21030 Federal Register / Vol. 72, No. 81 / Friday April 27, 2007 / Notices 

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1—Continued 

21 CFR Section No. of 

Recordkeepers 

Annual Frequency 

per Recordkeeping 

Total Annual 

Records 

Hours per 

Record Total Hours 

1271.50(a) 2,017 38.64 77,944 5 389,720 

1271.55(d)(1) 2,017 38.64 77,944 1 77,944 

1271.55(d)(2) 2,017 1 2,017 1 2,017 

1271.55(d)(4) 2,017 1 2,017 120 242,040 

1271.60(d)(3) and 1271.65(b)(3) 605 1 605 2 1,210 

1271.155(f) 8 1 8 0.25 2 

1271.160(b)(3) and (b)(6) 1,449 12 17,388 1 17,388 

1271.160(d) 1,449 12 17,388 1 17,388 

1271.190(d)(2) 1,449 12 17,388 1 17,388 

1271.195(d) 1,449 12 17,388 1 17,388 

1271.200(e) 1,449 12 17,388 1 17,388 

1271.210(d) 1,449 12 17,388 1 17,388 

1271.230(a) 1,449 12 17,388 1 17,388 

1271.230(c) 1,449 1 1,449 1 1,449 

1271.260(d) 1,449 12 17,388 0.25 4,347 

1271.260(e) 1,449 365 528,885 0.08 42,310.8 

1271.265(c)(1) 1,449 1,071.16 1,552,105 0.08 124,168.33 

1271.265(c)(3) 725 1 725 1 725 

1271.265(e) 1,449 1,071.16 1,552,105 0.08 124,168.33 

1271.270(a) 1,449 1,071.16 1,552,105 0.25 388,026.25 

1271.270(e) 1,614 2 3,228 0.5 1,614 

1271.290(d) and (e) 1,449 50.34 72,944 0.25 18,236 

1271.320(b) 1,009 5 5,045 1 5,045 

Total 1,605,723.7 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

2Sections 1271.47(a), 1271.85(b)(2), 1271.160(b)(2), 1271.180(a), 1271.190(d)(1), 1271.200(b) and (c), 1271.230(a), 1271.250(a),

1271.265(e), and 1271.320(a). 

Dated: April 20, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–8038 Filed 4–26–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2007P–0149] 

Canned Pacific Salmon 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 Peter Pan Seafoods, Inc., to market 

test canned Pacific salmon that deviates 

from the U.S. standard of identity for 

canned Pacific salmon. The purpose of 

the temporary permit is to allow the 

applicant to measure consumer 

acceptance of the product 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: Ritu 

Nalubola, Center for Food Safety and 


cprice-sewell on PROD1PC66 with NOTICES
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 


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