Draft Guidance for Industry on Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification; Availability, 33564-33568 [2014-13544]
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Federal Register / Vol. 79, No. 112 / Wednesday, June 11, 2014 / Notices
Anyone with knowledge that any of
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2014. Furthermore, any interested
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sufficient facts to merit an FDA
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Petitions should be in the format
specified in 21 CFR 10.30.
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with the docket number found in
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may be viewed in the Division of
Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Dated: June 5, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–13566 Filed 6–10–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–D–0609]
Draft Guidance for Industry on Drug
Supply Chain Security Act
Implementation: Identification of
Suspect Product and Notification;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Drug Supply Chain
Security Act Implementation:
Identification of Suspect Product and
Notification.’’ The draft guidance
addresses new provisions in the Federal
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SUMMARY:
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Food, Drug, and Cosmetic Act (the
FD&C Act), as amended by the Drug
Supply Chain Security Act (DSCSA).
The draft guidance is intended to aid
certain trading partners (manufacturers,
repackagers, wholesale distributors, and
dispensers) in identifying a suspect
product and terminating notifications
regarding illegitimate product. This
draft guidance identifies specific
scenarios that could significantly
increase the risk of a suspect product
entering the pharmaceutical distribution
supply chain; provides
recommendations on how trading
partners can identify the product and
determine whether the product is a
suspect product as soon as practicable;
and for product that has been
determined to be illegitimate, or (for
manufacturers) has a high risk of
illegitimacy, sets forth the process by
which trading partners should notify
FDA of illegitimate product and how
they must terminate the notifications, in
consultation with FDA.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by August 11,
2014. Submit either electronic or
written comments concerning the
collection of information proposed in
the draft guidance by August 11, 2014.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201,
Silver Spring, MD 20993–0002; or the
Office of Communication, Outreach and
Development, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 1401 Rockville
Pike, Suite 200N, Rockville, MD 20852–
1448. Send one self-addressed adhesive
label to assist that office in processing
your requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Carolyn Becker, Office of Compliance,
Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
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301–796–3100, drugtrackandtrace@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Drug Supply Chain Security Act
Implementation: Identification of
Suspect Product and Notification.’’ On
November 27, 2013, the DSCSA (Title II
of Pub. L. 113–54) was signed into law.
Section 202 of the DSCSA adds section
582(h)(2) to the FD&C Act (21 U.S.C.
360eee–1(h)(2)), which requires FDA to
issue guidance to aid certain trading
partners (manufacturers, repackagers,
wholesale distributors, and dispensers)
in identifying a suspect product and
terminating notifications regarding an
illegitimate product. This guidance
identifies specific scenarios that could
significantly increase the risk of a
suspect product entering the
pharmaceutical distribution supply
chain and provides recommendations
on how trading partners can identify the
product and determine whether the
product is a suspect product as soon as
practicable.
Starting January 1, 2015, section 582
of the FD&C Act requires trading
partners, upon determining that a
product in their possession or control is
illegitimate, to notify FDA and all
immediate trading partners (that they
have reason to believe may have
received the illegitimate product) not
later than 24 hours after making the
determination. Manufacturers are
additionally required under section
582(b)(4)(B)(ii)(II) of the FD&C Act to
notify FDA and immediate trading
partners (that the manufacturer has
reason to believe may possess a product
manufactured by or purported to be
manufactured by the manufacturer) not
later than 24 hours after the
manufacturer determines or is notified
by FDA or a trading partner that there
is a high risk that the product is
illegitimate. This draft guidance
addresses how trading partners should
notify FDA using Form FDA 3911. In
addition, in accordance with section
582(h)(2) of the FD&C Act, this guidance
sets forth the process by which trading
partners must terminate the
notifications using Form FDA 3911, in
consultation with FDA, regarding
illegitimate product or, for a
manufacturer, a product with a high risk
of illegitimacy, under section
582(b)(4)(B), (c)(4)(B), (d)(4)(B), and
(e)(4)(B).
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
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The draft guidance, when finalized, will
represent the Agency’s current thinking
on identification of suspect product and
notification. Guidance documents
generally do not create or confer any
rights for or on any person and do not
operate to bind FDA or the public. An
alternative approach may be used if
such approach satisfies the
requirements of the applicable statutes
and regulations. For this particular
document, section 582 of the FD&C Act
gives FDA authority to issue binding
guidance on the process for terminating
notifications of illegitimate product.
Specifically, subsection (h)(2)(A) states
that FDA ‘‘shall issue a guidance
document to aid trading partners in the
identification of a suspect product and
notification termination. Such guidance
document shall . . . set forth the
process by which manufacturers,
repackagers, wholesale distributors, and
dispensers shall terminate notifications
in consultation with the Secretary
regarding illegitimate product. . . .’’
Thus, insofar as section IV.B of this
guidance sets forth the process by which
trading partners must terminate
notifications of illegitimate product in
consultation with FDA, it will have
binding effect upon finalization.
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II. Paperwork Reduction Act of 1995
This draft guidance contains
information collection provisions that
are subject to review by the Office of
Management and Budget under the
Paperwork Reduction Act of 1995 (44
U.S.C. 3501–3520). The title,
description, and respondent description
of the information collection are given
under this section with an estimate of
the reporting and third-party disclosure
burdens. Included in the estimate is the
time for reviewing instructions,
searching existing data sources,
gathering and maintaining the data
needed, and completing and reviewing
the collection of information.
We invite comments on these topics:
(1) Whether the proposed collection of
information is necessary for the proper
performance of FDA’s functions,
including whether the information will
have practical utility; (2) the accuracy of
FDA’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used; (3)
ways to enhance the quality, utility, and
clarity of the information to be
collected; and (4) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques,
when appropriate, and other forms of
information technology.
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Title: Drug Supply Chain Security Act
Implementation: Identification of
Suspect Product and Notification.
Description: Under section 202 of the
DSCSA, manufacturers, repackagers,
wholesale distributors, and dispensers
(e.g., pharmacies) must: (1) Notify FDA
when they have determined that a
product in their possession or control is
illegitimate, and for manufacturers,
when they have determined or been
notified by FDA or a trading partner that
a product has a high risk of illegitimacy;
(2) notify certain immediate trading
partners about an illegitimate product
that they may have received and, for
manufacturers, that a product has a high
risk of illegitimacy; (3) terminate
notifications regarding illegitimate
products, and, for manufacturers, a
product with a high risk of illegitimacy,
in consultation with FDA when the
notifications are no longer necessary;
and (4) notify immediate trading
partners when the notifications are
terminated.
1. Notifications to FDA
Under section 582(b)(4)(B)(ii),
(c)(4)(B)(ii), (d)(4)(B)(ii), and (e)(4)(B)(ii)
of the FD&C Act, and beginning not later
than January 1, 2015, a manufacturer,
repackager, wholesale distributor, and
dispenser who determines that a
product in its possession or control is
illegitimate, as defined in section 581 of
the FD&C Act (21 U.S.C. 360eee), must
notify FDA of that determination not
later than 24 hours after the
determination is made. In addition,
section 582(b)(4)(B)(ii)(II) of the FD&C
Act requires manufacturers to notify
FDA when a manufacturer determines
or is notified by FDA or a trading
partner that a product poses a high risk
of illegitimacy.
FDA estimates that a total of
approximately 5,000 notifications per
year will be made by all manufacturers,
repackagers, wholesale distributors, and
dispensers. This estimate includes the
notifications by trading partners who
have determined that illegitimate
product is in their possession or control,
as well as notifications by
manufacturers that have determined a
product poses a high risk of
illegitimacy. This estimate is based on
FDA’s experience with Field Alert
Reports (FARs) (Form FDA 3331)
required to be submitted by holders of
approved drug applications for certain
drug quality issues (21 CFR
314.81(b)(1)) 1 and with reports of the
1 FDA review of the number of Field Alert
Reports (FARs) received in calendar year 2013 was
approximately 5,000. Because FARs are incident
and product specific, the estimation does not
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falsification of drug sample records,
diversion, loss, and known theft of
prescription drug samples as currently
required under the Prescription Drug
Marketing Act (PDMA).2 Because
manufacturers, repackagers, and
wholesale distributors are responsible
for prescription drugs from the
manufacturing through distribution
processes, FDA assumes that most
notifications of illegitimate products
would be made by these three trading
partners. FDA is combining the
estimates for manufacturers and
repackagers because FDA establishment
and drug product listing database
indicates that many companies perform
activities of both manufacturers and
repackagers. While the DSCSA
specifically defines dispensers, for
estimation purposes, FDA is using
estimates for pharmacies in general
terms and based on those that must
comply with the new requirements
under section 582(d) of the FD&C Act.
FDA estimates that approximately 50
percent of the notifications will be made
by manufacturers and repackagers
(2,500), 45 percent by wholesaler
distributors (2,250), and 5 percent by
pharmacies (250).
FDA estimates that the number of
annual notifications will vary from 0–2
for manufacturers/repackagers, as well
as from pharmacies, with the vast
majority of companies making no
notifications. While FDA establishment
and drug product listing database
currently contains registrations for
approximately 6,500 manufacturers and
repackagers, we estimate that
approximately 2,500 manufacturers/
repackagers will notify FDA of
illegitimate product an average of one
time per year. While FDA estimates
approximately 69,000 pharmacy sites in
the United States, based on data from
the National Association of Chain Drug
Stores, the National Community
Pharmacists Association, and the
American Hospital Association, we
estimate that approximately 250
pharmacies will notify FDA of
illegitimate product an average of one
time per year.3 Because approximately
represent the number of companies that have
submitted a FAR to FDA.
2 FDA cursory review of the number of reports of
falsified drug sample records, diversion, loss, or
known theft of prescription drug samples under the
PDMA in calendar year 2013 was approximately
5,000. This number is being used for estimation
purposes only because the DSCSA exempts
transactions related to the distribution of product
samples by a manufacturer or licensed wholesale
distributor in accordance with section 503(d) of the
FD&C Act (21 U.S.C. 353(d)).
3 The estimate of the number of pharmacies in the
United States is based on combining estimates of:
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30 wholesale distributors are
responsible for over 90 percent of drug
distributions, based on sales,4 and
because FDA is estimating that over
2,200 small wholesale distributors
might be responsible for the remaining
10 percent of drug sales, we estimate
that each distributor will make about an
average of 1 notification per year to
account for the estimated 2,250
notifications FDA will receive regarding
illegitimate product.
FDA intends to make available Form
FDA 3911 on its Web page for notifying
FDA. Each notification should include
information about the person or entity
initiating the notification, the product
determined to be illegitimate, and a
description of the circumstances
surrounding the event that prompted
the notification. FDA estimates that
each notification will take about 1 hour.
The estimated total annual burden
hours for making notifications to FDA is
approximately 5,000 hours annually
(table 1).
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2. Notifications to Trading Partners of
an Illegitimate Product
Under section 582(b)(4)(B)(ii),
(c)(4)(B)(ii), (d)(4)(B)(ii), and (e)(4)(B)(ii)
of the FD&C Act, a trading partner who
determines that a product in its
possession is illegitimate must also
notify all immediate trading partners
that the trading partner has reason to
believe may have received such
illegitimate product of that
determination not later than 24 hours
after the determination is made. In
addition, a manufacturer is required,
under section 582(b)(4)(B)(ii)(II) of the
FD&C Act, to notify all immediate
trading partners that the manufacturer
has reason to believe may possess a
product manufactured by or purported
to be manufactured by the manufacturer
not later than 24 hours after the
manufacturer has determined or been
notified by FDA or a trading partner that
the product has a high risk of
illegitimacy.
(a) 41,000 chain pharmacies provided in a National
Association of Chain Drug Stores statement for the
Senate Budget Committee Conferees (October 29,
2013); (b) 23,000 independent pharmacies
represented by the National Community Pharmacist
Association (NCPA) according to NCPA’s 2014
media kit; and (c) 5,000 U.S. community hospitals
in the United States, based on 2012 American
Hospital Association Annual Survey and the
assumption that each hospital has at least one
pharmacy.
4 The estimate of the number of wholesale drug
distributors is based on the Healthcare Distribution
Management Association number of members and
estimation of the percentage of all prescription
drugs sold in the United States by these entities
provided in Congressional testimony before the U.S.
House of Representatives, Committee on Energy and
Commerce (April 25, 2013).
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Because the extent of distribution of
any illegitimate product is likely to vary
from one situation to another, FDA is
using estimates that assume wide
distribution of each illegitimate product.
FDA estimates that for each notification
made by a manufacturer or repackager
to FDA, approximately 30 trading
partners (based on the number of
distributors) will also be notified. This
results in approximately 75,000
notifications annually to trading
partners of manufacturers/repackagers.
This estimate includes the notifications
by manufacturers and repackagers who
have determined that illegitimate
product is in their possession or control,
as well as notifications by
manufacturers that have determined
that a product poses a high risk of
illegitimacy.
FDA estimates that a large wholesale
distributor might have up to 4,500
trading partners, but a small wholesale
distributor might have 200 trading
partners, for an average of
approximately 2,350. A wholesale
distributor would notify 2,350 trading
partners for each of the 2,250
illegitimate products identified,
resulting in approximately 5,287,500
notifications annually to wholesale
distributors’ trading partners.
FDA estimates that a pharmacy
purchases prescription drugs from an
average of two wholesale distributors.
Therefore, a pharmacy would notify 2
trading partners for each of the 250
illegitimate products identified,
resulting in approximately 500
notifications annually to pharmacy
trading partners.
Manufacturers/repackagers, wholesale
distributors, and pharmacies might
notify their trading partners using
existing systems and processes used for
similar types of communications, which
might include, but is not limited to,
posting of notifications on a company
Web site, sending an email, or mailing
or faxing a letter or notification. The
information contained in the
notification to the immediate trading
partner should be the same as or based
on the notification that was already
submitted to FDA. FDA estimates that
for all trading partners, each notification
of immediate trading partners will take
approximately 0.2 hours. The estimated
total burden hours of making
notifications to trading partners is
approximately 1,072,600 hours annually
(table 2).
3. Consultation With FDA and
Termination of Notification
Section 582(b)(4)(B)(iv), (c)(4)(B)(iv),
(d)(4)(B)(iv), and (e)(4)(B)(iv) of the
FD&C Act require that a trading partner,
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who determines in consultation with
FDA that a notification made under
section 582(b)(4)(B)(ii), (c)(4)(B)(ii),
(d)(4)(B)(ii), or (e)(4)(B)(ii) is no longer
necessary, must terminate the
notification. The draft guidance sets
forth the process by which trading
partners must consult with FDA to
terminate notifications that are no
longer necessary.
FDA is making available to trading
partners Form FDA 3911 on its Web
page to request a termination of
notification. Each request for
termination of notification must include
information about the person or entity
initiating the request for termination,
the illegitimate product or product with
a high risk of illegitimacy, the
notification that was issued, and an
explanation about what actions have
taken place or what information has
become available that make the
notification no longer necessary. The
request for a termination will be viewed
as the request for consultation with
FDA. FDA estimates that the same
amount of time will be required to
provide the information necessary to
request termination as is required to
make the notification. The time required
to investigate and resolve an illegitimate
product notification will vary, but FDA
assumes that each notification will
eventually be terminated at some point.
FDA assumes that the number of
requests for termination of a notification
per year will be the same as the original
number of notifications for a given year.
The estimated total burden hours of
making requests for termination of
notifications to FDA is approximately
5,000 hours annually (table 3).
4. Notifications to Trading Partners
That a Notification Has Been
Terminated
Section 582(b)(4)(B)(iv), (c)(4)(B)(iv),
(d)(4)(B)(iv), and (e)(4)(B)(iv) of the
FD&C Act require that a trading partner
who, in consultation with FDA,
terminates a notification made under
section 582(b)(4)(B)(ii), (c)(4)(B)(ii),
(d)(4)(B)(ii), or (e)(4)(B)(ii) must also
promptly notify immediate trading
partners that the notification has been
terminated.
FDA estimates that the burden for
notifying trading partners of an
illegitimate product and the number of
trading partners notified will be the
same as the estimates for notification of
termination. The estimated total burden
hours of notifying trading partners that
the notification is terminated is
approximately 1,072,600 hours annually
(table 4).
Description of Respondents:
Respondents are drug manufacturers,
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repackagers, wholesale distributors, and
dispensers and might include small
businesses in these categories.
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
Notifications to FDA
Average
burden per
response
Total annual
responses
Total hours
Manufacturers and Repackagers .......................................
Wholesale Distributors .......................................................
Dispensers .........................................................................
2,500
2,250
250
1
1
1
2,500
2,250
250
1 hour
1 hour
1 hour
2,500
2,250
250
Total ............................................................................
........................
..........................
........................
........................
5,000
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
Consultation with FDA and termination of notification
Number of
responses per
respondent
Number of
respondents
Average
burden per
response
Total annual
responses
Total hours
Manufacturers and Repackagers .......................................
Wholesale Distributors .......................................................
Dispensers .........................................................................
2,500
2,250
250
1
1
1
2,500
2,250
250
1 hour
1 hour
1 hour
2,500
2,250
250
Total ............................................................................
........................
..........................
........................
........................
5,000
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Notifications to trading partners of an illegitimate product
Number of
disclosures per
respondent
Number of
respondents
Average
burden per
disclosure
Total annual
disclosures
Manufacturers and Repackagers .......................................
2,500
30
75,000
Wholesale Distributors .......................................................
2,250
2,350
5,287,500
Dispensers .........................................................................
250
2
500
Total ............................................................................
........................
..........................
........................
1 There
Total hours
.20
(12 minutes)
.20
(12 minutes)
.20
(12 minutes)
15,000
1,057,500
........................
1,072,600
100
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 4—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
disclosures per
respondent
Number of
respondents
Notifications to trading partners of termination
Total annual
disclosures
Manufacturers and Repackagers .......................................
2,500
30
75,000
Wholesale Distributors .......................................................
2,250
2,350
5,287,500
Dispensers .........................................................................
250
2
500
Total ............................................................................
........................
..........................
........................
1 There
Total hours
.20
(12 minutes)
.20
(12 minutes)
.20
(12 minutes)
15,000
1,057,500
........................
1,072,600
100
are no capital costs or operating and maintenance costs associated with this collection of information.
5. Capital Costs
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Average
burden per
disclosure
There are no capital costs associated
with this collection of information. For
notifications to FDA, manufacturers,
repackagers, wholesale distributors, and
dispensers will be accessing and using
a system controlled by FDA. For
notifications of immediate trading
partners, manufacturers, repackagers,
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wholesale distributors, and dispensers
will be using current mechanisms,
which might include, but are not
limited to, posting of notifications on a
company Web site, sending an email, or
mailing or faxing a letter or notification.
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III. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
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Federal Register / Vol. 79, No. 112 / Wednesday, June 11, 2014 / Notices
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 https://
www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at https://
www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://www.fda.
gov/BiologicsBloodVaccines/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, or https://
www.regulations.gov.
Dated: June 4, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–13544 Filed 6–10–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–D–0636]
Global Unique Device Identification
Database; Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of the guidance entitled
‘‘Global Unique Device Identification
Database (GUDID): Guidance for
Industry’’. FDA has updated sections of
the document, ‘‘Global Unique Device
Identification (GUDID): Draft Guidance
for Industry’’ in order to finalize the
sections with the most questions from
GUDID submitters. The guidance
includes information about how device
labelers (in most instances, the device
manufacturer) will interface with the
GUDID by establishing GUDID accounts
and beginning their initial submissions.
Draft guidance sections on the device
identifier (DI) module have not been
finalized in this document and will be
addressed in a future document.
DATES: Submit either electronic or
written comments on this guidance at
any time. General comments on Agency
guidance documents are welcome at any
time.
ADDRESSES: An electronic copy of the
guidance document is available for
download from the Internet. See the
SUPPLEMENTARY INFORMATION section for
ehiers on DSK2VPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
15:19 Jun 10, 2014
Jkt 232001
For
information concerning the guidance as
it relates to devices regulated by CDRH:
Indira R. Konduri, UDI Regulatory
Policy Support, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 3303, Silver Spring,
MD 20993–0002, 301–796–5995, email:
udi@fda.hhs.gov.
For information concerning the
guidance as it relates to devices
regulated by CBER: Stephen Ripley,
Center for Biologics Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 71, Rm. 7301, Silver Spring,
MD 20993–0002, 240–402–7911.
FOR FURTHER INFORMATION CONTACT:
HHS.
ACTION:
information on electronic access to the
guidance. Submit written requests for a
single hard copy of the guidance
document entitled ‘‘Global Unique
Device Identification Database (GUDID):
Guidance for Industry’’ to the Office of
the Center Director, Guidance and
Policy Development, Center for Devices
and Radiological Health (CDRH), Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5431,
Silver Spring, MD 20993–0002.
Alternatively, you may submit written
requests for single copies of the
guidance to the Office of
Communication, Outreach and
Development, Center for Biologics
Evaluation and Research (CBER), Bldg.
71, Rm. 3128, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002.
Send one self-addressed adhesive label
to the office that you are ordering from
to assist in processing your request.
Submit electronic comments on the
guidance to https://www.regulations.gov.
Submit written comments to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852. Identify comments with the
docket number found in brackets in the
heading of this document.
SUPPLEMENTARY INFORMATION:
I. Background
Section 226 of the Food and Drug
Administration Amendments Act of
2007 (Public Law 110–85, 121 Stat. 824)
and section 614 of the Food and Drug
Administration Safety and Innovation
Act (Pub. L. 112–144, July 9, 2012)
amended the Federal Food, Drug, and
Cosmetic Act to add section 519(f) (21
U.S.C. 360i(f)), which directs FDA to
issue regulations establishing a unique
device identification (UDI) system for
medical devices along with
implementation timeframes for certain
medical devices. The UDI system final
PO 00000
Frm 00077
Fmt 4703
Sfmt 4703
rule was published on September 24,
2013 (78 FR 58785).
In developing the final rule, FDA
solicited and considered input from a
variety of stakeholders (e.g.,
manufacturers, global regulatory bodies,
the clinical community, and patient
advocates) to ensure that as many
perspectives as possible were
incorporated. The GUDID is a critical
component of the UDI system. The UDI
assigned to each device is a globally
unique, yet unintelligent code
identifying the device, and is composed
of the static DI portion and the dynamic
production identifier. The GUDID will
house the DI, along with key descriptive
or ‘‘attribute’’ information about the
device, which is reported and updated
to the GUDID by the device labeler.
Being unique for each device, the DI
component of the UDI can be effectively
used by stakeholders to access the
GUDID attribute information for that
device.
Labelers are responsible for
submitting information to the GUDID.
This guidance provides general
information to labelers that will enable
them to obtain a GUDID account and
begin initial submissions to the GUDID.
A draft version of this document (the
‘‘draft guidance’’) was released on
September 24, 2013 (78 FR 58545), with
a 60-day comment period, which ended
on November 25, 2013. More than 300
comments were received from 21
entities. To provide labelers with the
most accurate information as soon as it
is available, we are finalizing this
document in two phases. The first part
of the finalized guidance, which is now
being made available, addresses sections
of the draft guidance that received the
most comments and questions. The
remaining sections of the draft
guidance, including sections on the DI
module, will be finalized in one or more
parts to be published at a later date.
Keyed to the sections of the draft
guidance, the guidance document
released today deals with the following
topics and the related comments and
questions received during the comment
period ended on November 25, 2013:
(The remaining sections will be
finalized at a later time.)
2—Unique Device Identifier
3—Global Unique Device Identification
Database
3.1. GUDID Key Concepts
3.1.1 GUDID Account
3.1.2.2 Global Medical Device
Nomenclature
3.2 GUDID Modules
3.2.1 GUDID Web Interface
3.2.1.1 GUDID Account Management
Module
E:\FR\FM\11JNN1.SGM
11JNN1
]]>Agencies
[Federal Register Volume 79, Number 112 (Wednesday, June 11, 2014)]
[Notices]
[Pages 33564-33568]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-13544]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-D-0609]
Draft Guidance for Industry on Drug Supply Chain Security Act
Implementation: Identification of Suspect Product and Notification;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Drug Supply
Chain Security Act Implementation: Identification of Suspect Product
and Notification.'' The draft guidance addresses new provisions in the
Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the
Drug Supply Chain Security Act (DSCSA). The draft guidance is intended
to aid certain trading partners (manufacturers, repackagers, wholesale
distributors, and dispensers) in identifying a suspect product and
terminating notifications regarding illegitimate product. This draft
guidance identifies specific scenarios that could significantly
increase the risk of a suspect product entering the pharmaceutical
distribution supply chain; provides recommendations on how trading
partners can identify the product and determine whether the product is
a suspect product as soon as practicable; and for product that has been
determined to be illegitimate, or (for manufacturers) has a high risk
of illegitimacy, sets forth the process by which trading partners
should notify FDA of illegitimate product and how they must terminate
the notifications, in consultation with FDA.
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by August 11, 2014. Submit either electronic or written
comments concerning the collection of information proposed in the draft
guidance by August 11, 2014.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002; or
the Office of Communication, Outreach and Development, Center for
Biologics Evaluation and Research, Food and Drug Administration, 1401
Rockville Pike, Suite 200N, Rockville, MD 20852-1448. Send one self-
addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.
Submit electronic comments on the draft guidance to https://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Carolyn Becker, Office of Compliance,
Center for Drug Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-3100,
drugtrackandtrace@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Drug Supply Chain Security Act Implementation:
Identification of Suspect Product and Notification.'' On November 27,
2013, the DSCSA (Title II of Pub. L. 113-54) was signed into law.
Section 202 of the DSCSA adds section 582(h)(2) to the FD&C Act (21
U.S.C. 360eee-1(h)(2)), which requires FDA to issue guidance to aid
certain trading partners (manufacturers, repackagers, wholesale
distributors, and dispensers) in identifying a suspect product and
terminating notifications regarding an illegitimate product. This
guidance identifies specific scenarios that could significantly
increase the risk of a suspect product entering the pharmaceutical
distribution supply chain and provides recommendations on how trading
partners can identify the product and determine whether the product is
a suspect product as soon as practicable.
Starting January 1, 2015, section 582 of the FD&C Act requires
trading partners, upon determining that a product in their possession
or control is illegitimate, to notify FDA and all immediate trading
partners (that they have reason to believe may have received the
illegitimate product) not later than 24 hours after making the
determination. Manufacturers are additionally required under section
582(b)(4)(B)(ii)(II) of the FD&C Act to notify FDA and immediate
trading partners (that the manufacturer has reason to believe may
possess a product manufactured by or purported to be manufactured by
the manufacturer) not later than 24 hours after the manufacturer
determines or is notified by FDA or a trading partner that there is a
high risk that the product is illegitimate. This draft guidance
addresses how trading partners should notify FDA using Form FDA 3911.
In addition, in accordance with section 582(h)(2) of the FD&C Act, this
guidance sets forth the process by which trading partners must
terminate the notifications using Form FDA 3911, in consultation with
FDA, regarding illegitimate product or, for a manufacturer, a product
with a high risk of illegitimacy, under section 582(b)(4)(B),
(c)(4)(B), (d)(4)(B), and (e)(4)(B).
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115).
[[Page 33565]]
The draft guidance, when finalized, will represent the Agency's current
thinking on identification of suspect product and notification.
Guidance documents generally do not create or confer any rights for or
on any person and do not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
requirements of the applicable statutes and regulations. For this
particular document, section 582 of the FD&C Act gives FDA authority to
issue binding guidance on the process for terminating notifications of
illegitimate product. Specifically, subsection (h)(2)(A) states that
FDA ``shall issue a guidance document to aid trading partners in the
identification of a suspect product and notification termination. Such
guidance document shall . . . set forth the process by which
manufacturers, repackagers, wholesale distributors, and dispensers
shall terminate notifications in consultation with the Secretary
regarding illegitimate product. . . .'' Thus, insofar as section IV.B
of this guidance sets forth the process by which trading partners must
terminate notifications of illegitimate product in consultation with
FDA, it will have binding effect upon finalization.
II. Paperwork Reduction Act of 1995
This draft guidance contains information collection provisions that
are subject to review by the Office of Management and Budget under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The title,
description, and respondent description of the information collection
are given under this section with an estimate of the reporting and
third-party disclosure burdens. Included in the estimate is the time
for reviewing instructions, searching existing data sources, gathering
and maintaining the data needed, and completing and reviewing the
collection of information.
We invite comments on these topics: (1) Whether the proposed
collection of information is necessary for the proper performance of
FDA's functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Title: Drug Supply Chain Security Act Implementation:
Identification of Suspect Product and Notification.
Description: Under section 202 of the DSCSA, manufacturers,
repackagers, wholesale distributors, and dispensers (e.g., pharmacies)
must: (1) Notify FDA when they have determined that a product in their
possession or control is illegitimate, and for manufacturers, when they
have determined or been notified by FDA or a trading partner that a
product has a high risk of illegitimacy; (2) notify certain immediate
trading partners about an illegitimate product that they may have
received and, for manufacturers, that a product has a high risk of
illegitimacy; (3) terminate notifications regarding illegitimate
products, and, for manufacturers, a product with a high risk of
illegitimacy, in consultation with FDA when the notifications are no
longer necessary; and (4) notify immediate trading partners when the
notifications are terminated.
1. Notifications to FDA
Under section 582(b)(4)(B)(ii), (c)(4)(B)(ii), (d)(4)(B)(ii), and
(e)(4)(B)(ii) of the FD&C Act, and beginning not later than January 1,
2015, a manufacturer, repackager, wholesale distributor, and dispenser
who determines that a product in its possession or control is
illegitimate, as defined in section 581 of the FD&C Act (21 U.S.C.
360eee), must notify FDA of that determination not later than 24 hours
after the determination is made. In addition, section
582(b)(4)(B)(ii)(II) of the FD&C Act requires manufacturers to notify
FDA when a manufacturer determines or is notified by FDA or a trading
partner that a product poses a high risk of illegitimacy.
FDA estimates that a total of approximately 5,000 notifications per
year will be made by all manufacturers, repackagers, wholesale
distributors, and dispensers. This estimate includes the notifications
by trading partners who have determined that illegitimate product is in
their possession or control, as well as notifications by manufacturers
that have determined a product poses a high risk of illegitimacy. This
estimate is based on FDA's experience with Field Alert Reports (FARs)
(Form FDA 3331) required to be submitted by holders of approved drug
applications for certain drug quality issues (21 CFR 314.81(b)(1)) \1\
and with reports of the falsification of drug sample records,
diversion, loss, and known theft of prescription drug samples as
currently required under the Prescription Drug Marketing Act (PDMA).\2\
Because manufacturers, repackagers, and wholesale distributors are
responsible for prescription drugs from the manufacturing through
distribution processes, FDA assumes that most notifications of
illegitimate products would be made by these three trading partners.
FDA is combining the estimates for manufacturers and repackagers
because FDA establishment and drug product listing database indicates
that many companies perform activities of both manufacturers and
repackagers. While the DSCSA specifically defines dispensers, for
estimation purposes, FDA is using estimates for pharmacies in general
terms and based on those that must comply with the new requirements
under section 582(d) of the FD&C Act. FDA estimates that approximately
50 percent of the notifications will be made by manufacturers and
repackagers (2,500), 45 percent by wholesaler distributors (2,250), and
5 percent by pharmacies (250).
---------------------------------------------------------------------------
\1\ FDA review of the number of Field Alert Reports (FARs)
received in calendar year 2013 was approximately 5,000. Because FARs
are incident and product specific, the estimation does not represent
the number of companies that have submitted a FAR to FDA.
\2\ FDA cursory review of the number of reports of falsified
drug sample records, diversion, loss, or known theft of prescription
drug samples under the PDMA in calendar year 2013 was approximately
5,000. This number is being used for estimation purposes only
because the DSCSA exempts transactions related to the distribution
of product samples by a manufacturer or licensed wholesale
distributor in accordance with section 503(d) of the FD&C Act (21
U.S.C. 353(d)).
---------------------------------------------------------------------------
FDA estimates that the number of annual notifications will vary
from 0-2 for manufacturers/repackagers, as well as from pharmacies,
with the vast majority of companies making no notifications. While FDA
establishment and drug product listing database currently contains
registrations for approximately 6,500 manufacturers and repackagers, we
estimate that approximately 2,500 manufacturers/repackagers will notify
FDA of illegitimate product an average of one time per year. While FDA
estimates approximately 69,000 pharmacy sites in the United States,
based on data from the National Association of Chain Drug Stores, the
National Community Pharmacists Association, and the American Hospital
Association, we estimate that approximately 250 pharmacies will notify
FDA of illegitimate product an average of one time per year.\3\ Because
approximately
[[Page 33566]]
30 wholesale distributors are responsible for over 90 percent of drug
distributions, based on sales,\4\ and because FDA is estimating that
over 2,200 small wholesale distributors might be responsible for the
remaining 10 percent of drug sales, we estimate that each distributor
will make about an average of 1 notification per year to account for
the estimated 2,250 notifications FDA will receive regarding
illegitimate product.
---------------------------------------------------------------------------
\3\ The estimate of the number of pharmacies in the United
States is based on combining estimates of: (a) 41,000 chain
pharmacies provided in a National Association of Chain Drug Stores
statement for the Senate Budget Committee Conferees (October 29,
2013); (b) 23,000 independent pharmacies represented by the National
Community Pharmacist Association (NCPA) according to NCPA's 2014
media kit; and (c) 5,000 U.S. community hospitals in the United
States, based on 2012 American Hospital Association Annual Survey
and the assumption that each hospital has at least one pharmacy.
\4\ The estimate of the number of wholesale drug distributors is
based on the Healthcare Distribution Management Association number
of members and estimation of the percentage of all prescription
drugs sold in the United States by these entities provided in
Congressional testimony before the U.S. House of Representatives,
Committee on Energy and Commerce (April 25, 2013).
---------------------------------------------------------------------------
FDA intends to make available Form FDA 3911 on its Web page for
notifying FDA. Each notification should include information about the
person or entity initiating the notification, the product determined to
be illegitimate, and a description of the circumstances surrounding the
event that prompted the notification. FDA estimates that each
notification will take about 1 hour. The estimated total annual burden
hours for making notifications to FDA is approximately 5,000 hours
annually (table 1).
2. Notifications to Trading Partners of an Illegitimate Product
Under section 582(b)(4)(B)(ii), (c)(4)(B)(ii), (d)(4)(B)(ii), and
(e)(4)(B)(ii) of the FD&C Act, a trading partner who determines that a
product in its possession is illegitimate must also notify all
immediate trading partners that the trading partner has reason to
believe may have received such illegitimate product of that
determination not later than 24 hours after the determination is made.
In addition, a manufacturer is required, under section
582(b)(4)(B)(ii)(II) of the FD&C Act, to notify all immediate trading
partners that the manufacturer has reason to believe may possess a
product manufactured by or purported to be manufactured by the
manufacturer not later than 24 hours after the manufacturer has
determined or been notified by FDA or a trading partner that the
product has a high risk of illegitimacy.
Because the extent of distribution of any illegitimate product is
likely to vary from one situation to another, FDA is using estimates
that assume wide distribution of each illegitimate product. FDA
estimates that for each notification made by a manufacturer or
repackager to FDA, approximately 30 trading partners (based on the
number of distributors) will also be notified. This results in
approximately 75,000 notifications annually to trading partners of
manufacturers/repackagers. This estimate includes the notifications by
manufacturers and repackagers who have determined that illegitimate
product is in their possession or control, as well as notifications by
manufacturers that have determined that a product poses a high risk of
illegitimacy.
FDA estimates that a large wholesale distributor might have up to
4,500 trading partners, but a small wholesale distributor might have
200 trading partners, for an average of approximately 2,350. A
wholesale distributor would notify 2,350 trading partners for each of
the 2,250 illegitimate products identified, resulting in approximately
5,287,500 notifications annually to wholesale distributors' trading
partners.
FDA estimates that a pharmacy purchases prescription drugs from an
average of two wholesale distributors. Therefore, a pharmacy would
notify 2 trading partners for each of the 250 illegitimate products
identified, resulting in approximately 500 notifications annually to
pharmacy trading partners.
Manufacturers/repackagers, wholesale distributors, and pharmacies
might notify their trading partners using existing systems and
processes used for similar types of communications, which might
include, but is not limited to, posting of notifications on a company
Web site, sending an email, or mailing or faxing a letter or
notification. The information contained in the notification to the
immediate trading partner should be the same as or based on the
notification that was already submitted to FDA. FDA estimates that for
all trading partners, each notification of immediate trading partners
will take approximately 0.2 hours. The estimated total burden hours of
making notifications to trading partners is approximately 1,072,600
hours annually (table 2).
3. Consultation With FDA and Termination of Notification
Section 582(b)(4)(B)(iv), (c)(4)(B)(iv), (d)(4)(B)(iv), and
(e)(4)(B)(iv) of the FD&C Act require that a trading partner, who
determines in consultation with FDA that a notification made under
section 582(b)(4)(B)(ii), (c)(4)(B)(ii), (d)(4)(B)(ii), or
(e)(4)(B)(ii) is no longer necessary, must terminate the notification.
The draft guidance sets forth the process by which trading partners
must consult with FDA to terminate notifications that are no longer
necessary.
FDA is making available to trading partners Form FDA 3911 on its
Web page to request a termination of notification. Each request for
termination of notification must include information about the person
or entity initiating the request for termination, the illegitimate
product or product with a high risk of illegitimacy, the notification
that was issued, and an explanation about what actions have taken place
or what information has become available that make the notification no
longer necessary. The request for a termination will be viewed as the
request for consultation with FDA. FDA estimates that the same amount
of time will be required to provide the information necessary to
request termination as is required to make the notification. The time
required to investigate and resolve an illegitimate product
notification will vary, but FDA assumes that each notification will
eventually be terminated at some point. FDA assumes that the number of
requests for termination of a notification per year will be the same as
the original number of notifications for a given year. The estimated
total burden hours of making requests for termination of notifications
to FDA is approximately 5,000 hours annually (table 3).
4. Notifications to Trading Partners That a Notification Has Been
Terminated
Section 582(b)(4)(B)(iv), (c)(4)(B)(iv), (d)(4)(B)(iv), and
(e)(4)(B)(iv) of the FD&C Act require that a trading partner who, in
consultation with FDA, terminates a notification made under section
582(b)(4)(B)(ii), (c)(4)(B)(ii), (d)(4)(B)(ii), or (e)(4)(B)(ii) must
also promptly notify immediate trading partners that the notification
has been terminated.
FDA estimates that the burden for notifying trading partners of an
illegitimate product and the number of trading partners notified will
be the same as the estimates for notification of termination. The
estimated total burden hours of notifying trading partners that the
notification is terminated is approximately 1,072,600 hours annually
(table 4).
Description of Respondents: Respondents are drug manufacturers,
[[Page 33567]]
repackagers, wholesale distributors, and dispensers and might include
small businesses in these categories.
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Notifications to FDA Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Manufacturers and Repackagers.. 2,500 1 2,500 1 hour 2,500
Wholesale Distributors......... 2,250 1 2,250 1 hour 2,250
Dispensers..................... 250 1 250 1 hour 250
--------------------------------------------------------------------------------
Total...................... .............. ............... .............. .............. 5,000
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Consultation with FDA and Number of responses per Total annual Average burden Total hours
termination of notification respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Manufacturers and Repackagers.. 2,500 1 2,500 1 hour 2,500
Wholesale Distributors......... 2,250 1 2,250 1 hour 2,250
Dispensers..................... 250 1 250 1 hour 250
--------------------------------------------------------------------------------
Total...................... .............. ............... .............. .............. 5,000
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 3--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
Notifications to trading Number of
partners of an illegitimate Number of disclosures per Total annual Average burden Total hours
product respondents respondent disclosures per disclosure
----------------------------------------------------------------------------------------------------------------
Manufacturers and Repackagers.. 2,500 30 75,000 .20 15,000
(12 minutes)
Wholesale Distributors......... 2,250 2,350 5,287,500 .20 1,057,500
(12 minutes)
Dispensers..................... 250 2 500 .20 100
(12 minutes)
--------------------------------------------------------------------------------
Total...................... .............. ............... .............. .............. 1,072,600
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 4--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Notifications to trading Number of disclosures per Total annual Average burden Total hours
partners of termination respondents respondent disclosures per disclosure
----------------------------------------------------------------------------------------------------------------
Manufacturers and Repackagers.. 2,500 30 75,000 .20 15,000
(12 minutes)
Wholesale Distributors......... 2,250 2,350 5,287,500 .20 1,057,500
(12 minutes)
Dispensers..................... 250 2 500 .20 100
(12 minutes)
--------------------------------------------------------------------------------
Total...................... .............. ............... .............. .............. 1,072,600
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
5. Capital Costs
There are no capital costs associated with this collection of
information. For notifications to FDA, manufacturers, repackagers,
wholesale distributors, and dispensers will be accessing and using a
system controlled by FDA. For notifications of immediate trading
partners, manufacturers, repackagers, wholesale distributors, and
dispensers will be using current mechanisms, which might include, but
are not limited to, posting of notifications on a company Web site,
sending an email, or mailing or faxing a letter or notification.
III. Comments
Interested persons may submit either electronic comments regarding
this document to https://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the
[[Page 33568]]
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 https://www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet may obtain the document at
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
https://www.regulations.gov.
Dated: June 4, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-13544 Filed 6-10-14; 8:45 am]
BILLING CODE 4160-01-P
