[Federal Register Volume 83, Number 247 (Thursday, December 27, 2018)]
[Notices]
[Pages 66707-66708]
[FR Doc No: 2018-28120]

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[FRL-9988-21-Region 6]

Underground Injection Control Program; Hazardous Waste Injection
Restrictions; Petition for Exemption Reissuance--Class I Hazardous
Waste Injection; ANGUS Chemical Company

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of a final decision on a UIC no migration petition
reissuance.

-----------------------------------------------------------------------

SUMMARY: Notice is hereby given that a reissuance of an exemption to
the Land Disposal Restrictions, under the 1984 Hazardous and Solid
Waste Amendments to the Resource Conservation and Recovery Act, has
been granted to ANGUS for two Class I hazardous waste injection wells
located at their Sterlington, Louisiana site. The company has
adequately demonstrated to the satisfaction of the EPA by the petition
reissuance application and supporting documentation that, to a
reasonable degree of certainty, there will be no migration of hazardous
constituents from the injection zone for as long as the waste remains
hazardous. This final decision allows the underground injection by
ANGUS of the specific restricted hazardous waste (D002) identified in
this exemption reissuance request, into Class I hazardous waste
injection wells IW-1 and IW-2 until December 31, 2027, unless the EPA
moves to terminate this exemption. Additional conditions included in
this final decision may be reviewed by contacting the EPA Region 6
Ground Water/UIC Section. A public notice was issued August 28, 2018,
and the public comment period closed on October 15, 2018, and no
comments were received. This decision constitutes final Agency action
and there is no Administrative appeal.

DATES: This action is effective as of November 19, 2018.

ADDRESSES: Copies of the petition reissuance and all pertinent
information relating thereto are on file at the following location:
Environmental Protection Agency, Region 6, Water Division, Safe
Drinking Water Branch (6WQ-S), 1445 Ross Avenue, Dallas, Texas 75202-
2733.

FOR FURTHER INFORMATION CONTACT: Philip Dellinger, Chief, Ground Water/
UIC Section, EPA--Region 6, telephone<PHONE_NUMBER>.

    Dated: November 19, 2018.
Charles W. Maguire,
Director, Water Division.
[FR Doc. 2018-28120 Filed 12-26-18; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 82, Number 36 (Friday, February 24, 2017)]
[Notices]
[Page 11689]
[FR Doc No: 2017-03732]

-----------------------------------------------------------------------

SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting

    Notice is hereby given, pursuant to the provisions of the
Government in the Sunshine Act, Public Law 94-409, that the Commission
will host the SEC-NYU Dialogue on Securities Markets--Securities
Crowdfunding in the U.S. on Tuesday, February 28, 2017 beginning at
8:30 a.m., in the Auditorium, Room L-002.
    The event will include welcome remarks by SEC Acting Chairman
Michael Piwowar, concluding remarks by SEC Commissioner Kara Stein and
panel discussions that Commissioners may attend. The panel discussions
will explore the economic rationale and legal framework for securities
crowdfunding, investor protection and capital formation in securities
crowdfunding and empirical evidence and data on securities
crowdfunding. This Sunshine Act notice is being issued because a
majority of the Commission may attend the meeting.
    For further information, please contact Brent J. Fields from the
Office of the Secretary at<PHONE_NUMBER>.

    Dated: February 21, 2017.
Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-03732 Filed 2-22-17; 11:15 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 88, Number 153 (Thursday, August 10, 2023)]
[Notices]
[Pages 54320-54322]
[FR Doc No: 2023-17140]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-3103]

Development of Small Dispensers Assessment Under the Drug Supply
Chain Security Act; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is seeking
stakeholder comments on the development of a technology and software
assessment that examines the feasibility of dispensers with 25 or fewer
full-time employees conducting interoperable, electronic tracing of
products at the package level. FDA would like to obtain information
regarding issues to be addressed in the assessment related to the
accessibility of the necessary software and hardware to such
dispensers; whether the necessary software and hardware is
prohibitively expensive to obtain, install, and maintain for such
dispensers; and if the necessary hardware and software can be
integrated into business practices.

DATES: Either electronic or written comments on the notice must be
submitted by September 11, 2023.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of September 11, 2023. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:

     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2023-N-3103 for ``Development of Small Dispensers Assessment under
the Drug Supply Chain Security Act; Request for Comments.'' Received
comments, those filed in a timely manner (see ADDRESSES), will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, 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,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Daniel Bellingham, Office of
Compliance, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002,
301-796-3130, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    On November 27, 2013, the Drug Supply Chain Security Act (DSCSA)
(Title II of Pub. L. 113-54) was signed into law. The DSCSA outlines
steps to achieve interoperable, electronic tracing of products at the
package level to identify and trace certain prescription drugs as they
are distributed in the United States. Section 202 of the DSCSA added
the new sections 581 and 582 to the Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 360eee and 360eee-1). Under section 582(g)(3), FDA is
required to enter into a contract with a private, independent
consulting firm with expertise to conduct a technology and software
assessment that looks at the feasibility of dispensers with 25 or fewer
full-time employees conducting interoperable, electronic tracing of
products at the package level. Under section 582(g)(1), dispensers and
other trading partners will be required to, amongst other requirements,
exchange transaction information and transaction statements in a
secure, interoperable, electronic manner for each package; implement
systems and processes for package-level verification, including the
standardized numerical identifier; and implement systems and processes
to facilitate the gathering of information necessary to produce the
transaction information and statement for each transaction going back
to the manufacturer if FDA or a trading partner requests an
investigation in the event of a recall or for purposes of investigating
a suspect or illegitimate product. These enhanced drug distribution
security requirements are also referred to as ``enhanced product
tracing'' or ``enhanced verification.''

II. Purpose of the Request for Comments

    FDA is issuing this request for public comments prior to beginning
the assessment, in accordance with section 582(g)(3)(D). The statement
of work requires the selected firm to conduct an assessment that will
address the proposed questions articulated below. In addition to
commenting on the proposed questions below, stakeholders may provide
comments on any aspect of the small dispenser assessment under the
DSCSA.
    Stakeholders that may be interested in responding to this request
for information include manufacturers, repackagers, wholesale
distributors, dispensers, State and Federal authorities, solution
providers, and standards organizations, among others. FDA is
particularly interested in receiving comments from the various sectors
of the dispenser community, particularly pharmacies. FDA is seeking
comments on the following proposed questions for small dispensers
(i.e., dispensers with 25 or fewer full-time employees). We are
interested in receiving feedback on the questions themselves and
whether or not they should be edited to be more useful for the
assessment. FDA is also interested in any new questions that
stakeholders may recommend.
     Have you begun preparations for DSCSA requirements
regarding the interoperable, electronic tracing of products at the
package level required under section 582(g)(1) of the FD&C Act (i.e.,
enhanced product tracing or enhanced verification)?
     How are you currently exchanging data with your trading
partners (e.g., by

paper-based methods, electronic methods, or both)?
     If not currently exchanging data with trading partners in
a fully electronic manner, will you be able to in the near future? If
not, what are the barriers? Elaborate on why or how, as appropriate.
Please specify issues related to:
     accessibility of necessary software and hardware;
     cost to obtain, install, and maintain necessary software
and hardware, particularly if it is prohibitively expensive;
     integration of necessary software and hardware into
business practices, such as with wholesale distributors;
     other relevant information related to feasibility of
dispensers with 25 or fewer full-time employees to conduct
interoperable, electronic tracing of product at the package level.
     What type of software systems and hardware do you
currently utilize to facilitate the electronic exchange of DSCSA-
related data for transactions of products?
     What new or modified software systems and hardware do you
anticipate putting in place to comply with the interoperable,
electronic tracing requirements?
     How likely are you to change and upgrade your existing
software systems that are already in use so that you can comply with
the interoperable, electronic tracing requirements?
     Have you or do you plan to connect your system(s) with
your trading partner(s) (e.g., manufacturer(s), repackager(s), or
wholesale distributor(s)) in order to facilitate electronic DSCSA-
related data exchange? If so, have you experienced technical issues
when attempting to establish connectivity? If not, how do you or how do
you plan to manage electronic DSCSA-related data received from an
upstream trading partner (e.g., maintain the data in your dispenser
system or use a third-party agreement for another entity to
confidentially maintain the DSCSA-related data on your behalf (e.g.,
use of a secure web portal provided by your wholesale distributor))?
     Have you considered data integrity and security concerns
when establishing agreements with third-party entities (e.g., solution
providers or wholesale distributors) for electronic data exchange and
maintenance?
     Have you ever received transaction information from a
trading partner, such as your wholesale distributor, that does not
match the product that you received? If so, how long did it take to
resolve the discrepancy on average? What if any unique challenges arose
from these situations? How often does this happen?
     If you currently routinely scan a 2D data matrix barcode,
how often do you receive a 2D data matrix barcode of the product
identifier that cannot be scanned or read? Why are you unable to scan
or read the 2D data matrix barcode (e.g., barcode quality, scanner
performance, software issue) and what is your process for handling
these situations, including when manual steps are taken by your staff
when an automated process was inadequate or failed?
     If you currently routinely scan the 2D data matrix
barcode, how often you encounter a 2D data matrix barcode with missing
or inaccurate data? What are the reasons for this and what is your
process for handling these situations, including when manual steps are
taken by your staff when an automated process was inadequate or failed?
     What new demands do you expect the DSCSA requirements in
section 582(g)(1) of the FD&C Act to have on your current staff
resources?
     How long do you expect it will take to train staff on the
new requirements, how to use any new software or hardware, and any
process changes? What additional resources do you anticipate needing to
comply with the interoperable, electronic tracing requirements?
     Are there additional challenges not already identified
when operationalizing new systems and processes for interoperable,
electronic tracing of products at the package level required under
section 582(g)(1) of the FD&C Act (i.e., enhanced product tracing or
enhanced verification)?
    Stakeholders may provide other relevant information that may inform
the development of the small dispenser assessment under the DSCSA.

    Dated: August 7, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-17140 Filed 8-9-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 157 (Friday, August 14, 2015)]
[Proposed Rules]
[Pages 48793-48794]
[FR Doc No: 2015-20016]

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 300

[EPA-HQ-SFUND-1990-0010; FRL-9932-36-Region 4]

National Oil and Hazardous Substances Pollution Contingency Plan;
National Priorities List: Deletion of the Redwing Carriers, Inc.
(Saraland) Superfund Site

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule; notice of intent.

-----------------------------------------------------------------------

SUMMARY: The Environmental Protection Agency (EPA) Region 4 is issuing
a Notice of Intent to Delete the Redwing Carriers, Inc. (Saraland)
Superfund Site (Site) located in Mobile County, Alabama, from the
National Priorities List (NPL) and requests public comments on this
proposed action. The NPL, promulgated pursuant to section 105 of the
Comprehensive Environmental Response, Compensation, and Liability Act
(CERCLA) of 1980, as amended, is an appendix of the National Oil and
Hazardous Substances Pollution Contingency Plan (NCP). The EPA and the
State of Alabama, through the Alabama Department of Environmental
Management (ADEM), have determined that all appropriate response
actions under CERCLA have been completed. However, this deletion does
not preclude future actions under Superfund.

DATES: Comments must be received by September 14, 2015.

ADDRESSES: Submit your comments, identified by Docket ID no. EPA-HQ-
SFUND-1990-0010, by mail to Shelby Johnston, Remedial Project Manager,
Superfund Restoration and Sustainability Branch, Superfund Division,
U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW.,
Atlanta, Georgia 30303-8960. Comments may also be submitted
electronically or through hand delivery/courier by following the
detailed instructions in the ADDRESSES section of the direct final rule
located in the rules section of this Federal Register.

FOR FURTHER INFORMATION CONTACT: Shelby Johnston, Remedial Project
Manager, Superfund Restoration and Sustainability Branch, Superfund
Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth
Street SW., Atlanta, Georgia 30303-8960,<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION: In the ``Rules and Regulations'' Section of
this Federal Register, we are publishing a direct final Notice of
Deletion of the Site without prior Notice of Intent to Delete because
we view this as a noncontroversial revision and anticipate no adverse
comment. We have explained our reasons for this deletion in the direct
final Notice of Deletion, and those reasons are incorporated herein. If
we receive no adverse comment(s) on this deletion action, we will not
take further action on this Notice of Intent to Delete. If we receive
adverse comment(s), we will withdraw the direct final Notice of
Deletion, and it will not take effect. We will, as appropriate, address
all public comments in a subsequent final Notice of Deletion based on
this Notice of Intent to Delete. We will not institute a second comment
period on this Notice of Intent to Delete. Any parties interested in
commenting must do so at this time.
    For additional information, see the direct final Notice of Deletion
which is located in the Rules section of this Federal Register.

List of Subjects in 40 CFR Part 300

    Environmental protection, Air pollution control, Chemicals,
Hazardous waste, Hazardous substances, Intergovernmental relations,
Penalties, Reporting and recordkeeping requirements, Superfund, Water
pollution control, Water supply.

    Authority: 33 U.S.C. 1321(c)(2); 42 U.S.C. 9601-9657; E.O.
12777, 56 FR 54757, 3 CFR, 1991 Comp., p. 351; E.O. 12580, 52 FR
2923; 3 CFR, 1987 Comp., p. 193.

    Dated: August 3, 2015.
Heather McTeer Toney,
Regional Administrator, Region 4.
[FR Doc. 2015-20016 Filed 8-13-15; 8:45 am]
BILLING CODE 6560-50-P