Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act-Compliance Policies; Guidance for Industry; Availability
| Court | Food And Drug Administration |
| Citation | 88 FR 58498 |
| Published date | 28 August 2023 |
| Record Number | 2023-18359 |
| Section | Rules and Regulations |
58498
Federal Register / Vol. 88, No. 165 / Monday, August 28, 2023 / Rules and Regulations
AIRAC date State City Airport name FDC No. FDC date Procedure name
5-Oct-23 ....... AR Fayetteville .............. Drake Fld ................................. 3/7180 8/9/23 LOC RWY 16, Orig.
5-Oct-23 ....... AR Fayetteville .............. Drake Fld ................................. 3/7182 8/9/23 RNAV (GPS) RWY 34, Amdt 1C.
[FR Doc. 2023–18463 Filed 8–25–23; 8:45 a.m.]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Chapter I
[Docket No. FDA–2023–D–1909]
Enhanced Drug Distribution Security
Requirements Under Section 582(g)(1)
of the Federal Food, Drug, and
Cosmetic Act—Compliance Policies;
Guidance for Industry; Availability
AGENCY
: Food and Drug Administration,
Department of Health and Human
Services (HHS).
ACTION
: Notification of availability.
SUMMARY
: The Food and Drug
Administration (FDA, Agency, or we) is
announcing the availability of a final
guidance for industry entitled
‘‘Enhanced Drug Distribution Security
Requirements Under Section 582(g)(1)
of the Federal Food, Drug, and Cosmetic
Act—Compliance Policies.’’ This
guidance describes FDA’s compliance
policies regarding enforcement of
requirements for the interoperable,
electronic, package level product tracing
(referred to as enhanced drug
distribution security requirements)
under the Federal Food, Drug, and
Cosmetic Act (FD&C Act) that will go
into effect on November 27, 2023. FDA
believes the compliance policies
outlined in this guidance will help
supply chain stakeholders, particularly
trading partners, by accommodating the
additional time that may be needed to
continue to develop and refine
appropriate systems and processes to
conduct interoperable, electronic tracing
at the package level, to achieve robust
supply chain security under the Drug
Supply Chain Security Act (DSCSA)
while helping ensure continued patient
access to prescription drugs.
DATES
: The announcement of the
guidance is published in the Federal
Register on August 28, 2023.
ADDRESSES
: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
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–D–1909 for ‘‘Enhanced Drug
Distribution Security Requirements
Under Section 582(g)(1) of the Federal
Food, Drug, and Cosmetic Act—
Compliance Policies.’’ Received
comments 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, 240–402–7500.
•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, 240–402–7500.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of this guidance to the Division
of Drug Information, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002 or to the Office of Communication,
Outreach and Development, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
VerDate Sep<11>2014 17:47 Aug 25, 2023 Jkt 259001 PO 00000 Frm 00004 Fmt 4700 Sfmt 4700 E:\FR\FM\28AUR1.SGM 28AUR1
lotter on DSK11XQN23PROD with RULES1
58499
Federal Register / Vol. 88, No. 165 / Monday, August 28, 2023 / Rules and Regulations
1
The Office of the Federal Register has published
this document under the category ‘‘Rules and
Regulations’’ pursuant to its interpretation of 1 CFR
5.9(b). We note that the categorization as such for
purposes of publication in the Federal Register
does not affect the content or intent of the
document. See 1 CFR 5.1(c).
3128, Silver Spring, MD 20993–0002.
Send one self-addressed adhesive label
to assist that office in processing your
requests. See the
SUPPLEMENTARY
INFORMATION
section for electronic
access to the guidance document.
FOR FURTHER INFORMATION CONTACT
:
Elizabeth Pepinsky, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 4258,
Silver Spring, MD 20993–0002, 301–
796–3130, email: drugtrackandtrace@
fda.hhs.gov; or Anne Taylor, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993–0002,
240–402–7911.
SUPPLEMENTARY INFORMATION
:
I. Background
FDA is announcing the availability of
a guidance for industry entitled
‘‘Enhanced Drug Distribution Security
Requirements Under Section 582(g)(1)
of the Federal Food, Drug, and Cosmetic
Act—Compliance Policies.’’ This
guidance describes FDA’s compliance
policies regarding enforcement of
requirements for the interoperable,
electronic, package level product tracing
(referred to as enhanced drug
distribution security requirements)
under section 582(g)(1) of the FD&C Act
(21 U.S.C. 360eee-1(g)(1)) that will go
into effect on November 27, 2023. FDA
believes that these compliance policies
will facilitate the continued use of
product tracing and verification
methods currently being used while
accommodating the additional time that
may be needed by trading partners to
continue to develop and refine the
systems and processes for such
activities required under section
582(g)(1) of the FD&C Act.
We are issuing this guidance
consistent with our good guidance
practices (GGP) regulation (21 CFR
10.115). We are implementing this
guidance without prior public comment
because we have determined that prior
public participation is not feasible or
appropriate (21 CFR 10.115(g)(2)). The
Agency made this determination
because the Agency needs to
communicate its compliance policy in a
timely manner and provide stakeholders
notice of the compliance policy ahead of
the effective date of the enhanced
distribution security requirements.
Although this guidance document is
being implemented immediately, it
remains subject to comment in
accordance with FDA’s GGP regulation
and the Agency will consider all
comments received and determine
whether revisions to the guidance
document are appropriate.
The DSCSA, enacted on November 27,
2013, outlines critical steps for building
an electronic, interoperable system by
November 27, 2023, that will identify
and trace certain prescription drugs as
they are distributed within the United
States. Since the enactment of DSCSA,
FDA and trading partners have been
preparing for the implementation of the
enhanced drug distribution security
requirements imposed by section
582(g)(1) of the FD&C Act. Trading
partners are continuing to work to have
the necessary systems and processes in
place in anticipation of the November
27, 2023, effective date for these
requirements. While trading partners
have the obligation to comply with
section 582 requirements, including for
enhanced drug distribution security,
there are other stakeholders involved
and affected, including but not limited
to: solution providers, standards
organizations, trade and professional
organizations, state authorities, and
other Federal authorities.
FDA understands that collaboration
and alignment among trading partners
and other stakeholders throughout the
supply chain are critical for achieving
interoperability under the DSCSA. FDA
has heard from stakeholders, including
a broad representation of trading
partners, about concerns regarding
trading partner readiness and the need
for clarity and flexibility to ensure
trading partners can continue to move
product through the supply chain when
the enhanced drug distribution security
requirements under section 582(g)(1) of
the FD&C Act take effect. Most recently,
at a virtual public meeting on DSCSA
Implementation and Readiness Efforts
for 2023 held on December 7 and 8,
2022 (87 FR 67047, November 7, 2022),
stakeholders indicated that trading
partners throughout the supply chain
are at different stages of readiness, with
some trading partners being further
behind not only in terms of
understanding their obligations under
section 582(g)(1) of the FD&C Act, but
also being aware of the time and
resources necessary to meet those
obligations. Stakeholders also expressed
a need for clarity with respect to
treatment of product that is already in
the supply chain on November 27, 2023,
and the need for flexibility when the
requirements under section 582(g)(1)
take effect, to minimize potential
disruptions in the supply chain. In
addition, stakeholders are experiencing
challenges with predicting and planning
for the possible volume of requests for
product tracing information from
Federal and State authorities and other
trading partners, and the resources
needed to respond to such requests, in
accordance with section 582(g)(1) of the
FD&C Act.
While FDA generally expects trading
partners to have the systems and
processes in place to meet the enhanced
drug distribution security requirements
of section 582(g)(1) as of November 27,
2023, we recognize that some technical
and operational issues, including issues
involving trading partners and other
affected stakeholders, may not be fully
resolved by that time. The Agency also
understands that additional time
beyond November 27, 2023, may be
needed for systems to stabilize and be
fully interoperable for accurate, secure,
and timely electronic data exchange.
This guidance is intended to provide
clarity and flexibility to trading partners
to help ensure continued patient access
to prescription drugs as the supply
chain transitions to the interoperable,
electronic product tracing at the package
level under the DSCSA. The compliance
policies in this guidance can help
trading partners throughout the supply
chain implement the requirements
under section 582(g)(1) of the FD&C Act
by accommodating the additional time
that may be needed to implement,
troubleshoot, and mature their systems
and processes while supporting the
continued availability of products to
patients.
The guidance represents the current
thinking of FDA on ‘‘Enhanced Drug
Distribution Security Requirements
Under Section 582(g)(1) of the Federal
Food, Drug, and Cosmetic Act—
Compliance Policies.’’ It does not
establish any rights for any person and
is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations.
1
II. Paperwork Reduction Act
FDA concludes that this guidance
contains no collection of information.
Therefore, clearance by the Office of
Management and Budget under the
Paperwork Reduction Act of 1995 is not
required.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at https://
www.fda.gov/drugs/guidance-
compliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
VerDate Sep<11>2014 17:47 Aug 25, 2023 Jkt 259001 PO 00000 Frm 00005 Fmt 4700 Sfmt 4700 E:\FR\FM\28AUR1.SGM 28AUR1
lotter on DSK11XQN23PROD with RULES1
58500
Federal Register / Vol. 88, No. 165 / Monday, August 28, 2023 / Rules and Regulations
vaccines-blood-biologics/guidance-
compliance-regulatory-information-
biologics/biologics-guidances, https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents, or
https://www.regulations.gov.
Dated: August 22, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–18359 Filed 8–25–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 165
[USCG–USCG–2023–0043]
RIN 1625–AA00
Safety Zone, Illinois River MM 165.5
Peoria, IL
AGENCY
: Coast Guard, Department of
Homeland Security (DHS).
ACTION
: Temporary final rule.
SUMMARY
: The Coast Guard is
establishing a temporary safety zone for
all navigable waters within a half mile
radius of a crane boom located in the
Illinois River at Mile Marker (MM)
165.5. The safety zone is needed to
protect personnel, vessels, and the
marine environment from all potential
hazards associated with a crane boom
blocking the navigable channel and the
salvage operation for its removal. Entry
of vessels or persons into this zone is
prohibited unless specifically
authorized by the Captain of the Port
Sector Upper Mississippi River (COTP)
or a designated representative.
DATES
: This rule is effective without
actual notice from August 28, 2023,
through August 29, 2023. For the
purposes of enforcement, actual notice
will be used from August 23, 2023, until
August 28, 2023.
ADDRESSES
: To view documents
mentioned in this preamble as being
available in the docket, go to https://
www.regulations.gov, type USCG–2023–
0043 in the search box and click
‘‘Search.’’ Next, in the Document Type
column, select ‘‘Supporting & Related
Material.’’
FOR FURTHER INFORMATION CONTACT
: If
you have questions on this rule, call or
email MSTC Nathaniel Dibley, Sector
Upper Mississippi River Waterways
Management Division, U.S. Coast
Guard; telephone 314–269–2560, email
Nathaniel.D.Dibley@uscg.mil.
SUPPLEMENTARY INFORMATION
:
I. Table of Abbreviations
CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
§ Section
U.S.C. United States Code
II. Background Information and
Regulatory History
The Coast Guard is issuing this
temporary rule without prior notice and
opportunity to comment pursuant to
authority under section 4(a) of the
Administrative Procedure Act (APA) (5
U.S.C. 553(b)). This provision
authorizes an agency to issue a rule
without prior notice and opportunity to
comment when the agency for good
cause finds that those procedures are
‘‘impracticable, unnecessary, or contrary
to the public interest.’’ Under 5 U.S.C.
553(b)(B), the Coast Guard finds that
good cause exists for not publishing a
notice of proposed rulemaking (NPRM)
with respect to this rule because a
temporary safety zone must be
established immediately to protect
personnel, vessels, and the marine
environment from potential hazards
created by a crane boom protruding into
the navigable channel and lack
sufficient time to provide a reasonable
comment period and then consider
those comments before issuing the rule.
It is impracticable to publish an NPRM
because we must establish this safety
zone by August 23, 2023.
Under 5 U.S.C. 553(d)(3), the Coast
Guard finds that good cause exists for
making this rule effective less than 30
days after publication in the Federal
Register. Delaying the effective date of
this rule would be impracticable
because immediate action is needed to
respond to the potential safety hazards
associated with a crane boom blocking
the navigable channel.
III. Legal Authority and Need for Rule
The Coast Guard is issuing this rule
under authority in 46 U.S.C. 70034. The
Captain of the Port Sector Upper
Mississippi River (COTP) has
determined that potential hazards
associated with a crane boom blocking
the navigable channel and the salvage
operation taking place to remove it will
be a safety concern for anyone operating
or transiting within the Illinois River at
MM 165.5. This rule is needed to
protect personnel, vessels, and the
marine environment in the navigable
waters within the safety zone until the
crane boom has been removed from the
waterway.
IV. Discussion of the Rule
The salvaging of the crane boom will
occur at MM 165.5 beginning August 23,
2023. The safety zone is designed to
protect waterway users until work is
complete.
No vessel or person will be permitted
to enter the safety zone without
obtaining permission from the COTP or
a designated representative. A
designated representative is a
commissioned, warrant, or petty officer
of the U.S. Coast Guard (USCG) assigned
to units under the operational control of
USCG Sector Upper Mississippi River.
To seek permission to enter, contact the
COTP or a designated representative via
VHF–FM channel 16, or through USCG
Sector Upper Mississippi River at 314–
269–2332. Persons and vessels
permitted to enter the safety zone must
comply with all lawful orders or
directions issued by the COTP or
designated representative. The COTP or
a designated representative will inform
the public of the effective period for the
safety zone as well as any changes in the
dates and times of enforcement, as well
as reductions in the size of the safety
zone through Local Notice to Mariners
(LNMs), Broadcast Notices to Mariners
(BNMs), and/or Safety Marine
Information Broadcast (SMIB), as
appropriate.
V. Regulatory Analyses
We developed this rule after
considering numerous statutes and
Executive orders related to rulemaking.
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.
This rule has not been designated a
‘‘significant regulatory action,’’ under
section 3(f) of Executive Order 12866, as
amended by Executive Order 14094
(Modernizing Regulatory Review).
Accordingly, this rule has not been
reviewed by the Office of Management
and Budget (OMB).
This regulatory action determination
is based on a safety zone located within
a half mile radius of a crane boom on
the Illinois River at MM 165.5, near
Peoria, IL. The safety zone is expected
to be active until the crane boom has
been salvaged and the channel cleared.
VerDate Sep<11>2014 17:47 Aug 25, 2023 Jkt 259001 PO 00000 Frm 00006 Fmt 4700 Sfmt 4700 E:\FR\FM\28AUR1.SGM 28AUR1
lotter on DSK11XQN23PROD with RULES1
