Federal Register / Vol. 73, No. 22 / Friday, February 1, 2008 / Rules and Regulations 6017 

imposing requirements related to the 

regulation of nonprescription drug 

products. Section 751(b) through (e) of 

the act outlines the scope of the express 

preemption provision, the exemption 

procedures, and the exceptions to the 

provision. 

This final rule provides an additional 

statement of identity for skin protectants 

formulated and marketed as lip 

protectants and allows omission of a 

warning for certain lip protectant 

products. Any final rule has a 

preemptive effect in that it precludes 

States from issuing requirements related 

to the labeling of OTC skin protectant 

drug products that are different from or 

in addition to, or not otherwise identical 

with a requirement in the final rule. 

This preemptive effect is consistent 

with what Congress set forth in section 

751 of the act. Section 751(a) of the act 

displaces both State legislative 

requirements and State common law 

duties. We also note that even where the 

express preemption provision is not 

applicable, implied preemption may 

arise (see Geier v. American Honda Co., 

529 US 861 (2000)). 

We believe that the preemptive effect 

of the final rule is consistent with 

Executive Order 13132. Section 4(e) of 

the Executive order provides that ‘‘when 

an agency proposes to act through 

adjudication or rulemaking to preempt 

State law, the agency shall provide all 

affected State and local officials notice 

and an opportunity for appropriate 

participation in the proceedings.’’

We provided the States with an 

opportunity for appropriate 

participation in this rulemaking when 

we sought input from all stakeholders 

on the reduced labeling requirements 

that this rulemaking addresses, through 

publication of the request for comments 

in the Federal Register in the preamble 

to the final rule on June 4, 2003 (68 FR 

33362). We received no comments from 

any States in response to the request. 

In addition, on December 10, 2007, 

FDA’s Division of Federal and State 

Relations provided notice via e-mail 

transmission to elected officials of State 

governments and their representatives 

of national organization. The notice 

provided the States with further 

opportunity to comment. It advised the 

States of the publication of the request 

for comments and encouraged State and 

local governments to review the request 

and to provide any comments to the 

dockets for this rulemaking (Docket Nos. 

1978N–0021 and 1978N–0021P) by a 

date 30 days after the date of the notice 

(i.e., by January 10, 2008), or to contact 

certain named individuals. FDA 

received no comments in response to 

this notice. The notice has been filed in 

the previously mentioned dockets. 

In conclusion, we believe that we 

have complied with all of the applicable 

requirements under the Executive order 

and have determined that the 

preemptive effects of this rule are 

consistent with Executive Order 13132. 

VI. Environmental Impact 

We have determined under 21 CFR 

25.31(a) 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. 

VII. References 

The following references are on 

display in the Division of Dockets 

Management, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852 under 

Docket No. 1978N–0021 and may be 

seen by interested persons between 9 

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

Friday. 

1. Comment No. C67. 

2. Comment No. C68. 

3. Comment No. C69. 

List of Subjects in 21 CFR Part 347 

Labeling, Over-the-counter drugs. 

■ Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR part 347 is 

amended as follows: 

PART 347—SKIN PROTECTANT DRUG 

PRODUCTS FOR OVER-THECOUNTER HUMAN USE 

■ 1. The authority citation for 21 CFR 

part 347 continues to read as follows: 

Authority: 21 U.S.C. 321, 351, 352, 353, 

355, 360, 371. 

■ 2. Section 347.50 is amended by 

revising paragraphs (a) and (e)(1)(iii) to 

read as follows: 

§ 347.50 Labeling of skin protectant drug 

products. 

* * * * * 

(a) Statement of identity. The labeling 

of the product contains the established 

name of the drug, if any, and identifies 

the product with one or more of the 

following: 

(1) For any product. ‘‘Skin protectant’’

(optional, may add dosage form, e.g., 

‘‘cream,’’ ‘‘gel,’’ ‘‘lotion,’’ or 

‘‘ointment’’). 

(2) For any product formulated as a 

lip protectant. ‘‘Skin protectant,’’ ‘‘lip 

protectant,’’ or ‘‘lip balm’’ (optional, 

may add dosage form, e.g., ‘‘cream,’’

‘‘gel,’’ ‘‘lotion,’’ or ‘‘ointment’’). 

(3) For products containing any 

ingredient in § 347.10(b), (c), (j), (s), (t), 

and (u). ‘‘Poison ivy, oak, sumac 

drying’’ (optional, may add dosage form, 

e.g., ‘‘cream,’’ ‘‘gel,’’ ‘‘lotion,’’ or 

‘‘ointment’’). 

(4) For products containing any 

ingredient in § 347.10(b), (c), (f), (j), (o), 

(s), (t), and (u). ‘‘Poison ivy, oak, sumac 

protectant.’’

* * * * * 

(e) Products formulated and labeled 

as a lip protectant and that meet the 

criteria established in § 201.66(d)(10) of 

this chapter. * * * 

(1) * * * 

(iii) The ‘‘external use only’’ warning 

in § 347.50(c)(1) and in § 201.66(c)(5)(i) 

of this chapter may be omitted. The 

warnings in § 347.50(c)(2), (c)(3), and 

(c)(4) are not required. 

* * * * * 

Dated: January 28, 2008. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E8–1818 Filed 1–31–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 522 

Implantation or Injectable Dosage 

Form New Animal Drugs; 

Tulathromycin 

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 new animal 

drug application (NADA) filed by Pfizer, 

Inc. The supplemental NADA provides 

for veterinarian prescription use of 

tulathromycin injectable solution for the 

treatment of infectious bovine 

keratoconjunctivitis and the addition of 

a pathogen to the indication for use for 

treatment of swine respiratory disease. 

DATES: This rule is effective February 1, 

2008. 

FOR FURTHER INFORMATION CONTACT: Joan 

C. Gotthardt, Center for Veterinary 

Medicine (HFV–130), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276–8342, email: joan.gotthardt@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Pfizer, 

Inc., 235 East 42d St., New York, NY 

10017, filed a supplement to NADA 

141–244 for DRAXXIN (tulathromycin) 


pwalker on PROD1PC71 with PROPOSALS
6018 Federal Register / Vol. 73, No. 22 / Friday, February 1, 2008 / Rules and Regulations 

Injectable Solution. The supplemental 

NADA provides for treatment of 

infectious bovine keratoconjunctivitis 

associated with Moraxella bovis and the 

addition of a pathogen, Mycoplasma 

hyopneumoniae, to the indication for 

use for treatment of swine respiratory 

disease. The application is approved as 

of December 28, 2007, and the 

regulations are amended in 21 CFR 

522.2630 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. 

Under section 512(c)(2)(F)(iii) of the 

Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 360b(c)(2)(F)(iii)), this 

supplemental approval qualifies for 3 

years of marketing exclusivity beginning 

on the date of approval. 

The agency has determined under 21 

CFR 25.33(a)(1) and (d)(5) 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 Part 522 

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 part 522 is 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 § 522.2630, revise paragraphs 

(d)(1)(ii) and (d)(2)(ii) to read as follows: 

§ 522.2630 Tulathromycin. 

* * * * * 

(d) * * * 

(1) * * * 

(ii) Indications for use. For the 

treatment of bovine respiratory disease 

(BRD) associated with Mannheimia 

haemolytica, Pasteurella multocida, and 

Histophilus somni (Haemophilus 

somnus), and Mycoplasma bovis; for the 

control of respiratory disease in cattle at 

high risk of developing BRD associated 

with M. haemolytica, P. multocida, H. 

somni, and M. bovis; and for the 

treatment of infectious bovine 

keratoconjunctivitis (IBK) associated 

with Moraxella bovis. 

* * * * * 

(2) * * * 

(ii) Indications for use. For the 

treatment of swine respiratory disease 

(SRD) associated with Actinobacillus 

pleuropneumoniae, Pasteurella 

multocida, Bordetella bronchiseptica, 

Haemophilus parasuis, and 

Mycoplasma hyopneumoniae. 

* * * * * 

Dated: January 24, 2008. 

Bernadette Dunham, 

Director, Center for Veterinary Medicine. 

[FR Doc. E8–1906 Filed 1–31–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 558 

New Animal Drugs For Use in Animal 

Feed; Zilpaterol 

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 new animal drug 

application (NADA) filed by Intervet, 

Inc. The NADA provides for use of 

zilpaterol, monensin, and tylosin in 

three-way combination Type B and 

Type C medicated feeds for cattle fed in 

confinement for slaughter. 

DATES: This rule is effective February 1, 

2008. 

FOR FURTHER INFORMATION CONTACT: 

Gerald L. Rushin, Center for Veterinary 

Medicine (HFV–126), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276–8103, email: gerald.rushin@cvm.fda.gov. 

SUPPLEMENTARY INFORMATION: Intervet, 

Inc., P.O. Box 318, 29160 Intervet Lane, 

Millsboro, DE 19966, filed NADA 141–

276 that provides for use of ZILMAX 

(zilpaterol hydrochloride), and 

RUMENSIN (monensin), and TYLAN 

(tylosin phosphate) Type A medicated 

articles to make dry and liquid threeway combination Type B and Type C 

medicated feeds used for increased rate 

of weight gain, improved feed 

efficiency, and increased carcass 

leanness; for prevention and control of 

coccidiosis due to Eimeria bovis and E. 

zuernii; and for reduction of incidence 

of liver abscesses caused by 

Fusobacterium necrophorum and 

Arcanobacterium (Actinomyces) 

pyogenes in cattle fed in confinement 

for slaughter during the last 20 to 40 

days on feed. The NADA is approved as 

of January 10, 2008, and the regulations 

in 21 CFR 558.355, 558.625, and 

558.665 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(a)(2) 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 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 part 558 is amended as follows: 

PART 558—NEW ANIMAL DRUGS FOR 

USE IN ANIMAL FEEDS 

■ 1. The authority citation for 21 CFR 

part 558 continues to read as follows: 

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

■ 2. In § 558.355, add paragraph 

(f)(7)(iv) to read as follows: 

§ 558.355 Monensin. 

* * * * * 

(f) * * * 

(7) * * * 


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