Standards for the Interoperable Exchange of Information for Tracing of Human, Finished, Prescription Drugs, in Paper or Electronic Format; Public Workshop; Request for Comments, 18562-18563 [2014-07335]
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Federal Register / Vol. 79, No. 63 / Wednesday, April 2, 2014 / Notices
process, draft recommendations are
posted on FDA’s Web site and
announced periodically in the Federal
Register. The public is encouraged to
submit comments on those
recommendations within 60 days of
their announcement in the Federal
Register. FDA considers any comments
received, and either publishes final
recommendations or publishes revised
draft recommendations for comment.
Recommendations were last announced
in the Federal Register on November 6,
2013 (78 FR 66745). This notice
announces draft product-specific
recommendations, either new or
revised, that are posted on FDA’s Web
site.
II. Drug Products for Which New Draft
Product-Specific BE Recommendations
Are Available
FDA is announcing the availability of
a new draft guidance for industry on
product-specific BE recommendations
for drug products containing the
following active ingredients:
TABLE 2—REVISED DRAFT PRODUCT- ComplianceRegulatoryInformation/
SPECIFIC BE RECOMMENDATIONS Guidances/default.htm or https://
www.regulations.gov.
FOR DRUG PRODUCTS
A .....
B .....
D .....
I .......
L ......
M .....
N .....
O .....
T .....
Abiraterone acetate.
Amlodipine besylate; Benazepril hydrochloride.
Brimonidine tartrate (multiple reference listed drugs).
Doxycycline hyclate.
Dronabinol.
Dutasteride;
Tamsulosin
hydrochloride.
Icosapent Ethyl.
Leuprolide acetate (multiple reference
listed drugs and strengths).
Metoprolol succinate.
Morphine sulfate.
Mycophenolate mofetil (multiple reference listed drugs and dosage
forms).
Mycophenolic acid.
Naltrexone.
Octreotide acetate.
Trimethoprim.
Triptorelin pamoate
For a complete history of previously
published Federal Register notices
related to product-specific BE
TABLE 1—NEW DRAFT PRODUCT-SPE- recommendations, please go to https://
www.regulations.gov and enter Docket
CIFIC BE RECOMMENDATIONS FOR
No. FDA–2007–D–0369.
DRUG PRODUCTS
These draft and revised draft
guidances are being issued consistent
A ..... Amphotericin B.
with FDA’s good guidance practices
Atorvastatin calcium; Ezetimibe.
regulation (21 CFR 10.115). These
Axitinib.
guidances represent the Agency’s
B ..... Brinzolamide.
current thinking on product-specific
Buprenorphine.
design of BE studies to support ANDAs.
Buprenorphine hydrochloride.
Buprenorphine
hydrochloride; They do not create or confer any rights
for or on any person and do not operate
Naloxone hydrochloride.
C ..... Clobazam.
to bind FDA or the public. An
D ..... Desoximetasone (multiple reference alternative approach may be used if
listed drugs and dosage forms).
such approach satisfies the
Diazoxide.
requirements of the applicable statutes
E ..... Erythromycin.
and regulations.
Estradiol.
F .....
G .....
H .....
L ......
M .....
P .....
R .....
T .....
tkelley on DSK3SPTVN1PROD with NOTICES
V .....
Fentanyl citrate.
Guaifenesin.
Hydrochlorothiazide; Metoprolol succinate.
Levonorgestrel (multiple reference listed drugs).
Linagliptin; Metformin hydrochloride.
Mesalamine.
Perampanel.
Pindolol.
Prednisolone acetate.
Rabeprazole sodium.
Teriflunomide.
Tranylcypromine sulfate.
Verteporfin.
III. Drug Products for Which Revised
Draft Product-Specific BE
Recommendations Are Available
FDA is announcing the availability of
a revised draft guidance for industry on
product-specific BE recommendations
for drug products containing the
following active ingredients:
VerDate Mar<15>2010
17:01 Apr 01, 2014
Jkt 232001
IV. Comments
Interested persons may submit either
electronic comments on any of the
specific BE recommendations posted on
FDA’s Web site to https://
www.regulations.gov or written
comments to the Division of Dockets
Management (see ADDRESSES). It is only
necessaary to send one set of comments.
Identify comments with the docket
number found in brackets in the
heading of this document. The
guidances, notices, and received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
V. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
Dated: March 27, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–07330 Filed 4–1–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0337]
Standards for the Interoperable
Exchange of Information for Tracing of
Human, Finished, Prescription Drugs,
in Paper or Electronic Format; Public
Workshop; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public workshop;
request for comments.
ACTION:
The Food and Drug Administration
(FDA) is announcing a public workshop
entitled ‘‘Standards for the Interoperable
Exchange of Information for Tracing of
Human, Finished, Prescription Drugs, in
Paper or Electronic Format.’’ This
public workshop will provide a forum
for discussing the development of these
standards in the Drug Supply Chain
Security Act of 2013. In particular,
participants will be asked to provide
information, current practices, research,
and ideas on the interoperable exchange
of transaction information, transaction
history, and transaction statements, in
paper or electronic format, for each
transfer of drug product in which a
change of ownership occurs. This public
workshop will also provide a forum to
discuss the feasibility of establishing
standardized documentation to be used
by members of the pharmaceutical
distribution supply chain to convey this
information to the subsequent purchaser
of a drug product and to facilitate the
exchange of lot level data. As FDA
continues to work on developing
standards for interoperable exchange,
the Agency is seeking public input to
ensure that we consider information
regarding all drug supply chain
stakeholders.
DATES: The public workshop will be
held on May 8 and 9, 2014, from 9 a.m.
to 5 p.m.
ADDRESSES: The public workshop will
be held at FDA’s White Oak Campus,
10903 New Hampshire Ave. Bldg. 31
Conference Center, the Great Room (rm.
1503A), Silver Spring, MD 20993.
Entrance for the public meeting
E:\FR\FM\02APN1.SGM
02APN1
Federal Register / Vol. 79, No. 63 / Wednesday, April 2, 2014 / Notices
participants (non-FDA employees) is
through Building 1 where routine
security check procedures will be
performed. For parking and security
information, please refer to https://
www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm.
tkelley on DSK3SPTVN1PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
Connie T. Jung, Office of Compliance,
Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993, 301–
796–3130, FAX: 301–847–8722, email:
drugtrackandtrace@fda.hhs.gov.
Comments: In order to permit the
widest possible opportunity to obtain
public comment, FDA is soliciting
either electronic or written comments
on all aspects of the public workshop
topics. The deadline for submitting
comments related to this public
workshop is June 9, 2014.
Regardless of attendance at the public
workshop, interested persons may
submit either electronic comments
regarding the topics of the workshop to
https://www.regulations.gov or written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. It is only
necessary to send one set of comments.
Identify comments with the docket
number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
Registration: To register for the
workshop either: (1) Email your
registration information to
drugtrackandtrace@fda.hhs.gov or (2)
mail your registration information to
Connie T. Jung (see Contact Person).
Registration information should
include:
• ‘‘Registration’’ in the subject line,
and
• Registrant name, company or
organization, address, phone number,
and email address in the body of your
email or mailing.
Registration requests should be
received by April 24, 2014. Registration
is free. Seats are limited. FDA may limit
the numbers of participants from each
organization based on space limitations.
Registrants will receive confirmation
upon acceptance for participation in the
workshop. Onsite registration on the
day of the meeting will be based on
space availability on the day of the
event starting at 8 a.m. If registration
VerDate Mar<15>2010
17:01 Apr 01, 2014
Jkt 232001
reaches maximum capacity, FDA will
post a notice closing meeting
registration for the workshop on FDA’s
Web site at: https://www.fda.gov/Drugs/
NewsEvents/ucm388993.htm.
If you need special accommodations
due to a disability, please contact
Connie Jung (see FOR FURTHER
INFORMATION CONTACT) at least 7 days in
advance of the public workshop.
SUPPLEMENTARY INFORMATION:
I. Background
On November 27, 2013, the Drug
Supply Chain Security Act (DSCSA)
(Title II, Pub. L. 113–54) was signed into
law. The DSCSA outlines critical steps
to build an electronic, interoperable
system over the next 10 years to identify
and trace certain prescription drugs as
they are distributed within the United
States. Section 202 of the DSCSA, which
adds section 582(a)(2)(A) to the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act), requires the Secretary to
establish initial standards for the
interoperable exchange of transaction
information, transaction history, and
transaction statements, in paper or
electronic format, in consultation with
other appropriate Federal officials,
manufacturers, repackagers, wholesale
drug distributors, dispensers, and other
pharmaceutical distribution supply
chain stakeholders. The system that will
be established under the DSCSA will
enhance FDA’s ability to help protect
U.S. consumers from exposure to drugs
that may be counterfeit, stolen,
contaminated, or otherwise harmful by
improving detection and removal of
potentially dangerous drugs from the
drug supply chain.
FDA has used a multilayered
approach to improve the security of the
drug supply chain to protect U.S.
patients from unsafe, ineffective, and
poor quality drugs. In addition to
considering the standards developed
under section 505D of the FD&C Act (21
U.S.C. 355e), the DSCSA directs FDA to
establish initial standards for trading
partners to utilize to achieve the
interoperable exchange of transaction
information, transaction history, and
transaction statements. On February 20,
2014, FDA issued a Federal Register
notice (79 FR 9745) that established a
public docket (Docket No. FDA–2014–
N–0200) for this topic. FDA is seeking
additional stakeholder input based on
the information received in that docket.
II. Purpose of the Workshop
This public workshop is intended to
provide an opportunity for interested
persons to share information, current
practices, research, and ideas on the
feasibility of establishing standardized
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
18563
documentation to be used by members
of the pharmaceutical distribution
supply chain to convey the transaction
information, transaction history, and
transaction statement to the subsequent
purchaser of a drug product and to
facilitate the exchange of lot level data.
In addition, FDA is interested in
learning about practices, processes, and
systems that supply chain stakeholders
currently use to exchange information,
such as product information,
information related to the sale or change
of ownership of prescription drugs, or
communications about drugs in
distribution. Discussions at this public
workshop may also include current
practices and suggestions for the
exchange of information between
supply chain stakeholders to provide,
receive, and terminate notifications.
Discussions may also include how
trading partners should respond to
requests for verification of suspect drug
product, and respond to requests for
information from FDA or other
appropriate Federal or State officials in
the event of a recall or for the purpose
of investigating a suspect or illegitimate
drug product. Participants will not be
asked to develop consensus opinions
during the discussion, but rather to
provide their individual perspectives.
By May 2, 2014, FDA will post the
following information on our Web site
under Standards Development for
Interoperable Exchange of Tracing
Information at https://www.fda.gov/
Drugs/NewsEvents/ucm388993.htm:
• Workshop agenda;
• Workshop discussion topics.
Dated: March 27, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–07335 Filed 4–1–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2011–E–0677 and FDA–
2011–E–0678]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; ONSIOR
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
the regulatory review period for
ONSIOR and is publishing this notice of
that determination as required by law.
FDA has made the determination
SUMMARY:
E:\FR\FM\02APN1.SGM
02APN1
]]>Agencies
[Federal Register Volume 79, Number 63 (Wednesday, April 2, 2014)]
[Notices]
[Pages 18562-18563]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-07335]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0337]
Standards for the Interoperable Exchange of Information for
Tracing of Human, Finished, Prescription Drugs, in Paper or Electronic
Format; Public Workshop; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop; request for comments.
-----------------------------------------------------------------------
The Food and Drug Administration (FDA) is announcing a public
workshop entitled ``Standards for the Interoperable Exchange of
Information for Tracing of Human, Finished, Prescription Drugs, in
Paper or Electronic Format.'' This public workshop will provide a forum
for discussing the development of these standards in the Drug Supply
Chain Security Act of 2013. In particular, participants will be asked
to provide information, current practices, research, and ideas on the
interoperable exchange of transaction information, transaction history,
and transaction statements, in paper or electronic format, for each
transfer of drug product in which a change of ownership occurs. This
public workshop will also provide a forum to discuss the feasibility of
establishing standardized documentation to be used by members of the
pharmaceutical distribution supply chain to convey this information to
the subsequent purchaser of a drug product and to facilitate the
exchange of lot level data. As FDA continues to work on developing
standards for interoperable exchange, the Agency is seeking public
input to ensure that we consider information regarding all drug supply
chain stakeholders.
DATES: The public workshop will be held on May 8 and 9, 2014, from 9
a.m. to 5 p.m.
ADDRESSES: The public workshop will be held at FDA's White Oak Campus,
10903 New Hampshire Ave. Bldg. 31 Conference Center, the Great Room
(rm. 1503A), Silver Spring, MD 20993. Entrance for the public meeting
[[Page 18563]]
participants (non-FDA employees) is through Building 1 where routine
security check procedures will be performed. For parking and security
information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
FOR FURTHER INFORMATION CONTACT: Connie T. Jung, Office of Compliance,
Center for Drug Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-3130, FAX:
301-847-8722, email: drugtrackandtrace@fda.hhs.gov.
Comments: In order to permit the widest possible opportunity to
obtain public comment, FDA is soliciting either electronic or written
comments on all aspects of the public workshop topics. The deadline for
submitting comments related to this public workshop is June 9, 2014.
Regardless of attendance at the public workshop, interested persons
may submit either electronic comments regarding the topics of the
workshop to https://www.regulations.gov or written comments to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. It is only necessary
to send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at https://www.regulations.gov.
Registration: To register for the workshop either: (1) Email your
registration information to drugtrackandtrace@fda.hhs.gov or (2) mail
your registration information to Connie T. Jung (see Contact Person).
Registration information should include:
``Registration'' in the subject line, and
Registrant name, company or organization, address, phone
number, and email address in the body of your email or mailing.
Registration requests should be received by April 24, 2014.
Registration is free. Seats are limited. FDA may limit the numbers of
participants from each organization based on space limitations.
Registrants will receive confirmation upon acceptance for participation
in the workshop. Onsite registration on the day of the meeting will be
based on space availability on the day of the event starting at 8 a.m.
If registration reaches maximum capacity, FDA will post a notice
closing meeting registration for the workshop on FDA's Web site at:
https://www.fda.gov/Drugs/NewsEvents/ucm388993.htm.
If you need special accommodations due to a disability, please
contact Connie Jung (see FOR FURTHER INFORMATION CONTACT) at least 7
days in advance of the public workshop.
SUPPLEMENTARY INFORMATION:
I. Background
On November 27, 2013, the Drug Supply Chain Security Act (DSCSA)
(Title II, Pub. L. 113-54) was signed into law. The DSCSA outlines
critical steps to build an electronic, interoperable system over the
next 10 years to identify and trace certain prescription drugs as they
are distributed within the United States. Section 202 of the DSCSA,
which adds section 582(a)(2)(A) to the Federal Food, Drug, and Cosmetic
Act (the FD&C Act), requires the Secretary to establish initial
standards for the interoperable exchange of transaction information,
transaction history, and transaction statements, in paper or electronic
format, in consultation with other appropriate Federal officials,
manufacturers, repackagers, wholesale drug distributors, dispensers,
and other pharmaceutical distribution supply chain stakeholders. The
system that will be established under the DSCSA will enhance FDA's
ability to help protect U.S. consumers from exposure to drugs that may
be counterfeit, stolen, contaminated, or otherwise harmful by improving
detection and removal of potentially dangerous drugs from the drug
supply chain.
FDA has used a multilayered approach to improve the security of the
drug supply chain to protect U.S. patients from unsafe, ineffective,
and poor quality drugs. In addition to considering the standards
developed under section 505D of the FD&C Act (21 U.S.C. 355e), the
DSCSA directs FDA to establish initial standards for trading partners
to utilize to achieve the interoperable exchange of transaction
information, transaction history, and transaction statements. On
February 20, 2014, FDA issued a Federal Register notice (79 FR 9745)
that established a public docket (Docket No. FDA-2014-N-0200) for this
topic. FDA is seeking additional stakeholder input based on the
information received in that docket.
II. Purpose of the Workshop
This public workshop is intended to provide an opportunity for
interested persons to share information, current practices, research,
and ideas on the feasibility of establishing standardized documentation
to be used by members of the pharmaceutical distribution supply chain
to convey the transaction information, transaction history, and
transaction statement to the subsequent purchaser of a drug product and
to facilitate the exchange of lot level data. In addition, FDA is
interested in learning about practices, processes, and systems that
supply chain stakeholders currently use to exchange information, such
as product information, information related to the sale or change of
ownership of prescription drugs, or communications about drugs in
distribution. Discussions at this public workshop may also include
current practices and suggestions for the exchange of information
between supply chain stakeholders to provide, receive, and terminate
notifications. Discussions may also include how trading partners should
respond to requests for verification of suspect drug product, and
respond to requests for information from FDA or other appropriate
Federal or State officials in the event of a recall or for the purpose
of investigating a suspect or illegitimate drug product. Participants
will not be asked to develop consensus opinions during the discussion,
but rather to provide their individual perspectives. By May 2, 2014,
FDA will post the following information on our Web site under Standards
Development for Interoperable Exchange of Tracing Information at https://www.fda.gov/Drugs/NewsEvents/ucm388993.htm:
Workshop agenda;
Workshop discussion topics.
Dated: March 27, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-07335 Filed 4-1-14; 8:45 am]
BILLING CODE 4160-01-P
