Document ID: FDA-2005-N-0033-0014
Agency: fda
Document Type: Proposed Rule
Title: Use of Materials Derived From Cattle in Medical Products Intended for Use in Humans and Drugs Intended for Use in Ruminants; Reporting Information Regarding Falsification of Data
Posted Date: 2018-09-28T04:00Z

[Federal Register Volume 83, Number 189 (Friday, September 28, 2018)]
[Proposed Rules]
[Pages 49023-49024]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-21133]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Chapter I

[Docket Nos. FDA-2005-N-0033, FDA-2008-N-0115]

Use of Materials Derived From Cattle in Medical Products Intended 
for Use in Humans and Drugs Intended for Use in Ruminants; Reporting 
Information Regarding Falsification of Data

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; withdrawal.

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SUMMARY: The Food and Drug Administration (FDA, Agency, we) is 
announcing the withdrawal of two proposed rules that published in the 
Federal Register. These proposed rules are not currently considered 
viable candidates for final action. FDA is taking this action because 
the regulatory requirements set forth in the proposed rules are not 
needed at this time to protect the public health.

DATES: As of September 28, 2018, the proposed rules published on 
January 12, 2007, at 72 FR 1582, and February 19, 2010, at 75 FR 7412 
are withdrawn.

ADDRESSES: For access to the docket, go to https://www.regulations.gov 
and insert the docket number found in brackets in the heading of this 
document into the ``Search'' box and follow the prompts, and/or go to 
the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, 
MD 20852.

FOR FURTHER INFORMATION CONTACT: Brian Pendleton, Office of Policy, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 
4250, Silver Spring, MD 20993-0002, 301-796-4614, 
[email protected].

SUPPLEMENTARY INFORMATION: In 1990, FDA began a process of periodically 
conducting comprehensive reviews of its regulation process, including 
reviewing the backlog of proposed rulemakings that had not been 
finalized. As FDA removed many proposed rules not finalized, the Agency 
implemented a process of reviewing existing proposed rules every 5 
years.
    As part of this process and the Administration's regulatory reform 
initiative, we continue to conduct reviews of existing proposed rules. 
The review determines if the proposals are outdated, unnecessary, or 
can be revised to reduce regulatory burden while allowing FDA to 
achieve our public health mission and fulfill statutory obligations.
    As part of these efforts, FDA is withdrawing the following proposed 
rules:

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                                     Publication date,  Federal Register
       Title of proposed rule                      citation                         Docket No.                        Reason for withdrawal
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1. Use of Materials Derived from     January 12, 2007, 72 FR 1582.......  FDA-2005-N-0033                We are withdrawing the proposed rule because
 Cattle in Medical Products                                                                               the risk to public health posed by the
 Intended for Use in Humans and                                                                           potential use of materials derived from cattle
 Drugs Intended for Use in                                                                                in medical products has been significantly
 Ruminants.                                                                                               diminished since the issuance of the proposed
                                                                                                          rule, and we believe we can address any
                                                                                                          potential concerns through application of our
                                                                                                          premarketing review authority.
2. Reporting Information Regarding   February 19, 2010, 75 FR 7412......  FDA-2008-N-0115                The rule is not needed to protect research
 Falsification of Data.                                                                                   subjects or to help ensure the integrity of
                                                                                                          clinical trial data submitted to FDA in
                                                                                                          support of marketing applications and
                                                                                                          petitions for product approvals. Existing
                                                                                                          regulations require study sponsors to notify
                                                                                                          FDA when they end an investigator's
                                                                                                          participation in an investigation (21 CFR
                                                                                                          312.56(b)), and institutional review boards
                                                                                                          must notify us when they suspend or terminate
                                                                                                          their approval of research (21 CFR 56.113).
                                                                                                          Based on our review of recent data, we
                                                                                                          conclude that we are receiving adequate notice
                                                                                                          of falsification of data, and we do not
                                                                                                          believe that adopting the proposed
                                                                                                          requirements would provide us with substantial
                                                                                                          additional information.
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    The withdrawal of the proposed rules does not preclude the Agency 
from reinstituting rulemaking concerning the issues addressed in the 
proposed rules listed in the table. Should we decide to undertake such 
rulemakings in the future, we will re-propose the actions and provide 
new opportunities for comment. Furthermore, these proposed rules' 
withdrawal 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. If you need additional information about 
the subject

[[Page 49024]]

matter of the withdrawn proposed rules, you may review the Agency's 
website (https://www.fda.gov) for any current information on the 
matter.

    Dated: September 24, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-21133 Filed 9-27-18; 8:45 am]
 BILLING CODE 4164-01-P