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, 59638-59639 [2016-20766]

Download as PDF 59638 Federal Register / Vol. 81, No. 168 / Tuesday, August 30, 2016 / Notices Table 1 provides our estimate of the total annual recordkeeping burden of our regulations in part 120. We base our estimate of the average burden per recordkeeping on our experience with the application of HACCP principles in food processing. We base our estimate of the number of recordkeepers on our estimate of the total number of juice manufacturing plants affected by the regulations (plants identified in our official establishment inventory plus very small apple juice and very small orange juice manufacturers). These estimates assume that every processor will prepare sanitary standard operating procedures and an HACCP plan and maintain the associated monitoring records, and that every importer will require product safety specifications. In fact, there are likely to be some small number of juice processors that, based upon their hazard analysis, determine that they are not required to have an HACCP plan under these regulations. Dated: August 25, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–20779 Filed 8–29–16; 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; Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. 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 mstockstill on DSK3G9T082PROD with NOTICES SUMMARY: VerDate Sep<11>2014 20:04 Aug 29, 2016 Jkt 238001 (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: 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): 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 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 ‘‘Confidential Submissions,’’ publicly viewable at https://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 https:// 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: https://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 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 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, E:\FR\FM\30AUN1.SGM 30AUN1 Federal Register / Vol. 81, No. 168 / Tuesday, August 30, 2016 / Notices MD 20993–0002. Send one selfaddressed 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, GUDIDSupport@fda.hhs.gov. SUPPLEMENTARY INFORMATION: mstockstill on DSK3G9T082PROD with NOTICES 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. 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 https://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/default.htm. Guidance documents are also available at https://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 CDRH-Guidance@fda.hhs.gov 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2016–N–0001] Antimicrobial Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. Notice. II. Significance of Guidance ACTION: 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 SUMMARY: VerDate Sep<11>2014 20:04 Aug 29, 2016 Jkt 238001 The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Antimicrobial Drugs Advisory Committee. The general PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 59639 function of the committee is to provide advice and recommendations to the Agency on FDA’s regulatory issues. The meeting will be open to the public. DATES: The meeting will be held on November 4, 2016, from 8:30 a.m. to 5 p.m. ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993–0002. Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: https://www.fda.gov/ AdvisoryCommittees/ AboutAdvisoryCommittees/ ucm408555.htm. FOR FURTHER INFORMATION CONTACT: Lauren D. Tesh, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993–0002, 301– 796–9001, Fax: 301–847–8533, AMDAC@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800– 741–8138 (301–443–0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency’s Web site at https:// www.fda.gov/AdvisoryCommittees/ default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. SUPPLEMENTARY INFORMATION: Agenda: The committee will discuss new drug applications 209006 and 209007, solithromycin capsules and solithromycin for injection, sponsored by Cempra Pharmaceuticals, Inc., respectively, for the proposed indication of treatment of community-acquired bacterial pneumonia. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting. Background material is available at https://www.fda.gov/ AdvisoryCommittees/Calendar/ default.htm. Scroll down to the E:\FR\FM\30AUN1.SGM 30AUN1

Agencies

[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]

-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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: 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): 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 https://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 https://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: https://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 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 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, GUDIDSupport@fda.hhs.gov.

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 https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at https://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 CDRH-Guidance@fda.hhs.gov 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

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