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

27026 Federal Register / Vol. 66, No. 95 / Wednesday, May 16, 2001 / Rules and Regulations

substantial number of small entities.

The term ‘‘small entities’’ comprises

small businesses, not-for-profit

organizations that are independently

owned and operated and are not

dominant in their fields, and

governmental jurisdictions with

populations of less than 50,000.

The Coast Guard certifies under 5

U.S.C. 605(b) that this rule would not

have a significant economic impact on

a substantial number of small entities.

Assistance for Small Entities

Under the 213(a) of the Small

Business Regulatory Enforcement

Fairness Act of 1996 (Pub. L. 104–121,

we want to assist small entities in

understanding the rule so that they can

better evaluate its effects on them and

participate in the rulemaking process.

Collection of Information

This rule would call for no new

collection of information under the

Paperwork Reduction Act of 1995 (44

U.S.C. 3501–3520.).

Federalism

We have analyzed this rule under

Executive Order 13132 and have

determined that this rule would not

have implications for federalism under

that Order. No comments were received

with regards to federalism during NPRM

comment period.

Unfunded Mandates Reform Act

The Unfunded Mandates Reform Act

of 1995 (2 U.S.C. 1531–1538) governs

the issuance of Federal regulations that

require unfunded mandates. An

unfunded mandate is a regulation that

requires a State, local, or tribal

government or the private sector to

incur direct costs without the Federal

Government’s having first provided the

funds to pay those costs. This rule

would not impose an unfunded

mandate. No comments were received

with regards to unfunded mandates

during NPRM comment period.

Taking of Private Property

This rule would not effect a taking of

private property or otherwise have

taking implications under E.O. 12630,

Governmental Actions and Interference

with Constitutionally Protected Property

Rights. No comments were received

with regards to the taking of private

property during NPRM comment period.

Civil Justice Reform

This rule meets applicable standards

in sections 3(a) and 3(b)(2) of E.O.

12988, Civil Justice Reform, to minimize

litigation, eliminate ambiguity, and

reduce burden. No comments were

received with regards to the taking of

private property during NPRM comment

period.

Protection of Children

We have analyzed this rule under E.O.

13045, Protection of Children from

Environmental Health Risks and Safety

Risks. This rule is not an economically

significant rule and does not concern an

environmental risk to health or risk to

safety that may disproportionately affect

children.

Indian Tribal Governments

This rule does not have tribal

implications under Executive Order

13175, Consultation and Coordination

with Indian Tribal Governments,

because it does not have a substantial

direct effect on one or more Indian

tribes, on the relationship between the

Federal Government and Indian tribes,

or on the distribution of power and

responsibilities between the Federal

Government and Indian tribes.

Environment

We considered the environmental

impact of this rule and concluded that,

under figure 2–1, paragraph (32)(e), of

Commandant Instruction M16475.lC,

this rule is categorically excluded from

further environmental documentation.

Bridge Administration Program actions

that can be categorically excluded

include promulgation of operating

regulations or procedures for

drawbridges. A ‘‘Categorical Exclusion

Determination’’ is available in the

docket where indicated under

ADDRESSES.

List of Subjects in 33 CFR Part 117

Bridges

Regulations

For the reasons set out in the

preamble, the Coast Guard proposes to

amend Part 117 of Title 33, Code of

Federal Regulations, as follows:

PART 117—DRAWBRIDGE

OPERATION REGULATIONS

1. The authority citation for Part 117

continues to read as follows:

Authority: 33 U.S.C. 499; 49 CFR 1.46; 33

CFR 1.05–1(g); section 117.255 also issued

under the authority of Pub. L. 102–587, 106

Stat. 5039.

2. In § 117.458, paragraphs (a) and (b)

are redesignated paragraphs (b) and (c)

and a new paragraph (a) is added to read

as follows:

§ 117.458 Inner Harbor Navigation Canal,

New Orleans.

(a) The draws 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), shall open on signal; except that,

from 6:45 a.m. to 8:30 a.m. and from

4:45 p.m. to 6:45 p.m., Monday through

Friday, except federal holidays, the

draws need not open for the passage of

vessels. The draws shall open at any

time for a vessel in distress.

* * * * *

Dated: May 2, 2001.

Paul J. Pluta,

Rear Admiral, U.S. Coast Guard, Commander,

Eighth Coast Guard District

[FR Doc. 01–12238 Filed 5–15–01; 8:45 am]

BILLING CODE 4910–15–U

NATIONAL ARCHIVES AND RECORDS

ADMINISTRATION

36 CFR Parts 1220, 1228, 1232, 1234,

and 1236

RIN 3095–AB02

Records Disposition; Technical

Amendments

AGENCY: National Archives and Records

Administration (NARA).

ACTION: Final rule.

SUMMARY: NARA is correcting and

updating internal references and form

names covered in the records

management regulations. This final rule

will affect Federal agencies.

EFFECTIVE DATE: June 15, 2001.

FOR FURTHER INFORMATION CONTACT:

Nancy Allard or Lynn Dubose at

telephone number 301–713–7360 or fax

number 301–713–7270.

SUPPLEMENTARY INFORMATION: Several

amendments were made to Part 1228 in

1999, however, some internal references

to Part 1228 in other Parts in Subchapter

B and forms were not updated at that

time. This final rule contains technical

amendments such as designations for

NARA organizational components,

addresses, form titles, and crossreferences.

This final rule is not a significant

regulatory action for the purposes of

Executive Order 12866 and has not been

reviewed by the Office of Management

and Budget. As required by the

Regulatory Flexibility Act, I certify that

this final rule will not have a significant

impact on a substantial number of small

entities because it applies only to

Federal agencies. This final rule has no

federalism or tribalism implications.