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34652 Federal Register / Vol. 70, No.

114 / Wednesday, June 15, 2005 / Rules and Regulations

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

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