[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are withdrawn.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The review determines if the proposals are outdated, unnecessary, or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]
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