81 FR 79400 - Withdrawal of Two Proposed Rules

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

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

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 FDA is taking this action because these proposed rules are out of date.

[Federal Register Volume 81, Number 219 (Monday, November 14, 2016)]
[Proposed Rules]
[Page 79400]
From the Federal Register Online  [www.thefederalregister.org]
[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these proposed rules are out of date.

DATES: The proposed rules are withdrawn on November 14, 2016.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: [email protected].

SUPPLEMENTARY INFORMATION:

I. 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
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------

    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