Medical Devices; Medical Device Reporting; Baseline Reports; Confirmation of Effective Date, 53686 [E8-21756]
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53686
Federal Register / Vol. 73, No. 181 / Wednesday, September 17, 2008 / Rules and Regulations
information. Therefore, a freedom of
information summary is not required.
The agency has determined under 21
CFR 25.33(a)(1) that this action is of a
type that does not individually or
cumulatively have a significant effect on
the human environment. Therefore,
neither an environmental assessment
nor an environmental impact statement
is required.
This rule does not meet the definition
of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because
it is a rule of ‘‘particular applicability.’’
Therefore, it is not subject to the
congressional review requirements in 5
U.S.C. 801–808.
List of Subjects in 21 CFR Part 520
Animal drugs.
■ Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs and redelegated to
the Center for Veterinary Medicine, 21
CFR part 520 is amended as follows:
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
1. The authority citation for 21 CFR
part 520 continues to read as follows:
■
Authority: 21 U.S.C. 360b.
2. In 520.2215, revise paragraph (c)(3)
to read as follows:
■
§ 520.2215 Sulfadiazine/pyrimethamine
suspension.
*
*
*
*
*
(c) * * *
(3) Limitations. Do not use in horses
intended for human consumption.
Federal law restricts this drug to use by
or on the order of a licensed
veterinarian.
Dated: September 5, 2008.
William T. Flynn,
Acting Director, Center for Veterinary
Medicine.
[FR Doc. E8–21625 Filed 9–16–08; 8:45 am]
BILLING CODE 4160–01–S
MILLENNIUM CHALLENGE
CORPORATION
List of Subjects in 22 Part 1304
Freedom of Information Act
Procedures.
■ For the reasons set forth in the
preamble, the Millennium Challenge
Corporation adds 22 CFR part 1304 as
follows:
[Docket No. FDA–2008–N–0310]
Medical Devices; Medical Device
Reporting; Baseline Reports;
Confirmation of Effective Date
Food and Drug Administration,
HHS.
Direct final rule; confirmation of
effective date.
ACTION:
Jkt 214001
PART 1304—FREEDOM OF
INFORMATION ACT PROCEDURES
Sec.
1304.1 General Provisions.
1304.2 Definitions.
1304.3 Records available to the public.
1304.4 Requests for records.
1304.5 Responsibility for responding to
requests.
1304.6 Records not disclosed.
1304.7 Confidential commercial
information.
1304.8 Appeals.
1304.9 Fees.
Millennium Challenge
Corporation.
ACTION: Final rule.
21 CFR Part 803
mstockstill on PROD1PC66 with RULES
Dated: September 11, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–21756 Filed 9–16–08; 8:45 am]
AGENCY:
Food and Drug Administration
16:59 Sep 16, 2008
Authority: Therefore, under the Federal
Food, Drug, and Cosmetic Act and the Public
Health Service Act, and under authority
delegated to the Commissioner of Food and
Drugs, the amendments issued thereby
become effective on October 27, 2008.
Regulations Implementing the
Freedom of Information Act
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
VerDate Aug<31>2005
In the
Federal Register of June 13, 2008 (73 FR
33692), FDA solicited comments
concerning the direct final rule for a 75day period ending August 27, 2008.
FDA stated that the effective date of the
direct final rule would be on October
27, 2008, 60 days after the end of the
comment period, unless any significant
adverse comment was submitted to FDA
during the comment period. FDA did
not receive any significant adverse
comments.
SUPPLEMENTARY INFORMATION:
Millennium Challenge Corporation
public records.
DATES: This final rule is effective on
September 17, 2008.
ADDRESSES: Send comments to John
Mantini, FOIA Officer, Office of the
General Counsel, Millennium Challenge
Corporation, 875 Fifteenth Street, NW.,
Washington, DC 20005–2221.
FOR FURTHER INFORMATION CONTACT: John
Mantini, FOIA Officer, 202–521–3863.
SUPPLEMENTARY INFORMATION: The
Millennium Challenge Act (MCA) of
2003 established a new federal agency
called the Millennium Challenge
Corporation. Congress enacted the
Freedom of Information Act (FOIA) in
1966 and last modified it with the
Electronic Freedom of Information Act
amendments of 1996. On August 28,
2007, the Millennium Challenge
Corporation published a proposed rule
in the Federal Register, 72 FR 49238,
Aug. 28, 2007 to outline its procedures
to implement the FOIA regulations and
requested public comments. The
Millennium Challenge Corporation
received no comments during the 60day comment period. The Millennium
Challenge Corporation’s final
regulations are identical to those in the
proposed rule.
This final rule addresses
electronically available documents,
procedures for making requests, agency
handling of requests, records not
disclosed, changes in fees, and public
reading rooms as well as other related
provisions.
22 CFR Part 1304
BILLING CODE 4160–01–S
AGENCY:
SUMMARY: The Food and Drug
Administration (FDA) is confirming the
effective date of October 27, 2008, for
the final rule that appeared in the
Federal Register of June 13, 2008 (73 FR
33692). The direct final rule amends the
Medical Device Reporting regulation by
removing the requirement for baseline
reports. This document confirms the
effective date of the direct final rule.
DATES: Effective date confirmed:
October 27, 2008.
FOR FURTHER INFORMATION CONTACT:
Howard A. Press, Center for Devices and
Radiological Health (HFZ–531), Food
and Drug Administration, 1350 Piccard
Dr., Rockville, MD 20850, 240–276–
3457.
SUMMARY: The Millennium Challenge
Corporation is issuing a final rule to
update its Freedom of Information Act
regulations. The purpose of this final
rule is to outline the procedures by
which the Millennium Challenge
Corporation proposes to implement the
relevant provisions of the Freedom of
Information Act as required under that
statute. This document will assist
interested parties in obtaining access to
PO 00000
Frm 00002
Fmt 4700
Sfmt 4700
Authority: 5 U.S.C. 552, as amended.
§ 1304.1
General Provisions.
This part contains the regulations the
Millennium Challenge Corporation
(MCC) follows in implementing the
E:\FR\FM\17SER1.SGM
17SER1
]]>Agencies
[Federal Register Volume 73, Number 181 (Wednesday, September 17, 2008)]
[Rules and Regulations]
[Page 53686]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-21756]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 803
[Docket No. FDA-2008-N-0310]
Medical Devices; Medical Device Reporting; Baseline Reports;
Confirmation of Effective Date
AGENCY: Food and Drug Administration, HHS.
ACTION: Direct final rule; confirmation of effective date.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is confirming the
effective date of October 27, 2008, for the final rule that appeared in
the Federal Register of June 13, 2008 (73 FR 33692). The direct final
rule amends the Medical Device Reporting regulation by removing the
requirement for baseline reports. This document confirms the effective
date of the direct final rule.
DATES: Effective date confirmed: October 27, 2008.
FOR FURTHER INFORMATION CONTACT: Howard A. Press, Center for Devices
and Radiological Health (HFZ-531), Food and Drug Administration, 1350
Piccard Dr., Rockville, MD 20850, 240-276-3457.
SUPPLEMENTARY INFORMATION: In the Federal Register of June 13, 2008 (73
FR 33692), FDA solicited comments concerning the direct final rule for
a 75-day period ending August 27, 2008. FDA stated that the effective
date of the direct final rule would be on October 27, 2008, 60 days
after the end of the comment period, unless any significant adverse
comment was submitted to FDA during the comment period. FDA did not
receive any significant adverse comments.
Authority: Therefore, under the Federal Food, Drug, and Cosmetic
Act and the Public Health Service Act, and under authority delegated
to the Commissioner of Food and Drugs, the amendments issued thereby
become effective on October 27, 2008.
Dated: September 11, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-21756 Filed 9-16-08; 8:45 am]
BILLING CODE 4160-01-S
