[Federal Register Volume 81, Number 168 (Tuesday, August 30, 2016)]
[Notices]
[Pages 59638-59639]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-20766]


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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; Guidance for Industry 
and Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of the guidance entitled ``Enforcement Policy on 
National Health Related Item Code and National Drug Code Numbers 
Assigned to Devices.'' This guidance describes the Agency's intent not 
to enforce 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 finished devices that are 
manufactured and labeled prior to September 24, 2021. In addition, this 
guidance describes 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) that are submitted before September 
24, 2021.

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-2016-D-0199 for ``Enforcement Policy on National Health Related 
Item Code and National Drug Code Numbers Assigned to Devices; Guidance 
for Industry and Food and Drug Administration Staff.'' 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 
``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, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5431, Silver Spring,

[[Page 59639]]

MD 20993-0002. Send one self-addressed adhesive label 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 protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of February 3, 2016, FDA announced the 
availability of ``Draft Guidance for Industry and Food and Drug 
Administration Staff: Enforcement Policy on National Health Related 
Item Code and National Drug Code Numbers Assigned to Devices'' (81 FR 
5760) (the ``Draft Guidance''). The Draft Guidance described FDA's 
intent not to enforce before September 24, 2021, the prohibition 
against providing NHRIC and NDC numbers on device labels and device 
packages of certain devices that are manufactured and labeled prior to 
September 24, 2018. Interested persons were invited to comment by April 
4, 2016.
    FDA received 13 sets of comments on the Draft Guidance, the 
majority of which commented that stakeholders, including supply chain 
participants, pharmacies, and payers, would not be able to complete the 
work to transition away from use of NHRIC and NDC numbers by September 
24, 2018. Some commenters also expressed concern that after September 
24, 2021, retailers and pharmacies would need to send some devices with 
shelf lives exceeding 3 years, and with NHRIC or NDC numbers on their 
labels or device packages, back to the device labelers.
    FDA has revised the guidance to reflect the Agency's intent not to 
enforce the prohibition against providing NHRIC and NDC numbers on 
device labels and device packages, with respect to finished devices 
that are manufactured and labeled prior to September 24, 2021. We 
expect the UDI labeling requirements will be fully implemented by 
September 24, 2021. We also believe additional time is appropriate for 
stakeholders to adopt medical device reimbursement, supply chain, and 
procurement systems, which do not depend on having an NHRIC or NDC 
number on the device label.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents 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. Electronic Access

    Persons interested in obtaining a copy of the 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 at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance 
documents are also available at http://www.regulations.gov. Persons 
unable to download an electronic copy of ``Enforcement Policy on 
National Health Related Item Code and National Drug Code Numbers 
Assigned to Devices'' may send an email request to [email protected] to receive an electronic copy of the document. 
Please use the document number GUD1500044 to identify the guidance you 
are requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found 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, subparts A and B have 
been approved under OMB control number 0910-0720.

    Dated: August 24, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-20766 Filed 8-29-16; 8:45 am]
 BILLING CODE 4164-01-P