98-23106. Listing of Color Additives for Coloring Sutures; D&C Violet No. 2; Confirmation of Effective Date  

  • [Federal Register Volume 63, Number 167 (Friday, August 28, 1998)]
    [Rules and Regulations]
    [Pages 45943-45944]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 98-23106]
    
    
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    DEPARTMENT OF HEALTH AND HUMAN SERVICES
    
    Food and Drug Administration
    
    21 CFR Part 74
    
    [Docket No. 95C-0399]
    
    
    Listing of Color Additives for Coloring Sutures; D&C Violet No. 
    2; Confirmation of Effective Date
    
    AGENCY: Food and Drug Administration, HHS.
    
    ACTION: Final rule; confirmation of effective date.
    
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    SUMMARY: The Food and Drug Administration (FDA) is confirming the 
    effective date of May 27, 1998, for the final rule that amended the 
    color additive regulations to provide for the safe use of D&C Violet 
    No. 2 as a color additive in glycolide/dioxanone/trimethylene carbonate 
    tripolymer absorbable sutures for general surgery.
    
    DATES: Effective date confirmed: May 27, 1998.
    
    FOR FURTHER INFORMATION CONTACT: Ellen M. Waldron, Center for Food 
    Safety and Applied Nutrition (HFS-215), Food and Drug Administration, 
    200 C St. SW., Washington, DC 20204, 202-418-3089.
    
    SUPPLEMENTARY INFORMATION: In the Federal Register of April 23, 1998 
    (63 FR 20096), FDA amended the color additive regulations in 
    Sec. 74.3602 D&C Violet No. 2 (21 CFR 74.3602) to provide for the safe 
    use of D&C Violet No. 2 as a color additive in glycolide/dioxanone/
    
    [[Page 45944]]
    
    trimethylene carbonate tripolymer absorbable sutures for general 
    surgery.
        FDA gave interested persons until May 26, 1998, to file objections 
    or requests for a hearing. The agency received no objections or 
    requests for a hearing on the final rule. Therefore, FDA finds that the 
    effective date of the final rule that published in the Federal Register 
    of April 23, 1998, should be confirmed.
    
    List of Subjects in 21 CFR Part 74
    
        Color additives, Cosmetics, Drugs.
        Therefore, under the Federal Food, Drug, and Cosmetic Act (21 
    U.S.C. 321, 341, 342, 343, 348, 351, 352, 355, 361, 362, 371, 379e) and 
    under authority delegated to the Commissioner of Food and Drugs (21 CFR 
    5.10), notice is given that no objections or requests for a hearing 
    were filed in response to the April 23, 1998, final rule. Accordingly, 
    the amendments issued thereby became effective May 27, 1998.
    
        Dated: August 13, 1998.
    William K. Hubbard,
    Associate Commissioner for Policy Coordination.
    [FR Doc. 98-23106 Filed 8-27-98; 8:45 am]
    BILLING CODE 4160-01-F
    
    
    

Document Information

Effective Date:
5/27/1998
Published:
08/28/1998
Department:
Food and Drug Administration
Entry Type:
Rule
Action:
Final rule; confirmation of effective date.
Document Number:
98-23106
Dates:
Effective date confirmed: May 27, 1998.
Pages:
45943-45944 (2 pages)
Docket Numbers:
Docket No. 95C-0399
PDF File:
98-23106.pdf
CFR: (1)
21 CFR 74.3602