5760 Federal Register / Vol. 81, No. 22 / Wednesday, February 3, 2016 / Notices 

that it will take respondents 1,206 hours 

of time (67 respondents × 18 hours) to 

gather, copy, and submit brief 

statements about the product, a 

description of the details of the 

anticipated meeting, and data and 

information that generally would 

already have been generated for the 

planned research and/or product 

development. 

The total number of burden hours for 

this collection of information is 1,876 

hours (670 hours to prepare and submit 

meeting requests and 1,206 hours to 

prepare and submit information 

packages). 

Dated: January 29, 2016. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2016–02000 Filed 2–2–16; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2016–D–0199] 

Enforcement Policy on National Health 

Related Item Code and National Drug 

Code Numbers Assigned to Devices; 

Draft Guidance for Industry and Food 

and Drug Administration Staff; 

Availability and Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability; request 

for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the draft guidance for 

industry and FDA staff entitled 

‘‘Enforcement Policy on National Health 

Related Item Code and National Drug 

Code Numbers Assigned to Devices.’’ 

When finalized, this draft document 

will describe the Agency’s intent not to 

enforce, before September 24, 2021, the 

prohibition against providing National 

Health Related Item Code (NHRIC) or 

National Drug Code (NDC) numbers on 

device labels and device packages, with 

respect to certain finished devices 

manufactured and labeled prior to 

September 24, 2018. In addition, when 

finalized, this draft guidance will 

describe the Agency’s intent to continue 

considering requests for continued use 

of FDA labeler codes under a system for 

the issuance of unique device identifiers 

(UDIs) until September 24, 2018. This 

draft guidance is not the final version of 

the guidance nor is it in effect at this 

time. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the Agency 

considers your comments on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

either electronic or written comments 

on the draft guidance by April 4, 2016. 

ADDRESSES: You may submit comments 

as follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to http:// 

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 http://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): Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Division of Dockets 

Management, 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– 

2016–D–0199 for ‘‘Enforcement Policy 

on National Health Related Item Code 

and National Drug Code Numbers 

Assigned to Devices.’’ Received 

comments will be placed in the docket 

and, except for those submitted as 

‘‘Confidential Submissions,’’ publicly 

viewable at http://www.regulations.gov 

or at the Division of Dockets 

Management 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 

http://www.regulations.gov. Submit 

both copies to the Division of Dockets 

Management. 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: http://www.fda.gov/ 

regulatoryinformation/dockets/ 

default.htm. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to http:// 

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 Division of Dockets 

Management, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

An electronic copy of the draft 

guidance document is available for 

download from the Internet. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance. Submit written requests for a 

single hard copy of the draft guidance 

document entitled ‘‘Enforcement Policy 

on National Health Related Item Code 

and National Drug Code Numbers 

Assigned to Devices’’ to the Office of the 

Center Director, Guidance and Policy 

Development, Center for Devices and 

Radiological Health (CDRH), Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 66, Rm. 5431, 

Silver Spring, MD 20993–0002. 

Alternatively, you may submit written 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 81, No. 22 / Wednesday, February 3, 2016 / Notices 5761 

requests for a single copy of the draft 

guidance to the Office of 

Communications, Outreach, and 

Development, Center for Biologics 

Evaluation and Research (CBER), Food 

and Drug Administration, 10903 New 

Hampshire Ave. Bldg. 71, Rm. 3128, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to the 

office that you are ordering from to 

assist that office in processing your 

request. 

FOR FURTHER INFORMATION CONTACT: UDI 

Regulatory Policy Support, Center for 

Devices and Radiological Health, Food 

and Drug Administration, 10903 New 

Hampshire Ave. Bldg. 66, Rm. 3303, 

Silver Spring, MD 20993–0002, 301– 

796–5995, email: 

GUDIDSupport@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 226 of the Food and Drug 

Administration Amendments Act of 

2007 (Pub. L. 110–85) and Section 614 

of the Food and Drug Administration 

Safety and Innovation Act (Pub. L. 112– 

144) amended the Federal Food, Drug, 

and Cosmetic Act to add section 519(f) 

(21 U.S.C. 360i(f)), which directs FDA to 

issue regulations establishing a unique 

device identification system for medical 

devices along with implementation 

timeframes for certain medical devices. 

The final rule (UDI Rule), establishing 

the unique device identification system, 

was published on September 24, 2013 

(78 FR 58786). Among other 

requirements, the UDI Rule requires that 

the label and every device package of a 

medical device distributed in the United 

States bear a UDI, unless an exception 

or alternative applies (21 CFR 801.20). 

The unique device identification 

system is being phased in over seven 

years according to a series of 

compliance dates, based primarily on 

device classification. These compliance 

dates establish the dates after which 

devices placed into commercial 

distribution must bear a UDI on their 

labels and device packages as follows: 

September 24, 2014, for Class III devices 

and devices licensed under the Public 

Health Service Act (PHS Act); 

September 24, 2015, for implantable, 

life-supporting, or life-sustaining 

devices; September 24, 2016, for Class II 

devices; and September 24, 2018, for 

Class I and unclassified devices (78 FR 

58786 at 58815). 

To further the objectives of creating a 

national device identification system, 

the UDI Rule includes a provision that 

rescinds any NHRIC or NDC number, 

assigned to a medical device (21 CFR 

801.57). Under § 801.57(a), on the date 

a device is required to bear a UDI on its 

label, any NHRIC or NDC number 

assigned to that device is rescinded and 

may no longer be on the device label or 

on any device package. For a device not 

required to bear a UDI on its label, any 

NHRIC or NDC number assigned to that 

device is rescinded as of September 24, 

2018, and may no longer be on the 

device label or on any device package 

(§ 801.57(b)). 

Currently, medical devices available 

through a pharmacy and potentially 

eligible for reimbursement from payers 

are generally labeled with an 11-digit 

reimbursement number, typically using 

an NHRIC or NDC number assigned to 

the device. The draft guidance, when 

finalized, would describe the Agency’s 

intent not to enforce before September 

24, 2021, the prohibition against 

providing NHRIC and NDC numbers on 

device labels and device packages of 

finished class III devices; devices 

licensed under the PHS Act; class II 

devices; and implantable, lifesupporting or life-sustaining devices 

that are manufactured and labeled prior 

to September 24, 2018. This timeline 

would coincide with the schedule by 

which remaining class I and 

unclassified devices that do not qualify 

for an exception or alternative must bear 

a UDI on their labels and device 

packages. This enforcement policy, 

when finalized, would apply to the 

requirements under § 801.57(a) for class 

III devices; devices licensed under the 

PHS Act; class II devices; and 

implantable, life-supporting or lifesustaining devices only; it would not 

extend to any of the other requirements 

of the UDI Rule for these devices. 

FDA believes that continued 

implementation of UDI requirements 

under 21 CFR 801 subpart B and 21 CFR 

830 subpart E according to the 

scheduled compliance dates is 

important to achieving the objectives of 

the UDI Rule in a timely manner. 

However, it is not FDA’s intent to cause 

disruption to existing reimbursement, 

supply chain, and procurement 

processes, or to interfere potentially 

with patient access to treatment. We 

therefore recognize that additional time 

is appropriate for stakeholders to make 

changes to ensure that medical device 

reimbursement, supply chain, and 

procurement systems and processes will 

not depend on NHRIC and NDC 

numbers. 

Additionally, under § 801.57(c) and 

(d), a labeler may submit a request to 

FDA for continued use of a previously 

assigned FDA labeler code under a 

system for the issuance of UDIs. A 

labeler who has been assigned an FDA 

labeler code to facilitate use of NHRIC 

or NDC numbers may continue to use 

that labeler code under a system for the 

issuance of UDIs provided that such use 

is consistent with the framework of the 

issuing Agency that operates that system 

and that the labeler submits, and obtains 

FDA approval of, a request for 

continued use of the assigned labeler 

code (§ 801.57(c)). Under § 801.57(c)(2), 

the deadline to submit such a request is 

September 24, 2014. 

FDA intends to consider requests 

submitted to the Agency for continued 

use of an FDA labeler code under a 

system for the issuance of UDIs until 

September 24, 2018. In addition, FDA 

does not intend to take action against a 

labeler for incorporating a previously 

assigned FDA labeler code into its UDI 

without requesting approval to do so by 

the deadline set forth in § 801.57(c)(2), 

if that labeler submits a request that 

otherwise complies with § 801.57(c) and 

(d) by September 24, 2018. Labelers who 

have been granted continued use of an 

FDA labeler code by FDA should 

contact their FDA-accredited issuing 

Agency to incorporate the FDA labeler 

code into their UDIs. 

II. Significance of Guidance 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the current thinking of FDA 

on ‘‘Enforcement Policy on National 

Health Related Item Code and National 

Drug Code Numbers Assigned to 

Devices’’. It does not establish any rights 

for any person and is not binding on 

FDA or the public. You can use an 

alternative approach if it satisfies the 

requirements of the applicable statutes 

and regulations. 

III. Request for Comments 

FDA is seeking additional information 

on this issue. FDA is particularly 

interested in receiving information 

relating to the following question: 

• Is a time period through September 

24, 2018, an appropriate amount of 

additional time for stakeholders to 

adopt medical device reimbursement, 

supply chain, and procurement systems 

that do not depend on having NHRIC 

and NDC numbers on the device label? 

If not, why is this not an appropriate 

amount of time and how much more 

time would be reasonable? 

IV. Electronic Access 

Persons interested in obtaining a copy 

of the draft guidance may do so by 

downloading an electronic copy from 

the Internet. A search capability for all 

Center for Devices and Radiological 

Health guidance documents is available 

mstockstill on DSK4VPTVN1PROD with NOTICES

5762 Federal Register / Vol. 81, No. 22 / Wednesday, February 3, 2016 / Notices 

at http://www.fda.gov/MedicalDevices/ 

DeviceRegulationandGuidance/

GuidanceDocuments/default.htm or at 

http://www.fda.gov/BiologicsBlood

Vaccines/GuidanceCompliance

RegulatoryInformation/default.htm. 

Guidance documents are also available 

at http://www.regulations.gov. Persons 

unable to download an electronic copy 

of the draft guidance document entitled 

‘‘Enforcement Policy on National Health 

Related Item Code and National Drug 

Code Numbers Assigned to Devices’’ 

may send an email request to CDRHGuidance@fda.hhs.gov or to 

ocod@fda.hhs.gov, or by calling 1–800– 

835–4709 or 240–402–7800, to receive 

an electronic copy of the document. 

Please use the document number 

GUD1500044 to identify the guidance 

you are requesting. 

V. Paperwork Reduction Act of 1995 

This draft guidance refers to 

previously approved collections of 

information described in FDA 

regulations. These collections of 

information are subject to review by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (44 U.S.C. 3501–3520). The 

collections of information in 21 CFR 

part 801 have been approved under 

OMB control number 0910–0485, and 

the collections of information in 21 CFR 

part 830 have been approved under 

OMB control number 0910–0720. 

Dated: January 28, 2016. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2016–01892 Filed 2–2–16; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–D–0469] 

Applying Human Factors and Usability 

Engineering to Medical Devices; 

Guidance for Industry and Food and 

Drug Administration Staff; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the guidance entitled 

‘‘Applying Human Factors and Usability 

Engineering to Medical Devices.’’ FDA 

has developed this guidance document 

to assist industry in following 

appropriate human factors and usability 

engineering processes to maximize the 

likelihood that new medical devices 

will be safe and effective for the 

intended users, uses, and use 

environments. The recommendations in 

this guidance document are intended to 

support manufacturers in improving the 

design of medical devices to minimize 

potential use errors and resulting harm. 

FDA believes that these 

recommendations will enable 

manufacturers to assess and reduce risks 

associated with medical device use. 

DATES: Submit either electronic or 

written comments on this guidance at 

any time. General comments on Agency 

guidance documents are welcome at any 

time. 

ADDRESSES: You may submit comments 

as follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to http://

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 http://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): Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Division of Dockets 

Management, 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– 

2011–D–0469 for ‘‘Applying Human 

Factors and Usability Engineering to 

Medical Devices.’’ Received comments 

will be placed in the docket and, except 

for those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

http://www.regulations.gov or at the 

Division of Dockets Management 

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 

http://www.regulations.gov. Submit 

both copies to the Division of Dockets 

Management. 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: http://www.fda.gov/ 

regulatoryinformation/dockets/

default.htm. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to http://

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 Division of Dockets 

Management, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

An electronic copy of the guidance 

document is available for download 

from the Internet. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance. Submit written requests for a 

single hard copy of the guidance 

document entitled ‘‘Applying Human 

Factors and Usability Engineering to 

Medical Devices’’ to the Office of the 

Center Director, Guidance and Policy 

mstockstill on DSK4VPTVN1PROD with NOTICES