Standards for Standardized Numerical Identifier, Validation, Track and Trace, and Authentication for Prescription Drugs; Request for Comments, 14988-14991 [E8-5597]
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Federal Register / Vol. 73, No. 55 / Thursday, March 20, 2008 / Notices
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[FR Doc. E8–5770 Filed 3–19–08; 8:45 am]
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FEDERAL RESERVE SYSTEM
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Time and Date: 12:30 p.m.–3:30 p.m.,
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Determination of the Director,
Management Analysis and Services
Office, CDC, pursuant to Public Law 92–
463.
Matters To Be Discussed: The meeting
will include the review, discussion, and
evaluation of ‘‘Vision Health:
Developing an Integrative Approach to
Promotion and Protection, RFA DP08–
001.’’
Contact Person for More Information:
Susan B. Stanton, D.D.S., Scientific
Review Administrator, CDC, 1600
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Board of Governors of the Federal Reserve
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Robert deV. Frierson,
Deputy Secretary of the Board.
[FR Doc. E8–5630 Filed 3–19–08; 8:45 am]
Food and Drug Administration
BILLING CODE 6210–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel (SEP): Vision Health:
Developing an Integrative Approach to
Promotion and Protection, Request for
Application (RFA) DP08–001
In accordance with Section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces the aforementioned meeting.
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Dated: March 13, 2008.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. E8–5628 Filed 3–19–08; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2008–N–0120]
Standards for Standardized Numerical
Identifier, Validation, Track and Trace,
and Authentication for Prescription
Drugs; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; request for comments.
SUMMARY: The Food and Drug
Administration (FDA) is seeking
information and comments on issues
related to standards for identification,
validation, tracking and tracing, and
authentication for prescription drug
products. Particularly, we are requesting
information and comments from drug
manufacturers, distributors, pharmacies,
other supply chain stakeholders, foreign
regulators, standards organizations, and
other Federal agencies and interested
parties. This request is related to FDA’s
implementation of the Food and Drug
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Federal Register / Vol. 73, No. 55 / Thursday, March 20, 2008 / Notices
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Administration Amendments Act of
2007 (FDAAA).
Elsewhere in this issue of the Federal
Register, FDA is publishing a related
document entitled ‘‘Technologies for
Prescription Drug Identification,
Validation, Track and Trace, or
Authentication; Request for
Information.’’
DATES: Submit written or electronic
comments by May 19, 2008.
ADDRESSES: Submit written comments
to the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.Regulations.gov.
FOR FURTHER INFORMATION CONTACT: Ilisa
Bernstein, Office of Policy, Office of the
Commissioner, Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–3360, email: 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 created
section 505D of the Federal Food, Drug,
and Cosmetic Act (the act), which
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. Section
913 directs the Secretary to consult with
specific entities to prioritize and
develop standards for identification,
validation, authentication and tracking
and tracing of prescription drugs.
Section 913 of this legislation also
directs the Secretary to develop a
standardized numerical identifier
which, to the extent practicable, shall be
harmonized with international
consensus standards for such an
identifier, no later than 30 months after
the date of the enactment of FDAAA.
This standardized numerical identifier
is to be applied to a prescription drug
at the point of manufacturing and
repackaging (in which case the
numerical identifier shall be linked to
the numerical identifier applied at the
point of manufacturing) at the package
or pallet level, sufficient to facilitate the
identification, validation,
authentication, and tracking and tracing
of the prescription drug.
FDA has been engaged in an intense
effort to address counterfeit drugs for
several years. In 2004, FDA’s
Counterfeit Drug Task Force released a
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report (Task Force Report) outlining a
framework for public and private sector
actions that could further protect
Americans from counterfeit drugs,
including implementation of new track
and trace technologies to meet and
surpass goals of the Prescription Drug
Marketing Act, the Federal pedigree
law.
In 2006, FDA issued an update report
after conducting a fact-finding effort to
determine how much progress had been
made toward e-pedigree and electronic
track and trace. FDA found that
although significant progress was made
to set the stage for widespread use of epedigree in 2007, this goal likely would
not be met. Currently, there is no
widespread use of e-pedigree.
Currently, e-pedigree is not in
widespread use across the supply chain.
Elsewhere in this issue of the Federal
Register, FDA is publishing a related
document entitled ‘‘Technologies for
Prescription Drug Identification,
Validation, Track and Trace, or
Authentication; Request for
Information.’’ This related document
seeks information from technology
vendors and others regarding available
and emerging technologies for
identification, validation, track and
trace, and authentication of prescription
drugs, as set forth in 505D(b)(3) of the
act.
With this document, as a first step in
developing standards under section
505D(b) of the act, we are seeking
information from drug manufacturers,
distributors, pharmacies, other supply
chain stakeholders, foreign regulators,
standards organizations, other Federal
agencies, and other interested parties
related to identification, validation,
authentication, and tracking and tracing
of prescription drugs. Consistent with
the act, it is FDA’s preference that such
standards be the result of existing
private and public sector collaborative
standards processes. FDA intends to use
the response to these comments to
determine the state of standards
development in these areas and
determine how aggressively it may
move forward. Recognizing the
importance of uniform standards as well
as the need to allow for updating over
time, FDA would consider adopting
such standards through a guidance
process as quickly as possible.
II. Request for Comments
Please comment on the following
questions regarding the development of
standards related to section 505D of the
act.
A. Standard Numerical Identifier
1. Characteristics
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14989
a. Should the standardized numerical
identifier contain recognizable
characteristics (e.g., National Drug Code
number) or be random codes?
b. Should there be a common header
for item/product segregation based on
product type: biologic, solid oral dosage
form, etc.? If so, please elaborate.
c. How can parties in the supply
chain ensure that the numbers are
unique and are not duplicated?
d. How much value would there be in
having the numerical identifier in more
than one place for the product (e.g.,
package and pallet level)?
e. Should the numerical identifier be
machine readable, human readable, or
both?
f. Should the numerical identifier
include the lot number and/or batch
number?
2. Standards
a. Do standards currently exist for a
standardized numerical identifier of
prescription drugs?
1. If so, please describe and comment
on their application and use.
2. To what extent do these standards
reflect stakeholder consensus?
3. Comment on whether any of these
standards should be the standard
adopted by FDA.
4. If yes, why? Compare this standard
with other standards that exist.
5. If not, is there some aspect that
could be changed to make it acceptable
as the FDA standard?
6. Has this standard been adopted by
other countries?
b. Are standards in development or
planned for standardized numerical
identifiers of prescription drugs in the
supply chain? If so, who is developing
these standards and what is the timeline
for completion?
c. What are the elements, provisions,
and particular considerations that
should be included in a standardized
numerical identifier of prescription
drugs? Please be specific in your
response and include examples, where
possible.
d. Please comment on implementation
of standardized numerical identifiers of
prescription drugs in the U.S. supply
chain.
e. Please comment on any technical or
information technology concerns related
to a standardized numerical identifier.
f. Comment on any ‘‘lessons learned’’
from foreign experience with
standardized numerical identifiers.
3. Economic Impact
a. What are the usual practices and
associated costs that now exist for
applying bar codes and other
technologies for standardized numerical
identifiers on packages and pallets?
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Federal Register / Vol. 73, No. 55 / Thursday, March 20, 2008 / Notices
b. What are the associated costs for
the application, use, and maintenance of
standardized numerical identifiers?
c. What are the associated costs or
processes for updating the standards as
needed?
d. What are the benefits of using
standardized numerical identifiers?
4. Harmonization With Other Countries
a. What standards or unique
identification systems do other
countries have in place, currently under
development, or planned for the future?
If they are under development, please
include a timeline for completion.
b. Comment on any ‘‘lessons learned’’
from foreign experience with
standardized numerical identifiers.
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B. Standards for Validation
1. Do standards currently exist for
validation of prescription drugs?
a. If so, please describe and comment
on their application and use.
b. To what extent do these standards
reflect stakeholder consensus?
c. Comment on whether any of these
standards should be the standard
adopted by FDA.
d. If yes, why? Compare this standard
with other standards that exist.
e. If not, is there some aspect that
could be changed to make it acceptable
as the FDA standard?
f. Has this standard been adopted by
other countries?
2. Are standards in development or
planned for validation of prescription
drugs in the supply chain?
If so, who is developing these
standards and what is the timeline for
completion?
3. What are the elements, provisions,
and particular considerations that
should be included in a validation
standard for prescription drugs? Please
be specific in your response and include
examples, where possible.
4. Please comment on implementation
of validation of prescription drugs in the
U.S. supply chain.
5. Please comment on any technical or
information technology concerns related
to validation.
6. Comment on any ‘‘lessons learned’’
from foreign experience with validation.
C. Standards for Track and Trace
1. Do standards currently exist for track
and trace of products in the supply
chain, generally?
a. If so, please describe and comment
on their application and use.
b. To what extent do these standards
reflect stakeholder consensus?
c. Comment on whether any of these
standards should be the standard
adopted by FDA.
d. If yes, why? Compare this standard
with other standards that exist.
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e. If not, is there some aspect that
could be changed to make it acceptable
as the FDA standard?
f. Has this standard been adopted by
other countries?
g. If standards are under development
or planned for the future, please include
a timeline for completion.
2. Do standards currently exist for track
and trace of prescription drug products
in the supply chain?
a. If so, please describe and comment
on their application and use.
b. To what extent do these standards
reflect stakeholders consensus?
c. Comment on whether any of these
standards should be the standard
adopted by FDA.
d. If yes, why? Compare this standard
with other standards that exist.
e. If not, is there some aspect that
could be changed to make it acceptable
as the FDA standard?
f. Has this standard been adopted by
other countries?
3. Are standards in development for
track and trace of prescription drugs in
the supply chain?
If so, who is developing these
standards and what is the timeline for
completion?
4. What are the elements, provisions,
and particular considerations that
should be included in a track and trace
standard for prescription drugs? Please
be specific in your response and include
examples, where possible.
5. Please comment on implementation
of track and trace for prescription drugs
in the U.S. supply chain, including, but
not limited to, feasibility, costs,
timeline, interoperability, information
technology, and data storage.
6. Discuss how the data generated from
track and trace should be held, where it
should be held, concerns related to data
security, and means for access to ensure
interoperability for data sharing. What
elements should be included in such a
standard for data exchange, storage, and
interoperability?
7. Comment on any ‘‘lessons learned’’
from foreign experience with track and
trace.
D. Standards for Authentication
1. Do standards currently exist for
authentication of products in the supply
chain, generally?
a. If so, please describe and comment
on the application and use.
b. To what extent do these standards
reflect stakeholders consensus?
c. Comment on whether any of these
standards should be the standard
adopted by FDA.
d. If yes, why? Compare this standard
with other standards that exist.
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e. If not, is there some aspect that
could be changed to make it acceptable
as the FDA standard?
f. Has this standard been adopted by
other countries?
2. Do standards currently exist for
authentication of prescription drug
products in the supply chain?
a. If so, please describe and comment
on the application and use.
b. To what extent do these standards
reflect stakeholders consensus?
c. Comment on whether any of these
standards should be the numerical
identifier standard adopted by FDA.
d. If yes, why? Compare this standard
with other standards that exist.
e. If not, is there some aspect that
could be changed to make it acceptable
as the FDA standard?
f. Has this standard been adopted by
other countries?
3. Are standards in development for
authentication of prescription drugs in
the supply chain?
If so, who is developing these
standards and what is the timeline for
completion?
4. What are the elements, provisions,
and particular considerations that
should be included in an authentication
standard for prescription drugs? Please
be as specific as possible and include
examples, where possible.
5. Please comment on implementation
of authentication for prescription drugs
in the U.S. supply chain, including, but
not limited to, feasibility, costs,
timeline, interoperability, information
technology, and data storage.
6. Comment on any ‘‘lessons learned’’
from foreign experience with
authentication.
E. Prioritization
Please comment on the priority for
development and implementation of
identification, validation,
authentication, and tracking and tracing
standards.
1. Should certain standards be
developed and implemented before
others?
2. Should certain standards be
developed and implemented
concurrently?
III. 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
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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),
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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.
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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?
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]]>Agencies
[Federal Register Volume 73, Number 55 (Thursday, March 20, 2008)]
[Notices]
[Pages 14988-14991]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-5597]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0120]
Standards for Standardized Numerical Identifier, Validation,
Track and Trace, and Authentication for Prescription Drugs; Request for
Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is seeking information
and comments on issues related to standards for identification,
validation, tracking and tracing, and authentication for prescription
drug products. Particularly, we are requesting information and comments
from drug manufacturers, distributors, pharmacies, other supply chain
stakeholders, foreign regulators, standards organizations, and other
Federal agencies and interested parties. This request is related to
FDA's implementation of the Food and Drug
[[Page 14989]]
Administration Amendments Act of 2007 (FDAAA).
Elsewhere in this issue of the Federal Register, FDA is publishing
a related document entitled ``Technologies for Prescription Drug
Identification, Validation, Track and Trace, or Authentication; Request
for Information.''
DATES: Submit written or electronic comments by May 19, 2008.
ADDRESSES: Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Submit electronic comments to https://
www.Regulations.gov.
FOR FURTHER INFORMATION CONTACT: Ilisa Bernstein, Office of Policy,
Office of the Commissioner, Food and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301-827-3360, 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 created section 505D of the Federal
Food, Drug, and Cosmetic Act (the act), which 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.
Section 913 directs the Secretary to consult with specific entities to
prioritize and develop standards for identification, validation,
authentication and tracking and tracing of prescription drugs. Section
913 of this legislation also directs the Secretary to develop a
standardized numerical identifier which, to the extent practicable,
shall be harmonized with international consensus standards for such an
identifier, no later than 30 months after the date of the enactment of
FDAAA. This standardized numerical identifier is to be applied to a
prescription drug at the point of manufacturing and repackaging (in
which case the numerical identifier shall be linked to the numerical
identifier applied at the point of manufacturing) at the package or
pallet level, sufficient to facilitate the identification, validation,
authentication, and tracking and tracing of the prescription drug.
FDA has been engaged in an intense effort to address counterfeit
drugs for several years. In 2004, FDA's Counterfeit Drug Task Force
released a report (Task Force Report) outlining a framework for public
and private sector actions that could further protect Americans from
counterfeit drugs, including implementation of new track and trace
technologies to meet and surpass goals of the Prescription Drug
Marketing Act, the Federal pedigree law.
In 2006, FDA issued an update report after conducting a fact-
finding effort to determine how much progress had been made toward e-
pedigree and electronic track and trace. FDA found that although
significant progress was made to set the stage for widespread use of e-
pedigree in 2007, this goal likely would not be met. Currently, there
is no widespread use of e-pedigree.
Currently, e-pedigree is not in widespread use across the supply
chain.
Elsewhere in this issue of the Federal Register, FDA is publishing
a related document entitled ``Technologies for Prescription Drug
Identification, Validation, Track and Trace, or Authentication; Request
for Information.'' This related document seeks information from
technology vendors and others regarding available and emerging
technologies for identification, validation, track and trace, and
authentication of prescription drugs, as set forth in 505D(b)(3) of the
act.
With this document, as a first step in developing standards under
section 505D(b) of the act, we are seeking information from drug
manufacturers, distributors, pharmacies, other supply chain
stakeholders, foreign regulators, standards organizations, other
Federal agencies, and other interested parties related to
identification, validation, authentication, and tracking and tracing of
prescription drugs. Consistent with the act, it is FDA's preference
that such standards be the result of existing private and public sector
collaborative standards processes. FDA intends to use the response to
these comments to determine the state of standards development in these
areas and determine how aggressively it may move forward. Recognizing
the importance of uniform standards as well as the need to allow for
updating over time, FDA would consider adopting such standards through
a guidance process as quickly as possible.
II. Request for Comments
Please comment on the following questions regarding the development
of standards related to section 505D of the act.
A. Standard Numerical Identifier
1. Characteristics
a. Should the standardized numerical identifier contain
recognizable characteristics (e.g., National Drug Code number) or be
random codes?
b. Should there be a common header for item/product segregation
based on product type: biologic, solid oral dosage form, etc.? If so,
please elaborate.
c. How can parties in the supply chain ensure that the numbers are
unique and are not duplicated?
d. How much value would there be in having the numerical identifier
in more than one place for the product (e.g., package and pallet
level)?
e. Should the numerical identifier be machine readable, human
readable, or both?
f. Should the numerical identifier include the lot number and/or
batch number?
2. Standards
a. Do standards currently exist for a standardized numerical
identifier of prescription drugs?
1. If so, please describe and comment on their application and use.
2. To what extent do these standards reflect stakeholder consensus?
3. Comment on whether any of these standards should be the standard
adopted by FDA.
4. If yes, why? Compare this standard with other standards that
exist.
5. If not, is there some aspect that could be changed to make it
acceptable as the FDA standard?
6. Has this standard been adopted by other countries?
b. Are standards in development or planned for standardized
numerical identifiers of prescription drugs in the supply chain? If so,
who is developing these standards and what is the timeline for
completion?
c. What are the elements, provisions, and particular considerations
that should be included in a standardized numerical identifier of
prescription drugs? Please be specific in your response and include
examples, where possible.
d. Please comment on implementation of standardized numerical
identifiers of prescription drugs in the U.S. supply chain.
e. Please comment on any technical or information technology
concerns related to a standardized numerical identifier.
f. Comment on any ``lessons learned'' from foreign experience with
standardized numerical identifiers.
3. Economic Impact
a. What are the usual practices and associated costs that now exist
for applying bar codes and other technologies for standardized
numerical identifiers on packages and pallets?
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b. What are the associated costs for the application, use, and
maintenance of standardized numerical identifiers?
c. What are the associated costs or processes for updating the
standards as needed?
d. What are the benefits of using standardized numerical
identifiers?
4. Harmonization With Other Countries
a. What standards or unique identification systems do other
countries have in place, currently under development, or planned for
the future? If they are under development, please include a timeline
for completion.
b. Comment on any ``lessons learned'' from foreign experience with
standardized numerical identifiers.
B. Standards for Validation
1. Do standards currently exist for validation of prescription drugs?
a. If so, please describe and comment on their application and use.
b. To what extent do these standards reflect stakeholder consensus?
c. Comment on whether any of these standards should be the standard
adopted by FDA.
d. If yes, why? Compare this standard with other standards that
exist.
e. If not, is there some aspect that could be changed to make it
acceptable as the FDA standard?
f. Has this standard been adopted by other countries?
2. Are standards in development or planned for validation of
prescription drugs in the supply chain?
If so, who is developing these standards and what is the timeline
for completion?
3. What are the elements, provisions, and particular considerations
that should be included in a validation standard for prescription
drugs? Please be specific in your response and include examples, where
possible.
4. Please comment on implementation of validation of prescription drugs
in the U.S. supply chain.
5. Please comment on any technical or information technology concerns
related to validation.
6. Comment on any ``lessons learned'' from foreign experience with
validation.
C. Standards for Track and Trace
1. Do standards currently exist for track and trace of products in the
supply chain, generally?
a. If so, please describe and comment on their application and use.
b. To what extent do these standards reflect stakeholder consensus?
c. Comment on whether any of these standards should be the standard
adopted by FDA.
d. If yes, why? Compare this standard with other standards that
exist.
e. If not, is there some aspect that could be changed to make it
acceptable as the FDA standard?
f. Has this standard been adopted by other countries?
g. If standards are under development or planned for the future,
please include a timeline for completion.
2. Do standards currently exist for track and trace of prescription
drug products in the supply chain?
a. If so, please describe and comment on their application and use.
b. To what extent do these standards reflect stakeholders
consensus?
c. Comment on whether any of these standards should be the standard
adopted by FDA.
d. If yes, why? Compare this standard with other standards that
exist.
e. If not, is there some aspect that could be changed to make it
acceptable as the FDA standard?
f. Has this standard been adopted by other countries?
3. Are standards in development for track and trace of prescription
drugs in the supply chain?
If so, who is developing these standards and what is the timeline
for completion?
4. What are the elements, provisions, and particular considerations
that should be included in a track and trace standard for prescription
drugs? Please be specific in your response and include examples, where
possible.
5. Please comment on implementation of track and trace for prescription
drugs in the U.S. supply chain, including, but not limited to,
feasibility, costs, timeline, interoperability, information technology,
and data storage.
6. Discuss how the data generated from track and trace should be held,
where it should be held, concerns related to data security, and means
for access to ensure interoperability for data sharing. What elements
should be included in such a standard for data exchange, storage, and
interoperability?
7. Comment on any ``lessons learned'' from foreign experience with
track and trace.
D. Standards for Authentication
1. Do standards currently exist for authentication of products in the
supply chain, generally?
a. If so, please describe and comment on the application and use.
b. To what extent do these standards reflect stakeholders
consensus?
c. Comment on whether any of these standards should be the standard
adopted by FDA.
d. If yes, why? Compare this standard with other standards that
exist.
e. If not, is there some aspect that could be changed to make it
acceptable as the FDA standard?
f. Has this standard been adopted by other countries?
2. Do standards currently exist for authentication of prescription drug
products in the supply chain?
a. If so, please describe and comment on the application and use.
b. To what extent do these standards reflect stakeholders
consensus?
c. Comment on whether any of these standards should be the
numerical identifier standard adopted by FDA.
d. If yes, why? Compare this standard with other standards that
exist.
e. If not, is there some aspect that could be changed to make it
acceptable as the FDA standard?
f. Has this standard been adopted by other countries?
3. Are standards in development for authentication of prescription
drugs in the supply chain?
If so, who is developing these standards and what is the timeline
for completion?
4. What are the elements, provisions, and particular considerations
that should be included in an authentication standard for prescription
drugs? Please be as specific as possible and include examples, where
possible.
5. Please comment on implementation of authentication for prescription
drugs in the U.S. supply chain, including, but not limited to,
feasibility, costs, timeline, interoperability, information technology,
and data storage.
6. Comment on any ``lessons learned'' from foreign experience with
authentication.
E. Prioritization
Please comment on the priority for development and implementation of
identification, validation, authentication, and tracking and tracing
standards.
1. Should certain standards be developed and implemented before
others?
2. Should certain standards be developed and implemented
concurrently?
III. 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
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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
