[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]


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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.

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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.

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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:
    <bullet> 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.
    <bullet> 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:
    <bullet> 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.
    <bullet> 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.
    <bullet> 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, <a href="/cdn-cgi/l/email-protection#327c76716247505e5b517a5753405b5c55725456531c5a5a411c555d44"><span class="__cf_email__" data-cfemail="6c22282f3c190e00050f24090d1e05020b2c0a080d4204041f420b031a">[email protected]</span></a>.

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.
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    \1\ See http://www.hhs.gov/ocr/privacy/hipaa/administrative/index.html (last accessed July 3, 2017).
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    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.
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    \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
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                                                                         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
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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?
    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 
<a href="/cdn-cgi/l/email-protection#2a646e697a5f48464349624f4b5843444d6a4c4e4b04424259044d455c"><span class="__cf_email__" data-cfemail="feb0babdae8b9c92979db69b9f8c979099be989a9fd096968dd0999188">[email protected]</span></a> on or before October 29, 2018.
    If you need special accommodations because of a disability, please 
send an email to <a href="/cdn-cgi/l/email-protection#e0aea4a3b095828c8983a8858192898e87a0868481ce888893ce878f96"><span class="__cf_email__" data-cfemail="8dc3c9ceddf8efe1e4eec5e8ecffe4e3eacdebe9eca3e5e5fea3eae2fb">[email protected]</span></a> 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


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