[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