Federal Register / Vol. 70, No. 220 / Wednesday, November 16, 2005 / Rules and Regulations 69435 

■ 10. In Supplement No. 1 to part 774 

(the Commerce Control List), Category 

3—Electronics, Export Control 

Classification Number (ECCN) 3A992 is 

amended by revising the License 

Requirements section to read as follows: 

3A992 General purpose electronic 

equipment not controlled by 3A002. 

License Requirements 

Reason for Control: AT. 

Control(s) Country chart 

AT applies to entire entry ...... AT Column 1. 

See §§ 740.19 and 742.20 of the EAR for 

additional information on Libya. 

* * * * * 

■ 11. In Supplement No. 1 to part 774 

(the Commerce Control List), Category 

3—Electronics, Export Control 

Classification Number (ECCN) 3B992 is 

amended by revising the License 

Requirements section to read as follows: 

3B992 Equipment not controlled by 3B002 

for the inspection or testing of Electronic 

components and materials, and specially 

designed components and accessories 

therefor. 

License Requirements 

Reason for Control: AT. 

Control(s) Country chart 

AT applies to entire entry ...... AT Column 1. 

See §§ 740.19 and 742.20 of the EAR for 

additional information on Libya. 

* * * * * 

■ 12. In Supplement No. 1 to part 774 

(the Commerce Control List), Category 

4—Computers, Export Control 

Classification Number (ECCN) 4A994 is 

amended by revising the License 

Requirements section to read as follows: 

4A994 Computers, ‘‘electronic assemblies’’, 

and related equipment not controlled by 

4A001 or 4A003, and specially designed 

components therefor. 

License Requirements 

Reason for Control: AT. 

Control(s) Country chart 

AT applies to entire entry ...... AT Column 1. 

See §§ 740.19 and 742.20 of the EAR for 

additional information on Libya. 

* * * * * 

■ 13. In Supplement No. 1 to part 774 

(the Commerce Control List), Category 

5—Telecommunications and 

Information Security’’—

Telecommunications, Export Control 

Classification Number (ECCN) 5A991 is 

amended by revising the License 

Requirements section to read as follows: 

5A991 Telecommunication equipment, not 

controlled by 5A001. 

License Requirements 

Reason for Control: AT. 

Control(s) Country chart 

AT applies to entire entry ...... AT Column 1. 

See §§ 740.19 and 742.20 of the EAR for 

additional information on Libya. 

* * * * * 

■ 14. In Supplement No. 1 to part 774 

(the Commerce Control List), Category 

5—Telecommunications and 

‘‘Information Security’’—Information 

Security, Export Control Classification 

Number (ECCN) 5A992 is amended by 

revising the License Requirements 

section to read as follows: 

5A992 Equipment not controlled by 5A002. 

License Requirements 

Reason for Control: AT. 

Control(s) Country chart 

AT applies to 5A992.a .......... AT Column 1. 

AT applies to 5A992.b .......... AT Column 2. 

See §§ 740.19 and 742.20 of the EAR for 

additional information on Libya. 

* * * * * 

■ 15. In Supplement No. 1 to part 774 

(the Commerce Control List), Category 

5—Telecommunications and 

‘‘Information Security’’—Information 

Security, Export Control Classification 

Number (ECCN) 5D992 is amended by 

revising the License Requirements 

section to read as follows: 

5D992 ‘‘Information Security’’ ‘‘software’’

not controlled by 5D002. 

License Requirements 

Reason for Control: AT. 

Control(s) Country chart 

AT applies to 5D992.a.1 and 

.b.1.

AT Column 1. 

AT applies to 5D992.a.2, b.2 

and c.

AT Column 2. 

See §§ 740.19 and 742.20 of the EAR for 

additional information on Libya. 

* * * * * 

■ 16. In Supplement No. 1 to part 774 

(the Commerce Control List), Category 

9—Propulsion Systems, Space Vehicles 

and Related Equipment, Export Control 

Classification Number (ECCN) 9A990 is 

amended by revising the License 

Requirements section to read as follows: 

9A990 Diesel engines, n.e.s., and tractors 

and specially designed parts therefor, n.e.s. 

License Requirements 

Reason for Control: AT. 

Control(s) Country chart 

AT applies to entire entry except 9A990.a.AT Column 1. 

AT applies to 9A990.a only ... AT Column 2. 

See §§ 740.19 and 742.20 of the EAR for 

additional information on Libya. 

* * * * * 

Dated: November 9, 2005. 

Matthew S. Borman, 

Deputy Assistant Secretary for Export 

Administration. 

[FR Doc. 05–22674 Filed 11–15–05; 8:45 am] 

BILLING CODE 3510–33–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 172 

[Docket No. 2004F–0374] 

Food Additives Permitted for Direct 

Addition to Food for Human 

Consumption; Vitamin D3

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

food additive regulations to provide for 

the safe use of vitamin D3 as a nutrient 

supplement in cheese and cheese 

products at a level above that currently 

allowed by the regulations. This action 

is in response to a petition filed by Kraft 

Foods Global, Inc. (Kraft). 

DATES: This rule is effective November 

16, 2005. Submit written or electronic 

objections and requests for a hearing by 

December 16, 2005. See Section VI of 

this document for information on the 

filing of objections. 

ADDRESSES: You may submit written 

objections and requests for a hearing, 

identified by Docket No. 2004F–0374, 

by any of the following methods: 

Electronic Submissions 

Submit electronic objections in the 

following ways: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. 

Follow the instructions for submitting 

comments. 

• Agency Web site: http:// 

www.fda.gov/dockets/ecomments. 

Written Submissions 

Submit written submissions in the 

following ways: 

• FAX: 301–827–6870. 

• Mail/Hand delivery/Courier [For 

paper, disk, or CD–ROM submissions]: 

69436 Federal Register / Vol. 70, No. 220 / Wednesday, November 16, 2005 / Rules and Regulations 

1Vitamin D comprises a group of fat-souble secosterols and comes in many forms. The two major 

physiologically relevant forms are vitamin D2 and 

vitamin D3. Vitamin D without a subscript 

represents either D2 or D3. As used in § 184.1950, 

the meaning of the term vitamin D includes 

crystalline vitamin D2, crystalline vitamin D3, 

vitamin D2 resin, and vitamin D3 resin. Section 

172.380 includes only crystalline vitamin D3. 

Division of Dockets Management (HFA–

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

To ensure more timely processing of 

objections, FDA is no longer accepting 

objections submitted to the agency by email. FDA encourages you to continue 

to submit electronic objections by using 

the Federal eRulemaking Portal or the 

agency Web site, as described in the 

Electronic Submissions portion of this 

paragraph. 

Instructions: All submissions received 

must include the agency name and 

docket number for this rulemaking. All 

objections received will be posted 

without change to http://www.fda.gov/ 

ohrms/dockets/default.htm, including 

any personal information provided. For 

detailed instructions on submitting 

objections, see the ‘‘Objections’’ heading 

of the SUPPLEMENTARY INFORMATION

section of this document. 

Docket: For access to the docket to 

read background documents or 

objections received, go to http:// 

www.fda.gov/ohrms/dockets/ 

default.htm 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: 

Judith L. Kidwell, Center for Food 

Safety and Applied Nutrition (HFS–

265), Food and Drug Administration, 

5100 Paint Branch Pkwy., College Park, 

MD 20740, 301–436–1071. 

SUPPLEMENTARY INFORMATION: 

I. Introduction 

In a notice published in the Federal 

Register of September 9, 2004 (69 FR 

54687), FDA announced that a food 

additive petition (FAP 4A4758) had 

been filed by Kraft Foods Global, Inc., 

c/o Hogan and Hartson, 555 13th St. 

NW., Washington, DC 20004. The 

petition proposed to amend the food 

additive regulations in § 172.380 

Vitamin D3 (21 CFR 172.380) to permit 

the use of vitamin D3 in cheese and 

cheese products at a level above that 

permitted in § 184.1950 Vitamin D (21 

CFR 184.1950). Currently, under 

§ 184.1950, milk products, which 

include cheese and cheese products, 

may be fortified with vitamin D at a 

level up to 89 International Units (IU) 

per (/) 100 grams (g). The petitioner 

requested that the maximum amount of 

vitamin D permitted in certain natural 

and processed cheeses be increased to 

81 IU vitamin D3/30 g. Cheese and 

cheese products identified in the 

petition for increased fortification levels 

are those with a reference amount 

customarily consumed (RACC) of 30 g 

as defined in § 101.12 (21 CFR 101.12), 

including standardized and 

nonstandardized natural cheese, 

processed cheese, cream cheese, and 

cheese spreads and dips. Hard grating 

cheeses with smaller reference amounts, 

such as Parmesan and Romano as 

defined in §§ 133.165 and 133.183 (21 

CFR 133.165 and 133.183), respectively, 

and those defined by the standards of 

identity in § 133.148 (21 CFR 133.148), 

are not included, nor are cheeses with 

larger reference amounts, such as 

cottage cheese or ricotta cheese. Cheeselike products made from nondairy 

starting materials (e.g., soy-based 

products) are not considered to be 

cheese and are not included. The new 

limit would permit vitamin D to be 

added to cheese and cheese products at 

a level slightly more than 20 percent of 

the reference daily intake (RDI) of 

vitamin D/30 g serving. Under § 101.54 

(21 CFR 101.54), food containing 10 to 

19 percent of the RDI of a nutrient is 

allowed to carry a label claim such as 

‘‘good source’’ and if the level is 20 

percent or more of the RDI, the food 

label may claim ‘‘excellent source.’’

Under § 172.380, vitamin D3 is 

approved for use as a nutrient 

supplement in calcium-fortified fruit 

juices, calcium-fortified fruit juice 

drinks, meal replacement and other-type 

bars, and soy-protein based meal 

replacement beverages represented for 

special dietary use in reducing or 

maintaining body weight. Vitamin D 1, 

including vitamin D3, also is affirmed as 

generally recognized as safe (GRAS) for 

use in food under § 184.1950 with the 

following limitations: 

Category of Food Maximum Levels in 

Food (as served) 

Breakfast cereals 350 IU/100 g 

Grain products and 

pasta 

90 IU/100 g 

Milk 42 IU/100 g 

Milk products 89 IU/100 g 

Additionally, under § 184.1950(c)(2) 

and (c)(3) vitamin D is affirmed as 

GRAS for use in infant formula and 

margarine, respectively. 

Vitamin D3, also known as 

cholecalciferol, is the chemical 9,10- 

seco(5Z,7E)-5,7,10(19)-cholestatrien-3- 

ol. Humans synthesize vitamin D3 in 

skin from its precursor, 7–

dehydrocholesterol under exposure to 

ultraviolet B radiation in sunlight. Other 

sources of naturally occurring vitamin D 

are foods such as butter, buttermilk, 

cheese, cream, eggs, fish, goat milk, 

meat fats and organ meats, and 

mushrooms. 

Vitamin D is essential for human 

health. The major function of vitamin D 

is to maintain blood serum 

concentrations of calcium and 

phosphorus by enhancing the 

absorption of these minerals from the 

small intestine. Vitamin D deficiency 

can lead to abnormalities in calcium 

and bone metabolism such as rickets in 

children or osteomalacia in adults. At 

high levels vitamin D may be toxic. 

Excessive intake of vitamin D elevates 

blood plasma calcium levels by 

increased intestinal absorption and/or 

mobilization from the bone. 

To ensure that vitamin D is not added 

to the U.S. food supply at levels that 

could raise safety concerns, FDA 

affirmed vitamin D as GRAS with 

specific limitations, as listed in 

§ 184.1950. Under 21 CFR 184.1(b)(2), 

an ingredient affirmed as GRAS with 

specific limitations may be used in food 

only within such limitations, including 

the category of food, functional use, and 

level of use. Any addition of vitamin D 

to food beyond those limitations set out 

in § 184.1950 requires either a food 

additive regulation or an amendment of 

§ 184.1950. 

To support the safety of the proposed 

uses of vitamin D3, Kraft submitted 

dietary intake estimates from current 

and proposed uses and from naturallyoccurring sources of vitamin D and 

compared these intake estimates to the 

tolerable upper intake level (UL) for 

vitamin D established by the Institute of 

Medicine (IOM) of the National 

Academies. Kraft also submitted a 

number of publications pertaining to 

human clinical studies on vitamin D. 

Based on this information, which is 

discussed in section II of this document, 

the petitioner concluded that the 

proposed use of vitamin D3 in cheese 

and cheese products is safe. 

II. Evaluation of Safety 

To establish with reasonable certainty 

that a food additive is not harmful 

under its intended conditions of use, 

FDA considers the projected human 

dietary intake of the additive, the 

additive’s toxicological data, and other 

Federal Register / Vol. 70, No. 220 / Wednesday, November 16, 2005 / Rules and Regulations 69437 

2The intake estimate included Parmesan cheese; 

however, fortification of hard grating cheeses such 

as Parmesan was not requested. 

3 ‘‘Prevention of Rickets and Vitamin D 

Deficiency: New Guidelines for Vitamin D Intake,’’

from the American Academy of Pediatrics in: 

Pediatrics Vol. III No. 4, pp. 908–910, April 2003. 

The AAP recommends a daily vitamin D 

supplement of 200 IU for the following groups: 

• All breast-fed infants unless they are weaned to 

at least 500 milliliter (mL)/d of vitamin D-fortified 

formula or milk. 

• All nonbreast-fed infants who are ingesting less 

than 500 mL/d of vitamin D-fortified formula or 

milk. 

• Children and adolescents who do not get regular 

sunlight exposure, do not ingest at least 500 mL/ 

d of vitamin D-fortified milk, or do not take a daily 

multivitamin supplement containing at least 200 IU 

of vitamin D. 

relevant information (such as published 

literature) available to the agency. FDA 

compares an individual’s estimated 

daily intake (EDI) of the additive from 

all sources to an acceptable intake level 

established by toxicological data. The 

EDI is determined by projections based 

on the amount of the additive proposed 

for use in particular foods and on data 

regarding the amount consumed from 

all sources of the additive. The agency 

commonly uses the EDI for the 90th

percentile consumer of a food additive 

as a measure of high chronic dietary 

intake. 

A. Estimated Daily Intake for Vitamin D 

The petitioner provided mean and 

90th percentile vitamin D intake 

estimates for consumers of cheese and 

cheese products from the following: (1) 

The proposed food uses; (2) current 

regulated food uses (including naturally 

occurring sources of vitamin D); and (3) 

dietary supplements.2 Intake estimates 

for the U.S. population 2 years of age 

and older were provided, as well as 

estimates for 18 population subgroups, 

including breast-fed and nonbreast-fed 

infants 0 to 11 months of age. The 

agency agrees with the methodology 

used to calculate these estimates, with 

the exception of intake estimates from 

dietary supplements for infants 0 to 11 

months of age. 

For consumers 2 years of age and 

older, Kraft estimated mean and 90th

percentile dietary intakes from current 

(including naturally occurring sources) 

and proposed food uses of vitamin D to 

be 335 IU per person per day (IU/p/d) 

and 582 IU/p/d, respectively. For breastfed infants 0 to 11 months of age, mean 

and 90th percentile intakes were 

estimated to be 180 IU/p/d and 322 IU/ 

p/d, respectively. For nonbreast-fed 

infants 0 to 11 months of age, mean and 

90th percentile intakes were estimated to 

be 443 IU/p/d and 696 IU/p/d, 

respectively. For children 1 to 3 years of 

age, mean and 90th percentile intake 

estimates were 383 IU/p/d and 583 IU/ 

p/d, respectively. 

The petitioner also considered the 

intake of vitamin D from dietary 

supplements. The National Health and 

Nutrition Examination Survey III 

(NHANES III) data indicate that 

approximately 33 percent of the U.S. 

population 2 years of age and older take 

dietary supplements. The NHANES III 

data also show that, when vitamin D is 

taken as a dietary supplement, the most 

frequent level is 400 IU/p/d. As a 

conservative estimate of intake of 

vitamin D from dietary supplements and 

conventional food, Kraft considered it 

appropriate to assume that consumers of 

cheese and cheese products who take 

dietary supplements likely would take 

dietary supplements containing 400 IU 

of vitamin D. They then added this 

value to the mean and 90th percentile 

intake estimates from current and 

proposed food uses for consumers 2 

years of age and older. For consumers of 

cheese and cheese products, mean and 

90th percentile dietary intakes from 

current and proposed food uses and 

dietary supplements were estimated to 

be 735 IU/p/d and 982 IU/p/d, 

respectively, for consumers 2 years of 

age and older. Kraft chose not to add a 

value of 400 IU from supplement use to 

intake estimates for infants 0 to 11 

months of age due to the low percentage 

of infants reported to use supplements 

(7 percent) in the NHANES III study. 

While we do not agree with Kraft’s 

choice to exclude supplement use in the 

vitamin D intake for infants, we believe 

that, in light of recent recommendations 

from the American Academy of 

Pediatrics (AAP),3 estimating a 

supplement intake of 200 IU/p/d is 

more appropriate than 400 IU/p/d for 

infants. 

Based on AAP recommendations, the 

agency assumed a vitamin D intake of 

200 IU from supplement use for infants 

0 to 11 months of age, resulting in 

exposure estimates at the 90th 

percentile of 522 IU/p/d and 896 IU/p/ 

d for breast-fed and nonbreast-fed 

infants, respectively. For all other 

populations (including children and 

adolescents) we assumed a supplement 

intake of 400 IU/p/d (Ref. 1). 

B. Acceptable Daily Intake for Vitamin 

D 

In 1997, the Standing Committee on 

the Scientific Evaluation of Dietary 

Reference Intakes of the Food and 

Nutrition Board at IOM conducted an 

extensive review of toxicology and 

metabolism studies on vitamin D 

published through 1996. The IOM 

published a detailed report that 

included a UL for vitamin D for infants, 

children, and adults. The IOM UL for 

vitamin D for children 1 to 18 years of 

age and adults is 2,000 IU/p/d. The UL 

for infants less than 1 year of age is 

1,000 IU/p/d. 

The IOM considers the UL as the 

highest daily intake level of a nutrient 

that is unlikely to pose a risk of adverse 

effects when the nutrient is consumed 

over long periods of time. The UL is 

determined using a risk assessment 

model developed specifically for 

nutrients and considers intake from all 

sources: Food, water, nutrient 

supplements, and pharmacological 

agents. The dose-response assessment, 

which concludes with an estimate of the 

UL, is built upon three toxicological 

concepts commonly used in assessing 

the risk of exposures to chemical 

substances: No-observed-adverse-effect 

level, lowest-observed-effect level, and 

an uncertainty factor. 

C. Safety Assessment 

To support the safety of their 

proposed uses for vitamin D3, Kraft 

submitted scientific articles published 

subsequent to the IOM report and 

issuance of the February 2003 final rule 

for the use of vitamin D3 in calciumfortified fruit juices and fruit juice 

drinks (68 FR 9000, February 27, 2003), 

including 12 clinical studies in humans 

in which subjects received both vitamin 

D and calcium supplementation for 

periods of up to 3 years. Kraft 

concluded that the recent publications 

continue to support the safe use of 

vitamin D supplementation in both 

animals and humans. FDA concurs with 

Kraft’s conclusions. 

FDA considered the UL established by 

IOM for infants, children, and adults 

relative to the intake estimates provided 

by the petitioner as the primary basis for 

assessing the safety of the proposed use 

of vitamin D3 in cheese and cheese 

products. For all children and adults 2 

years of age and older, mean and 90th 

percentile intake estimates from current 

and proposed food uses of vitamin D are 

well below the IOM UL of 2,000 IU/p/ 

d. For infants 0 to 11 months of age, 

mean and 90th percentile intakes are 

below the UL of 1000 IU/p/d. 

Additionally, when dietary supplements 

are included in the calculations, intake 

estimates remain below the UL. Because 

the EDI of vitamin D from all sources is 

less than the UL, the agency concludes 

that dietary exposure of vitamin D3 from 

its proposed use as a nutrient 

supplement in cheese and cheese 

products will not pose a safety concern. 

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