Federal Register / Vol. 75, No. 219 / Monday, November 15, 2010 / Rules and Regulations 69585 

Section 4.3 also issued under 19 U.S.C. 

288, 1441; 

* * * * * 

Section 4.9 also issued under 42 U.S.C. 

269; 

* * * * * 

§ 4.2 [Amended] 

■ 2. In § 4.2: 

■ a. Paragraph (a) is amended: by 

removing the word ‘‘Customs’’ each time 

that it appears and adding in its place 

the term ‘‘CBP’’; in the first sentence, by 

removing the words ‘‘bonded 

merchandise or’’, and by removing the 

word ‘‘shall’’ and adding in its place the 

word ‘‘must’’, and; in the second 

sentence, by removing the word ‘‘shall’’ 

and adding in its place the word ‘‘may’’; 

■ b. Paragraph (b) is amended by 

removing the word ‘‘Customs’’ and 

adding in its place the word ‘‘customs’’; 

■ c. Paragraph (c) is amended, in the 

first sentence, by removing the word 

‘‘may’’ and adding in its place the word 

‘‘must’’, and by removing the word 

‘‘shall’’ and adding in its place the word 

‘‘must’’; and; in the last sentence, by 

removing the word ‘‘shall’’ and adding in 

its place the word ‘‘will’’, and by 

removing the word ‘‘may’’ and adding in 

its place the word ‘‘must’’; and 

■ d. Paragraph (d) is amended by 

removing the word ‘‘shall’’ and adding in 

its place the word ‘‘must’’. 

§ 4.3 [Amended] 

■ 3. In § 4.3: 

■ a. Paragraph (a)(3) is amended by 

removing the words ‘‘merchandise on 

board which is being transported inbond (not including bonded ship’s 

stores or supplies), or’’, and adding the 

words ‘‘on board’’ after the words 

‘‘foreign merchandise’’; and 

■ b. Paragraph (b)(2) is amended by 

removing the word ‘‘Customs’’ each time 

that it appears and adding in its place 

the term ‘‘CBP’’. 

§ 4.9 [Amended] 

■ 4. In § 4.9: 

■ a. Paragraph (a) is amended by 

removing the word ‘‘Customs’’ each time 

that it appears and adding in its place 

the term ‘‘CBP’’; and 

■ b. Paragraph (b) is amended in the 

second sentence by removing the words 

‘‘when they have merchandise aboard 

which is being transported in-bond, or’’, 

by removing the third and fourth 

sentences, and by removing the word 

‘‘Customs’’ in the last sentence and 

adding in its place the term ‘‘CBP’’. 

§ 4.60 [Amended] 

■ 5. In § 4.60: 

■ a. Paragraph (a) is amended by 

removing the words ‘‘the Customs 

Service’’ and adding in their place the 

term ‘‘CBP’’; 

■ b. Paragraph (a)(3) is amended by 

removing the words ‘‘merchandise on 

board that is being transported in-bond 

(not including bonded ship’s stores or 

supplies), or’’; 

■ c. Paragraph (b)(1) is amended by 

removing the word ‘‘Customs’’ and 

adding in its place the word ‘‘customs’’; 

■ d. Paragraph (c) is amended by 

removing the word ‘‘shall’’ and adding in 

its place the word ‘‘will’’; 

■ e. Paragraph (d) is amended, in the 

first sentence, by removing the words 

‘‘shall be reported’’ and adding in their 

place the words ‘‘must be reported’’, and 

by removing the words ‘‘shall note’’ and 

adding in their place the words ‘‘will 

note’’, and; in the last sentence, by 

removing the word ‘‘shall’’ each time 

that it appears and adding in its place 

the word ‘‘must’’; and 

■ f. Paragraph (e) is amended by 

removing the word ‘‘shall’’ and adding in 

its place the word ‘‘will’’. 

PART 10—ARTICLES CONDITIONALLY 

FREE, SUBJECT TO A REDUCED 

RATE, ETC. 

■ 6. The general authority citation for 

part 10 continues to read as follows: 

Authority: 19 U.S.C. 66, 1202 (General 

Note 3(i), Harmonized Tariff Schedule of the 

United States (HTSUS)), 1321, 1481, 1484, 

1498, 1508, 1623, 1624, 3314. 

* * * * * 

■ 7. § 10.121 is revised to read as 

follows: 

§ 10.121 Visual or auditory materials of an 

educational, scientific, or cultural character. 

(a) Where photographic film and other 

articles described in subheading 

9817.00.40, Harmonized Tariff Schedule 

of the United States (HTSUS), are 

claimed to be free of duty under 

subheading 9817.00.40, HTSUS, there 

must be filed, in connection with the 

entry covering such articles, a document 

issued by the U.S. Department of State 

certifying that it has determined that the 

articles are visual or auditory materials 

of an educational, scientific, or cultural 

character within the meaning of the 

Agreement for Facilitating the 

International Circulation of Visual and 

Auditory Materials of an Educational, 

Scientific, and Cultural Character as 

required by U.S. note 1(a)(i), Subchapter 

XVII, chapter 98, HTSUS. 

(b) Articles entered under subheading 

9817.00.40, HTSUS, will be released 

from CBP custody prior to submission of 

the document required in paragraph (a) 

of this section only upon the deposit of 

estimated duties with the port director. 

Liquidation of an entry covering 

merchandise which has been released 

under this procedure will be suspended 

for a period of 90 days from the date of 

entry or until the required document is 

submitted, whichever occurs first. In the 

event that the director of the port of 

entry does not receive the required 

document within the 90-day period, the 

merchandise will be classified and 

liquidated in the ordinary course, 

without regard to subheading 

9817.00.40, HTSUS. 

Dated: November 9, 2010. 

David V. Aguilar, 

Acting Commissioner, U.S. Customs and 

Border Protection. 

[FR Doc. 2010–28709 Filed 11–12–10; 8:45 am] 

BILLING CODE 9111–14–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 510 and 520 

[Docket No. FDA–2010–N–0002] 

New Animal Drugs; Change of 

Sponsor; Sulfadiazine and 

Pyrimethamine Suspension 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

animal drug regulations to reflect a 

change of sponsor for sulfadiazine and 

pyrimethamine oral suspension from 

Animal Health Pharmaceuticals, LLC, to 

Pegasus Laboratories, Inc. 

DATES: This rule is effective November 

15, 2010. 

FOR FURTHER INFORMATION CONTACT: 

Steven D. Vaughn, Center for Veterinary 

Medicine (HFV–100), Food and Drug 

Administration, 7520 Standish Pl., 

Rockville, MD 20855, 240–276–8300, 

e-mail: steven.vaughn@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Animal 

Health Pharmaceuticals, LLC, 1805 Oak 

Ridge Circle, suite 101, St. Joseph, MO 

64506, has informed FDA that it has 

transferred ownership of, and all rights 

and interest in, NADA 141–240 for 

REBALANCE (sulfadiazine and 

pyrimethamine) Antiprotozoal Oral 

Suspension to Pegasus Laboratories, 

Inc., 8809 Ely Rd., Pensacola, FL 32514. 

Accordingly, the regulations are 

amended in 21 CFR 520.2215 to reflect 

this change of sponsorship. 

Following this change of sponsorship, 

Animal Health Pharmaceuticals, LLC, is 

no longer the sponsor of an approved 

application. Accordingly, § 510.600 (21 


jdjones on DSK8KYBLC1PROD with RULES
69586 Federal Register / Vol. 75, No. 219 / Monday, November 15, 2010 / Rules and Regulations 

CFR 510.600) is being amended to 

remove the entries for this firm. 

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 

21 CFR Part 510 

Administrative practice and 

procedure, Animal drugs, Labeling, 

Reporting and recordkeeping 

requirements. 

21 CFR Part 520 

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 

CFR parts 510 and 520 are amended as 

follows: 

PART 510—NEW ANIMAL DRUGS 

■ 1. The authority citation for 21 CFR 

part 510 continues to read as follows: 

Authority: 21 U.S.C. 321, 331, 351, 352, 

353, 360b, 371, 379e. 

§ 510.600 [Amended] 

■ 2. In § 510.600, in the table in 

paragraph (c)(1) remove the entry for 

‘‘Animal Health Pharmaceuticals, LLC’’; 

and in the table in paragraph (c)(2) 

remove the entry for ‘‘068718’’. 

PART 520—ORAL DOSAGE FORM 

NEW ANIMAL DRUGS 

■ 3. The authority citation for 21 CFR 

part 520 continues to read as follows: 

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

§ 520.2215 [Amended] 

■ 4. In paragraph (b) of § 520.2215, 

remove ‘‘068718’’ and add in its place 

‘‘055246’’. 

Dated: November 8, 2010. 

Steven D. Vaughn, 

Director, Office of New Animal Drug 

Evaluation, Center for Veterinary Medicine. 

[FR Doc. 2010–28549 Filed 11–12–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 516 

[Docket No. FDA–2010–N–0534] 

New Animal Drugs for Minor Use and 

Minor Species 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Direct final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending its 

regulations regarding new animal drugs 

for minor use and minor species to 

update language and to clarify the 

regulations consistent with the 

explanations in the preambles to the 

proposed and final rules establishing 

them. This action is being taken to 

ensure accuracy and clarity in the 

Agency’s regulations. 

Elsewhere in this issue of the Federal 

Register, FDA is publishing a 

companion proposed rule, under FDA’s 

usual procedure for notice-andcomment rulemaking, to provide a 

procedural framework to finalize the 

rule in the event the Agency receives 

any significant adverse comments and 

withdraws this direct final rule. The 

companion proposed rule and direct 

final rule are substantively identical. 

DATES: This rule is effective March 30, 

2011. Submit either electronic or 

written comments by January 31, 2011. 

If FDA receives no significant adverse 

comments within the specified 

comment period, the Agency will 

publish a document confirming the 

effective date of the final rule in the 

Federal Register within 30 days after 

the comment period on this direct final 

rule ends. If timely significant adverse 

comments are received, the Agency will 

publish a document in the Federal 

Register withdrawing this direct final 

rule before its effective date. 

ADDRESSES: You may submit comments, 

identified by Docket No. FDA–2010–N– 

0534, by any of the following methods: 

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 number 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 ‘‘Request for 

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: Meg 

Oeller, Center for Veterinary Medicine 

(HFV–50), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276–9005. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Minor Use and Minor Species 

Animal Health Act of 2004 amended the 

Federal Food, Drug, and Cosmetic Act 

(the FD&C Act) to establish new 

regulatory procedures that provide 

incentives intended to make more drugs 

legally available to veterinarians and 

animal owners for the treatment of 

minor animal species and uncommon 

diseases in major animal species. FDA 

published the final rule to implement 

these regulations (part 516 (21 CFR part 

516)) in the Federal Register of July 26, 

2007 (72 FR 41010). 

FDA is issuing this direct final rule to 

amend its regulations regarding new 

animal drugs for minor use and minor 

species (MUMS) in part 516 to update 

language and clarify the intent of the 

regulations consistent with the 

preambles to the proposed and final 

rules. 

In § 516.3(b), FDA is amending the 

definition of ‘‘Same dosage form’’ to 

make it clearer that the six dosage form 

categories listed in the regulations 

under § 516.3(b)(i) through (b)(vi) are 

the ‘‘categories’’ of dosage forms that the 

preamble to the proposed rule 

referenced as follows: ‘‘The second test 

of sameness which the statute 

establishes to determine eligibility of an 

animal drug for designation is ‘same 

dosage form.’ The agency proposes to 


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