contact lenses in which the additive is used. (c) Labeling. The label of the color additive shall conform to the requirements of §70.25 of this chapter. (d) Exemption from certification. Certification of this color additive is not necessary for the protection of the

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 certification requirements of section 721(c) of the act. [67 FR 65312, Oct. 24, 2002]

(a) A manufacturer shall develop and follow a written audit plan that is available at the manufacturing facility for Food and Drug Administration inspection. (b) The audit plan shall include audit procedures that set out the methods the manufacturer uses to determine whether the facility is operating in accordance with current good manufacturing practice, with the quality control procedures that are necessary to ensure that an infant

must include the information required in §112.173. If FDA determines that these comments should instead be treated as a separate request for a variance, FDA will notify the State, tribe, or foreign country that submitted these comments that a separate request must be submitted in accordance with §§112.172

As appropriate to the nature of the preventive control and its role in the facility's food safety system: (a) Written procedures. You must establish and implement written procedures, including the frequency with which they are to be performed, for monitoring the preventive control; and (b) Monitoring. You must monitor the

functions if it has provided knowledge at least equivalent to that provided through the standardized curriculum. (a) Developing a HACCP plan, which could include adapting a model or generic-type HACCP plan, that is appropriate for a specific processor, in order to meet the requirements of §123.6(b); (b) Reassessing and modifying the HACCP plan

(b) It is used or intended for use as a crystallization inhibitor in vegetable oils and as a release agent in vegetable oils and vegetable shortenings, whereby the additive does not exceed 0.125 percent of the combined weight of the oil or shortening. (c) To insure safe use of the additive, the label and labeling of the additive container shall bear, in addition to the other information required by the Act:

units. (2) Sodium polyacrylate-acrylamide resin is produced by the polymerization and subsequent hydrolysis of acrylonitrile in a sodium silicate-sodium hydroxide aqueous solution, with the greater part of the polymer being composed of acrylate units. (b) The additive contains not more than 0.05 percent of residual monomer calculated as acrylamide. (c) The additive is used or intended for use as

for use in the production of sugar (sucrose) from sugar beets by addition as mycelial pellets to the molasses to increase the yield of sucrose, followed by removal of the spent mycelial pellets by filtration. (d) The enzyme removal is such that there are no enzyme or mycelial residues remaining in the finished sucrose. [42 FR 14526, Mar. 15, 1977, as amended at 54 FR 24897, June 12, 1989]

(NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal__register/code__of__federal__regulations/ibr__locations.html. (b) The additive is used as an antimicrobial agent in the production of modified whey (including, but not limited to, whey protein concentrates and whey protein isolates) by ultrafiltration methods, at a level not to exceed 0.001 percent by

Substances migrating to food from cotton and cotton fabrics used in dry food packaging that are generally recognized as safe for their intended use, within the meaning of section 409 of the Act, are as follows: Beef tallow. Carboxymethylcellulose. Coconut oil, refined. Cornstarch.

Substances migrating to food from paper and paperboard products used in food packaging that are generally recognized as safe for their intended use, within the meaning of section 409 of the Act, are as follows: Alum (double sulfate of aluminum and ammonium potassium, or sodium). Aluminum hydroxide. Aluminum oleate.

the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal__register/code__of__federal__regulations/ibr__locations.html. (c) The ingredient is used to supply up to 0.009 part of total L-cysteine per 100 parts

), pp. 92-93, which is incorporated by reference. Copies may be obtained from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal__register/code__of__federal__regulations/ibr__locations.html. (c) The

51. Copies are available from the National Academy Press, Box 285, 2101 Constitution Ave. NW., Washington, DC 20055 (Internet address http://www.nap.edu), or may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go

government of any license currently or previously held by the applicant for the manufacture or distribution of any drugs, including controlled substances; (6) Compliance with licensing requirements under previously granted licenses, if any; (7) Compliance with requirements to maintain and/or make available to the State licensing authority or to Federal, State, or local law enforcement officials those records required under this section

of the medicated feed involved, and the specific details of the complaint. This record shall also include all correspondence from the complainant and/or memoranda of conversations with the complainant, and a description of all investigations made by the manufacturer and of the method of disposition of the complaint. (2) For medicated feeds whose manufacture require a medicated feed mill license (Form FDA 3448), records and reports of clinical and other experience

(a) The criteria in §§226.10 through 226.115, inclusive, shall apply in determining whether the methods used in, or the facilities and controls used for the manufacture, processing, packing, or holding of a Type A medicated article(s) conform to or are operated or administered in conformity with current good manufacturing practice to assure that a Type A medicated

The active ingredient of the product consists of any of the following, within the concentration specified for each ingredient, and the finished product provides a minimum SPF value of not less than 2 as measured by the testing procedures established in subpart D of this part: (a) Aminobenzoic acid (PABA) up to 15 percent. (b) Avobenzone up to 3 percent. (c) Cinoxate up to

responsibility for and initiates a clinical investigation. The sponsor may be an individual or pharmaceutical company, governmental agency, academic institution, private organization, or other organization. The sponsor does not actually conduct the investigation unless the sponsor is a sponsor-investigator. A person other than an individual that uses one or more of its own employees to conduct an investigation that it has initiated is a sponsor, not a sponsor-investigator, and the employees are investigators

percentage of equivalent crude protein from the nonprotein nitrogen. (3) If the feed additive premix, feed additive concentrate, or feed additive supplement contains more than 2 percent equivalent crude protein from diammonium phosphate, adequate directions for use and a prominent statement, “Warning—This feed should be used only in accordance with directions furnished on the label.”

authorized under this part to receive it. (d) Financial disclosure. A clinical investigator shall disclose to the sponsor sufficient accurate financial information to allow the applicant to submit complete and accurate certification or disclosure statements required under part 54 of this chapter. The investigator shall promptly update this information if any relevant changes occur during the course of the investigation and for 1 year

(a) In general. The labeler of a device must provide the information required by this subpart for each version or model required to bear a unique device identifier (UDI). (b) Voluntary submission of information. If a labeler voluntarily includes a UDI on the label of a device under

§876.9. (2) Class I for the urethrometer, urological bougie, filiform and filiform follower, and metal or plastic urethral sound. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §876.9

device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §884.9. The special controls for this device are: (1) The sale, distribution, and use of this device are restricted to prescription use in accordance with

(special controls). The special control for this device is FDA's “Class II Special Controls Guidance: Shoulder Joint Metal/Polymer/Metal Nonconstrained or Semi-Constrained Porous-Coated Uncemented Prosthesis.” [66 FR 12737, Feb. 28, 2001]

) Attempted or successful interference with audit trail functions. (6) For application service providers, attempted or successful annotation, alteration, or destruction of controlled substance prescriptions or logical access controls related to controlled substance prescriptions by any agent or employee of the application service provider. (b) The pharmacy application must analyze the audit trail at least once every calendar day and

which would be available to the Insurer but for said immunity in suits against the Insured or against the Insurer under the policy shall be available to the Insurer with respect to such officers and employees in suits against such officers and employees or against the Insurer under the policy.

determination is favorable, unless otherwise designated, the complete application is returned to the original processing official for docket preparation. If the determination is unfavorable, the designated processing official as decisionmaker participates in the appeal process to its conclusion. (c)-(e) [Reserved] (f) Closing agent. Unless there is a clear or apparent conflict of interest, closing will

. Details of security infractions including corrective action taken must be available to the CSA upon request. (c) In addition, NRC requires records for all classification actions (documents classified, declassified, or downgraded) to be submitted to the NRC Division of Security Operations. These may be submitted either on an “as completed” basis or monthly. The information may be submitted either electronically by an on-line system (NRC prefers the use of a dial-in