Blood Vessels Recovered With Organs and Intended for Use in Organ Transplantation; Withdrawal, 54198 [06-7644]

Download as PDF 54198 Federal Register / Vol. 71, No. 178 / Thursday, September 14, 2006 / Rules and Regulations withholding any portion of the information and show why the information is a trade secret or commercial or financial information that is privileged or confidential. Because CBP wished to continue its practice of not requiring business submitters of commercial information to designate such information as protected from disclosure, it published an interim rule in the Federal Register (68 FR 47453) on August 11, 2003, as CBP Decision 03–02 that amended Part 103 of the CBP regulations by adding a new § 103.35 to subpart C. New § 103.35 adopted Treasury’s established disclosure procedure that had been followed by Customs since 1987 to assure the trading community that the transfer of Customs from Treasury to DHS would not affect the treatment of commercial information that business submitters provide to CBP. The comment period for the interim regulations closed on October 10, 2003. No comments were received from the public in response to the interim rule, and CBP is now adopting the interim rule as a final rule without change. This final rule is being issued in accordance with 19 CFR 0.2(a) pertaining to the authority of the Secretary of the Department of Homeland Security, or his or her designee, to issue Customs regulations that are not related to customs revenue functions. Regulatory Flexibility Act and Executive Order 12866 As discussed above, these regulations were published as an interim rule on August 11, 2003. Because no notice of proposed rulemaking was required, the provisions of the Regulatory Flexibility Act (5 U.S.C. 601 et seq.) do not apply. Further, this document does not meet the criteria for a ‘‘significant regulatory action’’ as specified in Executive Order 12866. List of Subjects in 19 CFR Part 103 Administrative practice and procedure, Confidential commercial information, Freedom of Information, Reporting and recordkeeping requirements. Amendments to the Regulations For the reasons set forth above, the interim rule amending part 103 of title 19 of the Code of Federal Regulations (19 CFR part 103), which was published in the Federal Register at 68 FR 47453 on August 11, 2003, is adopted as a final rule without change. sroberts on PROD1PC70 with RULES VerDate Aug<31>2005 20:51 Sep 13, 2006 Jkt 208001 Systems Bureau, Health Resources and Services Administration, 5600 Fishers Lane, room 12C–06, Rockville, MD 20857, 301–443– 7577. HRSA and FDA published a direct final rule in the Federal Register of May 12, 2006 (71 FR 27606), to amend the regulations to consider as part of an organ those blood vessels recovered with the organ that are intended for use in organ transplantation (HRSA regulation); and to exclude such blood vessels from the definition of human cells, tissues, and cellular and tissue-based products (FDA regulation). HRSA and FDA received significant adverse comment in response to the direct final rule. Therefore, the direct final rule is being withdrawn. HRSA and FDA intend to finalize the proposed rule after considering comments. Authority: Therefore, under the Public Health Service Act and under authority delegated to the Commissioner of Food and Drugs and to the Administrator, Health Resources and Services Administration, the direct final rule published on May 12, 2006 (71 FR 27606), is withdrawn. SUPPLEMENTARY INFORMATION: BILLING CODE 9111–14–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 1271 [Docket No. 2006N–0051] Health Resources and Services Administration 42 CFR Part 121 Blood Vessels Recovered With Organs and Intended for Use in Organ Transplantation; Withdrawal AGENCIES: Food and Drug Administration, Health Resources and Services Administration, HHS. ACTION: Direct final rule; withdrawal. SUMMARY: The Health Resources and Services Administration (HRSA) and the Food and Drug Administration (FDA) published in the Federal Register of May 12, 2006 (71 FR 27606), a direct final rule to amend the regulations to consider as part of an organ those blood vessels recovered with the organ that are intended for use in organ transplantation; and to exclude such blood vessels from the definition of human cells, tissues, and cellular and tissue-based products. The comment period closed July 26, 2006. HRSA and FDA are withdrawing the direct final rule because FDA received significant adverse comment. The agencies will consider the comments received under our usual procedures for notice and comment in connection with the notice of proposed rulemaking that was published as a companion to the direct final rule (71 FR 27649). DATES: The direct final rule published on May 12, 2006 (71 FR 27606), is withdrawn effective September 14, 2006. SUMMARY: This final rule transfers responsibility for final agency decisions in connection with Post OfficeTM box termination, caller service termination, and denial of service appeals from the Judicial Officer Department to the vice president and Consumer Advocate. DATES: Effective Date: September 1, 2006. FOR FURTHER INFORMATION CONTACT: Signing Authority I Dated: September 8, 2006. Deborah J. Spero, Acting Commissioner, Customs and Border Protection. [FR Doc. E6–15225 Filed 9–13–06; 8:45 am] FOR FURTHER INFORMATION CONTACT: For information regarding FDA’s rule: Pamela Pope, Center for Biologics Evaluation and Research (HFM–17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852–1448, 301– 827–6210. For information regarding HRSA’s rule: Jim Burdick, Division of Transplantation, Healthcare PO 00000 Frm 00004 Fmt 4700 Sfmt 4700 Dated: September 6, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 06–7644 Filed 9–13–06; 8:45 am] BILLING CODE 4160–01–S POSTAL SERVICE 39 CFR Parts 111 and 958 Post Office Box and Caller Service Postal Service. Final rule. AGENCY: ACTION: Mr. Anthony F. Alverno, Chief Counsel, Customer Programs, 202–268–2997. SUPPLEMENTARY INFORMATION: At present, if a postmaster denies a customer’s application for Post Office box or caller service or terminates a customer’s Post Office box or caller service, the postmaster must issue a written letter explaining his or her decision and include a copy of the E:\FR\FM\14SER1.SGM 14SER1

Agencies

[Federal Register Volume 71, Number 178 (Thursday, September 14, 2006)]
[Rules and Regulations]
[Page 54198]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-7644]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1271

[Docket No. 2006N-0051]

Health Resources and Services Administration

42 CFR Part 121


Blood Vessels Recovered With Organs and Intended for Use in Organ 
Transplantation; Withdrawal

AGENCIES: Food and Drug Administration, Health Resources and Services 
Administration, HHS.

ACTION: Direct final rule; withdrawal.

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SUMMARY: The Health Resources and Services Administration (HRSA) and 
the Food and Drug Administration (FDA) published in the Federal 
Register of May 12, 2006 (71 FR 27606), a direct final rule to amend 
the regulations to consider as part of an organ those blood vessels 
recovered with the organ that are intended for use in organ 
transplantation; and to exclude such blood vessels from the definition 
of human cells, tissues, and cellular and tissue-based products. The 
comment period closed July 26, 2006. HRSA and FDA are withdrawing the 
direct final rule because FDA received significant adverse comment. The 
agencies will consider the comments received under our usual procedures 
for notice and comment in connection with the notice of proposed 
rulemaking that was published as a companion to the direct final rule 
(71 FR 27649).

DATES: The direct final rule published on May 12, 2006 (71 FR 27606), 
is withdrawn effective September 14, 2006.

FOR FURTHER INFORMATION CONTACT:
    For information regarding FDA's rule: Pamela Pope, Center for 
Biologics Evaluation and Research (HFM-17), Food and Drug 
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448, 301-827-6210.
    For information regarding HRSA's rule: Jim Burdick, Division of 
Transplantation, Healthcare Systems Bureau, Health Resources and 
Services Administration, 5600 Fishers Lane, room 12C-06, Rockville, MD 
20857, 301-443-7577.

SUPPLEMENTARY INFORMATION: HRSA and FDA published a direct final rule 
in the Federal Register of May 12, 2006 (71 FR 27606), to amend the 
regulations to consider as part of an organ those blood vessels 
recovered with the organ that are intended for use in organ 
transplantation (HRSA regulation); and to exclude such blood vessels 
from the definition of human cells, tissues, and cellular and tissue-
based products (FDA regulation).
    HRSA and FDA received significant adverse comment in response to 
the direct final rule. Therefore, the direct final rule is being 
withdrawn. HRSA and FDA intend to finalize the proposed rule after 
considering comments.
    Authority: Therefore, under the Public Health Service Act and under 
authority delegated to the Commissioner of Food and Drugs and to the 
Administrator, Health Resources and Services Administration, the direct 
final rule published on May 12, 2006 (71 FR 27606), is withdrawn.

    Dated: September 6, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 06-7644 Filed 9-13-06; 8:45 am]
BILLING CODE 4160-01-S