81 FR 5760 - Enforcement Policy on National Health Related Item Code and National Drug Code Numbers Assigned to Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability and Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 22 (February 3, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 22 (February 3, 2016)
| Page Range | 5760-5762 | |
| FR Document | 2016-01892 |
[Federal Register Volume 81, Number 22 (Wednesday, February 3, 2016)] [Notices] [Pages 5760-5762] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-01892] ----------------------------------------------------------------------- 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Enforcement Policy on National Health Related Item Code and National Drug Code Numbers Assigned to Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability and Request for Comments AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the draft guidance for industry and FDA staff entitled ``Enforcement Policy on National Health Related Item Code and National Drug Code Numbers Assigned to Devices.''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 In addition, when finalized, this draft guidance will describe the Agency's intent to continue considering requests for continued use of FDA labeler codes under a system for the issuance of unique device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 This draft guidance is not the final version of the guidance nor is it in effect at this time.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on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comments on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by April 4, 2016.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 [[Page 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: [email protected]. 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 Sec. 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 (Sec. 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, life-supporting 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 Sec. 801.57(a) for class III devices; devices licensed under the PHS Act; class II devices; and implantable, life-supporting or life- sustaining 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 Sec. 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 (Sec. 801.57(c)). Under Sec. 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 Sec. 801.57(c)(2), if that labeler submits a request that otherwise complies with Sec. 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 [[Page 5762]] at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm or at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/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 [email protected] or to [email protected], 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
![5760 Federal Register / Vol. 81, No. 22 / Wednesday, February 3, 2016 / Notices
that it will take respondents 1,206 hours DATES: Although you can comment on or at the Division of Dockets
of time (67 respondents × 18 hours) to any guidance at any time (see 21 CFR Management between 9 a.m. and 4 p.m.,
gather, copy, and submit brief 10.115(g)(5)), to ensure that the Agency Monday through Friday.
statements about the product, a considers your comments on this draft • Confidential Submissions—To
description of the details of the guidance before it begins work on the submit a comment with confidential
anticipated meeting, and data and final version of the guidance, submit information that you do not wish to be
information that generally would either electronic or written comments made publicly available, submit your
already have been generated for the on the draft guidance by April 4, 2016. comments only as a written/paper
planned research and/or product ADDRESSES: You may submit comments submission. You should submit two
development. as follows: copies total. One copy will include the
The total number of burden hours for information you claim to be confidential
Electronic Submissions with a heading or cover note that states
this collection of information is 1,876
hours (670 hours to prepare and submit Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS
meeting requests and 1,206 hours to following way: CONFIDENTIAL INFORMATION.’’ The
prepare and submit information • Federal eRulemaking Portal: http:// Agency will review this copy, including
packages). www.regulations.gov. Follow the the claimed confidential information, in
instructions for submitting comments. its consideration of comments. The
Dated: January 29, 2016. Comments submitted electronically, second copy, which will have the
Leslie Kux, including attachments, to http:// claimed confidential information
Associate Commissioner for Policy. www.regulations.gov will be posted to redacted/blacked out, will be available
[FR Doc. 2016–02000 Filed 2–2–16; 8:45 am] the docket unchanged. Because your for public viewing and posted on
BILLING CODE 4164–01–P comment will be made public, you are http://www.regulations.gov. Submit
solely responsible for ensuring that your both copies to the Division of Dockets
comment does not include any Management. If you do not wish your
DEPARTMENT OF HEALTH AND confidential information that you or a name and contact information to be
HUMAN SERVICES third party may not wish to be posted, made publicly available, you can
such as medical information, your or provide this information on the cover
Food and Drug Administration anyone else’s Social Security number, or sheet and not in the body of your
confidential business information, such comments and you must identify this
[Docket No. FDA–2016–D–0199] as a manufacturing process. Please note information as ‘‘confidential.’’ Any
that if you include your name, contact information marked as ‘‘confidential’’
Enforcement Policy on National Health information, or other information that will not be disclosed except in
Related Item Code and National Drug identifies you in the body of your accordance with 21 CFR 10.20 and other
Code Numbers Assigned to Devices; comments, that information will be applicable disclosure law. For more
Draft Guidance for Industry and Food posted on http://www.regulations.gov. information about FDA’s posting of
and Drug Administration Staff; • If you want to submit a comment comments to public dockets, see 80 FR
Availability and Request for Comments with confidential information that you 56469, September 18, 2015, or access
do not wish to be made available to the the information at: http://www.fda.gov/
AGENCY: Food and Drug Administration, regulatoryinformation/dockets/
public, submit the comment as a
HHS. default.htm.
written/paper submission and in the
ACTION:Notice of availability; request manner detailed (see ‘‘Written/Paper Docket: For access to the docket to
for comments. Submissions’’ and ‘‘Instructions’’). read background documents or the
electronic and written/paper comments
SUMMARY: The Food and Drug Written/Paper Submissions received, go to http://
Administration (FDA) is announcing the Submit written/paper submissions as www.regulations.gov and insert the
availability of the draft guidance for follows: docket number, found in brackets in the
industry and FDA staff entitled • Mail/Hand delivery/Courier (for heading of this document, into the
‘‘Enforcement Policy on National Health written/paper submissions): Division of ‘‘Search’’ box and follow the prompts
Related Item Code and National Drug Dockets Management (HFA–305), Food and/or go to the Division of Dockets
Code Numbers Assigned to Devices.’’ and Drug Administration, 5630 Fishers Management, 5630 Fishers Lane, Rm.
When finalized, this draft document Lane, Rm. 1061, Rockville, MD 20852. 1061, Rockville, MD 20852.
will describe the Agency’s intent not to • For written/paper comments An electronic copy of the draft
enforce, before September 24, 2021, the submitted to the Division of Dockets guidance document is available for
prohibition against providing National Management, FDA will post your download from the Internet. See the
Health Related Item Code (NHRIC) or comment, as well as any attachments, SUPPLEMENTARY INFORMATION section for
National Drug Code (NDC) numbers on except for information submitted, information on electronic access to the
device labels and device packages, with marked and identified, as confidential, guidance. Submit written requests for a
respect to certain finished devices if submitted as detailed in single hard copy of the draft guidance
manufactured and labeled prior to ‘‘Instructions.’’ document entitled ‘‘Enforcement Policy
September 24, 2018. In addition, when Instructions: All submissions received on National Health Related Item Code
finalized, this draft guidance will must include the Docket No. FDA– and National Drug Code Numbers
mstockstill on DSK4VPTVN1PROD with NOTICES
describe the Agency’s intent to continue 2016–D–0199 for ‘‘Enforcement Policy Assigned to Devices’’ to the Office of the
considering requests for continued use on National Health Related Item Code Center Director, Guidance and Policy
of FDA labeler codes under a system for and National Drug Code Numbers Development, Center for Devices and
the issuance of unique device identifiers Assigned to Devices.’’ Received Radiological Health (CDRH), Food and
(UDIs) until September 24, 2018. This comments will be placed in the docket Drug Administration, 10903 New
draft guidance is not the final version of and, except for those submitted as Hampshire Ave., Bldg. 66, Rm. 5431,
the guidance nor is it in effect at this ‘‘Confidential Submissions,’’ publicly Silver Spring, MD 20993–0002.
time. viewable at http://www.regulations.gov Alternatively, you may submit written
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![5762 Federal Register / Vol. 81, No. 22 / Wednesday, February 3, 2016 / Notices
at http://www.fda.gov/MedicalDevices/ will be safe and effective for the 2011–D–0469 for ‘‘Applying Human
DeviceRegulationandGuidance/ intended users, uses, and use Factors and Usability Engineering to
GuidanceDocuments/default.htm or at environments. The recommendations in Medical Devices.’’ Received comments
http://www.fda.gov/BiologicsBlood this guidance document are intended to will be placed in the docket and, except
Vaccines/GuidanceCompliance support manufacturers in improving the for those submitted as ‘‘Confidential
RegulatoryInformation/default.htm. design of medical devices to minimize Submissions,’’ publicly viewable at
Guidance documents are also available potential use errors and resulting harm. http://www.regulations.gov or at the
at http://www.regulations.gov. Persons FDA believes that these Division of Dockets Management
unable to download an electronic copy recommendations will enable between 9 a.m. and 4 p.m., Monday
of the draft guidance document entitled manufacturers to assess and reduce risks through Friday.
‘‘Enforcement Policy on National Health associated with medical device use. • Confidential Submissions—To
Related Item Code and National Drug DATES: Submit either electronic or submit a comment with confidential
Code Numbers Assigned to Devices’’ written comments on this guidance at information that you do not wish to be
may send an email request to CDRH- any time. General comments on Agency made publicly available, submit your
Guidance@fda.hhs.gov or to guidance documents are welcome at any comments only as a written/paper
ocod@fda.hhs.gov, or by calling 1–800– time. submission. You should submit two
835–4709 or 240–402–7800, to receive ADDRESSES: You may submit comments copies total. One copy will include the
an electronic copy of the document. as follows: information you claim to be confidential
Please use the document number with a heading or cover note that states
GUD1500044 to identify the guidance Electronic Submissions ‘‘THIS DOCUMENT CONTAINS
you are requesting. Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The
following way: Agency will review this copy, including
V. Paperwork Reduction Act of 1995
• Federal eRulemaking Portal: http:// the claimed confidential information, in
This draft guidance refers to www.regulations.gov. Follow the its consideration of comments. The
previously approved collections of instructions for submitting comments. second copy, which will have the
information described in FDA Comments submitted electronically, claimed confidential information
regulations. These collections of including attachments, to http:// redacted/blacked out, will be available
information are subject to review by the www.regulations.gov will be posted to for public viewing and posted on
Office of Management and Budget the docket unchanged. Because your http://www.regulations.gov. Submit
(OMB) under the Paperwork Reduction comment will be made public, you are both copies to the Division of Dockets
Act of 1995 (44 U.S.C. 3501–3520). The solely responsible for ensuring that your Management. If you do not wish your
collections of information in 21 CFR comment does not include any name and contact information to be
part 801 have been approved under confidential information that you or a made publicly available, you can
OMB control number 0910–0485, and third party may not wish to be posted, provide this information on the cover
the collections of information in 21 CFR such as medical information, your or sheet and not in the body of your
part 830 have been approved under anyone else’s Social Security number, or comments and you must identify this
OMB control number 0910–0720. confidential business information, such information as ‘‘confidential.’’ Any
Dated: January 28, 2016. as a manufacturing process. Please note information marked as ‘‘confidential’’
Leslie Kux, that if you include your name, contact will not be disclosed except in
Associate Commissioner for Policy. information, or other information that accordance with 21 CFR 10.20 and other
identifies you in the body of your applicable disclosure law. For more
[FR Doc. 2016–01892 Filed 2–2–16; 8:45 am]
comments, that information will be information about FDA’s posting of
BILLING CODE 4164–01–P
posted on http://www.regulations.gov. comments to public dockets, see 80 FR
• If you want to submit a comment 56469, September 18, 2015, or access
DEPARTMENT OF HEALTH AND with confidential information that you the information at: http://www.fda.gov/
do not wish to be made available to the regulatoryinformation/dockets/
HUMAN SERVICES
public, submit the comment as a default.htm.
Food and Drug Administration written/paper submission and in the Docket: For access to the docket to
manner detailed (see ‘‘Written/Paper read background documents or the
[Docket No. FDA–2011–D–0469] electronic and written/paper comments
Submissions’’ and ‘‘Instructions’’).
received, go to http://
Applying Human Factors and Usability Written/Paper Submissions www.regulations.gov and insert the
Engineering to Medical Devices; docket number, found in brackets in the
Submit written/paper submissions as
Guidance for Industry and Food and heading of this document, into the
follows:
Drug Administration Staff; Availability • Mail/Hand delivery/Courier (for ‘‘Search’’ box and follow the prompts
AGENCY: Food and Drug Administration, written/paper submissions): Division of and/or go to the Division of Dockets
HHS. Dockets Management (HFA–305), Food Management, 5630 Fishers Lane, Rm.
ACTION: Notice. and Drug Administration, 5630 Fishers 1061, Rockville, MD 20852.
Lane, Rm. 1061, Rockville, MD 20852. An electronic copy of the guidance
SUMMARY: The Food and Drug • For written/paper comments document is available for download
Administration (FDA) is announcing the submitted to the Division of Dockets from the Internet. See the
mstockstill on DSK4VPTVN1PROD with NOTICES
availability of the guidance entitled Management, FDA will post your SUPPLEMENTARY INFORMATION section for
‘‘Applying Human Factors and Usability comment, as well as any attachments, information on electronic access to the
Engineering to Medical Devices.’’ FDA except for information submitted, guidance. Submit written requests for a
has developed this guidance document marked and identified, as confidential, single hard copy of the guidance
to assist industry in following if submitted as detailed in document entitled ‘‘Applying Human
appropriate human factors and usability ‘‘Instructions.’’ Factors and Usability Engineering to
engineering processes to maximize the Instructions: All submissions received Medical Devices’’ to the Office of the
likelihood that new medical devices must include the Docket No. FDA– Center Director, Guidance and Policy
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Document Created: 2016-02-03 00:40:23
Document Modified: 2016-02-03 00:40:23
| 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; request for comments. | |
| 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. | |
| 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: [email protected] | |
| FR Citation | 81 FR 5760 |
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