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(6)(i) Ice cream, french ice cream, ice milk, fruit sherbets, water ices, quiescently frozen confections (with or without dairy ingredients), special dietary frozen desserts, and products made in semblance of the foregoing, when measured by and packaged in 12-liquid pint and 42-gallon measure-containers, as defined in the “Measure Container Code of National Bureau of Standards Handbook 44,” Specifications, Tolerances, and Other Technical Requirements for Weighing and Measuring Devices, Sec. 4.45 “Measure-Containers,' which is incorporated by reference, are exempt from the requirements of § 101.105(b)(2) of this chapter to the extent that net contents of 8-fluid ounces and 64-fluid ounces (or 2 quarts) may be expressed as 12 pint and 1/2 gallon, respectively. Copies are available from the Center for Food Safety and Applied Nutrition (HFS-150), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or available for inspection at the Office of the Federal Register, 800 North Capitol Street NW., suite 700, Washington, DC.

(ii) The foods named in paragraph (a)(6)(i) of this section, when measured by and packaged in 1-liquid pint, 1-liquid quart, and 1/2-gallon measure-containers, as defined in the “Measure Container Code of National Bureau of Standards Handbook 44,” Specifications, Tolerances, and Other Technical Requirements for Weighing and Measuring Devices, Sec. 4.45 “Measure-Containers,” which is incorporated by reference, are exempt from the dual netcontents declaration requirement of $ 101.105(j) of this chapter. Copies are available from the Center for Food Safety and Applied Nutrition (HFS150), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or available for inspection at the Office of the Federal Register, 800 North Capitol Street NW., suite 700, Washington, DC.

(iii) The foods named in paragraph (a)(6)(i) of this section, when measured by and packaged in 1/2-liquid pint, 1-liquid pint, 1-liquid quart, 12-gallon, and 1-gallon measured-containers, as defined in the “Measure Container Code of National Bureau of Standards Handbook 44,” Specifications, Tolerances, and Other Technical Requirements for

Weighing and Measuring Devices, Sec. 4.45 “Measure-Containers,” which is incorporated by reference, are exempt from the requirement of $ 101.105(f) of this chapter that the declaration of net contents be located within the bottom 30 percent of the principal display panel. Copies are available from the Center for Food Safety and Applied Nutrition (HFS-150), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or available for inspection at the Office of the Federal Register, 800 North Capitol Street NW., suite 700, Washington, DC.

(7)(i) Milk, cream, light cream, coffee or table cream, whipping cream, light whipping cream, heavy or heavy whipping cream,

or cultured sour cream, half-and-half, sour or cultured half-and-half, reconstituted or recombined milk and milk products, concentrated milk and milk products, skim or skimmed milk, vitamin D milk and milk products, fortified milk and milk products, homogenized milk, flavored milk and milk products, buttermilk, cultured buttermilk, cultured milk or cultured whole buttermilk, low-fat milk (0.5 to 2.0 percent butterfat), and acidified milk and milk products, when packaged in containers of 8 and 64-fluid-ounce capacity, are exempt from the requirements of $ 101.105(b)(2) of this chapter to the extent that net contents of 8 fluid ounces and 64 fluid ounces (or 2 quarts) may be expressed as 12 pint and 1/2 gallon, respectively.

(ii) The products listed in paragraph (a)(7)(i) of this section, when packaged in glass or plastic containers of 12-pint, 1-pint, l-quart, 1/2-gallon, and l-gallon capacities are exempt from the placement requirement of $ 101.105(f) of this chapter that the declaration of net contents be located within the bottom 30 percent of the principal display panel, provided that other required label information is conspicuously displayed on the cap or outside closure and the required net quantity of contents declaration is conspicuously blown, formed, or molded into or permanently applied to that part of the glass or plastic container that is at or above the shoulder of the container.

(iii) The products listed in paragraph (a)(7)(i) of this section, when packaged

in containers of 1-pint, 1-quart, and 42- in terms of ounces and pounds, to pergallon capacities are exempt from the mit declaration of “1-pound” or “one dual net-contents declaration require-pound”; and ment of $ 101.105(j) of this chapter.

(iii) In 4-ounce, 8-ounce, and 1-pound (8) Wheat flour products, as defined packages with continuous label copy by $8 137.105, 137.155, 137.160, 137.165, wrapping is exempt from the require137.170, 137.175, 137.180, 137.185, 137.200, ments of 88 101.3 and 101.105(f) of this and 137.205 of this chapter, packaged: chapter that the statement of identity

(i) In conventional 2-, 5-, 10 , 25–, 50– and net contents declaration appear in

and 100-pound packages are exempt lines generally parallel to the base on from the placement requirement of which the package rests as it is de$ 101.105(f) of this chapter that the dec- signed to be displayed, provided that laration of net contents be located such statement and declaration are not within the bottom 30 percent of the so positioned on the label as to be misarea of the principal display panel of leading or difficult to read as the packthe label; and

age is customarily displayed at retail. (ii) In conventional 2-pound packages (11) Margarine as defined in $ 166.110 are exempt from the dual net-contents of this chapter and imitations thereof declaration requirement of $ 101.105(j) in 1-pound rectangular packages, exof this chapter provided the quantity of cept for packages containing whipped contents is expressed in pounds.

or soft margarine or packages that (9)(i) Twelve shell eggs packaged in a contain more than four sticks, are excarton designed to hold 1 dozen eggs empt from the requirement of and designed to permit the division of $101.105(f) of this chapter that the decsuch carton by the retail customer at laration of the net quantity of contents the place of purchase into two portions appear within the bottom 30 percent of of one-half dozen eggs each are exempt the principal display panel and from from the labeling requirements of this the requirement of $ 101.105(j)(1) of this part with respect to each portion of chapter that such declaration be exsuch divided carton if the carton, when pressed both in ounces and in pounds to undivided, is in conformance with the permit declaration of "1-pound” or labeling requirements of this part. “one pound," provided an accurate

(ii) Twelve shell eggs packaged in a statement of net weight appears concarton designed to hold 1 dozen eggs spicuously on the principal display are exempt from the placement re- panel of the package. quirements for the declaration of con- (12) Corn flour and related products, tents prescribed by $101.105(f) of this as they are defined by $$ 137.211, 137.215, chapter if the required content declara- and $$ 137.230 through 137.290 of this tion is otherwise placed on the prin- chapter, packaged in conventional 5-, cipal display panel of such carton and 10_, 25–, 50–, and 100-pound bags are exif, in the case of such cartons designed empt from the placement requirement to permit division by retail customers of $ 101.105(f) of this chapter that the into two portions of one-half dozen declaration of net contents be located eggs each, the required content dec- within the bottom 30 percent of the laration is placed on the principal dis- area of the principal display panel of play panel in such a manner that the the label. context of the content declaration is (13)(i) Single strength and less than destroyed upon division of the carton. single strength fruit juice beverages,

(10) Butter as defined in 42 Stat. 1500 imitations thereof, and drinking water (excluding whipped butter):

when packaged in glass or plastic con(i) In 8-ounce and in 1-pound pack- tainers of 12-pint, 1-pint, l-quart, 12ages is exempt from the requirements gallon, and 1-gallon capacities are exof $ 101.105(f) of this chapter that the empt from the placement requirement net contents declaration be placed of $101.105(f) of this chapter that the within the bottom 30 percent of the declaration of net contents be located area of the principal display panel; within the bottom 30 percent of the

(ii) In 1-pound packages is exempt principal display panel: Provided, That from the requirements of $ 101.105(1)(1) other required label information is of this chapter that such declaration be conspicuously displayed on the cap or

outside closure and the required net quantity of contents declaration is conspicuously blown, formed, or molded into or permanently applied to that part of the glass or plastic container that is at or above the shoulder of the container.

(ii) Single strength and less than single strength fruit juice beverages, imitations thereof, and drinking water when packaged in glass, plastic, or paper (fluid milk type) containers of 1– pint, l-quart, and 12-gallon capacities are exempt from the dual net-contents declaration requirement of $ 101.105(j) of this chapter.

(iii) Single strength and less than single strength fruit juice beverages, imitations thereof, and drinking water when packaged in glass, plastic, or paper (fluid milk type) containers of 8 and 64-fluid-ounce capacity, are empt from the requirements of $ 101.105(b)(2) of this chapter to the extent that net contents of 8 fluid ounces and 64 fluid ounces (or 2 quarts) may be expressed as 1/2 pint (or half pint) and 12 gallon (or half gallon), respectively.

(14) The unit containers in a multiunit or multicomponent retail food package shall be exempt from regulations of section 403 (e)(1), (g)(2), (i)(2), (k), and (q) of the act with respect to the requirements for label declaration of the name and place of business of the manufacturer, packer, distributor; label declaration of ingredients; and nutrition information when:

(i) The multiunit or multicomponent retail food package labeling meets all the requirements of this part;

(ii) The unit containers are securely enclosed within and not intended to be separated from the retail package under conditions of retail sale; and

(iii) Each unit container is labeled with the statement “This Unit Not Labeled For Retail Sale” in type size not less than one-sixteenth of an inch in height. The word "Individual” may be used in lieu of or immediately preceding the word “Retail” in the statement.

(b) Drugs. Liquid over-the-counter veterinary preparations intended for injection shall be exempt from the declaration of net quantity of contents in terms of the U.S. gallon of 231 cubic inches and quart, pint, and fluid-ounce

subdivisions thereof as required by $201.62 (b), (i), and (j) of this chapter, and from the dual declaration requirements of $201.62(i) of this chapter, if such declaration of net quantity of contents is expressed in terms of the liter and milliliter, or cubic centimeter, with the volume expressed at 68 °F (20 °C).

(c) Cosmetics. Cosmetics in packages containing less than one-fourth ounce avoirdupois or one-eighth fluid ounce shall be exempt from compliance with the requirements of section 602(b)(2) of the Federal Food, Drug, and Cosmetic Act and section 4(a)(2) of the Fair Packaging and Labeling Act:

(1) When such cosmetics are affixed to a display card labeled in conformance with all labeling requirements of this part; or

(2) When such cosmetics are sold at retail as part of a cosmetic package consisting of an inner and outer container and the inner container is not for separate retail sale and the outer container is labeled in conformance with all labeling requirements of this part. [42 FR 15553, Mar. 22, 1977, as amended at 47 FR 946, Jan. 8, 1982; 47 FR 32421, July 27, 1982; 49 FR 13339, Apr. 4, 1984; 54 FR 9033, Mar. 3, 1989; 58 FR 2174, Jan. 6, 1993; 61 FR 14478, Apr. 2, 1996; 66 FR 56035, Nov. 6, 2001)

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Subparts C-D [Reserved]

Subpart E–Imports and Exports

$ 1.83 Definitions.

For the purposes of regulations prescribed under section 801(a), (b), and (c) of the Federal Food, Drug, and Cosmetic Act:

(a) The term owner or consignee means the person who has the rights of a consignee under the provisions of sections 483, 484, and 485 of the Tariff Act of 1930, as amended (19 U.S.C. 1483, 1484, 1485).

(b) The term district director means the director of the district of the Food and Drug Administration having jurisdiction over the port of entry through which an article is imported or offered for import, or such officer of the district as he may designate to act in his behalf in administering and enforcing the provisions of section 801 (a), (b), and (c).

$ 1.90 Notice of sampling.

When a sample of an article offered for import has been requested by the district director, the collector of customs having jurisdiction over the article shall give to the owner or consignee prompt notice of delivery of, or intention to deliver, such sample. Upon receipt of the notice, the owner or consignee shall hold such article and not distribute it until further notice from the district director or the collector of customs of the results of examination of the sample.

to

the act or to render it other than a food, drug, device, or cosmetic, such testimony shall include evidence in support of such application. If such application is not submitted at or prior to the hearing, the district director shall specify a time limit, reasonable in the light of the circumstances, for filing such application. $ 1.95 Application for authorization to

relabel and recondition. Application for authorization relabel or perform other action to bring the article into compliance with the act or to render it other than a food, drug, device or cosmetic may be filed only by the owner or consignee, and shall:

(a) Contain detailed proposals for bringing the article into compliance with the act or rendering it other than a food, drug, device, or cosmetic.

(b) Specify the time and place where such operations will be carried out and the approximate time for their completion.

$ 1.91 Payment for samples.

The Food and Drug Administration will pay for all import samples which are found to be in compliance with the requirements of the Federal Food, Drug, and Cosmetic Act. Billing for reimbursement should be made by the owner or consignee to the Food and Drug Administration district headquarters in whose territory the shipment was offered for import. Payment for samples will not be made if the article is found to be in violation of the act, even though subsequently brought into compliance under the terms of an authorization to bring the article into compliance or rendered not a food, drug, device, or cosmetic as set forth in $1.95.

$ 1.94 Hearing on refusal of admission.

(a) If it appears that the article may be subject to refusal of admission, the district director shall give the owner or consignee a written notice to that effect, stating the reasons therefor. The notice shall specify a place and a period of time during which the owner or consignee shall have an opportunity to introduce testimony. Upon timely request giving reasonable grounds therefor, such time and place may be changed. Such testimony shall be confined to matters relevant to the admissibility of the article, and may be introduced orally or in writing.

(b) If such owner or consignee submits or indicates his intention to submit an application for authorization to relabel or perform other action to bring the article into compliance with

§ 1.96 Granting of authorization to

relabel and recondition. (a) When authorization contemplated by $1.95 is granted, the district director shall notify the applicant in writing, specifying:

(1) The procedure to be followed;

(2) The disposition of the rejected articles or portions thereof;

(3) That the operations are to be carried out under the supervision of an officer of the Food and Drug Administration or the U.S. Customs Service, as the case may be;

(4) A time limit, reasonable in the light of the circumstances, for completion of the operations; and

(5) Such other conditions as are necessary to maintain adequate supervision and control over the article.

(b) Upon receipt of a written request for extension of time to complete such operations, containing reasonable grounds therefor, the district director may grant such additional time as he deems necessary.

(c) An authorization may be amended upon a showing of reasonable grounds therefor and the filing of an amended application for authorization with the district director.

(d) If ownership of an article covered by an authorization changes before the operations specified in the authorization have been completed, the original owner will be held responsible, unless the new owner has executed a bond and obtained a new authorization. Any authorization granted under this section shall supersede and nullify any previously granted authorization with respect to the article. [42 FR 15553, Mar. 22, 1977, as amended at 54 FR 9033, Mar. 3, 1989]

8 1.97 Bonds.

(a) The bonds required under section 801(b) of the act may be executed by the owner or consignee on the appropriate form of a customs single-entry or term bond, containing a condition for the redelivery of the merchandise or any part thereof upon demand of the collector of customs and containing a provision for the performance of conditions as may legally be imposed for the relabeling or other action necessary to bring the article into compliance with the act or rendering it other than a food, drug, device, or cosmetic, in such manner as is prescribed for such bond in the customs regulations in force on the date of request for authorization. The bond shall be filed with the collector of customs.

(b) The collector of customs may cancel the liability for liquidated damages incurred under the above-mentioned provisions of such a bond, if he receives an application for relief therefrom, upon the payment of a lesser amount or upon such other terms and conditions as shall be deemed appropriate under the law and in view of the circumstances, but the collector shall not act under this regulation in any case unless the district director is in full agreement with the action.

ant to section 801(b) of the act, as amended. The cost of such supervision shall include, but not be restricted to, the following:

(a) Travel expenses of the supervising officer.

(b) Per diem in lieu of subsistence of the supervising officer when away from his home station, as provided by law.

(c) The charge for the services of the supervising officer, which shall include administrative support, shall be computed at a rate per hour equal to 266 percent of the hourly rate of regular pay of a grade GS-11/4 employee, except that such services performed by a customs officer and subject to the provisions of the act of February 13, 1911, as amended (sec. 5, 36 Stat. 901, as amended (19 U.S.C. 267)), shall be calculated as provided in that act.

(d) The charge for the service of the analyst, which shall include administrative and laboratory support, shall be computed at a rate per hour equal to 266 percent of the hourly rate of regular pay of a grade GS-12/4 employee. The rate per hour equal to 266 percent of the equivalent hourly rate of regular pay of the supervising officer (GS-11/4) and the analyst (GS-12/4) is computed as follows:

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§ 1.99 Costs chargeable in connection

with relabeling and reconditioning

inadmissible imports. The cost of supervising the relabeling or other action in connection with an import of food, drugs, devices, or cosmetics which fails to comply with the Federal Food, Drug, and Cosmetic Act shall be paid by the owner or consignee who files an application requesting such action and executes a bond, pursu

NOTE: Ratio of equivalent gross annual number of working hours charged to Food and Drug appropriation to net number of annual working hours 4,512/1,696=266 pct.

(e) The minimum charge for services of supervising officers and of analysts shall be not less than the charge for 1

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