81 FR 59638 - 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 168 (August 30, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 168 (August 30, 2016)
| Page Range | 59638-59639 | |
| FR Document | 2016-20766 |
[Federal Register Volume 81, Number 168 (Tuesday, August 30, 2016)] [Notices] [Pages 59638-59639] From the Federal Register Online [www.thefederalregister.org] [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: 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
![59638 Federal Register / Vol. 81, No. 168 / Tuesday, August 30, 2016 / Notices
Table 1 provides our estimate of the (UDIs) that are submitted before ‘‘Confidential Submissions,’’ publicly
total annual recordkeeping burden of September 24, 2021. viewable at http://www.regulations.gov
our regulations in part 120. We base our DATES: Submit either electronic or or at the Division of Dockets
estimate of the average burden per written comments on this guidance at Management between 9 a.m. and 4 p.m.,
recordkeeping on our experience with any time. General comments on Agency Monday through Friday.
the application of HACCP principles in guidance documents are welcome at any • Confidential Submissions—To
food processing. We base our estimate of time. submit a comment with confidential
the number of recordkeepers on our information that you do not wish to be
ADDRESSES: You may submit comments
estimate of the total number of juice made publicly available, submit your
as follows: comments only as a written/paper
manufacturing plants affected by the
regulations (plants identified in our Electronic Submissions submission. You should submit two
official establishment inventory plus copies total. One copy will include the
Submit electronic comments in the
very small apple juice and very small information you claim to be confidential
following way:
orange juice manufacturers). These with a heading or cover note that states
• Federal eRulemaking Portal: http://
estimates assume that every processor ‘‘THIS DOCUMENT CONTAINS
www.regulations.gov. Follow the
will prepare sanitary standard operating CONFIDENTIAL INFORMATION.’’ The
instructions for submitting comments.
procedures and an HACCP plan and Agency will review this copy, including
Comments submitted electronically,
maintain the associated monitoring the claimed confidential information, in
including attachments, to http:// its consideration of comments. The
records, and that every importer will www.regulations.gov will be posted to
require product safety specifications. In second copy, which will have the
the docket unchanged. Because your claimed confidential information
fact, there are likely to be some small comment will be made public, you are
number of juice processors that, based redacted/blacked out, will be available
solely responsible for ensuring that your for public viewing and posted on http://
upon their hazard analysis, determine comment does not include any
that they are not required to have an www.regulations.gov. Submit both
confidential information that you or a copies to the Division of Dockets
HACCP plan under these regulations. third party may not wish to be posted, Management. If you do not wish your
Dated: August 25, 2016. such as medical information, your or name and contact information to be
Leslie Kux, anyone else’s Social Security number, or made publicly available, you can
Associate Commissioner for Policy. confidential business information, such provide this information on the cover
[FR Doc. 2016–20779 Filed 8–29–16; 8:45 am] as a manufacturing process. Please note sheet and not in the body of your
BILLING CODE 4164–01–P
that if you include your name, contact comments and you must identify this
information, or other information that information as ‘‘confidential.’’ Any
identifies you in the body of your information marked as ‘‘confidential’’
DEPARTMENT OF HEALTH AND comments, that information will be will not be disclosed except in
HUMAN SERVICES posted on http://www.regulations.gov. accordance with 21 CFR 10.20 and other
• If you want to submit a comment applicable disclosure law. For more
Food and Drug Administration with confidential information that you information about FDA’s posting of
do not wish to be made available to the comments to public dockets, see 80 FR
[Docket No. FDA–2016–D–0199]
public, submit the comment as a 56469, September 18, 2015, or access
Enforcement Policy on National Health written/paper submission and in the the information at: http://www.fda.gov/
Related Item Code and National Drug manner detailed (see ‘‘Written/Paper regulatoryinformation/dockets/
Code Numbers Assigned to Devices; Submissions’’ and ‘‘Instructions’’). default.htm.
Guidance for Industry and Food and Written/Paper Submissions Docket: For access to the docket to
Drug Administration Staff; Availability read background documents or the
Submit written/paper submissions as electronic and written/paper comments
AGENCY: Food and Drug Administration, follows: received, go to http://
HHS. • Mail/Hand delivery/Courier (for www.regulations.gov and insert the
ACTION: Notice of availability. written/paper submissions): Division of docket number, found in brackets in the
Dockets Management (HFA–305), Food heading of this document, into the
SUMMARY: The Food and Drug and Drug Administration, 5630 Fishers ‘‘Search’’ box and follow the prompts
Administration (FDA or Agency) is Lane, Rm. 1061, Rockville, MD 20852. and/or go to the Division of Dockets
announcing the availability of the • For written/paper comments Management, 5630 Fishers Lane, Rm.
guidance entitled ‘‘Enforcement Policy submitted to the Division of Dockets 1061, Rockville, MD 20852.
on National Health Related Item Code Management, FDA will post your An electronic copy of the guidance
and National Drug Code Numbers comment, as well as any attachments, document is available for download
Assigned to Devices.’’ This guidance except for information submitted, from the Internet. See the
describes the Agency’s intent not to marked and identified, as confidential, SUPPLEMENTARY INFORMATION section for
enforce the prohibition against if submitted as detailed in information on electronic access to the
providing National Health Related Item ‘‘Instructions.’’ guidance. Submit written requests for a
Code (NHRIC) or National Drug Code Instructions: All submissions received single hard copy of the guidance
(NDC) numbers on device labels and must include the Docket No. FDA– document entitled ‘‘Enforcement Policy
device packages, with respect to 2016–D–0199 for ‘‘Enforcement Policy on National Health Related Item Code
mstockstill on DSK3G9T082PROD with NOTICES
finished devices that are manufactured on National Health Related Item Code and National Drug Code Numbers
and labeled prior to September 24, 2021. and National Drug Code Numbers Assigned to Devices’’ to the Office of the
In addition, this guidance describes the Assigned to Devices; Guidance for Center Director, Guidance and Policy
Agency’s intent to continue considering Industry and Food and Drug Development, Center for Devices and
requests for continued use of FDA Administration Staff.’’ Received Radiological Health, Food and Drug
labeler codes under a system for the comments will be placed in the docket Administration, 10903 New Hampshire
issuance of unique device identifiers and, except for those submitted as Ave., Bldg. 66, Rm. 5431, Silver Spring,
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![Federal Register / Vol. 81, No. 168 / Tuesday, August 30, 2016 / Notices 59639
MD 20993–0002. Send one self- Policy on National Health Related Item function of the committee is to provide
addressed adhesive label to assist that Code and National Drug Code Numbers advice and recommendations to the
office in processing your request. Assigned to Devices’’. It does not Agency on FDA’s regulatory issues. The
FOR FURTHER INFORMATION CONTACT: UDI establish any rights for any person and meeting will be open to the public.
Regulatory Policy Support, Center for is not binding on FDA or the public. DATES: The meeting will be held on
Devices and Radiological Health, Food You can use an alternative approach if November 4, 2016, from 8:30 a.m. to 5
and Drug Administration, 10903 New it satisfies the requirements of the p.m.
Hampshire Ave., Bldg. 66, Rm. 3303, applicable statutes and regulations.
ADDRESSES: FDA White Oak Campus,
Silver Spring, MD 20993–0002, 301– III. Electronic Access 10903 New Hampshire Ave., Bldg. 31
796–5995, GUDIDSupport@fda.hhs.gov. Conference Center, the Great Room (Rm.
Persons interested in obtaining a copy
SUPPLEMENTARY INFORMATION: of the guidance may do so by 1503), Silver Spring, MD 20993–0002.
downloading an electronic copy from Answers to commonly asked questions
I. Background
the Internet. A search capability for all including information regarding special
In the Federal Register of February 3, Center for Devices and Radiological accommodations due to a disability,
2016, FDA announced the availability of Health guidance documents is available visitor parking, and transportation may
‘‘Draft Guidance for Industry and Food at http://www.fda.gov/MedicalDevices/ be accessed at: http://www.fda.gov/
and Drug Administration Staff: DeviceRegulationandGuidance/ AdvisoryCommittees/
Enforcement Policy on National Health GuidanceDocuments/default.htm. AboutAdvisoryCommittees/
Related Item Code and National Drug Guidance documents are also available ucm408555.htm.
Code Numbers Assigned to Devices’’ (81 at http://www.regulations.gov. Persons FOR FURTHER INFORMATION CONTACT:
FR 5760) (the ‘‘Draft Guidance’’). The unable to download an electronic copy Lauren D. Tesh, Center for Drug
Draft Guidance described FDA’s intent of ‘‘Enforcement Policy on National Evaluation and Research, Food and
not to enforce before September 24, Health Related Item Code and National Drug Administration, 10903 New
2021, the prohibition against providing Drug Code Numbers Assigned to Hampshire Ave., Bldg. 31, Rm. 2417,
NHRIC and NDC numbers on device Devices’’ may send an email request to Silver Spring, MD 20993–0002, 301–
labels and device packages of certain CDRH-Guidance@fda.hhs.gov to receive 796–9001, Fax: 301–847–8533,
devices that are manufactured and an electronic copy of the document. AMDAC@fda.hhs.gov, or FDA Advisory
labeled prior to September 24, 2018. Please use the document number Committee Information Line, 1–800–
Interested persons were invited to GUD1500044 to identify the guidance 741–8138 (301–443–0572 in the
comment by April 4, 2016. you are requesting. Washington, DC area). A notice in the
FDA received 13 sets of comments on
IV. Paperwork Reduction Act of 1995 Federal Register about last minute
the Draft Guidance, the majority of
modifications that impact a previously
which commented that stakeholders, This guidance refers to previously announced advisory committee meeting
including supply chain participants, approved collections of information cannot always be published quickly
pharmacies, and payers, would not be found in FDA regulations. These enough to provide timely notice.
able to complete the work to transition collections of information are subject to Therefore, you should always check the
away from use of NHRIC and NDC review by the Office of Management and Agency’s Web site at http://
numbers by September 24, 2018. Some Budget (OMB) under the Paperwork www.fda.gov/AdvisoryCommittees/
commenters also expressed concern that Reduction Act of 1995 (44 U.S.C. 3501– default.htm and scroll down to the
after September 24, 2021, retailers and 3520). The collections of information in appropriate advisory committee meeting
pharmacies would need to send some 21 CFR part 801, subparts A and B have link, or call the advisory committee
devices with shelf lives exceeding 3 been approved under OMB control information line to learn about possible
years, and with NHRIC or NDC numbers number 0910–0720. modifications before coming to the
on their labels or device packages, back
Dated: August 24, 2016. meeting.
to the device labelers.
Leslie Kux, SUPPLEMENTARY INFORMATION:
FDA has revised the guidance to
reflect the Agency’s intent not to enforce Associate Commissioner for Policy. Agenda: The committee will discuss
the prohibition against providing [FR Doc. 2016–20766 Filed 8–29–16; 8:45 am] new drug applications 209006 and
NHRIC and NDC numbers on device BILLING CODE 4164–01–P 209007, solithromycin capsules and
labels and device packages, with respect solithromycin for injection, sponsored
to finished devices that are by Cempra Pharmaceuticals, Inc.,
manufactured and labeled prior to DEPARTMENT OF HEALTH AND respectively, for the proposed indication
September 24, 2021. We expect the UDI HUMAN SERVICES of treatment of community-acquired
labeling requirements will be fully bacterial pneumonia.
Food and Drug Administration
implemented by September 24, 2021. FDA intends to make background
We also believe additional time is [Docket No. FDA–2016–N–0001] material available to the public no later
appropriate for stakeholders to adopt than 2 business days before the meeting.
medical device reimbursement, supply Antimicrobial Drugs Advisory If FDA is unable to post the background
chain, and procurement systems, which Committee; Notice of Meeting material on its Web site prior to the
do not depend on having an NHRIC or AGENCY: Food and Drug Administration, meeting, the background material will
be made publicly available at the
mstockstill on DSK3G9T082PROD with NOTICES
NDC number on the device label. HHS.
ACTION: Notice. location of the advisory committee
II. Significance of Guidance meeting, and the background material
This guidance is being issued SUMMARY: The Food and Drug will be posted on FDA’s Web site after
consistent with FDA’s good guidance Administration (FDA) announces a the meeting. Background material is
practices regulation (21 CFR 10.115). forthcoming public advisory committee available at http://www.fda.gov/
The guidance represents the current meeting of the Antimicrobial Drugs AdvisoryCommittees/Calendar/
thinking of FDA on ‘‘Enforcement Advisory Committee. The general default.htm. Scroll down to the
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Document Created: 2018-02-09 11:42:15
Document Modified: 2018-02-09 11:42:15
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability. | |
| Dates | Submit either electronic or written comments on this guidance at any time. General comments on Agency guidance documents are welcome at any time. | |
| 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] | |
| FR Citation | 81 FR 59638 |
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