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, 49023-49024 [2018-21133]
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Federal Register / Vol. 83, No. 189 / Friday, September 28, 2018 / Proposed Rules
United States’’ (September 18, 2008, 73
FR 54106).
The proposed rule does not reflect
current technology and industry
practice. For example, the proposed rule
directed owners or consignees to affix
labels to physical documents such as
invoices, packing lists, bills of lading,
and any other documents accompanying
refused food. Many of these documents
are now electronic. Therefore, since
implementation of the proposed rule
would not adequately address how to
permanently mark electronic
documentation accompanying refused
food, it would not achieve the public
health and efficiency benefits discussed
in the notice of proposed rulemaking.
As directed by section 304 of the FDA
Food Safety Modernization Act (Pub. L.
111–353) that was enacted after FDA
issued the proposed rule, FDA now
requires, as part of its prior notice
regulations, notice to FDA of the name
of any country to which imported food
has been refused entry. (See 21 CFR
1.281(a)(18).) This includes situations
where the United States has refused
entry, and it therefore provides FDA
with information related to what the
proposed marking rule would require.
FDA may reassess how to effectively
implement the labeling of
documentation accompanying refused
food and consider whether to issue a
revised proposed rule in the future.
The withdrawal of the proposal
identified in this document does not
preclude the Agency from reinstituting
rulemaking concerning the issues
addressed. Should we decide to
undertake such a rulemaking in the
future, we will re-propose the action
and provide a new opportunity for
comment. Furthermore, this proposed
Title of proposed rule
rule 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
matter of the withdrawn proposed rule,
you may review the Agency’s website
(https://www.fda.gov) for any current
information on the matter.
Food and Drug Administration
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, brian.pendleton@
fda.hhs.gov.
21 CFR Chapter I
SUPPLEMENTARY INFORMATION:
Dated: September 25, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–21145 Filed 9–27–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[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:
ACTION:
amozie on DSK3GDR082PROD with PROPOSALS1
17:53 Sep 27, 2018
Jkt 244001
Proposed rule; withdrawal.
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
SUMMARY:
Docket No.
1. Use of Materials Derived
January 12, 2007, 72 FR
from Cattle in Medical Prod1582.
ucts Intended for Use in Humans and Drugs Intended
for Use in Ruminants.
2. Reporting Information ReFebruary 19, 2010, 75 FR
garding Falsification of Data.
7412.
VerDate Sep<11>2014
Food and Drug Administration,
HHS.
Publication date,
Federal Register
citation
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
49023
FDA–2005–N–0033
FDA–2008–N–0115
Reason for withdrawal
We are withdrawing the proposed rule because the risk to public health posed
by the potential use of materials derived from cattle in medical products has
been significantly diminished since the issuance of the proposed rule, and
we believe we can address any potential concerns through application of our
premarketing review authority.
The rule is not needed to protect research 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.
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
PO 00000
Frm 00034
Fmt 4702
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:
Sfmt 4702
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
E:\FR\FM\28SEP1.SGM
28SEP1
49024
Federal Register / Vol. 83, No. 189 / Friday, September 28, 2018 / Proposed Rules
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
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 100
[Docket Number USCG–2018–0883]
RIN 1625–AA08
Special Local Regulation; Manasquan
Inlet, Manasquan, NJ
Coast Guard, DHS.
Notice of proposed rulemaking.
AGENCY:
ACTION:
The Coast Guard proposes to
establish a temporary special local
regulation for certain waters of the
Manasquan Inlet between Manasquan,
NJ, and Point Pleasant Beach, NJ. This
action is necessary to protect event
participants, spectators, and vessels
transiting the area from potential
hazards during the Manasquan Inlet
Intercoastal Tug marine event. During
the enforcement period, unauthorized
persons or vessels would be prohibited
from entering into, remaining within,
transiting through, or anchoring in the
regulated area unless authorized by the
Captain of the Port Delaware Bay or a
designated representative of the Captain
of the Port. We invite your comments on
this proposed rulemaking.
DATES: Comments and related material
must be received by the Coast Guard on
or before October 5, 2018.
ADDRESSES: You may submit comments
identified by docket number USCG–
2018–0883 using the Federal
eRulemaking Portal at https://
www.regulations.gov. See the ‘‘Public
Participation and Request for
Comments’’ portion of the
SUPPLEMENTARY INFORMATION section for
further instructions on submitting
comments.
FOR FURTHER INFORMATION CONTACT: If
you have questions about this proposed
rulemaking, call or email Petty Officer
Thomas Welker, U.S. Coast Guard;
Sector Delaware Bay, Waterways
Management Division; telephone (215)
271–4814, email Thomas.J.Welker@
uscg.mil.
SUPPLEMENTARY INFORMATION:
amozie on DSK3GDR082PROD with PROPOSALS1
SUMMARY:
VerDate Sep<11>2014
17:53 Sep 27, 2018
Jkt 244001
I. Table of Abbreviations
CFR Code of Federal Regulations
COTP Captain of the Port
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
§ Section
U.S.C. United States Code
II. Background, Purpose, and Legal
Basis
The Manasquan Beach and Recreation
Department notified the Coast Guard
that it will be conducting a tug of war
event from 11 a.m. to 1:30 p.m. on
October 20, 2018. The tug of war will
consist of teams on opposing sides of
the Manasquan Inlet with a rope
extended between the sides. The event
will span the entire width of the inlet.
Vessel operation in the area of the event
could be hazardous to both event
participants and vessels. The Captain of
the Port Delaware Bay (COTP) has
determined that a safety concern exists
for non-participant vessels within 400
feet of the tug of war rope.
The purpose of this rulemaking is to
ensure the safety of participants and
vessels transiting the regulated area
during the event. The Coast Guard
proposes this rulemaking under
authority in 33 U.S.C. 1231.
III. Discussion of Proposed Rule
The COTP proposes to establish a
temporary special local regulation to be
in effect from 11 a.m. to 1:30 p.m. on
October 20, 2018. The regulated area
would cover all waters within 400 feet
of the event located between
approximate locations 40°6′9.22″ N,
74°2′7.8″ W and 40°6′9.22″ N, 74°2′8.2″
W. During the event, the inlet would be
closed to all non-participant vessel
traffic. There is a 30-minute break
tentatively planned for midway through
the event. If circumstances permit,
during the break the rope will be
removed from navigable waters and
vessels may be allowed to transit
through the area at the discretion of the
COTP or COTP’s designated
representative. The regulation is
intended to ensure the safety of event
participants and vessels during the
scheduled 11 a.m. to 1:30 p.m. tug of
war event. No vessel or person would be
permitted to enter the regulated area
without obtaining permission from the
COTP or a designated representative of
the Captain of the Port. The regulatory
text we are proposing appears at the end
of this document.
IV. Regulatory Analyses
We developed this proposed rule after
considering numerous statutes and
Executive orders related to rulemaking.
PO 00000
Frm 00035
Fmt 4702
Sfmt 4702
Below we summarize our analyses
based on a number of these statutes and
Executive orders and we discuss First
Amendment rights of protestors.
A. Regulatory Planning and Review
Executive Orders 12866 and 13563
direct agencies to assess the costs and
benefits of available regulatory
alternatives and, if regulation is
necessary, to select regulatory
approaches that maximize net benefits.
Executive Order 13771 directs agencies
to control regulatory costs through a
budgeting process. This NPRM has not
been designated a ‘‘significant
regulatory action,’’ under Executive
Order 12866. Accordingly, the NPRM
has not been reviewed by the Office of
Management and Budget (OMB), and
pursuant to OMB guidance it is exempt
from the requirements of Executive
Order 13771.
This regulatory action determination
is based on the size, location, and
duration of the regulated area. While
this regulated area would impact a
designated area of the Manasquan River
Inlet for 2 and 1⁄2 hours, the event
sponsor has organized a 30 minute time
period during the event where vessels
would be able to transit through the
inlet. Moreover, the Coast Guard would
issue a Broadcast Notice to Mariners via
VHF–FM marine channel 16 about the
zone, and the rule would allow vessels
to seek permission to enter the zone
during the 30 minute time period during
the event.
B. Impact on Small Entities
The Regulatory Flexibility Act of
1980, 5 U.S.C. 601–612, as amended,
requires Federal agencies to consider
the potential impact of regulations on
small entities during rulemaking. The
term ‘‘small entities’’ comprises small
businesses, not-for-profit organizations
that are independently owned and
operated and are not dominant in their
fields, and governmental jurisdictions
with populations of less than 50,000.
The Coast Guard certifies under 5 U.S.C.
605(b) that this proposed rule would not
have a significant economic impact on
a substantial number of small entities.
While some owners or operators of
vessels intending to transit the regulated
area may be small entities, for the
reasons stated in section IV.A above,
this proposed rule would not have a
significant economic impact on any
vessel owner or operator.
If you think that your business,
organization, or governmental
jurisdiction qualifies as a small entity
and that this rule would have a
significant economic impact on it,
please submit a comment (see
E:\FR\FM\28SEP1.SGM
28SEP1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Publication date, Federal Register
Title of proposed rule citation Docket No. Reason for withdrawal
--------------------------------------------------------------------------------------------------------------------------------------------------------
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.
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
