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.

Proposed Rules Federal Register

38666 

Vol. 83, No. 152 

Tuesday, August 7, 2018 

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 (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/ 

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, NDCPublicHearing@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 


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Federal Register / Vol. 83, No. 152 / Tuesday, August 7, 2018 / Proposed Rules 38667 

1See http://www.hhs.gov/ocr/privacy/hipaa/ 

administrative/index.html (last accessed July 3, 

2017). 

2NDCs in the format and with the digits assigned 

by FDA are referred to as native NDCs. 

3An 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. 

4NDCs that contain additional digits necessary to 

comply with HIPAA standards are referred to as 

Converted NDCs. 

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) 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 (§ 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. 

When FDA moves to a 6-digit labeler 

code, although these new 11-digit native 

NDC2 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. 

TABLE 1—NDC CONVERSION EXAMPLE

Native NDC format 

Converted NDC format 

10-digit 

hyphenated 

11-digit 

converted 

(hyphenated) 

11-digit 

converted 

(unhyphenated) 

Native 10-digit (5–3–2) ........................................................................................ 10010–001–01 10010–0001–01 10010000101 


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TABLE 1—NDC CONVERSION EXAMPLE—Continued 

Native NDC format 

Converted NDC format 

10-digit 

hyphenated 

11-digit 

converted 

(hyphenated) 

11-digit 

converted 

(unhyphenated) 

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 

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 

AGENCY: Department of State. 

ACTION: Request for comments. 

SUMMARY: 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 

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. 

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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