
[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]


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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: 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 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 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: 
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


