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Parent RIN:   0910-AA58
HHS/FDA RIN: 0910-AE55 Publication ID: Fall 2000 
Title: Notification Procedures for GRAS Determinations 
Abstract: In response to President Clinton's memorandum to heads of departments and agencies entitled "Regulatory Reinvention Initiative," FDA has initiated rulemaking to retain, revise, or revoke certain of its regulations for food. FDA published an advance notice of proposed rulemaking (ANPRM) on December 29, 1995, requesting information on the need to retain, revise, or revoke its food standards of identity regulations and its common or usual name regulations. In the same issue of the Federal Register, FDA proposed to improve the coordination of the food additive, GRAS, and color additive approval process with USDA for substances used in meat and poultry products. FDA proposed to revoke several lower fat milk standards on November 9, 1995. On June 12, 1996, FDA published an ANPRM announcing its intention to review: (1) its human food labeling regulations pertaining to the exemption for soft drinks from requirements for the type size and placement of certain information on the information panel, requirements for listing "statements of identity," and requirements for flavor labeling; (2) its infant formula regulations to ensure that they fully reflect the Federal Food, Drug, and Cosmetic Act; (3) its regulations pertaining to the discharge of waste aboard casino ships, passenger ships, and ferries; and (4) its food additive regulations to consolidate certain existing regulations. In the same June 12 issue of the Federal Register, FDA published a second ANPRM seeking public comment on possible ways to streamline various food additive regulations. FDA also proposed on June 12, 1996, to revoke certain food labeling regulations pertaining to labeling of food with number of servings and labeling Kosher and Kosher-style foods and to revoke the agency's voluntary filing of cosmetic product experiences. The latter was published August 12, 1997. On October 13, 1995, FDA proposed to revoke certain agency regulations that were obsolete or no longer necessary to achieve public health goals. The final rule (pertaining to food regulations only) was published on June 3, 1996. A confirmation of effective date on those regulations, promulgated under the formal rulemaking procedures of section 701(e) of the Federal Food, Drug, and Cosmetic Act (21 USC 371(e)), pertaining to diabetic labeling (21 CFR 105.67) and sodium intake labeling (21 CFR 105.69), was published on August 27, 1996. In the Federal Register of April 17, 1997 (62 FR 18938), FDA proposed to establish a notification procedure for companies to use to inform FDA of a company's determination that use of a substance in food is generally recognized as safe (GRAS). 
Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Long-Term Actions 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 101; 21 CFR 145; 21 CFR 146; 21 CFR 150; 21 CFR 152; 21 CFR 155; 21 CFR 156; 21 CFR 102; 21 CFR 103; 21 CFR 131; 21 CFR 133; 21 CFR 135; 21 CFR 136; 21 CFR 137; ...; 21 CFR 139 (To search for a specific CFR, visit the Code of Federal Regulations.
Legal Authority: 15 USC 1453; 15 USC 1454; 15 USC 1455; 21 USC 321 et seq 
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  04/17/1997  62 FR 18938 
NPRM Comment Period Ended  07/16/1997   
Final Action  To Be Determined   
Additional Information: Federalism: Yes for Food Standards of Identity, Quality, and Fill of Container
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: State 
Small Entities Affected: Businesses  Federalism: Yes 
Included in the Regulatory Plan: No 
Agency Contact:
 
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