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Federal Register / Vol. 71, No.

84 / Tuesday, May 2, 2006 / Rules and Regulations 25747

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(the Commerce Control List), Category 17, 2006), is withdrawn.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

regarding the withdrawn rule will be and is in need of clarification.


considered in developing a final rule
using the usual Administrative List of Subjects in 26 CFR Part 1
Procedure Act notice-and-comment Income taxes, Reporting and
procedures. recordkeeping requirements.

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