2552 Federal Register / Vol. 62, No. 12 / Friday, January 17, 1997 / Rules and Regulations

Parks at (202) 501–7138, FAX (202)

501–7642, or E-mail usdafsis/

s=confer@mhs.attmail.com.

SUPPLEMENTARY INFORMATION: On July

25, 1996, FSIS published a final rule,

‘‘Pathogen Reduction; Hazard Analysis

and Critical Control Point (HACCP)

Systems’’ (61 FR 38805). This rule

introduced sweeping changes to the

meat and poultry inspection system.

The first stage in the implementation of

the rule begins on January 27, 1997,

when slaughter and processing

establishments must have written

sanitation standard operating

procedures to prevent direct product

contamination and ensure food safety,

and slaughter establishments must begin

testing for E. coli as a means of verifying

process control for preventing fecal

contamination.

To provide interested parties an

opportunity to further discuss issues

relating to the implementation of

Sanitation SOP’s and E. coli testing

requirements, FSIS will meet with the

public from 1 p.m. to 5 p.m. on January

23, 1997.

Done at Washington, DC, on: January 13,

1997.

Thomas J. Billy,

Administrator.

[FR Doc. 97–1235 Filed 1–14–97; 1:56 pm]

BILLING CODE 3410–DM–P

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. 96–CE–64–AD; Amendment 39–

9886; AD 97–02–02]

RIN 2120–AA64

Airworthiness Directives; Fairchild

Aircraft, Inc. SA26, SA226, and SA227

Series Airplanes

AGENCY: Federal Aviation

Administration, DOT.

ACTION: Final rule; request for

comments.

SUMMARY: This amendment adopts a

new airworthiness directive (AD) that

applies to Fairchild Aircraft, Inc.

(Fairchild) SA26, SA226, and SA227

series airplanes. This action requires

applying torque to the control column

pitch bearing attaching nuts, inspecting

for any looseness or movement of the

bearing assembly, and inspecting the

elevator control rod end bearing

retainer/dust seals for creasing. If either

of these problems are evident, this

action requires replacing these parts, as

well as installing a new bolt and washer

to the elevator control rod end bearing

assembly at the walking beam

connection. Reports of Fairchild SA227

series airplanes losing pitch control inflight prompted this action. The actions

specified by this AD are intended to

prevent loss of pitch control, which if

not corrected, could result in loss of the

airplane.

DATES: Effective February 6, 1997.

The incorporation by reference of

certain publications listed in the

regulations is approved by the Director

of the Federal Register as of February 6,

1997.

Comments for inclusion in the Rules

Docket must be received on or before

March 6, 1997.

ADDRESSES: Submit comments in

triplicate to the Federal Aviation

Administration (FAA), Central Region,

Office of the Assistant Chief Counsel,

Attention: Rules Docket 96–CE–64–AD,

Room 1558, 601 E. 12th Street, Kansas

City, Missouri 64106.

Service information that applies to

this AD may be obtained from Fairchild

Aircraft, Inc., P.O. Box 790490, San

Antonio, Texas, 78279–0490; telephone

(210) 824–9421. This information may

also be examined at the Federal

Aviation Administration (FAA), Central

Region, Office of the Assistant Chief

Counsel, Attention: Rules Docket 96–

CE–64–AD, Room 1558, 601 E. 12th

Street, Kansas City, Missouri 64106; or

at the Office of the Federal Register, 800

North Capitol Street, NW., suite 700,

Washington, DC.

FOR FURTHER INFORMATION CONTACT: Mr.

Werner Koch, Aerospace Engineer,

FAA, Fort Worth Airplane Certification

Office, 2601 Meacham Boulevard, Fort

Worth, Texas 76193–0150; telephone

(817) 222–5133; facsimile (817) 222–

5960.

SUPPLEMENTARY INFORMATION:

Events Leading to This Action

The FAA has recently received two

incident reports on Fairchild SA227

series airplanes in which the airplane

lost some pitch control because of

fatigue failure of the pitch pivot bearing

shaft. Further investigation revealed

fatigue and wear in the control column

pitch pivot bearings resulting from

insufficient torque on the control

column roller bearing stud attaching

nuts. While inspecting the pivot bearing

on four other Fairchild airplanes, it was

discovered that the rod end bearing

retainer of the elevator control rod at the

walking beam connection was deformed

or creased. This creasing is caused by

improper installation and could allow

the bearing to come apart, disconnecting

the joint, and possibly resulting in loss

of pitch control.

Fairchild has issued four service

bulletins (SB) numbered 26–27–30–046,

226–27–060, 227–27–041, and CC7–27–

010, dated December 11, 1996, which

specify applying torque to the control

column pitch bearing attaching nut,

inspecting the control column roller

bearing assembly for movement,

replacing the bearing and attaching nut

if necessary, inspecting the elevator

control rod end bearing retainer/dust

covers for creasing, replacing the rod

end assemblies, if necessary, and

installing a new bolt and washer to the

elevator control rod end bearing

assembly at the walking beam

connection.

FAA’s Determination

After examining the circumstances

and reviewing all available information

related to the incidents described above,

the FAA has determined that AD action

should be taken to prevent loss of pitch

control, which if not corrected, could

result in loss of the airplane.

Explanation of the Provisions of This

AD

Since an unsafe condition has been

identified that is likely to exist or

develop in other Fairchild SA26,

SA226, and SA227 series airplanes of

the same type design, this AD requires:

(1) Applying torque to the control

column pitch bearing attaching nut,

(2) Inspecting for movement in the

control column roller bearing assembly,

(3) Replacing the bearing assembly

and attaching nut, if applicable,

(4) Inspecting the elevator control rod

end bearing retainer/dust covers for

creasing,

(5) Replacing the elevator control rod

end assemblies, if applicable, and

(6) Installing a new bolt and adding a

washer to the elevator control rod end

bearing assembly at the walking beam

connection.

Related Service Information

These actions are to be done in

accordance with the

ACCOMPLISHMENT INSTRUCTIONS

in Fairchild SBs 26–27–30–046, 226–

27–060, 227–27–041, and CC7–27–010,

Issued December 11, 1996.

Since a situation exists (possible loss

of in-flight pitch control) that requires

the immediate adoption of this

regulation, it is found that notice and

opportunity for public prior comment

hereon are impracticable, and that good

cause exists for making this amendment

effective in less than 30 days.
Federal Register / Vol. 62, No. 12 / Friday, January 17, 1997 / Rules and Regulations 2553

Comments Invited

Although this action is in the form of

a final rule that involves requirements

affecting immediate flight safety and,

thus, was not preceded by notice and

opportunity to 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 should identify the

Rules Docket number and be submitted

in triplicate to the address specified

above. 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 notice

must submit a self-addressed, stamped

postcard on which the following

statement is made: ‘‘Comments to

Docket No. 96–CE–64–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 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

(otherwise, an evaluation is not

required). A copy of it, if filed, may be

obtained from the Rules Docket.

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 a new airworthiness directive

(AD) to read as follows:

97–02–02 Fairchild Aircraft, Inc.:

Amendment 39–9886; Docket No. 96–

CE–64–AD.

Applicability: Models SA26, SA226,

SA227–AC, SA227–AT, SA227–BC, SA227–

TT, and SA227–CC/DC (serial numbers CC/

DC784, and CC/DC790 through CC/DC884),

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 (e) of this AD.

The request should include an assessment of

the effect of the modification, alteration, or

repair on the unsafe condition addressed by

this AD; and, if the unsafe condition has not

been eliminated, the request should include

specific proposed actions to address it.

Compliance: Required within the next 75

hours time-in-service (TIS) after the effective

date of this AD, unless already accomplished.

To prevent loss of pitch control, which if

not corrected, could result in loss of the

airplane, accomplish the following:

(a) Apply torque to the control column

pitch bearing attaching nuts and inspect for

movement in accordance with the

ACCOMPLISHMENT INSTRUCTIONS

section of Fairchild Aircraft (Fairchild)

Service Bulletin (SB) No. 26–27–30–046,

226–27–060, 227–27–041, or CC7–27–010,

dated December 11, 1996, whichever is

applicable.

(1) If there is no movement, then no further

action is necessary.

(2) If there is movement, prior to further

flight, replace the pitch control column roller

bearing and attaching nut in accordance with

Fairchild SB 26–27–30–046, 226–27–060,

227–27–041, or CC7–27–010, dated

December 11, 1996, whichever is applicable.

(b) Inspect the elevator control rod end

bearing retainer/dust seals for evidence of

creasing in accordance with Fairchild SB 26–

27–30–046, 226–27–060, 227–27–041, or

CC7–27–010, dated December 11, 1996,

whichever is applicable.

(1) If no creasing is found, then rod end

assembly replacement is not necessary.

(2) If creasing is found, prior to further

flight, replace the elevator control rod end

assembly in accordance with Fairchild SB

26–27–30–046, 226–27–060, 227–27–041, or

CC7–27–010, dated December 11, 1996,

whichever is applicable.

(c) Install a new washer (part number (P/

N) AN970–4) and replace the bolt (P/N

NAS6604D31) with a new bolt (P/N

NAS6604D34) on the elevator control rod

end bearing assembly at the walking beam

connections in accordance with Fairchild SB

26–27–30–046, 226–27–060, 227–27–041, or

CC7–27–010, dated December 11, 1996,

whichever is applicable.

(d) 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.

(e) An alternative method of compliance or

adjustment of the compliance time that

provides an equivalent level of safety may be

approved by the Manager, Fort Worth

Airplane Certification Office, 2601 Meacham

Boulevard, Fort Worth, Texas 76193–0150.

The request shall be forwarded through an

appropriate FAA Maintenance Inspector,

who may add comments and then send it to

the Manager, Fort Worth Airplane

Certification Office.

Note 2: Information concerning the

existence of approved alternative methods of

compliance with this AD, if any, may be

obtained from the Fort Worth Airplane

Certification Office.

(f) The inspections and replacement

required by this AD shall be done in

accordance with FAIRCHILD AIRCRAFT

Service Bulletin No. SB 26–27–30–046, 226–

27–060, 227–27–041, or CC7–27–010, Issued:

December 11, 1996. 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 Fairchild Aircraft, Inc., P.O.

Box 790490, San Antonio, Texas 78279–

0490; telephone (210) 824–9421. Copies may

be inspected at the FAA, Central Region,

Office of the Assistant Chief Counsel, Room

1558, 601 E. 12th Street, Kansas City,

Missouri, or at the Office of the Federal

Register, 800 North Capitol Street, NW., suite

700, Washington, DC.

(g) This amendment (39–9886) becomes

effective on February 6, 1997.
2554 Federal Register / Vol. 62, No. 12 / Friday, January 17, 1997 / Rules and Regulations

Issued in Kansas City, Missouri, on January

6, 1997.

Henry A. Armstrong,

Acting Manager, Small Airplane Directorate,

Aircraft Certification Service.

[FR Doc. 97–814 Filed 1–16–97; 8:45 am]

BILLING CODE 4910–13–U

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 5

Delegations of Authority and

Organization; Center for Drug

Evaluation and Research

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

regulations for delegations of authority

relating to functions performed by the

Center for Drug Evaluation and Research

(CDER). This amendment updates the

titles of CDER delegates and

organizational components to reflect the

organizational restructuring. This action

is intended to ensure the accuracy and

consistency of the regulations.

EFFECTIVE DATE: January 17, 1997.

FOR FURTHER INFORMATION CONTACT:

Rixie L. Scott, Center for Drug

Evaluation and Research (HFD–54),

Food and Drug Administration,

5600 Fishers Lane, Rockville, MD

20857, 301–827–0494, or

Donna G. Page, Division of

Management Systems and Policy

(HFA–340), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–

4816.

SUPPLEMENTARY INFORMATION: CDER

recently underwent a major

organizational restructuring. The Center

level structure was approved by the

Commissioner of Food and Drugs and

published in the Federal Register of

October 13, 1995 (60 FR 53379). Most of

the authorities delegated to the center

officials are amended in this document

to reflect new titles and organization

placement under the restructuring.

This document revises the delegations

of authority contained in part 5 (21 CFR

part 5) relating to the functions assigned

to CDER.

Further redelegation of the authorities

delegated is not authorized. Authority

delegated to a position by title may be

exercised by a person officially

designated to serve in such position in

an acting capacity or on a temporary

basis.

List of Subjects in 21 CFR Part 5

Authority delegations (Government

agencies), Imports, Organization and

functions (Government agencies).

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs, 21 CFR part 5 is

amended as follows:

PART 5—DELEGATIONS OF

AUTHORITY AND ORGANIZATION

1. The authority citation for 21 CFR

part 5 continues to read as follows:

Authority: 5 U.S.C. 504, 552, App. 2; 7

U.S.C. 138a, 2271; 15 U.S.C. 638, 1261–1282,

3701–3711a; secs. 2–12 of the Fair Packaging

and Labeling Act (15 U.S.C. 1451–1461); 21

U.S.C. 41–50, 61–63, 141–149, 467f, 679(b),

801–886, 1031–1309; secs. 201–903 of the

Federal Food, Drug, and Cosmetic Act (21

U.S.C. 321–394); 35 U.S.C. 156; secs. 301,

302, 303, 307, 310, 311, 351, 352, 361, 362,

1701–1706, 2101 of the Public Health Service

Act (42 U.S.C. 241, 242, 242a, 242l, 242n,

243, 262, 263, 264, 265, 300u–300u–5,

300aa–1); 42 U.S.C. 1395y, 3246b, 4332,

4831(a), 10007–10008; E.O. 11490, 11921,

and 12591.

2. Section 5.22 is amended by revising

paragraphs (a)(13)(i) through (a)(13)(v)

and by adding new paragraphs

(a)(13)(vi) through (a)(13)(viii) to read as

follows:

§ 5.22 Certification of true copies and use

of Department seal.

(a) * * *

(13)(i) The Director, Deputy Center

Director for Review Management, and

Deputy Center Director for

Pharmaceutical Science, Center for Drug

Evaluation and Research (CDER).

(ii) The Director and Deputy Director,

Office of Management, CDER.

(iii) The Director and Deputy Director,

Office of Compliance, CDER.

(iv) The Directors of the Offices of

Drug Evaluation I, II, III, IV, and V, and

the Director and Deputy Director of the

Office of Epidemiology and

Biostatistics, Office of Review

Management, CDER.

(v) The Directors and Deputy

Directors of the Offices of Testing and

Research, Generic Drugs, New Drug

Chemistry, and Clinical Pharmacology

and Biopharmaceutics, Office of

Pharmaceutical Science, CDER.

(vi) The Chief, Freedom of

Information Staff, Office of Training and

Communications, CDER.

(vii) The Directors of the Divisions of

Labeling and Nonprescription Drug

Compliance, Prescription Drug

Compliance and Surveillance, and

Manufacturing and Product Quality,

Office of Compliance, CDER.

(viii) The Director and Deputy

Director, Division of Bioequivalence,

Office of Generic Drugs, Office of

Pharmaceutical Science, CDER.

* * * * *

3. Section 5.23 is amended by revising

paragraph (b) to read as follows:

§ 5.23 Disclosure of official records.

* * * * *

(b) The Chief, Product Information

Management Branch, Division of

Database Management, Office of

Management, Center for Drug

Evaluation and Research (CDER), is

authorized to sign affidavits regarding

the presence or absence of records of

Registration of Drug Establishments.

* * * * *

4. Section 5.25 is amended by revising

paragraph (a)(6) to read as follows:

§ 5.25 Research, investigation, and testing

programs and health information and health

promotion programs.

(a) * * *

(6) The Director, Deputy Center

Director for Review Management, and

Deputy Center Director for

Pharmaceutical Science, Center for Drug

Evaluation and Research (CDER).

* * * * *

5. Section 5.26 is amended by revising

paragraph (g) to read as follows:

§ 5.26 Service fellowships.

* * * * *

(g) The Director, Deputy Center

Director for Review Management, and

Deputy Center Director for

Pharmaceutical Science, Center for Drug

Evaluation and Research (CDER), and

the Director and Deputy Director, Office

of Management, CDER.

* * * * *

6. Section 5.30 is amended by revising

paragraphs (a)(2) and (c)(3) to read as

follows:

§ 5.30 Hearings.

(a) * * *

(2) The Director, Deputy Center

Director for Review Management, and

Deputy Center Director for

Pharmaceutical Science, Center for Drug

Evaluation and Research (CDER); the

Directors of the Offices of Drug

Evaluation I, II, III, IV, and V, Office of

Review Management, CDER; and the

Director and Deputy Director, Office of

Compliance, CDER.

* * * * *

(c) * * *

(3) The Director, Deputy Center

Director for Review Management, and

Deputy Center Director for

Pharmaceutical Science, CDER; the