83 FR 49023 - 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 189 (September 28, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 189 (September 28, 2018)
| Page Range | 49023-49024 | |
| FR Document | 2018-21133 |
[Federal Register Volume 83, Number 189 (Friday, September 28, 2018)] [Proposed Rules] [Pages 49023-49024] From the Federal Register Online [www.thefederalregister.org] [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28, 2018, the proposed rules published on January 12, 2007, at 72 FR 1582, and February 19, 2010, at 75 FR 7412 are withdrawn.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
![Federal Register / Vol. 83, No. 189 / Friday, September 28, 2018 / Proposed Rules 49023
United States’’ (September 18, 2008, 73 rule withdrawal is only intended to rules are not needed at this time to
FR 54106). address the specific actions identified in protect the public health.
The proposed rule does not reflect this document, and not any other DATES: As of September 28, 2018, the
current technology and industry pending proposals that the Agency has proposed rules published on January 12,
practice. For example, the proposed rule issued or is considering. If you need 2007, at 72 FR 1582, and February 19,
directed owners or consignees to affix additional information about the subject 2010, at 75 FR 7412 are withdrawn.
labels to physical documents such as matter of the withdrawn proposed rule, ADDRESSES: For access to the docket, go
invoices, packing lists, bills of lading, you may review the Agency’s website to https://www.regulations.gov and
and any other documents accompanying (https://www.fda.gov) for any current insert the docket number found in
refused food. Many of these documents information on the matter. brackets in the heading of this
are now electronic. Therefore, since Dated: September 25, 2018. document into the ‘‘Search’’ box and
implementation of the proposed rule Leslie Kux, follow the prompts, and/or go to the
would not adequately address how to Dockets Management Staff, 5630 Fishers
Associate Commissioner for Policy.
permanently mark electronic Lane, Rm. 1061, Rockville, MD 20852.
[FR Doc. 2018–21145 Filed 9–27–18; 8:45 am]
documentation accompanying refused
BILLING CODE 4164–01–P FOR FURTHER INFORMATION CONTACT:
food, it would not achieve the public
health and efficiency benefits discussed Brian Pendleton, Office of Policy, Food
in the notice of proposed rulemaking. and Drug Administration, 10903 New
DEPARTMENT OF HEALTH AND Hampshire Ave., Bldg. 32, Rm. 4250,
As directed by section 304 of the FDA
HUMAN SERVICES Silver Spring, MD 20993–0002, 301–
Food Safety Modernization Act (Pub. L.
111–353) that was enacted after FDA 796–4614, brian.pendleton@
Food and Drug Administration fda.hhs.gov.
issued the proposed rule, FDA now
requires, as part of its prior notice 21 CFR Chapter I SUPPLEMENTARY INFORMATION: In 1990,
regulations, notice to FDA of the name FDA began a process of periodically
of any country to which imported food [Docket Nos. FDA–2005–N–0033, FDA– conducting comprehensive reviews of
has been refused entry. (See 21 CFR 2008–N–0115] its regulation process, including
1.281(a)(18).) This includes situations reviewing the backlog of proposed
Use of Materials Derived From Cattle in
where the United States has refused rulemakings that had not been finalized.
Medical Products Intended for Use in
entry, and it therefore provides FDA As FDA removed many proposed rules
Humans and Drugs Intended for Use in
with information related to what the not finalized, the Agency implemented
Ruminants; Reporting Information
proposed marking rule would require. a process of reviewing existing proposed
Regarding Falsification of Data
FDA may reassess how to effectively rules every 5 years.
implement the labeling of AGENCY: Food and Drug Administration, As part of this process and the
documentation accompanying refused HHS. Administration’s regulatory reform
food and consider whether to issue a ACTION: Proposed rule; withdrawal. initiative, we continue to conduct
revised proposed rule in the future. reviews of existing proposed rules. The
The withdrawal of the proposal SUMMARY: The Food and Drug review determines if the proposals are
identified in this document does not Administration (FDA, Agency, we) is outdated, unnecessary, or can be revised
preclude the Agency from reinstituting announcing the withdrawal of two to reduce regulatory burden while
rulemaking concerning the issues proposed rules that published in the allowing FDA to achieve our public
addressed. Should we decide to Federal Register. These proposed rules health mission and fulfill statutory
undertake such a rulemaking in the are not currently considered viable obligations.
future, we will re-propose the action candidates for final action. FDA is As part of these efforts, FDA is
and provide a new opportunity for taking this action because the regulatory withdrawing the following proposed
comment. Furthermore, this proposed requirements set forth in the proposed rules:
Publication date,
Title of proposed rule Federal Register Docket No. Reason for withdrawal
citation
1. Use of Materials Derived January 12, 2007, 72 FR FDA–2005–N–0033 We are withdrawing the proposed rule because the risk to public health posed
from Cattle in Medical Prod- 1582. by the potential use of materials derived from cattle in medical products has
ucts Intended for Use in Hu- been significantly diminished since the issuance of the proposed rule, and
mans and Drugs Intended we believe we can address any potential concerns through application of our
for Use in Ruminants. premarketing review authority.
2. Reporting Information Re- February 19, 2010, 75 FR FDA–2008–N–0115 The rule is not needed to protect research subjects or to help ensure the integ-
garding Falsification of Data. 7412. rity of clinical trial data submitted to FDA in support of marketing applications
and petitions for product approvals. Existing regulations require study spon-
sors to notify FDA when they end an investigator’s participation in an inves-
tigation (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 ade-
quate notice of falsification of data, and we do not believe that adopting the
proposed requirements would provide us with substantial additional informa-
amozie on DSK3GDR082PROD with PROPOSALS1
tion.
The withdrawal of the proposed rules undertake such rulemakings in the address the specific actions identified in
does not preclude the Agency from future, we will re-propose the actions this document, and not any other
reinstituting rulemaking concerning the and provide new opportunities for pending proposals that the Agency has
issues addressed in the proposed rules comment. Furthermore, these proposed issued or is considering. If you need
listed in the table. Should we decide to rules’ withdrawal is only intended to additional information about the subject
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![49024 Federal Register / Vol. 83, No. 189 / Friday, September 28, 2018 / Proposed Rules
matter of the withdrawn proposed rules, I. Table of Abbreviations Below we summarize our analyses
you may review the Agency’s website CFR Code of Federal Regulations
based on a number of these statutes and
(https://www.fda.gov) for any current COTP Captain of the Port Executive orders and we discuss First
information on the matter. DHS Department of Homeland Security Amendment rights of protestors.
Dated: September 24, 2018. FR Federal Register A. Regulatory Planning and Review
Leslie Kux, NPRM Notice of proposed rulemaking
§ Section Executive Orders 12866 and 13563
Associate Commissioner for Policy. U.S.C. United States Code direct agencies to assess the costs and
[FR Doc. 2018–21133 Filed 9–27–18; 8:45 am] benefits of available regulatory
BILLING CODE 4164–01–P II. Background, Purpose, and Legal alternatives and, if regulation is
Basis necessary, to select regulatory
The Manasquan Beach and Recreation approaches that maximize net benefits.
DEPARTMENT OF HOMELAND Department notified the Coast Guard Executive Order 13771 directs agencies
SECURITY that it will be conducting a tug of war to control regulatory costs through a
event from 11 a.m. to 1:30 p.m. on budgeting process. This NPRM has not
Coast Guard October 20, 2018. The tug of war will been designated a ‘‘significant
consist of teams on opposing sides of regulatory action,’’ under Executive
33 CFR Part 100 the Manasquan Inlet with a rope Order 12866. Accordingly, the NPRM
[Docket Number USCG–2018–0883] extended between the sides. The event has not been reviewed by the Office of
will span the entire width of the inlet. Management and Budget (OMB), and
RIN 1625–AA08 Vessel operation in the area of the event pursuant to OMB guidance it is exempt
could be hazardous to both event from the requirements of Executive
Special Local Regulation; Manasquan
Inlet, Manasquan, NJ participants and vessels. The Captain of Order 13771.
the Port Delaware Bay (COTP) has This regulatory action determination
AGENCY: Coast Guard, DHS. determined that a safety concern exists is based on the size, location, and
ACTION: Notice of proposed rulemaking. for non-participant vessels within 400 duration of the regulated area. While
feet of the tug of war rope. this regulated area would impact a
SUMMARY: The Coast Guard proposes to The purpose of this rulemaking is to designated area of the Manasquan River
establish a temporary special local ensure the safety of participants and Inlet for 2 and 1⁄2 hours, the event
regulation for certain waters of the vessels transiting the regulated area sponsor has organized a 30 minute time
Manasquan Inlet between Manasquan, during the event. The Coast Guard period during the event where vessels
NJ, and Point Pleasant Beach, NJ. This proposes this rulemaking under would be able to transit through the
action is necessary to protect event authority in 33 U.S.C. 1231. inlet. Moreover, the Coast Guard would
participants, spectators, and vessels issue a Broadcast Notice to Mariners via
transiting the area from potential III. Discussion of Proposed Rule
VHF–FM marine channel 16 about the
hazards during the Manasquan Inlet The COTP proposes to establish a zone, and the rule would allow vessels
Intercoastal Tug marine event. During temporary special local regulation to be to seek permission to enter the zone
the enforcement period, unauthorized in effect from 11 a.m. to 1:30 p.m. on during the 30 minute time period during
persons or vessels would be prohibited October 20, 2018. The regulated area the event.
from entering into, remaining within, would cover all waters within 400 feet
transiting through, or anchoring in the of the event located between B. Impact on Small Entities
regulated area unless authorized by the approximate locations 40°6′9.22″ N, The Regulatory Flexibility Act of
Captain of the Port Delaware Bay or a 74°2′7.8″ W and 40°6′9.22″ N, 74°2′8.2″ 1980, 5 U.S.C. 601–612, as amended,
designated representative of the Captain W. During the event, the inlet would be requires Federal agencies to consider
of the Port. We invite your comments on closed to all non-participant vessel the potential impact of regulations on
this proposed rulemaking. traffic. There is a 30-minute break small entities during rulemaking. The
DATES: Comments and related material tentatively planned for midway through term ‘‘small entities’’ comprises small
must be received by the Coast Guard on the event. If circumstances permit, businesses, not-for-profit organizations
or before October 5, 2018. during the break the rope will be that are independently owned and
ADDRESSES: You may submit comments removed from navigable waters and operated and are not dominant in their
identified by docket number USCG– vessels may be allowed to transit fields, and governmental jurisdictions
2018–0883 using the Federal through the area at the discretion of the with populations of less than 50,000.
eRulemaking Portal at https:// COTP or COTP’s designated The Coast Guard certifies under 5 U.S.C.
www.regulations.gov. See the ‘‘Public representative. The regulation is 605(b) that this proposed rule would not
Participation and Request for intended to ensure the safety of event have a significant economic impact on
Comments’’ portion of the participants and vessels during the a substantial number of small entities.
SUPPLEMENTARY INFORMATION section for scheduled 11 a.m. to 1:30 p.m. tug of While some owners or operators of
further instructions on submitting war event. No vessel or person would be vessels intending to transit the regulated
comments. permitted to enter the regulated area area may be small entities, for the
without obtaining permission from the reasons stated in section IV.A above,
FOR FURTHER INFORMATION CONTACT: If
COTP or a designated representative of this proposed rule would not have a
amozie on DSK3GDR082PROD with PROPOSALS1
you have questions about this proposed significant economic impact on any
the Captain of the Port. The regulatory
rulemaking, call or email Petty Officer vessel owner or operator.
text we are proposing appears at the end
Thomas Welker, U.S. Coast Guard; If you think that your business,
of this document.
Sector Delaware Bay, Waterways organization, or governmental
Management Division; telephone (215) IV. Regulatory Analyses jurisdiction qualifies as a small entity
271–4814, email Thomas.J.Welker@ We developed this proposed rule after and that this rule would have a
uscg.mil. considering numerous statutes and significant economic impact on it,
SUPPLEMENTARY INFORMATION: Executive orders related to rulemaking. please submit a comment (see
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Document Created: 2018-09-28 01:23:46
Document Modified: 2018-09-28 01:23:46
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Proposed Rules | |
| Action | Proposed rule; withdrawal. | |
| 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. | |
| 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] | |
| FR Citation | 83 FR 49023 |
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