Current Good Manufacturing Practice Regulation and Investigational New Drugs; Withdrawal, 25747 [06-4091]

Download as PDF Federal Register / Vol. 71, No. 84 / Tuesday, May 2, 2006 / Rules and Regulations 228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August 2, 2005, 70 FR 45273 (August 5, 2005). DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Supplement No. 1 to Part 774 [Corrected] 21 CFR Part 210 2. In Supplement No. 1 to part 774 (the Commerce Control List), Category 4—Computers, Export Control Classification Number (ECCN) 4E001 the ‘‘TSR’’ paragraph of the License Exceptions section, and the ‘‘items’’ paragraph in the List of Items Controlled section, are corrected to read as follows: [Docket No. 2005N–0285] 4E001 ‘‘Technology’’ according to the General Technology Note, for the ‘‘development’’, ‘‘production’’ or ‘‘use’’ of equipment or ‘‘software’’ controlled by 4A (except 4A980, 4A993 or 4A994) or 4D (except 4D980, 4D993, 4D994), and other specified technology, see List of Items Controlled. SUMMARY: The Food and Drug Administration (FDA) is withdrawing the direct final rule that published in the Federal Register of January 17, 2006, to amend its current good manufacturing practice (CGMP) regulations for human drugs, including biological products, to exempt most investigational ‘‘Phase 1’’ drugs from complying with the requirements in FDA’s regulations. FDA is withdrawing the rule because significant adverse comments were received. DATES: The revision of 21 CFR part 210, published at 71 FR 2458 (January 17, 2006), is withdrawn as of May 2, 2006. FOR FURTHER INFORMATION CONTACT: Monica Caphart, Center for Drug Evaluation and Research (HFD– 320), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827– 9047, or Christopher Joneckis, Food and Drug Administration, Center for Biologics Evaluation and Research (HFM–1), 1401 Rockville Pike, Rockville, MD 20852, 301–435–5681. SUPPLEMENTARY INFORMATION: FDA published a direct final rule on January 17, 2006 (71 FR 2458), that was intended to revise the current good manufacturing practice (CGMP) regulations for human drugs, including biological products, to exempt most investigational ‘‘Phase 1’’ drugs from complying with the requirements in FDA’s regulations. In response to the direct final rule, the agency received significant adverse comments about the proposed revisions to the rule. Under FDA’s direct final rule procedures, the receipt of any significant adverse comment will result in the withdrawal of the direct final rule. Thus, this direct final rule is being withdrawn, effective immediately. Comments received by the agency regarding the withdrawn rule will be considered in developing a final rule using the usual Administrative Procedure Act notice-and-comment procedures. I * * * * * License Exceptions CIV: * * * TSR: Yes, except technology for commodities controlled by ECCN 4A003.b or ECCN 4A003.c is limited to technology for computers or electronic assemblies with an ‘‘Adjusted Peak Performance’’ (‘‘APP’’) not exceeding 0.1 Weighted TeraFLOPS (WT). APP: * * *. List of Items Controlled Unit: * * * Related Controls: * * * Related Definitions: * * * Items: a. ‘‘Technology’’ according to the General Technology Note, for the ‘‘development,’’ ‘‘production,’’ or ‘‘use’’ of equipment or ‘‘software’’ controlled by 4A (except 4A980, 4A993 or 4A994) or 4D (except 4D980, 4D993, 4D994). b. ‘‘Technology’’, other than that controlled by 4E001.a, specially designed or modified for the ‘‘development’’ or ‘‘production’’ of: b.1. ‘‘Digital computers’’ having an ‘‘Adjusted Peak Performance’’ (‘‘APP’’) exceeding 0.04 Weighted TeraFLOPS (WT); or b.2. ‘‘Electronic assemblies’’ specially designed or modified for enhancing performance by aggregation of processors so that the ‘‘APP’’ of the aggregation exceeds the limit in 4E001.b.1. Dated: April 27, 2006. Eileen M. Albanese, Director, Office of Exporter Services. [FR Doc. 06–4123 Filed 5–1–06; 8:45 am] rmajette on PROD1PC67 with RULES BILLING CODE 3510–33–P VerDate Aug<31>2005 14:26 May 01, 2006 Jkt 208001 Current Good Manufacturing Practice Regulation and Investigational New Drugs; Withdrawal AGENCY: Food and Drug Administration, HHS. ACTION: PO 00000 25747 For the reasons set forth in the preamble of this notice, and under the authority of the Federal Food, Drug, and Cosmetic Act, and under authority delegated to the Commissioner of Food and Drugs, the revision of 21 CFR part 210, published at 71 FR 2458 (January 17, 2006), is withdrawn. Dated: April 25, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 06–4091 Filed 5–1–06; 8:45 am] BILLING CODE 4160–01–S Direct final rule; withdrawal. Frm 00009 Fmt 4700 Sfmt 4700 DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Part 1 [TD 9253] RIN 1545–AY92 Revisions to Regulations Relating to Withholding of Tax on Certain U.S. Source Income Paid to Foreign Persons and Revisions of Information Reporting Regulations; Correction Internal Revenue Service (IRS), Treasury. ACTION: Correcting amendment. AGENCY: SUMMARY: This document corrects final regulations and removal of temporary regulations (TD 9253) that was published in the Federal Register on Tuesday, March 14, 2006 (71 FR 13003) relating to the withholding of tax under section 1441 on certain U.S. source income paid to foreign persons and related requirements governing collection, deposit, refunds, and credits of withheld amounts under sections 1461 through 1463. DATES: This correction is effective March 14, 2006. FOR FURTHER INFORMATION CONTACT: Ethan Atticks, (202) 622–3840 (not a toll-free number). SUPPLEMENTARY INFORMATION: Background The final regulations and removal of temporary regulations (TD 9253) that is the subject of this correction are under section 1441 of the Internal Revenue Code. Need for Correction As published, TD 9253 contains an error that may prove to be misleading and is in need of clarification. List of Subjects in 26 CFR Part 1 Income taxes, Reporting and recordkeeping requirements. E:\FR\FM\02MYR1.SGM 02MYR1

Agencies

[Federal Register Volume 71, Number 84 (Tuesday, May 2, 2006)]
[Rules and Regulations]
[Page 25747]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-4091]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 210

[Docket No. 2005N-0285]


Current Good Manufacturing Practice Regulation and 
Investigational New Drugs; Withdrawal

AGENCY: Food and Drug Administration, HHS.

ACTION: Direct final rule; withdrawal.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is withdrawing the 
direct final rule that published in the Federal Register of January 17, 
2006, to amend its current good manufacturing practice (CGMP) 
regulations for human drugs, including biological products, to exempt 
most investigational ``Phase 1'' drugs from complying with the 
requirements in FDA's regulations. FDA is withdrawing the rule because 
significant adverse comments were received.

DATES: The revision of 21 CFR part 210, published at 71 FR 2458 
(January 17, 2006), is withdrawn as of May 2, 2006.

FOR FURTHER INFORMATION CONTACT:
    Monica Caphart, Center for Drug Evaluation and Research (HFD-320), 
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 
301-827-9047, or
    Christopher Joneckis, Food and Drug Administration, Center for 
Biologics Evaluation and Research (HFM-1), 1401 Rockville Pike, 
Rockville, MD 20852, 301-435-5681.

SUPPLEMENTARY INFORMATION: FDA published a direct final rule on January 
17, 2006 (71 FR 2458), that was intended to revise the current good 
manufacturing practice (CGMP) regulations for human drugs, including 
biological products, to exempt most investigational ``Phase 1'' drugs 
from complying with the requirements in FDA's regulations. In response 
to the direct final rule, the agency received significant adverse 
comments about the proposed revisions to the rule.
    Under FDA's direct final rule procedures, the receipt of any 
significant adverse comment will result in the withdrawal of the direct 
final rule. Thus, this direct final rule is being withdrawn, effective 
immediately. Comments received by the agency regarding the withdrawn 
rule will be considered in developing a final rule using the usual 
Administrative Procedure Act notice-and-comment procedures.
    For the reasons set forth in the preamble of this notice, and under 
the authority of the Federal Food, Drug, and Cosmetic Act, and under 
authority delegated to the Commissioner of Food and Drugs, the revision 
of 21 CFR part 210, published at 71 FR 2458 (January 17, 2006), is 
withdrawn.

    Dated: April 25, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 06-4091 Filed 5-1-06; 8:45 am]
BILLING CODE 4160-01-S

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.