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25746 Federal Register / Vol. 71, No.

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

DEPARTMENT OF COMMERCE ‘‘applies’’ should have been ‘‘applied’’ decrease may be reduced over time as
and the second reference to ‘‘9B005’’ higher performance systems are
Bureau of Industry and Security should have been ‘‘9B006.’’ ECCN marketed. Send comments regarding
9B006 controls certain acoustic these burden estimates or any other
15 CFR Part 774 vibration test equipment. aspect of these collections of
The rule also revised Export Control information, including suggestions for
[Docket No. 060404096–6112–02]
Classification Number (ECCN) 4E001. reducing the burden, to OMB Desk
RIN 0694–AD66 The regulatory text for ECCN 4E001 Officer, New Executive Office Building,
appeared on page 20894 and contained Washington, DC 20503; and to the
Implementation of New Formula for two errors. The first error was in the Office of Administration, Bureau of
Calculating Computer Performance: License Exception TSR paragraph of the Industry and Security, Department of
Adjusted Peak Performance (APP) in License Exceptions section. The phrase Commerce, 14th and Pennsylvania
Weighted TeraFLOPS; Bulgaria; XP ‘‘ ‘Adjusted Peak Performance’ (‘APP’) Avenue, NW., Room 6883, Washington,
and MT Controls exceeding 0.1 Weighted TeraFLOPS DC 20230.
AGENCY: Bureau of Industry and (WT)’’ should have stated ‘‘ ‘Adjusted 3. This rule does not contain policies
Security, Commerce. Peak Performance’ (‘APP’) not exceeding with Federalism implications as that
0.1 Weighted TeraFLOPS (WT)’’ term is defined under E.O. 13132.
ACTION: Correcting amendments.
(emphasis added). The second error 4. The provisions of the
SUMMARY: This document corrects four occurred in paragraph .b.2 of the Items Administrative Procedure Act (5 U.S.C.
errors that appeared in a rule published paragraph in the ‘‘List of Items 553) requiring notice of proposed
by the Bureau of Industry and Security Controlled’’ section. The reference to rulemaking, the opportunity for public
on April 24, 2006 (71 FR 20876). That ‘‘4D001.b.1’’ should have stated participation, and a delay in effective
rule implemented a new formula for ‘‘4E001.b.1.’’ ECCN 4E001.b.1 controls date, are inapplicable because this
computer performance as agreed to by certain technology that is specially regulation involves a military and
the Wassenaar Arrangement, moved designed or modified for the foreign affairs function of the United
Bulgaria from Computer Tier 3 to development or production of certain States (5 U.S.C. 553(a)(1)). Further, no
Computer Tier 1, and made other digital computers. other law requires that a notice of
related technical changes. This document corrects all four errors. proposed rulemaking and an
DATES: Effective May 2, 2006. Rulemaking Requirements opportunity for public comment be
FOR FURTHER INFORMATION CONTACT: For 1. This final rule has been determined given for this final rule. Because a
questions of a general nature contact to be not significant for purposes of E.O. notice of proposed rulemaking and an
Sharron Cook, Office of Exporter 12866. opportunity for public comment are not
Services, Regulatory Policy Division at 2. Notwithstanding any other required to be given for this rule under
(202) 482–2440 or e-mail: provision of law, no person is required the Administrative Procedure Act or by
scook@bis.doc.gov. to respond to, nor shall any person be any other law, the analytical
For questions of a technical nature subject to a penalty for failure to comply requirements of the Regulatory
contact: Joseph Young, Office of with a collection of information, subject Flexibility Act (5 U.S.C. 601 et seq.) are
National Security and Technology to the requirements of the Paperwork not applicable. Therefore, this
Transfer Controls at 202–482–4197 or e- Reduction Act of 1995 (44 U.S.C. 3501 regulation is issued in final form.
mail: jyoung@bis.doc.gov. et seq.) (PRA), unless that collection of Although there is no formal comment
SUPPLEMENTARY INFORMATION: information displays a currently valid period, public comments on this
Office of Management and Budget regulation are welcome on a continuing
Background (OMB) Control Number. This rule basis. Comments should be submitted to
On April 24, 2006, the Bureau of involves three collections of information Sharron Cook, Office of Exporter
Industry and Security published a final subject to the PRA. The first collection Services, Bureau of Industry and
rule to implement the Wassenaar has been approved by OMB under Security, Department of Commerce, P.O.
Arrangement’s December 2005 control number 0694–0088, ‘‘Multi- Box 273, Washington, DC 20044.
agreement to revise the formula for Purpose Application,’’ and carries a List of Subjects in 15 CFR Part 774
calculating computer performance from burden hour estimate of 58 minutes for
Composite Theoretical Performance a manual or electronic submission. The Exports, Reporting and recordkeeping
(CTP) measured in Millions of second collection has been approved by requirements.
Theoretical Operations Per Second OMB under control number 0694–0106, ■ For the reasons set forth in the
(MTOPS) to Adjusted Peak Performance ‘‘Reporting and Recordkeeping preamble, 15 CFR part 774 is corrected
(APP) measured in Weighted Requirements under the Wassenaar by making the following correcting
TeraFLOPS (Trillion Floating point Arrangement,’’ and carries a burden amendements:
Operations Per Second) (WT) (71 FR hour estimate of 21 minutes for a
20876) and to make certain other manual or electronic submission. The PART 774—[CORRECTED]
technical changes to the EAR. One such third collection has been approved by
■ 1. The authority citation for part 774
change was to remove missile OMB under control number 0694–0073,
continues to read as follows:
technology as a reason for control from ‘‘Export Controls of High Performance
some Export Control Classification Computers,’’ and carries a burden hour Authority: 50 U.S.C. app. 2401 et seq.; 50
Numbers (ECCNs). In the preamble to estimate of 78 hours for a manual or U.S.C. 1701 et seq.; 10 U.S.C. 7420; 10 U.S.C.
the rule, the discussion of the changes electronic submission. This rule is 7430(e); 18 U.S.C. 2510 et seq.; 22 U.S.C.
287c, 22 U.S.C. 3201 et seq., 22 U.S.C. 6004;
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made to Missile Technology Controls expected to result in an immediate 30 U.S.C. 185(s), 185(u); 42 U.S.C. 2139a; 42
contained two typographical errors. In decrease in license applications, and in U.S.C. 6212; 43 U.S.C. 1354; 46 U.S.C. app.
the second sentence under the heading associated reporting and support 466c; 50 U.S.C. app. 5; Sec. 901–911, Pub. L.
‘‘Missile Technology Controls’’ in the documentation requirements, for high 106–387; Sec. 221, Pub. L. 107–56; E.O.
third column on page 20878, the word performance computers; however, this 13026, 61 FR 58767, 3 CFR, 1996 Comp., p.

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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
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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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