[Federal Register Volume 73, Number 240 (Friday, December 12, 2008)]
[Proposed Rules]
[Pages 75625-75626]
From the Federal Register Online via the Government Publishing 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DATES: The proposals identified in this document are withdrawn as of 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