Federal Register / Vol. 72, No. 81 / Friday April 27, 2007 / Notices 21031 

Applied Nutrition (HFS–820), Food and 

Drug Administration, 5100 Paint Branch 

Pkwy., College Park, MD 20740, 301–

436–2371. 

SUPPLEMENTARY INFORMATION: In 

accordance with 21 CFR 130.17 

concerning temporary permits to 

facilitate market testing of foods 

deviating from the requirements of the 

standards of identity issued under 

section 401 of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 341), FDA 

is giving notice that a temporary permit 

has been issued to Peter Pan Seafoods, 

Inc., 2200 Sixth Ave., suite 1000, 

Seattle, WA 98121. 

The permit covers limited interstate 

marketing tests of products identified as 

(1) Deming’s ‘‘Skinless & Boneless Pink 

Salmon’’ and ‘‘Skinless & Boneless Red 

Sockeye Salmon’’ and (2) Double‘‘Q’’

‘‘Skinless & Boneless Pink Salmon’’ and 

‘‘Skinless & Boneless Red Sockeye 

Salmon.’’ These canned salmon 

products may deviate from the U.S. 

standard of identity for canned Pacific 

salmon (21 CFR 161.170) in that the 

products are prepared by removing the 

skin and bones of the salmon used and, 

therefore, in lieu of the optional forms 

of pack provided in 21 CFR 

161.170(a)(3), this temporary marketing 

permit provides for an alternate 

‘‘skinless and boneless’’ form of pack. 

The test product meets all the 

requirements of the standard with the 

exception of the ‘‘skinless and boneless’’

form of pack. The purpose of the 

temporary permit is to allow the 

applicant to measure consumer 

acceptance of the product, identify mass 

production problems, and assess 

commercial feasibility. 

This permit provides for the 

temporary marketing of not more than 

1.13 million pounds (or 513 thousand 

kilograms) of the test product annually. 

The test products will be manufactured 

by Peter Pan Seafoods, Inc., at its Valdez 

Facility, P.O. Box 1027, Valdez, AK 

99686–1027 and Dillingham Facility, 

P.O. Box 410, Dillingham, AK 99576. 

The test products will be distributed by 

Peter Pan Seafoods, Inc., throughout the 

United States except Alaska. The 

information panel of the labels will bear 

nutrition labeling in accordance with 21 

CFR 101.9. Each of the ingredients used 

in the food must be declared on the 

labels as required by the applicable 

sections of 21 CFR part 101. This permit 

is effective for 15 months, beginning on 

the date the permit holder introduces or 

causes the introduction of the product 

into interstate commerce, but not later 

than July 27, 2007. 

Dated: April 20, 2007. 

Barbara Schneeman, 

Director, Office of Nutritional Products, 

Labeling and Dietary Supplements, Center for 

Food Safety and Applied Nutrition. 

[FR Doc. E7–8039 Filed 4–27–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2007P–0150] 

Iceberg Water Deviating From Identity 

Standard; Temporary Permit for Market 

Testing 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a temporary permit has been issued 

to Canada Ice Enterprises, Inc., to 

market a product designated as ‘‘80 

degrees north Iceberg Water’’ that 

deviates from the U.S. standard of 

identity for bottled water. The purpose 

of the temporary permit is to allow the 

applicant to measure consumer 

acceptance of the product, identify mass 

production problems, and assess 

commercial feasibility. 

DATES: This permit is effective for 15 

months, beginning on the date the 

permit holder introduces or causes the 

introduction of the test product into 

interstate commerce, but not later than 

July 27, 2007. 

FOR FURTHER INFORMATION CONTACT: 

Loretta A. Carey, Center for Food Safety 

and Applied Nutrition (HFS–820), Food 

and Drug Administration, 5100 Paint 

Branch Pkwy., College Park, MD 20740, 

301–436–2371. 

SUPPLEMENTARY INFORMATION: In 

accordance with 21 CFR 130.17 

concerning temporary permits to 

facilitate market testing of foods 

deviating from the requirements of the 

standards of identity issued under 

section 401 of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 341), FDA 

is giving notice that a temporary permit 

has been issued to Canada Ice 

Enterprises, Inc., P.O. Box 722, St. 

Anthony, NL A0K 4S0. 

This permit covers limited interstate 

marketing tests of products identified as 

‘‘80 degrees north Iceberg Water’’ that 

deviate from the U.S. standard of 

identity for bottled water (§ 165.110 (21 

CFR 165.110)) in that the source of the 

water is an iceberg. The test product 

meets all the requirements of the 

standard with the exception of the 

source definition. The purpose of this 

permit is to allow the applicant to 

measure consumer acceptance of the 

product, identify mass production 

problems, and assess commercial 

feasibility. 

This permit provides for the 

temporary marketing of 500,000 cases of 

24 x 500 milliliter bottles and 500,000 

cases of 12 x 1 liter bottles, totaling 1 

million cases per year. The total fluid 

quantity covered by this application is 

12 million liters (3,170,065 gallons). The 

test product will be manufactured for 

Canada Ice Enterprises, Inc., 10 

Cremilliare Rd., St. Anthony, NL 

Canada A0K 4S0. Canada Ice 

Enterprises, Inc., will distribute the test 

products throughout the United States. 

The information panel of the labels 

must bear nutrition labeling in 

accordance with 21 CFR 101.9. The 

bottled water must be manufactured in 

accordance with the quality standards 

in § 165.110(b) and the requirements for 

processing and bottling of bottled 

drinking water in 21 CFR part 129. This 

permit is effective for 15 months, 

beginning on the date the food is 

introduced or caused to be introduced 

into interstate commerce, but not later 

than (see DATES). 

Dated: April 20, 2007. 

Barbara Schneeman, 

Director, Office of Nutritional Products, 

Labeling and Dietary Supplements, Center for 

Food Safety and Applied Nutrition. 

[FR Doc. E7–8040 Filed 4–26–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2007N–0068] 

Medical Device User Fee and 

Modernization Act; Public Meeting; 

Correction 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; correction. 

SUMMARY: The Food and Drug 

Administration is correcting a notice 

that appeared in the Federal Register of 

April 18, 2007 (72 FR 19528). The 

document announced a public meeting 

on April 30, 2007, to discuss the 

agency’s proposed recommendations for 

the reauthorization of the Medical 

Device User Fee and Modernization Act 

of 2002 (MUDFMA I) for fiscal years 

2008 through 2012, as well as other 

proposals to improve the review of 

medical devices and the third party 


cprice-sewell on PROD1PC66 with NOTICES
21032 Federal Register / Vol. 72, No. 81 / Friday April 27, 2007 / Notices 

inspection program. The correction is 

being made to reflect a change in 

location for the April 30, 2007, meeting. 

The location of the meeting is being 

changed because of water damage in the 

original meeting location. 

FOR FURTHER INFORMATION CONTACT: For 

information regarding this notice and 

the original notice, contact: Erik Mettler, 

Office of Policy and Planning, Food and 

Drug Administration (HF–11), 5600 

Fishers Lane, Rockville, MD 20857, 

301–827–3360, FAX 301–594–6777, 

email: Erik.Mettler@fda.hhs.gov. For 

information regarding registration, 

contact: Cynthia Garris, Office of 

Communication, Education, and 

Radiation Programs, Center for Devices 

and Radiological Health, Food and Drug 

Administration (HFZ–220), 1350 

Piccard Ave., Rockville, MD 20850, 

240–276–3150 ext. 121, FAX: 240–276–

3151, email: cynthia.garris@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In FR Doc. 

07–1919, appearing on page 19528 in 

the Federal Register of Wednesday, 

April 18, 2007, the following correction 

is made: 

1. On page 19528, in the third 

column, the first sentence under 

‘‘ADDRESSES’’ is corrected to read ‘‘The 

public meeting will be held at the Food 

and Drug Administration, White Oak 

site, at 10903 New Hampshire Ave., 

Silver Spring, MD 20993, Bldg. 2, rm. 

2031.’’

Dated: April 23, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 07–2085 Filed 4–24–07; 3:18 pm] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2006D–0441] 

Guidance for Industry: Protocols for 

the Conduct of Method Transfer 

Studies for Type C Medicated Feed 

Assay Methods; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the guidance for industry 

(#136) entitled ‘‘Guidance for Industry: 

Protocols for the Conduct of Method 

Transfer Studies for Type C Medicated 

Feed Assay Methods.’’ This guidance 

provides our recommendations for 

protocols for conducting the transfer 

study of a single-laboratory validated 

Type C medicated feed assay method to 

laboratories that have no experience 

with the test method. 

DATES: Submit written or electronic 

comments on agency guidances at any 

time. 

ADDRESSES: Submit written requests for 

single copies of the guidance document 

to the Communications Staff (HFV–12), 

Center for Veterinary Medicine (CVM), 

Food and Drug Administration, 7519 

Standish Pl., Rockville, MD 20855. Send 

one self-addressed adhesive label to 

assist that office in processing your 

requests. 

Submit written comments to the 

Division of Dockets Management (HFA–

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. Submit electronic comments 

on the guidance document to http:// 

www.fda.gov/dockets/ecomments. 

Comments should be identified with the 

full title of the guidance and the docket 

number found in brackets in the 

heading of this document. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Rebecca L. Owen, Center for Veterinary 

Medicine (HFV–141), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276–9842, email: rebecca.owen@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of November 

14, 2006 (71 FR 66335), FDA published 

a notice of availability for a draft 

guidance entitled ‘‘Guidance for 

Industry: Protocols for the Conduct of 

Method Transfer Studies for Type C 

Medicated Feed Assay Methods’’ giving 

interested persons until January 29, 

2007, to comment on the draft guidance. 

No comments were received. Therefore, 

the final guidance has not been 

substantively changed from the draft 

version. 

Section 512(b) of the Federal Food, 

Drug, and Cosmetic Act (the act) (21 

U.S.C. 360b) establishes the 

requirements for a new animal drug 

approval. FDA regulations specify the 

information you (the sponsor) must 

submit as part of your new animal drug 

application (NADA) and the proper 

format for the NADA submission 

(§ 514.1 (21 CFR 514.1)). As part of your 

NADA submission, you must describe 

analytical procedures capable of 

determining the active component(s) of 

the new animal drug within a 

reasonable degree of accuracy and of 

assuring the identity of such 

components (21 CFR 514.1(b)(5)(vii)). 

This includes a description of 

practicable methods of analysis (assay 

methods) that have adequate sensitivity 

to determine the amount of the new 

animal drug in the final dosage form (21 

CFR 514.1(b)(5)(vii)(a)). In the case of a 

Type A medicated article, the Type C 

medicated feed is a final dosage form 

used to treat the animal. Thus, as part 

of the NADA review process, FDA looks 

at assay methods for determining the 

amount of a new animal drug in Type 

C medicated feed. 

This guidance provides 

recommendations for protocols for 

conducting the transfer study of a 

single-laboratory validated Type C 

medicated feed assay method to 

laboratories that have no experience 

with the test method. Many testing 

laboratories, including state feed 

laboratories and contract laboratories, 

use Type C medicated feed assay 

methods to determine whether the drug 

in a medicated feed is within the assay 

limits. The term ‘‘assay limits’’ refers to 

the amount of the drug detected when 

a Type B/C feed is assayed. The limit is 

a range that is codified at 21 CFR 

558.4(d). When feed assay values fall 

within this range, it indicates that the 

feed has been prepared with the correct 

amount of Type A medicated article. 

Because many different laboratories use 

medicated feed assays, it is important 

that the assay methods are reproducible. 

Sponsors should conduct method 

transfer studies to evaluate 

reproducibility. A method transfer study 

is part of the evaluation process for a 

Type C medicated feed assay method 

and demonstrates the transferability of 

the feed assay method among different 

laboratories by comparing the results 

each laboratory obtains when using the 

method to analyze a specific set of feed 

samples. Sponsors may expand the 

method transfer study to include other 

medicated feed products, such as Top 

Dress Type C, Free-Choice Type C, and 

Type B medicated feeds. 

II. Paperwork Reduction Act of 1995 

This guidance refers to previously 

approved collections of information 

found in FDA regulations. These 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501–

3520). The collections of information in 

§ 514.1 have been approved under OMB 

Control Nos. 0910–0032 and 0910–0154. 

III. Significance of Guidance 

This level 1 guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 


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