Withdrawal of Certain Proposed Rules and Other Proposed Actions, 75625-75626 [E8-29331]
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Federal Register / Vol. 73, No. 240 / Friday, December 12, 2008 / Proposed Rules
penalty for failure to comply with a
collection of information subject to the
requirements of the Paperwork
Reduction Act unless that collection of
information displays a current valid
OMB Control Number.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Executive Order 12866
[Docket No. FDA–2008–N–0622]
This rule has been determined to be
significant for purposes of Executive
Order 12866.
Withdrawal of Certain Proposed Rules
and Other Proposed Actions
Executive Order 13132
HHS.
ACTION:
List of Subjects in 19 CFR Part 360
Administrative practice and
procedure, Business and industry,
Imports, Reporting and recordkeeping
requirements, Steel.
For reasons discussed in the
preamble, we propose amending 19 CFR
360 as follows:
PART 360—STEEL IMPORT
MONITORING AND ANALYSIS SYSTEM
1. The authority citation for part 360
continues to read as follows:
Authority: 13 U.S.C. 301(a) and 302.
2. Section 360.105 is revised to read
as follows.
§ 360.105 Duration of the steel import
licensing requirement.
The licensing program will be in
effect through March 21, 2013, but may
be extended upon review and
notification in the Federal Register
prior to this expiration date. Licenses
will be required on all subject imports
entered during this period, even if the
entry summary documents are not filed
until after the expiration of this
program. The licenses will be valid for
10 business days after the expiration of
this program to allow for the final filing
of required Customs documentation.
Dated: November 26, 2008.
Christopher A. Padilla,
Under Secretary for International Trade.
[FR Doc. E8–28683 Filed 12–11–08; 8:45 am]
rwilkins on PROD1PC63 with PROPOSALS
BILLING CODE 3510–DS–P
16:22 Dec 11, 2008
21 CFR Chapter I
AGENCY:
This rule does not contain policies
with federalism implications as that
term is defined in EO 13132.
VerDate Aug<31>2005
Food and Drug Administration
Jkt 217001
Food and Drug Administration,
Notice of withdrawal.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
withdrawal of a certain advance notice
of proposed rulemaking (ANPRM) and
proposed rules (NPRMs) that published
in the Federal Register more than 5
years ago. These proposals are no longer
considered viable candidates for final
action at this time.
DATES: The proposals identified in this
document are withdrawn as of
December 12, 2008.
FOR FURTHER INFORMATION CONTACT:
For Center for Drug Evaluation and
Research actions: Michael D.
Bernstein, Office of Regulatory
Policy, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm.
6240, Silver Spring, MD 20993–
0002, 301–796–3478.
For Center for Food Safety and
Nutrition actions: Felicia Ellison,
Center for Food Safety and Applied
Nutrition (HFS–265), Food and
Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD
20740, 301–436–1264.
For all other actions: Erik Mettler,
Office of the Commissioner, Food
and Drug Administration, 10903
New Hampshire Ave., WO1, Rm.
4324, Silver Spring, MD 20993,
301–796–4830.
SUPPLEMENTARY INFORMATION:
I. Background
In 1990, the Food and Drug
Administration (FDA) began the process
of conducting periodic, comprehensive
reviews of its regulations process that
included reviewing the backlog of
ANPRMs, notices of proposed
rulemaking, and other notices for which
no final action or withdrawal notice had
been issued. In the Federal Register of
December 30, 1991 (56 FR 67440), FDA
issued its first notice withdrawing 89
proposed rules that had published
before December 31, 1985, but had
never been finalized. Then again, in the
Federal Register of January 20, 1994 (59
PO 00000
Frm 00002
Fmt 4702
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75625
FR 3042), the agency withdrew an
additional nine outstanding proposed
rules.
FDA published a notice in the Federal
Register of April 22, 2003 (68 FR
19766), announcing its intent to
withdraw 84 proposed rules and other
proposed actions that had published in
the Federal Register more than 5 years
ago, but that had never been finalized.
Included in this list were 19 proposed
rules that were originally proposed for
withdrawal in 1991, but at that time the
agency decided to defer its decision to
withdraw or finalize them until a later
date. In the Federal Register of
November 26, 2004 (69 FR 68831), the
agency withdrew 81 proposed rules and
other proposed actions.
The agency has conducted another
review of its regulations process and
found withdrawal is justified for four
proposals.
II. NPRMs and ANPRMs To Be
Withdrawn
Title: Labeling Declaration for FD&C
Yellow No. 6 and FD&C Yellow No. 5;
Amendment of Standard of Identity for
Cheese Product (Proposed Rule, 92N–
0334 (60 FR 37611, July 21, 1995))
Reason: Since the publication of this
proposal, the underlying science and
economic analyses have become
outdated.
Title: Over-the-Counter Drug Products
Containing Phenylpropanolamine;
Required Labeling (Proposed Rule, 95N–
0060 (61 FR 5912, February 14, 1996))
Reason: The agency’s ‘‘Over-theCounter Drug Products Containing
Phenylpropanolamine; Required
Labeling’’ (Proposed Rule, 95N–0060
(61 FR 5912, February 14, 1996)) has
been superseded by the issuance of a
new proposed rule entitled
‘‘Phenylpropanolamine-Containing Drug
Products for Over-the-Counter Human
Use; Tentative Final Monographs’’
(1976N–0052N and 1981N–0022 (70 FR
75988, December 22, 2005)).
Title: Reinvention of Administrative
Procedures Regulations (ANPRM, 96N–
0163 (61 FR 28116, June 4, 1996))
Reason: The ANPRM requested
comments on whether there should be
possible changes to various existing
administrative regulations under the
‘‘Reinventing Government’’ initiative.
Since publication, some of the
regulations have been addressed in
separate rulemakings. The remaining
regulations are not under current
consideration for rulemaking.
Title: Marketing Exclusivity and
Patent Provisions for Certain Antibiotic
Drugs (Proposed Rule, 99N–3088 (65 FR
3623, January 24, 2000))
E:\FR\FM\12DEP1.SGM
12DEP1
75626
Federal Register / Vol. 73, No. 240 / Friday, December 12, 2008 / Proposed Rules
Reason: The provision of law which
‘‘Marketing Exclusivity and Patent
Provisions for Certain Antibiotic Drugs’’
(Proposed Rule) was intended to
implement, section 125(d) of the
Medicare Modernization Act (Public
Law 105–115), was superseded by the
enactment of Public Law 110–379 (S.
3560) on October 8, 2008, which
included new provisions on marketing
exclusivity and patent provisions for
certain antibiotic drugs.
The withdrawal of the proposals
identified in this document does not
preclude the agency from reinstituting
rulemaking concerning the issues
addressed in the proposals listed in the
previous paragraphs. Should we decide
to undertake such rulemakings in the
future, we will re-propose the actions
and provide new opportunities for
comment. Furthermore, this notice is
only intended to address the specific
actions identified in this document, and
not any other pending proposals that the
agency has issued or is considering.
The agency notes that withdrawal of
a proposal does not necessarily mean
that the preamble statement of the
proposal no longer reflects the current
position of FDA on the matter
addressed. You may wish to review the
agency’s Web site (https://www.fda.gov)
for any current guidance on the matter.
III. Withdrawal of the Proposed Rules
and ANPRM
For the reasons described in this
document, FDA is withdrawing the
aforementioned proposed rules and
ANPRM.
Dated: December 3, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–29331 Filed 12–11–08; 8:45 am]
BILLING CODE 4160–01–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 52
[EPA–R09–OAR–2008–0863; FRL–8751–5]
Revisions to the California State
Implementation Plan, Approval of the
Ventura County Air Pollution Control
District—Reasonably Available Control
Technology Analysis
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
SUMMARY: EPA is proposing to approve
revisions to the Ventura County Air
Pollution Control District (VCAPCD)
portion of the California State
Implementation Plan (SIP). These
revisions concern the District’s analysis
of whether its rules meet Reasonably
Available Control Technology (RACT)
under the 8-hour ozone National
Ambient Air Quality Standard
(NAAQS). We are approving the
analysis under the Clean Air Act as
amended in 1990 (CAA or the Act). We
are taking comments on this proposal
and plan to follow with a final action.
DATES: Any comments must arrive by
January 12, 2009.
ADDRESSES: Submit comments,
identified by docket number EPA–R09–
OAR–2008–0863, by one of the
following methods:
1. Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
on-line instructions.
2. E-mail: steckel.andrew@epa.gov.
3. Mail or deliver: Andrew Steckel
(Air-4), U.S. Environmental Protection
Agency Region IX, 75 Hawthorne Street,
San Francisco, CA 94105–3901.
Instructions: All comments will be
included in the public docket without
change and may be made available
online at https://www.regulations.gov,
including any personal information
provided, unless the comment includes
Confidential Business Information (CBI)
or other information whose disclosure is
restricted by statute. Information that
you consider CBI or otherwise protected
should be clearly identified as such and
should not be submitted through
https://www.regulations.gov or e-mail.
https://www.regulations.gov is an
‘‘anonymous access’’ system, and EPA
will not know your identity or contact
information unless you provide it in the
body of your comment. If you send email directly to EPA, your e-mail
address will be automatically captured
and included as part of the public
comment. If EPA cannot read your
comment due to technical difficulties
and cannot contact you for clarification,
EPA may not be able to consider your
comment.
Docket: The index to the docket for
this action is available electronically at
https://www.regulations.gov and in hard
copy at EPA Region IX, 75 Hawthorne
Street, San Francisco, California. While
all documents in the docket are listed in
the index, some information may be
publicly available only at the hard copy
location (e.g., copyrighted material), and
some may not be publicly available in
either location (e.g., CBI). To inspect the
hard copy materials, please schedule an
appointment during normal business
hours with the contact listed in the FOR
FURTHER INFORMATION CONTACT section.
FOR FURTHER INFORMATION CONTACT:
Stanley Tong, EPA Region IX, (415)
947–4122, tong.stanley@epa.gov.
SUPPLEMENTARY INFORMATION:
Throughout this document, ‘‘we,’’ ‘‘us’’
and ‘‘our’’ refer to EPA.
Table of Contents
I. The State’s Submittal
A. What document did the State submit?
B. Are there other versions of this
document?
C. What is the purpose of the submitted
RACT SIP analysis?
II. EPA’s Evaluation and Action
A. How is EPA evaluating the RACT SIP
analysis?
B. Does the analysis meet the evaluation
criteria?
C. EPA recommendations to strengthen the
SIP
D. Public Comment and Final Action
III. Statutory and Executive Order Reviews
I. The State’s Submittal
A. What document did the State submit?
Table 1 lists the document addressed
by this proposal with the date that it
was adopted by the local air agency and
submitted by the California Air
Resources Board.
TABLE 1—SUBMITTED DOCUMENT
rwilkins on PROD1PC63 with PROPOSALS
Local agency
Document
VCAPCD .............................................
2006 Reasonably Available Control Technology Analysis .............................
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12DEP1
06/27/06
Submitted
01/31/07
Agencies
[Federal Register Volume 73, Number 240 (Friday, December 12, 2008)]
[Proposed Rules]
[Pages 75625-75626]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-29331]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Chapter I
[Docket No. FDA-2008-N-0622]
Withdrawal of Certain Proposed Rules and Other Proposed Actions
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of withdrawal.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
withdrawal of a certain advance notice of proposed rulemaking (ANPRM)
and proposed rules (NPRMs) that published in the Federal Register more
than 5 years ago. These proposals are no longer considered viable
candidates for final action at this time.
DATES: The proposals identified in this document are withdrawn as of
December 12, 2008.
FOR FURTHER INFORMATION CONTACT:
For Center for Drug Evaluation and Research actions: Michael D.
Bernstein, Office of Regulatory Policy, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6240, Silver Spring, MD 20993-0002, 301-796-3478.
For Center for Food Safety and Nutrition actions: Felicia Ellison,
Center for Food Safety and Applied Nutrition (HFS-265), Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-
436-1264.
For all other actions: Erik Mettler, Office of the Commissioner,
Food and Drug Administration, 10903 New Hampshire Ave., WO1, Rm. 4324,
Silver Spring, MD 20993, 301-796-4830.
SUPPLEMENTARY INFORMATION:
I. Background
In 1990, the Food and Drug Administration (FDA) began the process
of conducting periodic, comprehensive reviews of its regulations
process that included reviewing the backlog of ANPRMs, notices of
proposed rulemaking, and other notices for which no final action or
withdrawal notice had been issued. In the Federal Register of December
30, 1991 (56 FR 67440), FDA issued its first notice withdrawing 89
proposed rules that had published before December 31, 1985, but had
never been finalized. Then again, in the Federal Register of January
20, 1994 (59 FR 3042), the agency withdrew an additional nine
outstanding proposed rules.
FDA published a notice in the Federal Register of April 22, 2003
(68 FR 19766), announcing its intent to withdraw 84 proposed rules and
other proposed actions that had published in the Federal Register more
than 5 years ago, but that had never been finalized. Included in this
list were 19 proposed rules that were originally proposed for
withdrawal in 1991, but at that time the agency decided to defer its
decision to withdraw or finalize them until a later date. In the
Federal Register of November 26, 2004 (69 FR 68831), the agency
withdrew 81 proposed rules and other proposed actions.
The agency has conducted another review of its regulations process
and found withdrawal is justified for four proposals.
II. NPRMs and ANPRMs To Be Withdrawn
Title: Labeling Declaration for FD&C Yellow No. 6 and FD&C Yellow
No. 5; Amendment of Standard of Identity for Cheese Product (Proposed
Rule, 92N-0334 (60 FR 37611, July 21, 1995))
Reason: Since the publication of this proposal, the underlying
science and economic analyses have become outdated.
Title: Over-the-Counter Drug Products Containing
Phenylpropanolamine; Required Labeling (Proposed Rule, 95N-0060 (61 FR
5912, February 14, 1996))
Reason: The agency's ``Over-the-Counter Drug Products Containing
Phenylpropanolamine; Required Labeling'' (Proposed Rule, 95N-0060 (61
FR 5912, February 14, 1996)) has been superseded by the issuance of a
new proposed rule entitled ``Phenylpropanolamine-Containing Drug
Products for Over-the-Counter Human Use; Tentative Final Monographs''
(1976N-0052N and 1981N-0022 (70 FR 75988, December 22, 2005)).
Title: Reinvention of Administrative Procedures Regulations (ANPRM,
96N-0163 (61 FR 28116, June 4, 1996))
Reason: The ANPRM requested comments on whether there should be
possible changes to various existing administrative regulations under
the ``Reinventing Government'' initiative. Since publication, some of
the regulations have been addressed in separate rulemakings. The
remaining regulations are not under current consideration for
rulemaking.
Title: Marketing Exclusivity and Patent Provisions for Certain
Antibiotic Drugs (Proposed Rule, 99N-3088 (65 FR 3623, January 24,
2000))
[[Page 75626]]
Reason: The provision of law which ``Marketing Exclusivity and
Patent Provisions for Certain Antibiotic Drugs'' (Proposed Rule) was
intended to implement, section 125(d) of the Medicare Modernization Act
(Public Law 105-115), was superseded by the enactment of Public Law
110-379 (S. 3560) on October 8, 2008, which included new provisions on
marketing exclusivity and patent provisions for certain antibiotic
drugs.
The withdrawal of the proposals identified in this document does
not preclude the agency from reinstituting rulemaking concerning the
issues addressed in the proposals listed in the previous paragraphs.
Should we decide to undertake such rulemakings in the future, we will
re-propose the actions and provide new opportunities for comment.
Furthermore, this notice is only intended to address the specific
actions identified in this document, and not any other pending
proposals that the agency has issued or is considering.
The agency notes that withdrawal of a proposal does not necessarily
mean that the preamble statement of the proposal no longer reflects the
current position of FDA on the matter addressed. You may wish to review
the agency's Web site (https://www.fda.gov) for any current guidance on
the matter.
III. Withdrawal of the Proposed Rules and ANPRM
For the reasons described in this document, FDA is withdrawing the
aforementioned proposed rules and ANPRM.
Dated: December 3, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-29331 Filed 12-11-08; 8:45 am]
BILLING CODE 4160-01-S