E8-29331. 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The proposals identified in this document are withdrawn as of December 12, 2008.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))

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.