81 FR 37561 - Breast Cancer Fund, Center for Environmental Health, Center for Food Safety, Center for Science in the Public Interest, Clean Water Action, Consumer Federation of America, Earthjustice, Environmental Defense Fund, Improving Kids' Environment, Learning Disabilities Association of America, and Natural Resources Defense Council; Filing of Food Additive Petition; Correction
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 112 (June 10, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 112 (June 10, 2016)
| Page Range | 37561-37562 | |
| FR Document | 2016-13739 |
[Federal Register Volume 81, Number 112 (Friday, June 10, 2016)] [Proposed Rules] [Pages 37561-37562] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-13739] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 175, 176, 177, and 178 [Docket No. FDA-2016-F-1253] Breast Cancer Fund, Center for Environmental Health, Center for Food Safety, Center for Science in the Public Interest, Clean Water Action, Consumer Federation of America, Earthjustice, Environmental Defense Fund, Improving Kids' Environment, Learning Disabilities Association of America, and Natural Resources Defense Council; Filing of Food Additive Petition; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Notice of petition; correction. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or we) is correcting a notice entitled ``Breast Cancer Fund, Center for Environmental Health, Center for Food Safety, Center for Science in the Public Interest, Clean Water Action, Consumer Federation of America, Earthjustice, Environmental Defense Fund, Improving Kids' Environment, Learning Disabilities Association of America, and Natural Resources Defense Council; Filing of Food Additive Petition'' that appeared in the Federal Register of May 20, 2016 (81 FR 31877). The document announced that Breast Cancer Fund, Center for Environmental Health, Center for Food Safety, Center for Science in the Public Interest, Clean Water Action, Consumer Federation of America, Earthjustice, Environmental Defense Fund, Improving Kids' Environment, Learning Disabilities Association of America, and Natural Resources Defense Council filed a petition proposing that we amend and/or revoke specified regulations to no longer provide for the food contact use of specified ortho- phthalates, but omitted two items. This document corrects that error. FOR FURTHER INFORMATION CONTACT: Kelly Randolph, Center for Food Safety and Applied Nutrition (HFS-275), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835, 240-402-1188. SUPPLEMENTARY INFORMATION: In FR Doc. 2016-11866, appearing on page 31878 in the Federal Register of Friday, May 20, 2016, the following correction is made: On page 31878, in the third column, under the heading ``Sec. 175.300 Resinous and Polymeric Coatings,'' the [[Page 37562]] document is corrected to add ``Butyl phthalyl butyl glycolate (CAS No. 85-70-1)'' and ``Ethyl phthalyl ethyl glycolate (CAS No. 84-72-0)'' in alphabetical order. Dated: June 7, 2016. Dennis M. Keefe, Director, Office of Food Additive Safety, Center for Food Safety and Applied Nutrition. [FR Doc. 2016-13739 Filed 6-9-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 112 / Friday, June 10, 2016 / Proposed Rules 37561
§ 416.903b Evidence from statutorily statutorily excluded medical sources DEPARTMENT OF HEALTH AND
excluded medical sources. submit to us either directly or through HUMAN SERVICES
(a) General. We will not consider a representative, claimant, or other
evidence from the following medical individual or entity. Food and Drug Administration
sources statutorily excluded under
(1) Statutorily excluded medical
section 223(d)(5)(C) of the Social 21 CFR Parts 175, 176, 177, and 178
Security Act (Act), as amended, unless sources must provide a written
we find good cause under paragraph (b) statement, which contains the following [Docket No. FDA–2016–F–1253]
of this section: information:
Breast Cancer Fund, Center for
(1) Any medical source that has been (i) A heading stating: ‘‘WRITTEN Environmental Health, Center for Food
convicted of a felony under section 208 STATEMENT REGARDING SECTION Safety, Center for Science in the Public
or under section 1632 of the Act; 223(d)(5)(C) OF THE SOCIAL Interest, Clean Water Action,
(2) Any medical source that has been SECURITY ACT—DO NOT REMOVE’’ Consumer Federation of America,
excluded from participation in any
(ii) The name and title of the medical Earthjustice, Environmental Defense
Federal health care program under
source; Fund, Improving Kids’ Environment,
section 1128 of the Act; or
(3) Any medical source that has (iii) The applicable excluding event(s) Learning Disabilities Association of
received a final decision imposing a stated in paragraphs (a)(1)–(a)(3) of this America, and Natural Resources
civil monetary penalty or assessment, or Defense Council; Filing of Food
section;
both, for submitting false evidence Additive Petition; Correction
(iv) The date of the medical source’s
under section 1129 of the Act. felony conviction under sections 208 or AGENCY: Food and Drug Administration,
(b) Good cause. We may find good HHS.
1632 of the Act, if applicable;
cause to consider evidence from a
(v) The date of the imposition of a ACTION: Notice of petition; correction.
statutorily excluded medical source
under section 223(d)(5)(C) of the Act, as civil monetary penalty or assessment, or SUMMARY: The Food and Drug
amended, if: both, for the submission of false Administration (FDA or we) is
(1) The evidence from the medical evidence, under section 1129 of the Act, correcting a notice entitled ‘‘Breast
source consists of evidence of treatment if applicable; and Cancer Fund, Center for Environmental
that occurred before the date the source (vi) The basis, effective date, Health, Center for Food Safety, Center
was convicted of a felony under section for Science in the Public Interest, Clean
anticipated length of the exclusion, and
208 or under section 1632 of the Act; Water Action, Consumer Federation of
(2) The evidence from the medical whether the Office of the Inspector
General of the Department of Health and America, Earthjustice, Environmental
source consists of evidence of treatment Defense Fund, Improving Kids’
that occurred during a period in which Human Services waived the exclusion,
if the excluding event was the medical Environment, Learning Disabilities
the source was not excluded from Association of America, and Natural
participation in any Federal health care source’s exclusion from participation in
any Federal health care program under Resources Defense Council; Filing of
program under section 1128 of the Act; Food Additive Petition’’ that appeared
(3) The evidence from the medical section 1128 of the Act.
in the Federal Register of May 20, 2016
source consists of evidence of treatment (2) The written statement provided by (81 FR 31877). The document
that occurred before the date the source an excluded medical source may not be announced that Breast Cancer Fund,
received a final decision imposing a removed by any individual or entity Center for Environmental Health, Center
civil monetary penalty or assessment, or prior to submitting evidence to us. for Food Safety, Center for Science in
both, for submitting false evidence the Public Interest, Clean Water Action,
under section 1129 of the Act; (3) We may request that the excluded
medical source provide us with Consumer Federation of America,
(4) The sole basis for the medical
additional information or clarify any Earthjustice, Environmental Defense
source’s exclusion under section
information submitted that bears on the Fund, Improving Kids’ Environment,
223(d)(5)(C) of the Act, as amended, is
medical source’s exclusion(s) under Learning Disabilities Association of
that the source cannot participate in any
section 223(d)(5)(C) of the Act, as America, and Natural Resources Defense
Federal health care program under
Council filed a petition proposing that
section 1128 of the Act, but the Office amended.
we amend and/or revoke specified
of Inspector General of the Department [FR Doc. 2016–13744 Filed 6–9–16; 8:45 am] regulations to no longer provide for the
of Health and Human Services granted BILLING CODE 4191–02–P food contact use of specified ortho-
a waiver of the section 1128 exclusion;
phthalates, but omitted two items. This
or
document corrects that error.
(5) The evidence is a laboratory
finding about a physical impairment FOR FURTHER INFORMATION CONTACT:
and there is no indication that the Kelly Randolph, Center for Food Safety
finding is unreliable. and Applied Nutrition (HFS–275), Food
(c) Statutorily excluded medical and Drug Administration, 5100 Paint
sources’ reporting requirements. Branch Pkwy., College Park, MD 20740–
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
Statutorily excluded medical sources (as 3835, 240–402–1188.
described in paragraph (a) of this SUPPLEMENTARY INFORMATION: In FR Doc.
section) must inform us in writing that 2016–11866, appearing on page 31878
they are excluded under section in the Federal Register of Friday, May
223(d)(5)(C) of the Act, as amended, 20, 2016, the following correction is
each time they submit evidence related made:
to a claim for benefits under titles II or On page 31878, in the third column,
XVI of the Act. This reporting under the heading ‘‘§ 175.300
requirement applies to evidence that Resinous and Polymeric Coatings,’’ the
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![37562 Federal Register / Vol. 81, No. 112 / Friday, June 10, 2016 / Proposed Rules
document is corrected to add ‘‘Butyl DHS Department of Homeland Security regulation is necessary, to select
phthalyl butyl glycolate (CAS No. 85– E.O. Executive order regulatory approaches that maximize
70–1)’’ and ‘‘Ethyl phthalyl ethyl FR Federal Register net benefits. E.O. 13563 emphasizes the
NPRM Notice of proposed rulemaking
glycolate (CAS No. 84–72–0)’’ in importance of quantifying both costs
Pub. L. Public Law
alphabetical order. § Section and benefits, of reducing costs, of
Dated: June 7, 2016. U.S.C. United States Code harmonizing rules, and of promoting
flexibility. This NPRM has not been
Dennis M. Keefe, II. Background, Purpose, and Legal designated a ‘‘significant regulatory
Director, Office of Food Additive Safety, Basis action,’’ under E.O. 12866. Accordingly,
Center for Food Safety and Applied Nutrition.
On January 28, 2016, the Nashville the NPRM has not been reviewed by the
[FR Doc. 2016–13739 Filed 6–9–16; 8:45 am]
Paddle Company notified the Coast Office of Management and Budget.
BILLING CODE 4164–01–P
Guard that it will be conducting a race This regulatory action determination
from 9 a.m. to noon on July 30, 2016. is based on the size, location, duration,
The event will consist of at least 75 and time-of-day of the special local
DEPARTMENT OF HOMELAND participants on various sized stand up regulated area.
SECURITY paddle boards and kayaks on the This proposed special local regulation
Cumberland River. The Captain of the restricts transit on the Cumberland
Coast Guard Port Ohio Valley (COTP) has River from mile 190.0 to 191.5, for a
determined that additional safety short duration of 3 hours for one day;
33 CFR Part 100 measures are necessary to protect Broadcast Notices to Mariners and Local
[Docket Number USCG–2016–0169] participants, spectators, and waterway Notices to Mariners will also inform the
users during this event. Therefore, the community of this special local
RIN 1625–AA08 regulation so that they may plan
Coast Guard proposes to establish a
special local regulation on specified accordingly for this short restriction on
Special Local Regulation; Cumberland
waters of the Cumberland River. This transit. Vessel traffic may request
River, Mile 190.0 to 191.5; Nashville, TN
proposed regulation would be in effect permission from the COTP Ohio Valley
AGENCY: Coast Guard, DHS. from 9 a.m. until noon on July 30, 2016. or a designated representative to enter
ACTION: Notice of proposed rulemaking. The purpose of this rulemaking is to the restricted area.
ensure the safety of vessels and B. Impact on Small Entities
SUMMARY: The Coast Guard proposes to participants of the navigable waters
establish a special local regulation for before, during, and after the scheduled The Regulatory Flexibility Act of
all waters of the Cumberland River event. The Coast Guard proposes this 1980, 5 U.S.C. 601–612, as amended,
beginning at mile marker 190.0 and rulemaking under authority in 33 U.S.C. requires Federal agencies to consider
ending at mile marker 191.5 from 9 a.m. 1233, which authorizes the Coast Guard the potential impact of regulations on
until noon on July 30, 2016. This to establish and define special local small entities during rulemaking. The
proposed special regulation is necessary regulations under 33 CFR 100. term ‘‘small entities’’ comprises small
to provide safety for the participants in businesses, not-for-profit organizations
the ‘‘Music City SUP Race’’ marine III. Discussion of Proposed Rule that are independently owned and
event. This proposed rulemaking would The Captain of the Port Ohio Valley operated and are not dominant in their
prohibit persons and vessels from being proposes to establish a special local fields, and governmental jurisdictions
in the special local regulated area unless regulated area from 9 a.m.to noon on with populations of less than 50,000.
authorized by the Captain of the Port July 30, 2016 for all waters of the The Coast Guard certifies under 5 U.S.C.
Ohio Valley or a designated Cumberland River beginning at mile 605(b) that this proposed rule would not
representative. We invite your marker 190.0 and ending at mile marker have a significant economic impact on
comments on this proposed rulemaking. 191.5. The duration of the special local a substantial number of small entities.
DATES: Comments and related material regulated area is intended to ensure the While some owners or operators of
must be received by the Coast Guard on safety of vessels, participants, and these vessels intending to transit the special
or before June 27, 2016. navigable waters before, during, and local regulated area may be small
ADDRESSES: You may submit comments after the scheduled event. No vessel or entities, for the reasons stated in section
identified by docket number USCG– person would be permitted to enter the IV.A above this proposed rule would
2016–0169 using the Federal special local regulated area without not have a significant economic impact
eRulemaking Portal at http:// obtaining permission from the COTP or on any vessel owner or operator.
a designated representative. The If you think that your business,
www.regulations.gov. See the ‘‘Public
regulatory text we are proposing appears organization, or governmental
Participation and Request for
at the end of this document. jurisdiction qualifies as a small entity
Comments’’ portion of the
and that this rule would have a
SUPPLEMENTARY INFORMATION section for IV. Regulatory Analyses significant economic impact on it,
further instructions on submitting
We developed this proposed rule after please submit a comment (see
comments.
considering numerous statutes and ADDRESSES) explaining why you think it
FOR FURTHER INFORMATION CONTACT: If executive orders (E.O.s) related to qualifies and how and to what degree
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
you have questions about this proposed rulemaking. Below we summarize our this rule would economically affect it.
rulemaking, call or email Petty Officer analyses based on a number of these Under section 213(a) of the Small
Ashley Schad, MSD Nashville, statutes and E.O.s, and we discuss First Business Regulatory Enforcement
Nashville, TN, at 615–736–5421 or at Amendment rights of protestors. Fairness Act of 1996 (Pub. L. 104–121),
Ashley.M.Schad@uscg.mil. we want to assist small entities in
SUPPLEMENTARY INFORMATION:
A. Regulatory Planning and Review understanding this proposed rule. If the
E.O.s 12866 and 13563 direct agencies rule would affect your small business,
I. Table of Abbreviations to assess the costs and benefits of organization, or governmental
CFR Code of Federal Regulations available regulatory alternatives and, if jurisdiction and you have questions
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Document Created: 2018-02-08 07:35:34
Document Modified: 2018-02-08 07:35:34
| 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 | Notice of petition; correction. | |
| Contact | Kelly Randolph, Center for Food Safety and Applied Nutrition (HFS-275), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835, 240-402-1188. | |
| FR Citation | 81 FR 37561 | |
| CFR Citation | 21
CFR
175 21 CFR 176 21 CFR 177 21 CFR 178 |
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