New Mailing Standards for the Separation of Hazardous Materials, 46575-46576 [2020-15774]
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Federal Register / Vol. 85, No. 149 / Monday, August 3, 2020 / Proposed Rules
for viewing by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday; they are also available
electronically at https://
www.regulations.gov. FDA has verified
the website addresses, as of the date this
document publishes in the Federal
Register, but websites are subject to
change over time.
1. FDA. Submission of Food and Drug
Administration Import Data in the
Automated Commercial Environment.
Federal Register (Docket No. FDA–2016–
N–1487). Online November 29, 2016.
Cited: January 31, 2017. https://
www.federalregister.gov/documents/
2016/11/29/2016-28582/submission-offood-and-drug-administration-importdata-in-the-automated-commercialenvironment.
2. FDA. Submission of Food and Drug
Administration Import Data in the
Automated Commercial Environment
(Final Rule) Regulatory Impact Analysis.
Economic Impact Analyses of FDA
Regulations. Online November 29, 2016.
Cited: January 31, 2017. https://
www.fda.gov/AboutFDA/Reports
ManualsForms/Reports/Economic
Analyses/ucm530862.htm.
3. FDA. Office of Regulatory Affairs
Reporting, Analysis, and Decision
Support System (ORADSS). 2015–2017
data.
List of Subjects in 21 CFR Part 1
Cosmetics, Drugs, Exports, Food
labeling, Imports, Labeling, Reporting
and recordkeeping requirements.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, we propose that 21
CFR part 1 be amended as follows:
PART 1—GENERAL ENFORCEMENT
REGULATIONS
1. The authority citation for part 1
continues to read as follows:
■
Authority: 15 U.S.C. 1333, 1453, 1454,
1455, 4402; 19 U.S.C. 1490, 1491; 21 U.S.C.
321, 331, 332, 333, 334, 335a, 342, 343, 350c,
350d, 350e, 350j, 350k, 352, 355, 360b,
360ccc, 360ccc–1, 360ccc–2, 362, 371, 373,
374, 379j–31, 381, 382, 384a, 384b, 384d,
387, 387a, 387c, 393; 42 U.S.C. 216, 241, 243,
262, 264, 271; Pub. L. 107–188, 116 Stat. 594,
668–69; Pub. L. 111–353, 124 Stat. 3885,
3889.
2. Amend § 1.71 by adding in
alphabetical order the definition for
‘‘Veterinary device’’ to read as follows:
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■
§ 1.71
Definitions.
*
*
*
*
*
Veterinary device means a device as
defined in section 201(h) of the Federal
Food, Drug, and Cosmetic Act, that is
intended for use in animals.
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16:51 Jul 31, 2020
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3. Revise § 1.72 introductory text to
read as follows:
■
§ 1.72 Data elements that must be
submitted in ACE for articles regulated by
FDA.
General. When filing an entry in ACE,
the ACE filer shall submit the following
information for food contact substances,
drugs, biological products, HCT/Ps,
medical devices, veterinary devices,
radiation-emitting electronic products,
cosmetics, and tobacco products.
*
*
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■ 4. Revise § 1.75 to read as follows:
§ 1.75 Animal drugs and veterinary
devices.
(a) Animal drugs. In addition to the
data required to be submitted in § 1.72,
an ACE filer must submit the following
information at the time of filing entry in
ACE for animal drugs:
(1) Registration and listing. For a drug
intended for animal use, the Drug
Registration Number and the Drug
Listing Number if the foreign
establishment where the drug was
manufactured, prepared, propagated,
compounded, or processed before being
imported or offered for import into the
United States is required to register and
list the drug under part 207 of this
chapter. For the purposes of this
section, the Drug Registration Number
that must be submitted in ACE at the
time of entry is the Unique Facility
Identifier of the foreign establishment
where the animal drug was
manufactured, prepared, propagated,
compounded, or processed before being
imported or offered for import into the
United States. The Unique Facility
Identifier is the identifier submitted by
a registrant in accordance with the
system specified under section 510(b) of
the Federal Food, Drug, and Cosmetic
Act. For the purposes of this section, the
Drug Listing Number is the National
Drug Code number of the animal drug
article being imported or offered for
import.
(2) New animal drug application
number. For a drug intended for animal
use that is the subject of an approved
application under section 512 of the
Federal Food, Drug, and Cosmetic Act,
the number of the new animal drug
application or abbreviated new animal
drug application. For a drug intended
for animal use that is the subject of a
conditionally approved application
under section 571 of the Federal Food,
Drug, and Cosmetic Act, the application
number for the conditionally approved
new animal drug.
(3) Veterinary minor species index file
number. For a drug intended for use in
animals that is the subject of an Index
PO 00000
Frm 00016
Fmt 4702
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46575
listing under section 572 of the Federal
Food, Drug, and Cosmetic Act, the
Minor Species Index File number of the
new animal drug on the Index of Legally
Marketed Unapproved New Animal
Drugs for Minor Species.
(4) Investigational new animal drug
file number. For a drug intended for
animal use that is the subject of an
investigational new animal drug or
generic investigational new animal drug
file under part 511 of this chapter, the
number of the investigational new
animal drug or generic investigational
new animal drug file.
(b) Veterinary devices. An ACE filer
must submit the data specified in § 1.72
at the time of filing entry in ACE for
veterinary devices.
Dated: July 2, 2020.
Stephen M. Hahn,
Commissioner of Food and Drugs.
In concurrence with FDA:
Dated: July 2, 2020.
Timothy E. Skud,
Deputy Assistant Secretary (Tax, Trade, and
Tariff Policy), Department of the Treasury.
[FR Doc. 2020–15571 Filed 7–31–20; 8:45 am]
BILLING CODE 4164–01–P
POSTAL SERVICE
39 CFR Part 113
New Mailing Standards for the
Separation of Hazardous Materials
Postal ServiceTM.
ACTION: Proposed revision; request for
comment.
AGENCY:
The Postal Service proposes
to amend Publication 52, Hazardous,
Restricted, and Perishable Mail (Pub
52), to incorporate requirements for
mailers to separate all air-eligible
hazardous material (HAZMAT) from
surface only transportation HAZMAT
shipments and other non-HAZMAT
items when tendering mail to the Postal
Service in the domestic mail. Air
eligible products, services or classes
include Priority Mail Express®, Priority
Mail®, First-Class Package Service®,
Priority Mail Return Service® or FirstClass Package Return Service® and
surface only transportation are mail
using Parcel Select®, Parcel Select
Lightweight®, USPS Retail Ground®, or
USPS Ground Return Service ®.
Additionally, the Postal Service for
consistency will incorporate the current
standard operating procedures for
separation as it pertains to acceptance
and dispatch personnel.
DATES: We must receive your comments
on or before September 2, 2020.
SUMMARY:
E:\FR\FM\03AUP1.SGM
03AUP1
46576
Federal Register / Vol. 85, No. 149 / Monday, August 3, 2020 / Proposed Rules
Mail or deliver written
comments to the Manager, Product
Classification, U.S. Postal Service, 475
L’Enfant Plaza SW, Room 4446,
Washington, DC 20260–5015. If sending
comments by email, include the name
and address of the commenter and send
to PCFederalRegister@usps.gov, with a
subject line of ‘‘HAZMAT Separation’’.
Faxed comments will not be accepted.
All submitted comments and
attachments are part of the public record
and subject to disclosure. Do not
enclose any material in your comments
that you consider to be confidential or
inappropriate for public disclosure.
You may inspect and photocopy all
written comments, by appointment
only, at USPS® Headquarters Library,
475 L’Enfant Plaza SW, 11th Floor
North, Washington, DC 20260. These
records are available for review Monday
through Friday, 9 a.m. to 4 p.m. by
calling 202–268–2906.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Dale
Kennedy (202) 268–6592 or Mary
Collins (202) 268–5551.
The Postal
Service is proposing to amend PUB 52
with the provisions described below
and, once adopted, will incorporate the
revised PUB 52 by reference into part
113. You may view the text of the
proposed edits to PUB 52 at: https://
pe.usps.com/.
Air carriers are required to review
HAZMAT shipments and complete
HAZMAT checklists at the time of
acceptance to mitigate risk to aviation.
The Postal Service tenders mail,
including packages containing both
non-hazardous and hazardous materials
to its contracted air carriers in sealed
containers. Due to the sealed nature of
the containers, air carriers are often
unaware of the specific hazardous
materials they are accepting and
transporting. In order to facilitate the
review of tendered items, certain air
carriers require the Postal Service to
separate HAZMAT mail from nonHAZMAT mail and tender the items at
a specific time of day.
The Postal Service HAZMAT standard
operating procedures state air-eligible
HAZMAT must be separated with
appropriate documentation from other
non-HAZMAT mail for air
transportation. The proposed change
will require mailers to separate all aireligible HAZMAT prior to acceptance to
allow these pieces to flow in a more
efficient manner and prevent comingled packages of surface only
transportation HAZMAT and non-
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SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
16:51 Jul 31, 2020
Jkt 250001
HAZMAT mail when tendered to air
carriers.
Brittany Johnson,
Attorney, Federal Compliance.
[FR Doc. 2020–15774 Filed 7–31–20; 8:45 am]
BILLING CODE 7710–12–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 52
[EPA–R03–OAR–2020–0268; FRL–10011–
85–Region 3]
Air Plan Approval; Pennsylvania; 1997
8-Hour Ozone NAAQS Second
Maintenance Plan for the Franklin
County Area
Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
AGENCY:
The Environmental Protection
Agency (EPA) is proposing to approve a
state implementation plan (SIP) revision
submitted by the Commonwealth of
Pennsylvania. This revision pertains to
the Commonwealth’s plan, submitted by
the Pennsylvania Department of
Environmental Protection (DEP), for
maintaining the 1997 8-hour ozone
national ambient air quality standard
(NAAQS) (referred to as the ‘‘1997
ozone NAAQS’’) in the Franklin County,
Pennsylvania area (Franklin County
Area). This action is being taken under
the Clean Air Act (CAA).
DATES: Written comments must be
received on or before September 2,
2020.
SUMMARY:
Submit your comments,
identified by Docket ID No. EPA–R03–
OAR–2020–0268 at https://
www.regulations.gov, or via email to
spielberger.susan@epa.gov. For
comments submitted at Regulations.gov,
follow the online instructions for
submitting comments. Once submitted,
comments cannot be edited or removed
from Regulations.gov. For either manner
of submission, EPA may publish any
comment received to its public docket.
Do not submit electronically any
information you consider to be
confidential business information (CBI)
or other information whose disclosure is
restricted by statute. Multimedia
submissions (audio, video, etc.) must be
accompanied by a written comment.
The written comment is considered the
official comment and should include
discussion of all points you wish to
make. EPA will generally not consider
comments or comment contents located
outside of the primary submission (i.e.,
ADDRESSES:
PO 00000
Frm 00017
Fmt 4702
Sfmt 4702
on the web, cloud, or other file sharing
system). For additional submission
methods, please contact the person
identified in the FOR FURTHER
INFORMATION CONTACT section. For the
full EPA public comment policy,
information about CBI or multimedia
submissions, and general guidance on
making effective comments, please visit
https://www.epa.gov/dockets/
commenting-epa-dockets.
FOR FURTHER INFORMATION CONTACT:
David Talley, Planning &
Implementation Branch (3AD30), Air &
Radiation Division, U.S. Environmental
Protection Agency, Region III, 1650
Arch Street, Philadelphia, Pennsylvania
19103. The telephone number is (215)
814–2117. Mr. Talley can also be
reached via electronic mail at
talley.david@epa.gov.
SUPPLEMENTARY INFORMATION: On March
10, 2020, DEP submitted a revision to
the Pennsylvania SIP to incorporate a
plan for maintaining the 1997 ozone
NAAQS in the Franklin County Area
through July 25, 2027, in accordance
with CAA section 175A.
I. Background
In 1979, under section 109 of the
CAA, EPA established primary and
secondary NAAQS for ozone at 0.12
parts per million (ppm), averaged over
a 1-hour period. 44 FR 8202 (February
8, 1979). On July 18, 1997 (62 FR
38856),1 EPA revised the primary and
secondary NAAQS for ozone to set the
acceptable level of ozone in the ambient
air at 0.08 ppm, averaged over an 8-hour
period. EPA set the 1997 ozone NAAQS
based on scientific evidence
demonstrating that ozone causes
adverse health effects at lower
concentrations and over longer periods
of time than was understood when the
pre-existing 1-hour ozone NAAQS was
set.
Following promulgation of a new or
revised NAAQS, EPA is required by the
CAA to designate areas throughout the
nation as attaining or not attaining the
NAAQS. On April 30, 2004 (69 FR
23858), EPA designated Franklin
County as nonattainment for the 1997
ozone NAAQS.
Once a nonattainment area has three
years of complete and certified air
quality data that has been determined to
attain the NAAQS, and the area has met
1 In March 2008, EPA completed another review
of the primary and secondary ozone standards and
tightened them further by lowering the level for
both to 0.075 ppm. 73 FR 16436 (March 27, 2008).
Additionally, in October 2015, EPA completed a
review of the primary and secondary ozone
standards and tightened them by lowering the level
for both to 0.70 ppm. 80 FR 65292 (October 26,
2015).
E:\FR\FM\03AUP1.SGM
03AUP1
Agencies
[Federal Register Volume 85, Number 149 (Monday, August 3, 2020)]
[Proposed Rules]
[Pages 46575-46576]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-15774]
=======================================================================
-----------------------------------------------------------------------
POSTAL SERVICE
39 CFR Part 113
New Mailing Standards for the Separation of Hazardous Materials
AGENCY: Postal ServiceTM.
ACTION: Proposed revision; request for comment.
-----------------------------------------------------------------------
SUMMARY: The Postal Service proposes to amend Publication 52,
Hazardous, Restricted, and Perishable Mail (Pub 52), to incorporate
requirements for mailers to separate all air-eligible hazardous
material (HAZMAT) from surface only transportation HAZMAT shipments and
other non-HAZMAT items when tendering mail to the Postal Service in the
domestic mail. Air eligible products, services or classes include
Priority Mail Express[supreg], Priority Mail[supreg], First-Class
Package Service[supreg], Priority Mail Return Service[supreg] or First-
Class Package Return Service[supreg] and surface only transportation
are mail using Parcel Select[supreg], Parcel Select
Lightweight[supreg], USPS Retail Ground[supreg], or USPS Ground Return
Service [supreg]. Additionally, the Postal Service for consistency will
incorporate the current standard operating procedures for separation as
it pertains to acceptance and dispatch personnel.
DATES: We must receive your comments on or before September 2, 2020.
[[Page 46576]]
ADDRESSES: Mail or deliver written comments to the Manager, Product
Classification, U.S. Postal Service, 475 L'Enfant Plaza SW, Room 4446,
Washington, DC 20260-5015. If sending comments by email, include the
name and address of the commenter and send to
[email protected], with a subject line of ``HAZMAT
Separation''. Faxed comments will not be accepted. All submitted
comments and attachments are part of the public record and subject to
disclosure. Do not enclose any material in your comments that you
consider to be confidential or inappropriate for public disclosure.
You may inspect and photocopy all written comments, by appointment
only, at USPS[supreg] Headquarters Library, 475 L'Enfant Plaza SW, 11th
Floor North, Washington, DC 20260. These records are available for
review Monday through Friday, 9 a.m. to 4 p.m. by calling 202-268-2906.
FOR FURTHER INFORMATION CONTACT: Dale Kennedy (202) 268-6592 or Mary
Collins (202) 268-5551.
SUPPLEMENTARY INFORMATION: The Postal Service is proposing to amend PUB
52 with the provisions described below and, once adopted, will
incorporate the revised PUB 52 by reference into part 113. You may view
the text of the proposed edits to PUB 52 at: https://pe.usps.com/.
Air carriers are required to review HAZMAT shipments and complete
HAZMAT checklists at the time of acceptance to mitigate risk to
aviation. The Postal Service tenders mail, including packages
containing both non-hazardous and hazardous materials to its contracted
air carriers in sealed containers. Due to the sealed nature of the
containers, air carriers are often unaware of the specific hazardous
materials they are accepting and transporting. In order to facilitate
the review of tendered items, certain air carriers require the Postal
Service to separate HAZMAT mail from non-HAZMAT mail and tender the
items at a specific time of day.
The Postal Service HAZMAT standard operating procedures state air-
eligible HAZMAT must be separated with appropriate documentation from
other non-HAZMAT mail for air transportation. The proposed change will
require mailers to separate all air-eligible HAZMAT prior to acceptance
to allow these pieces to flow in a more efficient manner and prevent
co-mingled packages of surface only transportation HAZMAT and non-
HAZMAT mail when tendered to air carriers.
Brittany Johnson,
Attorney, Federal Compliance.
[FR Doc. 2020-15774 Filed 7-31-20; 8:45 am]
BILLING CODE 7710-12-P