Withdrawal of Two Proposed Rules

Federal Register, Volume 81 Issue 219 (Monday, November 14, 2016)

Federal Register Volume 81, Number 219 (Monday, November 14, 2016)

Proposed Rules

Page 79400

From the Federal Register Online via the Government Publishing Office www.gpo.gov

FR Doc No: 2016-27329

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Chapter 1

Docket No. FDA-2008-N-0622

Withdrawal of Two Proposed Rules

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 two proposed rules that published in the Federal Register more than 5 years ago. These proposed rules are no longer considered viable candidates for final action. FDA is taking this action because these proposed rules are out of date.

DATES: The proposed rules are withdrawn on November 14, 2016.

FOR FURTHER INFORMATION CONTACT: Lisa M. Helmanis, Regulations Policy and Management Staff, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3326, Silver Spring, MD 20993-0002, 301-796-9135, email: Lisa.Helmanis.@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

  1. Background

In 1990, FDA began a process of periodically conducting comprehensive reviews of its regulation process, including reviewing the backlog of notices of proposed rulemakings that were never finalized. As FDA removed many proposed rules that had not been finalized, the Agency was able to clean out the backlog and implement a process of reviewing these proposed rules every 5 years. In the Federal Register of December 12, 2008 (73 FR 75625), FDA withdrew four proposed rules that were more than 5 years old that it did not intend to finalize.

Recently, FDA has conducted a review of proposed rules that are more than 5 years old, and is announcing the withdrawal the following two proposed rules:

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Publication date and

Title of proposed rule Docket No. Reason for withdrawal

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  1. Availability for Public 1/18/2001, 00N-0989..... FDA has reconsidered our

    Disclosure and Submission to position on this issue and

    FDA for Public Disclosure of deemed our concerns from

    Certain Data and Information 2001 outdated. We will

    Related to Human Gene continue to assess whether

    Therapy or rulemaking in this area is

    Xenotransplantation. necessary, and if so, we

    will proceed with a new

    proposed rule.

  2. Crabmeat; Amendment of Common 4/23/1998, 94P-0043..... This proposed rule is

    or Usual Name Regulation. obsolete because FDA has

    created a new process that

    allows for routine updates

    to the seafood names

    without going through

    notice and comment

    rulemaking. See FDA's Guide

    to Acceptable Market Names

    for Seafood Sold in

    Interstate Commerce.

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    The withdrawal of these proposals identified in this document does not preclude the Agency from reinstituting rulemaking concerning the issues addressed in the proposals listed in the chart. 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.

    Dated: November 8, 2016.

    Leslie Kux,

    Associate Commissioner for Policy.

    FR Doc. 2016-27329 Filed 11-10-16; 8:45 am

    BILLING CODE 4164-01-P

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