Future Format of the National Drug Code; Public Hearing; Request for Comments, 38666-38669 [2018-16807]
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38666
Proposed Rules
Federal Register
Vol. 83, No. 152
Tuesday, August 7, 2018
This section of the FEDERAL REGISTER
contains notices to the public of the proposed
issuance of rules and regulations. The
purpose of these notices is to give interested
persons an opportunity to participate in the
rule making prior to the adoption of the final
rules.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 15
[Docket No. FDA–2018–N–2610]
Future Format of the National Drug
Code; Public Hearing; Request for
Comments
AGENCY:
Food and Drug Administration,
HHS.
Notification of public hearing;
request for comments.
ACTION:
The Food and Drug
Administration (FDA or the Agency) is
announcing a public hearing and an
opportunity for public comment on the
future format of the National Drug Code
(NDC). FDA is seeking input from a
variety of stakeholders through
comments and responses to FDA
questions included in this notice and
associated web content to be published
ahead of the hearing. The questions are
intended to allow FDA to obtain
stakeholders’ perspectives on the impact
of any future changes made to the length
and format of the NDC.
DATES: The public hearing will be held
on November 5, 2018, from 8:30 a.m. to
5 p.m. The hearing may be extended or
end early depending on the level of
public participation. Persons seeking to
attend or present at the public hearing
must register by October 15, 2018.
Electronic or written comments will be
accepted after the public hearing until
January 5, 2019.
ADDRESSES: The public hearing will be
held at the FDA White Oak Campus,
10903 New Hampshire Ave., Building
31 Conference Center, the Great Room
(Rm. 1503 Section B and C), Silver
Spring, MD 20993–0002. Entrance for
the public hearing participants (nonFDA employees) is through Building 1,
where routine security check
procedures will be performed. For
parking and security information, please
refer to https://www.fda.gov/AboutFDA/
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You may submit comments as
follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA-2018N-2610 for ‘‘Future Format of the
National Drug Code; Public Hearing;
Request for Comments.’’ Received
comments, those filed in a timely
manner (see DATES), will be placed in
the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
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https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Leyla Rahjou-Esfandiary, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2262,
Silver Spring, MD 20993, 301–796–
3185, NDCPublicHearing@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
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I. Background
The NDC is an FDA standard for
uniquely identifying drugs in the United
States. Currently, NDCs assigned by
FDA contain 10 digits. As described in
§ 207.33(b) (21 CFR 207.33(b)), NDCs
consist of three segments: the labeler
code, the product code, and the package
code. At some point in the next 10 to
15 years, NDC formatting will need to be
updated to accommodate longer NDCs
because new labelers are continually
entering the U.S. market. In 2016, when
FDA published the ‘‘Requirements for
Foreign and Domestic Establishment
Registration and Listing for Human
Drugs, Including Drugs That Are
Regulated Under a Biologics License
Application, and Animal Drugs, Final
Rule’’ FDA stated that when it runs out
of 5-digit labeler codes, it will begin
assigning 6-digit labeler codes. (81 FR
60170, August 31, 2016). As a result,
FDA will add two new 11-digit NDC
formats to accommodate the longer
labeler codes. However, FDA
acknowledged that some stakeholders
expressed an interest in FDA moving to
a single, standard format for NDCs and
announced that it would initiate a
public discussion of future formatting
options (81 FR 60170 at 60187). Because
of the widespread use and dependency
on NDCs in prescribing, dispensing,
reimbursement, safety, clinical
management, supply chain
management, and pharmaceutical
manufacturing and labeling systems, the
Agency is holding a public hearing and
requesting comments from stakeholders
on the impact of the transition to 6-digit
labeler codes.
Section 510 of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C.
360) requires each registered drug
establishment to provide FDA with a
current list of all drugs manufactured,
prepared, propagated, compounded, or
processed by the establishment for
commercial distribution. Drug products
are identified and reported using the
NDC.
The NDC for each listed drug in the
United States is a unique 10-digit, 3-
segment number. The 3 segments of
NDC include the labeler code, product
code, and package code. A labeler code
is a unique 4-, 5-, or (in the future) 6digit number assigned by FDA that
identifies the manufacturer, repacker,
relabeler, or private label distributor of
the drug. The second segment, the
product code, identifies a specific
strength, dosage form, and formulation
of a drug manufactured, repackaged,
relabeled, or distributed by the labeler.
The third segment, the package code,
identifies package sizes and types.
Different package codes only
differentiate between different
quantitative and qualitative attributes of
the product packaging. Both the product
and package codes are proposed by
persons submitting drug listing
information. FDA will assign a proposed
NDC if it has not been used previously,
is not currently in use, and has not been
reserved for future assignment to a
different product. The NDC for a given
drug is currently in one of the following
configurations (with each number
representing the number of digits in that
segment): 4–4–2, 5–3–2, or 5–4–1.
According to current regulations,
labeler codes may consist of 4, 5, or 6
digits (§ 207.33(b)(1)). Currently, 5-digit
labeler codes are being assigned by
FDA. A 5-digit labeler code format
provides FDA with 90,000 labeler codes
that could be assigned to drug
manufacturers and private label
distributors ranging from 10,000 to
99,999. Based on current assignment
rates, FDA anticipates that it will run
out of 5-digit labeler codes in
approximately 15 years. FDA will begin
assigning 6-digit labeler codes at some
point in the future due to exhaustion of
5-digit labeler codes. Moving up to 6digit labeler codes will expand NDCs to
11 digits and, per regulation, allows for
two additional NDC configurations: 6–
3–2 and 6–4–1, for a total of five
possible NDC configurations (including
the three 10-digit NDC configurations).
The Health Insurance Portability and
Accountability Act (HIPAA) (Pub. L.
104–191) contains provisions calling for
38667
the administrative simplification ‘‘of the
national standards for electronic health
care transactions and code sets, unique
health identifiers, and security’’ 1 and
specifically references the NDC. In its
implementation of these rules, in
August 2000, the Department of Health
and Human Services (HHS) published a
final rule on standards for electronic
transactions that established NDC
numbers as the standard medical data
code set for reporting drugs and
biologics in all standard transactions
under HIPAA (65 FR 50312). If a
HIPAA-covered transaction includes a
drug, the NDC is required to be a part
of the medical code data set (see 45 CFR
subpart J 162.1002(a)(3)). However, in
the preamble to the HIPAA regulations,
HHS stated that it was adopting a
uniform 11-digit format to conform with
customary practice used in computer
systems (65 FR 50312 at 50329). The
HIPAA standard 11-digit NDC format is
standardized such that the labeler code
is always 5 digits, the product code is
always 4 digits, and the package code
always 2 digits. To convert a 10-digit
NDC to an 11-digit HIPAA standard
NDC, a leading zero is added to the
appropriate segment to create the 11digit configuration as defined above.
When FDA moves to a 6-digit labeler
code, although these new 11-digit native
NDC 2 configurations will have the same
number of digits as required by the
HIPAA standards, they will not be in
the same format.3 Additionally, some of
the systems that utilize HIPAA standard
11-digit NDCs 4 do not use hyphens to
separate the segments which, as
illustrated below, will result in some 11digit native NDCs being
indistinguishable from HIPAA standard
11-digit NDCs. Therefore, to ensure
unhyphenated NDCs are
distinguishable, FDA anticipates that
the HIPAA standards, and other code
sets that currently require 10-digit
native NDCs to be converted to 11-digit
NDCs, will likely be updated in some
manner.
TABLE 1—NDC CONVERSION EXAMPLE
Converted NDC format
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Native NDC format
Native 10-digit (5–3–2) ........................................................................................
1 See https://www.hhs.gov/ocr/privacy/hipaa/
administrative/ (last accessed July 3,
2017).
2 NDCs in the format and with the digits assigned
by FDA are referred to as native NDCs.
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11-digit
converted
(hyphenated)
10-digit
hyphenated
10010–001–01
3 An 11-digit native NDC will have an extra
labeler code digit but will be short a digit in either
the product code or package code.
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10010–0001–01
11-digit
converted
(unhyphenated)
10010000101
4 NDCs that contain additional digits necessary to
comply with HIPAA standards are referred to as
Converted NDCs.
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Federal Register / Vol. 83, No. 152 / Tuesday, August 7, 2018 / Proposed Rules
TABLE 1—NDC CONVERSION EXAMPLE—Continued
Converted NDC format
Native NDC format
10-digit
hyphenated
Native 11-digit (6–3–2) ........................................................................................
................................
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II. Purpose and Scope of the Hearing
The purpose of this public hearing is
to obtain and discuss stakeholder
feedback on the future format of NDCs.
FDA is seeking information on the
following topics:
1. The impact of transitioning from a
5-digit labeler code to a 6-digit labeler
code, including the business, economic,
information technology, and medical/
clinical practice impacts, and its impact
on the safety and security of drug
products.
2. Issues associated with the current
lack of NDC uniformity in the
marketplace.
3. What should FDA consider as it
explores any further changes or
expansion to the format or length of the
NDC?
4. How to best transition to a new
format for the NDC.
To facilitate stakeholder feedback,
some options for discussion and
questions will be posted in the docket
and on FDA’s website at https://
www.fda.gov/Drugs/NewsEvents/
ucm574488.htm at least 30 days prior to
the hearing. These options and
questions are not meant to be
exhaustive. We encourage interested
stakeholders to address these and/or
other issues related to the formatting of
NDCs. FDA encourages stakeholders to
provide the rationale and basis for their
comments, including any available data
and information, and any underlying
assumptions. For example, to provide
context associated with a stakeholders
response, FDA also is interested in the
following information within the
submission or testimony.
1. How would you describe your
business or area of focus (e.g., payor,
hospital, health care practitioner,
benefit manager or administrator,
pharmacy, manufacturer, repackager,
wholesale distributor, third-party
logistics provider, drug compendia,
standard setting organization,
government entity)?
2. How do you or your members use
the NDC?
3. What challenges does your
organization or your members face with
the current NDC and how do you
overcome these challenges?
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4. What changes, if any, would you or
your members need to make to your
systems to accommodate the 6-digit
labeler code or other larger NDC
formats?
III. Registration
Registration and Requests for Oral
Presentations
The FDA Conference Center at the
White Oak location is a Federal facility
with security procedures and limited
seating. Attendance is free and early
registration is recommended.
Individuals who wish to attend must
register on or before October 15, 2018,
at https://www.fda.gov/Drugs/
NewsEvents/ucm574488.htm and
provide complete contact information,
including name, title, affiliation, email,
and phone number. Those without
internet access may register by
contacting Leyla Rahjou-Esfandiary at
301–796–3185. FDA may allow onsite
registration if space is available. If
registration reaches maximum capacity,
FDA will post a notice closing
registration at https://www.fda.gov/
Drugs/NewsEvents/ucm574488.htm.
This hearing will include public
comment sessions. Individuals who
wish to present during a public
comment session at the public hearing
must register as noted at https://
www.fda.gov/Drugs/NewsEvents/
ucm574488.htm and identify the topics
or questions (see section II) they wish to
address in their presentation and the
stakeholder group they best associate
with, if any, to help FDA organize the
presentations. Individuals and
organizations with common interests are
urged to consolidate or coordinate their
presentations and request time for a
joint presentation.
FDA will do its best to accommodate
requests to present during the public
comment session and will determine the
amount of time allotted for each oral
presentation and the approximate time
that each oral presentation is scheduled
to begin. FDA will notify registered
presenters of their scheduled times and
make available an agenda and
background material at https://
www.fda.gov/Drugs/NewsEvents/
ucm574488.htm on or before October
22, 2018. Once FDA notifies registered
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11-digit
converted
(hyphenated)
100100–001–01
11-digit
converted
(unhyphenated)
10010000101
presenters of their scheduled times,
presenters should submit an electronic
copy of their presentation to
NDCPublicHearing@fda.hhs.gov on or
before October 29, 2018.
If you need special accommodations
because of a disability, please send an
email to NDCPublicHearing@
fda.hhs.gov at least 7 days before the
hearing.
Streaming Webcast of the Public
Hearing
A link to the live webcast of this
public hearing will be available at
https://www.fda.gov/Drugs/NewsEvents/
ucm574488.htm on the day of public
hearing. A video record of the public
hearing will be available at https://
www.fda.gov/Drugs/NewsEvents/
ucm574488.htm following the hearing.
IV. Notice of Public Hearing Under 21
CFR Part 15
The Commissioner of Food and Drugs
is announcing that the public hearing
will be held in accordance with part 15
(21 CFR part 15). The hearing will be
conducted by a presiding officer, who
will be accompanied by FDA senior
management from the Office of the
Commissioner and the relevant centers/
offices.
Under § 15.30(f), the hearing is
informal and the rules of evidence do
not apply. No participant may interrupt
the presentation of another participant.
Only the presiding officer and panel
members may question any person
during or at the conclusion of each
presentation. At their discretion, the
presiding officer(s) may permit
questions to be submitted from the
audience for response by FDA or other
persons attending the hearing
(§ 15.30(e)). Public hearings under part
15 are subject to FDA’s policy and
procedures for electronic media
coverage of FDA’s public administrative
proceedings (21 CFR part 10, subpart C).
Under § 10.205, representatives of the
electronic media may be permitted,
subject to certain limitations, to
videotape, film, or otherwise record
FDA’s public administrative
proceedings, including presentations by
participants. The hearing will be
transcribed as stipulated in § 15.30(b)
(see Transcripts). To the extent that the
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conditions for the hearing, as described
in this notice, conflict with any
provisions set out in part 15, this notice
acts as a waiver of those provisions as
specified in § 15.30(h).
Transcripts
Please be advised that as soon as a
transcript is available, it will be
accessible at https://
www.regulation.gov. It may be viewed at
the Dockets Management Staff (see
ADDRESSES). A transcript will also be
available in either hardcopy or on CD–
ROM, after submission of a Freedom of
Information request. The Freedom of
Information office address is available
on the Agency’s website at https://
www.fda.gov.
Dated: July 31, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–16807 Filed 8–6–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF STATE
22 CFR Chapter I
48 CFR Chapter 6
[Public Notice: 10489]
Reducing Regulation and Public
Burden, and Controlling Cost
Department of State.
Request for comments.
AGENCY:
ACTION:
As part of its continuing
implementation of Executive Order
13771, ‘‘Reducing Regulation and
Controlling Regulatory Costs,’’ issued by
the President on January 30, 2017, the
Department of State (the Department) is
seeking comments and information from
interested parties to assist the
Department in identifying existing
regulations, paperwork requirements
and other regulatory obligations that can
be modified or repealed, consistent with
law, to achieve meaningful burden
reduction while continuing to achieve
the Department’s statutory obligations.
DATES: Written comments and related
material must be received on or before
September 6, 2018.
ADDRESSES: You may submit comments
by email to the following address:
RegsReform@state.gov.
FOR FURTHER INFORMATION CONTACT:
Alice Kottmyer, Attorney-Adviser, 202–
647–2318; or Janet Freer, Director of the
Office of Directives Management. Both
can be reached at RegsReform@
state.gov.
SUPPLEMENTARY INFORMATION: On
January 30, 2017, President Trump
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issued Executive Order 13771, Reducing
Regulation and Controlling Regulatory
Costs. Under that Executive Order, for
every one new regulation issued, at least
two prior regulations must be identified
for elimination, and the cost of planned
regulations must be prudently managed
and controlled through a budgeting
process. On February 24, 2017, the
President issued Executive Order 13777,
Enforcing the Regulatory Reform
Agenda. That Executive Order directs
agencies to take specific steps to
identify and alleviate unnecessary
regulatory burdens placed on the
American people. We are seeking
comments on Department regulations,
guidance documents, and collections of
information that you believe should be
removed or modified to alleviate
unnecessary burdens. The Department
is also requesting economic data to
support any proposed changes.
The Regulatory Reform Task Force
Executive Order 13777 directs
agencies to designate a Regulatory
Reform Officer (RRO) and to establish a
Regulatory Reform Task Force (RRTF).
The Deputy Secretary of State is the
RRO. Other RRTF members include
senior officials in the Department’s
primary regulatory bureaus (Bureaus of
Consular Affairs, Educational and
Cultural Affairs, Political-Military
Affairs, and Administration), as well as
other Department officials with
expertise in legal requirements,
planning and budget.
One of the duties of the RRTF is to
evaluate existing regulations and make
recommendations to the Secretary
regarding their repeal, replacement, or
modification. Executive Order 13777
further directs that the RRTF attempt to
identify regulations that:
• Eliminate jobs, or inhibit job
creation;
• Are outdated, unnecessary, or
ineffective;
• Impose costs that exceed benefits;
• Create a serious inconsistency or
otherwise interfere with regulatory
reform initiatives and policies;
• Are inconsistent with the
requirements of section 515 of the
Treasury and General Government
Appropriations Act, 2001 (44 U.S.C.
3516 note), or the guidance issued
pursuant to that provision, in particular
those regulations that rely in whole or
in part on data, information, or methods
that are not publicly available or that are
insufficiently transparent to meet the
standard of reproducibility; or
• Derive from or implement
Executive Orders or other Presidential
directives that have been subsequently
rescinded or substantially modified.
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38669
Section 3(e) of the Executive Order
calls on the RRTF to ‘‘seek input and
other assistance, as permitted by law,
from entities significantly affected by
Federal regulations, including State,
local, and tribal governments, small
businesses, consumers,
nongovernmental organizations, and
trade associations’’ on regulations that
meet some or all of the criteria above.
The Department sought input in 2017
(see 82 FR 32493), and again solicits
your comments.
Location of Department Regulations
Existing Department of State
regulations can be found in the Code of
Federal Regulations (CFR) in two places:
• 22 CFR Chapter I (parts 1 through
199), which contains rules governing
Department operations); and
• 48 CFR Chapters VI (part 600),
which contains the Department’s
Acquisition Rules.
In addition, guidance regarding
Department grants can be found at 2
CFR chapter VI.
You may view the most up-to-date
versions of these authorities in the
electronic CFR, located at www.ecfr.gov.
Location of Department Guidance
Department guidance that relates to
the missions of the rulemaking bureaus
(identified above) can be found in a
number of locations on the state.gov
public website. The Department is
interested in comments regarding any of
the guidance located on its public site.
For your convenience, the following
sites cover specific missions:
• For Consular Affairs, including
passports and visas, please visit https://
travel.state.gov.
• For Educational and Cultural
Affairs, including the Exchange Visitor
Program, please visit https://
exchanges.state.gov/.
• For Defense Trade issues, please
visit: https://www.pmddtc.state.gov/.
You are invited to provide comment
on any guidance published by the
Department that you feel should be
considered for modification or
elimination, in accordance with E.O.
13777.
Location of the Department’s Unified
Agenda Submission
The Department’s most current
submission to the Unified Agenda of
Regulatory and Deregulatory Actions is
located at https://www.reginfo.gov/
public/do/eAgendaMain. Select
‘‘Department of State’’ from the
dropdown menu. The Agenda consists
of regulatory and de-regulatory actions
either in progress or contemplated by
the Department. The rules are identified
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]]>Agencies
[Federal Register Volume 83, Number 152 (Tuesday, August 7, 2018)]
[Proposed Rules]
[Pages 38666-38669]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-16807]
========================================================================
Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
========================================================================
Federal Register / Vol. 83, No. 152 / Tuesday, August 7, 2018 /
Proposed Rules
[[Page 38666]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 15
[Docket No. FDA-2018-N-2610]
Future Format of the National Drug Code; Public Hearing; Request
for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notification of public hearing; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing a public hearing and an opportunity for public comment on
the future format of the National Drug Code (NDC). FDA is seeking input
from a variety of stakeholders through comments and responses to FDA
questions included in this notice and associated web content to be
published ahead of the hearing. The questions are intended to allow FDA
to obtain stakeholders' perspectives on the impact of any future
changes made to the length and format of the NDC.
DATES: The public hearing will be held on November 5, 2018, from 8:30
a.m. to 5 p.m. The hearing may be extended or end early depending on
the level of public participation. Persons seeking to attend or present
at the public hearing must register by October 15, 2018. Electronic or
written comments will be accepted after the public hearing until
January 5, 2019.
ADDRESSES: The public hearing will be held at the FDA White Oak Campus,
10903 New Hampshire Ave., Building 31 Conference Center, the Great Room
(Rm. 1503 Section B and C), Silver Spring, MD 20993-0002. Entrance for
the public hearing participants (non-FDA employees) is through Building
1, where routine security check procedures will be performed. For
parking and security information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2018-N-2610 for ``Future Format of the National Drug Code; Public
Hearing; Request for Comments.'' Received comments, those filed in a
timely manner (see DATES), will be placed in the docket and, except for
those submitted as ``Confidential Submissions,'' publicly viewable at
https://www.regulations.gov or at the Dockets Management Staff between
9 a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Leyla Rahjou-Esfandiary, Center for
Drug Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2262, Silver Spring, MD 20993, 301-796-
3185, [email protected].
SUPPLEMENTARY INFORMATION:
[[Page 38667]]
I. Background
The NDC is an FDA standard for uniquely identifying drugs in the
United States. Currently, NDCs assigned by FDA contain 10 digits. As
described in Sec. 207.33(b) (21 CFR 207.33(b)), NDCs consist of three
segments: the labeler code, the product code, and the package code. At
some point in the next 10 to 15 years, NDC formatting will need to be
updated to accommodate longer NDCs because new labelers are continually
entering the U.S. market. In 2016, when FDA published the
``Requirements for Foreign and Domestic Establishment Registration and
Listing for Human Drugs, Including Drugs That Are Regulated Under a
Biologics License Application, and Animal Drugs, Final Rule'' FDA
stated that when it runs out of 5-digit labeler codes, it will begin
assigning 6-digit labeler codes. (81 FR 60170, August 31, 2016). As a
result, FDA will add two new 11-digit NDC formats to accommodate the
longer labeler codes. However, FDA acknowledged that some stakeholders
expressed an interest in FDA moving to a single, standard format for
NDCs and announced that it would initiate a public discussion of future
formatting options (81 FR 60170 at 60187). Because of the widespread
use and dependency on NDCs in prescribing, dispensing, reimbursement,
safety, clinical management, supply chain management, and
pharmaceutical manufacturing and labeling systems, the Agency is
holding a public hearing and requesting comments from stakeholders on
the impact of the transition to 6-digit labeler codes.
Section 510 of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
(21 U.S.C. 360) requires each registered drug establishment to provide
FDA with a current list of all drugs manufactured, prepared,
propagated, compounded, or processed by the establishment for
commercial distribution. Drug products are identified and reported
using the NDC.
The NDC for each listed drug in the United States is a unique 10-
digit, 3-segment number. The 3 segments of NDC include the labeler
code, product code, and package code. A labeler code is a unique 4-, 5-
, or (in the future) 6-digit number assigned by FDA that identifies the
manufacturer, repacker, relabeler, or private label distributor of the
drug. The second segment, the product code, identifies a specific
strength, dosage form, and formulation of a drug manufactured,
repackaged, relabeled, or distributed by the labeler. The third
segment, the package code, identifies package sizes and types.
Different package codes only differentiate between different
quantitative and qualitative attributes of the product packaging. Both
the product and package codes are proposed by persons submitting drug
listing information. FDA will assign a proposed NDC if it has not been
used previously, is not currently in use, and has not been reserved for
future assignment to a different product. The NDC for a given drug is
currently in one of the following configurations (with each number
representing the number of digits in that segment): 4-4-2, 5-3-2, or 5-
4-1.
According to current regulations, labeler codes may consist of 4,
5, or 6 digits (Sec. 207.33(b)(1)). Currently, 5-digit labeler codes
are being assigned by FDA. A 5-digit labeler code format provides FDA
with 90,000 labeler codes that could be assigned to drug manufacturers
and private label distributors ranging from 10,000 to 99,999. Based on
current assignment rates, FDA anticipates that it will run out of 5-
digit labeler codes in approximately 15 years. FDA will begin assigning
6-digit labeler codes at some point in the future due to exhaustion of
5-digit labeler codes. Moving up to 6-digit labeler codes will expand
NDCs to 11 digits and, per regulation, allows for two additional NDC
configurations: 6-3-2 and 6-4-1, for a total of five possible NDC
configurations (including the three 10-digit NDC configurations).
The Health Insurance Portability and Accountability Act (HIPAA)
(Pub. L. 104-191) contains provisions calling for the administrative
simplification ``of the national standards for electronic health care
transactions and code sets, unique health identifiers, and security''
\1\ and specifically references the NDC. In its implementation of these
rules, in August 2000, the Department of Health and Human Services
(HHS) published a final rule on standards for electronic transactions
that established NDC numbers as the standard medical data code set for
reporting drugs and biologics in all standard transactions under HIPAA
(65 FR 50312). If a HIPAA-covered transaction includes a drug, the NDC
is required to be a part of the medical code data set (see 45 CFR
subpart J 162.1002(a)(3)). However, in the preamble to the HIPAA
regulations, HHS stated that it was adopting a uniform 11-digit format
to conform with customary practice used in computer systems (65 FR
50312 at 50329). The HIPAA standard 11-digit NDC format is standardized
such that the labeler code is always 5 digits, the product code is
always 4 digits, and the package code always 2 digits. To convert a 10-
digit NDC to an 11-digit HIPAA standard NDC, a leading zero is added to
the appropriate segment to create the 11-digit configuration as defined
above.
---------------------------------------------------------------------------
\1\ See https://www.hhs.gov/ocr/privacy/hipaa/administrative/ (last accessed July 3, 2017).
---------------------------------------------------------------------------
When FDA moves to a 6-digit labeler code, although these new 11-
digit native NDC \2\ configurations will have the same number of digits
as required by the HIPAA standards, they will not be in the same
format.\3\ Additionally, some of the systems that utilize HIPAA
standard 11-digit NDCs \4\ do not use hyphens to separate the segments
which, as illustrated below, will result in some 11-digit native NDCs
being indistinguishable from HIPAA standard 11-digit NDCs. Therefore,
to ensure unhyphenated NDCs are distinguishable, FDA anticipates that
the HIPAA standards, and other code sets that currently require 10-
digit native NDCs to be converted to 11-digit NDCs, will likely be
updated in some manner.
---------------------------------------------------------------------------
\2\ NDCs in the format and with the digits assigned by FDA are
referred to as native NDCs.
\3\ An 11-digit native NDC will have an extra labeler code digit
but will be short a digit in either the product code or package
code.
\4\ NDCs that contain additional digits necessary to comply with
HIPAA standards are referred to as Converted NDCs.
Table 1--NDC Conversion Example
----------------------------------------------------------------------------------------------------------------
Converted NDC format
-----------------------------------------------------------
Native NDC format 10-digit 11-digit converted 11-digit converted
hyphenated (hyphenated) (unhyphenated)
----------------------------------------------------------------------------------------------------------------
Native 10-digit (5-3-2)............................. 10010-001-01 10010-0001-01 10010000101
[[Page 38668]]
Native 11-digit (6-3-2)............................. .................. 100100-001-01 10010000101
----------------------------------------------------------------------------------------------------------------
II. Purpose and Scope of the Hearing
The purpose of this public hearing is to obtain and discuss
stakeholder feedback on the future format of NDCs. FDA is seeking
information on the following topics:
1. The impact of transitioning from a 5-digit labeler code to a 6-
digit labeler code, including the business, economic, information
technology, and medical/clinical practice impacts, and its impact on
the safety and security of drug products.
2. Issues associated with the current lack of NDC uniformity in the
marketplace.
3. What should FDA consider as it explores any further changes or
expansion to the format or length of the NDC?
4. How to best transition to a new format for the NDC.
To facilitate stakeholder feedback, some options for discussion and
questions will be posted in the docket and on FDA's website at https://www.fda.gov/Drugs/NewsEvents/ucm574488.htm at least 30 days prior to
the hearing. These options and questions are not meant to be
exhaustive. We encourage interested stakeholders to address these and/
or other issues related to the formatting of NDCs. FDA encourages
stakeholders to provide the rationale and basis for their comments,
including any available data and information, and any underlying
assumptions. For example, to provide context associated with a
stakeholders response, FDA also is interested in the following
information within the submission or testimony.
1. How would you describe your business or area of focus (e.g.,
payor, hospital, health care practitioner, benefit manager or
administrator, pharmacy, manufacturer, repackager, wholesale
distributor, third-party logistics provider, drug compendia, standard
setting organization, government entity)?
2. How do you or your members use the NDC?
3. What challenges does your organization or your members face with
the current NDC and how do you overcome these challenges?
4. What changes, if any, would you or your members need to make to
your systems to accommodate the 6-digit labeler code or other larger
NDC formats?
III. Registration
Registration and Requests for Oral Presentations
The FDA Conference Center at the White Oak location is a Federal
facility with security procedures and limited seating. Attendance is
free and early registration is recommended. Individuals who wish to
attend must register on or before October 15, 2018, at https://www.fda.gov/Drugs/NewsEvents/ucm574488.htm and provide complete contact
information, including name, title, affiliation, email, and phone
number. Those without internet access may register by contacting Leyla
Rahjou-Esfandiary at 301-796-3185. FDA may allow onsite registration if
space is available. If registration reaches maximum capacity, FDA will
post a notice closing registration at https://www.fda.gov/Drugs/NewsEvents/ucm574488.htm.
This hearing will include public comment sessions. Individuals who
wish to present during a public comment session at the public hearing
must register as noted at https://www.fda.gov/Drugs/NewsEvents/ucm574488.htm and identify the topics or questions (see section II)
they wish to address in their presentation and the stakeholder group
they best associate with, if any, to help FDA organize the
presentations. Individuals and organizations with common interests are
urged to consolidate or coordinate their presentations and request time
for a joint presentation.
FDA will do its best to accommodate requests to present during the
public comment session and will determine the amount of time allotted
for each oral presentation and the approximate time that each oral
presentation is scheduled to begin. FDA will notify registered
presenters of their scheduled times and make available an agenda and
background material at https://www.fda.gov/Drugs/NewsEvents/ucm574488.htm on or before October 22, 2018. Once FDA notifies
registered presenters of their scheduled times, presenters should
submit an electronic copy of their presentation to
[email protected] on or before October 29, 2018.
If you need special accommodations because of a disability, please
send an email to [email protected] at least 7 days before
the hearing.
Streaming Webcast of the Public Hearing
A link to the live webcast of this public hearing will be available
at https://www.fda.gov/Drugs/NewsEvents/ucm574488.htm on the day of
public hearing. A video record of the public hearing will be available
at https://www.fda.gov/Drugs/NewsEvents/ucm574488.htm following the
hearing.
IV. Notice of Public Hearing Under 21 CFR Part 15
The Commissioner of Food and Drugs is announcing that the public
hearing will be held in accordance with part 15 (21 CFR part 15). The
hearing will be conducted by a presiding officer, who will be
accompanied by FDA senior management from the Office of the
Commissioner and the relevant centers/offices.
Under Sec. 15.30(f), the hearing is informal and the rules of
evidence do not apply. No participant may interrupt the presentation of
another participant. Only the presiding officer and panel members may
question any person during or at the conclusion of each presentation.
At their discretion, the presiding officer(s) may permit questions to
be submitted from the audience for response by FDA or other persons
attending the hearing (Sec. 15.30(e)). Public hearings under part 15
are subject to FDA's policy and procedures for electronic media
coverage of FDA's public administrative proceedings (21 CFR part 10,
subpart C). Under Sec. 10.205, representatives of the electronic media
may be permitted, subject to certain limitations, to videotape, film,
or otherwise record FDA's public administrative proceedings, including
presentations by participants. The hearing will be transcribed as
stipulated in Sec. 15.30(b) (see Transcripts). To the extent that the
[[Page 38669]]
conditions for the hearing, as described in this notice, conflict with
any provisions set out in part 15, this notice acts as a waiver of
those provisions as specified in Sec. 15.30(h).
Transcripts
Please be advised that as soon as a transcript is available, it
will be accessible at https://www.regulation.gov. It may be viewed at
the Dockets Management Staff (see ADDRESSES). A transcript will also be
available in either hardcopy or on CD-ROM, after submission of a
Freedom of Information request. The Freedom of Information office
address is available on the Agency's website at https://www.fda.gov.
Dated: July 31, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-16807 Filed 8-6-18; 8:45 am]
BILLING CODE 4164-01-P
