[Federal Register Volume 79, Number 236 (Tuesday, December 9, 2014)]
[Notices]
[Pages 73083-73086]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-28711]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-D-2083]
Draft Guidance for Industry on Drug Supply Chain Security Act
Implementation: Annual Reporting by Prescription Drug Wholesale
Distributors and Third-Party Logistics Providers; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Drug Supply
Chain Security Act Implementation: Annual Reporting by Prescription
Drug Wholesale Distributors and Third-Party Logistics Providers.'' This
draft guidance addresses new provisions in the Federal Food, Drug, and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 The draft guidance describes FDA's expectations
for prescription drug wholesale distributors (wholesale distributors)
and third-party logistics providers (3PLs) about reporting to FDA under
the DSCSA.
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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by February 9, 2015. Submit either electronic or written
comments concerning the collection of information proposed in the draft
guidance by February 9, 2015.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug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, 10001 New
Hampshire Ave., Hillandale Building, 4th Floor, 4147, Silver Spring, MD
20993; or the Office of Communication, Outreach and Development, Center
for Biologics Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993.
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electronic access to the draft guidance document.
Submit electronic comments on the draft guidance to http://www.regulations.gov.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: Suzanne Barone, Office of Compliance,
Center for Drug Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-3130,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Drug Supply Chain Security Act Implementation: Annual
Reporting by Prescription Drug Wholesale Distributors and Third-Party
Logistics Providers.'' This guidance is being issued to facilitate
implementation of new reporting provisions under the DSCSA. On November
27, 2013, the DSCSA (Title II of Pub. L. 113-54) was signed into law.
The DSCSA outlines new requirements for the licensing of prescription
drug wholesale distributors and 3PLs.
Section 204 of the DSCSA amends section 503(e) of the FD&C Act (21
U.S.C. 353(e)) and outlines requirements for reporting by wholesale
distributors. Section 503(e)(2)(A) of the FD&C Act (as amended)
requires wholesale distributors to report annually, beginning on
January 1, 2015. Information to be reported includes State licensure
information and contact information for each facility. Wholesale
distributors are also to report to FDA any significant disciplinary
actions taken by the State or Federal Government, such as revocation or
suspension of a license. Section 204 of the DSCSA also amends section
503(e)(2)(B) of the FD&C Act and requires FDA to make information about
wholesale distributors' licensure available to the public on FDA's Web
site. Updates to the public information are to be made on a schedule to
be determined by FDA.
Section 205 of the DSCSA adds section 584 to the FD&C Act. Section
584 sets forth requirements for licensure and reporting by 3PLs. Under
section 584 of the FD&C Act (as amended) (21 U.S.C. 360eee-3), 3PLs are
required to report annually to FDA, beginning on November 27, 2014 (1
year after the date of enactment of the DSCSA). Third-party logistic
providers are required to report State licensure information, name and
address for each facility, and all trade names under which each
facility conducts business.
[[Page 73084]]
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking about
information that should be submitted to FDA, the timing of the
submissions, a preferred format for the submissions, and a preferred
method for reporting to FDA by wholesale distributors and 3PLs. It does
not create or confer any rights for or on any person and does 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.
II. Paperwork Reduction Act of 1995
The 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 burdens.
Included in the estimate is the time for reviewing instructions,
searching existing data sources, and completing and reviewing the
collection of information annually.
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: Annual
Reporting by Prescription Drug Wholesale Distributors and Third-Party
Logistics Providers.
Description: On November 27, 2013, the DSCSA was signed into law.
Section 503(e)(2) of the FD&C Act requires licensed wholesale
distributors to report annually, beginning January 1, 2015. Information
to be reported includes each State by which the wholesale distributor
is licensed and the appropriate identification number of each license;
and the name, address, and contact information of each facility at
which, and all trade names under which, the wholesale distributor
conducts business. Wholesale distributors are also required to report
any significant disciplinary actions, such as revocation or suspension
of a license. In addition, FDA is requesting the voluntary submission
of a unique facility identifier, the expiration date of each State
license, and documents associated with the disciplinary action, such as
consent decree, final State Board ruling, etc.
The DSCSA also outlines reporting requirements for 3PLs. Under
section 584 of the FD&C Act (as amended), 3PLs are required to report
to FDA annually, beginning 1 year after the enactment of the DSCSA
(November 27, 2014), the State by which a facility is licensed and the
appropriate identification number and the name, address, and all trade
names under which the facility conducts business. Because certain
additional information will be useful to FDA in its enforcement of the
Act, FDA is also requesting that 3PLs voluntarily provide the same
information as wholesale distributors. The ultimate goal is for the
public database to serve as a single repository of licensing and
facility information for wholesale drug distributors and 3PLs
conducting business in the United States.
A. Estimates of Reporters
The exact number of wholesale distributors required to report to
FDA is unknown because the license status information for each
wholesale distributor facility is currently maintained by each State.
The DSCSA excludes several categories of businesses from the definition
of wholesale distribution that may have been licensed by States as
wholesale distributors before the DSCSA was enacted. FDA estimates that
about 5,000 wholesale distributor facilities will report to FDA. This
number is based on estimates of active wholesale facilities that
distribute pharmaceuticals which include drugs, proprietaries, and
sundries according to Dun & Bradstreet. This number may be an
overestimation since this category may contain distributors that do not
distribute prescription drugs.
The exact number of prescription drug 3PLs in the United States is
also unknown because prior to the enactment of DSCSA, most states
licensed 3PLs as wholesale distributors with the exception of
Florida.\1\ The International Warehouse Logistics Association (IWLA)
has stated that the best estimate of the number of 3PLs involved with
prescription drugs is indicated by the number licensed by Florida.\2\
Therefore, FDA is using the number of 3PLs licensed by Florida as an
estimate of the number of 3PLs in the United States. The Florida Drugs,
Devices, and Cosmetics Licensee Files database (on July 16, 2014)
contains 136 warehouses licensed as 3PLs, located in 28 different
states. The location of each facility was verified by license number.
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\1\ Title XXXIII chapter 499 Florida statues (http://www.flsenate.gov/laws/statutes/2011/0499.01)
\2\ ``Third-Party Logistics Providers Licensure Requirements''
Pat O'Connor, IWLA, presented at DQSA: Meeting Supply
Responsibilities, Food and Drug Law Institute, February 20, 2014,
Washington, DC.
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B. Initial Report
FDA estimates that the time and effort for wholesale distributors
and 3PLs to make the initial report to FDA will be greater than
reporting for subsequent reports made thereafter because of the amount
of information submitted will include all State licensure information.
Subsequent reports submitted to FDA will only include information that
needs to be updated or added.
Each wholesale distributor must report the following information
for each facility:
Name, address, and contact information (including email
address and telephone number),
each State license and license identifying number,
all trade names that the facility conducts business as
(dba), and
significant disciplinary actions.
In addition, FDA is requesting that wholesale distributors report
the following information:
Expiration dates for each State license,
unique facility identifier (D-U-N-S number), and
documents associated with the disciplinary action, such as
a consent decree, final State Board ruling, etc.
3PLs should submit the same information as wholesale distributors,
including significant disciplinary actions. Some of this information is
required under the DSCSA to be submitted by 3PLs including name,
address, State license, and State license identifying number; the other
categories are voluntary for 3PLs.
The information listed above is readily available to the
facilities, including the unique facility identifier. FDA currently
prefers D-U-N-S number as the unique facility identification for the
location of each facility. For a facility that has not been assigned a
number, a number may be obtained for no cost directly from Dun &
Bradstreet (http://www.dnb.com). Each facility may have differing
[[Page 73085]]
numbers of State license information to input and may or may not have
any significant disciplinary actions for each State. FDA is providing a
Web portal for the efficient entry and submission of this information.
Companies using this portal will not have to convert the information to
report into an extensible markup language (XML) file in the Structured
Product Label (SPL) format and submit it separately through the FDA
gateway. No special computer program or expertise is required if the
Web portal is used. We estimate that it will take wholesale
distributors and 3PLs on average about 0.5 hours per facility to
collect and input this information for the initial reporting, for a
total burden for the first year of 2,568 hours. Refer to table 1.
C. Subsequent Annual Reports
FDA will maintain the information submitted previously for each
facility's initial report. This information will be readily accessible
through the FDA-supplied Web portal. This eliminates the need for re-
entry of all of the information each year. We estimate that it will
take 0.25 hours each subsequent year to review and update information
such as, but not limited to, a license expiration date following
renewal or a resolution of a disciplinary action. The total annual
burden for wholesale distributors and 3PLs is 1,284 hours (table 2).
D. Significant Disciplinary Action Reports
Wholesale distributors are required and 3PLs are requested to
report significant disciplinary actions. The number of distributors and
3PLs that will have significant disciplinary action taken against them
is unknown. Disciplinary actions are currently handled by the
individual States' regulatory authorities. FDA does not believe that
the number of significant disciplinary actions that would limit the
ability of a wholesale distributor or 3PL to warehouse and/or
distribute prescription drugs would be greater than 1 percent of the
total number of facilities that report on an annual basis. This would
be equivalent to approximately 50 wholesale distributors and 2 3PLs.
Significant disciplinary action information requested should be readily
available to each wholesale distributor and 3PL involved in the action.
FDA estimates that it will take 0.5 hours for the wholesale distributor
or 3PL to access the system, input information, and upload documents
(if available) using the Web portal. FDA estimates that the total
annual burden of reporting significant disciplinary action is 26 hours
(table 3).
E. Other Voluntary Reports
FDA is also requesting that a wholesale distributor or 3PL notify
FDA within 30 days if a facility goes out of business or voluntarily
withdraws a State or Federal license. FDA estimates that this reporting
type will occur infrequently; involving five wholesale distributor
facilities and one 3PL facility per year. We estimate that it will take
0.25 hours to update the company or license status. FDA estimates that
the total annual burden of reporting these voluntary reports is 1.5
hours (table 4).
Description of Respondents: Respondents are prescription drug
wholesale distributors and third-party logistics providers and might
include small businesses in these categories.
Table 1--Initial Report Burden 1 2
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Number of
Initial reporting to FDA Number of responses per Total initial Average burden Total hours
respondents respondent responses per response
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Wholesale Distributors....... 5,000 1 5,000 0.5 hour (30 2,500
minutes).
3PLs......................... 136 1 136 0.5 hour (30 68
minutes).
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Total.................... .............. .............. .............. ................. 2568
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\1\ Any fraction is rounded up to a whole number.
\2\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2--Subsequent Reports Burden \1\
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Number of
Annual reporting to FDA Number of responses per Total Average burden Total hours
respondents respondent responses per response
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Wholesale distributors....... 5,000 1 5,000 0.25 hour (15 1,250
minutes).
3PLs......................... 136 1 136 0.25 hour (15 34
minutes).
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Total.................... .............. .............. .............. ................. 1,284
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 3--Significant Disciplinary Action Report Burden \1\
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Number of
Significant disciplinary Number of responses per Total Average burden Total hours
actions respondents respondent responses per response
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Wholesale distributors....... 50 1 50 0.5 hour (30 25
minutes).
3PLs......................... 2 1 2 0.5 hour (30 1
minutes).
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[[Page 73086]]
Total.................... .............. .............. .............. ................. 26
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 4--Other Voluntary Reports Burden \1\
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Number of
Other voluntary reports Number of responses per Total Average burden Total hours
respondents respondent responses per response
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Wholesale distributors....... 5 1 5 0.25 hour (15 1.25
minutes).
3PLs......................... 1 1 1 0.25 hour (15 0.25
minutes).
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Total.................... .............. .............. .............. ................. 1.50
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
F. Capital Costs
There are no capital costs associated with this collection and
reporting of information if the FDA-provided Web portal is used for
reporting.
III. Comments
Interested persons may submit either electronic comments regarding
this document to http://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 docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet may obtain the document at
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
http://www.regulations.gov.
Dated: December 3, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-28711 Filed 12-8-14; 8:45 am]
BILLING CODE 4164-01-P