpart E of part 807 of this chapter 

subject to the limitations in § 872.9. If 

the device is a orthodontic metal bracket 

that is a reprocessed single use device 

(SUD) as defined in § 807.3(u) of this 

chapter, the exemption from premarket 

notification does not apply and the 

manufacturer must submit a premarket 

notification that includes validation 

data as described in § 807.3(v). 

29. Section 872.5470 is amended by 

revising paragraph (b) to read as follows: 

§ 872.5470 Orthodontic plastic bracket. 

* * * * * 

(b) Classification. Class II (special 

controls). If the device is a reprocessed 

single use device (SUD) as defined in 

§ 807.3(u) of this chapter, the exemption 

from premarket notification does not 

apply and the manufacturer must 

submit a premarket notification that 

includes validation data as described in 

§ 807.3(v). 

PART 874—EAR, NOSE, AND THROAT 

DEVICES 

30. The authority citation for 21 CFR 

part 874 continues to read as follows: 

Authority: 21 U.S.C. 351, 360, 360c, 360e, 

360j, 371. 

31. Section 874.4140 is amended by 

revising paragraph (b) to read as follows: 


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§ 874.4140 Ear, nose, and throat bur. 

* * * * * 

(b) Classification. Class I (general 

controls). The device is exempt from the 

premarket notification procedures in 

subpart E of part 807 of this chapter 

subject to the limitations in § 874.9. If 

the device is an ear, nose, and throat 

(ENT) high speed microdebrider or an 

ENT diamond coated bur and it is a 

reprocessed single use device (SUD) as 

defined in § 807.3(u) of this chapter, the 

exemption from premarket notification 

does not apply and the manufacturer 

must submit a premarket notification 

that includes validation data as 

described in § 807.3(v). 

32. Section 874.4420 is amended by 

revising paragraph (b) to read as follows: 

§ 874.4420 Ear, nose, and throat manual 

surgical instrument. 

* * * * * 

(b) Classification. Class I (general 

controls). The device is exempt from the 

premarket notification procedures in 

subpart E of part 807 of this chapter 

subject to the limitations in § 874.9. If 

the device is a laryngeal, sinus, or 

tracheal trocar that is a reprocessed 

single use device (SUD) as defined in 

§ 807.3(u) of this chapter, the exemption 

from premarket notification does not 

apply and the manufacturer must 

submit a premarket notification that 

includes validation data as described in 

§ 807.3(v). 

33. Section 874.4680 is amended by 

revising paragraph (b) to read as follows: 

§ 874.4680 Bronchoscope (flexible or rigid) 

and accessories. 

* * * * * 

(b) Classification. Class II (special 

controls). If the device is a 

bronchoscope (nonrigid) biopsy forceps 

that is a reprocessed single use device 

(SUD) as defined in § 807.3(u) of this 

chapter, a premarket notification 

submission for the device must include 

validation data as described in 

§ 807.3(v). 

PART 876—GASTROENTEROLOGYUROLOGY DEVICES 

34. The authority citation for 21 CFR 

part 876 continues to read as follows: 

Authority: 21 U.S.C. 351, 360, 360c, 360e, 

360j, 360l, 371. 

35. Section 876.1075 is amended by 

revising paragraph (b) to read as follows: 

§ 876.1075 Gastroenterology-urology 

biopsy instrument. 

* * * * * 

(b) Classification. (1) Class II (special 

controls). If the device is a 

gastroenterology-urology (G–U) biopsy 

needle and needle set or a biopsy 

instrument and it is a reprocessed single 

use device (SUD) as defined in 

§ 807.3(u) of this chapter, a premarket 

notification submission for the device 

must include validation data as 

described in § 807.3(v). 

(2) Class I (general controls) for the 

biopsy forceps cover and the nonelectric biopsy forceps. The devices 

subject to this paragraph (b)(2) are 

exempt from the premarket notification 

procedures in subpart E of part 807 of 

this chapter subject to the limitations in 

§ 876.9. If the device is a non-electric 

biopsy forceps that is a reprocessed SUD 

as defined in § 807.3(u) of this chapter, 

the exemption from premarket 

notification does not apply and the 

manufacturer must submit a premarket 

notification that includes validation 

data as described in § 807.3(v). 

36. Section 876.1500 is amended by 

revising paragraph (b)(1) to read as 

follows: 

§ 876.1500 Endoscope and accessories. 

* * * * * 

(b) Classification. (1) Class II (special 

controls). If the device is an endoscopic 

needle, an endoilluminator, a general 

and plastic surgery laparoscope, or a 

spring-loaded pneumoperitoneum 

needle and it is a reprocessed single use 

device (SUD) as defined in § 807.3(u) of 

this chapter, a premarket notification 

submission for the device must include 

validation data as described in 

§ 807.3(v). 

* * * * * 

37. Section 876.4300 is amended by 

revising paragraph (b) to read as follows: 

§ 876.4300 Endoscopic electrosurgical 

unit and accessories. 

* * * * * 

(b) Classification. Class II (special 

controls). If the device is an active 

urological electrosurgical electrode, a 

flexible suction coagulator electrode, an 

electric biopsy forceps, a flexible snare, 

or an endoscopic (with or without 

accessories) electrosurgical unit that is a 

reprocessed single use device (SUD) as 

defined in § 807.3(u) of this chapter, a 

premarket notification submission for 

the device must include validation data 

as described in § 807.3(v). 

38. Section 876.4680 is amended by 

revising paragraph (b) to read as follows: 

§ 876.4680 Ureteral stone dislodger. 

* * * * * 

(b) Classification. Class II (special 

controls). The device is exempt from the 

premarket notification procedures in 

subpart E of part 807 of this chapter 

subject to the limitations in § 876.9. If 

the device is a flexible and basket stone 

dislodger that is a reprocessed single 

use device (SUD) as defined in 

§ 807.3(u) of this chapter, a premarket 

notification submission for the device 

must include validation data as 

described in § 807.3(v). 

39. Section 876.5010 is amended by 

revising paragraph (b) to read as follows: 

§ 876.5010 Biliary catheter and 

accessories. 

* * * * * 

(b) Classification. Class II (special 

controls). The device is exempt from the 

premarket notification procedures in 

subpart E of part 807 of this chapter 

subject to the limitations in § 876.9. If 

the device is a biliary catheter that is a 

reprocessed single use device (SUD) as 

defined in § 807.3(u) of this chapter, a 

premarket notification submission for 

the device must include validation data 

as described in § 807.3(v). 

40. Section 876.5540 is amended in 

paragraph (b)(3) to read as follows: 

§ 876.5540 Blood access device and 

accessories. 

* * * * * 

(b) * * * 

(3) Class II (special controls) for 

accessories for both the implanted and 

the nonimplanted blood access devices 

not listed in paragraph (b)(4) of this 

section. If the device is a single needle 

dialysis set (coaxial flow) or fistula 

needle and it is a reprocessed single use 

device (SUD) as defined in § 807.3(u) of 

this chapter, a premarket notification 

submission for the device must include 

validation data as described in 

§ 807.3(v). 

* * * * * 

41. Section 876.5820 is amended by 

revising paragraph (b)(1) to read as 

follows: 

§ 876.5820 Hemodialysis system and 

accessories. 

* * * * * 

(b) Classification. (1) Class II (special 

controls) (for hemodialysis systems and 

all accessories directly associated with 

the extracorporeal blood system and the 

dialysate delivery system). If the device 

is a single needle dialysis set with unidirectional pump that is a reprocessed 

single use device (SUD) as defined in 

§ 807.3(u) of this chapter, a premarket 

notification submission for the device 

must include validation data as 

described in § 807.3(v). 

* * * * * 

PART 878—GENERAL AND PLASTIC 

SURGERY DEVICES 

42. The authority citation for 21 CFR 

part 878 continues to read as follows: 

Authority: 21 U.S.C. 351, 360, 360c, 360e, 

360j, 360l, 371. 


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43. Section 878.4200 is amended by 

revising paragraph (b) to read as follows: 

§ 878.4200 Introduction/drainage catheter 

and accessories. 

* * * * * 

(b) Classification. Class I (general 

controls). The device is exempt from the 

premarket notification procedures in 

subpart E of part 807 of this chapter 

subject to the limitations in § 878.9. If 

the device is a catheter needle that is a 

reprocessed single use device (SUD) as 

defined in § 807.3(u) of this chapter, the 

exemption from premarket notification 

does not apply and the manufacturer 

must submit a premarket notification 

that includes validation data as 

described in § 807.3(v). 

44. Section 878.4300 is amended by 

revising paragraph (b) to read as follows: 

§ 878.4300 Implantable clip. 

* * * * * 

(b) Classification. Class II (special 

controls). If the device is a reprocessed 

single use device (SUD) as defined in 

§ 807.3(u) of this chapter, a premarket 

notification submission for the device 

must include validation data as 

described in § 807.3(v). 

45. Section 878.4400 is amended by 

revising paragraph (b) to read as follows: 

§ 878.4400 Electrosurgical cutting and 

coagulation device and accessories. 

* * * * * 

(b) Classification. Class II (special 

controls). If the device is an endoscopic 

or laparoscopic electrosurgical 

accessory that is a reprocessed single 

use device (SUD) as defined in 

§ 807.3(u) of this chapter, a premarket 

notification submission for the device 

must include validation data as 

described in § 807.3(v). 

46. Section 878.4750 is amended by 

revising paragraph (b) to read as follows: 

§ 878.4750 Implantable staple. 

* * * * * 

(b) Classification. Class II (special 

controls). If the device is a reprocessed 

single use device (SUD) as defined in 

§ 807.3(u) of this chapter, a premarket 

notification submission for the device 

must include validation data as 

described in § 807.3(v). 

47. Section 878.4800 is amended by 

revising paragraph (b) to read as follows: 

§ 878.4800 Manual surgical instrument for 

general use. 

* * * * * 

(b) Classification. Class I (general 

controls). The device is exempt from the 

premarket notification procedures in 

subpart E of part 807 of this chapter 

subject to the limitations in § 878.9. If 

the device is a percutaneous biopsy 

device, a gastroenterology-urology 

needle, a cardiovascular biopsy needle, 

or an aspiration and injection needle 

and it is a reprocessed single use device 

(SUD) as defined in § 807.3(u) of this 

chapter, the exemption from premarket 

notification does not apply and the 

manufacturer must submit a premarket 

notification that includes validation 

data as described in § 807.3(v). 

PART 880—GENERAL HOSPITAL AND 

PERSONAL USE DEVICES 

48. The authority citation for 21 CFR 

part 880 continues to read as follows: 

Authority: 21 U.S.C. 351, 360, 360c, 360e, 

360j, 371. 

49. Section 880.5570 is amended by 

revising paragraph (b) to read as follows: 

§ 880.5570 Hypodermic single lumen 

needle. 

* * * * * 

(b) Classification. Class II (special 

controls). If the device is a reprocessed 

single use device (SUD) as defined in 

§ 807.3(u) of this chapter, a premarket 

notification submission for the device 

must include validation data as 

described in § 807.3(v). 

50. Section 880.5860 is amended by 

revising paragraph (b) to read as follows: 

§ 880.5860 Piston syringe. 

* * * * * 

(b) Classification. Class II (special 

controls). If the device is a reprocessed 

single use device (SUD) as defined in 

§ 807.3(u) of this chapter, a premarket 

notification submission for the device 

must include validation data as 

described in § 807.3(v). 

PART 882—NEUROLOGICAL DEVICES 

51. The authority citation for 21 CFR 

part 882 continues to read as follows: 

Authority: 21 U.S.C. 351, 360, 360c, 360e, 

360j, 371. 

52. Section 882.4190 is amended by 

revising paragraph (b) to read as follows: 

§ 882.4190 Clip forming/cutting 

instrument. 

* * * * * 

(b) Classification. Class I (general 

controls). The device is exempt from the 

premarket notification procedures in 

subpart E of part 807 of this chapter 

subject to the limitations in § 882.9. If 

the device is a reprocessed single use 

device (SUD) as defined in § 807.3(u) of 

this chapter, the exemption from 

premarket notification does not apply 

and the manufacturer must submit a 

premarket notification that includes 

validation data as described in 

§ 807.3(v). 

53. Section 882.4300 is amended by 

revising paragraph (b) to read as follows: 

§ 882.4300 Manual cranial drills, burrs, 

trephines, and accessories. 

* * * * * 

(b) Classification. Class II (special 

controls). If the device is a reprocessed 

single use device (SUD) as defined in 

§ 807.3(u) of this chapter, a premarket 

notification submission for the device 

must include validation data as 

described in § 807.3(v). 

54. Section 882.4305 is amended by 

revising paragraph (b) to read as follows: 

§ 882.4305 Powered compound cranial 

drills, burrs, trephines, and their 

accessories. 

* * * * * 

(b) Classification. Class II (special 

controls). If the device is a reprocessed 

single use device (SUD) as defined in 

§ 807.3(u) of this chapter, a premarket 

notification submission for the device 

must include validation data as 

described in § 807.3(v). 

55. Section 882.4310 is amended by 

revising paragraph (b) to read as follows: 

§ 882.4310 Powered simple cranial drills, 

burrs, trephines, and their accessories. 

* * * * * 

(b) Classification. Class II (special 

controls). If the device is a reprocessed 

single use device (SUD) as defined in 

§ 807.3(u) of this chapter, a premarket 

notification submission for the device 

must include validation data as 

described in § 807.3(v). 

PART 884—OBSTETRICAL AND 

GYNECOLOGICAL DEVICES 

56. The authority citation for 21 CFR 

part 884 continues to read as follows: 

Authority: 21 U.S.C. 351, 360, 360c, 360e, 

360j, 371. 

57. Section 884.1720 is amended by 

revising paragraph (b)(1) to read as 

follows: 

§ 884.1720 Gynecologic laparoscope and 

accessories. 

* * * * * 

(b) (1) Classification. Class II (special 

controls). If the device is a reprocessed 

single use device (SUD) as defined in 

§ 807.3(u) of this chapter, a premarket 

notification submission for the device 

must include validation data as 

described in § 807.3(v). 

* * * * * 

58. Section 884.1730 is amended by 

revising paragraph (b)(2) to read as 

follows: 

§ 884.1730 Laparoscopic insufflator. 

* * * * * 

(b) * * * 


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(2) Class I for tubing and tubing/filter 

kits which include accessory 

instruments that are not used to effect 

intra-abdominal insufflation 

(pneumoperitoneum). The devices 

subject to this paragraph (b)(2) are 

exempt from the premarket notification 

procedures in subpart E of part 807 of 

this chapter, subject to the limitations in 

§ 884.9. If the device is a reprocessed 

single use device (SUD) as defined in 

§ 807.3(u) of this chapter, the exemption 

from premarket notification does not 

apply and the manufacturer must 

submit a premarket notification that 

includes validation data as described in 

§ 807.3(v). 

59. Section 884.4530 is amended by 

revising paragraph (b)(2) to read as 

follows: 

§ 884.4530 Obstetric-gynecologic 

specialized manual instrument. 

* * * * * 

(b) * * * 

(2) Class I for the amniotome, uterine 

curette, cervical dilator (fixed-size 

bougies), cerclage needle, intrauterine 

device (IUD) remover, uterine sound, 

and gynecological biopsy forceps. The 

devices subject to this paragraph (b)(2) 

are exempt from the premarket 

notification procedures in subpart E of 

part 807 of this chapter, subject to the 

limitations in § 884.9. If the device is a 

gynecological biopsy forceps that is a 

reprocessed single use device (SUD) as 

defined in § 807.3(u) of this chapter, the 

exemption from premarket notification 

does not apply and the manufacturer 

must submit a premarket notification 

that includes validation data as 

described in § 807.3(v). 

60. Section 884.6100 is amended by 

revising paragraph (b) to read as follows: 

§ 884.6100 Assisted reproduction needles. 

* * * * * 

(b) Classification. Class II (special 

controls) (mouse embryo assay 

information, endotoxin testing, 

sterilization validation, design 

specifications, labeling requirements, 

biocompatibility testing, and clinical 

testing). If the device is a reprocessed 

single use device (SUD) as defined in 

§ 807.3(u) of this chapter, the exemption 

from premarket notification does not 

apply and the manufacturer must 

submit a premarket notification that 

includes validation data as described in 

§ 807.3(v). 

PART 886—OPTHALMIC DEVICES 

61. The authority citation for 21 CFR 

part 886 continues to read as follows: 

Authority: 21 U.S.C. 351, 360, 360c, 360e, 

360j, 371. 

62. Section 886.4350 is amended by 

revising paragraph (b) to read as follows: 

§ 886.4350 Manual ophthalmic surgical 

instrument. 

* * * * * 

(b) Classification. Class I (general 

controls). The device is exempt from the 

premarket notification procedures in 

subpart E of part 807 of this chapter, 

subject to the limitations in § 886.9. If 

the device is an ophthalmic knife that 

is a reprocessed single use device (SUD) 

as defined in § 807.3(u) of this chapter, 

the exemption from premarket 

notification does not apply and the 

manufacturer must submit a premarket 

notification that includes validation 

data as described in § 807.3(v). 

63. Section 886.4370 is amended by 

revising paragraph (b) to read as follows: 

§ 886.4370 Keratome. 

* * * * * 

(b) Classification. Class I (general 

controls). If the device is a reprocessed 

single use device (SUD) as defined in 

§ 807.3(u) of this chapter, a premarket 

notification submission for the device 

must include validation data as 

described in § 807.3(v). 

64. Section 886.4670 is amended by 

revising paragraph (b) to read as follows: 

§ 886.4670 Phacofragmentation system. 

* * * * * 

(b) Classification. Class II (special 

controls). If the device is a 

phacoemulsification needle that is a 

reprocessed single use device (SUD) as 

defined in § 807.3(u) of this chapter, a 

premarket notification submission for 

the device must include validation data 

as described in § 807.3(v). 

PART 892—RADIOLOGY DEVICES 

65. The authority citation for 21 CFR 

part 892 continues to read as follows: 

Authority: 21 U.S.C. 351, 360, 360c, 360e, 

360j, 371. 

66. Section 892.5730 is amended by 

revising paragraph (b) to read as follows: 

§ 892.5730 Radionuclide brachytherapy 

source. 

* * * * * 

(b) Classification. Class II (special 

controls). If the device is an isotope 

needle that is a reprocessed single use 

device (SUD) as defined in § 807.3(u) of 

this chapter, a premarket notification 

submission for the device must include 

validation data as described in 

§ 807.3(v). 

Dated: September 6, 2006. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 06–8165 Filed 9–22–06; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[COTP San Francisco Bay 06–036] 

RIN 1625–AA00 

Safety Zone; Red Bull Air Show 

Practice, San Francisco Bay, CA 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of proposed rulemaking. 

SUMMARY: The Coast Guard proposes a 

safety zone to be used to keep spectator 

vessels out of the path and away from 

the area directly below participating 

aircraft during the fleet week air show 

practice in order to ensure the safety of 

event participants and spectators. 

DATES: Comments and related material 

must reach the Coast Guard on or before 

October 10, 2006. 

ADDRESSES: You may mail comments 

and related material to the Waterways 

Safety Branch, U.S. Coast Guard Sector 

San Francisco, 1 Yerba Buena Island, 

San Francisco, California 94130. The 

Waterways Safety Branch maintains the 

public docket for this rulemaking. 

Comments and material received from 

the public, as well as documents 

indicated in this preamble as being 

available in the docket, will become part 

of this docket and will be available for 

inspection or copying at the Waterways 

Safety Branch between 9 a.m. and 4 

p.m., Monday through Friday, except 

Federal holidays. 

FOR FURTHER INFORMATION CONTACT: 

Ensign Erin Bastick, U.S. Coast Guard 

Sector San Francisco, at (415) 556–2950 

or Sector San Francisco 24 hour 

Command Center at (415) 399–3547. 

SUPPLEMENTARY INFORMATION: 

Request for Comments 

We encourage you to participate in 

this rulemaking by submitting 

comments and related material. If you 

do so, please include your name and 

address, identify the docket number for 

this rulemaking (COTP San Francisco 

Bay 06–036), indicate the specific 

section of this document to which each 

comment applies, and give the reason 

for each comment. Please submit all 

comments and related material in an 

unbound format, no larger than 81⁄2 by 

11 inches, suitable for copying. If you 

would like to know they reached us, 

please enclose a stamped, self-addressed 

postcard or envelope. We will consider 

all comments and material received 

during the comment period. We may 


cprice-sewell on PROD1PC66 with PROPOSALS