Withdrawal of Certain Proposed Rules and Other Proposed Actions, 75625-75626 [E8-29331]

Download as PDF 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 DATES: The proposals identified in this document are withdrawn as of December 12, 2008.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 Sfmt 4702 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 (http://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: http://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 http://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 http://www.regulations.gov or e-mail. http://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 http://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 ............................. VerDate Aug<31>2005 16:22 Dec 11, 2008 Jkt 217001 PO 00000 Frm 00003 Fmt 4702 Sfmt 4702 Adopted E:\FR\FM\12DEP1.SGM 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.

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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 (http://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