Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / Proposed Rules 79317 

requiring exceptional piloting skill, 

alertness, or strength, and without 

exceeding the limit load factor. This 

requirement also includes aircraft 

control through the hoist operator’s 

control. 

(3) For SAR modes at airspeeds below 

VMINI, the following requirements of 

Appendix B to part 29 must be met and 

will be used as an extension to the IFR 

certification envelope of the basic 

aircraft: 

(i) Static Longitudinal Stability: The 

requirements of paragraph IV of 

Appendix B are not applicable. 

(ii) Static Lateral-Directional Stability: 

The requirements of paragraph V of 

Appendix B are not applicable. 

(iii) Dynamic Stability: The 

requirements of paragraph VI of 

Appendix B are replaced with the 

following two paragraphs: 

(A) Any oscillation must be damped 

and any aperiodic response must not 

double in amplitude in less than 10 

seconds. This requirement must also be 

met with degraded upper mode(s) of the 

AFCS. An ‘‘upper mode’’ is a mode that 

utilizes a fully coupled autopilot to 

provide an operational SAR profile. 

(B) After any upset, the AFCS must 

return the aircraft to the last 

commanded position within 10 seconds 

or less. 

(4) With any of the upper mode(s) of 

the AFCS engaged, the pilot must be 

able to manually recover the aircraft and 

transition to the normal (Appendix B) 

IFR flight profile envelope without 

exceptional skill, alertness, or strength. 

(e) One-Engine Inoperative (OEI) 

Performance Information. 

(1) The following performance 

information must be provided in the 

Rotorcraft Flight Manual Supplement 

(RFMS): 

(i) OEI performance information and 

emergency procedures, providing the 

maximum weight that will provide a 

minimum clearance of 15 feet above the 

surface, following failure of the critical 

engine in a hover. The maximum weight 

must be presented as a function of the 

hover height for the temperature and 

pressure altitude range requested for 

certification. The effects of wind must 

be reflected in the hover performance 

information. 

(ii) Hover OGE performance with the 

critical engine inoperative for OEI 

continuous and time-limited power 

ratings for those weights, altitudes, and 

temperatures for which certification is 

requested. 

Note: These OEI performance requirements 

do not replace performance requirements that 

may be needed to comply with the 

airworthiness or operational standards 

(§ 29.865 or 14 CFR part 133) for external 

loads or human external cargo. 

(f) RFMS. 

(1) The RFMS must contain, at a 

minimum: 

(i) Limitations necessary for safe 

operation of the SAR system to include: 

(A) Minimum crew requirements. 

(B) Maximum SAR weight. 

(C) Engagement criteria for each of the 

SAR modes to include MUH (as 

determined in subparagraph (c)(3)). 

(ii) Normal and emergency procedures 

for operation of the SAR system (to 

include operation of the hoist operator 

control), with AFCS failure modes, 

AFCS degraded modes, and engine 

failures. 

(iii) Performance information: 

(A) OEI performance and height-loss. 

(B) Hover OGE performance 

information, utilizing OEI continuous 

and time-limited power ratings. 

(C) The maximum wind envelope 

demonstrated in flight test. 

(g) Flight Demonstration. 

(1) Before approval of the SAR 

system, an acceptable flight 

demonstration of all the coupled SAR 

modes is required. 

(2) The AFCS must provide fail-safe 

operations during coupled maneuvers. 

The demonstration of fail-safe 

operations must include a pilot 

workload assessment associated with 

manually flying the aircraft to an 

altitude greater than 200 feet above the 

surface and an airspeed of at least the 

best rate of climb airspeed (Vy). 

(3) For any failure condition of the 

SAR system not shown to be extremely 

improbable, the pilot must be able to 

make a smooth transition from one 

flight mode to another without 

exceptional piloting skill, alertness, or 

strength. 

(4) Failure conditions that are not 

shown to be extremely improbable must 

be demonstrated by analysis, ground 

testing, or flight testing. For failures 

demonstrated in flight, the following 

normal pilot recovery times are 

acceptable: 

(i) Transition modes (Cruise-to-Hover/ 

Hover-to-Cruise) and Hover modes: 

Normal pilot recognition plus 1 second. 

(ii) Cruise modes: Normal pilot 

recognition plus 3 seconds. 

(5) All AFCS malfunctions must 

include evaluation at the low-speed and 

high-power flight conditions typical of 

SAR operations. Additionally, AFCS 

hard-over, slow-over, and oscillatory 

malfunctions, particularly in yaw, 

require evaluation. AFCS malfunction 

testing must include a single or a 

combination of failures (for example, 

erroneous data from and loss of the 

radio altimeter, attitude, heading, and 

altitude sensors) which are not shown to 

be extremely improbable. 

(6) The flight demonstration must 

include the following environmental 

conditions: 

(i) Swell into wind. 

(ii) Swell and wind from different 

directions. 

(iii) Cross swell. 

(iv) Swell of different lengths (short 

and long swell). 

Issued in Fort Worth, Texas, on December 

14, 2010. 

Bruce E. Cain, 

Acting Manager, Rotorcraft Directorate, 

Aircraft Certification Service. 

[FR Doc. 2010–31867 Filed 12–17–10; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 39 

[Docket No. FAA–2010–1199; Directorate 

Identifier 2010–NM–225–AD] 

RIN 2120–AA64 

Airworthiness Directives; The Boeing 

Company Model 737–600, –700, –700C, 

–800, and –900 Series Airplanes 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Notice of proposed rulemaking 

(NPRM). 

SUMMARY: We propose to supersede an 

existing airworthiness directive (AD) 

that applies to the products listed above. 

The existing AD currently requires 

replacement of the power control relays 

in the P91 and P92 power distribution 

panels for the fuel boost and override 

pumps with new, improved relays 

having a ground fault interrupter (GFI) 

feature, or installation and maintenance 

of universal fault interrupters (UFIs) 

using a certain supplemental type 

certificate. Since we issued that AD, we 

have determined that we need to clarify 

which relays may be replaced by 

installation of UFIs. This proposed AD 

would continue to require the actions of 

the existing AD and also specify which 

relays may be replaced by GFIs or UFIs. 

We are proposing this AD to prevent 

pump housing burn-through due to 

electrical arcing, which could create a 

potential ignition source inside a fuel 

tank. This condition, in combination 

with flammable fuel vapors, could result 

in a fuel tank explosion and consequent 

loss of the airplane. 

DATES: We must receive comments on 

this proposed AD by February 3, 2011. 


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79318 Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / Proposed Rules 

ADDRESSES: You may send comments by 

any of the following methods: 

• Federal eRulemaking Portal: Go to 

http://www.regulations.gov. Follow the 

instructions for submitting comments. 

• Fax: 202–493–2251. 

• Mail: U.S. Department of 

Transportation, Docket Operations, 

M–30, West Building Ground Floor, 

Room W12–140, 1200 New Jersey 

Avenue, SE., Washington, DC 20590. 

• Hand Delivery: Deliver to Mail 

address above between 9 a.m. and 

5 p.m., Monday through Friday, except 

Federal holidays. 

For service information identified in 

this AD, contact Boeing Commercial 

Airplanes, Attention: Data & Services 

Management, P.O. Box 3707, MC 2H–65, 

Seattle, Washington 98124–2207; 

telephone 206–544–5000, extension 1; 

fax 206–766–5680; e-mail 

me.boecom@boeing.com; Internet 

https://www.myboeingfleet.com. You 

may review copies of the referenced 

service information at the FAA, 

Transport Airplane Directorate, 1601 

Lind Avenue, SW., Renton, Washington. 

For information on the availability of 

this material at the FAA, call 425–227– 

1221. 

Examining the AD Docket 

You may examine the AD docket on 

the Internet at http:// 

www.regulations.gov; or in person at the 

Docket Management Facility between 

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

Friday, except Federal holidays. The AD 

docket contains this proposed AD, the 

regulatory evaluation, any comments 

received, and other information. The 

street address for the Docket Office 

(phone: 800–647–5527) is in the 

ADDRESSES section. Comments will be 

available in the AD docket shortly after 

receipt. 

FOR FURTHER INFORMATION CONTACT: 

Georgios Roussos, Aerospace Engineer, 

Systems and Equipment Branch, ANM– 

130S, FAA, Seattle Aircraft Certification 

Office, 1601 Lind Avenue, SW., Renton, 

Washington 98057–3356; telephone 

(425) 917–6482; fax (425) 917–6590. 

SUPPLEMENTARY INFORMATION: 

Comments Invited 

We invite you to send any written 

relevant data, views, or arguments about 

this proposed AD. Send your comments 

to an address listed under the 

ADDRESSES section. Include ‘‘Docket No. 

FAA–2010–1199; Directorate Identifier 

2010–NM–225–AD’’ at the beginning of 

your comments. We specifically invite 

comments on the overall regulatory, 

economic, environmental, and energy 

aspects of this proposed AD. We will 

consider all comments received by the 

closing date and may amend this 

proposed AD because of those 

comments. 

We will post all comments we 

receive, without change, to http:// 

www.regulations.gov, including any 

personal information you provide. We 

will also post a report summarizing each 

substantive verbal contact we receive 

about this proposed AD. 

Discussion 

On July 27, 2010, we issued AD 2010– 

17–05, Amendment 39–16395 (75 FR 

50859, August 18, 2010), for certain 

Model 737–600, –700, –700C, –800, and 

–900 series airplanes. That AD requires 

replacement of the power control relays 

in the P91 and P92 power distribution 

panels for the fuel boost and override 

pumps with new, improved relays 

having a ground fault interrupter (GFI) 

feature, or installation and maintenance 

of universal fault interrupters (UFIs) 

using a certain supplemental type 

certificate. That AD resulted from fuel 

system reviews conducted by the 

manufacturer. We issued that AD to 

prevent pump housing burn-through 

due to electrical arcing, which could 

create a potential ignition source inside 

a fuel tank. This condition, in 

combination with flammable fuel 

vapors, could result in a fuel tank 

explosion and consequent loss of the 

airplane. 

Actions Since Existing AD Was Issued 

Since we issued AD 2010–17–05, we 

have determined that there are errors in 

paragraph (f) of that AD. Paragraph (f)(2) 

of AD 2010–17–05 contained a 

typographical error in the reference to 

the STC number; that AD refers to ‘‘STC 

ST02079LA’’ instead of the intended 

‘‘ST02076LA.’’ That paragraph also 

permits, in error, installation of the STC 

as an acceptable means of compliance 

for replacing relays R18, R19, R20, R21, 

R54, and R55. STC ST02076LA is a 

method of compliance only for relays 

R54 and R55. 

Since the STC number was referenced 

incorrectly, no operator could have used 

STC ST02076LA as a method of 

compliance for relays R18, R19, R20, or 

R21, unless an alternative method of 

compliance (AMOC) was approved. No 

AMOCs were approved for AD 2010– 

17–05. 

Paragraph (g)(1) of this notice of 

proposed rulemaking (NPRM) has been 

revised to specify that Boeing Alert 

Service Bulletin 737–28A1201, Revision 

1, dated May 28, 2009, must be used to 

accomplish replacement of relays R18, 

R19, R20, and R21. Paragraph (g)(2) of 

this NPRM has been revised to specify 

that relays R54 and R55 must be 

replaced in accordance with either the 

service bulletin or by installing and 

maintaining UFIs using STC 

ST02076LA. 

FAA’s Determination 

We are proposing this AD because we 

evaluated all the relevant information 

and determined the unsafe condition 

described previously is likely to exist or 

develop in other products of the same 

type design. 

Proposed AD Requirements 

This proposed AD would retain 

certain requirements of AD 2010–17–05 

with new compliance times. This 

proposed AD would also correct the 

reference to the STC and specify which 

relays may be replaced with UFIs by 

installing STC ST02076LA. 

Change to Existing AD 

Since AD 2010–17–05 was issued, the 

AD format has been revised, and certain 

paragraphs have been rearranged. As a 

result, the corresponding paragraph 

identifiers have changed in this 

proposed AD, as listed in the following 

table: 

REVISED PARAGRAPH IDENTIFIERS

Requirement in AD 

2010–17–05 

Corresponding 

requirement in this 

proposed AD 

Paragraph (f) ............. Paragraph (g). 

Paragraph (g) ............ Paragraph (h). 

Costs of Compliance 

We estimate that this proposed AD 

affects 754 airplanes of U.S. registry. 

We estimate the following costs to 

comply with this proposed AD: 


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ESTIMATED COSTS

Action Labor cost Parts cost Cost per 

product 

Cost on U.S. 

operators 

Installation of GFI relays (retained actions from existing 

AD—which are restated as a convenience for operators).

8 work-hours × $85 per hour 

= $680.

$11,010 $11,690 $8,814,260 

The new requirements of this 

proposed AD add no additional 

economic burden. 

Authority for This Rulemaking 

Title 49 of the United States Code 

specifies the FAA’s authority to issue 

rules on aviation safety. Subtitle I, 

section 106, describes the authority of 

the FAA Administrator. Subtitle VII, 

Aviation Programs, describes in more 

detail the scope of the Agency’s 

authority. 

We are issuing this rulemaking under 

the authority described in subtitle VII, 

part A, subpart III, section 44701, 

‘‘General requirements.’’ Under that 

section, Congress charges the FAA with 

promoting safe flight of civil aircraft in 

air commerce by prescribing regulations 

for practices, methods, and procedures 

the Administrator finds necessary for 

safety in air commerce. This regulation 

is within the scope of that authority 

because it addresses an unsafe condition 

that is likely to exist or develop on 

products identified in this rulemaking 

action. 

Regulatory Findings 

We have determined that this 

proposed AD would not have federalism 

implications under Executive Order 

13132. This proposed AD would not 

have a substantial direct effect 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. 

For the reasons discussed above, I 

certify that the proposed regulation: 

(1) Is not a ‘‘significant regulatory 

action’’ under Executive Order 12866, 

(2) Is not a ‘‘significant rule’’ under the 

DOT Regulatory Policies and Procedures 

(44 FR 11034, February 26, 1979), 

(3) Will not affect intrastate aviation 

in Alaska, and 

(4) Will not have a significant 

economic impact, positive or negative, 

on a substantial number of small entities 

under the criteria of the Regulatory 

Flexibility Act. 

List of Subjects in 14 CFR Part 39 

Air transportation, Aircraft, Aviation 

safety, Incorporation by reference, 

Safety. 

The Proposed Amendment 

Accordingly, under the authority 

delegated to me by the Administrator, 

the FAA proposes to amend 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. The FAA amends § 39.13 by 

removing airworthiness directive (AD) 

2010–17–05, Amendment 39–16395 (75 

FR 50859, August 18, 2010), and adding 

the following new AD: 

The Boeing Company: Docket No. FAA– 

2010–1199; Directorate Identifier 2010– 

NM–225–AD. 

Comments Due Date 

(a) The FAA must receive comments on 

this AD action by February 3, 2011. 

Affected ADs 

(b) This AD supersedes AD 2010–17–05, 

Amendment 39–16395. 

Applicability 

(c) This AD applies to The Boeing 

Company Model 737–600, –700, –700C, 

–800, and –900 series airplanes, certificated 

in any category; as identified in Boeing Alert 

Service Bulletin 737–28A1201, Revision 1, 

dated May 28, 2009. 

Subject 

(d) Joint Aircraft System Component 

(JASC)/Air Transport Association (ATA) of 

America Code 28: Fuel. 

Unsafe Condition 

(e) This AD was prompted by fuel system 

reviews conducted by the manufacturer. We 

are issuing this AD to prevent pump housing 

burn-through due to electrical arcing, which 

could create a potential ignition source 

inside a fuel tank. This condition, in 

combination with flammable fuel vapors, 

could result in a fuel tank explosion and 

consequent loss of the airplane. 

Compliance 

(f) Comply with this AD within the 

compliance times specified, unless already 

done. 

Replacement or Installation 

(g) Within 60 months after the effective 

date of this AD, do the actions required in 

paragraphs (g)(1) and (g)(2) of this AD. 

(1) Replace the power control relays that 

are located in the R18, R19, R20, and R21 

positions in the P91 and P92 power 

distribution panels for the fuel boost pumps 

with new, improved relays, part number 

KDAG–X4F–001, having a ground fault 

interrupter (GFI) feature, in accordance with 

the Accomplishment Instructions of Boeing 

Alert Service Bulletin 737–28A1201, 

Revision 1, dated May 28, 2009. 

(2) Replace the power control relays that 

are located in the R54 and R55 positions in 

the P91 and P92 power distribution panels 

for the fuel override pumps, in accordance 

with the actions required in paragraph 

(g)(2)(i) or (g)(2)(ii) of this AD. 

(i) Replace with new, improved relays, part 

number KDAG–X4F–001, having a GFI 

feature, in accordance with the 

Accomplishment Instructions of Boeing Alert 

Service Bulletin 737–28A1201, Revision 1, 

dated May 28, 2009. 

(ii) Install and maintain TDG Aerospace 

universal fault interrupters (UFIs) using 

Supplemental Type Certificate ST02076LA, 

issued October 26, 2007. 

Note: Boeing Alert Service Bulletin 737– 

28A1201, Revision 1, dated May 28, 2009, 

refers to Honeywell Service Bulletin 

1151932–24–61 and Honeywell Service 

Bulletin 1151934–24–62, both Revision 5, 

both dated May 25, 2009, as additional 

sources of guidance for replacement of the 

power control relays in the P91 and P92 

power distribution panels. 

Credit for Actions Accomplished in 

Accordance With Previous Service 

Information 

(h) Actions done before the effective date 

of this AD in accordance with Boeing Alert 

Service Bulletin 737–28A1201, dated 

February 19, 2007, are acceptable for 

compliance with the requirements of 

paragraphs (g)(1) and (g)(2)(i) of this AD, 

provided that Revision 5 of Honeywell 

Service Bulletins 1151932–24–61 and 

1151934–24–62, both dated May 25, 2009, is 

used as an additional source of guidance. 

Alternative Methods of Compliance 

(AMOCs) 

(i)(1) The Manager, Seattle Aircraft 

Certification Office (ACO), FAA, has the 

authority to approve AMOCs for this AD, if 

requested using the procedures found in 14 

CFR 39.19. In accordance with 14 CFR 39.19, 

send your request to your principal inspector 

or local Flight Standards District Office, as 

appropriate. If sending information directly 

to the manager of the ACO, send it to the 

attention of the person identified in the 

Related Information section of this AD. 

Information may be e-mailed to: 9-ANMSeattle-ACO-AMOC-Requests@faa.gov. 

(2) Before using any approved AMOC, 

notify your Principal Maintenance Inspector 


jlentini on DSKJ8SOYB1PROD with PROPOSALS
79320 Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / Proposed Rules 

or Principal Avionics Inspector, as 

appropriate, or lacking a principal inspector, 

your local Flight Standards District Office. 

Related Information 

(j) For more information about this AD, 

contact Georgios Roussos, Aerospace 

Engineer, Systems and Equipment Branch, 

ANM–130S, FAA, Seattle Aircraft 

Certification Office, 1601 Lind Avenue, SW., 

Renton, Washington 98057–3356; telephone 

(425) 917–6482; fax (425) 917–6590. 

(k) For service information identified in 

this AD, contact Boeing Commercial 

Airplanes, Attention: Data & Services 

Management, P.O. Box 3707, MC 2H–65, 

Seattle, Washington 98124–2207; telephone 

206–544–5000, extension 1; fax 206–766– 

5680; e-mail me.boecom@boeing.com; 

Internet https://www.myboeingfleet.com. You 

may review copies of the referenced service 

information at the FAA, Transport Airplane 

Directorate, 1601 Lind Avenue, SW., Renton, 

Washington. For information on the 

availability of this material at the FAA, call 

425–227–1221. 

Issued in Renton, Washington, on 

December 10, 2010. 

Ali Bahrami, 

Manager, Transport Airplane Directorate, 

Aircraft Certification Service. 

[FR Doc. 2010–31828 Filed 12–17–10; 8:45 am] 

BILLING CODE 4910–13–P 

SECURITIES AND EXCHANGE 

COMMISSION 

17 CFR Parts 240 and 249 

[Release No. 34–63347; File No. S7–35–10] 

RIN 3235–AK79 

Security-Based Swap Data Repository 

Registration, Duties, and Core 

Principles 

Correction 

In proposed rule document 2010– 

29719 beginning on page 77306 in the 

issue of December 10, 2010, make the 

following corrections: 

1. On page 77320, in the third 

column, footnote 74, in the fourth line, 

‘‘recordkeeping’’ should read ‘‘record 

keeping’’. 

2. On page 77321, in the second 

column, below the heading Request for 

Comment, in the fifth bulleted 

paragraph, in the tenth line, ‘‘requiring’’ 

should read ‘‘require’’. 

3. On page 77324, in the third 

column, footnote 90, in the fifth line, 

‘‘recordkeeping’’ should read ‘‘record 

keeping’’. 

4. On page 77338, the last line of text 

in the third column, prior to footnote 

164 on the page, should read 

‘‘information maintained by the 

SDR,165’’. 

5. On the same page, in the same 

column, after footnote 164, add footnote 

165 to read as follows: 

165See Public Law 111–203 (adding 

Exchange Act Section 12(n)(5)(D)(i)). 

6. On page 77347, in the second 

column, in the tenth line from the 

bottom of the page, ‘‘conflict’’ should 

read ‘‘conflicts’’. 

7. On page 77356, in the third 

column, in thirty-first line, 

‘‘systematically’’ should read 

‘‘systemically’’. 

8. On the same page, in the same line 

of the same column, ‘‘Therefor’’ should 

read ‘‘Therefore’’. 

§ 249.1500 [Corrected] 

9. On page 77375, in § 249.1500, 

before the first line in the first column, 

insert the following text: 

EXHIBITS—BUSINESS ORGANIZATION 

13. List as Exhibit A any person as defined 

in Section 3(a)(9) of the 

10. On the same page, in the second 

column, in the fifth, eleventh, and 

fifteenth lines from the bottom of the 

page, ‘‘l5’’ should read ‘‘15’’. 

[FR Doc. C1–2010–29719 Filed 12–17–10; 8:45 am] 

BILLING CODE 1505–01–D 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 500 

[Docket No. FDA–2010–N–0612] 

Animal Drugs, Feeds, and Related 

Products; Regulation of Carcinogenic 

Compounds in Food-Producing 

Animals 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Proposed rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is proposing to 

amend its regulations regarding 

compounds of carcinogenic concern 

used in food-producing animals. 

Specifically, the Agency is clarifying the 

definition of ‘‘So’’ and revising the 

definition of ‘‘Sm’’ so that it conforms to 

the clarified definition of So. Other 

clarifying and conforming changes are 

also being made. 

DATES: Submit either electronic or 

written comments on the proposed rule 

by March 7, 2011. Submit comments on 

information collection issues under the 

Paperwork Reduction Act of 1995 by 

January 19, 2011 (see the ‘‘Paperwork 

Reduction Act of 1995’’ section of this 

document). 

ADDRESSES: You may submit comments, 

identified by Docket No. FDA–2010–N– 

0612, by any of the following methods, 

except that comments on information 

collection issues under the Paperwork 

Reduction Act of 1995 must be 

submitted to the Office of Regulatory 

Affairs, Office of Management and 

Budget (OMB) (see the ‘‘Paperwork 

Reduction Act of 1995’’ section of this 

document). 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Written Submissions 

Submit written submissions in the 

following ways: 

• Fax: 301–827–6870. 

• Mail/Hand delivery/Courier (for 

paper, disk, or CD–ROM submissions): 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, Rm. 1061, Rockville, 

MD 20852. 

Instructions: All submissions received 

must include the Agency name and 

Docket No. and Regulatory Information 

Number (RIN) (if a RIN number has been 

assigned) for this rulemaking. All 

comments received may be posted 

without change to http:// 

www.regulations.gov, including any 

personal information provided. For 

additional information on submitting 

comments, see the ‘‘Comments’’ heading 

of the SUPPLEMENTARY INFORMATION

section of this document. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http:// 

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Division of Dockets 

Management, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Kevin Greenlees, Center for Veterinary 

Medicine (HFV–100), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 301–827–6975. 

e-mail: kevin.greenlees@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Federal Food, Drug, and Cosmetic 

Act (the FD&C Act) contains three 

anticancer, or Delaney, clauses: Sections 

409(c)(3)(A), 512(d)(1)(I), and 

721(b)(5)(B)(i) (21 U.S.C. 348(c)(3)(A), 

360b(d)(1)(I), and 379e(b)(5)(B)(i)), 

pertaining to food additives, new animal 

drugs, and color additives, respectively. 


jlentini on DSKJ8SOYB1PROD with PROPOSALS