Federal Register / Vol. 66, No. 95 / Wednesday, May 16, 2001 / Rules and Regulations 27023

(d) * * *

(1) * * *

(xii) Amount per ton. Narasin, 27 to

45 grams; nicarbazin, 27 to 45 grams;

and bambermycins, 1 to 2 grams.

(A) Indications for use. For the

prevention of coccidiosis caused by

Eimeria tenella, E. necatrix, E.

acervulina, E. maxima, E. brunetti, and

E. mivati, and for increased rate of

weight gain and improved feed

efficiency.

(B) Limitations. Feed continuously as

the sole ration. Do not allow adult

turkeys, horses, or other equines access

to formulations containing narasin.

Ingestion of narasin by these animals

has been fatal. Do not feed to laying

hens. Withdraw 5 days before slaughter.

Narasin and nicarbazin as provided by

000986, bambermycins by 012799 in

§ 510.600(c) of this chapter.

* * * * *

Dated: April 23, 2001.

Linda Tollefson,

Deputy Director, Center for Veterinary

Medicine.

[FR Doc. 01–12229 Filed 5–15–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 864 and 876

[Docket No. 01P–0087]

Gastroenterology-Urology Devices;

Classification of Tissue Culture Media

for Human Ex Vivo Tissue and Cell

Culture Processing Applications

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is classifying

tissue culture media for human ex vivo

tissue and cell culture processing

applications into class II (special

controls). The special control that will

apply to this device is a guidance

document entitled ‘‘Class II Special

Controls Guidance Document: Tissue

Culture Media for Human Ex Vivo

Tissue and Cell Culture Processing

Applications; Final Guidance for

Industry and FDA Reviewers.’’ The

agency is taking this action in response

to a petition submitted under the

Federal Food, Drug, and Cosmetic Act

(the act) as amended by the Medical

Device Amendments of 1976, the Safe

Medical Devices Act of 1990, and the

Food and Drug Administration

Modernization Act of 1997. The agency

is classifying these devices into class II

(special controls) in order to provide a

reasonable assurance of the safety and

effectiveness of the devices.

DATES: This rule is effective May 16,

2001.

FOR FURTHER INFORMATION CONTACT:

Carolyn Y. Neuland, Center for Devices

and Radiological Health (HFZ–473),

Food and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–1220.

SUPPLEMENTARY INFORMATION:

I. Background

In accordance with section 513(f)(1) of

the act (21 U.S.C. 360c(f)(1)), devices

that were not in commercial distribution

before May 28, 1976, the date of

enactment of the Medical Device

Amendments of 1976, generally referred

to as postamendments devices, are

classified automatically by statute into

class III without any FDA rulemaking

process. These devices remain in class

III and require premarket approval,

unless and until the device is classified

or reclassified into class I or II or FDA

issues an order finding the device to be

substantially equivalent, in accordance

with section 513(i) of the act, to a

predicate device that does not require

premarket approval. The agency

determines whether new devices are

substantially equivalent to previously

marketed devices by means of

premarket notification procedures in

section 510(k) of the act (21 U.S.C.

360(k)) and 21 CFR part 807 of the FDA

regulations.

Section 513(f)(2) of the act provides

that any person who submits a

premarket notification under section

510(k) of the act for a device that has not

previously been classified may, within

30 days after receiving an order

classifying the device in class III under

section 513(f)(1) of the act, request FDA

to classify the device under the criteria

set forth in section 513(a)(1) of the act.

FDA shall, within 60 days of receiving

such a request, classify the device by

written order. This classification shall

be the initial classification of the device.

Within 30 days after the issuance of an

order classifying the device, FDA must

publish a notice in the Federal Register

announcing such classification.

In accordance with section 513(f)(1) of

the act, FDA issued an order on

December 5, 2000, classifying the

Dulbecco’s Modified Eagle medium for

human ex vivo tissue and cell culture

processing applications in class III,

because it was not substantially

equivalent to a device that was

introduced or delivered for introduction

into interstate commerce for commercial

distribution before May 28, 1976, or a

device that was subsequently

reclassified into class I or class II.

On December 19, 2000, FDA filed a

petition submitted by Life Technologies,

Inc., requesting classification of the

Dulbecco’s Modified Eagle medium for

human ex vivo tissue and cell culture

processing applications into class II

under section 513(f)(2) of the act. After

review of the information submitted in

the petition, FDA determined that the

Dulbecco’s Modified Eagle medium for

human ex vivo tissue and cell culture

processing applications can be classified

in class II with the establishment of

special controls. The solutions are

indicated for use in human ex vivo

tissue and cell culture processing

applications. FDA believes that class II

special controls, in addition to the

general controls, will provide

reasonable assurance of the safety and

effectiveness of the device for this

intended use.

In addition to the general controls of

the act, the Dulbecco’s Modified Eagle

medium for human ex vivo tissue and

cell culture processing applications is

subject to a special control guidance

document entitled ‘‘Class II Special

Controls Guidance Document: Tissue

Culture Media for Human Ex Vivo

Tissue and Cell Culture Processing

Applications; Final Guidance for

Industry and FDA Reviewers.’’

Section 510(m) of the act provides

that FDA may exempt a class II device

from the premarket notification

requirements under section 510(k) of the

act, if FDA determines that premarket

notification is not necessary to provide

reasonable assurance of the safety and

effectiveness of the device. FDA has

determined that premarket notification

is necessary to provide reasonable

assurance of the safety and effectiveness

of this type of device for this intended

use and, therefore, the device is not

exempt from the premarket notification

requirements. FDA review of bench data

and labeling will ensure that minimum

levels of performance for both safety

and effectiveness are addressed before

marketing clearance. Thus, persons who

intend to market this device for this

intended use must submit to FDA a

premarket notification submission

containing information on the device

before marketing the device.

On February 16, 2001, FDA issued an

order to the petitioner classifying the

Dulbecco’s Modified Eagle medium for

human ex vivo tissue and cell culture

processing applications, and

substantially equivalent devices of this

generic type, into class II under the

generic name, tissue culture media for

27024 Federal Register / Vol. 66, No. 95 / Wednesday, May 16, 2001 / Rules and Regulations

human ex vivo tissue and cell culture

processing applications. FDA identifies

this generic type of device as tissue

culture media for human ex vivo tissue

and cell culture processing applications

consisting of cell and tissue culture

media and components that are

composed of chemically defined

components (e.g., amino acids,

vitamins, inorganic salts) that are

essential for the ex vivo development,

survival, and maintenance of tissues

and cells of human origin. The solutions

are indicated for use in human ex vivo

tissue and cell culture processing

applications. This order also identified

as a special control applicable to this

device a guidance document entitled

‘‘Class II Special Controls Guidance

Document: Tissue Culture Media for

Human Ex Vivo Tissue and Cell Culture

Processing Applications; Final

Guidance for Industry and FDA

Reviewers.’’

FDA is codifying this device by

adding § 876.5885. FDA is also

amending 21 CFR 864.2220 Synthetic

cell and tissue culture media and

components, to clarify that the device

described in that section does not

include tissue culture media for human

ex vivo tissue and cell culture

processing applications.

II. Electronic Access

In order to receive the document

entitled, ‘‘Class II Special Controls

Guidance Document: Tissue Culture

Media for Human Ex Vivo Tissue and

Cell Culture Processing Applications;

Final Guidance for Industry and FDA

Reviewers’’ via your fax machine, call

the CDRH Facts-on-Demand system at

800–899–0381 or 301–827–0111 from a

touch-tone telephone. At the first voice

prompt press 1 to access DSMA Facts,

at second voice prompt press 2, and

then enter the document number 1325.

Then follow the remaining voice

prompts to complete your request.

Persons interested in obtaining a copy of

the guidance may also do so using the

Internet. CDRH maintains an entry on

the Internet for easy access to

information including text, graphics,

and files that may be downloaded to a

personal computer with access to the

Internet. Updated on a regular basis, the

CDRH home page includes the

document entitled ‘‘Class II Special

Controls Guidance Document: Tissue

Culture Media for Human Ex Vivo

Tissue and Cell Culture Processing

Applications; Final Guidance for

Industry and FDA Reviewers,’’ device

safety alerts,Federal Register reprints,

information on premarket submissions

(including lists of approved applications

and manufacturers’ addresses), small

manufacturers’ assistance, information

on video conferencing and electronic

submissions, Mammography Matters,

and other device-oriented information.

The CDRH home page may be accessed

at www.fda.gov/cdrh.

III. Environmental Impact

The agency has determined under 21

CFR 25.34(b) 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.

IV. Analysis of Impacts

FDA has examined the impacts of the

final rule under Executive Order 12866

and the Regulatory Flexibility Act (5

U.S.C. 601–612) (as amended by subtitle

D of the Small Business Regulatory

Fairness Act of 1996 (Public Law 104–

121)), 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). The

agency believes that this final rule is

consistent with the regulatory

philosophy and principles identified in

the Executive order. In addition, the

final rule is not a significant regulatory

action as defined by the Executive order

and so it is not subject to review under

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. FDA knows of only one

manufacturer of this type of device.

Classification of these devices in class II

will relieve this manufacturer of the

device of the cost of complying with the

premarket approval requirements of

section 515 of the act (21 U.S.C. 360e)

and may permit small potential

competitors to enter the market place by

lowering their costs. The agency,

therefore, certifies that this final rule

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 of anticipated costs and

benefits before proposing any rule that

may result in an expenditure by State,

local, and tribal governments, in the

aggregate, or by the private sector, of

$100 million in any one year (adjusted

annually for inflation). The Unfunded

Mandates Reform Act does not require

FDA to prepare a statement of costs and

benefits for the final rule, because the

final rule is not expected to result in any

1-year expenditure that would

exceed$100 million.

V. Federalism

FDA has analyzed this final rule in

accordance with the principles set forth

in Executive Order 13132. FDA has

determined that the rule does not

contain policies that have substantial

direct effects on the States, or 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, the

agency has concluded that the rule does

not contain policies that have

federalism implications as defined in

the order and, consequently, a

federalism summary impact statement is

not required.

VI. Paperwork Reduction Act of 1995

This final rule contains no collection

of information. Therefore, clearance by

the Office of Management and Budget

under the Paperwork Reduction Act of

1995 is not required.

List of Subjects

21 CFR Part 864

Biologics, Blood, Laboratories,

Medical devices, Packaging and

containers.

21 CFR Part 876

Medical devices.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs, 21 CFR parts 864

and 876 are amended as follows:

PART 864—HEMATOLOGY AND

PATHOLOGY DEVICES

1. The authority citation for 21 CFR

part 864 continues to read as follows:

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

360j, 371.

2. Section 864.2220 is amended by

revising paragraph (a) to read as follows:

§ 864.2220 Synthetic cell and tissue

culture media and components

(a) Identification. Synthetic cell and

tissue culture media and components

are substances that are composed

entirely of defined components (e.g.,

amino acids, vitamins, inorganic salts)

that are essential for the survival and

development of cell lines of humans

and other animals. This does not

Federal Register / Vol. 66, No. 95 / Wednesday, May 16, 2001 / Rules and Regulations 27025

include tissue culture media for human

ex vivo tissue and cell culture

processing applications as described in

§ 876.5885 of this chapter.

* * * * *

PART 876—GASTROENTEROLOGYUROLOGY DEVICES

1. 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.

2. Section 876.5885 is added to

subpart F to read as follows:

§ 876.5885 Tissue culture media for human

ex vivo tissue and cell culture processing

applications.

(a) Identification. Tissue culture

media for human ex vivo tissue and cell

culture processing applications consist

of cell and tissue culture media and

components that are composed of

chemically defined components (e.g.,

amino acids, vitamins, inorganic salts)

that are essential for the ex vivo

development, survival, and

maintenance of tissues and cells of

human origin. The solutions are

indicated for use in human ex vivo

tissue and cell culture processing

applications.

(b) Classification. Class II (special

controls): FDA guidance document,

‘‘Class II Special Controls Guidance

Document: Tissue Culture Media for

Human Ex Vivo Processing

Applications; Final Guidance for

Industry and FDA Reviewers.’’

Dated: May 7, 2001.

Linda S. Kahan,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 01–12227 Filed 5–15–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF TRANSPORTATION

Coast Guard

33 CFR Part 117

[CGD08–01–002]

RIN 2115–AE47

Drawbridge Operating Regulation;

Inner Harbor Navigation Canal, New

Orleans, LA

AGENCY: Coast Guard, DOT.

ACTION: Final rule.

SUMMARY: The Coast Guard is changing

the regulation governing the operation

of the SR 46 (St. Claude Avenue) bridge,

mile 0.5 (GIWW mile 6.2 East of Harvey

Lock), the SR 39 (Judge Seeber/

Claiborne Avenue) bridge, mile 0.9

(GIWW mile 6.7 East of Harvey Lock),

and the Florida Avenue bridge, mile 1.7

(GIWW mile 7.5 East of Harvey Lock),

across the Inner Harbor Navigation

Canal in New Orleans, Orleans Parish,

Louisiana. This rule allows for the

uninterrupted flow of commuter traffic

while still providing for the reasonable

needs of navigation.

DATES: This rule is effective June 15,

2001.

ADDRESSES: Comments and materials

received from the public, as well as

documents indicated in this preamble as

being available in the docket, will be

available for inspection or copying at

the office of the Eighth Coast Guard

District, Bridge Administration Branch,

Hale Boggs Federal Building, Room

1313, 501 Magazine Street, New

Orleans, Louisiana 70130–3396 between

7 a.m. and 3 p.m., Monday through

Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Mr.

David Frank, Bridge Administration

Branch, Commander (obc), Eighth Coast

Guard District, 501 Magazine Street,

New Orleans, Louisiana, 70130–3396,

telephone number 504–589–2965.

SUPPLEMENTARY INFORMATION:

Regulatory Information

On February 22, 2001, a notice of

proposed rulemaking (NPRM) entitled

Drawbridge Operating Regulation; Inner

Harbor Navigation Canal, New Orleans,

Louisiana, was published in the Federal

Register (66 FR 11129). Sixteen letters

of comment were received on the

proposed rule. No public hearing was

requested, and none was held.

Background and Purpose

To meet the needs of commuters who

cross these three bridges in the morning

and afternoon en route to and from work

in the Lower Ninth Ward area of New

Orleans and in St. Bernard Parish, the

Coast Guard proposed to codify the

historic accommodation with marine

interests that allows the bridges to

remain closed-to-navigation and open to

vehicular traffic during the morning and

afternoon rush hours.

During the past several years,

although no regulation has ever been

established, all parties have accepted

the spirit of the ‘‘closure’’ during

morning and afternoon rush hours and

the bridges have not opened during

these time periods. The Coast Guard

proposes to codify the accepted historic

practices of these three bridges. Another

factor we considered is the relocation of

the Industrial Canal Lock previously

discussed in detail in the Notice of

Proposed Rulemaking.

The rule would establish the same

operation schedules for all three draws

to facilitate the flow of vehicular traffic

during rush hours while still meeting

the reasonable needs of navigation.

Discussion of Comments and Changes

Sixteen letters were received

containing signatures in support of or

commenting on the NPRM published in

the Federal Register and reprinted in a

local Coast Guard Public Notice CGD08–

05–01 mailed on March 8, 2001.

Thirteen respondents, one being the

Louisiana Department of Transportation

and Development, wrote in support of

the proposal with no changes requested.

One response was received containing

forty-nine signatures in support of the

proposal. Two respondents wrote letters

in support of the project but requested

that a modification be made to the

proposed hours of closure. These

respondents were individual commuters

who wanted the hours of the closure to

begin earlier in the morning to

accommodate their work hours.

However, the Port of New Orleans and

the Louisiana Department of

Transportation and Development

provided traffic counts with the

proposal and the traffic counts indicated

that the proposed hours of closure

correspond to the peak traffic crossing

the bridges for the majority of the

commuters. Therefore, no changes to the

proposal were made based upon these

responses. No changes have been

incorporated into the Final Rule.

Regulatory Evaluation

This rule is not a ‘‘significant

regulatory action’’ under section 3(f) of

Executive Order 12866 and does not

require an assessment of potential costs

and benefits under section 6(a)(3) of that

Order. The Office of Management and

Budget has not reviewed it under that

Order. It is not significant under the

regulatory policies and procedures of

the Department of Transportation (DOT)

(44 FR 11040; February 26, l979).

We expect the economic impact of

this proposed temporary rule to be so

minimal that a full Regulatory

Evaluation under paragraph 10(e) of the

regulatory policies and procedures of

DOT is unnecessary.

This rule maintains the existing

historically accepted curfews with a

minor change allowing the bridge to

remain closed-to-navigation an

additional 30 minutes.

Small Entities

Under the Regulatory Flexibility Act

(5 U.S.C. 601 et seq.), the Coast Guard

considers whether this rule would have

a significant economic impact on a