[Federal Register Volume 79, Number 63 (Wednesday, April 2, 2014)]
[Notices]
[Pages 18562-18563]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-07335]
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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.
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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 http://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: [email protected].
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 http://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 http://www.regulations.gov.
Registration: To register for the workshop either: (1) Email your
registration information to [email protected] 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:
http://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 http://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