method” is defined in 40 CFR 63.90. (4) Approval of major change to monitoring under 40 CFR 63.8(f). A “major change to monitoring” is defined in 40 CFR 63.90. (5) Approval of a major change to recordkeeping/reporting under 40 CFR 63.10(f). A “major change to recordkeeping/reporting” is defined in 40 CFR 63.90. (6) Approval of a program for the removal of mercury switches under

§67.11 have not been or will not be met. (b) The Administrator shall notify the State in writing of his action under paragraph (a) of this section and shall state the reasons for his action. (c) In all cases of delegation (whether or not express provision is made in the notice of delegation) the Administrator shall retain continuing authority to issue notices

emphasis on the specific safety and health hazards, emergency operations including shutdown, and safe work practices applicable to the employee's job tasks. (2) In lieu of initial training for those employees already involved in operating a process on June 21, 1999 an owner or operator may certify in writing that the employee has the required knowledge, skills, and abilities to safely carry out the duties and responsibilities as specified in the operating procedures

Management or an agency employee designated in the notice. (2) For purposes of a hearing under §13.1 (a) or (b), all participants who file a notice of participation under §12.32(e)(6)(ii) are deemed to be parties and entitled to participate in selection of the Board under

or occurring and which could not reasonably have been anticipated, e.g., the closing of a portion of a meeting which is made known for the first time on the day of the meeting, the matter may be handled by an oral petition in lieu of a written petition. (b) If the person objects to a denial of access to an advisory committee document, administrative review is in accordance with the procedures established by the Department of Health and Human Services under 45 CFR

environmental effect abroad, the responsible agency official shall determine, in accordance with section 2-4 (a) and (b) of the Executive Order, whether the subject action calls for: (1) An EIS; (2) A bilateral or multilateral environmental study; or (3) A concise environmental review. (d) In preparing environmental documents under this subpart, the responsible official shall

(a) Any person may file a petition with FDA, no later than 180 days after the publication of a regulatory review period determination under §60.20, that challenges FDA's determination by alleging that the applicant for patent term restoration did not act with due diligence in seeking FDA approval of the product during the regulatory review period.

(e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health and therefore batches thereof are exempt from the requirements of section 721(c) of the act.

For the purposes of regulations promulgated under section 401 of the act: (a) The term general statement of substandard quality means the statement “Below Standard in Quality Good Food—Not High Grade” printed in two lines of Cheltenham bold condensed caps. The words “Below Standard in Quality” constitute the first line, and the second immediately follows. If the quantity of the contents of the

Food, Drug, and Cosmetic Act, adequate directions for use to provide a final product that complies with the limitations prescribed in paragraph (c) of this section. (e) Labels of manufactured food products containing the additive shall bear, in the ingredient statement, the name of the additive, “vitamin D2 bakers yeast,” in the proper order of decreasing predominance in the finished food.

. Oleic acid derived from tall oil fatty acids conforming with §172.862 may be used as a substitute for or together with the oleic acid permitted by this paragraph. (d) Polyglycerol esters of butter oil fatty acids are used as emulsifiers in combination with other approved emulsifiers in dry, whipped topping base. The fatty acids used in the production of the polyglycerol

) The enzyme is used at levels not to exceed current good manufacturing practice in the following food categories: cheeses as defined in §170.3(n)(5) of this chapter; fat and oils as defined in §170.(3)(n)(12) of this chapter; and milk products as defined in §170.(3)(n)(31) of this chapter. Use of this food ingredient is limited to nonstandarized foods and those foods for which the relevant standards of

Synthetic flavoring substances and adjuvants that are generally recognized as safe for their intended use, within the meaning of section 409 of the Act, are as follows: Acetaldehyde (ethanal). Acetoin (acetyl methylcarbinol). Anethole (parapropenyl anisole). Benzaldehyde (benzoic aldehyde).

(a) Ozone (O3, CAS Reg. No. 10028-15-6) is an unstable blue gas with a pungent, characteristic odor, which occurs freely in nature, It is produced commercially by passing electrical discharges or ionizing radiation through air or oxygen. (b) The ingredient must be of a purity suitable for its intended use in accordance with

on how to provide registration and listing information in electronic format (specifying for example method of transmission, media, file formats, preparation, and organization of files). (2) Information provided in electronic format must comply with part 11 of this chapter, except as follows: (i) Advertisements and labeling, including the content of labeling, required under this part are exempt from the requirements in

that are required to be kept under §314.81, or a request for a copy of the application from FDA's files. FDA will provide a copy of the application to the new owner under the fee schedule in §20.45 of FDA's public information regulations. (b) The new owner shall advise FDA

the eye to protect and lubricate mucous membrane surfaces and relieve dryness and irritation. (e) Emollient. An agent, usually a fat or oil, which is applied locally to eyelids to protect or soften tissues and to prevent drying and cracking. (f) Eyewash, eye lotion, irrigating solution. A sterile aqueous solution intended for washing, bathing, or flushing

demulcent combination identified in paragraph (b) of this section. (e) Any two or more emollient active ingredients identified in §349.14 may be combined as necessary to give the product proper consistency for application to the eye.

§507.38(a)(1); (5) The written procedures for monitoring the implementation of the preventive controls as required by §507.40(a); (6) The written corrective action procedures as required by §507.42(a)(1); and

in dogs—(1) Amount. 5 milligrams per pound of body weight, at 8-hour intervals, 1 to 2 hours prior to feeding, to be continued 36 to 48 hours after all symptoms have subsided. If no improvement is seen within 5 days, stop treatment, reevaluate diagnosis, and change therapy. (2) Indications for use. Oral treatment of infections caused by susceptible organisms as follows: Upper

The food additive silicon dioxide may be safely used in animal feed in accordance with the following conditions: (a) The food additive is manufactured by vapor phase hydrolysis or by other means whereby the particle size is such as to accomplish the intended effect. (b) It is used or intended for use as an anticaking agent, antifoaming agent, carrier, and/or grinding aid in animal feed, including

Natural extractives (solvent-free) used in conjunction with spices, seasonings, and flavorings that are generally recognized as safe for their intended use, within the meaning of section 409 of the act, are as follows: Open Table

PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before October 4, 2012, for any permanent pacemaker electrode device that was in commercial distribution before May 28, 1976, or that has, on or before October 4, 2012, been found to be substantially equivalent to any permanent pacemaker electrode device that was in commercial distribution before May 28, 1976. Any other pacemaker repair or replacement material device shall have an approved PMA

in the order to show cause under §1314.150, which request shall be granted by the Administrator, who shall fix a date for such hearing as early as reasonably possible.

(c) Each take-back event should have at least one receptacle for the collection of controlled substances. The collection receptacle should be a securely locked, substantially constructed container with an outer container and a removable inner liner as specified in §1317.60 of this chapter. The outer container should include a small opening that allows contents to be added to the inner

), successor to REA with respect to administering certain electric and telephone programs. See 7 CFR 1700.1. RUS Loan Agreement means the agreement between the borrower and RUS providing for loans pursuant to the Act. RUS Notes means those notes, bonds or other obligations evidencing indebtedness created by loans made pursuant to Titles I, II or III of the Act

A product is considered to be nondomestic for the purpose of compliance with the “Buy American” requirement if: (a) The product is manufactured outside the United States or any eligible country; or (b) The product is manufactured in the United States or in any eligible country, but the cost of nondomestic components used therein constitutes 50 percent or more of the cost of all components. The cost of

, Department of Agriculture (“FmHA”) or its successor agency under Public Law 103-354, amends the “Self-Help Technical Assistance Grant Agreement” between the parties dated _________ 19__, (“Agreement”). The Agreement is amended by providing additional financial assistance in the amount of ____ to be made available by FmHA or its successor agency under Public Law 103-354 to Grantee pursuant to section 523 of Title V of the Housing Act of 1949 for the purpose of assisting in

Security Information other than that noted in paragraph (a)(1)(i) of this section except that access to certain Confidential COMSEC information is permitted as authorized by a National Communications Security Committee waiver dated February 14, 1984. (2) An established “need-to-know” for the matter (See Definitions, §95.5). (3) NRC-approved

) of this section, the Proposed Remedial Order may be issued as a final order. (c) A person who files a Notice of Objection shall on the same day serve a copy of the Notice upon the person to whom the Proposed Remedial Order is directed, the DOE Office that issued the Proposed Remedial Order, and the DOE Assistant General Counsel for Administrative Litigation. (d) The Notice shall include a certification of compliance with the