Medical Devices; Medical Device Reporting; Confirmation of Effective Date, 34652 [05-11786]

Download as PDF 34652 Federal Register / Vol. 70, No. 114 / Wednesday, June 15, 2005 / Rules and Regulations normal business hours from our Help line at (202) 502–8222 or the Public Reference Room at (202) 502–8371 Press 0, TTY (202) 502–8659. E-Mail the Public Reference Room at public.referenceroom@ferc.gov. Effective Date 11. These regulations are effective immediately upon publication in the Federal Register. In accordance with 5 U.S.C. 553(d)(3), the Commission finds that good cause exists to make this Final Rule effective immediately. It concerns only a matter of internal operations and will not affect the rights of persons appearing before the Commission. There is therefore no reason to make it effective at a later time. 12. The provisions of 5 U.S.C. 801 regarding Congressional review of Final Rules do not apply to this Final Rule, because the rule concerns agency procedure and practice and will not substantially affect the rights of nonagency parties. 13. The Commission is issuing this as a final rule without a period for public comment. Under 5 U.S.C. 553(b), notice and comment procedures are unnecessary where a rulemaking concerns only agency procedure and practice, or where the agency finds that notice and comment is unnecessary. This rule concerns only matters of agency procedure and will not significantly affect regulated entities or the general public. List of Subjects in 18 CFR Part 375 Authority delegations (Government agencies), Seals and insignia, Sunshine Act. By the Commission. Linda Mitry, Deputy Secretary. In consideration of the foregoing, the Commission amends part 375, chapter I, title 18, Code of Federal Regulations, as follows. I PART 375—THE COMMISSION 1. The authority citation for part 375 continues to read as follows: I Authority: 5 U.S.C. 551–557; 15 U.S.C. 717–717w, 3301–3432; 16 U.S.C. 791–825r, 2601–2645; 42 U.S.C. 7101–7352. 2. Section 375.307 is amended by revising paragraphs (f)(3) and (k)(4) and by adding paragraph (f)(4) to read as follows: I § 375.307 Delegations to the Director of the Office of Markets, Tariffs and Rates. * * * * * (f) * * * (3) Advise the filing party of any actions taken under paragraph (f)(1) or VerDate jul<14>2003 16:54 Jun 14, 2005 Jkt 205001 (f)(2) of this section and designate rate schedules, rate schedule changes, and notices of changes in rates, and the effective date hereof; and (4) Refer to the Chief Administrative Law Judge (Chief ALJ), with the Chief ALJ’s concurrence, uncontested interim natural gas rate motions that would result in lower rates, pending Commission action on settlement agreements. * * * * * (k) * * * (4) Refer to the Chief Administrative Law Judge (Chief ALJ), with the Chief ALJ’s concurrence, uncontested interim electric rate motions that would result in lower rates, pending Commission action on settlement agreements. * * * * * I 3. Section 375.311 is revised to read as follows: § 375.311 Delegations to the Director, Office of External Affairs. The Commission authorizes the Director, Office of External Affairs, or the Director’s designee, to take all actions required or permitted to be taken by the Director under Secs. 388.108 through 388.110 of this chapter. [FR Doc. 05–11553 Filed 6–14–05; 8:45 am] BILLING CODE 6717–01–P and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, 301–827– 2983. SUPPLEMENTARY INFORMATION: In the Federal Register of February 28, 2005 (70 FR 9516), FDA solicited comments concerning the direct final rule for a 75day period ending May 16, 2005. FDA stated that the effective date of the direct final rule would be on July 13, 2005, 60 days after the end of the comment period, unless any significant adverse comment was submitted to FDA during the comment period. FDA received 16 comments, 3 of which supported the plain language revisions and several of which requested further revisions or substantive changes to the medical device reporting rule. The agency did not receive any significant adverse comment on the plain language revisions. Authority: Therefore, under the Federal Food, Drug, and Cosmetic Act, and under authority delegated to the Commissioner of Food and Drugs, notice is given that no objections were filed in response to the February 28, 2005, direct final rule. Accordingly, the amendments issued thereby are effective July 13, 2005. Dated: June 9, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 05–11786 Filed 6–14–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration DEPARTMENT OF STATE 21 CFR Part 803 22 CFR Parts 120, 123, 124, 126, and 127 [Docket No. 2004N–0527] [Public Notice 5108] Medical Devices; Medical Device Reporting; Confirmation of Effective Date AGENCY: Food and Drug Administration, HHS. Direct final rule; confirmation of effective date. SUMMARY: The Food and Drug Administration (FDA) is confirming the effective date of July 13, 2005, for the direct final rule that appeared in the Federal Register of February 28, 2005 (70 FR 9516). The direct final rule revised the medical device reporting regulations into plain language in order to make the regulations easier to understand. This document confirms the effective date of the direct final rule. DATES: Effective date confirmed: July 13, 2005. FOR FURTHER INFORMATION CONTACT: Howard Press, Center for Devices and Radiological Health (HFZ–531), Food Frm 00026 Amendments to the International Traffic in Arms Regulations: Various Fmt 4700 Sfmt 4700 Department of State. Final rule. AGENCY: ACTION: ACTION: PO 00000 Z–RIN 1400–ZA15 SUMMARY: The Department of State is amending and/or clarifying the content of a number of provisions of the International Traffic in Arms Regulations (ITAR). The affected parts of the ITAR are: Part 120—Purpose and Definitions; Part 123—Licenses for the Export of Defense Articles; Part 124— Agreements, Off-Shore Procurement and Other Defense Services; Part 126— General Policies and Provisions; and Part 127—Violations and Penalties. See SUPPLEMENTARY INFORMATION for a description of the changes and clarifications for each respective part. DATES: Effective June 15, 2005. ADDRESSES: Interested parties are invited to submit written comments to E:\FR\FM\15JNR1.SGM 15JNR1

Agencies

[Federal Register Volume 70, Number 114 (Wednesday, June 15, 2005)]
[Rules and Regulations]
[Page 34652]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-11786]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 803

[Docket No. 2004N-0527]


Medical Devices; Medical Device Reporting; Confirmation of 
Effective Date

AGENCY: Food and Drug Administration, HHS.

ACTION: Direct final rule; confirmation of effective date.

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SUMMARY: The Food and Drug Administration (FDA) is confirming the 
effective date of July 13, 2005, for the direct final rule that 
appeared in the Federal Register of February 28, 2005 (70 FR 9516). The 
direct final rule revised the medical device reporting regulations into 
plain language in order to make the regulations easier to understand. 
This document confirms the effective date of the direct final rule.

DATES: Effective date confirmed: July 13, 2005.

FOR FURTHER INFORMATION CONTACT: Howard Press, Center for Devices and 
Radiological Health (HFZ-531), Food and Drug Administration, 1350 
Piccard Dr., Rockville, MD 20850, 301-827-2983.

SUPPLEMENTARY INFORMATION: In the Federal Register of February 28, 2005 
(70 FR 9516), FDA solicited comments concerning the direct final rule 
for a 75-day period ending May 16, 2005. FDA stated that the effective 
date of the direct final rule would be on July 13, 2005, 60 days after 
the end of the comment period, unless any significant adverse comment 
was submitted to FDA during the comment period. FDA received 16 
comments, 3 of which supported the plain language revisions and several 
of which requested further revisions or substantive changes to the 
medical device reporting rule. The agency did not receive any 
significant adverse comment on the plain language revisions.

    Authority: Therefore, under the Federal Food, Drug, and Cosmetic 
Act, and under authority delegated to the Commissioner of Food and 
Drugs, notice is given that no objections were filed in response to 
the February 28, 2005, direct final rule. Accordingly, the 
amendments issued thereby are effective July 13, 2005.

    Dated: June 9, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-11786 Filed 6-14-05; 8:45 am]
BILLING CODE 4160-01-S
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