69438 Federal Register / Vol. 70, No. 220 / Wednesday, November 16, 2005 / Rules and Regulations 

III. Conclusion 

Based on all data relevant to vitamin 

D3 reviewed by the agency, FDA 

concludes that there is a reasonable 

certainty that no harm will result from 

the use of vitamin D3 as a nutrient 

supplement in cheese and cheese 

products, excluding cottage cheese, 

ricotta cheese, and hard grating cheeses, 

such as Parmesan and Romano as 

defined in §§ 133.165 and 133.183, 

respectively, and those defined by the 

standard of identity in § 133.148, at 

levels up to 81 IU/30 g of cheese. Thus, 

vitamin D3 is safe for the proposed use 

and the agency concludes that the food 

additive regulations should be amended 

as set forth in this document. To ensure 

that only food grade vitamin D3 is used 

in food, the additive must meet the 

specifications set forth in § 172.380. 

In accordance with § 171.1(h) (21 CFR 

171.1(h)), the petition and the 

documents that FDA considered and 

relied upon in reaching its decision to 

approve the petition are available for 

inspection at the Center for Food Safety 

and Applied Nutrition by appointment 

with the information contact person (see 

FOR FURTHER INFORMATION CONTACT). As 

provided in § 171.1(h), the agency will 

delete from the documents any 

materials that are not available for 

public disclosure before making the 

documents available for inspection. 

IV. Environmental Effects 

The agency has previously considered 

the environmental effects of this rule as 

announced in the notice of filing for 

FAP 4A4758. No new information or 

comments have been received that 

would affect the agency’s previous 

determination that there is no 

significant impact on the human 

environment and that an environmental 

impact statement is not required. 

V. Paperwork Reduction Act of 1995 

This final rule contains no collection 

of information. Therefore, clearance by 

the Office of Management and Budget 

under the Paperwork Reduction Act of 

1995 is not required. 

VI. Objections 

Any person who will be adversely 

affected by this regulation may file with 

the Division of Dockets Management 

(see ADDRESSES) written or electronic 

objections. Each objection shall be 

separately numbered, and each 

numbered objection shall specify with 

particularity the provisions of the 

regulation to which objection is made 

and the grounds for the objection. Each 

numbered objection on which a hearing 

is requested shall specifically so state. 

Failure to request a hearing for any 

particular objection shall constitute a 

waiver of the right to a hearing on that 

objection. Each numbered objection for 

which a hearing is requested shall 

include a detailed description and 

analysis of the specific factual 

information intended to be presented in 

support of the objection in the event 

that a hearing is held. Failure to include 

such a description and analysis for any 

particular objection shall constitute a 

waiver of the right to a hearing on the 

objection. For written objections, three 

copies of all documents shall be 

submitted and shall be identified with 

the docket number found in brackets in 

the heading of this document. Any 

objections received in response to the 

regulation may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

VII. Reference 

The following reference has been 

placed on display at the Division of 

Dockets Management (see ADDRESSES) 

and may be seen by interested persons 

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

through Friday. 

1. Memorandum from Folmer, Division of 

Petition Review, Chemistry Review Group, to 

Kidwell, Division of Petition Review, 

February 2, 2005. 

List of Subjects in 21 CFR Part 172 

Food additives, Reporting and 

recordkeeping requirements. 

■ Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR part 172 is 

amended as follows: 

PART 172—FOOD ADDITIVES 

PERMITTED FOR DIRECT ADDITION 

TO FOOD FOR HUMAN 

CONSUMPTION 

■ 1. The authority citation for 21 CFR 

part 172 continues to read as follows: 

Authority: 21 U.S.C. 321, 341, 342, 348, 

371, 379e. 

■ 2. Section 172.380 is amended by 

adding paragraph (c)(5) to read as 

follows: 

§ 172.380 Vitamin D3. 

* * * * * 

(c) * * * 

(5) At levels not to exceed 81 IU per 

30 grams in cheese and cheese products 

as defined under § 170.3(n)(5) of this 

chapter, excluding cottage cheese, 

ricotta cheese, and hard grating cheeses 

such as Parmesan and Romano as 

defined in §§ 133.165 and 133.183 of 

this chapter, and those defined by 

standard of identity in § 133.148 of this 

chapter. 

Dated: November 4, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–22670 Filed 11–15–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 520 

Oral Dosage Form New Animal Drugs; 

Tylosin 

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 

Elanco Animal Health. The 

supplemental NADA provides for use of 

tylosin soluble powder in honey bees 

for the control of American foulbrood 

(Paenibacillus larvae). 

DATES: This rule is effective November 

16, 2005. 

FOR FURTHER INFORMATION CONTACT: Joan 

C. Gotthardt, Center for Veterinary 

Medicine (HFV–130), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 301–827–7571, email: joan.gotthardt@fda.gov. 

SUPPLEMENTARY INFORMATION: Elanco 

Animal Health, A Division of Eli Lilly 

& Co., Lilly Corporate Center, 

Indianapolis, IN 46285, filed a 

supplement to NADA 13 076 that 

provides for the use of TYLAN (tylosin 

tartrate) Soluble in honey bees for the 

control of American foulbrood 

(Paenibacillus larvae). The approval of 

this supplemental NADA relied on 

publicly available safety and 

effectiveness data contained in Public 

Master File (PMF) 5783 which were 

compiled under National Research 

Support Project 7 (NRSP 7), a national 

agricultural research program for 

obtaining clearances for use of new 

drugs in minor animal species and for 

special uses. The supplemental NADA 

is approved as of October 17, 2005, and 

the regulations in 21 CFR 520.2640 are 

amended to reflect the approval. The 

basis of approval is discussed in the 

freedom of information summary. 

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 

Federal Register / Vol. 70, No. 220 / Wednesday, November 16, 2005 / Rules and Regulations 69439 

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 carefully considered 

the potential environmental impact of 

this action and has concluded that the 

action will not have a significant impact 

on the human environment and that an 

environmental impact statement is not 

required. FDA’s finding of no significant 

impact and the evidence supporting that 

finding, contained in an environmental 

assessment, may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

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 520 

Animal drugs. 

■ 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 520 is 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. 

■ 2. In § 520.2640, revise paragraph (e) 

introductory text, and add paragraph 

(e)(4) to read as follows: 

§ 520.2640 Tylosin. 

* * * * * 

(e) Conditions of use—

* * * * * 

(4) Honey bees—(i) Amount. Mix 200 

milligrams tylosin in 20 grams 

confectioners’/powdered sugar. Use 

immediately. Apply (dust) this mixture 

over the top bars of the brood chamber 

once weekly for 3 weeks. 

(ii) Indications for use. For the control 

of American foulbrood (Paenibacillus 

larvae). 

(iii) Limitations. The drug should be 

fed early in the spring or fall and 

consumed by the bees before the main 

honey flow begins, to avoid 

contamination of production honey. 

Complete treatments at least 4 weeks 

before main honey flow. 

Dated: November 3, 2005. 

Stephen F. Sundlof, 

Director, Center for Veterinary Medicine. 

[FR Doc. 05–22752 Filed 11–15–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 117 

[CGD01–05–100] 

Drawbridge Operation Regulations: 

Connecticut River, CT 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of temporary deviation 

from regulations. 

SUMMARY: The Commander, First Coast 

Guard District, has issued a temporary 

deviation from the drawbridge operation 

regulations for the Amtrak Old 

Saybrook-Old Lyme Bridge, mile 3.4, 

across the Connecticut River, 

Connecticut. This deviation from the 

regulations allows the bridge to operate 

on a fixed schedule for bridge openings 

from November 21, 2005 through 

December 22, 2005. This deviation is 

necessary in order to facilitate necessary 

scheduled bridge maintenance. 

DATES: This deviation is effective from 

November 21, 2005 through December 

22, 2005. 

FOR FURTHER INFORMATION CONTACT: Judy 

Leung-Yee, Project Officer, First Coast 

Guard District, at (212) 668–7195. 

SUPPLEMENTARY INFORMATION: The Old 

Saybrook-Old Lyme Bridge, at mile 3.4, 

across the Connecticut River has a 

vertical clearance in the closed position 

of 19 feet at mean high water and 22 feet 

at mean low water. The existing 

drawbridge operating regulations are 

listed at 33 CFR 117.205(b). 

The owner of the bridge, National 

Railroad Passenger Corporation 

(Amtrak), requested a temporary 

deviation from the drawbridge operating 

regulations to facilitate scheduled 

electrical bridge repairs. In order to 

complete the above repairs the bridge 

must open on a fixed bridge opening 

schedule. 

This deviation to the operating 

regulations allows the Old SaybrookOld Lyme Bridge to operate from 

November 21, 2005 through December 

22, 2005, as follows: 

From Monday through Friday, the 

bridge shall open on signal at 8:15 a.m., 

12:15 p.m., and 2:15 p.m., daily. From 

4 p.m. through 8 a.m. the bridge shall 

open on signal after a four-hour advance 

notice is given by calling the number 

posted at the bridge. 

On Saturday and Sunday, the bridge 

shall open on signal at 8 a.m., 10 a.m., 

1 p.m., and 4 p.m., daily. From 4 p.m. 

through 8 a.m. the bridge shall open on 

signal after a four-hour advance notice 

is given by calling the number posted at 

the bridge. 

The bridge shall open on signal for 

commercial vessels at any time after a 

four-hour advance notice is given by 

calling the number posted at the bridge. 

In accordance with 33 CFR 117.35(c), 

this work will be performed with all due 

speed in order to return the bridge to 

normal operation as soon as possible. 

This deviation from the operating 

regulations is authorized under 33 CFR 

117.35. 

Dated: November 4, 2005. 

Gary Kassof, 

Bridge Program Manager, First Coast Guard 

District. 

[FR Doc. 05–22647 Filed 11–15–05; 8:45 am] 

BILLING CODE 4910–15–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 117 

[CGD08–05–052] 

Drawbridge Operation Regulations; 

Berwick Bay, Morgan City, LA 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of temporary deviation 

from regulations. 

SUMMARY: The Commander, Eighth 

Coast Guard District, has issued a 

temporary deviation from the regulation 

governing the operation of the 

Burlington Northern Railway Vertical 

Lift Span Railroad Bridge across 

Berwick Bay, mile 17.5 [Gulf 

Intracoastal Waterway (Morgan City to 

Port Allen Alternate Route), mile 0.4], at 

Morgan City, St. Mary Parish, Louisiana. 

This deviation provides for two (2) fourhour bridge closures to conduct 

scheduled maintenance to the railroad 

on the drawbridge. 

DATES: This deviation is effective from 

8 a.m. on Tuesday, November 29, 2005 

until noon on Wednesday, November 

30, 2005. 

ADDRESSES: Materials referred to in this 

document are available for inspection or 

copying at the office of the Eighth Coast 

Guard District, Bridge Administration 

Branch, Hale Boggs Federal Building, 

room 1313, 500 Poydras Street, New 

Orleans, Louisiana 70130–3310 between