81_FR_79619 81 FR 79400 - Withdrawal of Two Proposed Rules

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)

Page Range79400-79400
FR Document2016-27329

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 FDA is taking this action because these proposed rules are out of date.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

-----------------------------------------------------------------------

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these proposed rules are out of date.

DATES: The proposed rules are withdrawn on November 14, 2016.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

----------------------------------------------------------------------------------------------------------------
                                                            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



                                               79400                       Federal Register / Vol. 81, No. 219 / Monday, November 14, 2016 / Proposed Rules

                                               (o) Related Information                                        DEPARTMENT OF HEALTH AND                              Commissioner, Food and Drug
                                                  (1) For more information about this AD,                     HUMAN SERVICES                                        Administration, 10903 New Hampshire
                                               contact Wayne Lockett, Aerospace Engineer,                                                                           Ave., Bldg. 32, Rm. 3326, Silver Spring,
                                               Airframe Branch, ANM–120S, FAA, Seattle                        Food and Drug Administration                          MD 20993–0002, 301–796–9135, email:
                                               ACO, 1601 Lind Avenue SW., Renton, WA                                                                                Lisa.Helmanis.@fda.hhs.gov.
                                               98057–3356; phone: 425–917–6447; fax: 425–                     21 CFR Chapter 1                                      SUPPLEMENTARY INFORMATION:
                                               917–6590; email: wayne.lockett@faa.gov.                        [Docket No. FDA–2008–N–0622]
                                                  (2) For service information identified in                                                                         I. Background
                                               this AD, contact Boeing Commercial                             Withdrawal of Two Proposed Rules                         In 1990, FDA began a process of
                                               Airplanes, Attention: Data & Services                                                                                periodically conducting comprehensive
                                               Management, P.O. Box 3707, MC 2H–65,                           AGENCY:    Food and Drug Administration,              reviews of its regulation process,
                                               Seattle, WA 98124–2207; telephone 206–                         HHS.                                                  including reviewing the backlog of
                                               544–5000, extension 1; fax 206–766–5680;                       ACTION:   Notice of withdrawal.                       notices of proposed rulemakings that
                                               Internet https://www.myboeingfleet.com. You                                                                          were never finalized. As FDA removed
                                               may view this referenced service information                   SUMMARY:   The Food and Drug                          many proposed rules that had not been
                                               at the FAA, Transport Airplane Directorate,                    Administration (FDA) is announcing the                finalized, the Agency was able to clean
                                               1601 Lind Avenue SW., Renton, Washington.                      withdrawal of two proposed rules that                 out the backlog and implement a
                                               For information on the availability of this                    published in the Federal Register more                process of reviewing these proposed
                                               material at the FAA, call 425–227–1221.                        than 5 years ago. These proposed rules                rules every 5 years. In the Federal
                                                                                                              are no longer considered viable                       Register of December 12, 2008 (73 FR
                                                 Issued in Renton, Washington, on
                                                                                                              candidates for final action. FDA is                   75625), FDA withdrew four proposed
                                               September 12, 2016.
                                                                                                              taking this action because these                      rules that were more than 5 years old
                                               Michael Kaszycki,                                              proposed rules are out of date.
                                               Acting Manager, Transport Airplane
                                                                                                                                                                    that it did not intend to finalize.
                                                                                                              DATES: The proposed rules are                            Recently, FDA has conducted a
                                               Directorate, Aircraft Certification Service.
                                                                                                              withdrawn on November 14, 2016.                       review of proposed rules that are more
                                               [FR Doc. 2016–22699 Filed 11–10–16; 8:45 am]
                                                                                                              FOR FURTHER INFORMATION CONTACT: Lisa                 than 5 years old, and is announcing the
                                               BILLING CODE 4910–13–P
                                                                                                              M. Helmanis, Regulations Policy and                   withdrawal the following two proposed
                                                                                                              Management Staff, Office of the                       rules:

                                                                                                                                      Publication date and
                                                                                        Title of proposed rule                                                                 Reason for withdrawal
                                                                                                                                          Docket No.

                                               1 ...................    Availability for Public Disclosure and Submission          1/18/2001, 00N–0989 ....      FDA has reconsidered our position on this issue
                                                                          to FDA for Public Disclosure of Certain Data                                             and deemed our concerns from 2001 outdated.
                                                                          and Information Related to Human Gene Ther-                                              We will continue to assess whether rulemaking
                                                                          apy or Xenotransplantation.                                                              in this area is necessary, and if so, we will pro-
                                                                                                                                                                   ceed with a new proposed rule.
                                               2 ...................    Crabmeat; Amendment of Common or Usual                     4/23/1998, 94P–0043 ....      This proposed rule is obsolete because FDA has
                                                                          Name Regulation.                                                                         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                              Dated: November 8, 2016.                            of 2016 and to amend its regulations
                                               identified in this document does not                           Leslie Kux,                                           regarding responding to subpoenas. The
                                               preclude the Agency from reinstituting                         Associate Commissioner for Policy.                    NMB also proposes to update these
                                               rulemaking concerning the issues                               [FR Doc. 2016–27329 Filed 11–10–16; 8:45 am]          regulations where needed in accordance
                                               addressed in the proposals listed in the                       BILLING CODE 4164–01–P
                                                                                                                                                                    with Department of Justice guidance,
                                               chart. Should we decide to undertake                                                                                 Executive Order 12,600, and changes in
                                               such rulemakings in the future, we will                                                                              Agency practice and procedure.
                                               re-propose the actions and provide new                         NATIONAL MEDIATION BOARD                              DATES: Submit comments on or before
                                               opportunities for comment.                                                                                           January 13, 2017. The NMB will hold a
                                               Furthermore, this notice is only                               29 CFR Part 1208                                      public hearing on Thursday, December
                                               intended to address the specific actions                       [Docket No. C–7156]                                   8, 2016. Submit requests to speak at the
                                               identified in this document, and not any                                                                             hearing until 4 p.m. EST on Thursday,
                                                                                                              RIN 3140–AA00
                                               other pending proposals that the Agency                                                                              December 1, 2016.
                                               has issued or is considering. The                              Access to Information                                 ADDRESSES:   You may submit comments
                                               Agency notes that withdrawal of a
                                                                                                              AGENCY:  National Mediation Board.                    by any of the methods listed below.
                                               proposal does not necessarily mean that                                                                              Please submit requests to speak and
Lhorne on DSK30JT082PROD with PROPOSALS




                                               the preamble statement of the proposal                         ACTION: Proposed rule with request for
                                                                                                                                                                    materials for the public hearing only to
                                               no longer reflects the current position of                     comments; notice of hearing.                          the NMB’s physical or email address.
                                               FDA on the matter addressed. You may                                                                                 Clearly identify all submissions by
                                               wish to review the Agency’s Web site                           SUMMARY:    The National Mediation
                                                                                                              Board (NMB or Board) proposes to                      Docket Number C–7156.
                                               (http://www.fda.gov) for any current
                                                                                                              revise its Freedom of Information Act                   • Federal eRulemaking Portal: http://
                                               guidance on the matter.
                                                                                                              (FOIA) regulations in order to                        www.regulations.gov. Follow the
                                                                                                              implement the FOIA Improvement Act                    instructions for submitting comments.


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Document Created: 2018-10-24 10:48:43
Document Modified: 2018-10-24 10:48:43
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionProposed Rules
ActionNotice of withdrawal.
DatesThe proposed rules are withdrawn on November 14, 2016.
ContactLisa 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]
FR Citation81 FR 79400 

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