53326 Federal Register / Vol. 70, No. 173 / Thursday, September 8, 2005 / Proposed Rules 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 880 

[Docket No. 2001P–0120 (Formerly Docket 

No. 01P–0120)] 

Medical Devices; Needle-Bearing 

Devices; Withdrawal of Advance 

Notice of Proposed Rulemaking 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Advance notice of proposed 

rulemaking; withdrawal. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

withdrawal of an advance notice of 

proposed rulemaking (ANPRM) 

concerning needle-bearing devices. FDA 

is concerned about the significant health 

risk posed by needlestick and other 

percutaneous injuries but FDA believes 

that the actions it has taken and 

continues to take along with the actions 

taken by the Occupational Safety and 

Health Administration (OSHA) are 

addressing the issue adequately at this 

time. 

DATES: The ANPRM published at 67 FR 

41890 (June 20, 2002), is withdrawn as 

of September 7, 2005. 

ADDRESSES: Responses to petitions and 

references may be seen in the Division 

of Dockets Management (HFA–305), 

Food and Drug Administration, 5630 

Fishers Lane, rm. 1061, Rockville, MD 

20852 or on the Internet at http:// 

www.fda.gov/ohrms/dockets/ 

default.htm. 

FOR FURTHER INFORMATION CONTACT: 

Myrna Hanna, Center for Devices and 

Radiological Health (HFZ–215), Food 

and Drug Administration, 1350 Piccard 

Dr., Rockville, MD 20850, 301–827–

2974. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On March 6, 2001, FDA received and 

then filed a petition that had been 

submitted jointly by Public Citizen’s 

Health Research Group (HRG), a 

consumer advocacy group, and the 

Service Employees International Union 

(SEIU) (the ‘‘HRG/SEIU petition’’). The 

HRG/SEIU petition requested that FDA 

take certain actions to further reduce the 

risk of needlestick injuries to healthcare 

workers. On September 5, 2001, FDA 

issued a response to this petition. In its 

response, FDA stated that it did not 

have sufficient information to take the 

actions requested by the petitioners, but 

that FDA would publish an ANPRM 

inviting interested persons to submit 

additional data and information to assist 

FDA in determining a proper course of 

action. 

In the Federal Register of June 20, 

2002 (67 FR 41890), FDA published an 

ANPRM on this topic. FDA invited 

interested persons to submit comments 

on the HRG/SEIU petition and other 

matters related to needlestick 

prevention by September 18, 2002. FDA 

received more than 50 written and 

electronic comments from a wide 

variety of individuals and organizations. 

II. HRG/SEIU Petition 

The following is a brief summary of 

the HRG/SEIU petition. The petition 

and FDA’s response are available from 

the Division of Dockets Management 

(see ADDRESSES). In requesting the 

petition and response, refer to docket 

number 2001P–0120. 

A. Banning 

The HRG/SEIU petition requested that 

FDA ban the following: 

1. Intravenous (IV) catheters, blood 

collection devices (needles and tube 

holders) and blood collection needle 

sets (‘‘butterfly syringes’’) that do not 

meet the criteria identified in FDA’s 

April 16, 1992, safety alert. This safety 

alert says that needle-bearing devices 

should have a fixed safety feature that 

meets all of the following criteria: 

(1) It provides a barrier between the 

hands and needles after use; 

(2) It allows or requires the worker’s 

hands to remain behind the needle at all 

times; 

(3) It is an integral part of the device, 

and not an accessory; and 

(4) It is in effect before disassembly, 

if any, and remains in effect after 

disposal. 

The safety alert also suggests that the 

device should be simple and easy to use 

requiring little training. 

2. Glass capillary tubes; and 

3. IV infusion equipment that does 

not use needleless technology or 

recessed needles. 

B. Performance Standard 

The HRG/SEIU petition requested that 

FDA issue performance standards based 

on the five design criteria identified in 

the FDA safety alert following the 

procedures set forth in 21 CFR part 861. 

C. Labeling 

Finally, the HRG/SEIU petition 

requested that FDA require that the 

labeling for ‘‘conventional syringes’’

state: ‘‘TO PREVENT POSSIBLE 

EXPOSURE TO HIV AND HEPATITIS, 

DO NOT USE FOR STANDARD BLOOD 

DRAWS.’’ The petitioners stated that 

current labeling for syringes does not 

contain adequate warning of the hazards 

that the device presents. 

III. Comments 

A. Banning 

A few comments supported the ban 

proposed in the HRG/SEIU petition. 

One of these comments submitted three 

studies that showed a significant 

decrease in needlesticks when safety 

devices were used. In their comment, 

HRG objected to FDA’s conclusion in 

the petition response that there was 

insufficient information to relate 

injuries to specific devices so as to 

justify banning them. HRG suggested 

that FDA should make a greater effort to 

extract the data from its own records to 

support a ban. Many comments opposed 

a ban. Several of these comments 

suggested that the criteria for banning a 

device under section 516 of the Federal 

Food, Drug, and Cosmetic Act (the act) 

(21 U.S.C. 360f) were not met. Many of 

the comments suggested that a ban 

would create a critical shortage of 

necessary devices. 

The legal standard to be applied by 

FDA in deciding whether it is 

appropriate to ban a device is set out in 

section 516 of the act. This section 

states that FDA may ban a device if it 

finds that the device presents a 

‘‘substantial deception or an 

unreasonable and substantial risk of 

illness or injury.’’ The regulations 

implementing section 516 state that, in 

determining whether the risk of illness 

or injury is substantial, FDA will need 

to consider whether the risk posed by 

continued marketing of the device is 

important, material, or significant in 

relation to the benefit to the public 

health from continued marketing (21 

CFR 895.21(a)(1)). 

In its response to the HRG/SEIU 

petition, FDA stated that it did not have 

sufficient information to conclude that 

there is a legal basis for banning the 

devices identified in the petition. In 

support of their petition, the petitioners 

refer to occupational exposure data 

obtained from the Epinet database 

coordinated by the University of 

Virginia (Ref. 1) The Epinet data show 

that 52 hospitals with a total average 

daily census of 9,681 patients reported 

3,180 sharp object injuries in 1998. 

Syringes accounted for 33 percent of 

these injuries; needles on IV lines, 2 

percent; butterfly needles, 8 percent; 

vacuum tube blood collection needles, 6 

percent; IV catheter stylets and glass 

capillary tubes, less than 1 percent. 

The petition also cited similar data 

from the Centers for Disease Control and 

Prevention (CDC). The CDC reported 

Federal Register / Vol. 70, No. 173 / Thursday, September 8, 2005 / Proposed Rules 53327 

that, for the period from June 1995 to 

July 1999, there were 4,951 sharp object 

injuries reported to its surveillance 

system. Of these reported injuries, 29 

percent involved hypodermic needles, 

13 percent butterfly needles, 6 percent 

IV catheter stylets, and 4 percent blood 

drawing needles. The petition also 

stated that 8 percent of exposures with 

hollow bore needles were categorized as 

IV line-related. 

Although the HRG/SEIU petition 

addressed the number of injuries related 

to generic types of devices, it did not 

show: (1) Which specific devices were 

used; (2) how many devices of that type 

were used during the relevant time 

period; (3) what the design 

characteristics of those devices were; or 

(4) whether the devices met any or all 

of the design criteria listed. In the 

absence of such information about 

specific devices, FDA was unable to 

conclude that any particular device 

presented a ‘‘substantial deception or an 

unreasonable and substantial risk of 

illness or injury.’’ FDA has not received 

any information since publication of the 

ANPRM that would lead it to reach a 

different conclusion. 

B. Performance Standards 

Many of the comments expressed a 

willingness to participate in the 

development of a performance standard 

for needle-bearing devices. Many of 

these same comments and other 

comments, however, expressed doubt as 

to whether a standard could be 

developed because of the wide range of 

devices and technologies. No comments 

proposed any specific parameters for 

such a standard. FDA has consulted 

with some standard development 

organizations. The representatives of 

these groups expressed some 

willingness to work with FDA to 

develop a standard but also 

acknowledged the difficulty of 

developing a standard to address so 

many different devices. FDA will 

continue to work with these standard 

development groups to determine if one 

or more useful standards could be 

developed. 

C. Labeling 

Some comments suggested that the 

labeling statement for conventional 

syringes proposed in the HRG/SEIU 

petition may be useful. Many comments 

suggested that the labeling statement 

was unnecessary. 

In its response to the HRG/SEIU 

petition, FDA stated that the 

information in the proposed statement 

is well known to healthcare 

professionals who use these types of 

devices and, therefore, under 21 CFR 

801.109(c), FDA would not ordinarily 

require such a statement in the labeling. 

FDA has not found anything in the 

comments to suggest a different 

conclusion. 

D. National Association for the Primary 

Prevention of Sharps Injuries List 

The National Association for the 

Primary Prevention of Sharps Injuries 

(NAPPSI) requested that FDA post on its 

Web site and disseminate NAPPSI’s 

Safety Device List. This list includes 

sharps injury prevention devices. 

Several comments supported this 

proposal. 

FDA is in favor of health care 

professionals having access to 

information that will help them choose 

safer medical devices. However, FDA 

believes that it would be difficult to 

ensure that NAPPSI’s Safety Device List 

was up to date at all times. FDA, 

nevertheless, encourages health care 

professionals and others to make use of 

whatever information is available to 

choose safe devices. 

E. The OSHA Bloodborne Pathogens 

Standard 

Several comments suggested that the 

OSHA Bloodborne Pathogens (BBP) 

standard, together with the actions that 

FDA has been taking, provides sufficient 

protection. 

FDA has been working together with 

OSHA to reduce the risk of sharps 

injuries to healthcare workers and 

others. FDA regulates medical devices, 

including those containing sharps, 

under the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 301 et seq.). 

OSHA maintains authority to regulate 

workplace controls for the protection of 

employees (Refs. 2 and 3). 

In the Federal Register of December 6, 

1991 (56 FR 64004), OSHA issued its 

BBP standard (29 CFR 1910.1030). The 

standard reflects OSHA’s determination 

that a combination of engineering and 

work practice controls, personal 

protective equipment, training, medical 

surveillance, hepatitis B vaccination, 

signs and labels, and other requirements 

would minimize the risk of disease 

transmission. FDA provided extensive 

input and comment to OSHA during the 

development of this standard. 

On November 6, 2000, President 

Clinton signed the Needlestick Safety 

and Prevention Act (Public Law 106–

430). This statute required OSHA to 

revise several aspects of the BBP 

standard within 6 months. In the 

Federal Register of January 18, 2001 (66 

FR 5318), OSHA published a final rule 

amending the BBP standard. The final 

rule went into effect on April 18, 2001. 

Again, FDA provided input and 

comment to OSHA during the 

development of the amended BBP 

standard. 

The amended BBP standard added 

new requirements to the annual review 

and update of a covered employer’s 

exposure control plan. Specifically, 

under these new requirements, each 

covered employer must document the 

extent to which it uses, or has 

considered using, products that will 

minimize workplace exposure to 

needlesticks and other percutaneous 

injuries. The annual update and review 

of each covered employer’s plan must 

also reflect changes in technology that 

eliminate or reduce exposure to 

bloodborne pathogens and document 

consideration and implementation of 

appropriate commercially available and 

effective safer medical devices designed 

to eliminate or minimize occupational 

exposure. Each employer subject to the 

rule is also required to solicit input from 

nonmanagerial employees responsible 

for direct patient care who are 

potentially exposed to injuries from 

contaminated sharps in the 

identification, evaluation, and selection 

of effective engineering and work 

practice controls. The employer must 

document the solicitation in the 

exposure control plan. 

IV. Conclusion 

FDA has cleared several hundred 

devices with needlestick prevention 

features. FDA continues to work with 

manufacturers to assist in the clearance 

of devices with needle-free technology 

or needlestick prevention features. 

On November 12, 2002, FDA issued a 

guidance document entitled 

‘‘Needlesticks Medical Device Reporting 

Guidance for User Facilities, 

Manufacturers, and Importers.’’ This 

guidance document outlines FDA’s 

policy for determining when an event 

involving needlesticks and blood 

exposure is reportable as a serious 

injury and when it is reportable as a 

malfunction. 

On March 2, 2001, FDA issued a 

guidance document entitled ‘‘Premarket 

Approval Applications (PMA) for 

Sharps Needle Destruction.’’ This 

document provides guidance to 

manufacturers on the types of issues 

and areas of concern that need to be 

addressed when submitting a PMA for 

sharps needle destruction devices 

intended for use in healthcare facilities. 

FDA has cosponsored several national 

meetings on needlestick prevention 

issues. FDA continues to work with 

health care professionals on educational 

issues concerning the safe use of needlebearing devices. 

53328 Federal Register / Vol. 70, No. 173 / Thursday, September 8, 2005 / Proposed Rules 

As noted previously, FDA is working 

with consensus standards development 

groups to determine whether standards 

could be developed to address the issue 

of needlesticks related to medical 

devices. 

FDA believes that these actions, in 

conjunction with the actions taken by 

OSHA under its BBP standard, are 

sufficient to address the risk of 

needlestick injuries related to the use of 

needle-bearing medical devices. FDA, 

therefore, does not intend to take any of 

the specific actions requested in the 

HRG/SEIU petition at this time and is 

withdrawing the ANPRM published in 

the Federal Register of June 20, 2002. 

V. References 

The following references have been 

placed on display in the Division of 

Dockets Management (see ADDRESSES) 

and may be seen by interested persons 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

1. Petition from Public Citizen Health 

Research Group and the Service Employees 

International Union (Docket No. 2001P–0120) 

and FDA’s response dated September 5, 

2001. 

2. Letter from Dr. Michael A. Friedman, 

Deputy Commissioner for Operations, Food 

and Drug Administration, to Charles N. 

Jeffress, Assistant Secretary of Labor for 

Occupational Safety and Health, dated 

December 18, 1998. 

3. Letter from Charles N. Jeffress, Assistant 

Secretary of Labor for Occupational Safety 

and Health, to Dr. Michael A. Friedman, 

Deputy Commissioner for Operations, Food 

and Drug Administration, dated February 8, 

1999. 

Dated: August 29, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–17733 Filed 9–7–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF THE TREASURY 

Alcohol and Tobacco Tax and Trade 

Bureau 

27 CFR Parts 4, 24, and 27 

[Re: Notice No. 51] 

RIN 1513–AB00 

Certification Requirements for 

Imported Natural Wine (2005R–002P); 

Correction 

AGENCY: Alcohol and Tobacco Tax and 

Trade Bureau (TTB), Treasury. 

ACTION: Notice of proposed rulemaking; 

correction. 

SUMMARY: On August 24, 2005, TTB 

published a notice of proposed 

rulemaking in the Federal Register 

regarding the certification requirements 

for imported natural wine. We also 

published a temporary rule on the same 

subject in the same issue. In that notice 

of proposed rulemaking, a cross 

reference contains an incorrect CFR 

section number. This document corrects 

that error. 

FOR FURTHER INFORMATION CONTACT: Gail 

Davis, International Trade Division, 

Alcohol and Tobacco Tax and Trade 

Bureau, telephone 202–927–8110. 

SUPPLEMENTARY INFORMATION: On August 

24, 2005, TTB published a notice of 

proposed rulemaking, Notice No. 51, in 

the Federal Register entitled 

‘‘Certification Requirements for 

Imported Natural Wine’’ (70 FR 49516). 

Notice No. 51 was cross-referenced to a 

temporary rule on the same subject, 

which was published in the same issue 

as T.D. TTB–31 (70 FR 49479). Notice 

No. 51 contains a cross reference with 

an incorrect CFR section number. 

Therefore, in the Federal Register of 

August 24, 2005, on page 49518, in the 

first column, in paragraph number (7), 

the cross-reference instruction should 

read as follows: 

[The text of proposed § 27.140 is the 

same as the text of § 27.140 as set forth 

in the temporary rule published 

elsewhere in this issue of the Federal 

Register.] 

Dated: June 1, 2005. 

Francis W. Foote, 

Director, Regulations and Rulings Division. 

[FR Doc. 05–17756 Filed 9–7–05; 8:45 am] 

BILLING CODE 4810–31–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 117 

[USCG–2005–22363] [Formerly CGD08–05–

049] 

RIN 1625–AA09 

Drawbridge Operation Regulation; 

Lafourche Bayou, Lafourche Parish, 

LA 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of proposed rulemaking; 

change of address and docket number 

for comments. 

SUMMARY: On September 2, 2005, the 

Coast Guard published a notice and 

requested comments on a proposed 

change to regulations governing six 

drawbridges across Bayou Lafourche, 

south of the Gulf Intracoastal Waterway, 

in Lafourche Parish, Louisiana. The 

proposed rule would change bridge 

schedules so that they would remain 

closed to navigation at various times on 

weekdays during the school year to 

facilitate the safe, efficient movement of 

staff, students and other residents 

within the parish. That notice was 

signed August 26, 2005, before 

Hurricane Katrina struck New Orleans 

and caused that city to be flooded. We 

have changed the address and docket 

number where comments on the 

proposed rule should be sent because of 

flood conditions in New Orleans. 

DATES: Comments and related material 

must reach the Coast Guard on or before 

November 1, 2005. 

ADDRESSES: You may submit comments 

identified by Coast Guard docket 

number USCG–2005–22363 to the 

Docket Management Facility at the U.S. 

Department of Transportation. To avoid 

duplication, please use only one of the 

following methods: 

(1) Web site: http://dms.dot.gov. 

(2) Mail: Docket Management Facility, 

U.S. Department of Transportation, 400 

Seventh Street SW., Washington, DC 

20590–0001. 

(3) Fax: 202–493–2251. 

(4) Delivery: Room PL–401 on the 

Plaza level of the Nassif Building, 400 

Seventh Street SW., Washington, DC, 

between 9 a.m. and 5 p.m., Monday 

through Friday, except Federal holidays. 

The telephone number is 202–366–

9329. 

(5) Federal eRulemaking Portal: 

http://www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Roger Wiebusch, Bridge Administration 

Branch, telephone 314–539–3900, ext. 

2378. 

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 (USCG–2005–22363), 

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 change 

this proposed rule in view of them.