Federal Register / Vol. 76, No. 59 / Monday, March 28, 2011 / Rules and Regulations 17025 

(1) Starting at a speed sufficiently 

above the minimum steady flight speed 

to ensure that a steady rate of speed 

reduction can be established, apply the 

longitudinal control so that the speed 

reduction does not exceed one knot per 

second until the control reaches the 

stop. 

(2) The longitudinal control must be 

maintained at the stop until the airplane 

has reached a stabilized flight condition 

and then recovered by normal recovery 

techniques. 

(3) The requirements for turning flight 

maneuver demonstrations must also be 

met with accelerated rates of entry to 

the incidence limit, up to the maximum 

rate achievable. 

6. Characteristics in High Incidence 

Maneuvers—In lieu of the requirements 

of § 25.203, the following special 

condition is issued: 

(a) Throughout maneuvers with a rate 

of deceleration of not more than 1 knot 

per second, both in straight flight and in 

30 degree banked turns, the airplane’s 

characteristics must be as follows: 

(1) No abnormal airplane nose-up 

pitching. 

(2) No uncommanded nose-down 

pitching (which is indicative of stall). 

However, reasonable attitude changes 

associated with stabilizing the incidence 

at alpha limit as the longitudinal control 

reaches the stop is acceptable. Any 

reduction of pitch attitude associated 

with stabilizing the incidence at the 

alpha limit should be achieved 

smoothly and at a low pitch rate, so it 

is not likely to be mistaken for natural 

stall identification. 

(3) No uncommanded lateral or 

directional motion, and the pilot must 

retain good lateral and directional 

control by conventional use of the 

cockpit controls throughout the 

maneuver. 

(4) The airplane must not exhibit 

buffeting of a magnitude or severity that 

would act as a deterrent to completing 

the maneuver specified in § 25.201(a) as 

amended by this special condition. 

(b) In maneuvers with increased rates 

of deceleration, some degradation of 

characteristics associated with a 

transient excursion beyond the 

stabilized alpha-limit is acceptable. 

However, the airplane must not exhibit 

dangerous characteristics or 

characteristics that would deter the pilot 

from holding the longitudinal control on 

the aft stop for a period of time 

appropriate to the maneuvers. 

(c) It must always be possible to 

reduce incidence by conventional use of 

the longitudinal control. 

(d) The rate at which the airplane can 

be maneuvered from trim speeds 

associated with scheduled operating 

speeds, such as V2 and VREF up to alphalimit, should not be unduly damped or 

significantly slower than can be 

achieved on conventionally controlled 

transport airplanes. 

7. Atmospheric Disturbances— 

Operation of the high incidence 

protection function must not adversely 

affect aircraft control during expected 

levels of atmospheric disturbances, nor 

impede the application of recovery 

procedures in case of windshear. 

Simulator tests and analysis may be 

used to evaluate such conditions, but 

must be validated by limited flight 

testing to confirm handling qualities at 

critical loading conditions. 

8. Longitudinal Control—In lieu of the 

requirements of § 25.145(a), (a)(1) and 

(b)(6), the following special conditions 

are issued: 

(a) It must be possible, at any point 

between the trim speed prescribed in 

§ 25.103(b)(6) as amended by this 

special condition and Vmin, to pitch the 

nose downward so that the acceleration 

to this selected trim speed is prompt. 

(b) With the landing gear extended, no 

change in trim control, or exertion of 

more than 50 pounds control force 

(representative of the maximum shortterm force that can be applied readily by 

one hand) may be required for the 

following maneuver: With power off, 

flaps extended and the airplane 

trimmed at 1.3 VSR1, obtain and 

maintain airspeeds between Vmin and 

either 1.6VSR1 or VFE, whichever is 

lower. 

9. Airspeed Indicating System—In 

lieu of § 25.1323(c)(1) and (c)(2), the 

following special conditions are issued: 

(a) VMO to Vmin with the flaps 

retracted; and 

(b) Vmin to VFE with flaps in the 

landing position. 

Issued in Renton, Washington, on March 

18, 2011. 

KC Yanamura, 

Acting Manager, Transport Airplane 

Directorate, Aircraft Certification Service. 

[FR Doc. 2011–7144 Filed 3–25–11; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 520 and 529 

[Docket No. FDA–2011–N–0003] 

New Animal Drugs; Oxytetracycline 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

animal drug regulations to reflect 

approval of a supplemental abbreviated 

new animal drug application (ANADA) 

filed by Pennfield Oil Co. The 

supplemental ANADA provides for use 

of oxytetracycline hydrochloride soluble 

powder for control of American and 

European foulbrood in honey bees and 

for skeletal marking of finfish fry and 

fingerlings. 

DATES: This rule is effective March 28, 

2011. 

FOR FURTHER INFORMATION CONTACT: John 

K. Harshman, Center for Veterinary 

Medicine (HFV–170), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276–8197, 

e-mail: john.harshman@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Pennfield 

Oil Co., 14040 Industrial Rd., Omaha, 

NE 68144, filed a supplement to 

ANADA 200–026 that provides for use 

of PENNOX 343 (oxytetracycline HCl) 

Soluble Powder for control of American 

and European foulbrood in honey bees 

and for skeletal marking of finfish fry 

and fingerlings by immersion. The 

supplemental ANADA is approved as of 

December 6, 2010, and the regulations 

in 21 CFR 520.1660d and 529.1660 are 

amended to reflect the approval. 

In accordance with the freedom of 

information provisions of 21 CFR part 

20 and 21 CFR 514.11(e)(2)(ii), a 

summary of safety and effectiveness 

data and information submitted to 

support approval of this application 

may be seen in the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852, between 

9 a.m. and 4 p.m., Monday through 

Friday. 

The Agency has determined under 21 

CFR 25.33 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. 

This rule does not meet the definition 

of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because 

it is a rule of ‘‘particular applicability.’’ 

Therefore, it is not subject to the 

congressional review requirements in 

5 U.S.C. 801–808. 

List of Subjects in 21 CFR Parts 520 and 

529 

Animal drugs. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs and redelegated to 

the Center for Veterinary Medicine, 21 


jdjones on DSK8KYBLC1PROD with RULES
17026 Federal Register / Vol. 76, No. 59 / Monday, March 28, 2011 / Rules and Regulations 

CFR parts 520 and 529 are amended as 

follows: 

PART 520—ORAL DOSAGE FORM 

NEW ANIMAL DRUGS 

■ 1. The authority citation for 21 CFR 

part 520 continues to read as follows: 

Authority: 21 U.S.C. 360b. 

§ 520.1660d [Amended] 

■ 2. In paragraph (b)(6) of § 520.1660d, 

remove ‘‘cattle, and sheep’’ and in its 

place add ‘‘cattle, sheep, and honey 

bees.’’ 

PART 529—CERTAIN OTHER DOSAGE 

FORM NEW ANIMAL DRUGS 

■ 3. The authority citation for 21 CFR 

part 529 continues to read as follows: 

Authority: 21 U.S.C. 360b. 

§ 529.1660 [Amended] 

■ 4. In paragraph (b)(2) of § 529.1660, 

remove ‘‘Nos. 000069 and 059130’’ and 

in its place add ‘‘Nos. 000069, 048164, 

and 059130’’. 

Dated: March 23, 2011. 

David Dorsey, 

Acting Deputy Commissioner for Policy, 

Planning and Budget. 

[FR Doc. 2011–7216 Filed 3–25–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 522 and 558 

[Docket No. FDA–2011–N–0003] 

New Animal Drugs; Arsanilate Sodium; 

Sulfaethoxypyridazine 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule; correcting 

amendments. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

animal drug regulations to remove 

sections pertaining to use of arsanilate 

sodium and sulfaethoxypyridazine in 

medicated feed because there are no 

currently approved new animal drug 

applications (NADAs) for such uses. 

Conforming amendments are also being 

made. This action is being taken to 

improve the accuracy of the regulations. 

DATES: This rule is effective March 28, 

2011. 

FOR FURTHER INFORMATION CONTACT: 

George K. Haibel, Center for Veterinary 

Medicine (HFV–6), Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855, 240–276–9019, 

e-mail: George.Haibel@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: FDA has 

determined the animal drug regulations 

describe conditions of use for arsanilate 

sodium and sulfaethoxypyridazine in 

medicated feed for which no NADA is 

currently approved. 

1. Arsanilate sodium § 558.60 (21 CFR 

558.60). In the Federal Register of 

December 18, 1986 (51 FR 45346), FDA 

proposed to remove § 558.20 Drugs used 

in medicated feeds in use before January 

1, 1958, which are not otherwise listed; 

interim listing (21 CFR 558.20) because 

this section in part 558 subpart A— 

General Provisions did not provide an 

appropriate basis upon which to 

approve medicated feed applications 

and because several of the drugs listed 

were not the subject of approved 

NADAs. Among other exceptions, FDA 

proposed to transfer the arsanilate 

sodium provisions of § 558.20 to 

§ 558.60 in subpart B—Specific New 

Animal Drugs for Use in Animal Feeds 

(subpart B) to reflect their status as 

approved conditions of use. 

In 1991, FDA issued a final rule 

removing most of § 558.20 (56 FR 19263, 

April 26, 1991) and codifying approved 

uses in subpart B. Elsewhere in the 

same issue of the Federal Register, FDA 

reproposed the removal of the 

remaining portions of § 558.20 that 

pertained to certain uses of arsanilate 

sodium (56 FR 19332, April 26, 1991). 

FDA reproposed those portions of the 

rule because it recognized that some of 

the uses it had proposed to codify in 

subpart B did not appear to be the 

subject of approved NADAs, as 

previously stated. In the discussion of 

the reproposed changes, FDA tentatively 

concluded that NADA 8–966 for 

arsanilate sodium for use in swine feed 

was voluntarily withdrawn by a letter 

dated November 12, 1973. The Agency 

acknowledged this withdrawal by a 

letter dated January 16, 1974 (see 56 FR 

19332 at 19333, Refs. 1 and 2). 

In 1992, FDA issued a final rule 

removing the remaining portions of 

§ 558.20 (57 FR 1641, January 15, 1992) 

and noted that no evidence or 

comments were received on the 1991 

reproposed rule, which had requested 

that anyone claiming to hold an 

approved NADA for arsanilate sodium 

in swine feed submit evidence to 

substantiate the approval. FDA 

concluded that NADA 8–966 providing 

for use of arsanilate sodium in 

medicated feeds for swine was 

voluntarily withdrawn at the request of 

the sponsor (see 56 FR 19332 and Refs. 

1 and 2 of the reproposal). 

After careful review of its NADA 

records, FDA has concluded that all 

uses of arsanilate sodium in medicated 

feeds in NADA 8–966 were voluntarily 

withdrawn by the sponsor in 1973 and 

that there is no currently approved 

NADA providing for the use of 

arsanilate sodium in medicated feed or 

in any dosage form. Accordingly, the 

animal drug regulations in part 558 (21 

CFR part 558) are amended by removing 

§ 558.60. Conforming amendments are 

also being made in §§ 558.55 and 

558.680 by removing reference to use in 

combination with amprolium and 

zoalene, respectively. This action is 

being taken to comply with the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act) and to improve the accuracy of the 

regulations. 

2. Sulfaethoxypyridazine (§§ 558.579). 

In 1966, FDA approved a food additive 

petition and codified the safe use of 

sulfaethoxypyridazine in feed and 

drinking water of swine at § 121.280 (21 

CFR 121.280) (31 FR 2425 at 2426, 

February 5, 1966). In 1968, § 121.280 

was amended to add use in cattle in 

feed and water, and by tablet and 

injection, and to make all uses, 

including use in feed restriction to ‘‘for 

sale by or on the order of a licensed 

veterinarian’’ (33 FR 627 at 628, January 

18, 1968). A 1969 amendment revised 

that use restriction to read ‘‘for use by 

or on the order of a licensed 

veterinarian’’ (34 FR 20272, December 

25, 1969). 

In a 1976 reorganization of certain 

food additive regulations from 21 CFR 

part 121 to new part 558 New Animal 

Drugs For Use in Animal Feed, 

§ 121.280 was redesignated as § 558.579 

(41 FR 10983 at 11005, March 15, 1976). 

In the intervening 35 years there have 

been no required annual drug 

experience reports, or any product 

stability reports, submitted for any 

NADA for use of sulfaethoxypyridazine 

in medicated feed. At this time and after 

careful review of its NADA records, 

FDA has concluded that that there is no 

approved NADA for the use of 

sulfaethoxypyridazine in medicated 

feed for swine or cattle. Accordingly, 

the animal drug regulations in part 558 

are amended by removing § 558.579. A 

conforming amendment is also being 

made in 21 CFR 522.2240 to remove a 

provision for administration of 

sulfaethoxypyridazine injectable 

solution followed by use of 

sulfaethoxypyridazine medicated cattle 

feed. This action is being taken to 

comply with the FD&C Act and to 

improve the accuracy of the regulations. 

This rule does not meet the definition 

of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because 

it is a rule of ‘‘particular applicability.’’ 


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