[Federal Register: March 20, 2008 (Volume 73, Number 55)]
[Notices]
[Page 14991-14992]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20mr08-49]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0121]
Technologies for Prescription Drug Identification, Validation,
Track and Trace, or Authentication; Request for Information
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for information.
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SUMMARY: The Food and Drug Administration (FDA) is requesting comments
and information regarding technologies used for the identification,
validation, tracking and tracing, and authentication of prescription
drugs. This request is related to FDA's implementation of the Food and
Drug Administration Amendments Act of 2007 (FDAAA).
Elsewhere in this issue of the Federal Register, FDA is publishing
a related document entitled ``Standards for Standardized Numerical
Identifier, Validation, Track and Trace, and Authentication for
Prescription Drugs; Request for Comments.''
DATES: Submit written or electronic comments and information by May 19,
2008.
ADDRESSES: Submit written comments and information to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
and information to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.Regulations.gov.
FOR FURTHER INFORMATION CONTACT: Ilisa Bernstein, Office of Policy (HF-
11), Food and Drug Administration, 5600 Fishers Lane, rm. 14C-03,
Rockville, MD 20857, phone: 301-827-3360, FAX 301-594-6777, e-mail:
ilisa.bernstein@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
On September 27, 2007, FDAAA (Public Law 3580) was signed into law.
Section 913 of this legislation requires the Secretary of Health and
Human Services (the Secretary) to develop standards and identify and
validate effective technologies for the purpose of securing the drug
supply chain against counterfeit, diverted, subpotent, substandard,
adulterated, misbranded, or expired drugs. Specifically, section 913
created section 505D(b) of the Federal Food, Drug, and Cosmetic Act
(the act), which directs the development of standards for the
identification, validation, authentication, and tracking and tracing of
prescription drugs. Section 505D(b)(3) states that the standards
developed under 505D ``shall address promising technologies, which may
include--(A) radio-frequency identification; (B) nanotechnology; (C)
encryption technologies; and (D) other track and trace or
authentication technologies.''
FDA has previously identified counterfeit drugs as a threat to the
safety of the public and the pharmaceutical supply chain.
1. In 2004, FDA's Counterfeit Drug Task Force issued a report (Task
Force Report) on the threat of counterfeit medications and measures
that can be taken by private and public stakeholders to make the U.S.
drug supply chain more safe and secure. The 2004 Task Force Report
stated, among other things, that:
Widespread use of electronic track and trace technology
would help secure the integrity of the drug supply chain by providing
an accurate drug ``pedigree,'' which is a record of the chain of
custody of the product as it moves through the supply chain from
manufacturer to pharmacy;
Radio Frequency Identification (RFID) is a promising
technology as a means to achieve e-pedigree; and
Widespread adoption and use of electronic track and trace
technology would be feasible by 2007.
2. In 2006, the Task Force issued an update report which stated
that the goal of widespread use of e-pedigree and track and trace
technologies by 2007 would probably not be met. The voluntary approach
taken did not provide enough incentives for the adoption and
implementation of the technologies and e-pedigree.
As part of the efforts listed above, we received information about
various technologies for the identification, track and trace, and
authentication of prescription drugs, and we met with companies to
learn more about these technologies. We are aware that significant
progress has been made and new technologies are emerging for the
identification, track and trace, and authentication of prescription
drugs. In order to address the ``promising technologies'' related to
standards development, as described in section 505D(b)(3) of the act,
we are seeking information from technology vendors and others. Rather
than meet individually with companies, for efficiency and to further
our understanding and knowledge, we are requesting that information be
submitted to the docket number listed above.
Elsewhere in this issue of the Federal Register, FDA is publishing
a related document entitled ``Standards for Standardized Numerical
Identifier, Validation, Track and Trace, and Authentication for
Prescription Drugs; Request for Comments.'' Under section 505D(b)(1)
and (b)(2) of the act, this related document seeks information from
drug manufacturers, distributors, pharmacies, other supply chain
stakeholders, foreign regulators, standards organizations, and other
Federal agencies and interested parties on issues related to standards
for identification, validation, tracking and tracing, and
authentication for prescription drug products.
We are particularly interested in the following information
regarding available and emerging technologies for identification,
validation, track and trace, and authentication of prescription drugs:
1. What are the RFID technologies, encrypting technologies, and
nanotechnologies that are relevant? What are other relevant
technologies?
2. Please provide information related to:
Strengths for identification, validation, track and trace,
or authentication;
Limitations for identification, validation, track and
trace, or authentication;
Costs of implementation and use;
Benefits to the public health;
Feasibility for widespread use;
Utility for e-pedigree.
3. Is the technology interoperable with other technologies? If so,
describe.
4. What standards are necessary for supply chain use of the
specific technology? What is the status of development of such
standards?
[[Page 14992]]
II. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments and information. Submit
a single copy of electronic comments and information or two paper
copies of any mailed comments and information, except that individuals
may submit one paper copy. Comments and information are to be
identified with the name of the technology and the docket number found
in brackets in the heading of this document. A copy of this notice and
received comments may be seen in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.
Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA
through FDMS only.
Dated: March 13, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-5599 Filed 3-19-08; 8:45 am]
BILLING CODE 4160-01-S