Technologies for Prescription Drug Identification, Validation, Track and Trace, or Authentication; Request for Information, 14991-14992 [E8-5599]
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Federal Register / Vol. 73, No. 55 / Thursday, March 20, 2008 / Notices
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. E8–5597 Filed 3–19–08; 8:45 am]
BILLING CODE 4160–01–S
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.
mstockstill on PROD1PC66 with NOTICES
ACTION:
Notice; request for information.
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 https://
www.Regulations.gov.
FOR FURTHER INFORMATION CONTACT: Ilisa
Bernstein, Office of Policy (HF–11),
VerDate Aug<31>2005
16:44 Mar 19, 2008
Jkt 214001
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.
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
14991
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?
E:\FR\FM\20MRN1.SGM
20MRN1
14992
Federal Register / Vol. 73, No. 55 / Thursday, March 20, 2008 / Notices
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Eye Institute; Notice of Closed
Meetings
mstockstill on PROD1PC66 with NOTICES
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of the following
meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Eye Institute
Special Emphasis Panel, NEI Clinical Grant
Applications.
Date: March 26, 2008.
Time: 2 p.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
VerDate Aug<31>2005
16:44 Mar 19, 2008
Jkt 214001
Place: National Institutes of Health, 5635
Fishers Lane, Bethesda, MD 20892.
(Telephone Conference Call)
Contact Person: Houmam H. Araj, PhD,
Scientific Review Administrator, Division of
Extramural Research, National Eye Institute,
NIH, 5635 Fishers Lane, Suite 1300,
Bethesda, MD 20892–9602, 301–451–2020,
haraj@mail.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Name of Committee: National Eye Institute
Special Emphasis Panel, Secondary Data
Analysis Grant Applications.
Date: March 28, 2008.
Time: 3 p.m. to 6 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 5635
Fishers Lane, Bethesda, MD 20892.
(Telephone Conference Call)
Contact Person: Houmam H. Araj, PhD,
Scientific Review Administrator, Division of
Extramural Research, National Eye Institute,
NIH, 5635 Fishers Lane, Suite 1300,
Bethesda, MD 20892–9602, 301–451–2020,
haraj@mail.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Name of Committee: National Eye Institute
Special Emphasis Panel, NEI Epidemiology
Grant Applications.
Date: April 1, 2008.
Time: 12 p.m. to 1 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health/NEI,
5635 Fishers Lane, Bethesda, MD 20892.
(Telephone Conference Call)
Contact Person: Anne E. Schaffner, PhD,
Scientific Review Administrator, Division of
Extramural Research, National Eye Institute,
5635 Fishers Lane, Suite 1300, MSC 9300,
Bethesda, MD 20892–9300, (301) 451–2020.
aes@nei.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Name of Committee: National Eye Institute
Special Emphasis Panel, NEI Genetics and
Genomics Applications.
Date: April 10, 2008.
Time: 12:30 p.m. to 3 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health/NEI,
5635 Fishers Lane, Bethesda, MD 20892.
(Telephone Conference Call)
Contact Person: Anne E. Schaffner, PhD,
Scientific Review Administrator, Division of
Extramural Research, National Eye Institute,
5635 Fishers Lane, Suite 1300, MSC 9300,
Bethesda, MD 20892–9300, (301) 451–2020,
aes@nei.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.867, Vision Research,
National Institutes of Health, HHS)
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
Dated: March 13, 2008.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E8–5568 Filed 3–19–08; 8:45 am]
BILLING CODE 4140–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Agency Information Collection
Activities: Proposed Collection;
Comment Request
In compliance with section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 concerning
opportunity for public comment on
proposed collections of information, the
Substance Abuse and Mental Health
Services Administration will publish
periodic summaries of proposed
projects. To request more information
on the proposed projects or to obtain a
copy of the information collection
plans, call the SAMHSA Reports
Clearance Officer on (301) 443–7978.
Comments Are Invited On: (a)
Whether the proposed collections of
information are necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) ways to enhance the
quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Proposed Project: The Coordinating
Center to Support State Incentive Grants
to Build Capacity for Alternatives to
Restraint and Seclusion (OMB No.
0930–0271) Revision.
The Substance Abuse and Mental
Health Services Administration’s
(SAMHSA) Center for Mental Health
Services has funded a Data Collection
and Analysis for the Alternatives to
Restraint and Seclusion Grant Program.
This contract is an evaluation of
SAMHSA’s State Incentive Grants to
Build Capacity for Alternatives to
Restraint and Seclusion. These grants
are designed to promote the
implementation and evaluation of best
practice approaches to reducing the use
of restraint and seclusion in mental
health facilities. Grantees consist of 8
sites (state mental health agencies), all
of which will be implementing
E:\FR\FM\20MRN1.SGM
20MRN1
]]>Agencies
[Federal Register Volume 73, Number 55 (Thursday, March 20, 2008)]
[Notices]
[Pages 14991-14992]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-5599]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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
