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.’’ 


jdjones on DSK8KYBLC1PROD with RULES
Federal Register / Vol. 76, No. 59 / Monday, March 28, 2011 / Rules and Regulations 17027 

Therefore, it is not subject to the 

congressional review requirements in 5 

U.S.C. 801–808. 

List of Subjects 

21 CFR Part 522 

Animal drugs. 

21 CFR Part 558 

Animal drugs, Animal feeds. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under the 

authority delegated to the Commissioner 

of Food and Drugs and redelegated to 

the Center for Veterinary Medicine, 21 

CFR parts 522 and 558 are amended as 

follows: 

PART 522—IMPLANTATION OR 

INJECTABLE DOSAGE FORM NEW 

ANIMAL DRUGS 

■ 1. The authority citation for 21 CFR 

part 522 continues to read as follows: 

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

■ 2. In § 522.2240 revise paragraph 

(e)(3) to read as follows: 

§ 522.2240 Sulfaethoxypyridazine. 

* * * * * 

(e) * * * 

(3) Limitations. Administer 

intravenously for not more than 4 days; 

or first treatment may be followed by 3 

days of treatment with 

sulfaethoxypyridazine in drinking water 

or tablets in accordance with 

§§ 520.2240a(e) and 520.2240b(e) of this 

chapter; as sodium 

sulfaethoxypyridazine; do not treat 

within 16 days of slaughter; as sole 

source of sulfonamide; milk that has 

been taken from animals during 

treatment and for 72 hours (6 milkings) 

after the latest treatment must not be 

used for food. Federal law restricts this 

drug to use by or on the order of a 

licensed veterinarian. 

PART 558—NEW ANIMAL DRUGS FOR 

USE IN ANIMAL FEEDS 

■ 3. The authority citation for 21 CFR 

part 558 continues to read as follows: 

Authority: 21 U.S.C. 360b, 371. 

§ 558.4 [Amended] 

■ 4. In § 558.4, in paragraph (d), in the 

‘‘Category II’’ table, remove the entries 

for ‘‘Arsanilate sodium’’ and 

‘‘Sulfaethoxypyridazine’’. 

§ 558.55 [Amended] 

■ 5. In § 558.55, in the tables in 

paragraphs (d)(2)(i), (d)(2)(ii), and 

(d)(2)(iv), remove the entries for 

‘‘Arsanilate sodium 90 (0.01%)’’. 

§ 558.60 [Removed] 

■ 6. Remove § 558.60. 

§ 558.579 [Removed] 

■ 7. Remove § 558.579. 

§ 558.680 [Amended] 

■ 8. In § 558.680, in the tables in 

paragraphs (d)(1)(i), (d)(1)(ii), and 

(d)(1)(iii), remove the entries for 

‘‘Arsanilate sodium 90 (0.01%)’’. 

Dated: March 23, 2011. 

David Dorsey, 

Acting Deputy Commissioner for Policy, 

Planning and Budget. 

[FR Doc. 2011–7214 Filed 3–25–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF STATE 

22 CFR Part 62 

[Public Notice: 7346] 

RIN 1400–AC67 

Exchange Visitor Program—Fees and 

Charges 

Correction 

In rule document 2011–4276, 

appearing on pages 10498–10500 in the 

issue of Friday, February 25, 2011, make 

the following correction: 

On page 10498, in the second column, 

in the DATES section, ‘‘Effective Date: 

This rule is effective 30 days from 

February 25, 2011’’ should read 

‘‘Effective Date: This rule is effective 

March 28, 2011’’. 

[FR Doc. C1–2011–4276 Filed 3–25–11; 8:45 am] 

BILLING CODE 1505–01–D 

DEPARTMENT OF THE INTERIOR 

National Park Service 

36 CFR Part 7 

RIN 1024–AD96 

Special Regulation: Areas of the 

National Park System, National Capital 

Region 

AGENCY: National Park Service, Interior. 

ACTION: Final rule. 

SUMMARY: The National Park Service 

(NPS) is physically moving the office of 

the Division of Park Programs, National 

Mall and Memorial Parks (NAMA) 

which processes applications for special 

events and demonstrations permits for 

nine parks in the National Capital 

Region (NCR). This rule updates the 

address and location of the office where 

these permit applications may be 

obtained and where completed 

applications are to be submitted by mail 

or in person. 

DATES: Effective March 28, 2011. 

FOR FURTHER INFORMATION CONTACT: 

Robbin M. Owen, Chief, Division of 

Park Programs, National Park Service, 

National Capital Region, 900 Ohio Drive 

SW., Washington, DC 20024. Telephone: 

(202) 619–7225. 

SUPPLEMENTARY INFORMATION: During the 

fourth week of March, the NPS is 

expecting to move the Division of Park 

Programs from 1100 Ohio Drive, SW., to 

the nearby 900 Ohio Drive, SW., 

Washington, DC 20024. Now codified at 

36 CFR 7.96(g)(3), the NPS 1975 

rulemaking established a centralized 

location where permit applications for 

special events and demonstrations, must 

be submitted, Monday—Friday from 8 

a.m. to 4 p.m., holidays excepted. As the 

NPS explained the NCR regulatory 

permit application process the: 

Applications will be immediately date-andtime stamped upon receipt. * * * This 

provision for official receipt only during 

office hours is designed to permit the Park 

Service to properly process applications 

within the prescribed time period. 40 FR 

58652 (1975) 

As Acting Secretary of the Interior 

Nathaniel P. Reed explained, at 41 FR 

12880 (1976): 

It is the opinion of the Department that 

receipt of the application in this single 

location is necessary in order to effectively 

administer the priority system for the use of 

park lands, to ensure that the application will 

be considered by an official of responsible 

rank, and to allow for consideration of the 

permit within the applicable time limitation. 

Even though executed permit applications 

must be received at that location, application 

blanks may be obtained at other locations in 

the National Capital Parks area.* * * 

As to why applications had to be 

received at the permit offices during 

regular business hours, the NPS 

explained at 41 FR 12880 (1976), that: 

[T]his limitation is necessary in order that 

the required security precautions and 

augmentation of forces and services may be 

provided. The Department has weighed the 

administrative burdens that the absence of 

this limitation would impose upon the 

various government agencies involved 

against possible effects upon the exercise of 

First Amendment freedoms and believes on 

balance that these effects are inconsequential. 

This impact is further lessened since 

demonstrations may be conducted in certain 

areas without permit pursuant to paragraph 

(b). 

Need for Change: The technical 

amendment is needed to provide the 

public with the new address of the 

relocated permit office where special 


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