This section of the FEDERAL REGISTER

contains regulatory documents having general

applicability and legal effect, most of which

are keyed to and codified in the Code of

Federal Regulations, which is published under

50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by

the Superintendent of Documents. Prices of

new books are listed in the first FEDERAL

REGISTER issue of each week.

Rules and Regulations Federal Register

26063

Vol. 63, No. 91

Tuesday, May 12, 1998

DEPARTMENT OF HOUSING AND

URBAN DEVELOPMENT

Office of Federal Housing Enterprise

Oversight

12 CFR Part 1720

RIN 2550–AA05

Implementation of the Privacy Act of

1974

AGENCY: Office of Federal Housing

Enterprise Oversight, HUD.

ACTION: Final regulation.

SUMMARY: The Office of Federal Housing

Enterprise Oversight is adopting as final

without change the interim regulation

that was published at 63 FR 8840 on

February 23, 1998. This final regulation

implements the Privacy Act of 1974 by

setting forth the procedures by which an

individual may request access to records

about him/her that are maintained by

OFHEO, amendment of such records, or

an accounting of disclosures of such

records.

DATES: This final regulation is effective

June 11, 1998.

FOR FURTHER INFORMATION CONTACT: Gary

L. Norton, Deputy General Counsel, or

Isabella W. Sammons, Associate General

Counsel, Office of General Counsel,

Office of Federal Housing Enterprise

Oversight, 1700 G Street, NW., Fourth

Floor, Washington, DC 20552, telephone

(202) 414–3800 (not a toll-free number).

The toll-free telephone number for the

Telecommunications Device for the Deaf

is (800) 877–8339.

SUPPLEMENTARY INFORMATION:

The Office of Federal Housing

Enterprise Oversight (OFHEO)

published an interim regulation at 63 FR

8840 on February 23, 1998, that

implemented the Privacy Act of 1974.

OFHEO requested comments on the

interim regulation, but did not receive

any. Accordingly, the interim

regulation, which amended Chapter

XVII of title 12 of the Code of Federal

Regulations by adding part 1720, is

adopted as a final regulation without

change.

Dated: May 5, 1998.

Mark A. Kinsey,

Acting Director.

[FR Doc. 98–12588 Filed 5–11–98; 8:45 am]

BILLING CODE 4220–01–P

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 36

Noise Standards: Aircraft Type and

Airworthiness Certification

CFR Correction

In Title 14 of the Code of Federal

Regulations, parts 1 to 59, revised as of

January 1, 1998, on page 779, in

appendix A to part 36, the following

text was removed and should be

reinstated below each equation.

Appendix A to Part 36 [Corrected]

1. In the first column, in paragraph

(d)(1)(i), the omitted text should read as

follow:

* * * * *

where SPLi and SPLic are the measured and

corrected sound pressure levels, respectively,

in the i-th one-third octave band. The first

correction term accounts for the effects of

change in atmospheric sound absorption

where αi and αio are the sound absorption

coefficients for the test (determined under

section A36.9(d)) and reference atmospheric

conditions, respectively, for the i-th one-third

octave band and KQ is the measured takeoff

sound propagation path. The second

correction term accounts for the effects of

atmospheric sound absorption on the change

in the sound propagation path length where

KQc is the corrected takeoff sound

propagation path. The third correction term

accounts for the effects of the inverse square

law on the change in the sound propagation

path length.

* * * * *

2. Also, in the first column, in

paragraph (d)(2)(i), the omitted text

should read as follows:

* * * * *

where NS and NSr are the measured and

reference approach sound propagation paths,

respectively.

* * * * *

3. In the second column, in paragraph

(d)(3), the omitted text should read as

follows:

* * * * *

where LX is the measured sideline sound

propagation path from station L (Figure A1)

to position X of the aircraft for which PNLTM

is observed at station L and LXc is the

corrected sideline sound propagation path.

* * * * *

BILLING CODE 1505–01–D

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. 98–NM–111–AD; Amendment

39–10522; AD 98–10–10]

RIN 2120–AA64

Airworthiness Directives; Boeing

Model 747 and 767 Series Airplanes

AGENCY: Federal Aviation

Administration, DOT.

ACTION: Final rule; request for

comments.

SUMMARY: This amendment adopts a

new airworthiness directive (AD) that is

applicable to certain Boeing Model 747

and 767 series airplanes. This action

requires a one-time inspection to

confirm the installation of Teflon

sleeves over certain electrical wires

inside conduits installed in the fuel

tanks; and corrective actions, if

necessary. This amendment is prompted

by a report of missing Teflon sleeves,

which protect the wiring insulation

from chafing. The actions specified in

this AD are intended to prevent such

chafing, which could eventually expose

the electrical conductor creating the

potential for arcing from the wire to the

conduit, and consequent fuel tank fire/

explosion.

DATES: Effective May 27, 1998.

The incorporation by reference of

certain publications listed in the

regulations is approved by the Director

of the Federal Register as of May 27,

1998.

Comments for inclusion in the Rules

Docket must be received on or before

July 13, 1998.

ADDRESSES: Submit comments in

triplicate to the Federal Aviation

Administration (FAA), Transport

Airplane Directorate, ANM–114,
26064 Federal Register / Vol. 63, No. 91 /Tuesday, May 12, 1998 /Rules and Regulations

Attention: Rules Docket No. 98-NM–

111-AD, 1601 Lind Avenue, SW.,

Renton, Washington 98055–4056.

The service information referenced in

this AD may be obtained from Boeing

Commercial Airplane Group, P.O. Box

3707, Seattle, Washington 98124–2207.

This information may be examined at

the FAA, Transport Airplane

Directorate, 1601 Lind Avenue, SW.,

Renton, Washington; or at the Office of

the Federal Register, 800 North Capitol

Street, NW., suite 700, Washington, DC.

FOR FURTHER INFORMATION CONTACT: Ed

Hormel, Aerospace Engineer,

Propulsion Branch, ANM–140S, FAA,

Transport Airplane Directorate, Seattle

Aircraft Certification Office, 1601 Lind

Avenue, SW., Renton, Washington

98055–4056; telephone (425) 227–2681;

fax (425) 227–1181.

SUPPLEMENTARY INFORMATION: On July

17, 1996, shortly after takeoff from John

F. Kennedy International Airport in

Jamaica, New York, a Boeing Model 747

series airplane was involved in an

accident during which the center fuel

tank exploded. Ensuing investigations of

the cause of the accident have focused

on the fuel tank explosion.

A recent inspection of the main fuel

tanks on a Model 747 series airplane

indicated that the inner and outer

Teflon sleeves were missing from wiring

within the conduit of the aft boost pump

to the number 4 main fuel tank. The

reason for the missing sleeves has not

been determined. Missing Teflon

sleeves could result in chafing of the

wire insulation encasing the fuel pump

wiring. These conditions, if not

corrected, could eventually expose the

electrical conductor creating the

potential for arcing from the wire to the

conduit, and consequent fuel tank fire/

explosion.

Similar Airplanes

The vibration environment and the

conduit and wiring installations

associated with fuel pumps in the wing

fuel tanks of Model 747 and 767 series

airplanes are similar. Therefore, the

FAA has determined that both models

may be subject to the unsafe condition

identified in this AD.

Related AD’s

The FAA has issued a number of AD’s

to address various fuel-tank related

unsafe conditions on Boeing Model 747

series airplanes, including the

following:

• AD 79–05–04, amendment 39–3431

(44 FR 12636, March 8, 1979). This AD

was prompted by a report indicating

that fuel pump wires had chafed

through the insulation in an aluminum

conduit inside an auxiliary fuel tank on

a Model 747 series airplane. Electrical

arcing from the chafed wire to the

aluminum conduit had burned a hole in

the conduit permitting fuel leakage;

however, the arcing did not result in a

fire or explosion. That AD requires

discontinued use of the auxiliary fuel

tanks unless Teflon sleeving is installed

over the wire bundles in accordance

with Boeing Alert Service Bulletin 747–

28A2091, Revision 1, dated February 5,

1979.

• AD 79–06–02, amendment 39–3439

(44 FR 16362, March 19, 1979). Because

the conduit and wiring installations for

the auxiliary fuel tanks are similar to

those of the number 1 and number 4

main fuel tanks on Model 747 series

airplanes, an inspection of the boost

pump wiring of the main fuel tank was

conducted on other airplanes of this

model. Although none of the wires

inspected had worn completely through

the insulation, chafing through 80

percent of the total insulation thickness

was found on numerous wires. The

reported chafing was attributed to

vibration of the wires against the

conduit wall. Based on these results, AD

79–26–02 was issued to require

inspection, repair, and modification of

the boost pump wires of the outboard

main (number 1 and number 4) fuel

tanks on Model 747 series airplanes.

Corrective actions involve replacing

chafed wires, installing wire ties at

equal intervals, and installing doublelayer Teflon sleeves over the wires, in

accordance with Boeing Alert Service

Bulletin 747–28A2092, dated February

12, 1979.

• AD 96–26–06, amendment 39–9870

(62 FR 304, January 1, 1997). Following

the 1996 accident, AD 96–26–06 was

issued to require a one-time inspection

in accordance with Boeing Alert Service

Bulletin 747–28A2201, dated December

19, 1996. The purpose of this inspection

was to detect damage to the Teflon

sleeving and wire bundles to the

forward and aft boost pumps for the

number 1 and number 4 main fuel tanks

and to the auxiliary tank jettison pumps

(if installed) on Model 747 series

airplanes equipped with aluminum

conduits. At the time AD 96–26–06 was

issued, the FAA had determined that

sleeving inside aluminum conduits was

more susceptible to chafing and burnthrough in the event of arcing than

sleeving inside stainless steel conduits.

• AD 97–26–07, amendment 39–

10250 (62 FR 65352, December 12,

1997). Based on damage reports from

two operators that had replaced the

aluminum conduits with stainless steel

conduits and had found significant

chafing on 48 percent of the airplanes

checked, the FAA concluded that

stainless steel conduit installations also

should be inspected. Therefore, the FAA

issued AD 97–26–07, which supersedes

AD 96–26–06 to expand the inspection

requirements to include Model 747

series airplanes having stainless steel

conduits, and to add repetitive

inspections of the Teflon sleeving on all

Model 747 series airplanes to determine

whether the sleeving would continue to

provide a protective barrier after

extended time in service.

Explanation of Relevant Service

Information

The FAA has reviewed and approved

Boeing Message M–7200–98–01080,

dated March 18, 1998 (hereinafter

refered to as the ‘‘message’’). The

message describes procedures for a onetime inspection to confirm installation

of Teflon sleeving over wiring in

conduits in the boost pumps of the

numbers 1 and 4 main fuel tanks on

Boeing Model 747 series airplanes, and

in the main and center wing tanks on

Model 767 series airplanes; and

corrective actions, if necessary. The

corrective actions involve follow-on

inspections, installation of Teflon

sleeves, and replacement of damaged

wiring and conduits. Accomplishment

of the actions specified in the message

is intended to adequately address the

identified unsafe condition.

The message refers to Boeing Alert

Service Bulletin 747–28A2204 as an

additional source of service information

for accomplishment of the requirements

of this AD.

Explanation of the Requirements of the

Rule

Since an unsafe condition has been

identified that is likely to exist or

develop on other airplanes of the same

type design, this AD is being issued to

prevent chafing of electrical wiring

inside the conduits, which could

eventually expose the electrical

conductor creating the potential for

arcing from the wire to the conduit, and

consequent fuel tank fire/explosion.

This AD requires accomplishment of the

actions specified in the message

described previously, except as

described below. This AD also requires

operators to send any damaged wires

and conduits, and to submit a report to

the FAA.

Differences Between the Rule and the

Message

Operators should note that, whereas

the message provides a compliance time

of 30 days, the rule requires compliance

within 60 days. Although the message

recommends a 30-day compliance time,
Federal Register / Vol. 63, No. 91 /Tuesday, May 12, 1998 /Rules and Regulations 26065

the manufacturer, through a subsequent

review of the number of affected

airplanes, has advised the FAA that 30

days will be insufficient to accomplish

the actions required by this AD on such

a large fleet. The FAA has determined

that a 60-day compliance time is

appropriate in consideration of the

safety implications of this AD, the size

of the affected fleet, and the practical

aspects of an orderly inspection within

the allotted time.

Determination of Rule’s Effective Date

Since a situation exists that requires

the immediate adoption of this

regulation, it is found that notice and

opportunity for prior public comment

hereon are impracticable, and that good

cause exists for making this amendment

effective in less than 30 days.

Comments Invited

Although this action is in the form of

a final rule that involves requirements

affecting flight safety and, thus, was not

preceded by notice and an opportunity

for public comment, comments are

invited on this rule. Interested persons

are invited to comment on this rule by

submitting such written data, views, or

arguments as they may desire.

Communications shall identify the

Rules Docket number and be submitted

in triplicate to the address specified

under the caption ADDRESSES. All

communications received on or before

the closing date for comments will be

considered, and this rule may be

amended in light of the comments

received. Factual information that

supports the commenter’s ideas and

suggestions is extremely helpful in

evaluating the effectiveness of the AD

action and determining whether

additional rulemaking action would be

needed.

Comments are specifically invited on

the overall regulatory, economic,

environmental, and energy aspects of

the rule that might suggest a need to

modify the rule. All comments

submitted will be available, both before

and after the closing date for comments,

in the Rules Docket for examination by

interested persons. A report that

summarizes each FAA-public contact

concerned with the substance of this AD

will be filed in the Rules Docket.

Commenters wishing the FAA to

acknowledge receipt of their comments

submitted in response to this rule must

submit a self-addressed, stamped

postcard on which the following

statement is made: ‘‘Comments to

Docket Number 98–NM–111–AD.’’ The

postcard will be date stamped and

returned to the commenter.

Regulatory Impact

The regulations adopted herein will

not 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. Therefore, in

accordance with Executive Order 12612,

it is determined that this final rule does

not have sufficient federalism

implications to warrant the preparation

of a Federalism Assessment.

The FAA has determined that this

regulation is an emergency regulation

that must be issued immediately to

correct an unsafe condition in aircraft,

and that it is not a ‘‘significant

regulatory action’’ under Executive

Order 12866. It has been determined

further that this action involves an

emergency regulation under DOT

Regulatory Policies and Procedures (44

FR 11034, February 26, 1979). If it is

determined that this emergency

regulation otherwise would be

significant under DOT Regulatory

Policies and Procedures, a final

regulatory evaluation will be prepared

and placed in the Rules Docket. A copy

of it, if filed, may be obtained from the

Rules Docket at the location provided

under the caption ADDRESSES.

List of Subjects in 14 CFR Part 39

Air transportation, Aircraft, Aviation

safety, Incorporation by reference,

Safety.

Adoption of the Amendment

Accordingly, pursuant to the

authority delegated to me by the

Administrator, the Federal Aviation

Administration amends part 39 of the

Federal Aviation Regulations (14 CFR

part 39) as follows:

PART 39—AIRWORTHINESS

DIRECTIVES

1. The authority citation for part 39

continues to read as follows:

Authority: 49 U.S.C. 106(g), 40113, 44701.

§ 39.13 [Amended]

2. Section 39.13 is amended by

adding the following new airworthiness

directive:

98–10–10 Boeing: Amendment 39–10522.

Docket 98–NM–111–AD.

Applicability: Model 747 series airplanes,

line positions 0001 through 1145 inclusive,

that have not been inspected in accordance

with AD 96–26–06, amendment 39–9870

(reference Boeing Alert Service Bulletin 747–

28A2204, dated December 19, 1996), or AD

97–26–07, amendment 39–10250 (reference

Boeing Alert Service Bulletin 747–28A2204,

Revision 1, dated October 30, 1997); and

Model 767 series airplanes, line positions

001 through 689 inclusive, and 691;

certificated in any category.

Note 1: This AD applies to each airplane

identified in the preceding applicability

provision, regardless of whether it has been

modified, altered, or repaired in the area

subject to the requirements of this AD. For

airplanes that have been modified, altered, or

repaired so that the performance of the

requirements of this AD is affected, the

owner/operator must request approval for an

alternative method of compliance in

accordance with paragraph (d) of this AD.

The request should include an assessment of

the effect of the modification, alteration, or

repair on the unsafe condition addressed

specific proposed actions to address it.

Compliance: Required as indicated, unless

accomplished previously.

To prevent chafing of the wire insulation

inside conduits installed in the fuel tanks,

which could eventually expose the electrical

conductor creating the potential for arcing

from the wire to the conduit, and consequent

fuel tank fire/explosion, accomplish the

following:

(a) Within 60 days after the effective date

of this AD, perform a one-time visual

inspection to confirm installation of Teflon

sleeves over the electrical wires to the boost

pumps installed inside conduits in the

numbers 1 and 4 main fuel tanks (for Model

747 series airplanes), or in the main and

center wing tanks (for Model 767 series

airplanes), as applicable, in accordance with

Boeing Message M–7200–98–01080, dated

March 18, 1998.

(b) If any Teflon sleeve is found to be

missing during the inspection required by

paragraph (a) of this AD, prior to further

flight, inspect to detect damage to the wires,

in accordance with Boeing Message M–7200–

98–01080, dated March 18, 1998.

(1) If no damage is found, prior to further

flight, install a Teflon sleeve in accordance

with the message.

(2) If any damage is found, prior to further

flight, inspect to detect damage to the

conduits in accordance with the message.

(i) If no damage is found, prior to further

flight, replace any damaged wire and install

a Teflon sleeve in accordance with the

message.

(ii) If any damage is found, prior to further

flight, replace any damaged wire and conduit

and install a Teflon sleeve, in accordance

with the messsage.

Note 2: Boeing Message M–7200–98–

01080, dated March 18, 1998, refers to Boeing

Alert Service Bulletin 747–28A2204 as an

additional source of service information.

(c) Within 10 days after finding any

damage during any inspection required by

paragraph (b) of this AD, send damaged

wiring and conduits and submit a report to

the Manager, Seattle Aircraft Certification

Office (ACO), FAA, Transport Airplane

Directorate, 1601 Lind Avenue, SW., Renton,

Washington 98055–4056; fax (425) 227–1181.

The report must include the following:

• The airplane model number;

• The airplane line position;

• The total number of hours time-inservice accumulated on the airplane;
26066 Federal Register / Vol. 63, No. 91 /Tuesday, May 12, 1998 /Rules and Regulations

• The total number of flight cycles

accumulated on the airplane;

• A description of the area of the wiring

where the sleeving was missing; and

• A description of the damage found.

Information collection requirements

contained in this regulation have been

approved by the Office of Management and

Budget (OMB) under the provisions of the

Paperwork Reduction Act of 1980 (44 U.S.C.

3501 et seq.) and have been assigned OMB

Control Number 2120–0056.

(d) An alternative method of compliance or

adjustment of the compliance time that

provides an acceptable level of safety may be

used if approved by the Manager, Seattle

ACO. Operators shall submit their requests

through an appropriate FAA Principal

Maintenance Inspector, who may add

comments and then send it to the Manager,

Seattle ACO.

Note 3: Information concerning the

existence of approved alternative methods of

compliance with this AD, if any, may be

obtained from the Seattle ACO.

(e) Special flight permits may be issued in

accordance with sections 21.197 and 21.199

of the Federal Aviation Regulations (14 CFR

21.197 and 21.199) to operate the airplane to

a location where the requirements of this AD

can be accomplished.

(f) The actions shall be done in accordance

with Boeing Message M–7200–98–01080,

dated March 18, 1998. This incorporation by

reference was approved by the Director of the

Federal Register in accordance with 5 U.S.C.

552(a) and 1 CFR part 51. Copies may be

obtained from Boeing Commercial Airplane

Group, P.O. Box 3707, Seattle, Washington

98124–2207. Copies may be inspected at the

FAA, Transport Airplane Directorate, 1601

Lind Avenue, SW., Renton, Washington; or at

the Office of the Federal Register, 800 North

Capitol Street, NW., suite 700, Washington,

DC.

(g) This amendment becomes effective on

May 27, 1998.

Issued in Renton, Washington, on May 5,

1998.

John J. Hickey,

Acting Manager, Transport Airplane

Directorate, Aircraft Certification Service.

[FR Doc. 98–12512 Filed 5–11–98; 8:45 am]

BILLING CODE 4910–13–U

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 430, 431, 432, 433, 436,

440, 441, 442, 443, 444, 446, 448, 449,

450, 452, 453, 455, and 460

[Docket No. 98N–0211]

Removal of Regulations Regarding

Certification of Antibiotic Drugs

AGENCY: Food and Drug Administration,

HHS.

ACTION: Direct final rule.

SUMMARY: The Food and Drug

Administration (FDA) is repealing its

regulations governing certification of

antibiotic drugs. The agency is taking

this action in accordance with

provisions of the Food and Drug

Administration Modernization Act of

1997 (FDAMA). FDAMA repealed the

statutory provision in the Federal Food,

Drug, and Cosmetic Act (the act) under

which the agency certified antibiotic

drugs. FDAMA also made conforming

amendments to the act.

DATES: The direct final rule is effective

September 24, 1998. Submit written

comments on or before July 27, 1998. If

no timely significant adverse comments

are received, the agency will publish a

document in the Federal Register before

August 25, 1998, confirming the

effective date of the direct final rule. If

timely significant adverse comments are

received, the agency will publish a

document of significant adverse

comment in the Federal Register

withdrawing this direct final rule before

August 25, 1998.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Wayne H. Mitchell or Christine F.

Rogers, Center for Drug Evaluation and

Research (HFD–7), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–594–2041.

SUPPLEMENTARY INFORMATION:

I. FDAMA

On November 21, 1997, the President

signed FDAMA (Pub. L. 105–115).

Section 125(b) of FDAMA repealed

section 507 of the act (21 U.S.C. 357).

Section 507 of the act was the section

under which the agency certified

antibiotic drugs. Section 125(b) of

FDAMA also made conforming

amendments to the act.

FDA has determined that it will be

most efficient to make changes in its

regulations to reflect the repeal of

section 507 of the act in phases. In this

first phase, this direct final rule removes

parts 430 through 460 (21 CFR parts 430

through 460). These regulations provide

the procedures and standards used to

certify antibiotic drugs, including FDA’s

antibiotic drug monographs. FDA plans

to initiate a second phase direct final

rulemaking procedure to make various,

noncontroversial conforming

amendments to the balance of Title 21

of the Code of Federal Regulations

(CFR), such as removing citations to

section 507 of the act and references to

the certification of antibiotics. The

agency recognizes that as it implements

the transition from regulating the

premarket review and approval of

antibiotic drugs under section 507 of the

act to section 505 of the act (21 U.S.C.

355), other issues may arise that could

require additional rulemaking. These

issues will be addressed in the third

phase of implementation.

II. Direct Final Rulemaking

FDA has determined that the subject

of this rulemaking is suitable for a direct

final rule. The repeal of section 507 of

the act eliminates the statutory

provision on which the agency relied to

certify antibiotic drugs. FDA will,

therefore, remove all provisions of Title

21 of the CFR that were issued primarily

to carry out the agency’s program for the

certification of antibiotic drugs under

former section 507 of the act. The

actions taken should be

noncontroversial and the agency does

not anticipate receiving any significant

adverse comments on this rule.

If FDA does not receive significant

adverse comment on or before July 27,

1998, the agency will publish a

document in the Federal Register before

August 25, 1998, confirming the

effective date of the direct final rule. A

significant adverse comment is one 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. A

comment recommending a rule change

in addition to this rule will not be

considered a significant adverse

comment, unless the comment states

why this rule would be ineffective

without the additional change. If timely

significant adverse comments are

received, the agency will publish a

notice of significant adverse comment in

the Federal Register withdrawing this

direct final rule before August 25, 1998.

Elsewhere in this issue of the Federal

Register, FDA is publishing a

companion proposed rule, which is

identical to the direct final rule, that

provides a procedural framework within

which the rule may be finalized in the

event the direct final rule is withdrawn

because of significant adverse comment.

The comment period for the direct final

rule runs concurrently with that of the

companion proposed rule. Any

comments received under the

companion proposed rule will be

treated as comments regarding the direct

final rule. Likewise, significant adverse

comments submitted to the direct final

rule will be considered as comments to

the companion proposed rule and the

agency will consider such comments in

developing a final rule. FDA will not